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Sample records for action 90-day petition

  1. 77 FR 9618 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Thermophilic Ostracod as Endangered or Threatened AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of 90-day petition finding. SUMMARY: We, the U.S. Fish and...

  2. 78 FR 69376 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List 19 Species and 3...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ...We (NMFS) announce a 90-day finding on a petition to list 19 species and 3 subpopulations of sharks as threatened or endangered under the Endangered Species Act (ESA). We find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted for 9 species: Centrophorus harrissoni, Isogomphodon oxyrhynchus, Mustelus fasciatus,......

  3. 77 FR 71757 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Phoenix...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list Phoenix dactylifera `Sphinx' (sphinx date palm) as endangered or threatened under the Endangered Species Act of 1973, as amended (Act). We find that the petition does not present substantial scientific or commercial information indicating that the petitioned action may be warranted. We find that......

  4. 78 FR 72622 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List 11 Tarantula...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-03

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 90-Day Finding... AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of petition finding and initiation of status review. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on...

  5. 77 FR 21920 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Eastern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-12

    ... a notice of a 90-day finding for the petition in the Federal Register on July 22, 1994 (59 FR 37439... warranted but precluded by other higher priority actions (60 FR 15281). At that time, a listing priority..., 2005 (70 FR 24870). On October 7, 2002, as part of an agreement regarding multiple species, the...

  6. 76 FR 12683 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Texas...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Texas Kangaroo Rat as Endangered or Threatened AGENCY: Fish and Wildlife....S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the...

  7. 77 FR 55458 - Endangered and Threatened Species; 90-Day Finding on Petition To Delist the Southern Oregon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-10

    ... these petitions was published on October 7, 2011 (76 FR 62375) and a second negative 90-day finding for the fourth petition was published on January 11, 2012 (77 FR 1668). The new petition largely..., changes in salmon landings over the past 1-2 decades, and increases in Pacific Ocean water temperature....

  8. 77 FR 43799 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Gila...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... Regional Office. On December 16, 2009 (74 FR 66866), we published a partial 90-day finding on the petition... and, therefore, less habitat available. Increased siltation may be due to historical overgrazing...

  9. 76 FR 23256 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Arapahoe...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-26

    ... published two 90-day findings, on January 6, 2009 (74 FR 419), and February 5, 2009 (74 FR 6122). The February 5, 2009 (74 FR 6122), 90-day finding concluded that the petition did not present substantial..., as critical habitat for the Preble's meadow jumping mouse (Zapus hudsonius preblei) (68 FR 37275)....

  10. 77 FR 59582 - Endangered and Threatened Wildlife; 90-Day Finding on Petitions To List the Northeastern Pacific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-28

    ...We, NMFS, announce a 90-day finding on two petitions received to list the northeastern Pacific Ocean population of great white shark (Carcharodon carcharias) as a threatened or endangered distinct population segment (DPS) under the Endangered Species Act (ESA) and to designate critical habitat concurrently with the listing. We find that the petitions and information in our files present......

  11. 77 FR 47583 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Desert...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list desert massasauga (Sistrurus catenatus edwardsii), a rattlesnake found in the southwestern United States, as endangered or threatened under the Endangered Species Act of 1973, as amended (Act), and to designate critical habitat. Based on our review, we find that the petition presents substantial......

  12. 77 FR 1900 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Humboldt...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the Humboldt marten (Martes americana humboldtensis) as endangered or threatened and designate critical habitat under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition presents substantial scientific or commercial information indicating that......

  13. 75 FR 67341 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Bay...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-02

    ... on a Petition To List the Bay Springs Salamander as Endangered AGENCY: Fish and Wildlife Service..., announce a 90-day finding on a petition to list the Bay Springs salamander (Plethodon ainsworthi) as... Springs salamander or its habitat at any time. DATES: The finding announced in this document was made...

  14. 75 FR 13068 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Berry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-18

    ...We, the U.S. Fish and Wildlife Service, announce a 90-day finding on a petition to list the Berry Cave salamander (Gyrinophilus gulolineatus) as endangered under the Endangered Species Act of 1973, as amended. Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing this species may be warranted. Therefore, with the......

  15. 75 FR 51969 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Oklahoma...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list Calopogon oklahomensis (Oklahoma grass pink orchid) as endangered or threatened under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing the plant species, C.......

  16. 75 FR 13720 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Striped...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the striped newt (Notophthalmus perstriatus) as threatened under the Endangered Species Act of 1973, as amended (Act). We find that the petition presents substantial scientific or commercial information indicating that listing the striped newt may be warranted. Therefore, with the publication of......

  17. 77 FR 4973 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the San...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-01

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the San Bernardino flying squirrel (Glaucomys sabrinus californicus) as endangered or threatened and to designate critical habitat under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition presents substantial scientific or commercial information......

  18. 77 FR 27403 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Eastern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the eastern diamondback rattlesnake (Crotalus adamanteus) as threatened under the Endangered Species Act of 1973, as amended (Act) and to designate critical habitat. Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing the......

  19. 76 FR 9309 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Sand...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ...We, the U.S. Fish and Wildlife Service, announce a 90-day finding on a petition to list the sand verbena moth, Copablepharon fuscum, as endangered or threatened under the Endangered Species Act of 1973, as amended. Based on our review, we find the petition presents substantial information indicating that listing the sand verbena moth may be warranted. Therefore, with the publication of this......

  20. 76 FR 36049 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Utah...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the Utah population of the Gila monster (Heloderma suspectum) as an endangered or a threatened distinct population segment (DPS) under the Endangered Species Act of 1973, as amended (Act), and to designate critical habitat. Based on our review, we find that the petition does not present......

  1. 77 FR 39666 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Maytenus cymosa

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ...We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the Maytenus cymosa (Caribbean mayten), a tree, as endangered or threatened under the Endangered Species Act of 1973, as amended (Act), and to designate critical habitat. Based on our review, we find that the petition does not present substantial information indicating that listing M. cymosa may......

  2. 75 FR 18782 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Thorne's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Thorne's Hairstreak Butterfly as Endangered Correction In Federal...

  3. 75 FR 42059 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Giant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... that listing the GPE may be warranted (72 FR 57273). On January 24, 2008, the petitioners filed a... presented a threat (72 FR 57273). The 2009 petition includes a letter of support from Samuel W. James... educational purposes as a potential threat to the GPE. In our October 9, 2007, 90-day finding (72 FR 57273)...

  4. 78 FR 66675 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Multiple Species of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... purposes of listing, delisting, and reclassifying a species under the ESA (``DPS Policy''; 61 FR 4722; February 7, 1996). A species, subspecies, or DPS is ``endangered'' if it is in danger of extinction... extinction risk of concern for the species at issue. To make a 90-day finding on a petition to list a...

  5. 78 FR 57611 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Alabama Shad as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... In 1997, we added Alabama shad to our Candidate Species List (62 FR 37562; July 14, 1997). At that... (49 FR 38900; October 1, 1984). In 2004, we created the Species of Concern list (69 FR 19975; April 15... published a negative 90-day finding in the Federal Register (76 FR 9320) stating that the petition did...

  6. 78 FR 29098 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Iliamna Lake Seals as a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... Vertebrate Population Segments under the ESA (DPS Policy, 61 FR 4722; February 7, 1996). This policy... species under the ESA (61 FR 4722; February 7, 1996). The policy established two criteria that must be met... Threatened Wildlife; 90-Day Finding on a Petition To List Iliamna Lake Seals as a Threatened or...

  7. 76 FR 60431 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the American...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ..., 2005, the Service issued a 90-day finding (70 FR 38849), which found that the petition presented... threatened or ] endangered was not warranted (72 FR 4967). Species Information This section is a summary of the species information presented in the Service's 2007 12-month finding (72 FR 4967),...

  8. 75 FR 52928 - Endangered and Threatened Wildlife and Plants; Notice of 90-Day Finding for a Petition to List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-30

    ...We (NMFS) received a petition to list Georgia Basin populations of China rockfish (Sebastes nebulosus) and tiger rockfish (S. nigrocinctus) as endangered or threatened species under the Endangered Species Act (ESA). We determine that the petition does not present substantial evidence to indicate that the petitioned action may be...

  9. 21 CFR 60.34 - FDA action on petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false FDA action on petitions. 60.34 Section 60.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PATENT TERM RESTORATION Due Diligence Petitions § 60.34 FDA action on petitions. (a) Within 90 days after FDA receives...

  10. 9 CFR 124.32 - APHIS action on petition.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false APHIS action on petition. 124.32 Section 124.32 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF... Diligence Petitions § 124.32 APHIS action on petition. (a) Within 90 days after APHIS receives a...

  11. 75 FR 22063 - Endangered and Threatened Wildlife and Plants; 90-day Finding on a Petition to List the Mohave...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... threatened species. At that time, the species was a category 2 candidate (November 15, 1994; 59 FR 58988... petitioned action may be warranted (60 FR 46569). Species Information The Mohave ground squirrel... occurrence and extent/ severity of predation by coyotes, house cats, common ravens, domestic dogs, and...

  12. 76 FR 62259 - Endangered and Threatened Wildlife and Plants; Partial 90-Day Finding on a Petition To List 404...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... September 27, 2011 (76 FR 59836), making substantial findings for 374 species and noting that 19 species had... 1--Previous Federal Register (FR) Notices Addressing the Petitioned Species Publication FR Citation date Action Species 59 FR 58982 11/15/1994 Endangered and Spotted frog; Threatened Rogue Creek...

  13. 76 FR 7820 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition to List the Texas Pipefish as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-11

    ... petition (74 FR 419). (The Texas pipefish is a marine fish that primarily uses seagrass habitat within... threats to the species'' (74 FR 419). With respect to application of the listing factors in ESA section 4... action may be warranted for the Texas pipefish (74 FR 419; January 6, 2009). ESA Statutory and...

  14. 75 FR 19925 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List a Distinct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-16

    ... Fish and Wildlife Service 50 CFR Part 17 Endangered and Threatened Wildlife and Plants; 90-Day Finding... 90-day finding (56 FR 1159) indicating that the fisher in the Pacific States is a distinct population... habitat needs, population size and trends, and demographic parameters (56 FR 1159). On December 29,...

  15. 78 FR 10601 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition to List 44 Species of Corals as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-14

    ... National Oceanic and Atmospheric Administration RIN 0648-XC209 Endangered and Threatened Wildlife; 90-Day... Species Act AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric... temperature, availability of hard substrate, currents and sediment load, and seawater chemistry...

  16. 76 FR 18701 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Peary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-05

    ... on a Petition To List the Peary Caribou and Dolphin and Union Population of the Barren-Ground Caribou...-day finding on a petition to list the Peary (Rangifer tarandus pearyi) and the Dolphin and Union... caribou (R. t. pearyi) and the Dolphin and Union population of the barren- ground caribou (R....

  17. 76 FR 46238 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Straight...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ... petition does not present substantial information indicating that listing either of the species may be... in response to this petition. However, we ask the public to submit to us any new information that may... Office, 1387 South Vinnell Way, Room 368, Boise, ID 83709. Please submit any new information,...

  18. 75 FR 1567 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Eastern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-12

    ... September 9, 2009 (74 FR 46401). In that finding, we found that the petition presented substantial... commercial, recreational, scientific, or educational purposes; c) Disease or predation; d) The inadequacy...

  19. 75 FR 35746 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Honduran...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-23

    ..., scientific, or educational purposes; (c) Disease or predation; (d) The inadequacy of existing regulatory..., recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing.... Overutilization for Commercial, Recreational, Scientific, or Educational Purposes The petition does not...

  20. 76 FR 10299 - Endangered and Threatened Wildlife and Plants: 90-Day Finding on a Petition To List the Wild...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-24

    ... completed a 90-day finding on August 15, 2007 (72 FR 45717). Based upon the information available at that... FR 54707), for the Arctic grayling (Thymallus arcticus) and a 12-month finding published on September 22, 2010, for the plant Agave eggersiana (75 FR 57720), we have focused on wild populations in...

  1. 78 FR 23533 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist the Wood Bison

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-19

    ... February 8, 2011 (76 FR ] 6734). Please refer to that document for the complete listing history. Here we... Wildlife, which was published in the Federal Register on June 2, 1970 (35 FR 8491). In 1974, the first list... of Wild Fauna and Flora (CITES). In a 90-day finding published on November 25, 1998 (63 FR 65164),...

  2. 76 FR 61531 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List 10 Subspecies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... candidate species (49 FR 21664). This subspecies is currently known as Euphilotes pallescens mattonii. This subspecies was again included in our Category 2 candidate list for November 21, 1991 (56 FR 58804), at which..., 1994 list (59 FR 58982). Please see Table 1. ] Table 1--Petitioned Great Basin Butterflies, With...

  3. 78 FR 21086 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Two...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... Policy) (61 FR 4722; February 7, 1996). Under our DPS Policy, we analyze three elements prior to making a... threatened?) (61 FR 4722). This finding considers whether the petitioned Oregon Cascades-California... control of exploitation, management of habitat, conservation status, or regulatory mechanisms exist (61...

  4. 76 FR 67652 - Listing Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... candidate species (69 FR 19976; April 15, 2004). Within 12 months of the receipt of the petition (August 5... warranted, we will determine whether any populations of these species meet the DPS policy criteria (61 FR... regarding listings under the ESA, including a policy for peer review of scientific data (59 FR 34270)....

  5. 75 FR 21568 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Harlequin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... on a Petition to List the Harlequin Butterfly as Endangered AGENCY: Fish and Wildlife Service... butterfly (Atlantea tulita), a butterfly endemic to Puerto Rico, as endangered under the Endangered Species... butterfly may be warranted. Therefore, with the publication of this notice, we are initiating a review...

  6. 76 FR 20613 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Spring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... and Threatened Wildlife and Plants (56 FR 58804, November 21, 1991; 59 FR 58982, November 15, 1994... Review (61 FR 7595), we adopted a single category of candidate species defined as follows: ``Those... on a Petition To List Spring Mountains Acastus Checkerspot Butterfly as Endangered AGENCY: Fish...

  7. 76 FR 25660 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition to Revise Critical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ... the petitioned revision may be warranted (75 FR 41436, July 16, 2010). Under the ESA, NMFS, and USFWS.... The petitioner also cited the proposed Pacific leatherback critical habitat (75 FR 319; January 5... Sea Turtle Under the Endangered Species Act AGENCY: National Marine Fisheries Service (NMFS),...

  8. 77 FR 47003 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on Petitions To List the Two Spring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... Spring Mountains Dark Blue Butterflies Petition On November 21, 1991 (56 FR 58804), we added Euphilotes... FR 58982). ] In the February 28, 1996, Candidate Notice of Review (CNOR) (61 FR 7595), we adopted a... list of candidate species as a Category 2 candidate species (54 FR 554-579). Morand's...

  9. 76 FR 50971 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Leona's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... encroachment, and fire (Xerces Society for Invertebrate Conservation 2010, pp. 10-11). The petition recognizes... the Leona's little blue butterfly habitat (Xerces Society for Invertebrate Conservation 2010, p. 11... equipment operations to the Leona's little blue butterfly habitat (Xerces Society for...

  10. 77 FR 52301 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Prince of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... on a Petition To List the Prince of Wales Flying Squirrel as Threatened or Endangered AGENCY: Fish... flying squirrel (Glaucomys sabrinus griseifrons) as an endangered or threatened species under the... status of, or threats to, the Prince of Wales flying squirrel or its habitat at any time. DATES:...

  11. 76 FR 67401 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List All...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ..., 2011, notice (76 FR 54423) for more details. FOR FURTHER INFORMATION CONTACT: Janine Van Norman, Chief...-8339. SUPPLEMENTARY INFORMATION: On September 1, 2011, we published in the Federal Register (76 FR... on a Petition To List All Chimpanzees (Pan troglodytes) as Endangered AGENCY: Fish and...

  12. 75 FR 838 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition to List Atlantic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... Vertebrate Population Segments under the Endangered Species Act (61 FR 4722; February 7, 1996). This policy... Species The most recent status review of Atlantic sturgeon was completed in 2007 (72 FR 15865; April 3... important factors contributing to the continued decline of this species. The petition also cites...

  13. 75 FR 1744 - Endangered and Threatened Wildlife and Plants; Partial 90-Day Finding on a Petition to List 475...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ... Request for Information section in our original notice--74 FR 66865--for more information). FOR FURTHER... endangered under the Act (16 U.S.C. 1531 et seq.) (74 FR 66865). We found that the petition presented..., see our original notice at 74 FR 66865. Sara Prigan, Federal Register Liaison. BILLING CODE 4310-55-P...

  14. 75 FR 50739 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Brian Head...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... be warranted (74 FR 6122). That finding included the Brian Head mountainsnail in a table of species... Forest Guardians (now WildEarth Guardians) requesting that the Service: (1) Consider for listing all full... a petition from WildEarth Guardians dated June 12, 2008, to emergency list 32 species including...

  15. 76 FR 10310 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-24

    ... petition finding (59 FR 28741), we determined that, although the S. adiaste adiaste may be declining... by nonnative plants, livestock grazing, and over- collection (December 5, 1997, 62 FR 64306, pp... butterflies. The primary threat to the Callippe (62 FR 64306), Behren's (62 FR 64306), Myrtle's (June 22,...

  16. 75 FR 39656 - Listing Endangered and Threatened Wildlife and Plants; 90-Day Finding on Petitions to List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-12

    ... describing what constitutes a DPS of a taxonomic species (61 FR 4722; February 7, 1996). The joint DPS policy...,'' specifically pointing out hypercapnia, an increase in the amount of carbon dioxide in the tissues (Fabry et al., 2008). As noted in the HSUS petition, Fabry et al. (2008) indicates that increases in carbon...

  17. 77 FR 51763 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Queen Conch as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ..., delisting, and reclassifying a species under the ESA (``DPS Policy''; 61 FR 4722; February 7, 1996). A... ESA, including a policy for peer review of scientific data (59 FR 34270). The intent of the peer... critical habitat. The petition states that the species is declining and threatened with extinction due...

  18. 77 FR 1668 - Endangered and Threatened Species; 90-Day Finding on Petition To Delist the Southern Oregon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ... published in the Federal Register on October 7, 2011 (76 FR 62375). The current petition largely reiterates... Unit of Coho Salmon Under the Endangered Species Act AGENCY: National Marine Fisheries Service (NMFS... California Coast (SONCC) Evolutionarily Significant Unit (ESU) of coho salmon (Oncorhynchus kisutch)...

  19. 76 FR 7528 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Revise Critical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-10

    ... February 10, 2006 (71 FR 7119- 7120, 7153, 7194). The petition requested that, pursuant to the Act, the..., on September 19, 1994 (59 FR 48136). Critical habitat for 4 vernal pool crustaceans and 11 vernal... August 6, 2003 (68 FR 46684). The 2003 final critical habitat for the 4 vernal pool crustaceans and...

  20. 76 FR 12308 - Listing Endangered and Threatened Species: 90-Day Finding on a Petition to List Six Species of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-07

    ... Threatened Species Under the Endangered Species Act AGENCY: National Marine Fisheries Service (NMFS... received a petition from the Center for Marine Conservation (now the Ocean Conservancy) requesting that we....S. DPS of smalltooth sawfish as endangered on April 1, 2003 (68 FR 15674). Smalltooth sawfish...

  1. 75 FR 48914 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to Delist the Tiger...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ... 1969 (ESCA) (35 FR 6069, April 14, 1970). We finalized this action on June 2, 1970 (35 FR 8491), but... under Appendix A of the ``U.S. List of Endangered Foreign Fish and Wildlife'' (37 FR 6476, March 30...). On January 4, 1974, we categorized the tiger as endangered foreign wildlife under 50 CFR 17.11 (39...

  2. 75 FR 42033 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Pinus albicaulis

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... published in the Federal Register on January 27, 1994 (59 FR 3824). Species Information Pinus albicaulis is... soil erosion by physically stabilizing soils, initiating succession as a hardy pioneer or as an early... listing actions (e.g., 75 FR 13910, March 23, 2010). The petitioner also cites several other models...

  3. 75 FR 30313 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Castanea pumila

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... Federal Action On July 1, 1975 (40 FR 27924), Castanea pumila var. ozarkensis was included as one of the... as an endangered species under the Act in 1976 (41 FR 17 24524). We, however, did not finalize that... candidate on December 15, 1980 (45 FR 82480 82569). It was again advertised as a category 2 candidate...

  4. 76 FR 38095 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Eastern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... Federal Actions On September 18, 1985 (50 FR 37958), November 21, 1991 (56 FR 58804), and November 15, 1994 (59 FR 58982), the Service issued Notices of Review identifying the eastern small-footed bat as a ``category-2 candidate'' for listing under the Act. However, on December 5, 1996 (50 FR 64481), the...

  5. 90-Day Cycle Handbook

    ERIC Educational Resources Information Center

    Park, Sandra; Takahashi, Sola

    2013-01-01

    90-Day Cycles are a disciplined and structured form of inquiry designed to produce and test knowledge syntheses, prototyped processes, or products in support of improvement work. With any type of activity, organizations inevitably encounter roadblocks to improving performance and outcomes. These barriers might include intractable problems at…

  6. 29 CFR 37.80 - What happens if a recipient fails to issue a Notice of Final Action within 90 days of the date on...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true What happens if a recipient fails to issue a Notice of Final Action within 90 days of the date on which a complaint was filed? 37.80 Section 37.80 Labor Office of the Secretary of Labor IMPLEMENTATION OF THE NONDISCRIMINATION AND EQUAL OPPORTUNITY PROVISIONS OF THE WORKFORCE INVESTMENT ACT OF 1998...

  7. 29 CFR 37.79 - If, before the 90-day period has expired, a recipient issues a Notice of Final Action with which...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 1 2010-07-01 2010-07-01 true If, before the 90-day period has expired, a recipient issues a Notice of Final Action with which the complainant is dissatisfied, how long does the complainant have to file a complaint with the Director? 37.79 Section 37.79 Labor Office of the Secretary of Labor IMPLEMENTATION OF THE NONDISCRIMINATION...

  8. 29 CFR 102.125 - Action on petition.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 2 2010-07-01 2010-07-01 false Action on petition. 102.125 Section 102.125 Labor Regulations Relating to Labor NATIONAL LABOR RELATIONS BOARD RULES AND REGULATIONS, SERIES 8 Amendments § 102.125 Action on petition. Upon the filing of such petition, the Board shall consider the same and...

  9. 77 FR 37836 - Petition Requesting Commission Action Regarding Crib Bumpers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II Petition Requesting Commission Action Regarding Crib Bumpers AGENCY: U.S. Consumer Product Safety Commission. ACTION: Petition for rulemaking. SUMMARY: The U.S. Consumer...

  10. 77 FR 19755 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the San...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ..., we published a 90-day finding (58 FR 36184) in the Federal Register that the petition contained... FR 869) on the petition to list the longfin smelt. We determined that the petitioned action was not... FR 24911) in which we concluded that the petition provided substantial information indicating...

  11. 22 CFR 1422.4 - Investigation of petition and posting of notice of petition; action by Regional Director.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of petition; action by Regional Director. 1422.4 Section 1422.4 Foreign Relations FOREIGN SERVICE... petition and posting of notice of petition; action by Regional Director. (a) Upon the request of the... recognition or certification; and (4) A statement that all interested parties are to advise the...

  12. 22 CFR 1422.4 - Investigation of petition and posting of notice of petition; action by Regional Director.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of petition; action by Regional Director. 1422.4 Section 1422.4 Foreign Relations FOREIGN SERVICE... petition and posting of notice of petition; action by Regional Director. (a) Upon the request of the... recognition or certification; and (4) A statement that all interested parties are to advise the...

  13. 22 CFR 1422.4 - Investigation of petition and posting of notice of petition; action by Regional Director.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of petition; action by Regional Director. 1422.4 Section 1422.4 Foreign Relations FOREIGN SERVICE... petition and posting of notice of petition; action by Regional Director. (a) Upon the request of the... recognition or certification; and (4) A statement that all interested parties are to advise the...

  14. 22 CFR 1422.4 - Investigation of petition and posting of notice of petition; action by Regional Director.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... of petition; action by Regional Director. 1422.4 Section 1422.4 Foreign Relations FOREIGN SERVICE... petition and posting of notice of petition; action by Regional Director. (a) Upon the request of the... recognition or certification; and (4) A statement that all interested parties are to advise the...

  15. 22 CFR 1422.4 - Investigation of petition and posting of notice of petition; action by Regional Director.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of petition; action by Regional Director. 1422.4 Section 1422.4 Foreign Relations FOREIGN SERVICE... petition and posting of notice of petition; action by Regional Director. (a) Upon the request of the... recognition or certification; and (4) A statement that all interested parties are to advise the...

  16. 14 CFR 221.600 - Actions under assigned authority and petitions for review of staff action.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of Transportation's Regulations, 14 CFR 385.13, such actions shall be understood to include the... Transportation in its Organization Regulations, 14 CFR 385.13. Persons entitled to petition for review of this action pursuant to the Department's Regulations, 14 CFR 385.50, may file such petitions within seven...

  17. 14 CFR 221.600 - Actions under assigned authority and petitions for review of staff action.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... of Transportation's Regulations, 14 CFR 385.13, such actions shall be understood to include the... Transportation in its Organization Regulations, 14 CFR 385.13. Persons entitled to petition for review of this action pursuant to the Department's Regulations, 14 CFR 385.50, may file such petitions within seven...

  18. 14 CFR 221.600 - Actions under assigned authority and petitions for review of staff action.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... of Transportation's Regulations, 14 CFR 385.13, such actions shall be understood to include the... Transportation in its Organization Regulations, 14 CFR 385.13. Persons entitled to petition for review of this action pursuant to the Department's Regulations, 14 CFR 385.50, may file such petitions within seven...

  19. 14 CFR 221.600 - Actions under assigned authority and petitions for review of staff action.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... of Transportation's Regulations, 14 CFR 385.13, such actions shall be understood to include the... Transportation in its Organization Regulations, 14 CFR 385.13. Persons entitled to petition for review of this action pursuant to the Department's Regulations, 14 CFR 385.50, may file such petitions within seven...

  20. 15 CFR 2016.1 - Action following receipt of petitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 15 Commerce and Foreign Trade 3 2010-01-01 2010-01-01 false Action following receipt of petitions. 2016.1 Section 2016.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... COUNTRY ELIGIBILITY OR DUTY-FREE TREATMENT UNDER THE ANDEAN TRADE PREFERENCE ACT (ATPA), AS AMENDED §...

  1. 49 CFR 228.107 - Action on petition.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... accordance with the provisions of part 211, title 49, CFR, concerning the processing of requests for special..., DEPARTMENT OF TRANSPORTATION HOURS OF SERVICE OF RAILROAD EMPLOYEES; RECORDKEEPING AND REPORTING; SLEEPING QUARTERS Construction of Railroad-Provided Sleeping Quarters § 228.107 Action on petition. (a)...

  2. 49 CFR 228.107 - Action on petition.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... accordance with the provisions of part 211, title 49, CFR, concerning the processing of requests for special..., DEPARTMENT OF TRANSPORTATION HOURS OF SERVICE OF RAILROAD EMPLOYEES; RECORDKEEPING AND REPORTING; SLEEPING QUARTERS Construction of Railroad-Provided Sleeping Quarters § 228.107 Action on petition. (a)...

  3. 49 CFR 228.107 - Action on petition.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... accordance with the provisions of part 211, title 49, CFR, concerning the processing of requests for special..., DEPARTMENT OF TRANSPORTATION HOURS OF SERVICE OF RAILROAD EMPLOYEES; RECORDKEEPING AND REPORTING; SLEEPING QUARTERS Construction of Railroad-Provided Sleeping Quarters § 228.107 Action on petition. (a)...

  4. 15 CFR 2016.1 - Action following receipt of petitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 15 Commerce and Foreign Trade 3 2014-01-01 2014-01-01 false Action following receipt of petitions. 2016.1 Section 2016.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... COUNTRY ELIGIBILITY OR DUTY-FREE TREATMENT UNDER THE ANDEAN TRADE PREFERENCE ACT (ATPA), AS AMENDED §...

  5. 15 CFR 2016.1 - Action following receipt of petitions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 3 2013-01-01 2013-01-01 false Action following receipt of petitions. 2016.1 Section 2016.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... COUNTRY ELIGIBILITY OR DUTY-FREE TREATMENT UNDER THE ANDEAN TRADE PREFERENCE ACT (ATPA), AS AMENDED §...

  6. 15 CFR 2016.1 - Action following receipt of petitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Action following receipt of petitions. 2016.1 Section 2016.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... COUNTRY ELIGIBILITY OR DUTY-FREE TREATMENT UNDER THE ANDEAN TRADE PREFERENCE ACT (ATPA), AS AMENDED §...

  7. 15 CFR 2016.1 - Action following receipt of petitions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 15 Commerce and Foreign Trade 3 2012-01-01 2012-01-01 false Action following receipt of petitions. 2016.1 Section 2016.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... COUNTRY ELIGIBILITY OR DUTY-FREE TREATMENT UNDER THE ANDEAN TRADE PREFERENCE ACT (ATPA), AS AMENDED §...

  8. 49 CFR 552.8 - Notification of agency action on the petition.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 6 2010-10-01 2010-10-01 false Notification of agency action on the petition. 552... HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PETITIONS FOR RULEMAKING, DEFECT, AND NONCOMPLIANCE ORDERS General § 552.8 Notification of agency action on the petition. After considering...

  9. 40 CFR 78.6 - Action on petition for administrative review.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 17 2013-07-01 2013-07-01 false Action on petition for administrative review. 78.6 Section 78.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) APPEAL PROCEDURES § 78.6 Action on petition for administrative review. (a) If...

  10. 76 FR 33309 - Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... (74 FR 3611), FDA announced the availability of a draft version of this guidance and provided... Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability... and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic...

  11. 78 FR 48641 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ..., WC Docket No. 10-90, Report and Order, FCC 13-73, published at 78 FR 38227, June 26, 2013 and... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS... Communications Commission. ACTION: Petition for reconsideration. SUMMARY: In this document, a Petition...

  12. 76 FR 24846 - Petition for Reconsideration of Action of Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ...In this document, a Petition for Reconsideration (Petition) has been filed in the Commission's Rulemaking proceeding listed below by Kona Coast Radio, LLC (``Kona Coast''), seeking reconsideration of actions taken in a Report and Order in Kahuku and Kualapuu, Hawaii. In the Report and Order, the Media Bureau (the Bureau) allotted FM Channel 296C2 at Kualapuu, Hawaii, and granted the proposal......

  13. 75 FR 77872 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Petition for Reconsideration of Action in Rulemaking Proceeding December 3, 2010. A Petition for Reconsideration has been filed in the Commission's Rulemaking proceeding listed in this document and published pursuant to 47 CFR 1.429(e)....

  14. 75 FR 77872 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Petition for Reconsideration of Action in Rulemaking Proceeding December 1, 2010. A Petition for Reconsideration has been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR...

  15. 75 FR 39945 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Petition for Reconsideration of Action in Rulemaking Proceeding June 7, 2010. Petition for Reconsideration has been filed in the Commission's Rulemaking Proceeding listed in this Public Notice and published pursuant to 47 CFR 1.429(e). The...

  16. 76 FR 7208 - Petitions for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Petitions for Reconsideration of Action in Rulemaking Proceeding February 2, 2011. Petitions for Reconsideration have been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR...

  17. 22 CFR 42.43 - Suspension or termination of action in petition cases.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 22 Foreign Relations 1 2012-04-01 2012-04-01 false Suspension or termination of action in petition cases. 42.43 Section 42.43 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Petitions § 42.43 Suspension or...

  18. 22 CFR 42.43 - Suspension or termination of action in petition cases.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 22 Foreign Relations 1 2014-04-01 2014-04-01 false Suspension or termination of action in petition cases. 42.43 Section 42.43 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Petitions § 42.43 Suspension or...

  19. 22 CFR 42.43 - Suspension or termination of action in petition cases.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 22 Foreign Relations 1 2011-04-01 2011-04-01 false Suspension or termination of action in petition cases. 42.43 Section 42.43 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Petitions § 42.43 Suspension or...

  20. 22 CFR 42.43 - Suspension or termination of action in petition cases.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 22 Foreign Relations 1 2013-04-01 2013-04-01 false Suspension or termination of action in petition cases. 42.43 Section 42.43 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Petitions § 42.43 Suspension or...

  1. 22 CFR 42.43 - Suspension or termination of action in petition cases.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Suspension or termination of action in petition cases. 42.43 Section 42.43 Foreign Relations DEPARTMENT OF STATE VISAS VISAS: DOCUMENTATION OF IMMIGRANTS UNDER THE IMMIGRATION AND NATIONALITY ACT, AS AMENDED Petitions § 42.43 Suspension or...

  2. 75 FR 63475 - Petitions for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Petitions for Reconsideration of Action in Rulemaking Proceeding September 23, 2010. Petitions for Reconsideration have been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR...

  3. 75 FR 39633 - Extension of Deadline for Action on Section 126 Petition From New Jersey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-12

    ...The EPA is extending by 6 months the deadline for EPA to take action on a petition submitted by the New Jersey Department of Environmental Protection (NJDEP). The petition requests that EPA make a finding under the Clean Air Act (CAA) that the coal-fired Portland Generating Station in Upper Mount Bethel Township, Northampton County, Pennsylvania, is emitting air pollutants in violation of the......

  4. 40 CFR 799.9346 - TSCA 90-day inhalation toxicity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 33 2013-07-01 2013-07-01 false TSCA 90-day inhalation toxicity. 799.9346 Section 799.9346 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC SUBSTANCES CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS Health Effects Test Guidelines...

  5. 49 CFR Appendix A to Part 553 - Statement of Policy: Action on Petitions for Reconsideration

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... policy of the National Highway Traffic Safety Administration to issue notice of the action taken on a... 49 Transportation 6 2010-10-01 2010-10-01 false Statement of Policy: Action on Petitions for...) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RULEMAKING PROCEDURES Pt....

  6. 49 CFR Appendix A to Part 553 - Statement of Policy: Action on Petitions for Reconsideration

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Reconsideration A Appendix A to Part 553 Transportation Other Regulations Relating to Transportation (Continued..., App. A Appendix A to Part 553—Statement of Policy: Action on Petitions for Reconsideration It is the policy of the National Highway Traffic Safety Administration to issue notice of the action taken on...

  7. 15 CFR 2006.0 - Submission of petitions requesting action under section 301.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 3 2011-01-01 2011-01-01 false Submission of petitions requesting action under section 301. 2006.0 Section 2006.0 Commerce and Foreign Trade Regulations Relating to... FOR ACTION UNDER SECTION 301 OF THE TRADE ACT OF 1974, AS AMENDED § 2006.0 Submission of...

  8. 40 CFR 78.6 - Action on petition for administrative review.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Action on petition for administrative review. 78.6 Section 78.6 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... Appeals Board will issue an order under § 78.20(c) of this part. (b)(1) The Environmental Appeals...

  9. 21 CFR 1316.93 - Ruling on petition for expedited release in an administrative forfeiture action.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Ruling on petition for expedited release in an administrative forfeiture action. 1316.93 Section 1316.93 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Expedited Forfeiture Proceedings for Certain Property § 1316.93 Ruling...

  10. 78 FR 26739 - Notice of Final Action on Petition From Earthjustice To List Coal Mines as a Source Category and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... AGENCY 40 CFR Part 63 Notice of Final Action on Petition From Earthjustice To List Coal Mines as a Source Category and To Regulate Air Emissions From Coal Mines AGENCY: Environmental Protection Agency (EPA..., the Acting EPA Administrator, Bob Perciasepe, signed a letter denying a petition to add coal mines...

  11. 77 FR 42238 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Six Sand...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-18

    ... 1973, as amended (Act). In our 90- day finding on this petition (76 FR 47123, August 4, 2011), we... Mountain serican scarab, may be warranted (76 FR 47123, August 4, 2011). Therefore, no further action is... off-road vehicle (ORV) use (43 FR 35636). The Service stated that ORV activity compacts dead...

  12. 76 FR 62213 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Mohave...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... that time, the species was a category 2 candidate (November 15, 1994; 59 FR 58982), and was first... action may be warranted (60 FR 46569). On September 5, 2005, we received a petition, dated August 30... CFR 424.14(a). On April 27, 2010, the Service made its 90-day finding (75 FR 22063), concluding...

  13. Baroreflex Sensitivity Decreases During 90-Day Bed Rest

    NASA Technical Reports Server (NTRS)

    Stenger, M. B.; Arzeno, N. M.; Platts, S. H.

    2008-01-01

    Baroreflex sensitivity (BRS) decreases during spaceflight and simulated spaceflight (head down bed rest [BR]). However, previous studies have only examined BRS in response to a limited blood pressure (BP) range or to a single sudden change in BP. PURPOSE: The purpose of this study was to examine BRS during 90 days of 6deg head-down tilt BR over a broad range of BP perturbations. METHODS: Nineteen normal volunteers (12M, 7F) were tested one day before BR, and then near BR days 30, 60 and 90. BP was pharmacologically altered by continuous infusions of phenylephrine (PE) and sodium nitroprusside (SNP). Electrocardiogram and continuous BP were collected during 10 min of normal saline (NS), followed by increasing concentrations of PE (10 min each of 0.4, 0.8 and 1.6 micro-g/kg/min). After a 20 min break, NS was infused again for 10 min, followed by increasing concentrations of SNP (10 min each of 0.4, 0.8, 1.2 micro-g/kg/min). Baroreceptor sensitivity was measured as the slope of a sequence of 3 or more beats in which the systolic BP and following R-R interval (RR) both increased or decreased. Spectral heart rate variability (HRV) and mean RR were analyzed using data from only the NS infusions. Two-way repeated-measures analysis of variance was performed to examine the effects of BR and gender. RESULTS: RR decreased (p<0.001) from pre- BR across BR days. High frequency in normalized units, a measure of parasympathetic activity, decreased with BR (p=0.027) and was lower (p=0.046) in men (0.39+/-0.02, mean+/-SEM) than women (0.48+/-0.02). The spontaneous baroreflex slope, our measure of BRS, increased with PE and decreased with SNP across BR (p<0.001). The percentage decrease in BRS from pre- to post-BR appeared to be larger in women (43.6+/-7.0%) than in men (31.3+/-3.9%, p=0.06). CONCLUSION: Parasympathetic activity and baroreflex sensitivity decrease during 90 days of BR, and BRS tends to diminish more in women than in men.

  14. 90-Day toxicity study of dichloroacetate in dogs.

    PubMed

    Cicmanec, J L; Condie, L W; Olson, G R; Wang, S R

    1991-08-01

    Male and female juvenile beagle dogs were dosed daily for 90 days with dichloroacetate (DCA). The compound was administered orally via gelatin capsules at doses of 0, 12.5, 39.5, and 72 mg/kg/day. Each dose group consisted of five males and five females. The dogs were observed clinically and blood samples were taken at 15-day intervals for hematologic and serum chemistry values. Decreased total erythrocyte count and hemoglobin levels were observed in mid- and high-dose dogs beginning at Day 30. Serum concentrations of LDH were elevated at Days 30 and 45 in females and at Day 75 in males treated with DCA at 72 mg/kg/day. One female of the high-dose group died at Day 50 and two high-dose males died at Days 51 and 74. Hindlimb partial paralysis was observed in many high-dose dogs. Vacuolization of myelinated white tracts of cerebrum, cerebellum, and/or spinal cord was observed in many high-dose dogs as well as some mid- and low-dose subjects. Degeneration of testicular germinal epithelium and syncytial giant cell formation was noted in males of all dose groups. Hepatic vacuolar change and chronic hepatitis appeared only in DCA-treated dogs. In addition, suppurative bronchopneumonia and chronic pancreatitis were noted in many high-dose and some middose subjects. A "no-adverse-effect level" was not determined in this study. PMID:1765225

  15. 17 CFR 171.41 - Petition for a stay of effective date of a member responsibility action pending a hearing by the...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... fundamental fairness; and (2) The likelihood that the denial of the petition would result in irreparable harm... Association unless, in its view, expedited action on the petition is necessary to protect petitioner's right to a meaningful determination of the right to a stay. If the Commission grants the petition prior...

  16. 49 CFR 228.107 - Action on petition.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...). If individual air conditioning and heating systems are to be utilized, projections may relate to... the Railroad Safety Board for action in accordance with the provisions of part 211, title 49,...

  17. 50 CFR 424.14 - Petitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... a petition within 30 days. (b) Petitions to list, delist, or reclassify species. (1) To the maximum extent practicable, within 90 days of receiving a petition to list, delist, or reclassify a species, the... to list, delist, or reclassify species, and (B) Expeditious progress is being made to list,...

  18. 50 CFR 424.14 - Petitions.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... a petition within 30 days. (b) Petitions to list, delist, or reclassify species. (1) To the maximum extent practicable, within 90 days of receiving a petition to list, delist, or reclassify a species, the... to list, delist, or reclassify species, and (B) Expeditious progress is being made to list,...

  19. 50 CFR 424.14 - Petitions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... COMMERCE); ENDANGERED SPECIES COMMITTEE REGULATIONS SUBCHAPTER A LISTING ENDANGERED AND THREATENED SPECIES... a petition within 30 days. (b) Petitions to list, delist, or reclassify species. (1) To the maximum extent practicable, within 90 days of receiving a petition to list, delist, or reclassify a species,...

  20. 49 CFR 228.107 - Action on petition.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the Railroad Safety Board for action in accordance with the provisions of part 211, title 49, CFR..., DEPARTMENT OF TRANSPORTATION HOURS OF SERVICE OF RAILROAD EMPLOYEES Construction of Employee Sleeping... available information that the proposed sleeping quarters will be so situated and constructed as to...

  1. 76 FR 11737 - Petition for Reconsideration of Action of Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ...In this document, a Petition for Reconsideration (Petition) has been filed in the Commission's Rulemaking proceeding listed in this document (Table of Allotments, FM Broadcast Stations (Pacific Junction,...

  2. 77 FR 30485 - Petitions for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-23

    ...In this document, Petitions for Reconsideration (Petitions) have been filed in the Commission's Rulemaking proceeding by the Consumer Electronics Association, Telecommunications for the Deaf and Hard of Hearing, Inc., et al., and TVGuardian,...

  3. 77 FR 25 - Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... application. Examples include: Petitions suggesting a particular method for determining the bioequivalence of... as when we are making decisions about the bioequivalence requirements for a generic drug product or... issues with the innovator drug); November 12, 2009 (publication of a draft bioequivalence guidance...

  4. 75 FR 69889 - Extension of Deadline for Action on the Second Section 126 Petition From New Jersey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... NAAQS on June 2, 2010 (75 FR 35520). Specifically, EPA established the new 1-hour SO 2 NAAQS at a level... and the ] current deadline for a response to that petition is January 12, 2011 (75 FR 39633). II... ``significant regulatory action'' under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4,...

  5. 49 CFR 24.503 - Replacement housing payment for 90-day mobile home occupants.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 1 2011-10-01 2011-10-01 false Replacement housing payment for 90-day mobile home... ASSISTANCE AND REAL PROPERTY ACQUISITION FOR FEDERAL AND FEDERALLY-ASSISTED PROGRAMS Mobile Homes § 24.503 Replacement housing payment for 90-day mobile home occupants. A displaced tenant or owner-occupant of a...

  6. 49 CFR 24.503 - Replacement housing payment for 90-day mobile home occupants.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Replacement housing payment for 90-day mobile home... ASSISTANCE AND REAL PROPERTY ACQUISITION FOR FEDERAL AND FEDERALLY-ASSISTED PROGRAMS Mobile Homes § 24.503 Replacement housing payment for 90-day mobile home occupants. A displaced tenant or owner-occupant of a...

  7. 19 CFR Annex Viii-A to Part 351 - Schedule for 90-Day Sunset Reviews

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 3 2011-04-01 2011-04-01 false Schedule for 90-Day Sunset Reviews VIII Annex VIII-A to Part 351 Customs Duties INTERNATIONAL TRADE ADMINISTRATION, DEPARTMENT OF COMMERCE ANTIDUMPING AND COUNTERVAILING DUTIES Pt. 351, Annex VIII-A Annex VIII-A to Part 351—Schedule for 90-Day...

  8. 19 CFR Annex Viii-A to Part 351 - Schedule for 90-Day Sunset Reviews

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Schedule for 90-Day Sunset Reviews VIII Annex VIII-A to Part 351 Customs Duties INTERNATIONAL TRADE ADMINISTRATION, DEPARTMENT OF COMMERCE ANTIDUMPING AND COUNTERVAILING DUTIES Pt. 351, Annex VIII-A Annex VIII-A to Part 351—Schedule for 90-Day...

  9. 49 CFR 24.503 - Replacement housing payment for 90-day mobile home occupants.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 1 2012-10-01 2012-10-01 false Replacement housing payment for 90-day mobile home occupants. 24.503 Section 24.503 Transportation Office of the Secretary of Transportation UNIFORM RELOCATION... Replacement housing payment for 90-day mobile home occupants. A displaced tenant or owner-occupant of a...

  10. 49 CFR 24.503 - Replacement housing payment for 90-day mobile home occupants.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false Replacement housing payment for 90-day mobile home occupants. 24.503 Section 24.503 Transportation Office of the Secretary of Transportation UNIFORM RELOCATION... Replacement housing payment for 90-day mobile home occupants. A displaced tenant or owner-occupant of a...

  11. 49 CFR 24.503 - Replacement housing payment for 90-day mobile home occupants.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 1 2013-10-01 2013-10-01 false Replacement housing payment for 90-day mobile home occupants. 24.503 Section 24.503 Transportation Office of the Secretary of Transportation UNIFORM RELOCATION... Replacement housing payment for 90-day mobile home occupants. A displaced tenant or owner-occupant of a...

  12. Readmission After Robot-assisted Radical Cystectomy: Outcomes and Predictors at 90-Day Follow-up

    PubMed Central

    Al-Daghmin, Ali; Aboumohamed, Ahmed; Din, Rakeeba; Khan, Aabroo; Raza, Syed Johar; Sztorc, Jenna; Mehedint, Diana; Sharif, Mohammad; Shi, Yi; Wilding, Gregory; Guru, Khurshid A.

    2015-01-01

    OBJECTIVE To characterize the outcomes and predictors of readmission after robot-assisted radical cystectomy (RARC) during early (30-day) and late (31–90–day) postoperative periods. METHODS We retrospectively evaluated our prospectively maintained RARC quality assurance database of 272 consecutive patients operated between 2005 and 2012. We evaluated the relationship of readmission with perioperative outcomes and examined possible predictors during the postoperative period. RESULTS Overall 30- and 90-day mortality was 0.7% and 4.8%, respectively, with 25.5% patients readmitted within 90 days after RARC (61% of them were readmitted within 30 days and 39% were readmitted between 31–90 days postoperatively). Infection-related problems were the most common cause of readmission during early and late periods. Overall operative time and obesity were significantly associated with readmission (P = .034 and .033, respectively). Body mass index and female gender were independent predictors of 90-day readmission (P = .004 and .014, respectively). Having any type of complication correlated with 90-day readmission (P = .0045); meanwhile, when complications were graded on the basis of Clavien grading system, only grade 1–2 complications statistically correlated with readmission (P = .046). Four patients needed reoperation (2 patients in early “for appendicitis and adhesive small bowel obstruction” and 2 in late “for ureteroenteric stricture” readmission); meanwhile, 6 patients needed percutaneous procedures (4 patients in early “1 for anastomotic leak and 3 for pelvic collections” and 2 “for pelvic collections and ureterocutaneous fistula” in late readmission). CONCLUSION The rate of readmission within 90 days after RARC is significant. Female gender and body mass index are independent predictors of readmission. Outcomes at 90 days provide more thorough results, essential to proper patient counseling. PMID:24468509

  13. 77 FR 39206 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-02

    ...In this document, Petitions for Reconsideration (Petition) have been filed in the Commission's Rulemaking proceeding by AARL, The National Association for Amateur Radio requesting that the Commission reconsider and modify the Second Report and Order governing unlicensed Broadband over Power Line (BPL)...

  14. 77 FR 53163 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-31

    ... MHz Band, Report and Order, FCC 12-55, published at 77 FR 33972, June 8, 2012 in WT Docket Nos. 11-110... of the Orange County, California Sheriff's Department. DATES: Oppositions to the Petition must...

  15. 77 FR 60343 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... of 1991, Petition for Reconsideration of SatCom Marketing LLC, Report and Order, published at 77 FR... Engagement, and Anthony S. Mendoza, Esq. on behalf of SatCom Marketing, LLC. DATES: Oppositions to...

  16. SUBCHRONIC 90-DAY TOXICITY OF DICHLOROACETIC AND TRICHLORACETIC ACID IN RATS

    EPA Science Inventory

    Male Sprague-Dawley rats were treated with either dichloroacetic acid (DCA) or trichloroacetic acid (TCA) in the drinking water at levels of 0, 50, 500 and 5000 ppm for a period of 90 days to determine the toxicities associated with subchronic exposure. ll animals were sacrificed...

  17. ACUTE, 14-DAY REPEATED DOSING, AND 90-DAY SUBCHRONIC TOXICITY STUDIES OF POTASSIUM PICLORAM (JOURNAL VERSION)

    EPA Science Inventory

    Potassium picloram was administered either by gavage (acute studies) or in drinking water to male and female Sprague-Dawley derived rats (14-day and 90-day studies). The acute oral LD50 was 950 mg/kg (812-1120) for males and 686 mg/kg (599-786) for females. Depression, prostratio...

  18. 49 CFR 24.402 - Replacement housing payment for 90-day occupants.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false Replacement housing payment for 90-day occupants. 24.402 Section 24.402 Transportation Office of the Secretary of Transportation UNIFORM RELOCATION... classified as “low income” by the U.S. Department of Housing and Urban Development's Annual Survey of...

  19. 49 CFR 24.402 - Replacement housing payment for 90-day occupants.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 1 2014-10-01 2014-10-01 false Replacement housing payment for 90-day occupants. 24.402 Section 24.402 Transportation Office of the Secretary of Transportation UNIFORM RELOCATION ASSISTANCE AND REAL PROPERTY ACQUISITION FOR FEDERAL AND FEDERALLY-ASSISTED PROGRAMS Replacement...

  20. 49 CFR 24.402 - Replacement housing payment for 90-day occupants.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... occupied the displacement dwelling for at least 90 days immediately prior to the initiation of negotiations... or she moves from the displacement dwelling; or (ii) For an owner-occupant, the later of: (A) The date he or she receives final payment for the displacement dwelling, or in the case of...

  1. 49 CFR 24.402 - Replacement housing payment for 90-day occupants.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... occupied the displacement dwelling for at least 90 days immediately prior to the initiation of negotiations... or she moves from the displacement dwelling; or (ii) For an owner-occupant, the later of: (A) The date he or she receives final payment for the displacement dwelling, or in the case of...

  2. 49 CFR 24.402 - Replacement housing payment for 90-day occupants.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... occupied the displacement dwelling for at least 90 days immediately prior to the initiation of negotiations... or she moves from the displacement dwelling; or (ii) For an owner-occupant, the later of: (A) The date he or she receives final payment for the displacement dwelling, or in the case of...

  3. A 90-Day Tenofovir Reservoir Intravaginal Ring for Mucosal HIV Prophylaxis

    PubMed Central

    Johnson, Todd J.; Clark, Meredith R.; Albright, Theodore H.; Nebeker, Joel S.; Tuitupou, Anthony L.; Clark, Justin T.; Fabian, Judit; McCabe, R. Tyler; Chandra, Neelima; Doncel, Gustavo F.; Friend, David R.

    2012-01-01

    A vaginal gel containing the antiretroviral tenofovir (TFV) recently demonstrated 39% protection against HIV infection in women. We designed and evaluated a novel reservoir TFV intravaginal ring (IVR) to potentially improve product effectiveness by providing a more controlled and sustained vaginal dose to maintain cervicovaginal concentrations. Polyurethane tubing of various hydrophilicities was filled with a high-density TFV/glycerol/water semisolid paste and then end-sealed to create IVRs. In vitro, TFV release increased with polyurethane hydrophilicity, with 35 weight percent water-swelling polyurethane IVRs achieving an approximately 10-mg/day release for 90 days with mechanical stiffness similar to that of the commercially available NuvaRing. This design was evaluated in two 90-day in vivo sheep studies for TFV pharmacokinetics and safety. Overall, TFV vaginal tissue, vaginal fluid, and plasma levels were relatively time independent over the 90-day duration at approximately 104 ng/g, 106 ng/g, and 101 ng/ml, respectively, near or exceeding the highest observed concentrations in a TFV 1% gel control group. TFV vaginal fluid concentrations were approximately 1,000-fold greater than levels shown to provide significant protection in women using the TFV 1% gel. There were no toxicological findings following placebo and TFV IVR treatment for 28 or 90 days, although slight to moderate increases in inflammatory infiltrates in the vaginal epithelia were observed in these animals compared to naïve animals. In summary, the controlled release of TFV from this reservoir IVR provided elevated sheep vaginal concentrations for 90 days to merit its further evaluation as an HIV prophylactic. PMID:23006751

  4. 76 FR 32911 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Striped...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... petition in early 2010. On March 23, 2010, we published a 90-day finding (75 FR 13720) that the petition... information (75 FR 13720, March 23, 2010). Below, we briefly summarize previously presented information, and.... However, in our 90-day finding (75 FR 13720, March 23, 2010), we determined that there was no evidence...

  5. 76 FR 61855 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Cactus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ... 2, 2008 (73 FR 31418), we published a 90-day finding in which we determined that the petition... June 2, 2008 90-day finding (73 FR 31418). Following the publication of our 90-day finding on this.... When we previously listed the pygmy-owl as endangered in 1997 (62 FR 10730; March 10, 1997), and in...

  6. 76 FR 72891 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Scalloped Hammerhead...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ..., delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). A species, subspecies... overfished stocks within 2 years'' (76 FR 23794; April 28, 2011). This status determination is specific to... in the Atlantic Ocean, including the Caribbean Sea and Gulf of Mexico (76 FR 53652; August 29,...

  7. 75 FR 17062 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Thorne's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... listing Thorne's hairstreak (71 FR 44980) or Hermes copper butterflies (71 FR 44966) was warranted. (For a... finding, please see the August 8, 2006 Federal Register Notice (71 FR 44980)). On March 17, 2009, CBD and... the Federal Register on August 8, 2006 (71 FR 44980). ] Evaluation of Information for this...

  8. 76 FR 31920 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Golden...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... interactions are not as common in this region. Deforestation events have increased in golden-winged warbler... by increasing deforestation and migrating individuals are impacted by the increasing number...

  9. 77 FR 54548 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Eagle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-05

    ... because fish in the early life-history stages are gradually being selected for survival in a hatchery... gradually being selected for survival in the early life-history stages in a hatchery environment, rather... basic biological traits and their migratory life history, as evidenced by their annual attempt to...

  10. 76 FR 61825 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List 29 Mollusk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ..., low oxygen, increased water temperatures, and sedimentation. Population numbers are declining... oxygen, and is sensitive to pollution, elevated temperatures, and sedimentation, according to Furnish...

  11. 77 FR 45 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Sierra Nevada...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... facilitate invasion by coyotes and nonnative red fox, resulting in increased competition, predation, and... dogs, and increased coyote predation due to recreation activities, logging, and fire suppression... domestic dogs may be a threat to Sierra Nevada red fox. Coyote Predation--Information Provided in...

  12. 75 FR 32869 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List a Distinct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    .... irremotus) and the eastern timber wolf (C. l. lycaon) in the Great Lakes region (39 FR 1158, January 4, 1974..., 1976 (41 FR 17736), in Mexico and the southwestern United States. On June 14, 1976 (41 FR 24062), we... threatened listing in Minnesota (43 FR 9607, March 9, 1978). Recovery efforts that followed were...

  13. 77 FR 71759 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Prairie...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... the Endangered Species Act (61 FR 4722, February 7, 1996), three elements are considered in the... the DPS policy (61 FR 4722), this consideration of the population segment's significance may include... availability for the plains spotted skunk. (5) Information regarding the impacts of predation by coyotes...

  14. 77 FR 67784 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Heller...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-14

    ... information about the Heller Cave springtail's habitat outside of the type locality, diet, reproduction, or.... 1996, pp. 2-3). In general, Collembola exhibit sexual differentiation (male and female individuals), and reproduction occurs through the deposition and reception of spermatophores (sperm packets);...

  15. 76 FR 304 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Red Knot...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ... our list of candidate species with a listing priority number of 6 (71 FR 53758-53759). ``Warranted but... threats were determined to be imminent (73 FR 75178-75179, December 10, 2008). Because we determined that... number of 3 for this subspecies (74 FR 57825-57826, November 9, 2009). Accordingly, as we addressed...

  16. 75 FR 23654 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Hermes Copper...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... Hermes copper (71 FR 44966) or Thorne's hairstreak butterflies (71 FR 44980) was warranted. (For a... (75 FR 17062) concluding that listing Thorne's hairstreak butterfly may be warranted. This notice... finding (71 FR 44966, August 8, 2006) is limited to Marschalek and Deutschman's (2008) study of the...

  17. 77 FR 24908 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Aliciella...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... gilia (identified as Gilia formosa) as a Category 2 species (50 FR 39526, September 27, 1985). Category... Category 2 designation for Aztec gilia (again identified as Gilia formosa) (55 FR 6184; February 21, 1990... formosa) was ``declining,'' but was still considered a Category 2 species (58 FR 51144, September 30,...

  18. 77 FR 32922 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-04

    ... (75 FR 28636, May 21, 2010; Service 2009b, p. 15). Lane Mountain milk-vetch was listed as endangered... (76 FR 29108, May 19, 2011). No recovery plan has been completed for Lane Mountain milk-vetch. A... designated concurrent with the listing (52 FR 28780, August 3, 1987). At the time of listing, this...

  19. 76 FR 62375 - Endangered and Threatened Species; 90-Day Finding on Petitions To Delist Coho Salmon Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... California Coast (SONCC) coho salmon ESU, which is listed as threatened (70 FR 37160; June 28, 2005), and... June 28, 2005 (70 FR 37160). In that final rule, we concluded that the SONCC coho salmon ESU includes... Endangered Species Act Listing Determinations for Pacific Salmon and Steelhead'' (70 FR 37204; June 28,...

  20. 77 FR 75091 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ..., 1996 (61 FR 4722) (DPS policy). According to the DPS policy, two elements must be satisfied in order..., and southeastern British Columbia under the Act on January 14, 1983 (48 FR 1722). A second emergency rule to extend emergency protection was published in the Federal Register on October 25, 1983 (48...

  1. 76 FR 20302 - Listing Endangered and Threatened Species; 90-Day Finding on a Petition To List Chinook Salmon

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-12

    ... Definition of Species Under the Endangered Species Act to Pacific Salmon (ESU Policy; 56 FR 58612; November... and fall-run fish (63 FR 11487; March 9, 1998). The Petitioners recommend three alternatives for... FR ] 11482, 11493; March 9, 1998), and we use it exclusively for defining distinct...

  2. 75 FR 16745 - Endangered and Threatened Species; 90-Day Finding on a Petition to Delist Coho Salmon South of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... salmon ESU. The CCC coho salmon ESU was listed as a threatened species on October 31, 1996 (61 FR 56138), and subsequently reclassified as an endangered species on June 28, 2005 (70 FR 37160). For more... FR 33102; June 14, 2004) or ``Final Rule Endangered and Threatened Species; Threatened Status...

  3. 77 FR 61559 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Nassau Grouper as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... speckled hind were made on June 1, 2011 (76 FR 31592), and May 1, 2012 (77 FR 25687), respectively. ESA... species under the ESA (``DPS Policy''; 61 FR 4722; February 7, 1996). A species, subspecies, or DPS is... scientific data (59 FR 34270). The intent of the peer review policy is to ensure listings are based on...

  4. 75 FR 77602 - Endangered and Threatened Species; 90-Day Finding on Petitions To Delist the Eastern Distinct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... April 5, 1990 (55 FR 12645). Critical habitat was designated on August 27, 1993 (58 FR 45269), based on... Steller sea lions under the ESA: A western DPS and an eastern DPS (62 FR 24345, 62 FR 30772). Due to... to recover, given the long term sustained growth of the population as a whole. However,...

  5. 76 FR 31903 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to Reclassify the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... endangered under the Act (41 FR 24062). All species were found to have declining numbers due to the present.... On September 23, 1999 (64 FR 51499), we published in the Federal Register a finding, in accordance... Under the Endangered Species Act'' (61 FR 4722, February 7, 1996), three elements are considered in...

  6. 78 FR 25044 - Listing Endangered or Threatened Species: 90-Day Finding on a Petition To Include the Killer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-29

    ... phrase ``Distinct Population Segment,'' or DPS (61 FR 4722; February 7, 1996). The DPS Policy requires... a species as defined by the ESA (67 FR 44133; July 1, 2002). Because of the uncertainties regarding... December 22, 2004 (69 FR 76673). After considering public comments on the proposed rule and other...

  7. 76 FR 55638 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Snowy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-08

    ... 6, 2000; 65 FR 41782) and our extension of the comment period for that proposal (65 FR 64414... the final rule for the designation of critical habitat for wintering piping plover (66 FR 36038; July... under the Act on March 5, 1993 (58 FR 12864). The Pacific coast population is defined as...

  8. 78 FR 69033 - Endangered and Threatened Wildlife; 90-Day Finding on Petitions To List the Pinto Abalone as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ..., delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). A species, subspecies... metric tons per year, an order of magnitude lower than catches recorded in the mid- 1900s. The incidental...-per-unit-effort fell by 90 percent between the peak of the fishery in 1979 (172 metric tons) and...

  9. 76 FR 36053 - Endangered and Threatened Wildlife and Plants; Revised 90-Day Finding on a Petition To Reclassify...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... Utah prairie dogs (see Figure 1 below) (UDWR 2005, entire; 72 FR 7843). As of 2010, the Awapa Plateau... FR 22330), the 1991 Utah Prairie Dog Recovery Plan (Service 1991, pp. iv, 11), and the 2010 Draft...-day finding published on February 21, 2007 (72 FR 7843), constituted our compliance with...

  10. 76 FR 59835 - Endangered and Threatened Wildlife and Plants; Partial 90-Day Finding on a Petition To List 404...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... 24, 2011; 75 FR 36035)), spectaclecase (Cumberlandia monodonta) ((currently proposed for listing as endangered (January 19, 2011; 76 FR 3392)), narrow pigtoe (Fusconaia escambia), round ebonyshell (Fusconaia... listing as endangered (January 19, 2011; 76 FR 3392)), fuzzy pigtoe (Pleurobema strodeanum),...

  11. 76 FR 3069 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    .... We published a notice May 21, 2010 (75 FR 28636), announcing the review of Acmispon dendroideus... either plant. A notice of review initiation was published for the two Eureka Valley plants in 1983 (48 FR 55100; December 8, 1983), 1991 (56 FR 56882; November 6, 1991), and 2005 (70 FR 39327; July 7,...

  12. 77 FR 48934 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Bicknell...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... announced that finding in the Animal Candidate Review for Listing as Endangered or Threatened Species (59 FR... thrush from candidate status (61 FR 64481). Although the Bicknell's thrush was removed from the list of... 2010 Candidate Notice of Review (75 FR 69222). The agreements also include additional...

  13. 75 FR 32728 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List van Rossem's...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-09

    ... Regarding the Recognition of Distinct Vertebrate Population Segments under the Endangered Species Act, 61 FR..., 1994, notice of candidate review (59 FR 58982). Category 2 taxa were defined as those taxa for which... FR 7596), we announced our decision to discontinue recognition of Category 2 candidates,...

  14. 77 FR 70733 - Listing Endangered or Threatened Species: 90-Day Finding on a Petition To Delist the Southern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ...' interpretation of the phrase ``Distinct Population Segment,'' or DPS (61 FR 4722; February 7, 1996). The DPS... killer whales did not constitute a species as defined by the ESA (67 FR 44133; July 1, 2002). Because of... December 22, 2004 (69 FR 76673). After considering public comments on the proposed rule and other...

  15. 75 FR 316 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition to List the Insular Population...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ... Segments under the ESA (DPS Policy, 61 FR 4722; February 7, 1996). This policy clarifies the agencies... section 3(16)) for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR... organisms (Briggs, 1961, 1966; Carlquist, 1966). They cite Baird et al. (2008) to support the theory...

  16. 75 FR 6616 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition to List 83 Species of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-10

    ... early 1980s as primary factors in this ecological shift (73 FR 72210; November 26, 2008). The petitioner... available to indicate a need to list the species under the ESA'' (71 FR 61022; October 17, 2006). We... permit adaptive management (Policy on the Evaluation of Conservation Efforts; 68 FR 15100; March 28,...

  17. 76 FR 66255 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to Delist the Coastal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... published a final rule to list the coastal California gnatcatcher as a threatened species (58 FR 16742). In... (58 FR 65088). On December 10, 1993, the Service published in the Federal Register a final rule... additional 30 days, until January 26, 1995 (59 FR 66509). On March 27, 1995, the Service published in...

  18. 75 FR 57431 - Listing Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... phrase ``distinct population segment of any species of vertebrate fish or wildlife'' (61 FR 4722). The... fishery and increase the Harpoon category daily incidental retention limit (74 FR 57128; November 4, 2009... a result of bioaccumulation. Storelli et al. (2008) concluded that exposure to EDCs over a...

  19. 77 FR 37367 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Black...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-21

    ..., 1994 (59 FR 58982). Category 2 candidates were taxa for which information was available indicating that... and threats. In the February 28, 1996, Notice of Review (61 FR 7595), we discontinued the use of... bioaccumulation of heavy metals, and climate change'' (WEG 2011, p. 16). ``One breeding pair must...

  20. 76 FR 78891 - Listing Endangered and Threatened Wildlife and Plants; 90-Day Finding on Petitions To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... any species of vertebrate fish and wildlife'' (61 FR 4722). The joint DPS policy describes two... climate change to specific impacts on thorny skate. One possibility is that global warming could cause a... represent the southernmost population of the species in the world. They state that, as global...

  1. 76 FR 78601 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Western...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... impact of warming temperatures and altered precipitation patterns on diminishing sea ice (73 FR 28288... recent models of carbon dioxide (CO 2 ) induced global warming predicts the complete loss of glaciers in... decades demonstrate that changes in climate are occurring. Examples include warming of the global...

  2. 77 FR 52293 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Mimulus...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-29

    ... Species (50 FR 39526, September 27, 1985). In that document, we included the species as a Category 2..., 1996 (61 FR 64481). This decision resulted in the deletion of Rocky Mountain monkeyflower from the list... to list 206 species, including Rocky Mountain monkeyflower (74 FR 6122, February 5, 2009). We...

  3. 77 FR 33143 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Southern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... Distinct Vertebrate Population Segments Under the Endangered Species Act (61 FR 4722; February 7, 1996... contributes to global warming. The IPCC also summarized changes in the amount, intensity, frequency, and type of precipitation associated with warming global temperatures (Trenberth et al. 2007, p. 262)....

  4. 78 FR 19176 - Endangered and Threatened Wildlife; 90-day Finding on a Petition to List Sperm Whales in the Gulf...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... listed as a single endangered species throughout their global range (35 FR 8495; June 2, 1970). The... Population Segment,'' or DPS (61 FR 4722; February 7, 1996). The DPS Policy requires the consideration of two... (February 7, 1996; 61 FR 4722) identifies two elements that must be considered when identifying a DPS:...

  5. 78 FR 53391 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To Delist the North Pacific...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... the phrase ``Distinct Population Segment,'' or DPS (61 FR 4722; February 7, 1996). The DPS Policy... and any threats faced by the species; (3) provides information regarding the status of the species... species' status and trends, or in information describing impacts and threats to the species. We...

  6. 75 FR 16713 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition to List the Bumphead...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-02

    ... Efforts, 68 FR 15100; March 28, 2003). In some cases, conservation efforts may be relatively new or may... peer review of scientific data (59 FR 34270). The intent of the peer review policy is to ensure... protection are subjecting the bumphead parrotfish to extinction in the foreseeable future. The...

  7. 75 FR 17363 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List a Stonefly...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... information that listing of those species may be warranted (74 FR 419). The stonefly and mayfly were included... present substantial information indicating that the species may be at risk of extinction now or in the..., flood, habitat destruction, pollution, exotic species), could result in extinction. However, in order...

  8. 76 FR 49412 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Saltmarsh Topminnow...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-10

    .... In 2004, NMFS created the Species of Concern list (69 FR 19975; April 15, 2004) to encompass species... include NMFS' recent proposed ESA listing of largetooth sawfish (75 FR 25174): ``Wetland losses in the..., subspecies, or DPS is ``endangered'' if it is in danger of extinction throughout all or a significant...

  9. 78 FR 6299 - Endangered and Threatened Wildlife; 90-Day Finding on Two Petitions To List White Marlin as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ..., 2002, that white marlin did not warrant ESA listing (67 FR 57204). In 2006, per a settlement agreement... information regarding the status of and threats to the species (71 FR 76639) and convened a new biological.... After considering the AWMSR, we determined the white marlin was neither threatened or endangered (73...

  10. 78 FR 50032 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Whale Shark as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ... FR 4722; February 7, 1996). A species, subspecies, or DPS is ``endangered'' if it is in danger of extinction throughout all or a significant portion of its range, and ``threatened'' if it is likely to become... discrete from other populations of the species and significant to the species as a whole (61 FR...

  11. 78 FR 63941 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List 23 Species of Corals as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... danger of extinction throughout all or a significant portion of its range, and ``threatened'' if it is... if a reasonable person would conclude that the unknown information itself suggests an extinction risk... evaluate whether the information indicates that the species at issue faces extinction risk that is...

  12. 76 FR 31592 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition To List Goliath...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... grouper (previously known as jewfish) as a candidate species under the ESA (56 FR 26797). On April 15... FR 19976). We transferred 25 candidate species, including goliath grouper, to this species of concern... concern list in 2006 (71 FR 61022). ESA Statutory and Regulatory Provisions and Evaluation...

  13. 77 FR 25687 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition to List Speckled Hind as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-01

    ... species' extinction risk. For example, our 2007 status review for the Atlantic white marlin (73 FR 843... speckled hind. A negative finding for goliath grouper was made on June 1, 2011 (76 FR 31592), while the... FR 4722; February 7, 1996). A species, subspecies, or DPS is ``endangered'' if it is in danger...

  14. 77 FR 51767 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Five Species of Sturgeon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... species under the ESA (``DPS Policy''; 61 FR 4722; February 7, 1996). A species, subspecies, or DPS is ``endangered'' if it is in danger of extinction throughout all or a significant portion of its range, and... person would conclude that the unknown information itself suggests an extinction risk of concern for...

  15. 75 FR 59690 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition To List Warsaw Grouper...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ...' extinction risk. For example, our 2007 status review for the Atlantic white marlin (73 FR 843, January 4... list on April 15, 2004 (69 FR 19975). Warsaw grouper had previously been included on our ESA candidate species list since 1999 (64 FR 33466, June 23, 1999). A species of concern is one about which we have...

  16. 76 FR 56381 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Franklin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-13

    ... bee (54 FR 554). Category 2 candidates were species for which we had information indicating that... in Candidate Review notices published on November 21, 1991 (56 FR 58804) and November 15, 1994 (59 FR... FR 64481; December 5, 1996). Franklin's bumble bee has not held a Federal conservation...

  17. 76 FR 18138 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Spring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... proposed critical habitat designation (effective November 29, 1979) (45 FR 5782). The spring pygmy sunfish... habitat (42 FR 60765). We withdrew the critical habitat portion of the proposal on March 6, 1979 (44 FR 12382). We then proposed critical habitat again for the species on July 27, 1979 (44 FR 44418)....

  18. 77 FR 70727 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the African...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... significant long-term African lion population declines. (4) Information on the correlation between climate change and African lion population dynamics, including, but not limited to: (a) Climate change... indirectly through changes in regional climate; and (b) Quantitative research on the relationship of...

  19. 77 FR 45571 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To Delist the Green Turtle in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ...,'' or DPS (61 FR 4722; February 7, 1996). The DPS Policy requires the consideration of two elements when... commercial data available after conducting a review of the species' status, that the species is no longer... under the ESA is no longer required. A species may be delisted on the basis of recovery only if the...

  20. 75 FR 41436 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition to Revise Critical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... boundary of Puerto Rico's territorial waters but has no demonstrated scientific/ecological basis as... no information that would provide a basis for implementing section 7 consultations on impacts to designated critical habitat, because no sufficiently defined features of the habitat have been identified,...

  1. 77 FR 58084 - Endangered and Threatened Wildlife and Plants; 90-Day Findings on Petitions To Delist U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-19

    ... oryx, 1,500 addax, and 750 dama gazelle in captivity worldwide (70 FR 52319). These include at least 1... their entirety, i.e. wherever found, on June 2, 1970 (35 FR 8491). On November 5, 1991, we published in the Federal Register (56 FR 56491) a proposed rule to list the scimitar-horned oryx, addax, and...

  2. 75 FR 13717 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List the Southern...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ..., Texas pimpleback, false spike, Mexican fawnsfoot, and Texas fawnsfoot, in a separate finding (74 FR... document was made on March 23, 2010. ADDRESSES: This finding is available on the Internet at http://www... margin; the beak cavity is moderately deep. For a more detailed description, see Williams et al. 2008,...

  3. 75 FR 55730 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on Petitions To Delist the Gray...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    .... baileyi), was listed as endangered on April 28, 1976, (41 FR 17736) with its known range given as ``Mexico, USA (Arizona, New Mexico, Texas).'' On June 14, 1976, (41 FR 240624) the subspecies C. l. monstrabilis... as ``Texas, New Mexico, Mexico.'' On March 9, 1978, we published a rule (43 FR 9607) relisting...

  4. 76 FR 9320 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Alabama Shad as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-17

    ...: Background In 1997, we added Alabama shad to our Candidate Species List (62 FR 37562; July 14, 1997). At that... (49 FR 38900; October 1, 1984). In 2004, we created the Species of Concern list (69 FR 19975; April 15..., delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). A species,...

  5. 75 FR 38776 - Endangered and Threatened Wildlife and Plants; 90-Day Finding for a Petition to List Puget Sound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-06

    ... our Policy on Applying the Definition of Species under the ESA to Pacific Salmon (56 FR 58612... 25, 1995 (60 FR 38011). In that document, we delineated several ESUs of coho salmon throughout the... apparently stable. For this reason, we concluded that listing was not warranted (60 FR 38011; July 25,...

  6. 78 FR 13614 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Humphead Wrasse as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ..., delisting, and reclassifying a species under the ESA (``DPS Policy''; 61 FR 4722; February 7, 1996). A... listings under the ESA, including a policy for peer review of scientific data (59 FR 34270). The intent of... about 2-60 m depth (Sadovy et al., 2003; Donaldson and Sadovy, 2001). Small, post-settled...

  7. 77 FR 47352 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List Graptopetalum...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-08

    ... Endangered or Threatened Species (45 FR 82480, December 15, 1980). Category 1 candidates were defined as... Plant Taxa for Listing as Endangered or Threatened Species (48 FR 53640, November 28, 1983). Category 2... of Final Decision on Identification of Candidates for Listing as Endangered or Threatened (61...

  8. 76 FR 23265 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Smooth...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-26

    ... generally nonmigratory; however, some local movement occurs during the dry season, when many groups leave... Startek-Foote 2000, section 5, p. 1). Records in the Dry Tortugas suggest some movement between the... component of the diet during the dry season (Quinn and Startek-Foote 2000, section 1, p. 1 and section 7,...

  9. 76 FR 56607 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List 42 Great...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-13

    ... States (August 18, 2009; 74 FR 41649); thus, these three species are not included in this finding. In the... from the phylum Mollusca, class Gastropoda, superorder Caenogastropoda (Bouchet and Rocroi 2005, pp....

  10. 76 FR 20911 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Prairie...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ..., saltcedar and Russian olive encroachment has been shown to alter stream geomorphology by narrowing and... functions of a stream in terms of hydrology, biology, geomorphology, connectivity, and water quality at...

  11. 78 FR 55046 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... The gypsum wild-buckwheat was federally listed as threatened on February 18, 1981 (46 FR 5730, January... habitat on November 5, 1987 (52 FR 37420, October 6, 1987). A recovery plan was issued September 30, 1991... was federally listed as endangered without critical habitat on October 31, 1988 (53 FR...

  12. 76 FR 78898 - Endangered and Threatened Wildlife; 90-Day Finding on Petition To List the Barndoor Skate, Winter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... population segment of any species of vertebrate fish and wildlife'' (61 FR 4722). The joint DPS policy... considering adding to the Endangered Species Act (ESA) candidate species list (64 FR 2629; January 15, 1999... revised list of candidate species, which included barndoor skates (64 FR 33466; June 23, 1999). In...

  13. 76 FR 47123 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List Six Sand Dune...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... and threats were not available to support proposed rules (59 FR 58982; November 15, 1994). In the February 28, 1996, Candidate Notice of Review (CNOR) (61 FR 7595), we adopted a single category of... proposed to list Giuliani's dune scarab as endangered or threatened in 1978 (43 FR 35636; August 10,...

  14. 77 FR 26478 - Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List the Dwarf Seahorse as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-04

    ... population segment'' for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR... second most exported ornamental fish in Florida. Koldewey et al. (2010) conducted an international review... distinct population segment (DPS) that interbreeds when mature (16 U.S.C. 1532(16)). A joint NMFS-U.S....

  15. 75 FR 48294 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition to List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-10

    ... as an endangered species under the Act in 1976 (41 FR 24524, June 16, 1976). It was included in the... be extinct in the wild although known to be extant in cultivation (U45 FR 82480, December 15, 1980... Presidio (71 FR 10608, March 2, 2006; NPS 2006), also participated. Species Information...

  16. 75 FR 34077 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on Five Petitions to List Seven...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... Stone 1990, pp. 60-66; 73 FR 73801). Beyond the direct effects of trampling and consuming native plants... anthracinus was historically known from numerous coastal strand and lowland dry forest locations up to 2,000... occurred in montane dry forest (Magnacca 2005a, p. 2). Although it was previously unknown from the...

  17. 78 FR 46322 - Endangered and Threatened Species; 90-Day Finding on Petition To Delist the Southern Oregon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... coho salmon ESU under the ESA on three separate occasions (62 FR 24588, May 6, 1997; 70 FR 37160, June..., 1997 (62 FR 24588). In this determination, we concluded that coho salmon populations in this ESU were... threatened. In the proposed listing determination for west coast salmon and steelhead ESUs (69 FR 33102;...

  18. 76 FR 40868 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Bay...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... candidate for protection under the Act in the November 21, 1991, Federal Register (56 FR 58804). It was... 1996 (Notice of Candidate Review; February 28, 1996; 61 FR 7596), and only species for which the... Wildlife Refuge (NWR) (part of the Texas Chenier Plains NWR Complex), Chambers and Jefferson...

  19. 76 FR 51929 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Delist the Valley...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... August 10, 1978 (43 FR 35636). A rule re-proposing critical habitat was issued on May 2, 1980 (45 FR... designating critical habitat was published in the Federal Register on August 8, 1980 (45 FR 52803). On June 28... the beetle (70 FR 39327). Information from the public was accepted until September 6, 2005....

  20. 78 FR 58507 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List 10 Sturgeon...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... affecting their continued existence. (3) The potential effects of climate change on each species and its... sturgeon (Acipenser baerii). Endangered Decreasing China; Kazakhstan; Mongolia; Russia. Yangtze sturgeon (Acipenser Critically Endangered.. Decreasing China. dabryanus). Russian sturgeon (Acipenser...

  1. 75 FR 46894 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Mexican...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-04

    ... endangered subspecies on April 28, 1976 (41 FR 17742). The gray wolf species (Canis lupus) in North America... threatened (43 FR 9607). This listing of the species as a whole subsumed the previous Mexican wolf subspecies... the purpose of research and conservation (43 FR 9607). We initiated recovery programs for the...

  2. 77 FR 43218 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Sonoran...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-24

    ... evidence that this species may warrant listing due to habitat destruction from exotic plant invasion... information in our files, supporting that mechanical or chemical removal of invasive plant species is a threat... to mining; exotic plant invasion and control; real estate development; livestock grazing;...

  3. 78 FR 29100 - Endangered and Threatened Wildlife; 90-Day Finding on Petitions To List the Dusky Shark as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ..., delisting, and reclassifying a vertebrate species under the ESA (61 FR 4722; February 7, 1996) (``DPS Policy... the definition of ``significant'' defined in the Services' DPS Policy and used for DPS analysis (76 FR... list in 1997 (62 FR 37560; July 14, 1997), but subsequently transferred the Northwest Atlantic and...

  4. 78 FR 24701 - Endangered and Threatened Wildlife; 90-Day Finding on Petitions To List the Great Hammerhead...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... hammerhead shark is considered to be a candidate species (69 FR 19975; April 15, 2004). Within 12 months of...'' for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR 4722... Caribbean Sea and Gulf of Mexico (76 FR 53652; August 29, 2011). However, the exemption available...

  5. 77 FR 39670 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List a Distinct...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... states, as discussed below. On February 15, 1983 (48 FR 6752), the Service included the black bear in... (55 FR 25341) to list the Louisiana black bear (Ursus americanus luteolus) as threatened in Louisiana... similarity of appearance. On January 7, 1992, a final rule was published in the Federal Register (57 FR...

  6. 76 FR 54423 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List All...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-01

    ..., to allow all interested parties to submit comments and information. On December 28, 1988 (53 FR 52452... rule listing the chimpanzee and 25 other species of primates under the Act (41 FR 45990); the..., requesting that the chimpanzee be reclassified from threatened to endangered. On March 23, 1988 (53 FR...

  7. 76 FR 15947 - Endangered and Threatened Wildlife; Notice of 90-Day Finding on a Petition To List the Caribbean...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ... the Endangered Species Act (ESA) AGENCY: National Marine Fisheries Service (NMFS), National Oceanic..., delisting, and reclassifying a species under the ESA (61 FR 4722; February 7, 1996). A species, subspecies... characteristics, it is not particularly surprising that a small, buried animal, commonly found away from...

  8. 76 FR 30082 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the Spot...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... Comprehensive Wildlife Conservation Strategy (2005b, pp. 1093-1094) suggests that the spot- tailed earless..., pp. 1-2) and TPWD's Conservation Wildlife Strategy (2005a, p. 1094), which mentioned that the...

  9. Subchronic 90-day oral (Gavage) toxicity study of a Luo Han Guo mogroside extract in dogs.

    PubMed

    Qin, X; Xiaojian, S; Ronggan, L; Yuxian, W; Zhunian, T; Shouji, G; Heimbach, J

    2006-12-01

    A combined 28-day and 90-day oral (Gavage) study was conducted in male and female dogs to investigate the safety of PureLo, a non-caloric sweetener derived from the Chinese fruit Luo Han Guo, which achieves its sweetness from the presence of triterpene glycosides known as mogrosides. Three dogs of each sex were administered 10 mL/kg bw/day of either an aqueous solution providing 3000 mg/kg bw/day of PureLo or distilled water for either 28 days or 90 days. Measurements included clinical observations, body weight, food consumption, hematology, blood chemistry, urinalysis, gross necropsy, organ weight, and histopathology. There were no significant adverse effects on any of these measures. Based on the lack of toxicological effects in the study, the NOAEL for PureLo is 3000 mg/kg bw/day when administered to dogs by Gavage for 90 consecutive days. PMID:17011100

  10. Safety assessment of meat from transgenic cattle by 90-day feeding study in rats.

    PubMed

    Liu, Shan; Li, Chen-Xi; Feng, Xiao-Lian; Wang, Hui-Ling; Liu, Hai-Bo; Zhi, Yuan; Geng, Gui-Ying; Zhao, Jie; Xu, Hai-Bin

    2013-07-01

    The study was carried out to evaluate the subchronic toxicity of meat derived from human lactoferrin gene-modified cattle in male and female Wistar rats. Rats were fed 5% or 10% transgenic meat diet, 5% or 10% conventional meat diet, or AIN93G diet for 90 days. During the study, body weight and food consumption were weighed weekly and clinical observations were conducted daily. At the end of the study, urinary examination, hematology and blood biochemistry examination, macroscopic and microscopic examinations were performed. There were no biologically significant differences in these factors between the rat groups fed transgenic meat diet and conventional meat diet. Therefore, the present 90-day rodent feeding study suggests that meat derived from the transgenic cattle is equivalent to meat from conventional cattle in use as dietary supplements. PMID:23583492

  11. 12 CFR 220.117 - Exception to 90-day rule in special cash account.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... the language and intent of the above-quoted exception in § 220.4(c)(8), until it has been honored by... substantially the same as language found in section 4(f) of Regulation T as originally promulgated in 1934. The language of the subject exception to the 90-day rule of § 220.4(c)(8), i.e., the exception based...

  12. 90-Day feeding and genotoxicity studies on a refined arachidonic acid-rich oil.

    PubMed

    Casterton, P L; Curry, L L; Lina, B A R; Wolterbeek, A P M; Kruger, C L

    2009-10-01

    The safety of a refined arachidonic acid-rich oil (RAO) was evaluated for reverse mutation, chromosome aberration and gene mutation, and in a 90-day Wistar rat feeding study with in utero exposure. The results of the genotoxicity assays were all negative. The in utero phase of the 90-day study involved dietary exposure to 0.5%, 1.5% and 5% RAO and two controls diets, a standard feed low-fat diet and a high-fat diet supplemented with 5% corn oil. This exposure covered four-weeks prior to mating, through mating, gestation and lactation until offspring (F(1)) weaning. A subsequent 90-day feeding study in the F(1) rats evaluated the same test and control diets. Statistically significant effects were seen for selected histopathology, clinical chemistry and organ weight endpoints; however, other than increased absolute and relative monocytes seen in both sexes of high-dose rats, the observations were not attributed to treatment for one or more reasons. Based on these findings, no adverse treatment-related effects for RAO were seen at up to 5% in the diet, equivalent to an overall average RAO intake of 3170 mg/kg bwt/day. These and similar findings for other refined ARA-rich oils establish a strong body of evidence for the safety of this RAO. PMID:19576260

  13. 78 FR 39232 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ..., published at 78 FR 15615, March 12, 2013, in IB Docket No. 04-112, and published pursuant to 47 CFR 1.429(e... behalf of the Voice on the Net (VON) Coalition. DATES: Oppositions to the Petition must be filed on or... 6712-01-P...

  14. 77 FR 69586 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... Microwave Licenses, Petition for Reconsideration of Wireless Strategies, Inc., published at 77 FR 54421, September 5, 2012, and at 77 FR 54511, September 5, 2012, and published pursuant to 47 CFR 1.429(e) of the... of Part 101 of the Commission's Rules to Facilitate the Use of Microwave for Wireless Backhaul...

  15. 78 FR 71024 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This notice... (65 FR 19477-78). Docket: To read background documents or comments received, go to...

  16. 76 FR 39975 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments received, go... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  17. 76 FR 16653 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-24

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  18. 77 FR 13385 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  19. 76 FR 38265 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-29

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  20. 78 FR 21702 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  1. 75 FR 19672 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-15

    ... in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  2. 78 FR 67442 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  3. 78 FR 3068 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to ] http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  4. 76 FR 20806 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  5. 75 FR 15771 - Petitions for Exemption; Summary of Petitions Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-30

    ... published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments received, go... Federal Aviation Administration Petitions for Exemption; Summary of Petitions Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petitions for exemption received. SUMMARY:...

  6. 75 FR 21388 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-23

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  7. 78 FR 21701 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  8. 76 FR 45648 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  9. 77 FR 44309 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  10. 78 FR 53186 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  11. 78 FR 67441 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  12. 75 FR 80106 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  13. 75 FR 51164 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-18

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  14. 76 FR 63342 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  15. 77 FR 54650 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-05

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  16. 76 FR 65772 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to ] http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  17. 76 FR 26335 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to ] http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  18. 77 FR 13384 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  19. 75 FR 15771 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-30

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  20. 78 FR 4190 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-18

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  1. 75 FR 70965 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments received, go... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration, DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  2. 75 FR 10342 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-05

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  3. 76 FR 39976 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  4. 75 FR 80107 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  5. 75 FR 47882 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  6. 75 FR 55394 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-10

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  7. 78 FR 21701 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  8. 76 FR 54287 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-31

    ... Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  9. 76 FR 33400 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ... Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  10. 75 FR 60164 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  11. 75 FR 19672 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-15

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to ] http://www... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  12. 78 FR 36294 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  13. 78 FR 53185 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-28

    ... published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments received, go... Federal Aviation Administration Petition for Exemption; Summary of Petition Received AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of petition for exemption received. SUMMARY: This...

  14. The impact of 90-day prescriptions on adherence at workplace pharmacies compared to traditional mail order.

    PubMed

    Patwardhan, Avinash; Davis, Jeffery; Murphy, Patricia; Khandelwal, Nikhil; Sherman, Bruce; Manfred, James

    2011-12-01

    This study evaluated adherence to medications used to treat chronic conditions for patients with 90-day prescriptions, comparing patients with access to workplace pharmacy services versus patients using mail order services. De-identified pharmacy claims data were used to compute medication possession ratio and gaps in therapy. Results were compared for patients who filled 90-day prescriptions at workplace pharmacies versus patients who filled 90-day prescriptions using mail order pharmacy services in a 1-year period. Statistical tests to assess between group differences were performed controlling for differences because of age, sex, number of select chronic conditions, number of unique medication therapeutic classes, and patient out-of-pocket cost per therapy day. Statistically significant differences were found between patients who filled their maintenance medications at the worksite compared to those who used mail-order pharmacy services. Patients filling prescriptions at a workplace pharmacy were 22% less likely to have a gap in therapy of over 30 days compared to similar patients using mail order services. Workplace pharmacy utilizers also had overall adherence rates 3.68% higher than patients who utilized mail order pharmacy services. Our analysis suggests that it may not be just the quantity of medication dispensed that impacts patients' adherence to their prescription medication, but a variety of other factors including pharmacist-patient interaction. Having a pharmacist on-site and available to patients with chronic considerations could provide added value. These results can aid employers and other stakeholders to decide which prescription benefits to offer their employees and members. PMID:22092153

  15. 75 FR 55792 - PETITION FOR RECONSIDERATION OF ACTION IN RULEMAKING PROCEEDING

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ...A Petition for Reconsideration has been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR Section 1.429(e). The full text of this document is available for viewing and copying in Room CY-B402, 445 12th Street, S.W., Washington, D.C. or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI) (1-......

  16. 75 FR 19401 - Petition for Reconsideration of Action in Rulemaking Proceeding

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ...Petitions for Reconsideration have been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR Section 1.429(e). The full text of these documents is available for viewing and copying in Room CY-B402, 445 12th Street, SW, Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI) (1-......

  17. 75 FR 51072 - PETITION FOR RECONSIDERATION OF ACTION IN RULEMAKING PROCEEDING

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-18

    ...A Petition for Reconsideration has been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR Section 1.429(e). The full text of this document is available for viewing and copying in Room CY-B402, 445 12th Street, SW, Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI)......

  18. 75 FR 51072 - PETITION FOR RECONSIDERATION OF ACTION IN RULEMAKING PROCEEDING

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-18

    ...Petitions for Reconsideration have been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR Section 1.429(e). The full text of these documents is available for viewing and copying in Room CY-B402, 445 12th Street, SW, Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI)......

  19. The 90-day oral toxicity of d-psicose in male Wistar rats

    PubMed Central

    Matsuo, Tatsuhiro; Ishii, Reika; Shirai, Yoko

    2012-01-01

    d-Psicose is a rare sugar present in small quantities in natural products. In a previous study, we showed that d-psicose suppresses increase in plasma glucose and reduces body fat accumulation in rats. Based on acute toxicity testing in rats, d-psicose is classified as an ordinary substance (LD50 = 16 g/kg). Elucidating the effects of sub-chronic feeding of d-psicose in rats is essential before it can be utilized as a physiologically functional food. In this study, male Wistar rats (3 weeks old) were fed diets containing 3% d-psicose or sucrose for 90 days. The body weight gain and intra-abdominal adipose tissue weight did not differ between the sucrose and the d-psicose groups. The weights of the liver and kidneys were significantly higher in the d-psicose group than in the sucrose group. However, no gross pathological findings were evident at dietary doses of 3% d-psicose or were correlated with hypertrophy of the liver and kidney. In a clinical chemistry analysis, the erythrocyte and leukocyte courts were significantly higher in the d-psicose group, but that was not considered to be toxicologically significant. Therefore, the present study found no adverse effects of d-psicose in rats fed a diet containing 3% d-psicosefor 90 days. PMID:22448098

  20. 75 FR 30338 - Endangered and Threatened Wildlife and Plants; 12-month Finding on a Petition to List the White...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... may be warranted. On November 9, 2004, we announced our 90-day finding (69 FR 64889) that the petition... Finding on a Petition to List the White-tailed Prairie Dog as Endangered or Threatened AGENCY: Fish and... Wildlife Service announce a 12-month finding on a petition to list the white-tailed prairie dog...

  1. Program operational summary: Operational 90 day manned test of a regenerative life support system

    NASA Technical Reports Server (NTRS)

    Jackson, J. K.; Wamsley, J. R.; Bonura, M. S.; Seeman, J. S.

    1972-01-01

    An operational 90-day manned test of a regenerative life support system was successfully completed. This test was performed with a crew of four carefully selected and trained men in a space station simulator (SSS) which had a two gas atmosphere maintained at a total pressure of 68.9, 10 psia, and composed of oxygen at a partial pressure of 3.05 psia with nitrogen as the diluent. The test was planned to provide data on regenerative life support subsystems and on integrated system operations in a closed ecology, similar to that of a space station. All crew equipment and expendables were stored onboard at the start of the mission to eliminate the need for pass-in operations. The significant accomplishments of the test, some of the pertinent test results, some of the problem areas, and conclusions are presented.

  2. Ultrastructural response of rat lung to 90 days' exposure to oxygen at 450 mm Hg

    NASA Technical Reports Server (NTRS)

    Harrison, G. A.

    1974-01-01

    Young Sprague-Dawley rats were exposed to 100% oxygen at 450 mm Hg in constant environment capsules for 90 days. Lung tissue examined by electron microscopy revealed a number of changes, many similar to those observed after exposure to oxygen at 760 mm Hg for shorter periods of time. Alterations in vesicle size and number and in mitochondrial matrix and cristae appear in both the endothelial and epithelial cells. Blebbing and rarefication of cytoplasm occur in both cell layers of the alveolo-capillary wall. Also seen are fluid in the basement membrane, platelets in the capillaries, and alveolar fluid and debris. All of these alterations occur at 1 atm exposure. However, after exposure to 450 mm Hg the changes are not as widespread nor as destructive as they are at the higher pressure.

  3. Training plan for the 1164 {lt}90-day non-radioactive hazardous waste storage building

    SciTech Connect

    Demarest, J.L., Westinghouse Hanford

    1996-07-01

    In accordance with Washington Administrative Code (WAC), Chapter 173- 303, `Dangerous Waste Regulations,` a written training plan is required for a {lt}90-day accumulation area. WAC 173-303-200, `Accumulating Dangerous Waste On-site,` requires compliance with WAC- 173-303-330, Personnel Training. This training plan complies with WAC 173-303-330. This training plan, including the names of personnel in Table 1, may be given to a regulatory agency inspector upon request provided that this plan is cleared for public release. Training records associated with personnel identified in this plan are not be given to an outside regulatory agency inspector unless prior approval by the specific individual is obtained. Training records requests by regulatory agency inspectors without the individual`s approval are to be processed via a Freedom of Information Act request through the U.S. Department of Energy, Richland Operations Office.

  4. Bioregenerative Life Support Experiment for 90-days in a Closed Integrative Experimental Facility LUNAR PALACE 1

    NASA Astrophysics Data System (ADS)

    Liu, Hong

    A 90-day bioregenerative life support experiment with three-member crew was carried out in the closed integrative experimental facility, LUNAR PALACE 1 regenerating basic living necessities and disposing wastes to provide life support for crew. It was composed of higher plant module, animal module, and waste treatment module. The higher plant module included wheat, chufa, pea, carrot and green leafy vegetables, with aim to satisfy requirement of 60% plant food and 100% O2 and water for crew. The yellow mealworm was selected as animal module to provide partial animal protein for crew, and reared on plant inedible biomass. The higher plant and yellow mealworm were both cultivated and harvested in the conveyor-type manner. The partial plant inedible biomass and human feces were mixed and co- fermented in the waste treatment module for preparation of soil-like substrate by bioconversion, maintaining gas balance and increasing closure degree. Meanwhile, in the waste treatment module, the water and partial nitrogen from human urine were recovered by physical-chemical means. Circulation of O2 and water as well as food supply from crops cultivated in the LUNAR PALACE 1 were investigated and calculated, and simultaneously gas exchange, mass flow among different components and system closure degree were also analyzed, respectively. Furthermore, the system robustness with respect to internal variation was tested and evaluated by sensitivity analysis of the aggregative index consisting of key performance indicators like crop yield, gaseous equilibrium concentration, microbial community composition, biogenic elements dynamics, etc., and comprehensively evaluating the operating state, to number change of crew from 2 to 4 during the 90-day closed experiment period.

  5. Toxicity of colloidal silica nanoparticles administered orally for 90 days in rats

    PubMed Central

    Kim, Yu-Ri; Lee, Seung-Young; Lee, Eun Jeong; Park, Sung Ha; Seong, Nak-won; Seo, Heung-Sik; Shin, Sung-Sup; Kim, Seon-Ju; Meang, Eun-Ho; Park, Myeong-Kyu; Kim, Min-Seok; Kim, Cheol-Su; Kim, Soo-Ki; Son, Sang Wook; Seo, Young Rok; Kang, Boo Hyon; Han, Beom Seok; An, Seong Soo A; Lee, Beom-Jun; Kim, Meyoung-Kon

    2014-01-01

    This study was undertaken to investigate the potential toxicity and establish the no observed adverse effect level (NOAEL) and target organ(s) of negatively charged colloidal silica particles of different sizes, ie, SiO2EN20(−) (20 nm) or SiO2EN100(−) 2(100 nm), administered by gavage in Sprague-Dawley rats. After verification of the physicochemical properties of the SiO2 particles to be tested, a preliminary dose range-finding study and 90-day repeated dose study were conducted according to the Organisation for Economic Cooperation and Development test guideline. Based on the results of the 14-day dose range-finding study, a high dose was determined to be 2,000 mg/kg, and middle and low doses were set at 1,000 and 500 mg/kg, respectively. In the 90-day toxicity study, there were no animal deaths in relation to administration of SiO2 particles of either size. In addition, no treatment-related clinical changes or histopathological findings were observed in any of the experimental groups. Moreover, no difference in toxic effects from chronic exposure to SiO2EN20(−)(20 nm) or SiO2EN100(−) (100 nm) was observed. The results of this study indicate that the NOAEL for SiO2EN20(−) and SiO2 EN100(−) would most likely be 2,000 mg/kg, and no target organ was identified in rats of either sex. PMID:25565827

  6. Co-morbidities and 90-day outcomes in hospitalized COPD exacerbations.

    PubMed

    Roberts, Christopher M; Stone, Robert A; Lowe, Derek; Pursey, Nancy A; Buckingham, Rhona J

    2011-10-01

    COPD exacerbations resulting in hospitalization are accompanied by high mortality and morbidity. The contribution of specific co-morbidities to acute outcomes is not known in detail: existing studies have used either administrative data or small clinical cohorts and have provided conflicting results. Identification of co-existent diseases that affect outcomes provides opportunities to address these conditions proactively and improve overall COPD care. Cases were identified prospectively on admission then underwent retrospective case note audit to collect data including co-morbidities on up to 60 unselected consecutive acute COPD admissions between March and May in each hospital participating in the 2008 UK National COPD audit. Outcomes recorded were death in hospital, length of stay, and death and readmission at 90 days after index admission. 232 hospitals collected data on 9716 patients, mean age 73, 50% male, mean FEV1 42% predicted. Prevalence of co-morbidities were associated with increased age but better FEV1 and ex-smoker status and with worse outcomes for all four measures. Hospital mortality risk was increased with cor pulmonale, left ventricular failure, neurological conditions and non-respiratory malignancies whilst 90 day death was also increased by lung cancer and arrhythmias. Ischaemic and other heart diseases were important factors in readmission. This study demonstrates that co-morbidities adversely affect a range of short-term patient outcomes related to acute admission to hospital with exacerbations of COPD. Recognition of relevant accompanying diseases at admission provides an opportunity for specific interventions that may improve short-term prognosis. PMID:21864116

  7. A 90-Day Subchronic Toxicity Study of Submerged Mycelial Culture of Cordyceps cicadae (Ascomycetes) in Rats.

    PubMed

    Chen, Yen-Lien; Yeh, Shu-Hsing; Lin, Ting-Wei; Chen, Chin-Chu; Chen, Chin-Shuh; Kuo, Chia-Feng

    2015-01-01

    Cordyceps cicadae is a parasitic fungus that hibernates inside a host (Cicada flammata Dist.) and then grows its fruiting body on the surface of the insect. The complete insect/fungus combination of C. cicadae has been widely applied in Chinese traditional medicine. Recent studies have demonstrated that the medicinal benefits of cultured mycelia are as effective as those found in the wild. However, toxicological information regarding the chronic consumption of C. cicadae mycelia culture is not available. This study was conducted to evaluate the possible toxicity arising from repeated exposure to freeze-dried submerged mycelial culture of C. cicadae for 90 days. A total of eighty 8-week-old Sprague-Dawley rats were divided into 4 groups (10 males and 10 females in each group). C. cicadae was administered daily to animals by gavage at doses of 0, 500, 1000, and 2000 mg/kg body weight for 90 days. No animal deaths occurred and no treatment-related clinical signs were observed during the study period. No statistical differences in body weight gain, relative organ weight, hematology, serum chemistry, and urinalysis were observed. Gross necropsy and histopathological findings indicated that there was no treatment-related abnormality. Based on the results, the no observed adverse effect level of C. cicadae whole broth is determined to be > 2000 mg/kg for male and female Sprague-Dawley rats. The results of this study provides support for the use of C. cicadae fermentation product as a safe agent in functional food. PMID:26559863

  8. A 90 day chronic toxicity study of Nigerian herbal preparation DAS-77 in rats

    PubMed Central

    2012-01-01

    Background The herbal preparation DAS-77, used for the treatment of various ailments in Nigeria, contains the milled bark of Mangifera indica L. and root of Carica papaya L. Toxicological assessment of the preparation was carried out in this study. Methods In the acute toxicity study, DAS-77 was administered to mice p.o. up to 20 g/kg in divided doses and i.p. at 250–3000 mg/kg. Mortality within 24 h was recorded. In the chronic toxicity study, rats were treated p.o. for 90 days at doses of 80, 400 (therapeutic dose, TD) and 2000 mg/kg. By 90 days, animals were sacrificed and blood samples collected for hematological and biochemical analysis. Organs were harvested for weight determination, antioxidants and histopathological assessments. Results DAS-77 did not produce any lethality administered p.o. up to 20 g/kg in divided doses but the i.p. LD50 was 1122.0 mg/kg. At TD, DAS-77 produced significant (p < 0.05) reductions in body weight, food intake and K+, and increases in ovary weight, neutrophils and HDL, which were reversible. Histopathological presentations were generally normal. Effects at the other doses were comparable to those at TD except for reversible increases in antioxidants in the liver, kidney and testes, and sperm abnormality, and reductions in liver enzymes, sperm motility and count. Conclusions Findings in this study revealed that DAS-77 is relatively safe with the potential for enhancing in vivo antioxidant activity. However, possibly reversible side-effects include electrolyte imbalance and sterility in males. PMID:22892317

  9. A 90-Day Oral Toxicological Evaluation of the Methylurate Purine Alkaloid Theacrine

    PubMed Central

    Hirka, Gábor; Glávits, Róbert; Palmer, Philip A.; Endres, John R.; Pasics Szakonyiné, Ilona

    2016-01-01

    A 90-day repeated-dose oral toxicological evaluation was conducted according to GLP and OECD guidelines on the methylurate purine alkaloid theacrine, which is found naturally in certain plants. Four groups of Hsd.Brl.Han Wistar rats (ten/sex/group) were administered theacrine by gavage doses of 0 (vehicle only), 180, 300, and 375 mg/kg bw/day. Two females and one male in the 300 and 375 mg/kg bw/day groups, respectively, died during the study. Histological examination revealed centrilobular hepatocellular necrosis as the probable cause of death. In 375 mg/kg bw/day males, slight reductions in body weight development, food consumption, and feed efficiency, decreased weight of the testes and epididymides and decreased intensity of spermatogenesis in the testes, lack or decreased amount of mature spermatozoa in the epididymides, and decreased amount of prostatic secretions were detected at the end of the three months. At 300 mg/kg bw/day, slight decreases in the weights of the testes and epididymides, along with decreased intensity of spermatogenesis in the testes, and lack or decreased amount of mature spermatozoa in the epididymides were detected in male animals. The NOAEL was considered to be 180 mg/kg bw/day, as at this dose there were no toxicologically relevant treatment-related findings in male or female animals.

  10. Toxicological evaluation of L-proline in a 90-day feeding study with Fischer 344 rats.

    PubMed

    Tada, Y; Yano, N; Takahashi, H; Yuzawa, K; Ando, H; Kubo, Y; Nagasawa, A; Ohashi, N; Ogata, A; Nakae, D

    2010-10-01

    L-proline (L-Pro) is a non-essential amino acid, and has become widely used as supplements and health foods, recently. A subchronic oral toxicity study of L-Pro was conducted with groups of 10 male and 10 female Fischer 344 rats fed a powder diet containing 0%, 0.625%, 1.25%, 2.5% and 5.0% of L-Pro for 90 days. No treatment-related clinical signs and mortality were noted. We observed no clear treatment-related effects with regard to body weight, food intake or urinalysis data. The average daily water intakes of the treated female groups were significantly increased compared to the controls. The hematology (red blood cell parameter) and serum biochemistry (glucose, blood urea nitrogen, creatinine or uric acid) of the treated male and/or female groups were lower than those of the control groups. However, these changes were lacked dose-dependence, and no abnormalities were found in corresponding pathological findings. In conclusion, the no-observed-adverse-effect-level (NOAEL) for L-Pro was determined to be a dietary dose of 5.0% (2772.9 mg/kg body weight/day for males and 3009.3mg/kg body weight/day for females) under the present experimental conditions. PMID:20447433

  11. A 90-day subchronic toxicity study and reproductive toxicity studies on ACE-inhibiting lactotripeptide.

    PubMed

    Dent, M P; O'Hagan, S; Braun, W H; Schaetti, P; Marburger, A; Vogel, O

    2007-08-01

    In recent years there has been an increasing body of literature describing the antihypertensive effects of peptides produced from milk protein. The tripeptides isoleucine-proline-proline (IPP) and valine-proline-proline (VPP), isolated from hydrolysed casein have been shown to lower blood pressure by inhibiting angiotensin I-converting enzyme (ACE). This has led to the use of these tripeptides, collectively referred to as lactotripeptide (LTP) as ingredients of functional foods intended to help control blood pressure. A programme of studies including a 90-day repeat-dose oral gavage toxicity study in the rat and an embryo-fetal (pre-natal) development study in the rabbit was conducted to ensure the safety of this ACE-inhibiting ingredient. In addition, a non-standard pre- and post-natal development study in the rat was performed. This study included direct dosing of the neonates, and was designed specifically to investigate renal development and to ensure that the bioactive peptides were not associated with the same type of fetopathy exhibited by ACE inhibiting drugs. These studies showed that there were no adverse effects of treatment at the highest doses tested. PMID:17383063

  12. A 90-day oral (dietary) toxicity study of rebaudioside A in Sprague-Dawley rats.

    PubMed

    Nikiforov, Andrey I; Eapen, Alex K

    2008-01-01

    Rebaudioside A is one of several glycosides found in the leaves of Stevia rebaudiana (Bertoni) Bertoni (Compositae) stevia that has been identified as a potential sweetener. The present study (initiated in April 2006 and completed in October 2006) evaluated the safety of this sweetener when administered as a dietary admix at target exposure levels of 500, 1000, and 2000 mg/kg/day to Sprague-Dawley rats for 90 days. There were no treatment-related effects on the general condition and behavior of the animals as determined by clinical observations, functional observational battery, and locomotor activity assessments. Evaluation of clinical pathology parameters revealed no toxicologically relevant, treatment-related effects on hematology, serum chemistry, or urinalysis. Macroscopic and microscopic findings revealed no treatment-related effects on any organ evaluated. Lower mean body weight gains were noted in males in the 2000 mg/kg/day group throughout the study, which was considered to be test article related; however, given the small magnitude of the difference as compared to controls, this effect was not considered to be adverse. Results of this study clearly demonstrate that dietary administration of high concentrations of rebaudioside A for 90 consecutive days to Sprague-Dawley rats was not associated with any signs of toxicity. PMID:18293214

  13. Evaluation of silica nanoparticle toxicity after topical exposure for 90 days

    PubMed Central

    Ryu, Hwa Jung; Seong, Nak-won; So, Byoung Joon; Seo, Heung-sik; Kim, Jun-ho; Hong, Jeong-Sup; Park, Myeong-kyu; Kim, Min-Seok; Kim, Yu-Ri; Cho, Kyu-Bong; Seo, Mu Yeb; Kim, Meyoung-Kon; Maeng, Eun Ho; Son, Sang Wook

    2014-01-01

    Silica is a very common material that can be found in both crystalline and amorphous forms. Well-known toxicities of the lung can occur after exposure to the crystalline form of silica. However, the toxicities of the amorphous form of silica have not been thoroughly studied. The majority of in vivo studies of amorphous silica nanoparticles (NPs) were performed using an inhalation exposure method. Since silica NPs can be commonly administered through the skin, a study of dermal silica toxicity was necessary to determine any harmful effects from dermal exposures. The present study focused on the results of systemic toxicity after applying 20 nm colloidal silica NPs on rat skin for 90 days, in accordance with the Organization for Economic Cooperation and Development test guideline 411 with a good laboratory practice system. Unlike the inhalation route or gastrointestinal route, the contact of silica NPs through skin did not result in any toxicity or any change in internal organs up to a dose of 2,000 mg/kg in rats. PMID:25565831

  14. Evaluation of silica nanoparticle toxicity after topical exposure for 90 days.

    PubMed

    Ryu, Hwa Jung; Seong, Nak-won; So, Byoung Joon; Seo, Heung-sik; Kim, Jun-ho; Hong, Jeong-Sup; Park, Myeong-kyu; Kim, Min-Seok; Kim, Yu-Ri; Cho, Kyu-Bong; Seo, Mu Yeb; Kim, Meyoung-Kon; Maeng, Eun Ho; Son, Sang Wook

    2014-01-01

    Silica is a very common material that can be found in both crystalline and amorphous forms. Well-known toxicities of the lung can occur after exposure to the crystalline form of silica. However, the toxicities of the amorphous form of silica have not been thoroughly studied. The majority of in vivo studies of amorphous silica nanoparticles (NPs) were performed using an inhalation exposure method. Since silica NPs can be commonly administered through the skin, a study of dermal silica toxicity was necessary to determine any harmful effects from dermal exposures. The present study focused on the results of systemic toxicity after applying 20 nm colloidal silica NPs on rat skin for 90 days, in accordance with the Organization for Economic Cooperation and Development test guideline 411 with a good laboratory practice system. Unlike the inhalation route or gastrointestinal route, the contact of silica NPs through skin did not result in any toxicity or any change in internal organs up to a dose of 2,000 mg/kg in rats. PMID:25565831

  15. A 90-day subchronic toxicity study of neem oil, a Azadirachta indica oil, in mice.

    PubMed

    Wang, C; Cao, M; Shi, D-X; Yin, Z-Q; Jia, R-Y; Wang, K-Y; Geng, Y; Wang, Y; Yao, X-P; Yang, Z-R; Zhao, J

    2013-09-01

    To determine the no-observed-adverse-effect level (NOAEL) of exposure and target organs of neem oil for establishing safety criteria for human exposure, the subchronic toxicity study with neem oil in mice was evaluated. The mice (10 per sex for each dose) was orally administered with neem oil with the doses of 0 (to serve as a control), 177, 533 and 1600 mg/kg/day for 90 days. After the treatment period, observation of reversibility or persistence of any toxic effects, mice were continuously fed without treatment for the following 30 days. During the two test periods, the serum biochemistry, organ weight and histopathology were examined. The results showed that the serum biochemistry and organ coefficient in experimental groups had no statistical difference compared with those of the control group. At the 90th day, the histopathological examinations showed that the 1600 mg/kg/day dose of neem oil had varying degrees of damage on each organ except heart, uterus and ovarian. After 30-day recovery, the degree of lesions to the tissues was lessened or even restored. The NOAEL of neem oil was 177 mg/kg/day for mice and the target organs of neem oil were determined to be testicle, liver and kidneys. PMID:23444337

  16. 90-Day subchronic toxicity study of sodium molybdate dihydrate in rats.

    PubMed

    Murray, F Jay; Sullivan, Frank M; Tiwary, Asheesh K; Carey, Sandra

    2014-12-01

    This study investigated the subchronic toxicity of molybdenum (Mo) in Sprague-Dawley rats given sodium molybdate dihydrate in the diet for 90days at dose levels of 0, 5, 17 or 60mgMo/kgbw/day. The study complied with OECD Test Guideline (TG) 408, with additional examination of estrus cycles and sperm count, motility, and morphology from OECD TG 416. The overall no-observed-adverse-effect level was 17mgMo/kgbw/day, based on effects on body weight, body weight gain, food conversion efficiency and renal histopathology (females only) at 60mgMo/kgbw/day. No treatment-related adverse effects on reproductive organ weights or histopathology, estrus cycles or sperm parameters were observed at any dose level. No adverse effects were observed in the high dose animals after the 60-day recovery period, with the exception that male rats did not fully recover from reduced body weight. Serum blood, liver and kidney samples were analyzed for molybdenum, copper, zinc, manganese, iron, cobalt and selenium; high levels of molybdenum and copper were found in the serum, blood, liver and kidneys of rats treated with 60mgMo/kgbw/day. In conclusion, the LOAEL and NOAEL for molybdenum were determined to be 60 and 17mgMo/kgbw/day, respectively. PMID:24041747

  17. 77 FR 73054 - Petition for Modification

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF LABOR Mine Safety and Health Administration Petition for Modification AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice; correction. SUMMARY: This notice amends a petition for modification published...

  18. Zinc oxide nanoparticles: a 90-day repeated-dose dermal toxicity study in rats

    PubMed Central

    Ryu, Hwa Jung; Seo, Mu Yeb; Jung, Sung Kyu; Maeng, Eun Ho; Lee, Seung-Young; Jang, Dong-Hyouk; Lee, Taek-Jin; Jo, Ki-Yeon; Kim, Yu-Ri; Cho, Kyu-Bong; Kim, Meyoung-Kon; Lee, Beom Jun; Son, Sang Wook

    2014-01-01

    Zinc oxide (ZnO) works as a long-lasting, broad-spectrum physical sunblock, and can prevent skin cancer, sunburn, and photoaging. Nanosized ZnO particles are used often in sunscreens due to consumer preference over larger sizes, which appear opaque when dermally applied. Although the US Food and Drug Administration approved the use of nanoparticles (NPs) in sunscreens in 1999, there are ongoing safety concerns. The aim of this study was to evaluate the subchronic toxicity of ZnO NPs after dermal application according to the Organization for Economic Cooperation and Development Test Guidelines 411 using Good Laboratory Practice. Sprague Dawley rats were randomly divided into eight (one control, one vehicle control, three experimental, and three recovery) groups. Different concentrations of ZnO NPs were dermally applied to the rats in the experimental groups for 90 days. Clinical observations as well as weight and food consumption were measured and recorded daily. Hematology and biochemistry parameters were determined. Gross pathologic and histopathologic examinations were performed on selected tissues from all animals. Analyses of tissue were undertaken to determine target organ tissue distribution. There was no increased mortality in the experimental group. Although there was dose-dependent irritation at the site of application, there were no abnormal findings related to ZnO NPs in other organs. Increased concentrations of ZnO in the liver, small intestine, large intestine, and feces were thought to result from oral ingestion of ZnO NPs via licking. Penetration of ZnO NPs through the skin seemed to be limited via the dermal route. This study demonstrates that there was no observed adverse effect of ZnO NPs up to 1,000 mg/kg body weight when they are applied dermally. PMID:25565832

  19. Petroleum prices and profits in the 90 days following the invasion of Kuwait

    SciTech Connect

    Not Available

    1990-11-01

    For the third in the past 20 years the world has experienced an interruption in the flow of oil from the Persian Gulf. The Iraqi invasion of Kuwait on August 2, 1990, and shut down of Kuwait oil production capacity followed by the United Nations boycott of Iraqi oil removed 8 percent of the world's oil supply. The result was a sharp increase in the process of crude oil and petroleum products. These events raised numerous questions about the performance of energy markets and energy firms. This report supplies a first answer for some of those questions. At the time this report was prepared the invasion has been in effect for 90 days. Not all the data is available to fully answer every question. Some issues can only be completely resolved after more time has passed in which the invasion and its effects have had an opportunity to be fully assimilated. This report was specifically requested by W. Henson Moore, Deputy Secretary of Energy as a way of supplying the American public with what could be said about the current situation. Rumors abound and mixconceptions have proliferated. This report strives to give a proper perspective on some of the more vexing issues which the invasion produced. The Energy Information Administration (EIA) has addressed many questions in this report. By the way of summary these are the 10 most most frequently asked questions and EIA's quick answers. The page references tell the reader where to look in the report for further explanation. These are not the only issues addressed and EIA hopes that readers will be able to satisfy their curiosity about their own questions within the pages of this report.

  20. Zinc oxide nanoparticles: a 90-day repeated-dose dermal toxicity study in rats.

    PubMed

    Ryu, Hwa Jung; Seo, Mu Yeb; Jung, Sung Kyu; Maeng, Eun Ho; Lee, Seung-Young; Jang, Dong-Hyouk; Lee, Taek-Jin; Jo, Ki-Yeon; Kim, Yu-Ri; Cho, Kyu-Bong; Kim, Meyoung-Kon; Lee, Beom Jun; Son, Sang Wook

    2014-01-01

    Zinc oxide (ZnO) works as a long-lasting, broad-spectrum physical sunblock, and can prevent skin cancer, sunburn, and photoaging. Nanosized ZnO particles are used often in sunscreens due to consumer preference over larger sizes, which appear opaque when dermally applied. Although the US Food and Drug Administration approved the use of nanoparticles (NPs) in sunscreens in 1999, there are ongoing safety concerns. The aim of this study was to evaluate the subchronic toxicity of ZnO NPs after dermal application according to the Organization for Economic Cooperation and Development Test Guidelines 411 using Good Laboratory Practice. Sprague Dawley rats were randomly divided into eight (one control, one vehicle control, three experimental, and three recovery) groups. Different concentrations of ZnO NPs were dermally applied to the rats in the experimental groups for 90 days. Clinical observations as well as weight and food consumption were measured and recorded daily. Hematology and biochemistry parameters were determined. Gross pathologic and histopathologic examinations were performed on selected tissues from all animals. Analyses of tissue were undertaken to determine target organ tissue distribution. There was no increased mortality in the experimental group. Although there was dose-dependent irritation at the site of application, there were no abnormal findings related to ZnO NPs in other organs. Increased concentrations of ZnO in the liver, small intestine, large intestine, and feces were thought to result from oral ingestion of ZnO NPs via licking. Penetration of ZnO NPs through the skin seemed to be limited via the dermal route. This study demonstrates that there was no observed adverse effect of ZnO NPs up to 1,000 mg/kg body weight when they are applied dermally. PMID:25565832

  1. Intra- and Inter-Patient Symptom Variability in Fibromyalgia: Results of a 90-Day Assessment.

    PubMed

    Toussaint, Loren; Vincent, Ann; McAllister, Samantha J; Whipple, Mary

    2015-06-01

    Symptoms of fibromyalgia (FM)--chronic widespread pain, fatigue, unrefreshing sleep, dyscognition etcetera--present with varying degrees of severity in different individuals; however, studies reporting daily estimates of variability of symptoms are sparse. Given the limited literature on the stability and variability of FM symptoms, the purpose of the present study was to determine the feasibility of daily visual analogue, self-report measures to assess daily variability and time trends in core FM symptoms. Ten female patients completed daily assessments of common FM symptoms (pain, fatigue, anxiety, depression, stress, cognitive dysfunction, unrefreshing sleep and lightheadedness) for approximately 90 days. The completion rate was excellent (89.6%). The results demonstrated that average symptom intensity differs markedly across the different symptoms that were measured. Unrefreshing sleep, fatigue and pain are clearly higher in intensity than other symptoms and are followed by memory problems, stress, anxiety and depression. There is also notable average intra-individual change across time (10-15 points on a 100-point scale). Average symptom intensity does not appear to be related to the amount of symptom change within individuals. The results of the present study confirm that intensive longitudinal study, using comprehensive symptom assessment in patients with FM, is both possible and informative, in the sense that a rich description of the daily experience of living with FM can be obtained. Future work, utilizing larger samples, will offer the opportunity to investigate better the causes, consequences and correlates of the daily ups and downs of key symptoms that compromise quality of life in patients with FM. PMID:25408116

  2. Recent Trends in the Dispensing of 90-Day-Supply Prescriptions at Retail Pharmacies: Implications for Improved Convenience and Access

    PubMed Central

    Liberman, Joshua N.; Girdish, Charmaine

    2011-01-01

    Background Mail-service pharmacies offer consumers the convenience of prescriptions filled with a 90-day supply of medication. Unlike mail-service pharmacies, retail pharmacies traditionally dispensed maintenance medication prescriptions with a 30-day supply. However, the retail landscape changed in May 2008 with Walmart's announcement of an extension of its $4 Prescription Program to include 90-day-supply prescriptions. Objective To evaluate recent changes in access to and use of 90-day-supply maintenance medications dispensed via retail pharmacy. Summary As of the first quarter of 2007, the proportion of retail-dispensed maintenance medications with a 90-day supply (compared with all maintenance prescriptions dispensed) among Medicare Part D plans, self-insured employers, and private health plans was 5.1%, 5.1%, and 5.0%, respectively. As of December 2009, this ratio had risen to 8.0% for Medicare plans and 8.1% for commercial health plans; the ratio among employers had risen more modestly to 6.1%. Of particular interest and importance, the proportion increased similarly for brand and for generic medications. Conclusion There has been substantial growth in 90-day prescriptions dispensed via retail pharmacy, a trend that is likely to continue as more insurance providers adopt compatible benefit designs. It is important to continue monitoring these trends and to identify opportunities to rigorously evaluate their impact on medication adherence and healthcare costs. PMID:25126341

  3. A 90-day study of subchronic oral toxicity of 20 nm, negatively charged zinc oxide nanoparticles in Sprague Dawley rats

    PubMed Central

    Park, Hark-Soo; Shin, Sung-Sup; Meang, Eun Ho; Hong, Jeong-sup; Park, Jong-Il; Kim, Su-Hyon; Koh, Sang-Bum; Lee, Seung-Young; Jang, Dong-Hyouk; Lee, Jong-Yun; Sun, Yle-Shik; Kang, Jin Seok; Kim, Yu-Ri; Kim, Meyoung-Kon; Jeong, Jayoung; Lee, Jong-Kwon; Son, Woo-Chan; Park, Jae-Hak

    2014-01-01

    Purpose The widespread use of nanoparticles (NPs) in industrial and biomedical applications has prompted growing concern regarding their potential toxicity and impact on human health. This study therefore investigated the subchronic, systemic oral toxicity and no-observed-adverse-effect level (NOAEL) of 20 nm, negatively charged zinc oxide (ZnOSM20(−)) NPs in Sprague Dawley rats for 90 days. Methods The high-dose NP level was set at 500 mg/kg of bodyweight, and the mid- and low-dose levels were set at 250 and 125 mg/kg, respectively. The rats were observed during a 14-day recovery period after the last NP administration for the persistence or reduction of any adverse effects. Toxicokinetic and distribution studies were also conducted to determine the systemic distribution of the NPs. Results No rats died during the test period. However, ZnOSM20(−) NPs (500 mg/kg) induced changes in the levels of anemia-related factors, prompted acinar cell apoptosis and ductular hyperplasia, stimulated periductular lymphoid cell infiltration and excessive salivation, and increased the numbers of regenerative acinar cells in the pancreas. In addition, stomach lesions were seen at 125, 250, and 500 mg/kg, and retinal atrophy was observed at 250 and 500 mg/kg. The Zn concentration was dose-dependently increased in the liver, kidney, intestines, and plasma, but not in other organs investigated. Conclusion A ZnOSM20(−) NP NOAEL could not be established from the current results, but the lowest-observed-adverse-effect level was 125 mg/kg. Furthermore, the NPs were associated with a number of undesirable systemic actions. Thus, their use in humans must be approached with caution. PMID:25565828

  4. Effects of 30-, 60-, and 90-Day Bed Rest on Postural Control in Men and Women

    NASA Technical Reports Server (NTRS)

    Esteves, Julie; Taylor, Laura C.; Vanya, Robert D.; Dean, S. Lance; Wood, Scott J.

    2011-01-01

    INTRODUCTION Head-down-tilt bed rest (HDT) has been used as a safe gr ound-based analog to mimic and develop countermeasures for the physiological effects of spaceflight, including decrements in postural stability. The purpose of this investigation was to characterize the effects of 30-, 60-, and 90-day bed rest on postural control in men and women. METHODS Twenty-nine subjects (18M,11F) underwent 13 days of ambula tory acclimatization and were placed in 6? HDT for 30 (n=12), 60 (n=8), or 90 (n=9) days, followed by 14 days of ambulatory recovery. Computerized dynamic posturography (CDP) was used to assess changes in sensory and motor components of postural control, and recovery after HDT. Sensory Organization Tests (SOTs) objectively evaluate one?s ability to effectively use or suppress visual, vestibular, and proprioceptive information for postural control. Stability during the SOTs was assessed using peak-to-peak sway and convergence toward stability limits to derive an equilibrium score. Motor Control Tests (MCTs) evaluate one?s ability to recover from unexpected support surface perturbations, with performance determined by center-of-pressure path length. Whole-body kinematic data were collected to determine body-sway strategy used to maintain stability during each condition. Baselines were determined pre-HDT. Recovery was tracked post-HDT on days 0, 1, 2, and 4. RESULTS Immediately after HDT, subjects showed decreased performance on most SOTs, primarily on sway-referenced support conditions, typically returning to baseline levels within 4 days. MCT performance was not significantly affected. There were no significant gender or duration differences in performance. Kinematic data revealed a tendency to use ankle strategy to maintain an upright stance during most SOT conditions. Interestingly, six subjects (2M,4F) experienced orthostatic intolerance and were unable to complete day 0 testing. CONCLUSION HDT mimics some un loading mechanisms of spaceflight and

  5. Comparative 90-day dietary study of paraffin wax in Fischer-344 and Sprague-Dawley rats.

    PubMed

    Griffis, L C; Twerdok, L E; Francke-Carroll, S; Biles, R W; Schroeder, R E; Bolte, H; Faust, H; Hall, W C; Rojko, J

    2010-01-01

    Highly refined mineral hydrocarbons (MHCs) such as low melting point paraffin wax (LMPW) and low viscosity white oils can cause inflammatory changes in the liver and mesenteric lymph nodes (MLNs) of the Fischer-344 (F-344) rat. In contrast, only minimal MLN changes are seen in the Sprague-Dawley (S-D) rat with no changes in the liver. In this study, the response of female F-344 and S-D rats was compared after 90days dietary treatment with 0%, 0.2% or 2% LMPW. Effects in the F-344 rats were significantly greater than in the S-D rats: increased liver and splenic weights and inflammatory changes (hepatic microgranulomas) in these tissues were observed only in the F-344 rats. Microgranulomas in the MLNs were observed in both strains but the effects were substantially greater in the F-344 rats. Cellular markers of inflammation were examined in a subset of rats from each group using immunohistochemical staining. An increase in staining for CD3 (T-cells), CD8a (suppresser/cytotoxic T-cells) and CD4 (helper T-cells) correlated with an increase in lymphoid cells in the livers of treated F-344 rats. The majority of macrophages in the hepatic microgranulomas of treated F-344 rats were negative for the ED2 marker, indicating a likely origin from non-resident macrophages. Electron microscopy showed Kupffer cell hypertrophy and hyperplasia in treated F-344 rats. However, lysozyme staining (indicating activation of epithelioid macrophages) decreased with increasing granuloma size. Non-ED2 expressing cells may have been recruited but not sufficiently activated to be lysozyme positive. Inflammatory changes in the cardiac mitral valve noted in previous studies of LMPW were also seen in the F-344 rats in this study but not in the S-D rats. Chemical analysis showed that MHC accumulated in livers from treated F-344 but not S-D rats and the concentration was more than 2-fold greater in MLNs from the F-344 than from the S-D rats. The F-344 appears to be more immunologically sensitive to

  6. A 90-day dietary study on kappa carrageenan with emphasis on the gastrointestinal tract.

    PubMed

    Weiner, Myra L; Nuber, David; Blakemore, William R; Harriman, Jay F; Cohen, Samuel M

    2007-01-01

    Groups of Fischer 344 rats (20/sex/group) received control or treated diets at levels of 0, 25,000 or 50,000 ppm kappa carrageenan with a molecular weight range (Mw) of 196,000-257,000 Da for 90 days. The Low Molecular Weight Tail (LMT) ranged between 1.9% and 12.0%<50 kDa (mean 7%) based on the results of a program initiated to develop a validated analytical method to measure the LMT. This is the first GLP dietary study in which carrageenan is characterized by percentage LMT. Clinical examinations were performed daily. Individual food consumption/body weight measurements were made weekly. Ophthalmic exam was conducted prior to and at the end of treatment. Hematology/serum chemistry and urinalysis evaluations were done at necropsy, as were organ weight determinations for adrenals, brain, heart, kidneys, liver, ovaries, spleen, testes and thyroid with parathyroids. Full histopathological evaluation of organs was conducted on the control and 50,000 ppm groups, including hematoxylin-eosin-stained cross sections of paraffin-embedded rolled colon. Clinical signs were limited to soft feces in high dose rats and to a lesser extent in low dose rats. There were no treatment-related effects on body weights, urinalysis, hematology or clinical chemistry parameters, or on organ weights or ophthalmic, macroscopic or microscopic findings. The gastrointestinal tract appeared normal in detailed histopathological evaluation using the Swiss roll technique. The NOAEL is 50,000 ppm in the diet (mean calculated test material consumption of 3394+/-706 mg/kg/day in males, 3867+/-647 mg/kg/day in females). The results of the study provide evidence that it is not necessary to characterize carrageenan by a specification for LMT (less than 5% below 50 kDa) as has been done in Commission Directive 2004/45/EC of 16 April 2004 (Commission Directive, 2004/45/EC of 16 April 2004 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colors and sweeteners

  7. 46 CFR 550.403 - Contents of petitions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 9 2010-10-01 2010-10-01 false Contents of petitions. 550.403 Section 550.403 Shipping FEDERAL MARITIME COMMISSION REGULATIONS AND ACTIONS TO ADDRESS RESTRICTIVE FOREIGN MARITIME PRACTICES... Petitions for Section 19 Relief § 550.403 Contents of petitions. Petitions for relief from...

  8. 46 CFR 550.403 - Contents of petitions.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 9 2013-10-01 2013-10-01 false Contents of petitions. 550.403 Section 550.403 Shipping FEDERAL MARITIME COMMISSION REGULATIONS AND ACTIONS TO ADDRESS RESTRICTIVE FOREIGN MARITIME PRACTICES... Petitions for Section 19 Relief § 550.403 Contents of petitions. Petitions for relief from...

  9. 37 CFR 2.146 - Petitions to the Director.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Petitions to the Director. 2..., DEPARTMENT OF COMMERCE RULES OF PRACTICE IN TRADEMARK CASES Petitions and Action by the Director § 2.146 Petitions to the Director. (a) Petition may be taken to the Director: (1) From any repeated or final...

  10. 37 CFR 2.146 - Petitions to the Director.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Petitions to the Director. 2..., DEPARTMENT OF COMMERCE RULES OF PRACTICE IN TRADEMARK CASES Petitions and Action by the Director § 2.146 Petitions to the Director. (a) Petition may be taken to the Director: (1) From any repeated or final...

  11. 37 CFR 2.146 - Petitions to the Director.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Petitions to the Director. 2..., DEPARTMENT OF COMMERCE RULES OF PRACTICE IN TRADEMARK CASES Petitions and Action by the Director § 2.146 Petitions to the Director. (a) Petition may be taken to the Director: (1) From any repeated or final...

  12. 37 CFR 2.146 - Petitions to the Director.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Petitions to the Director. 2..., DEPARTMENT OF COMMERCE RULES OF PRACTICE IN TRADEMARK CASES Petitions and Action by the Director § 2.146 Petitions to the Director. (a) Petition may be taken to the Director: (1) From any repeated or final...

  13. 43 CFR 14.3 - Consideration of petitions.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Consideration of petitions. 14.3 Section 14.3 Public Lands: Interior Office of the Secretary of the Interior PETITIONS FOR RULEMAKING § 14.3 Consideration of petitions. The petition will be given prompt consideration and the petitioner will be notified promptly of action...

  14. 77 FR 22749 - Petition To List 83 Species of Coral as Threatened or Endangered Under the Endangered Species Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-17

    ... petitioned species (75 FR 6616). The 90-day finding was followed by a public comment period, during which we..., along with the information received on the 90-day finding (75 FR 6616; February 10, 2010), when we make... workshops on this topic. The Status Review Report examines the biology of, threats to, and extinction...

  15. 76 FR 62899 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... April 22, 2009, the Service issued its 90-day finding (74 FR 18336), concluding that the petition... Historic Park (SHP) in the south. Since the publication of our 90-day finding (74 FR 18336; April 26, 2009... plenty of suitable habitat in good to fair condition at all 14 occurrences that would adequately...

  16. 76 FR 44566 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Frigid...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... published a 90-day finding (74 FR 6122) for 165 of the 206 mountain- prairie species, which did not include... finding (74 FR 41649) for 38 mountain-prairie region species, and initiated status reviews on 29 of those... our publication of a 90-day finding (74 FR 41649) and initiation of status review on a petition...

  17. 77 FR 57921 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List 14 Aquatic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-18

    ... to in the petition and in our 90-day finding (76 FR 61826) as the nerite pebblesnail and the... late 2009, and published a 90-day finding on October 5, 2011 (76 FR 61826). We found that substantial... pebblesnail, respectively (76 FR 61836, 61843). Information that we reviewed for this status review...

  18. 78 FR 67036 - Extension of Deadline for Action on the Section 126 Petition From Eliot, Maine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-08

    ... significant regulatory action under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). B... Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on...

  19. Visual-motor response of crewmen during a simulated 90-day space mission as measured by the critical task battery

    NASA Technical Reports Server (NTRS)

    Allen, R. W.; Jex, H. R.

    1973-01-01

    In order to test various components of a regenerative life support system and to obtain data on the physiological and psychological effects of long duration exposure to confinement in a space station atmosphere, four carefully screened young men were sealed in a space station simulator for 90 days and administered a tracking test battery. The battery included a clinical test (Critical Instability Task) designed to measure a subject's dynamic time delay, and a more conventional steady tracking task, during which dynamic response (describing functions) and performance measures were obtained. Good correlation was noted between the clinical critical instability scores and more detailed tracking parameters such as dynamic time delay and gain-crossover frequency. The levels of each parameter span the range observed with professional pilots and astronaut candidates tested previously. The chamber environment caused no significant decrement on the average crewman's dynamic response behavior, and the subjects continued to improve slightly in their tracking skills during the 90-day confinement period.

  20. Influences of northward propagating 25-90-day and quasi-biweekly oscillations on eastern China summer rainfall

    NASA Astrophysics Data System (ADS)

    Chen, Jiepeng; Wen, Zhiping; Wu, Renguang; Chen, Zesheng; Zhao, Ping

    2015-07-01

    The present study reveals that rainfall anomalies associated with the 25-90-day (quasi-biweekly) tropical convective activity propagates northward (northwestward) into northern China (the Yangtze River). Enhanced rainfall over southern China results directly from enhanced convection propagating northward from the South China Sea (SCS)-western north Pacific (WNP), strengthened northward water vapor transport and intensified upper-level divergence. The anomalous anticyclone over SCS-WNP, which is induced by local lower sea surface temperature, provides a favorable condition for transporting more moisture to southern China. Stronger subtropical westerly jet and South Asia high strengthen upper-level divergence. The northward propagating 25-90-day oscillation over eastern China reaches farther north than the quasi-biweekly oscillation (QBWO). The intensity of QBWO in summer rainfall has significantly strengthened over southern China after 1993 but not for the 25-90-day oscillation. This is mainly contributed by an interdecadal increase in rainfall over southern China and the Yangtze River Basin in the wet phases of QBWO. The interdecadal enhancement of rainfall associated with the QBWO is attributed to three factors. One is lower tropospheric convergence caused by anomalous anticyclone over the WNP and anomalous cyclone over Korean Peninsula and Japan. The second is upper tropospheric divergence resulting from strengthening of subtropical westerly jet and the South Asia high. The last is enhanced ascent over South China through meridional vertical circulation.

  1. 78 FR 68659 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ..., 2008, we published a 12-month finding on the petition to list the Gunnison's prairie dog (73 FR 6660... published a 90-day finding in the Federal Register (71 FR 6241) determining that the petition did not... notice of review process (73 FR 75175, December 20, 2008; 74 FR 57804, November 9, 2009; 75 FR...

  2. First Report of 90-Day Support of Two Calves with a Continuous-Flow Total Artificial Heart

    PubMed Central

    Karimov, Jamshid H.; Moazami, Nader; Kobayashi, Mariko; Sale, Shiva; Such, Kimberly; Byram, Nicole; Sunagawa, Gengo; Horvath, David; Gao, Shengqiang; Kuban, Barry; Golding, Leonard A.; Fukamachi, Kiyotaka

    2015-01-01

    Objective The Cleveland Clinic continuous-flow total artificial heart (CFTAH) is a compact, single-piece, valveless, pulsatile pump providing self-regulated hemodynamic output to left/right circulation. We evaluated chronic in vivo pump performance, physiologic and hemodynamic parameters, and biocompatibility of the CFTAH in a well-established calf model. Methods CFTAH pumps have been implanted in 17 calves total. Hemodynamics, pump performance, and device-related adverse events were evaluated during studies and at necropsy. Results In vivo experiments demonstrated good hemodynamic performance (pump flow, 7.3 ± 0.7 L/min; left atrial pressure [LAP], 16 ± 3 mm Hg; right atrial pressure [RAP], 17 ± 3 mm Hg; RAP-LAP difference, 1 ± 2 mm Hg; mean arterial pressure, 103 ± 7 mm Hg; arterial pulse pressure, 30 ± 11 mm Hg; pulmonary arterial pressure, 34 ± 5 mm Hg). The CFTAH has operated within design specifications and never failed. With ever-improving pump design, the implants have shown no chronic hemolysis. Three recent animals with the CFTAH recovered well, with no postoperative anticoagulation, during planned in vivo durations of 30, 90, and 90 days (last two were intended to be 90-day studies). All these longest-surviving cases showed good biocompatibility, with no thromboembolism in organs. Conclusions The current CFTAH has demonstrated reliable self-regulation of hemodynamic output and acceptable biocompatibility without anticoagulation throughout 90 days of chronic implantation in calves. Meeting these milestones is in accord with our strategy to achieve transfer of this unique technology to surgical practice, thus filling the urgent need for cardiac replacement devices as destination therapy. PMID:26173607

  3. Toxicological assessment of a prototype e-cigaret device and three flavor formulations: a 90-day inhalation study in rats

    PubMed Central

    Werley, Michael S.; Kirkpatrick, Dan J.; Oldham, Michael J.; Jerome, Ann M.; Langston, Timothy B.; Lilly, Patrick D.; Smith, Donna C.; Mckinney, Willie J.

    2016-01-01

    Abstract A prototype electronic cigaret device and three formulations were evaluated in a 90-day rat inhalation study followed by a 42-day recovery period. Animals were randomly assigned to groups for exposure to low-, mid- and high-dose levels of aerosols composed of vehicle (glycerin and propylene glycol mixture); vehicle and 2.0% nicotine; or vehicle, 2.0% nicotine and flavor mixture. Daily targeted aerosol total particulate matter (TPM) doses of 3.2, 9.6 and 32.0 mg/kg/day were achieved by exposure to 1 mg/L aerosol for 16, 48 and 160 min, respectively. Pre-study evaluations included indirect ophthalmoscopy, virology and bacteriological screening. Body weights, clinical observations and food consumption were monitored weekly. Plasma nicotine and cotinine and carboxyhemoglobin levels were measured at days 28 and 90. After days 28, 56 and 90, lung function measurements were obtained. Biological endpoints after 90-day exposure and 42-day recovery period included clinical pathology, urinalysis, bronchoalveolar fluid (BALF) analysis, necropsy and histopathology. Treatment-related effects following 90 days of exposure included changes in body weight, food consumption and respiratory rate. Dose-related decreases in thymus and spleen weights, and increased BALF lactate dehydrogenase, total protein, alveolar macrophages, neutrophils and lung weights were observed. Histopathology evaluations revealed sporadic increases in nasal section 1–4 epithelial hyperplasia and vacuolization. Following the recovery period, effects in the nose and BALF were persistent while other effects were resolved. The no observed effect level based upon body weight decreases is considered to be the mid-dose level for each formulation, equivalent to a daily TPM exposure dose of approximately 9.6 mg/kg/day. PMID:26787428

  4. Toxicological assessment of a prototype e-cigaret device and three flavor formulations: a 90-day inhalation study in rats.

    PubMed

    Werley, Michael S; Kirkpatrick, Dan J; Oldham, Michael J; Jerome, Ann M; Langston, Timothy B; Lilly, Patrick D; Smith, Donna C; Mckinney, Willie J

    2016-01-01

    A prototype electronic cigaret device and three formulations were evaluated in a 90-day rat inhalation study followed by a 42-day recovery period. Animals were randomly assigned to groups for exposure to low-, mid- and high-dose levels of aerosols composed of vehicle (glycerin and propylene glycol mixture); vehicle and 2.0% nicotine; or vehicle, 2.0% nicotine and flavor mixture. Daily targeted aerosol total particulate matter (TPM) doses of 3.2, 9.6 and 32.0 mg/kg/day were achieved by exposure to 1 mg/L aerosol for 16, 48 and 160 min, respectively. Pre-study evaluations included indirect ophthalmoscopy, virology and bacteriological screening. Body weights, clinical observations and food consumption were monitored weekly. Plasma nicotine and cotinine and carboxyhemoglobin levels were measured at days 28 and 90. After days 28, 56 and 90, lung function measurements were obtained. Biological endpoints after 90-day exposure and 42-day recovery period included clinical pathology, urinalysis, bronchoalveolar fluid (BALF) analysis, necropsy and histopathology. Treatment-related effects following 90 days of exposure included changes in body weight, food consumption and respiratory rate. Dose-related decreases in thymus and spleen weights, and increased BALF lactate dehydrogenase, total protein, alveolar macrophages, neutrophils and lung weights were observed. Histopathology evaluations revealed sporadic increases in nasal section 1-4 epithelial hyperplasia and vacuolization. Following the recovery period, effects in the nose and BALF were persistent while other effects were resolved. The no observed effect level based upon body weight decreases is considered to be the mid-dose level for each formulation, equivalent to a daily TPM exposure dose of approximately 9.6 mg/kg/day. PMID:26787428

  5. A 90-day subchronic toxicity study with sodium formononetin-3'-sulphonate (Sul-F) delivered to dogs via intravenous administration.

    PubMed

    Li, Chunmei; Li, Guisheng; Gao, Yonglin; Sun, Chengfeng; Wang, Xiaoyan

    2016-06-01

    Sodium formononetin-3'-sulphonate (Sul-F) is a water-soluble derivate of formononetin, and an increasing number of studies have shown that Sul-F not only possesses favorable water solubility but also exhibits good lipid-lowering and bioactivities. In the current study, the toxicity of Sul-F was evaluated in dogs after 90-day intravenous infusion. Dogs were treated with Sul-F at dose of 0, 33.3, 100, and 300 mg/kg, and observed for 90-day followed by 28-day recovery period. Weekly measurement of body weight, temperature and food consumption were conducted. Ophthalmoscopy, ECG examination, urinalysis, serum biochemistry and hematology examination were performed at pre-test, on days 45 and 90, and following by 28-day recovery period. Histological examination was performed on day 90 and 28-day recovery period. No mortality, ophthalmic abnormalities or treatment-related findings in body weight, clinical chemistry, hematology, and histopathological examination were detected. However, a white crystal (non-metabolic Sul-F), transient vomiting and recoverable vascular stimulation were observed in 300 mg/kg/day Sul-F treated dogs. Under the conditions, the no-observed-adverse-effect-level (NOAEL) for Sul-F was 100 mg/kg in dogs. PMID:26924788

  6. The development and succession of microbial communities in 90-day Bioregenerative Life Support Experiment in the Lunar Palace 1

    NASA Astrophysics Data System (ADS)

    Sun, Yi; Liu, Hong; Fu, Yuming; Liu, Bojie; Su, Qiang; Xie, Beizhen; Qin, Youcai; Dong, Chen; Liu, Guanghui

    Lunar Palace 1, as an integrative experiment facility for permanent astrobase life-support artificial closed ecosystem, is an artificial ecosystem which consists of plant cultivation, animal breeding and waste treatment units. It has been used to carry out a 90-day bioregenerative life support experiment with three crew members. Apparently, it’s hard to prevent the growth of microorganisms in such closed ecosystem for their strong adaptive capacity. Original microorganisms in the cabin, microbes in the course of loads delivery and the autologous microorganism by crew members and animals themselves are all the main source of the interior microorganisms, which may grow and regenerate in air, water and plants. Therefore, if these microorganisms could not be effectively monitored and controlled, it may cause microbial contamination and even lead to the unsteadiness of the whole closed ecosystem. In this study, the development and succession of the microbial communities of air, water system, plant system, and key facilities surfaces in Lunar Palace 1 were continuously monitored and analyzed by using plate counting method and molecular biological method during the 90-day experiment. The results were quite useful for the controlling of internal microorganisms and the safe operation of the whole system, and could also reveal the succession rules of microorganisms in an artificial closed ecosystem.

  7. Safety assessment of essential oil from Minthostachys verticillata (Griseb.) Epling (peperina): 90-days oral subchronic toxicity study in rats.

    PubMed

    Escobar, Franco Matías; Sabini, María Carola; Cariddi, Laura Noelia; Sabini, Liliana Inés; Mañas, Fernando; Cristofolini, Andrea; Bagnis, Guillermo; Gallucci, Mauro Nicolas; Cavaglieri, Lilia Renée

    2015-02-01

    Minthostachys verticillata (Lamiaceae), popularly known as peperina is largely used in popular medicine for its digestive, carminative, antispasmodic and antirheumatic properties. There are no reports of repeated exposure toxicity to guarantee their safety. The present study investigated the chemical composition, analyzed by GC-FID, and the 90-day toxicity and genotoxicity effect of M. verticillata essential oil (Mv-EO), using Wistar rats as test animals. The rats were divided into four groups (5 rats/sex/group) and Mv-EO was administered on diet at doses of 0, 1, 4 and 7 g/kg feed. The main components of Mv-EO were pulegone (64.65%) and menthone (23.92%). There was no mortality, adverse effects on general conditions or changes in body weight, food consumption and feed conversion efficiency throughout the study in male and female rats. Subchronic administration of Mv-EO did not alter the weights, morphological and histopathological analyses of liver, kidney and intestine. Genotoxicity was tested by micronucleus and comet assays. Mv-EO up to a concentration of 7 g/kg feed for 90 days did not exert a cyto-genotoxic effect on the bone marrow and cells blood of Wistar rats. These results suggest that Mv-EO appears to be safe and could be devoid of any toxic risk. PMID:25445298

  8. 77 FR 3423 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the `I'iwi as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-24

    ...) and nonnative plants (Pratt et al. 2009, p. 152; 75 FR 18959, April 13, 2010). During dry periods... the continental United States. These assessments may not address the many species that could be pests..., that is, ] materials coming from the continental United States, and it relies on referrals from...

  9. 75 FR 57426 - Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To Reclassify the U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... population segment (DPS) policy (61 FR 4722; February 7, 1996). (5) Discreteness, significance, and status of... habitat, particularly in south Florida (49 FR 7332). The endangered status covered wood storks in the.... At the time of listing, critical habitat was considered but not designated for this species (49...

  10. Pulmonary toxicity of simulated lunar and Martian dusts in mice: I. Histopathology 7 and 90 days after intratracheal instillation

    NASA Technical Reports Server (NTRS)

    Lam, Chiu-Wing; James, John T.; McCluskey, Richard; Cowper, Shawn; Balis, John; Muro-Cacho, Carlos

    2002-01-01

    NASA is contemplating sending humans to Mars and to the moon for further exploration. Volcanic ashes from Arizona and Hawaii with mineral properties similar to those of lunar and Martian soils, respectively, are used to simulate lunar and Martian environments for instrument testing. Martian soil is highly oxidative; this property is not found in Earth's volcanic ashes. NASA is concerned about the health risk from potential exposure of workers in the test facilities. Fine lunar soil simulant (LSS), Martian soil simulant (MSS), titanium dioxide, or quartz in saline was intratracheally instilled into groups of 4 mice (C57BL/6J) at 0.1 mg/mouse (low dose, LD) or 1 mg/mouse (high dose, HD). Separate groups of mice were exposed to ozone (0.5 ppm for 3 h) prior to MSS instillation. Lungs were harvested for histopathological examination 7 or 90 days after the single dust treatment. The lungs of the LSS-LD groups showed no evidence of inflammation, edema, or fibrosis; clumps of particles and an increased number of macrophages were visible after 7 days but not 90 days. In the LSS-HD-7d group, the lungs showed mild to moderate alveolitis, and perivascular and peribronchiolar inflammation. The LSS-HD-90d group showed signs of mild chronic pulmonary inflammation, septal thickening, and some fibrosis. Foci of particle-laden macrophages (PLMs) were still visible. Lung lesions in the MSS-LD-7d group were similar to those observed in the LSS-HD-7d group. The MSS-LD-90d group had PLMs and scattered foci of mild fibrosis in the lungs. The MSS-HD-7d group showed large foci of PLMs, intra-alveolar debris, mild-to-moderate focal alveolitis, and perivascular and peribronchiolar inflammation. The MSS-HD-90d group showed focal chronic mild-to-moderate alveolitis and fibrosis. The findings in the O(3)-MSS-HD-90d group included widespread intra-alveolar debris, focal moderate alveolitis, and fibrosis. Lung lesions in the MSS groups were more severe with the ozone pretreatment. The effects of

  11. Training and certification program of the operating staff for a 90-day test of a regenerative life support system

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Prior to beginning a 90-day test of a regenerative life support system, a need was identified for a training and certification program to qualify an operating staff for conducting the test. The staff was responsible for operating and maintaining the test facility, monitoring and ensuring crew safety, and implementing procedures to ensure effective mission performance with good data collection and analysis. The training program was designed to ensure that each operating staff member was capable of performing his assigned function and was sufficiently cross-trained to serve at certain other positions on a contingency basis. Complicating the training program were budget and schedule limitations, and the high level of sophistication of test systems.

  12. APPLYING EXPERIENCE SAMPLING METHODS TO PARTNER VIOLENCE RESEARCH: SAFETY AND FEASIBILITY IN A 90-DAY STUDY OF COMMUNITY WOMEN

    PubMed Central

    Sullivan, Tami P.; Khondkaryan, Enna; Dos Santos, Nancy P.; Peters, Erica N.

    2011-01-01

    An experience sampling method (ESM) rarely has been applied in studies of intimate partner violence (IPV) despite the benefits to be gained. Because ESM approaches and women who experience IPV present unique challenges for data collection an empirical question exists: is it safe and feasible to apply ESM to community women who currently are experiencing IPV? A 90-day, design-driven feasibility study examined daily telephone data collection, daily paper diaries, and monthly retrospective semi-structured interview methods among a community sample of 123 women currently experiencing IPV to study within-person relationships between IPV and substance use. Findings suggest that ESM is a promising method for collecting data among this population and can elucidate daily dynamics of victimization as well as associated behaviors and experiences. Lessons learned from the application of ESM to this population are also discussed. PMID:21307033

  13. Dietary and Food Processing for a 90-day Bioregenerative Life Support Experiment in the Lunar Palace 1

    NASA Astrophysics Data System (ADS)

    Zhao, Zhiruo; Fu, Yuming; Dong, Chen; Liu, Guanghui

    A 4-day cycle dietary menu was developed to meet the requirements of balanced diet of the crew within the 90-day closed experiment of bioregenerative life support in the Lunar Palace 1. The menu consisted of items prepared from crops and insect grown inside the system, as well as prestored food. Dairy recipe was composed of breads, vegetables, meats and soups, which provided about 2900 kcal per crew member per day. During food processing, to maximize nutrient recovery and minimize waste production, the whole wheat grains and chufa nuts were milled. Further, the carrot leaves and yellow mealworms were used as salad materials and bread ingredients, respectively. The sensory acceptability of the dishes in the menu was evaluated by flavor, texture, and appearance. Our results show that all dishes in the 4-day cycle menu were highly acceptable, which satisfies nutritional requirement of the crew members in the closed habitation.

  14. A 90-day study of three bruchid-resistant mung bean cultivars in Sprague-Dawley rats.

    PubMed

    Yao, Yang; Cheng, Xuzhen; Ren, Guixing

    2015-02-01

    Mung bean has been traditionally and widely used as an edible and medicinal plant in the South and Southeast Asia. Bruchid resistance mung bean has more potential in commercial use, but scarcely been evaluated for safety through standard in vivo toxicological studies. In the present study, subchronic oral toxicity studies of bruchid-resistant mung bean were designed and conducted in Sprague-Dawley (SD) rats for 90 days. During the subchronic oral toxicity study, no mortality and toxicologically significant changes in clinical signs, food consumption, opthalmoscopic examination, hematology, clinical biochemistry, macroscopic findings, organ weights and histopathological examination were noted in animal administered diet containing bruchid-resistant mung bean. These results demonstrated that bruchid resistant mung bean is as safe as conventional mung bean. PMID:25533792

  15. [Ophthalmoscopic observations of ocular fundus in colony-born cynomolgus monkeys aged from 0 day to 90 days].

    PubMed

    Suzuki, M T; Narita, H; Tanaka, Y; Cho, F; Fukui, M

    1984-04-01

    Apparently healthy 242 colony-born cynomolgus monkeys (Macaca fascicularis) aged from 0 day to 90 days were examined for the findings of ocular fundus by using ophthalmoscope. One drop of mixed solution of 0.5% tropicamide and 0.5% phenylephrine hydrochloride was instilled into each eye of the monkey. Then, those monkeys were anesthetized with ketamine-HC1 at the dose level of 10mg/kg B. W. Regular and fluorescein photographs were taken with Kowa RC-II ophthalmoscope-camera by using daylight typed color film. Following findings were obtained in each age class: Retinal color was salmon pink with 0 to 3-days-old neonates, salmon pink and blue to green with 7 days to 14-days-old animals and blue to green with 60-days to 90-days-old monkeys. As regards optic disc, 0- to 14-days-old animals were observed to be light orange in color, and the infant aged more than 28-days showed orange color. Retinal arteries and veins were lightly reddish in color with every age class. Macular color was salmon pink in 0-day-old cases, slightly dark in 3-days-old neonates and very dark after 14-days of age. Lightly retinal reflex was noted in 0- and 7-days-old animals. The reflex was observable in 14-days-old animals without any case of exception. Retinal hemorrhages were recorded in 22 (67%) of 36 neonates born in natural condition and 10 (33%) of 30 neonates born by cesarean section. These findings will be useful as the criteria for ophthalmoscopic observations of the cynomolgus monkeys as laboratory use. PMID:6468512

  16. Toxicity of 100 nm zinc oxide nanoparticles: a report of 90-day repeated oral administration in Sprague Dawley rats

    PubMed Central

    Kim, Yu-Ri; Park, Jong-Il; Lee, Eun Jeong; Park, Sung Ha; Seong, Nak-won; Kim, Jun-Ho; Kim, Geon-Yong; Meang, Eun-Ho; Hong, Jeong-Sup; Kim, Su-Hyon; Koh, Sang-Bum; Kim, Min-Seok; Kim, Cheol-Su; Kim, Soo-Ki; Son, Sang Wook; Seo, Young Rok; Kang, Boo Hyon; Han, Beom Seok; An, Seong Soo A; Yun, Hyo-In; Kim, Meyoung-Kon

    2014-01-01

    Nanoparticles (NPs) are used commercially in health and fitness fields, but information about the toxicity and mechanisms underlying the toxic effects of NPs is still very limited. The aim of this study is to investigate the toxic effect(s) of 100 nm negatively (ZnOAE100[−]) or positively (ZnOAE100[+]) charged zinc oxide (ZnO) NPs administered by gavage in Sprague Dawley rats, to establish a no observed adverse effect level, and to identify target organ(s). After verification of the primary particle size, morphology, hydrodynamic size, and zeta potential of each test article, we performed a 90-day study according to Organisation for Economic Co-operation and Development test guideline 408. For the 90-day study, the high dose was set at 500 mg/kg and the middle and low doses were set at 125 mg/kg and 31.25 mg/kg, respectively. Both ZnO NPs had significant changes in hematological and blood biochemical analysis, which could correlate with anemia-related parameters, in the 500 mg/kg groups of both sexes. Histopathological examination showed significant adverse effects (by both test articles) in the stomach, pancreas, eye, and prostate gland tissues, but the particle charge did not affect the tendency or the degree of the lesions. We speculate that this inflammatory damage might result from continuous irritation caused by both test articles. Therefore, the target organs for both ZnOAE100(−) and ZnOAE100(+) are considered to be the stomach, pancreas, eye, and prostate gland. Also, the no observed adverse effect level for both test articles was identified as 31.25 mg/kg for both sexes, because the adverse effects were observed at all doses greater than 125 mg/kg. PMID:25565830

  17. Toxicity of 100 nm zinc oxide nanoparticles: a report of 90-day repeated oral administration in Sprague Dawley rats.

    PubMed

    Kim, Yu-Ri; Park, Jong-Il; Lee, Eun Jeong; Park, Sung Ha; Seong, Nak-won; Kim, Jun-Ho; Kim, Geon-Yong; Meang, Eun-Ho; Hong, Jeong-Sup; Kim, Su-Hyon; Koh, Sang-Bum; Kim, Min-Seok; Kim, Cheol-Su; Kim, Soo-Ki; Son, Sang Wook; Seo, Young Rok; Kang, Boo Hyon; Han, Beom Seok; An, Seong Soo A; Yun, Hyo-In; Kim, Meyoung-Kon

    2014-01-01

    Nanoparticles (NPs) are used commercially in health and fitness fields, but information about the toxicity and mechanisms underlying the toxic effects of NPs is still very limited. The aim of this study is to investigate the toxic effect(s) of 100 nm negatively (ZnO(AE100[-])) or positively (ZnO(AE100[+])) charged zinc oxide (ZnO) NPs administered by gavage in Sprague Dawley rats, to establish a no observed adverse effect level, and to identify target organ(s). After verification of the primary particle size, morphology, hydrodynamic size, and zeta potential of each test article, we performed a 90-day study according to Organisation for Economic Co-operation and Development test guideline 408. For the 90-day study, the high dose was set at 500 mg/kg and the middle and low doses were set at 125 mg/kg and 31.25 mg/kg, respectively. Both ZnO NPs had significant changes in hematological and blood biochemical analysis, which could correlate with anemia-related parameters, in the 500 mg/kg groups of both sexes. Histopathological examination showed significant adverse effects (by both test articles) in the stomach, pancreas, eye, and prostate gland tissues, but the particle charge did not affect the tendency or the degree of the lesions. We speculate that this inflammatory damage might result from continuous irritation caused by both test articles. Therefore, the target organs for both ZnO(AE100(-)) and ZnO(AE100(+)) are considered to be the stomach, pancreas, eye, and prostate gland. Also, the no observed adverse effect level for both test articles was identified as 31.25 mg/kg for both sexes, because the adverse effects were observed at all doses greater than 125 mg/kg. PMID:25565830

  18. A 90-Day Toxicology Study of Meat from Genetically Modified Sheep Overexpressing TLR4 in Sprague-Dawley Rats

    PubMed Central

    Hu, Rui; Kan, Tongtong; Li, Yan; Zhang, Xiaosheng; Zhang, Jinlong; Lian, Ling; Han, Hongbing; Lian, Zhengxing

    2015-01-01

    Genetic modification offers alternative strategies to traditional animal breeding. However, the food safety of genetically modified (GM) animals has attracted increasing levels of concern. In this study, we produced GM sheep overexpressing TLR4, and the transgene-positive offsprings (F1) were confirmed using the polymerase chain reaction (PCR) and Southern blot. The expression of TLR4 was 2.5-fold compared with that of the wild-type (WT) sheep samples. During the 90-day safety study, Sprague-Dawley rats were fed with three different dietary concentrations (3.75%, 7.5%, and 15% wt/wt) of GM sheep meat, WT sheep meat or a commercial diet (CD). Blood samples from the rats were collected and analyzed for hematological and biochemical parameters, and then compared with hematological and biochemical reference ranges. Despite a few significant differences among the three groups in some parameters, all other values remained within the normal reference intervals and thus were not considered to be affected by the treatment. No adverse diet-related differences in body weights or relative organ weights were observed. Furthermore, no differences were observed in the gross necropsy findings or microscopic pathology of the rats whose diets contained the GM sheep meat compared with rats whose diets contained the WT sheep meat. Therefore, the present 90-day rat feeding study suggested that the meat of GM sheep overexpressing TLR4 had no adverse effect on Sprague-Dawley rats in comparison with WT sheep meat. These results provide valuable information regarding the safety assessment of meat derived from GM animals. PMID:25874566

  19. Distribution, elimination, and biopersistence to 90 days of a systemically introduced 30 nm ceria-engineered nanomaterial in rats.

    PubMed

    Yokel, Robert A; Au, Tu C; MacPhail, Robert; Hardas, Sarita S; Butterfield, D Allan; Sultana, Rukhsana; Goodman, Michael; Tseng, Michael T; Dan, Mo; Haghnazar, Hamed; Unrine, Jason M; Graham, Uschi M; Wu, Peng; Grulke, Eric A

    2012-05-01

    Nanoceria is used as a catalyst in diesel fuel, as an abrasive in printed circuit manufacture, and is being pursued as an antioxidant therapeutic. Our objective is to extend previous findings showing that there were no reductions of cerium in organs of the mononuclear phagocyte (reticuloendothelial) system up to 30 days after a single nanoscale ceria administration. An ~5% aqueous dispersion of citrate-stabilized 30 nm ceria, synthesized and characterized in-house, or vehicle, was iv infused into rats terminated 1, 7, 30, or 90 days later. Cageside observations were obtained daily, body weight weekly. Daily urinary and fecal cerium outputs were quantified for 2 weeks. Nine organs were weighed and samples collected from 14 tissues/organs/systems, blood and cerebrospinal fluid for cerium determination. Histology and oxidative stress were assessed. Less than 1% of the nanoceria was excreted in the first 2 weeks, 98% in feces. Body weight gain was initially impaired. Spleen weight was significantly increased in some ceria-treated groups, associated with abnormalities. Ceria was primarily retained in the spleen, liver, and bone marrow. There was little decrease of ceria in any tissue over the 90 days. Granulomas were observed in the liver. Time-dependent oxidative stress changes were seen in the liver and spleen. Nanoscale ceria was persistently retained by organs of the mononuclear phagocyte system, associated with adverse changes. The results support concern about the long-term fate and adverse effects of inert nanoscale metal oxides that distribute throughout the body, are persistently retained, and produce adverse changes. PMID:22367688

  20. 77 FR 5201 - Ecolab, Inc.; Filing of Food Additive Petition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-02

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 173 Ecolab, Inc.; Filing of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that Ecolab, Inc., has filed a petition proposing that the food...

  1. 21 CFR 571.100 - Regulation based on petition.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulation based on petition. 571.100 Section 571...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVE PETITIONS Administrative Actions on Applications § 571.100 Regulation based on petition. (a) The Commissioner will forward for publication in the...

  2. 37 CFR 1.181 - Petition to the Director.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Petition to the Director. 1... Action by the Director § 1.181 Petition to the Director. (a) Petition may be taken to the Director: (1... rules specify that the matter is to be determined directly by or reviewed by the Director; and (3)...

  3. 37 CFR 1.181 - Petition to the Director.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2013-07-01 2013-07-01 false Petition to the Director. 1... Action by the Director § 1.181 Petition to the Director. (a) Petition may be taken to the Director: (1... the matter is to be determined directly by or reviewed by the Director; and (3) To invoke...

  4. 37 CFR 1.181 - Petition to the Director.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Petition to the Director. 1... Action by the Director § 1.181 Petition to the Director. (a) Petition may be taken to the Director: (1... rules specify that the matter is to be determined directly by or reviewed by the Director; and (3)...

  5. 37 CFR 1.181 - Petition to the Director.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 37 Patents, Trademarks, and Copyrights 1 2012-07-01 2012-07-01 false Petition to the Director. 1... Action by the Director § 1.181 Petition to the Director. (a) Petition may be taken to the Director: (1... rules specify that the matter is to be determined directly by or reviewed by the Director; and (3)...

  6. 47 CFR 1.429 - Petition for reconsideration.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Petition for reconsideration. 1.429 Section 1.429 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Rulemaking Proceedings Rulemaking Proceedings § 1.429 Petition for reconsideration. (a) Any interested person may petition for reconsideration of a final action...

  7. Phase II, Randomized, Placebo-controlled, 90-day Study of Emixustat HCL in Geographic Atrophy Associated with Dry Age-Related Macular Degeneration

    PubMed Central

    Dugel, Pravin U.; Novack, Roger L.; Csaky, Karl G.; Richmond, Preston P.; Birch, David G.; Kubota, Ryo

    2015-01-01

    Purpose This study assessed the safety, tolerability, and pharmacodynamics of emixustat hydrochloride (ACU-4429), a novel visual cycle modulator, in subjects with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD). Methods Subjects were randomly assigned to oral emixustat (2, 5, 7, or 10 mg once daily) or placebo (3:1 ratio) for 90 days. Recovery of rod photoreceptor sensitivity following a photobleach was measured by electroretinography. Safety evaluations included analysis of adverse events (AEs) and ophthalmic examinations. Results Seventy-two subjects (54 emixustat, 18 placebo) were evaluated. Emixustat suppressed rod photoreceptor sensitivity in a dose-dependent manner. Suppression plateaued by Day 14, and was reversible within 7-14 days after drug cessation. No systemic AEs of concern were noted. Dose-related ocular AEs (chromatopsia, 57% emixustat vs. 17% placebo; and delayed dark adaptation, 48% emixustat vs. 6% placebo) were mild to moderate, and the majority resolved on study or within 7-14 days after study drug cessation. Conclusions In this phase II study, emixustat produced a dose-dependent, reversible effect on rod function, and an ocular AE profile that is consistent with the proposed mechanism of action. These results support further testing of emixustat for the treatment of GA associated with dry AMD. PMID:25932553

  8. Fluid overload is associated with an increased risk for 90-day mortality in critically ill patients with renal replacement therapy: data from the prospective FINNAKI study

    PubMed Central

    2012-01-01

    Introduction Positive fluid balance has been associated with an increased risk for mortality in critically ill patients with acute kidney injury with or without renal replacement therapy (RRT). Data on fluid accumulation prior to RRT initiation and mortality are limited. We aimed to study the association between fluid accumulation at RRT initiation and 90-day mortality. Methods We conducted a prospective, multicenter, observational cohort study in 17 Finnish intensive care units (ICUs) during a five-month period. We collected data on patient characteristics, RRT timing, and parameters at RRT initiation. We studied the association of parameters at RRT initiation, including fluid overload (defined as cumulative fluid accumulation > 10% of baseline weight) with 90-day mortality. Results We included 296 RRT-treated critically ill patients. Of 283 patients with complete data on fluid balance, 76 (26.9%) patients had fluid overload. The median (interquartile range) time from ICU admission to RRT initiation was 14 (3.3 to 41.5) hours. The 90-day mortality rate of the whole cohort was 116 of 296 (39.2%; 95% confidence interval 38.6 to 39.8%). The crude 90-day mortality of patients with or without fluid overload was 45 of 76 (59.2%) vs. 65 of 207 (31.4%), P < 0.001. In logistic regression, fluid overload was associated with an increased risk for 90-day mortality (odds ratio 2.6) after adjusting for disease severity, time of RRT initiation, initial RRT modality, and sepsis. Of the 168 survivors with data on RRT use at 90 days, 34 (18.9%, 95% CI 13.2 to 24.6%) were still dependent on RRT. Conclusions Patients with fluid overload at RRT initiation had twice as high crude 90-day mortality compared to those without. Fluid overload was associated with increased risk for 90-day mortality even after adjustments. PMID:23075459

  9. A 90-day subchronic feeding study of genetically modified rice expressing Cry1Ab protein in Sprague-Dawley rats.

    PubMed

    Song, Huan; He, Xiaoyun; Zou, Shiying; Zhang, Teng; Luo, Yunbo; Huang, Kunlun; Zhu, Zhen; Xu, Wentao

    2015-04-01

    Bacillus thuringiensis (Bt) transgenic rice line (mfb-MH86) expressing a synthetic cry1Ab gene can be protected against feeding damage from Lepidopteran insects, including Sesamia inferens, Chilo suppressalis, Tryporyza incertulas and Cnaphalocrocis medinalis. Rice flour from mfb-MH86 and its near-isogenic control MH86 was separately formulated into rodent diets at concentrations of 17.5, 35 and 70 % (w/w) for a 90-day feeding test with rats, and all of the diets were nutritionally balanced. In this study, the responses of rats fed diets containing mfb-MH86 were compared to those of rats fed flour from MH86. Overall health, body weight and food consumption were comparable between groups fed diets containing mfb-MH86 and MH86. Blood samples were collected prior to sacrifice and a few significant differences (p < 0.05) were observed in haematological and biochemical parameters between rats fed genetically modified (GM) and non-GM diets. However, the values of these parameters were within the normal ranges of values for rats of this age and sex, thus not considered treatment related. In addition, upon sacrifice a large number of organs were weighed, macroscopic and histopathological examinations were performed with only minor changes to report. In conclusion, these results demonstrated that no toxic effect was observed in the conditions of the experiment, based on the different parameters assessed. GM rice mfb-MH86 is as safe and nutritious as non-GM rice. PMID:25367203

  10. An estimate of equatorial wave energy flux at 9- to 90-day periods in the Central Pacific

    NASA Technical Reports Server (NTRS)

    Eriksen, Charles C.; Richman, James G.

    1988-01-01

    Deep fluctuations in current along the equator in the Central Pacific are dominated by coherent structures which correspond closely to narrow-band propagating equatorial waves. Currents were measured roughly at 1500 and 3000 m depths at five moorings between 144 and 148 deg W from January 1981 to March 1983, as part of the Pacific Equatorial Ocean Dynamics program. In each frequency band resolved, a single complex empirical orthogonal function accounts for half to three quarters of the observed variance in either zonal or meridional current. Dispersion for equatorial first meridional Rossby and Rossby gravity waves is consistent with the observed vertical-zonal coherence structure. The observations indicate that energy flux is westward and downward in long first meridional mode Rossby waves at periods 45 days and longer, and eastward and downward in short first meridional mode Rossby waves and Rossby-gravity waves at periods 30 days and shorter. A local minimum in energy flux occurs at periods corresponding to a maximum in upper-ocean meridional current energy contributed by tropical instability waves. Total vertical flux across the 9- to 90-day period range is 2.5 kW/m.

  11. Toxicological evaluation of an Allium-based commercial product in a 90-day feeding study in Sprague-Dawley rats.

    PubMed

    Mellado-García, P; Puerto, M; Pichardo, S; Llana-Ruiz-Cabello, M; Moyano, R; Blanco, A; Jos, A; Cameán, A M

    2016-04-01

    Proallium AP(®) is a commercial Allium extract intended to be used in active food packaging as the antibacterial and antioxidant effects of some organosulfur compounds are well known. However, there is little information on its toxicity and the Scientific Committee on Food (UE) requires the safety assessment of substances used in food contact materials. Thus, the aim of this study was to conduct for the first time a subchronic oral toxicity study of Proallium AP(®) with groups of 10 males and 10 females Sprague-Dawley rats fed a diet containing 0, 25, 100, 400 mg/kg/d for 90 days. No treatment-related clinical signs or mortality were noted. Besides, no treatment-related effects with regard to any of the toxicological biomarkers considered were observed, including biochemical, haematological and histopathology parameters. In conclusion, the non-observed-adverse-effect-level (NOAEL) for Proallium AP(®) in rats was determined to be a dietary dose of 400 mg/kg/d under the present experimental conditions, a value 500-fold higher than the exposure derived from its potential use in active packaging. PMID:26827789

  12. Two-hour methyl isocyanate inhalation and 90-day recovery study in B6C3F1 mice

    SciTech Connect

    Boorman, G.A.; Uraih, L.C.; Gupta, B.N.; Bucher, J.R.

    1987-06-01

    B6C3F1 mice were exposed by inhalation to 0, 3, 10, and 30 ppm methyl isocyanate for 2 hr followed by a 90-day recovery period. Sixteen of eight (20%) male mice in the 30 ppm group died following exposure. There were no other unscheduled deaths in the mice. Five mice/sex/group were examined at 2 hr or at 1, 3, 7, 14, 28, 49, or 91 days following exposure. Chemical-related changes were restricted to the respiratory system. At 30 ppm there were extensive necrosis and erosion of the respiratory and olfactory epithelium in the nasal cavity. Severe necrosis and epithelial erosion were also found in the trachea and main bronchi. Regeneration of the mucosal epithelium occurred rapidly in the nasal cavity and airways. In the turbinates, mild incomplete olfactory epithelial regeneration persisted to day 91 in the male mice. Intraluminal fibrotic projections covered by respiratory epithelium and bronchial fibrosis were found in the major airways of the 30 ppm male and female mice by day 7. The intraluminal fibrosis persisted to day 91. In males with severe bronchial fibrosis, chronic alveolitis and atelectasis were found. In mice exposed to 3 or 10 ppm, persistent pulmonary changes were not found. These studies indicate that methyl isocyanate inhalation at or near lethal concentrations can cause persistent fibrosis of the major bronchi in mice.

  13. A 90-day toxicology study of high-amylose transgenic rice grain in Sprague-Dawley rats.

    PubMed

    Zhou, Xing Hua; Dong, Ying; Xiao, Xiang; Wang, Yun; Xu, Yong; Xu, Bin; Shi, Wei Dong; Zhang, Yi; Zhu, Li Jia; Liu, Qiao Quan

    2011-12-01

    A transgenic rice line (TRS) with high amylose level has been developed by antisense RNA inhibition of starch branching enzymes. Compositional analysis of TRS demonstrated that the content of resistant starch (RS) was significantly higher compared to conventional non-transgenic rice. High level of RS is an important raw material in food industry and has various physiological effects for human health. In order to provide the reliable theory basis for field release of TRS rice, we evaluated the potential health effects of long-term consumption of the TRS. The 90-day toxicology feeding experiment was conducted in Sprague-Dawley rats fed with diets containing 70% of either TRS rice flour, its near-isogenic rice flour or the control diet. The clinical performance variables (body weight, body weight gain and food consumption) were measured and pathological responses (hematological parameters and serum chemistry at the midterm and the completion of the experiment, urinalysis profile and serum sex hormone response at the completion of the experiment) were performed. Besides, clinical signs, relative organ weights and microscopic observations were also compared between TRS group and its near-isogenic rice group. The combined data indicates that high-amylose TRS grain is as safe as the conventional non-transgenic rice for rat consumption. PMID:21967780

  14. 21 CFR 171.100 - Regulation based on petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) FOOD FOR HUMAN CONSUMPTION (CONTINUED) FOOD ADDITIVE PETITIONS Administrative Actions on Applications... any meat product, meat food product, or poultry product subject to the Federal Meat Inspection...

  15. Herd-level risk factors for infectious diseases in Swedish dairy calves aged 0-90 days.

    PubMed

    Lundborg, G K; Svensson, E C; Oltenacu, P A

    2005-05-10

    The effect of environmental factors and management routines on the risk of diarrhoea, respiratory disease and other infectious diseases was investigated in 3081 heifer calves 0-90 days old in 122 Swedish dairy herds. The farmers kept records on cases of diseases in their heifer calves and in addition, project veterinarians clinically examined all calves every 2-3 months. At each visit, the veterinarians also measured the ammonia concentration and relative air humidity in the housing facilities for the calves. The cleanliness of the animals and their environment was recorded as a measure of the hygienic status of the farm. The presence or absence of draught (i.e. wind velocity>0.5 m/s) was recorded twice during the study period. The effect of these factors, as well as the placing of the calf pens, the nature of the pen walls, air volume per animal, management factors (such as the status of the caretaker and feeding routines) and presence or absence of a bovine viral diarrhoea virus (BVDV) infection in the herd, was evaluated by means of a two-level variance component logistic model. The placing of calf pens along an outer wall was significantly associated with the risk of diarrhoea (odds ratio (OR): 1.92, P<0.01). The risk for respiratory disease was significantly associated with an ammonia concentration below 6 ppm (OR: 0.42, P<0.05) while the odds ratio for moderately to severely increased respiratory sounds was significantly associated with a BVDV infection in the herd (OR: 2.39, P<0.05) and draught (OR: 3.7, P<0.02). Absence of draught was significantly associated with the risk for infectious diseases other than diarrhoea and respiratory disease (OR: 0.42, P<0.01). PMID:15820112

  16. Effects of 90-Day Feeding of Transgenic Maize BT799 on the Reproductive System in Male Wistar Rats

    PubMed Central

    Guo, Qian-ying; He, Li-xia; Zhu, Han; Shang, Jun-li; Zhu, Ling-yan; Wang, Jun-bo; Li, Yong

    2015-01-01

    BT799 is a genetically modified (GM) maize plant that expresses the Cry1Ac gene from Bacillus thuringiensis (Bt). The Cry1Ac gene was introduced into maize line Zhen58 to encode the Bt crystal protein and thus produce insect-resistant maize BT799. Expression of Bt protein in planta confers resistance to Lepidopteran pests and corn rootworms. The present study was designed to investigate any potential effects of BT799 on the reproductive system of male rats and evaluate the nutritional value of diets containing BT799 maize grain in a 90-day subchronic rodent feeding study. Male Wistar rats were fed with diets containing BT799 maize flours or made from its near isogenic control (Zhen58) at a concentration of 84.7%, nutritionally equal to the standard AIN-93G diet. Another blank control group of male rats were treated with commercial AIN-93G diet. No significant differences in body weight, hematology and serum chemistry results were observed between rats fed with the diets containing transgenic BT799, Zhen58 and the control in this 13-week feeding study. Results of serum hormone levels, sperm parameters and relative organ/body weights indicated no treatment-related side effects on the reproductive system of male rats. In addition, no diet-related changes were found in necropsy and histopathology examinations. Based on results of the current study, we did not find any differences in the parameters tested in our study of the reproductive system of male rats between BT799 and Zhen58 or the control. PMID:26633453

  17. Effects of 90-Day Feeding of Transgenic Maize BT799 on the Reproductive System in Male Wistar Rats.

    PubMed

    Guo, Qian-ying; He, Li-xia; Zhu, Han; Shang, Jun-li; Zhu, Ling-yan; Wang, Jun-bo; Li, Yong

    2015-12-01

    BT799 is a genetically modified (GM) maize plant that expresses the Cry1Ac gene from Bacillus thuringiensis (Bt). The Cry1Ac gene was introduced into maize line Zhen58 to encode the Bt crystal protein and thus produce insect-resistant maize BT799. Expression of Bt protein in planta confers resistance to Lepidopteran pests and corn rootworms. The present study was designed to investigate any potential effects of BT799 on the reproductive system of male rats and evaluate the nutritional value of diets containing BT799 maize grain in a 90-day subchronic rodent feeding study. Male Wistar rats were fed with diets containing BT799 maize flours or made from its near isogenic control (Zhen58) at a concentration of 84.7%, nutritionally equal to the standard AIN-93G diet. Another blank control group of male rats were treated with commercial AIN-93G diet. No significant differences in body weight, hematology and serum chemistry results were observed between rats fed with the diets containing transgenic BT799, Zhen58 and the control in this 13-week feeding study. Results of serum hormone levels, sperm parameters and relative organ/body weights indicated no treatment-related side effects on the reproductive system of male rats. In addition, no diet-related changes were found in necropsy and histopathology examinations. Based on results of the current study, we did not find any differences in the parameters tested in our study of the reproductive system of male rats between BT799 and Zhen58 or the control. PMID:26633453

  18. 19 CFR 206.13 - Who may file a petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations Relating to Global Safeguard Actions § 206.13 Who may file a petition....

  19. 77 FR 71432 - Agency Information Collection Activities: Immigrant Petition by Alien Entrepreneur, Form I-526...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-30

    ... Petition by Alien Entrepreneur, Form I-526, Revision of a Currently Approved Collection ACTION: 60-Day... information collection. (2) Title of the Form/Collection: Immigrant Petition by Alien Entrepreneur. (3)...

  20. 78 FR 42026 - Petition for Rulemaking To Eliminate Accessible Cords on Window Covering Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ...; ] CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II Petition for Rulemaking To Eliminate Accessible Cords on Window Covering Products AGENCY: Consumer Product Safety Commission. ACTION: Notice of petition for rulemaking. SUMMARY: The Consumer Product Safety Commission (CPSC or Commission) received...

  1. 7 CFR Appendix B to Subpart C of... - FSA-2510, Notice of Availability of Loan Servicing to Borrowers Who Are 90 Days Past Due

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 7 2011-01-01 2011-01-01 false FSA-2510, Notice of Availability of Loan Servicing to Borrowers Who Are 90 Days Past Due B Appendix B to Subpart C of Part 766 Agriculture Regulations of the... LOAN SERVICING-SPECIAL Loan Servicing Programs Pt. 766, Subpt. C, App. B Appendix B to Subpart C...

  2. 7 CFR Appendix B to Subpart C of... - FSA-2510, Notice of Availability of Loan Servicing to Borrowers Who Are 90 Days Past Due

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 7 2010-01-01 2010-01-01 false FSA-2510, Notice of Availability of Loan Servicing to Borrowers Who Are 90 Days Past Due B Appendix B to Subpart C of Part 766 Agriculture Regulations of the... LOAN SERVICING-SPECIAL Loan Servicing Programs Pt. 766, Subpt. C, App. B Appendix B to Subpart C...

  3. 77 FR 50504 - Clean Air Act Operating Permit Program; Action on Petition for Objection to State Operating...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... for Georgia-Pacific Consumer Products AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of... permit issued by the Wisconsin Department of Natural Resources (WDNR) to Georgia-Pacific Consumer Products (Georgia- Pacific). Sections 307(b) and 505(b)(2) of the Act provide that a petitioner may ask...

  4. 76 FR 47133 - Endangered and Threatened Wildlife and Plants; 90-Day Finding and 12-Month Determination on a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-04

    ... concerned. Previous Federal Actions In 1970, the leatherback sea turtle was listed as endangered (35 FR 8491... turtle on March 23, 1978 (43 FR 12050), in the U.S. Virgin Islands to include: ``A strip of land 0.2... designated critical habitat for the leatherback sea turtle on March 23, 1979 (44 FR 17710), in the...

  5. The Model for End-stage Liver Disease accurately predicts 90-day liver transplant wait-list mortality in Atlantic Canada

    PubMed Central

    Renfrew, Paul Douglas; Quan, Hude; Doig, Christopher James; Dixon, Elijah; Molinari, Michele

    2011-01-01

    OBJECTIVE: To determine the generalizability of the predictions for 90-day mortality generated by Model for End-stage Liver Disease (MELD) and the serum sodium augmented MELD (MELDNa) to Atlantic Canadian adults with end-stage liver disease awaiting liver transplantation (LT). METHODS: The predictive accuracy of the MELD and the MELDNa was evaluated by measurement of the discrimination and calibration of the respective models’ estimates for the occurrence of 90-day mortality in a consecutive cohort of LT candidates accrued over a five-year period. Accuracy of discrimination was measured by the area under the ROC curves. Calibration accuracy was evaluated by comparing the observed and model-estimated incidences of 90-day wait-list failure for the total cohort and within quantiles of risk. RESULTS: The area under the ROC curve for the MELD was 0.887 (95% CI 0.705 to 0.978) – consistent with very good accuracy of discrimination. The area under the ROC curve for the MELDNa was 0.848 (95% CI 0.681 to 0.965). The observed incidence of 90-day wait-list mortality in the validation cohort was 7.9%, which was not significantly different from the MELD estimate of 6.6% (95% CI 4.9% to 8.4%; P=0.177) or the MELDNa estimate of 5.8% (95% CI 3.5% to 8.0%; P=0.065). Global goodness-of-fit testing found no evidence of significant lack of fit for either model (Hosmer-Lemeshow χ2 [df=3] for MELD 2.941, P=0.401; for MELDNa 2.895, P=0.414). CONCLUSION: Both the MELD and the MELDNa accurately predicted the occurrence of 90-day wait-list mortality in the study cohort and, therefore, are generalizable to Atlantic Canadians with end-stage liver disease awaiting LT. PMID:21876856

  6. Platelet-to-Lymphocyte Ratio: A Novel Prognostic Factor for Prediction of 90-day Outcomes in Critically Ill Patients With Diabetic Ketoacidosis.

    PubMed

    Liu, Wen-Yue; Lin, Shi-Gang; Wang, Li-Ren; Fang, Chen-Chen; Lin, Yi-Qian; Braddock, Martin; Zhu, Gui-Qi; Zhang, Zhongheng; Zheng, Ming-Hua; Shen, Fei-Xia

    2016-01-01

    Diabetic ketoacidosis (DKA) is a life-threatening acute complication of diabetes mellitus and the novel systemic inflammation marker platelet-to-lymphocyte ratio (PLR) may be associated with clinical outcome in patients with DKA. This study aimed to investigate the utility of PLR in predicting 90-day clinical outcomes in patients with DKA. Patient data exacted from the Multiparameter Intelligent Monitoring in Intensive Care II (MIMIC II) database was analyzed. A cutoff value for PLR of 267.67 was determined using Youden index (P < 0.05) and used to categorize subjects into a high PLR group and a low PLR group. The hazard ratios (HRs) and 95% confidence intervals (CIs) for DKA were calculated across PLR. Clinical outcomes in our study were defined as intensive care unit (ICU) 90-day readmission and all-cause mortality. A total of 278 ICU admissions were enrolled and stratified by cutoff value of PLR. The incidence of readmission and mortality was 17.8% in the high PLR group, significantly higher than 7.4% in the low PLR group. In the multivariable model, after adjusting for known confounding variables including clinical parameters, comorbidities, laboratory parameters, the HRs for DKA were 2.573 (95% CI 1.239-5.345; P = 0.011), 2.648 (95% CI 1.269-5.527; P = 0.009), and 2.650 (95% CI 1.114-6.306; P = 0.028), respectively. The Kaplan-Meier survival curve showed that a high PLR level was associated with a higher risk for 90-day outcomes in patients with DKA. The authors report that higher PLR presents a higher risk for 90-day incidence of readmission and mortality in patients with DKA. It appears to be a novel independent predictor of 90-day outcomes in critically ill DKA patients in ICU units. PMID:26825908

  7. The added value of the 90-day repeated dose oral toxicity test for industrial chemicals with a low (sub)acute toxicity profile in a high quality dataset.

    PubMed

    Taylor, Katy; Andrew, David J; Rego, Laura

    2014-08-01

    A survey conducted on the EU Notification of New Substances (NONS) database suggested that for industrial chemicals with a profile of low toxicity in (sub)acute toxicity tests there is little added value to the conduct of the 90-day repeated dose study. Avoiding unnecessary animal testing is a central aim of the EU REACH chemicals legislation; therefore we sought to verify the profile using additional data. The OECD's eChemPortal was searched for substances that had both a 28-day and a 90-day study and their robust study summaries were then examined from the ECHA CHEM database. Out of 182 substances with high quality 28-day and 90-day study results, only 18 reported no toxicity of any kind in the (sub)acute tests. However, for 16 of these there were also no reported signs of toxicity at or close to the limit dose (1000mg/kgbw/d) in the 90-day study. Restricting the 'low (sub)acute toxicity in a high quality dataset' profile to general industrial chemicals of no known biological activity, whilst allowing irritant substances, increases the data set and improves the prediction to 95% (20 substances out of 21 substances). The low toxicity profile appears to be of low prevalence within industrial chemicals (10-15%), nevertheless, avoidance of the conduct of a redundant 90-day study for this proportion of the remaining REACH phase-in substances would avoid the use of nearly 50,000 animals and save industry 50million Euros, with no impact on the assessment of human health. PMID:24768988

  8. 76 FR 61298 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Lake...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    .... We published a notice of 90-day finding in the Federal Register on May 6, 2008 (73 FR 24915... (61 FR 4722), we are required to evaluate the discreteness and significance of the petitioned entity... Fisheries Service (now NOAA Fisheries (NOAAF) under their ESU policy (56 FR 58612; November 20,...

  9. 76 FR 61321 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition to List the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... January 10, 2008, the Service made its 90-day finding (73 FR 1855), concluding that the petition did... discreteness and significance criteria of the DPS policy (61 FR 4722; February 7, 1996), and, thus, may be a...)). Under the joint DPS ] policy of the Service and National Marine Fisheries Service (61 FR 4722;...

  10. 76 FR 45129 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Gopher...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ... Tombigbee Rivers in Alabama, Louisiana, and Mississippi) (52 FR 25376). On January 18, 2006, we received a... processing the petition in early February, 2007. On September 9, 2009, we published a 90-day finding (74 FR... information through http://www.regulations.gov until March 15, 2010 (75 FR 1567). Thereafter, we...

  11. 76 FR 31282 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List Puerto...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... published a 90-day finding (75 FR 21568) in which we concluded that the petition provided substantial... sedentary (not able to move or disperse in a given environment) (Carri n- Cabrera 2003, p. 51). Distribution... Number The Service adopted guidelines on September 21, 1983 (48 FR 43098), to establish a rational...

  12. 76 FR 44547 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Giant...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... may be warranted (72 FR 57273). On January 24, 2008, the petitioners filed a lawsuit in the U.S... habitat (75 FR 42059). Based on our review, we found the petition presented substantial scientific or...; Johnson-Maynard 2010, p. 2). In our 2010 90-day finding (75 FR 42059), we solicited scientific...

  13. 76 FR 48777 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Nueces...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... 90-day finding for 270 of the 475 petitioned species on January 6, 2009 (74 FR 419), concluding that... 192 southwestern species by December 9, 2009. On December 16, 2009 (74 FR 66866), we published a... threatened with extinction or whose range is only peripherally in Texas and could be easily extirpated....

  14. 78 FR 65938 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition and Proposed Rule...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... published a 90-day finding (77 FR 32922) that concluded that the petition presented substantial scientific... than 200 Inyo California towhees at time of listing in 1987 (52 FR 28780 (August 3, 1987)). Substantial..., 1982, Notice of Review of Candidate Species (47 FR 58454) as a result of habitat loss and...

  15. 76 FR 12667 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Mt...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    .... On May 30, 2007, we published a 90- day petition finding (72 FR 29933) in which we concluded that the... of status review (72 FR 29933), and additional scientific information from ongoing species surveys as... quino) (62 FR 2313; January 16, 1997) and Fender's blue butterfly (Icaricia icarioides fenderi) (65...

  16. Toxicity studies on agent GA (Phase 2): 90 day subchronic study of GA (Tabun) in cd rats. Appendices. Final report, July 1985-August 1991

    SciTech Connect

    Not Available

    1992-03-01

    The purpose of the report is to provide essential toxicologic information on Tabun administration over a 90 day period. This toxicologic information may be used to adjust the maximum-tolerated dose for subsequent dominant-lethal and two-generation reproduction studies. The objectives were to determine the toxic effects of nerve agent exposure (e.g., target organs); and to determine the effects of nerve agent GA on sperm morphology and motility and vaginal cytology.

  17. Vitamin D deficiency at admission is not associated with 90-day mortality in patients with severe sepsis or septic shock: Observational FINNAKI cohort study.

    PubMed

    Ala-Kokko, Tero I; Mutt, Shivaprakash J; Nisula, Sara; Koskenkari, Juha; Liisanantti, Janne; Ohtonen, Pasi; Poukkanen, Meri; Laurila, Jouko J; Pettilä, Ville; Herzig, Karl-Heinz

    2016-01-01

    Introduction Low levels of vitamin D have been associated with increased mortality in patients that are critically ill. This study explored whether vitamin D levels were associated with 90-day mortality in severe sepsis or septic shock. Methods Plasma vitamin D levels were measured on admission to the intensive care unit (ICU) in a prospective multicentre observational study. Results 610 patients with severe sepsis were included; of these, 178 (29%) had septic shock. Vitamin D deficiency (<50 nmol/L) was present in 333 (55%) patients. The 90-day mortality did not differ among patients with or without vitamin D deficiency (28.3% vs. 28.5%, p = 0.789). Diabetes was more common among patients deficient compared to those not deficient in vitamin D (30% vs. 18%, p < 0.001). Hospital-acquired infections at admission were more prevalent in patients with a vitamin D deficiency (31% vs. 16%, p < 0.001). A multivariable adjusted Cox regression model showed that low vitamin D levels could not predict 90-day mortality (<50 nmol/L: hazard ratio (HR) 0.99 (95% CI: 0.72-1.36), p > 0.9; and <25 nmol/L: HR 0.44 (95% CI: 0.22-0.87), p = 0.018). Conclusions Vitamin D deficiency detected upon ICU admission was not associated with 90-day mortality in patients with severe sepsis or septic shock. Key messages In severe sepsis and septic shock, a vitamin D deficiency upon ICU admission was not associated with increased mortality. Compared to patients with sufficient vitamin D, patients with deficient vitamin D more frequently exhibited diabetes, elevated C-reactive protein levels, and hospital-acquired infections upon ICU admission, and they more frequently developed acute kidney injury. PMID:26800186

  18. IN VIVO EVALUATION OF THE SEALING ABILITY OF TWO ENDODONTIC SEALERS IN ROOT CANALS EXPOSED TO THE ORAL ENVIRONMENT FOR 45 AND 90 DAYS

    PubMed Central

    Kopper, Patrícia Maria Poli; Vanni, José Roberto; Della Bona, Álvaro; de Figueiredo, José Antônio Poli; Porto, Sérgio

    2006-01-01

    This in vivo study evaluated the sealing ability of a resin-based sealer (AH Plus) and a zinc oxide-eugenol sealer (Endofill) in dogs' teeth, exposed to the oral environment for 45 and 90 days. Forty eight lower incisors from 8 dogs were endodonticaly treated. A stratified randomization determined the sealer use in each root canal. All canals were filled using the lateral condensation technique. The excess filling material at the cervical portion of the root canal was sectioned, leaving a 10-mm obturation length inside the canal. Teeth were provisionally sealed with glass ionomer cement for 24 h and the canals were exposed to the oral environment for either 45 or 90 days. Therefore, the experimental groups were as follows: A45- AH Plus for 45 days; A90- AH Plus for 90 days; E45- Endofill for 45 days; and E90- Endofill for 90 days (n=12). After the experimental period, the dogs were killed and the lower jaw was removed. The incisors were extracted and the roots were covered with two coats of nail varnish. The teeth were immersed in India ink for 96 h and submitted to diaphanization. Dye leakage (in mm) was measured using stereomicroscopy (10x magnification). The results were statistically analyzed using two-way ANOVA and Tukey test for multiple comparisons (á = 0.05). Group E90 (2.03±0.94) showed significantly higher mean leakage value than all other groups (p<0.001). None of the sealers, in both study conditions, were able to prevent dye leakage. PMID:19089029

  19. Influence of CO2 change during 90-day experiment on growth characteristics and photosynthetic activity in vegetables grown in Lunar Palace 1

    NASA Astrophysics Data System (ADS)

    Shao, Lingzhi; Liu, Hong; Wang, Minjuan; Fu, Yuming; Dong, Chen; Liu, Guanghui

    To establish bioregenerative life support system (BLSS) on lunar or Mars bases in the future, it is necessary to firstly conduct manned simulation experiments on the ground. For this purpose, Lunar palace 1 as an integrative experimental facility for permanent astrobase life support artificial closed ecosystem was set up, and 90-day experiment was carried out in this system. Vegtables as one of the important plant units, provide various nutrient content for crews in the system, such as vitamin, antioxidants and so on. However, it is not clear yet that how the CO _{2} change during 90-day experiment to affect on growth characteristics and photosynthetic activity in vegtables grown in the system. In this study, red lettuce, red rape, romaine lettuce, and bibb lettuce grown in the system were chosen as the subject investigated. Growth, expressed as dry weight, length of shoot and root, leaf area, was mearsured, and photosynthesis,expressed as net photosynthetic rate, intercellular CO _{2} concentration, chlorophyll contents and fluorescence was analyzed to detemind influence of CO _{2} change during 90-day experiment on growth in vegtables grown in the system.

  20. 22 CFR 1422.2 - Contents of petition; filing and service of petition; challenges to petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... showing. (e) Filing and service of petition and copies. (1) A petition for exclusive recognition, for an... 22 Foreign Relations 2 2010-04-01 2010-04-01 true Contents of petition; filing and service of...; filing and service of petition; challenges to petition. (a) Petition for exclusive recognition....

  1. 77 FR 65050 - Continental Tire North America, LLC, Mootness of Petition for Decision of Inconsequential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... November 29, 2010, in the Federal Register (75 FR 73159). No comments were received. To view the petition... National Highway Traffic Safety Administration Continental Tire North America, LLC, Mootness of Petition..., DOT. ACTION: Notice of petition mootness. SUMMARY: Continental Tire North America,...

  2. 78 FR 76408 - BMW of North America, LLC, Grant of Petition for Decision of Inconsequential Noncompliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... Register (77 FR 63415). One comment was received from Anne K. Mayer which supported granting BMW's petition... National Highway Traffic Safety Administration BMW of North America, LLC, Grant of Petition for Decision of... Transportation (DOT). ACTION: Grant of Petition. SUMMARY: BMW North America, LLC,\\1\\ a subsidiary of BMW...

  3. 77 FR 3031 - The Goodyear Tire & Rubber Company, Grant of Petition for Decision of Inconsequential Noncompliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-20

    ... Register (75 FR 81712). No comments were received. To view the petition and all supporting documents log... National Highway Traffic Safety Administration The Goodyear Tire & Rubber Company, Grant of Petition for.... ACTION: Notice of petition grant. SUMMARY: The Goodyear Tire & Rubber Company (Goodyear) \\1\\...

  4. 49 CFR 386.13 - Petitions to review and request for hearing: Driver qualification proceedings.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: Driver qualification proceedings. 386.13 Section 386.13 Transportation Other Regulations Relating to... § 386.13 Petitions to review and request for hearing: Driver qualification proceedings. (a) Within 60... disqualification, the driver or carrier may petition to review such action. Such petitions must be submitted to...

  5. 49 CFR 386.13 - Petitions to review and request for hearing: Driver qualification proceedings.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: Driver qualification proceedings. 386.13 Section 386.13 Transportation Other Regulations Relating to... § 386.13 Petitions to review and request for hearing: Driver qualification proceedings. (a) Within 60... disqualification, the driver or carrier may petition to review such action. Such petitions must be submitted to...

  6. 49 CFR 386.13 - Petitions to review and request for hearing: Driver qualification proceedings.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: Driver qualification proceedings. 386.13 Section 386.13 Transportation Other Regulations Relating to... § 386.13 Petitions to review and request for hearing: Driver qualification proceedings. (a) Within 60... disqualification, the driver or carrier may petition to review such action. Such petitions must be submitted to...

  7. 78 FR 76748 - Citizen Petition Submission; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ...The Food and Drug Administration (FDA) is modernizing its administrative regulations regarding submission of citizen petitions to explicitly provide for electronic submission. The current regulation does not recognize electronic methods for submitting citizen petitions; thus, this action will enable efficiency and ease in the filing of citizen...

  8. 46 CFR 550.402 - Filing of petitions.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 9 2014-10-01 2014-10-01 false Filing of petitions. 550.402 Section 550.402 Shipping FEDERAL MARITIME COMMISSION REGULATIONS AND ACTIONS TO ADDRESS RESTRICTIVE FOREIGN MARITIME PRACTICES REGULATIONS TO ADJUST OR MEET CONDITIONS UNFAVORABLE TO SHIPPING IN THE FOREIGN TRADE OF THE UNITED STATES Petitions for Section 19 Relief §...

  9. 17 CFR 9.24 - Petition for stay pending review.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Respect to Appeals § 9.24 Petition for stay pending review. (a) Time to file. (1) Within ten days after... notice of appeal. (2) Within ten days after a notice of summary action has been delivered in accordance... service of the Commission's ruling on the petition, not to exceed ten days, as the Commission...

  10. Genome-wide gene expression effects in B6C3F1 mouse intestinal epithelia following 7 and 90 days of exposure to hexavalent chromium in drinking water

    SciTech Connect

    Kopec, Anna K.; Kim, Suntae; Forgacs, Agnes L.; Zacharewski, Timothy R.; Proctor, Deborah M.; Harris, Mark A.; Haws, Laurie C.; Thompson, Chad M.

    2012-02-15

    Chronic administration of high doses of hexavalent chromium [Cr(VI)] as sodium dichromate dihydrate (SDD) elicits alimentary cancers in mice. To further elucidate key events underlying tumor formation, a 90-day drinking water study was conducted in B6C3F1 mice. Differential gene expression was examined in duodenal and jejunal epithelial samples following 7 or 90 days of exposure to 0, 0.3, 4, 14, 60, 170 or 520 mg/L SDD in drinking water. Genome-wide microarray analyses identified 6562 duodenal and 4448 jejunal unique differentially expressed genes at day 8, and 4630 and 4845 unique changes, respectively, in the duodenum and jejunum at day 91. Comparative analysis identified significant overlap in duodenal and jejunal differential gene expression. Automated dose–response modeling identified > 80% of the differentially expressed genes exhibited sigmoidal dose–response curves with EC{sub 50} values ranging from 10 to 100 mg/L SDD. Only 16 genes satisfying the dose-dependent differential expression criteria had EC{sub 50} values < 10 mg/L SDD, 3 of which were regulated by Nrf2, suggesting oxidative stress in response to SDD at low concentrations. Analyses of differentially expressed genes identified over-represented functions associated with oxidative stress, cell cycle, lipid metabolism, and immune responses consistent with the reported effects on redox status and histopathology at corresponding SDD drinking water concentrations. Collectively, these data are consistent with a mode of action involving oxidative stress and cytotoxicity as early key events. This suggests that the tumorigenic effects of chronic Cr(VI) oral exposure likely require chronic tissue damage and compensatory epithelial cell proliferation. Highlights: ► Mouse small intestine gene expression is highly responsive to hexavalent chromium [Cr(VI)]. ► Cr(VI) elicits more differential gene expression after 7 days of exposure than 90 days of exposure. ► Oral exposure to Cr(VI) leads to

  11. MELD-Na as a prognostic indicator of 30- and 90-day mortality in patients with end-stage liver disease after creation of transjugular intrahepatic portosystemic shunt.

    PubMed

    Ahmed, Rezwan; Santhanam, Prasanna; Rayyan, Yaser

    2015-10-01

    Previous studies have shown that the Model for End-Stage Liver Disease (MELD) score is superior to other liver disease scoring systems to establish optimal candidates for transjugular intrahepatic portosystemic shunt (TIPS) procedure and liver transplantation. Our aim was to compare MELD-Na score with MELD score as a predictor of 30-day as well as 90-day mortality for individuals with end-stage liver disease (ESLD) after creation of TIPS. We performed a chart review on cirrhotic patients who underwent TIPS procedure and documented presence and severity of ascites and hepatic encephalopathy, patient laboratory values, and results from TIPS procedures. We compared continuous variables by Student's t-test for independent samples and categorical variables by χ-test(s). In non-normal distributions, a nonparametric test was used. We performed a logistic regression to determine the effects of several variables and analyzed variable predictors of likelihood of death within 30 and 90 days of TIPS procedure. Of the six predictor variables, only MELD-Na score was a statistically significant predictor of 30- and 90-day mortality following TIPS procedure for ESLD (P=0.028). For each one point increase in MELD-Na score, the odds of death increased by 1.15 times [95% confidence interval (1.02-1.30), P=0.28]. Since hyponatremia may be associated with poor prognostic features of overall health, its incorporation into the MELD scoring system to predict mortality in ESLD after creation of TIPS serves a useful purpose. Our single-center experience suggests that the MELD-Na score is the most effective predictor of survival after TIPS creation. PMID:26111072

  12. Dam-related effects on heart girth at birth, morbidity and growth rate from birth to 90 days of age in Swedish dairy calves.

    PubMed

    Lundborg, G K; Oltenacu, P A; Maizon, D O; Svensson, E C; Liberg, P G A

    2003-08-01

    We investigated the effects of dam-related factors (such as calving performance, milk leakage, diseases, milk production, and somatic-cell count (SCC)) on heart girth at birth and the incidence risk of diarrhoea and respiratory disease during the first 90 days in Swedish dairy calves. The effects of these dam-related factors and environmental and management-related (but not dietary) factors on the calves' growth rate during the first 90 days of life also were analysed. The study used nearly 3,000 heifer calves born in 1998 on 122 farms in the south-west of Sweden. Individual health records were kept by the farmers and visiting project veterinarians. The calf's heart girth was measured at birth and weaning. We used generalised linear mixed models for the size of the calf at birth and growth rate. Variables associated with the heart girth at birth were breed, calving performance, mastitis in the dam in the last 49 days before calving, milk production and parity. Variables associated with the growth rate were breed, calving performance, disease in the calf during its first 90 days of life, heart girth at birth, and housing of calves. The effect of the dam on the relative risk of diarrhoea and/or respiratory disease in the calf was evaluated by a generalised linear mixed model with a logit link. Morbidity in the dam during late pregnancy, retained placenta and SCC were associated with the relative risk of respiratory disease in the calf. None of the explanatory variables (other then breed) was associated with the relative risk of diarrhoea. PMID:12900157

  13. Predictors of 30-Day Mortality and 90-Day Functional Recovery after Primary Intracerebral Hemorrhage : Hospital Based Multivariate Analysis in 585 Patients

    PubMed Central

    2009-01-01

    Objective The purpose of this study was to identify independent predictors of mortality and functional recovery in patients with primary intracerebral hemorrhage (PICH) and to improve functional outcome in these patients. Methods Data were collected retrospectively on 585 patients with supratentorial PICH admitted to the Stroke Unit at our hospital between 1st January 2004 and the 31st July 2008. Using multivariate logistic regression analysis, the associations between all selected variables and 30-day mortality and 90-day functional recoveries after PICH was evaluated. Results Ninety-day functional recovery was achieved in 29.1% of the 585 patients and 30-day mortality in 15.9%. Age (OR=7.384, p=0.000), limb weakness (OR=6.927, p=0.000), and hematoma volume (OR=5.293, p=0.000) were found to be powerful predictors of 90-day functional recovery. Furthermore, initial consciousness (OR=3.013, p=0.014) hematoma location (lobar, OR=2.653, p=0.003), ventricular extension of blood (OR=2.077, p=0.013), leukocytosis (OR=2.048, p=0.008), alcohol intake (drinker, OR=1.927, p=0.023), and increased serum aminotransferase (OR=1.892, p=0.035) were found to be independent predictors of 90-day functional recovery after PICH. On the other hand, a pupillary abnormality (OR=4.532, p=0.000) and initial unconsciousness (OR=3.362, p=0.000) were found to be independent predictors of 30-day mortality after PICH. Conclusion The predictors of mortality and functional recovery after PICH identified during this analysis may assist during clinical decision-making, when advising patients or family members about the prognosis of PICH and when planning intervention trials. PMID:19609417

  14. STS-90 Day 11 Highlights

    NASA Technical Reports Server (NTRS)

    1998-01-01

    On this eleventh day of the STS-90 mission, the flight crew, Cmdr. Richard A. Searfoss, Pilot Scott D. Altman, and Mission Specialists Richard M. Linnehan, Dafydd Rhys Williams and Kathryn P. Hire, and Payload Specialists Jay C. Buckey and James A. Pawelczyk once again take part in an experiment aimed at exploring the influence of gravity on blood pressure. The lower body negative pressure test places a stress on the cardiovascular system similar to that experienced when standing in Earth's gravity. Pawelczyk also takes part in the Valsalva test, which stimulates the pressure receptors in the neck and chest and measures those responses. Both Buckey and Pawelzyk participate as subjects and as operators in tests of the autonomic nervous system. All four science crew members conduct tests of their pulmonary systems as well as additional runs in a rotating chair to measure the response of their eyes and inner ears in maintaining balance in a weightless environment.

  15. STS-90 Day 06 Highlights

    NASA Technical Reports Server (NTRS)

    1998-01-01

    On this sixth day of the STS-90 mission, the flight crew, Cmdr. Richard A. Searfoss, Pilot Scott D. Altman, and Mission Specialists Richard M. Linnehan, Dafydd Rhys Williams and Kathryn P. Hire, and Payload Specialists Jay C. Buckey and James A. Pawelczyk are back on the job full-time as they begin the day six of on-orbit research on the human nervous system. Additional work with the Pulmonary Function Test (PFT) equipment which is collecting data on the crew's breathing patterns and blood concentrations of oxygen and carbon dioxide also takes place.

  16. STS-90 Day 14 Highlights

    NASA Technical Reports Server (NTRS)

    1998-01-01

    On this fourteenth day of the STS-90 mission, the flight crew, Cmdr. Richard A. Searfoss, Pilot Scott D. Altman, and Mission Specialists Richard M. Linnehan, Dafydd Rhys Williams and Kathryn P. Hire, and Payload Specialists Jay C. Buckey and James A. Pawelczyk focus on the efforts of Neurolab's Neuronal Plasticity Team to better understand how the adult nervous system adapts to the new environment of space. Columbia's science crew -- Mission Specialists Rick Linnehan and Dave Williams and Payload Specialists Jay Buckey and Jim Pawelczyk -- perform the second and final in-flight dissections of the adult male rats on board. The crew euthanizes and dissects nine rats and remove the vestibular or balance organs of the inner ear; the cerebellum, the part of the brain critical for maintaining balance and for processing information from the limbs so they can be moved smoothly; and the cerebrum, one part of which controls automatic functions such as body temperature regulation and the body's internal clock, and the cortical region that controls cognitive functions such as thinking. The first dissection, which was performed on the second day of the flight, went extremely well, according to Neurolab scientists.

  17. STS-90 Day 03 Highlights

    NASA Technical Reports Server (NTRS)

    1998-01-01

    On this third day of the STS-90 mission, the flight crew, Cmdr. Richard A. Searfoss, Pilot Scott D. Altman, and Mission Specialists Richard M. Linnehan, Dafydd Rhys Williams and Kathryn P. Hire, and Payload Specialists Jay C. Buckey and James A. Pawelczyk continue to conduct both human and animal research experiments in the Spacelab module. During the morning, the payload crew members Linnehan, Williams, Buckey and Pawelczyk performs transfer activities with the Animal Enclosure Module, setting up the General Purpose Work Station (GPWS) and operations with the ball catch experiment. In the afternoon, their attention will be on injections and dissections of some of the research animals and an objects recognition test.

  18. A 90-Day Dietary Toxicity Study of Genetically Modified Rice T1C-1 Expressing Cry1C Protein in Sprague Dawley Rats

    PubMed Central

    Tang, Xueming; Han, Fangting; Zhao, Kai; Xu, Yan; Wu, Xiao; Wang, Jinbin; Jiang, Lingxi; Shi, Wei

    2012-01-01

    In a 90-day study, Sprague Dawley rats were fed transgenic T1C-1 rice expressing Cry1C protein and were compared with rats fed non-transgenic parental rice Minghui 63 and rats fed a basal diet. No adverse effects on animal behavior or weight gain were observed during the study. Blood samples were collected and analyzed, and standard hematological and biochemical parameters were compared. A few of these parameters were found to be significantly different, but were within the normal reference intervals for rats of this breed and age, and were thus not considered to be treatment-related. Following sacrifice, a large number of organs were weighed, and macroscopic and histopathological examinations were performed with no changes reported. The aim of this study was to use a known animal model to determine the safety of the genetically modified (GM) rice T1C-1. The results showed no adverse or toxic effects due to T1C-1 rice when tested in this 90-day study. PMID:23300690

  19. 5 CFR 1201.114 - Petition and cross petition for review-content and procedure.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... review include a petition for review, a cross petition for review, a response to a petition for review, a response to a cross petition for review, and a reply to a response to a petition for review. (1) A petition... petition for review. (3) A response to a petition for review and a cross petition for review may...

  20. 5 CFR 1201.114 - Petition and cross petition for review-content and procedure.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... review include a petition for review, a cross petition for review, a response to a petition for review, a response to a cross petition for review, and a reply to a response to a petition for review. (1) A petition... petition for review. (3) A response to a petition for review and a cross petition for review may...

  1. Induction of multiple granulomas in the liver with severe hepatocyte damage by montan wax, a natural food additive, in a 90-day toxicity study in F344 rats.

    PubMed

    Ikeda, Mico; Yamakawa, Keiko; Saoo, Kousuke; Matsuda, Yoko; Hosokawa, Kyoko; Takeuchi, Hijiri; Li, Jia-Qing; Zeng, Yu; Yokohira, Masanao; Imaida, Katsumi

    2008-02-01

    Montan wax is a mineral wax extracted from lignite type coal. It has been registered as a food additive in Japan though there have been no reports of toxicological evaluation, mainly due to the fact that it is considered a natural product. As part of a general safety assessment of montan wax, we have performed a 90-day toxicity study in Fisher 344 (F344) rats. Groups of 10 males and 10 females were given the material at dose levels of 0 (Group 1), 0.56 (Group 2), 1.67 (Group 3), or 5% (Group 4) in the diet for 90 days. During the experiment, there were no remarkable changes in general conditions and no deaths occurred in any group. On hematological examination, Hb, Ht, MCV and MCH were significantly decreased and WBC was significantly increased in all treated rats. On serum biochemical examination, AST and ALT were found to be elevated more than four fold in all treated groups as compared to the respective control group values in both sexes. Furthermore, relative organ weights for the liver, spleen, lung and kidneys were increased in all treated groups of both sexes. Histopathological examination revealed diffuse multiple granulomas in the livers with severe hepatocyte damage and lymphocytic infiltration. Granulomatous lesions were also apparent in the mesenteric lymph nodes in all treated males and females. These findings clearly demonstrate that montan wax, at doses of more than 0.56% in the diet, induces multiple granulomas with severe inflammation in the liver. Because pathological, hematological and serum biochemical changes were observed in the lowest dose group, a no-observed-adverse-effect level (NOAEL) could not be determined in the present study. PMID:17950973

  2. Effect of complications within 90 days on patient-reported outcomes 3 months and 12 months following elective surgery for lumbar degenerative disease.

    PubMed

    Chotai, Silky; Parker, Scott L; Sivaganesan, Ahilan; Sielatycki, J Alex; Asher, Anthony L; McGirt, Matthew J; Devin, Clinton J

    2015-12-01

    OBJECT There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs. METHODS Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis). RESULTS Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1

  3. In vivo genotoxicity evaluation of lung cells from Fischer 344 rats following 28 days of inhalation exposure to MWCNTs, plus 28 days and 90 days post-exposure.

    PubMed

    Kim, Jin Sik; Sung, Jae Hyuck; Choi, Byung Gil; Ryu, Hyeon Yeol; Song, Kyung Seuk; Shin, Jae Hoon; Lee, Jong Seong; Hwang, Joo Hwan; Lee, Ji Hyun; Lee, Gun Ho; Jeon, Kisoo; Ahn, Kang Ho; Yu, Il Je

    2014-03-01

    Despite their useful physico-chemical properties, carbon nanotubes (CNTs) continue to cause concern over occupational and human health due to their structural similarity to asbestos. Thus, to evaluate the toxic and genotoxic effect of multi-wall carbon nanotubes (MWCNTs) on lung cells in vivo, eight-week-old rats were divided into four groups (each group = 25 animals), a fresh air control (0 mg/m(3)), low (0.17 mg/m(3)), middle (0.49 mg/m(3)), and high (0.96 mg/m(3)) dose group, and exposed to MWCNTs via nose-only inhalation 6 h per day, 5 days per week for 28 days. The count median length and geometric standard deviation for the MWCNTs determined by TEM were 330.18 and 1.72 nm, respectively, and the MWCNT diameters ranged from 10 to 15 nm. Lung cells were isolated from five male and five female rats in each group on day 0, day 28 (only from males) and day 90 following the 28-day exposure. The total number of animals used was 15 male and 10 female rats for each concentration group. To determine the genotoxicity of the MWCNTs, a single cell gel electrophoresis assay (Comet assay) was conducted on the rat lung cells. As a result of the exposure, the olive tail moments were found to be significantly higher (p < 0.05) in the male and female rats from all the exposed groups when compared with the fresh air control. In addition, the high-dose exposed male and middle and high-dose exposed female rats retained DNA damage, even 90 days post-exposure (p < 0.05). To investigate the mode of genotoxicity, the intracellular reactive oxygen species (ROS) levels and inflammatory cytokine levels (TNF-α, TGF- β, IL-1, IL-2, IL-4, IL-5, IL-10, IL-12 and IFN-γ) were also measured. For the male rats, the H2O2 levels were significantly higher in the middle (0 days post-exposure) and high- (0 days and 28 days post-exposure) dose groups (p < 0.05). Conversely, the female rats showed no changes in the H2O2 levels. The inflammatory cytokine levels in the

  4. A 90-day study of sub-chronic oral toxicity of 20 nm positively charged zinc oxide nanoparticles in Sprague Dawley rats

    PubMed Central

    Park, Hark-Soo; Kim, Seon-Ju; Lee, Taek-Jin; Kim, Geon-Yong; Meang, EunHo; Hong, Jeong-Sup; Kim, Su-Hyon; Koh, Sang-Bum; Hong, Seung-Guk; Sun, Yle-Shik; Kang, Jin Seok; Kim, Yu-Ri; Kim, Meyoung-Kon; Jeong, Jayoung; Lee, Jong-Kwon; Son, Woo-Chan; Park, Jae-Hak

    2014-01-01

    Purpose The study reported here was conducted to determine the systemic oral toxicity and to find the no-observed-adverse-effect level of 20 nm positively charged zinc oxide (ZnOSM20(+)) nanoparticles in Sprague Dawley rats for 90 days. Methods For the 90-day toxicity study, the high dose was set as 500 mg per kg of body weight (mg/kg) and the middle and low dose were set to 250 mg/kg and 125 mg/kg, respectively. The rats were held for a 14-day recovery period after the last administration, to observe for the persistence or reduction of any toxic effects. A distributional study was also carried out for the systemic distribution of ZnOSM20(+) NPs. Results No rats died during the test period. There were no significant clinical changes due to the test article during the experimental period in functional assessment, body weight, food and water consumption, ophthalmological testing, urine analysis, necropsy findings, or organ weights, but salivation was observed immediately after administration in both sexes. The total red blood cell count was increased, and hematocrit, albumin, mean cell volume, mean cell hemoglobin, and mean cell hemoglobin concentration were decreased significantly compared with control in both 500 mg/kg groups. Total protein and albumin levels were decreased significantly in both sexes in the 250 and 500 mg/kg groups. Histopathological studies revealed acinar cell apoptosis in the pancreas, inflammation and edema in stomach mucosa, and retinal atrophy of the eye in the 500 mg/kg group. Conclusion There were significant parameter changes in terms of anemia in the hematological and blood chemical analyses in the 250 and 500 mg/kg groups. The significant toxic change was observed to be below 125 mg/kg, so the no-observed-adverse-effect level was not determined, but the lowest-observed-adverse-effect level was considered to be 125 mg/kg in both sexes and the target organs were found to be the pancreas, eye, and stomach. PMID:25565829

  5. Collagen content in the vastus lateralis and the soleus muscle following a 90-day bed rest period with or without resistance exercises

    PubMed Central

    Nielsen, Rasmus Oestergaard; Schjerling, Peter; Tesch, Per; Stål, Per; Langberg, Henning

    2015-01-01

    Summary Introduction spaceflight seems associated with deterioration of the function of the skeletal muscles. Since muscle collagen is critical for muscle function, an improved understanding of the content of the muscle collagen during long-term inactivity seems important. Bed-rest with in-bed resistance training serves as a proxy for the conditions in space. Therefore, ground-based studies may improve the understanding of the consequences of long-term inactivity. Purpose the purpose is to compare the change in collagen protein in the vastus lateralis (VL) and the soleus (SOL) muscle amongst persons exposed to a 90-day bed rest with or without resistance exercise. Methods an explorative analysis was completed based on data from a randomized, controlled trial. The intervention group (BRE, SOL n=4, VL n=8) performed supine-based squat exercises, whereas the controls (BE, SOL n=6, VL n=12) remained inactive during follow-up. Muscle biopsies from vastus lateralis and soleus were taken at baseline (pre) and after 90-days’ follow-up (post). Muscle collagen (μg collagen/mg protein) was quantified. Two-way repeated measurements ANOVA was used to compare the interaction between the intervention (BRE/BR) and time (pre/post) for each muscle. Results the collagen content of VL was similar between pre and post in the BRE group (−3.8 μg collagen/mg protein [95% CI: −22.0; 14.4], p=0.68) while it rose amongst individuals in the BR group (14.9 μg collagen/mg protein [95% CI: −0.01; 29.7], p=0.05). The difference of 18.66 [95% CI: −6.5; 43.9] between BRE and BR across time was, however, not significant (p=0.14). No significant reduction in SOL muscle collagen content was observed from pre to post in the BR group (−9.3 μg collagen/mg protein [95% CI: −24.9; 6.4], p=0.25) or in the BRE group (−6.5 μg collagen/mg protein [95% CI: −25.6; 12.6], p=0.50). There was no difference in the effect of BR versus BRE over time (mean difference −2.78 μg collagen

  6. Safety assessment of SDA soybean oil: results of a 28-day gavage study and a 90-day/one generation reproduction feeding study in rats.

    PubMed

    Hammond, Bruce G; Lemen, Joan K; Ahmed, Gulam; Miller, Kathleen D; Kirkpatrick, Jeannie; Fleeman, Tammye

    2008-12-01

    Long chain polyunsaturated fatty acids (LC-PUFAs) in the diet reduce risk of cardiac mortality. Fish oils are a dietary source of LC-PUFAs (EPA, DHA) but intake is low in Western diets. Adding beneficial amounts of LC-PUFAs to foods is limited by their instability and potential to impart off-flavors. Stearidonic acid (SDA), a precursor of EPA in man, is more stable than EPA/DHA in food matrices. SDA is present in fish oils (0.5-4%) and in nutraceuticals (echium, borage oil). Genes for Delta6, Delta15 desaturases were introduced into soybeans that convert linoleic and alpha-linolenic acid to SDA (15-30% fatty acids). Since addition of SDA soybean oil into human foods increases SDA intake, toxicology studies were undertaken to assess its safety. In a 28-day pilot study, rats were gavaged with SDA soybean oil at dosages up to 3g/kg body weight/day; no treatment-related adverse effects were observed. A 90-day/one generation rat reproduction study was subsequently conducted where SDA soybean oil was added to diets to provide daily doses of 1.5 and 4 g/kg body weight. There were no treatment-related adverse effects on parental animals or on reproductive performance and progeny development. PMID:18804141

  7. Evaluation of 90-day Repeated Dose Oral Toxicity, Glycometabolism, Learning and Memory Ability, and Related Enzyme of Chromium Malate Supplementation in Sprague-Dawley Rats.

    PubMed

    Feng, Weiwei; Wu, Huiyu; Li, Qian; Zhou, Zhaoxiang; Chen, Yao; Zhao, Ting; Feng, Yun; Mao, Guanghua; Li, Fang; Yang, Liuqing; Wu, Xiangyang

    2015-11-01

    Our previous study showed that chromium malate improved the regulation of blood glucose in mice with alloxan-induced diabetes. The present study was designed to evaluate the 90-day oral toxicity of chromium malate in Sprague-Dawley rats. The present study inspected the effect of chromium malate on glycometabolism, glycometabolism-related enzymes, lipid metabolism, and learning and memory ability in metabolically healthy Sprague-Dawley rats. The results showed that all rats survived and pathological, toxic, feces, and urine changes were not observed. Chromium malate did not cause measurable damage on liver, brain, and kidney. The fasting blood glucose, serum insulin, insulin resistance index, C-peptide, hepatic glycogen, glucose-6-phosphate dehydrogenase, glucokinase, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglyceride levels of normal rats in chromium malate groups had no significant change when compared with control group and chromium picolinate group under physiologically relevant conditions. The serum and organ content of Cr in chromium malate groups had no significant change compared with control group. No significant changes were found in morris water maze test and superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), and true choline esterase (TChE) activity. The results indicated that supplementation with chromium malate did not cause measurable toxicity and has no obvious effect on glycometabolism and related enzymes, learning and memory ability, and related enzymes and lipid metabolism of female and male rats. The results of this study suggest that chromium malate is safe for human consumption. PMID:25900579

  8. Evaluation of the 90-day inhalation toxicity of petroleum and oil shale JP-5 jet fuel. Technical report, July 1977-July 1983

    SciTech Connect

    Gaworski, C.L.; MacEwen, J.D.; Vernot, E.H.; Haun, C.C.; Leahy, H.F.

    1985-04-01

    Subchronic 90-day inhalation studies were conducted to compare the toxicity of Petroleum and Oil Shale derived JP-5 jet fuel. Beagle dogs, Fischer 344 rats, and C57BL/6 mice were continuously exposed to JP-5 at concentrations of 150 mg/m cum and 750 mg/cum 3. Unexposed control groups were also maintained. All dogs and a portion of each rodent group were sacrificed and examined at exposure termination. Remaining rodents were held for observation up to 21 months postexposure. The most significant exposure related effect occurred in male rats, where JP-5 produced nephropathy characterized by hyaline droplets, necrosis, and intratubular casts. Accentuated tubular degeneration and medullary mineralization were noted in exposed rats held for long-term postexposure observation. Female rats were free of significant JP-5 related renal damage. Consistent with the pathologic changes in male rats exposed to 750 mg/cu m 3 were increased kidney weight and increased serum creatinine and BUN levels. Reduced body weight gains also occurred in male rats exposed to JP-5. No pathologic lesions were observed in dogs exposed to JP-5. Hepatocellular vacuolization and fatty change occurred in mice exposed to JP-5 from either source and in rats exposed to Shale JP-5. The results of this study suggest that there are no substantial differences between Petroleum and Shale JP-5.

  9. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study.

    PubMed

    Di Pierro, Francesco; Zanvit, Alberto; Nobili, Piero; Risso, Paolo; Fornaini, Carlo

    2015-01-01

    Dental caries is the most common chronic disease of childhood. Cariogram is a well-recognized algorithm-based software program based on different caries-related risk factors and intended to aid clinicians in performing more objective and consistent dental caries risk assessments. This type of approach precedes the diagnosis of caries and allows the dentist to identify at-risk patients and then take appropriate preventive measures before caries develop further. One of the etiological factors favoring the development of dental caries is the mutans streptococci. These acidogenic dental plaque inhabitants can be effectively antagonized by the activity of bacteriocins released by the probiotic Streptococcus salivarius M18 (salivarius M18). Moreover, salivarius M18 after colonizing the human oral mucosa produces the enzymes dextranase and urease that are able to counteract plaque formation and saliva acidity, respectively. Seventy-six subjects at high risk of dental caries were randomized and then either treated or not treated for 90 days with an oral formulation containing the oral probiotic salivarius M18 (Carioblis(®)). The results indicate that the use of salivarius M18 increases the chances of avoiding new dental caries development in children, and its application could be proposed as a new tool in the dentist's armory to be adopted in subjects considered at high risk on the basis of their Cariogram outcome. PMID:26491371

  10. Cariogram outcome after 90 days of oral treatment with Streptococcus salivarius M18 in children at high risk for dental caries: results of a randomized, controlled study

    PubMed Central

    Di Pierro, Francesco; Zanvit, Alberto; Nobili, Piero; Risso, Paolo; Fornaini, Carlo

    2015-01-01

    Dental caries is the most common chronic disease of childhood. Cariogram is a well-recognized algorithm-based software program based on different caries-related risk factors and intended to aid clinicians in performing more objective and consistent dental caries risk assessments. This type of approach precedes the diagnosis of caries and allows the dentist to identify at-risk patients and then take appropriate preventive measures before caries develop further. One of the etiological factors favoring the development of dental caries is the mutans streptococci. These acidogenic dental plaque inhabitants can be effectively antagonized by the activity of bacteriocins released by the probiotic Streptococcus salivarius M18 (salivarius M18). Moreover, salivarius M18 after colonizing the human oral mucosa produces the enzymes dextranase and urease that are able to counteract plaque formation and saliva acidity, respectively. Seventy-six subjects at high risk of dental caries were randomized and then either treated or not treated for 90 days with an oral formulation containing the oral probiotic salivarius M18 (Carioblis®). The results indicate that the use of salivarius M18 increases the chances of avoiding new dental caries development in children, and its application could be proposed as a new tool in the dentist’s armory to be adopted in subjects considered at high risk on the basis of their Cariogram outcome. PMID:26491371

  11. Safety assessment of freeze-dried powdered Tenebrio molitor larvae (yellow mealworm) as novel food source: Evaluation of 90-day toxicity in Sprague-Dawley rats.

    PubMed

    Han, So-Ri; Lee, Byoung-Seok; Jung, Kyung-Jin; Yu, Hee-Jin; Yun, Eun-Young; Hwang, Jae Sam; Moon, Kyoung-Sik

    2016-06-01

    Worldwide demand for novel food source has grown and edible insects are a promising food sources for humans. Tenebrio molitor, as known as yellow mealworm, has advantages of being rich in protein, and easy to raise as a novel food source. The objective of this study was to evaluate subchronic toxicity, including potential hypersensitivity, of freeze-dried powdered T. molitor larvae (fdTML) in male and female Sprague-Dawley rats. The fdTML was administered orally once daily at dose levels of 0, 300, 1000 and 3000 mg/kg/day for 90 days. A toxicological assessment was performed, which included mortality, clinical signs, body and organ weights, food consumption, ophthalmology, urinalysis, hematology, serum chemistry, gross findings, histopathologic examination and allergic reaction. There were no fdTML- related findings in clinical signs, urinalysis, hematology and serum chemistry, gross examination, histopathologic examination or allergic reaction. In conclusion, the No Observed Adverse Effect Level (NOAEL) for fdTML was determined to be in excess of 3000 mg/kg/day in both sexes of rats under the experimental conditions of this study. PMID:26993751

  12. Assessment of the reporting of quality and outcome measures in hepatic resections: a call for 90-day reporting in all hepatectomy series

    PubMed Central

    Egger, Michael E; Ohlendorf, Joanna M; Scoggins, Charles R; McMasters, Kelly M; Martin, Robert C G

    2015-01-01

    Background The aim of this paper is to assess the current state of quality and outcomes measures being reported for hepatic resections in the recent literature. Methods Medline and PubMed databases were searched for English language articles published between 1 January 2002 and 30 April 2013. Two examiners reviewed each article and relevant citations for appropriateness of inclusion, which excluded papers of liver donor hepatic resections, repeat hepatectomies or meta-analyses. Data were extracted and summarized by two examiners for analysis. Results Fifty-five studies were identified with suitable reporting to assess peri-operative mortality in hepatic resections. In only 35% (19/55) of the studies was the follow-up time explicitly stated, and in 47% (26/55) of studies peri-operative mortality was limited to in-hospital or 30 days. The time period in which complications were captured was not explicitly stated in 19 out of 28 studies. The remaining studies only captured complications within 30 days of the index operation (8/28). There was a paucity of quality literature addressing truly patient-centred outcomes. Conclusion Quality outcomes after a hepatic resection are inconsistently reported in the literature. Quality outcome studies for a hepatectomy should report mortality and morbidity at a minimum of 90 days after surgery. PMID:26228262

  13. 22 CFR 1422.2 - Contents of petition; filing and service of petition; challenges to petition.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...; filing and service of petition; challenges to petition. (a) Petition for exclusive recognition. A petition by a labor organization for exclusive recognition shall be submitted on a form prescribed by the... recognition or certification and the expiration date of any applicable agreement, if known to the...

  14. 22 CFR 1422.2 - Contents of petition; filing and service of petition; challenges to petition.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...; filing and service of petition; challenges to petition. (a) Petition for exclusive recognition. A petition by a labor organization for exclusive recognition shall be submitted on a form prescribed by the... recognition or certification and the expiration date of any applicable agreement, if known to the...

  15. 22 CFR 1422.2 - Contents of petition; filing and service of petition; challenges to petition.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...; filing and service of petition; challenges to petition. (a) Petition for exclusive recognition. A petition by a labor organization for exclusive recognition shall be submitted on a form prescribed by the... recognition or certification and the expiration date of any applicable agreement, if known to the...

  16. 27 CFR 72.39 - Final action.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 2 2010-04-01 2010-04-01 false Final action. 72.39... Remission or Mitigation of Forfeitures § 72.39 Final action. (a) Petitions for remission or mitigation of forfeiture. (1) The Director shall take final action on any petition filed pursuant to these...

  17. Modifications of azoxymethane-induced carcinogenesis and 90-day oral toxicities of 2-tetradecylcyclobutanone as a radiolytic product of stearic acid in F344 rats

    PubMed Central

    Sato, Makoto; Todoriki, Setsuko; Takahashi, Tetsuyuki; Hafez, Ezar; Takasu, Chie; Uehara, Hisanori; Yamakage, Kohji; Kondo, Takashi; Matsumoto, Kozo; Furuta, Masakazu; Izumi, Keisuke

    2015-01-01

    A 90-day oral toxicity test in rats was performed to evaluate the toxicity of 2-tetradecylcyclobutanone (2-tDCB), a unique radiolytic product of stearic acid. Six-week-old male and female F344 rats (n=15/group) were given 2-tDCB at concentrations of 0, 12, 60 and 300 ppm in a powder diet for 13 weeks. Slight dose-dependent increases in serum total protein and albumin in male rats were found, but these changes were not considered to be a toxic effect. The fasting, but not non-fasting, blood glucose levels of the male rats in the 300 ppm group and female rats in the 60 and 300 ppm groups were lower than those of the controls. Gas chromatography-mass spectrometry analysis showed dose-dependent accumulation of 2-tDCB in adipose tissue, notably in males. Next, we performed an azoxymethane (AOM)-induced two-stage carcinogenesis study. After injection of 6-week-old male F344 rats (n=30/group) once a week for 3 weeks, the animals received 2-tDCB at concentrations of 0, 10, 50 and 250 ppm in a powder diet for 25 weeks. The incidences of colon tumors for the 2-tDCB dosages were 34%, 45%, 40% and 37%, respectively, and were not statistically significant. These data suggest that 2-tDCB shows no toxic or tumor-modifying effects under the present conditions, and that the no-observed-adverse-effect level for 2-tDCB is 300 ppm in both sexes, equivalent to 15.5 mg/kg b.w./day in males and 16.5 mg/kg b.w./day in females. PMID:26028819

  18. Modifications of azoxymethane-induced carcinogenesis and 90-day oral toxicities of 2-tetradecylcyclobutanone as a radiolytic product of stearic acid in F344 rats.

    PubMed

    Sato, Makoto; Todoriki, Setsuko; Takahashi, Tetsuyuki; Hafez, Ezar; Takasu, Chie; Uehara, Hisanori; Yamakage, Kohji; Kondo, Takashi; Matsumoto, Kozo; Furuta, Masakazu; Izumi, Keisuke

    2015-04-01

    A 90-day oral toxicity test in rats was performed to evaluate the toxicity of 2-tetradecylcyclobutanone (2-tDCB), a unique radiolytic product of stearic acid. Six-week-old male and female F344 rats (n=15/group) were given 2-tDCB at concentrations of 0, 12, 60 and 300 ppm in a powder diet for 13 weeks. Slight dose-dependent increases in serum total protein and albumin in male rats were found, but these changes were not considered to be a toxic effect. The fasting, but not non-fasting, blood glucose levels of the male rats in the 300 ppm group and female rats in the 60 and 300 ppm groups were lower than those of the controls. Gas chromatography-mass spectrometry analysis showed dose-dependent accumulation of 2-tDCB in adipose tissue, notably in males. Next, we performed an azoxymethane (AOM)-induced two-stage carcinogenesis study. After injection of 6-week-old male F344 rats (n=30/group) once a week for 3 weeks, the animals received 2-tDCB at concentrations of 0, 10, 50 and 250 ppm in a powder diet for 25 weeks. The incidences of colon tumors for the 2-tDCB dosages were 34%, 45%, 40% and 37%, respectively, and were not statistically significant. These data suggest that 2-tDCB shows no toxic or tumor-modifying effects under the present conditions, and that the no-observed-adverse-effect level for 2-tDCB is 300 ppm in both sexes, equivalent to 15.5 mg/kg b.w./day in males and 16.5 mg/kg b.w./day in females. PMID:26028819

  19. 78 FR 12459 - State Implementation Plans: Response to Petition for Rulemaking; Findings of Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...The EPA is proposing to take action on a petition for rulemaking filed by the Sierra Club with the EPA Administrator on June 30, 2011 (the Petition). The Petition includes interrelated requests concerning the treatment of excess emissions in state rules by sources during periods of startup, shutdown, or malfunction (SSM). The EPA is proposing to grant in part and to deny in part the request in......

  20. Morbidity in Swedish dairy calves from birth to 90 days of age and individual calf-level risk factors for infectious diseases.

    PubMed

    Svensson, Catarina; Lundborg, Karin; Emanuelson, Ulf; Olsson, Sven-Ove

    2003-05-15

    The health of 3081 heifer calves born in 122 dairy herds in the south-west of Sweden from 1 January to 31 December, 1998, was monitored from birth until 90 days of age. The calves were kept either in individual pens (n=2167), in group pens, with 3-8 calves to a pen and manual feeding of milk (n=440), in group pens with 6-30 calves per pen and an automatic milk-feeding system (n=431), or with their dams (n=43). Disease incidence was recorded by farmers and project veterinarians, who clinically examined the calves and auscultated their lungs every 2-3 months. A disease was graded as 'severe' if the general loss of condition or of appetite in the calf continued for >2 days or if the animal suffered severe weight loss due to the disease. The effects of season, breed, housing, and type of colostrum feeding, and time, place and supervision of calving on the incidences of diarrhea, severe diarrhea, respiratory disease, other infectious disease and moderately to severely increased respiratory sounds, were analyzed by logistic-regression models (with herd as a random effect). The total morbidity rate was 0.081 cases per calf-month at risk. Incidence rates of arthritis, diarrhea, omphalophlebitis, respiratory disease and ringworm were 0.002, 0.035, 0.005, 0.025 and 0.009 cases per calf-months at risk, respectively. The odds ratios for diarrhea and severe diarrhea were increased in Swedish Red and Whites (OR: 1.6, 2.3) and in calves that received colostrum from first-lactation cows (OR: 1.3-1.8), and for severe diarrhea in calves born in summer or that received colostrum through suckling (OR: 1.7, 1.8). The odds ratios for respiratory disease and increased respiratory sounds were increased in calves housed in large-group pens with an automatic milk-feeding system (OR: 2.2, 2.8). Supervision of calving was associated with a decreased odds ratio for respiratory disease (OR: 0.7) and birth in individual maternity pen or tie stalls with a decreased odds ratio for increased

  1. 76 FR 61474 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-04

    ... in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background... Federal Aviation Administration [Summary Notice No. PE-2011-43 Petition for Exemption; Summary of Petition... received. SUMMARY: This notice contains a summary of a petition seeking relief from specified...

  2. 75 FR 39699 - Sterigenics International, Inc.; Withdrawal of Food Additive Petition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-12

    ... the Federal Register of November 30, 2004 (69 FR 69606), FDA announced that a food additive petition... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2004F-0455) Sterigenics International, Inc.; Withdrawal of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION:...

  3. 78 FR 77384 - DSM Nutritional Products; Filing of Food Additive Petition (Animal Use)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-23

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 DSM Nutritional Products; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products has filed...

  4. 76 FR 16839 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Petition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-25

    ... December 10, 2010 (75 FR 77001). Interested parties are encouraged to send comments to the OMB, Office of...; Petition for Classifying Labor Surplus Areas ACTION: Notice. SUMMARY: The Department of Labor (DOL) hereby... collection request (ICR) titled, ``Petition for Classifying Labor Surplus Areas,'' to the Office...

  5. 78 FR 32261 - Agency Information Collection Activities: Immigrant Petition by Alien Entrepreneur, Form Number I...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-29

    ..., 2012, at 77 FR 71432, allowing for a 60-day public comment period. USCIS did not receive any comments... Petition by Alien Entrepreneur, Form Number I-526; Revision of a Currently Approved Collection ACTION: 30... Petition by Alien Entrepreneur. (3) Agency form number, if any, and the applicable component of the...

  6. 78 FR 3081 - Petition for Exemption From the Federal Motor Vehicle Motor Theft Prevention Standard; Toyota

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-15

    ... National Highway Traffic Safety Administration Petition for Exemption From the Federal Motor Vehicle Motor... Transportation (DOT). ACTION: Grant of petition for exemption. SUMMARY: This document grants in full Toyota Motor... to be as effective in reducing and deterring motor vehicle theft as compliance with the...

  7. 77 FR 65706 - Agency Information Collection Activities: Immigrant Petition for Alien Worker, Form I-140...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... Petition for Alien Worker, Form I-140; Revision of a Currently Approved Collection ACTION: 60-Day Notice... Form/Collection: Immigrant Petition for Alien Worker. (3) Agency form number, if any, and the... information furnished on Form I-140 will be used by USCIS to classify aliens under sections 203(b)(1),...

  8. 78 FR 70515 - Petition To Promulgate Standards for Bears Under the Animal Welfare Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ...; ] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 3 Petition To Promulgate Standards for Bears Under the Animal Welfare Act Regulations AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice of petition. SUMMARY: We are notifying the public that the Animal and...

  9. 24 CFR 902.69 - PHA right of petition and appeal.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false PHA right of petition and appeal... appeal. (a) Appeal of troubled performer designation and petition for removal of troubled performer designation. A PHA may take any of the following actions: (1) Appeal its troubled performer...

  10. 24 CFR 902.69 - PHA right of petition and appeal.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false PHA right of petition and appeal... appeal. (a) Appeal of troubled performer designation and petition for removal of troubled performer designation. A PHA may take any of the following actions: (1) Appeal its troubled performer...

  11. 24 CFR 902.69 - PHA right of petition and appeal.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false PHA right of petition and appeal... appeal. (a) Appeal of troubled performer designation and petition for removal of troubled performer designation. A PHA may take any of the following actions: (1) Appeal its troubled performer...

  12. 24 CFR 902.69 - PHA right of petition and appeal.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false PHA right of petition and appeal... appeal. (a) Appeal of troubled performer designation and petition for removal of troubled performer designation. A PHA may take any of the following actions: (1) Appeal its troubled performer...

  13. 78 FR 15719 - Interconnect Solar Development LLC; Notice of Petition for Enforcement

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... Energy Regulatory Commission Interconnect Solar Development LLC; Notice of Petition for Enforcement Take... 1978 (PURPA), 16 U.S.C. 824a-3(h)(2006), Interconnect Solar Development LLC filed a Petition for... against the Idaho Public Utilities Commission and Idaho Power; find that their actions violated PURPA;...

  14. 15 CFR 2006.1 - Information to be included in petition.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 2006.1 Section 2006.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... 301 OF THE TRADE ACT OF 1974, AS AMENDED § 2006.1 Information to be included in petition. (a) General... page that the petition requests that action be taken under section 301 of the Trade Act and...

  15. 15 CFR 2006.1 - Information to be included in petition.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 2006.1 Section 2006.1 Commerce and Foreign Trade Regulations Relating to Foreign Trade Agreements... 301 OF THE TRADE ACT OF 1974, AS AMENDED § 2006.1 Information to be included in petition. (a) General... page that the petition requests that action be taken under section 301 of the Trade Act and...

  16. 77 FR 26755 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ...: Environmental Protection Agency (EPA). ACTION: Notice of a final decision on a no migration petition reissuance... adequately demonstrated to the satisfaction of the Environmental Protection Agency by the petition reissuance... location: Environmental Protection Agency, Region 6, Water Quality Protection Division, Source......

  17. 76 FR 53452 - Clean Air Act Operating Permit Program; Response to Petition To Reopen the 2001 Title V Permit...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-26

    ... AGENCY Clean Air Act Operating Permit Program; Response to Petition To Reopen the 2001 Title V Permit for...: Environmental Protection Agency (EPA). ACTION: Notice of action denying petition to reopen Title V permit... 2001 Title V permit issued by the Pennsylvania Department of Environmental Protection (PADEP)...

  18. 29 CFR 102.71 - Dismissal of petition; refusal to proceed with petition; requests for review by the Board of...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... extension of time within which to file the request for review shall be filed with the Board in Washington...; requests for review by the Board of action of the regional director. 102.71 Section 102.71 Labor... of action of the regional director. (a) If, after a petition has been filed and at any time prior...

  19. ADATSA Follow-Up Study of Extended Outpatient Care: A Comparison of 90 Days versus 180 Days of Outpatient Treatment for Clients of Washington State's Alcoholism and Drug Addiction Treatment and Support Act.

    ERIC Educational Resources Information Center

    Van Der Hyde, Vincent A.; And Others

    This study was designed to compare outcomes for two groups of alcohol and substance abuse clients (N=230): a control group assigned to regular 90 days of outpatient treatment, and an experimental group assigned to 180 days of extended outpatient care. Outcomes were compared in the following nine categories: (1) relapse, measured as reported…

  20. 17 CFR 201.430 - Appeal of actions made pursuant to delegated authority.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Procedure—(1) Notice of intention to petition for review. A party to an action made pursuant to delegated... written notice of intention to petition for review within five days after actual notice of the action to... notice of intention to petition for review pursuant to paragraph (b)(1) of this section, the...

  1. 5 CFR 1201.114 - Filing petition and cross petition for review.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... response to a petition for review or to a cross petition for review must be filed within 25 days after the... a motion for extension of time to file a petition for review, a cross petition, or a response only... petition for review, cross petition for review, or response that is filed late must be accompanied by...

  2. 5 CFR 1201.114 - Filing petition and cross petition for review.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... response to a petition for review or to a cross petition for review must be filed within 25 days after the... a motion for extension of time to file a petition for review, a cross petition, or a response only... petition for review, cross petition for review, or response that is filed late must be accompanied by...

  3. 5 CFR 1201.114 - Filing petition and cross petition for review.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... response to a petition for review or to a cross petition for review must be filed within 25 days after the... a motion for extension of time to file a petition for review, a cross petition, or a response only... petition for review, cross petition for review, or response that is filed late must be accompanied by...

  4. 29 CFR 90.11 - Petitions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 1 2011-07-01 2011-07-01 false Petitions. 90.11 Section 90.11 Labor Office of the Secretary of Labor CERTIFICATION OF ELIGIBILITY TO APPLY FOR WORKER ADJUSTMENT ASSISTANCE Petitions and Determinations of Eligibility To Apply for Adjustment Assistance § 90.11 Petitions. (a) Who may file petitions. A petition under section 221(a) of the...

  5. 78 FR 23246 - Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-18

    ... Protection Agency (EPA). ACTION: Notice of a final decision on a no migration petition reissuance. SUMMARY... application and supporting documentation that, to a reasonable degree of certainty, there will be no...

  6. 16 CFR 1051.9 - Factors the Commission considers in granting or denying petitions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Commission Action, 16 CFR 1009.8, sets forth the criteria upon which Commission priorities are based. ... denying petitions. (a) The major factors the Commission considers in deciding whether to grant or deny...

  7. 16 CFR 1051.9 - Factors the Commission considers in granting or denying petitions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Commission Action, 16 CFR 1009.8, sets forth the criteria upon which Commission priorities are based. ... denying petitions. (a) The major factors the Commission considers in deciding whether to grant or deny...

  8. 77 FR 44233 - Clothianidin; Emergency Petition To Suspend; Notice of Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... AGENCY Clothianidin; Emergency Petition To Suspend; Notice of Availability AGENCY: Environmental... immediately suspend Clothianidin and take other actions affecting the registration. The EPA is announcing the... organizations requesting that the EPA suspend registrations for the insecticide clothianidin for the...

  9. 77 FR 143 - Receipt of Request for Action

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... COMMISSION Receipt of Request for Action Notice is hereby given that by petition dated April 13, 2011, Paul... action to immediately suspend the operating licenses of General Electric boiling water reactors with Mark... ``petitioners.'' In their petition, the petitioners request: enforcement action to ensure that the public...

  10. Less incidence of coronary artery disease in general anesthesia compared to spinal-epidural anesthesia after total knee replacement: 90-day follow-up period by a population-based dataset.

    PubMed

    Hsieh, Jui-Yang; Lin, Hui-Wen

    2015-07-01

    Total knee replacement (TKR) is an effective and safe procedure. However, large-scale study to compare the incidence of coronary artery disease (CAD) after spinal or epidural anesthesia (SA-EA) or general anesthesia (GA) for TKR has not ever been conducted. To do so, we studied a population-based dataset from the Taiwan National Health Research Institute and hypothesized that the incidence of CAD might be different with regional than with general anesthesia. The risk of CAD-related events during a 90-day follow-up period among patients who received TKR under SA-EA or GA was evaluated in the present study. A total of 1500 patients from the Taiwan National Health Insurance claims database who underwent TKR from January 1, 2004, to December 31, 2006, were allocated into two groups. Group 1 included 1012 patients who received SA-EA during TKR procedure. Group 2 included 488 patients who received GA during this procedure. The number of patients who developed CAD during the 90-day follow-up period was 31 (3.1 %) in group 1 and 6 (1.2 %) in group 2. The Kaplan-Meier survival analysis of IHD-free cumulative survival rate during the 90-day follow-up period for patients who underwent TKR was significantly lower in group 1 than in group 2. The hazard ratio for the occurrence of CAD was 2.80 (95 % CI 1.16-6.78), and the hazard was higher for patients who received SA-EA than for patients who received GA after adjusted potential confounding factors. After the performance of TKR, patients had a potentially increased risk for CAD in SA-EA compared to GA during the 90-day follow-up period. PMID:25761988

  11. 78 FR 28163 - Zentox Corporation; Withdrawal of Food Additive Petition

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... Register of September 3, 2008 (73 FR 51490), we announced that Zentox Corp., c/o Burdock Group, 801 North... HUMAN SERVICES Food and Drug Administration 21 CFR Part 173 Zentox Corporation; Withdrawal of Food Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice of withdrawal. SUMMARY:...

  12. 19 CFR 206.42 - Who may file a petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Who may file a petition. 206.42 Section 206.42 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION NONADJUDICATIVE INVESTIGATIONS INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW...

  13. 19 CFR 206.33 - Who may file a petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Who may file a petition. 206.33 Section 206.33 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION NONADJUDICATIVE INVESTIGATIONS INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW...

  14. 19 CFR 206.62 - Who may file a petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Who may file a petition. 206.62 Section 206.62 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION NONADJUDICATIVE INVESTIGATIONS INVESTIGATIONS RELATING TO GLOBAL AND BILATERAL SAFEGUARD ACTIONS, MARKET DISRUPTION, TRADE DIVERSION, AND REVIEW...

  15. 21 CFR 571.100 - Regulation based on petition.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVE PETITIONS Administrative Actions on Applications... additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used...

  16. 21 CFR 571.100 - Regulation based on petition.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS FOOD ADDITIVE PETITIONS Administrative Actions on Applications... additive may be safely used (including, but not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity that may be used...

  17. 47 CFR 1.106 - Petitions for reconsideration.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false Petitions for reconsideration. 1.106 Section 1.106 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE General Rules of Practice and Procedure Reconsideration and Review of Actions Taken by the Commission and Pursuant to Delegated Authority; Effective Dates...

  18. 49 CFR 190.9 - Petitions for finding or approval.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... justify the action. Unless otherwise specified, no public proceeding is held on a petition before it is.... (ii) Where there is no state agency certified to participate, the Administrator, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue, SE, Washington, DC 20590. (2)...

  19. 49 CFR 190.9 - Petitions for finding or approval.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... justify the action. Unless otherwise specified, no public proceeding is held on a petition before it is.... (ii) Where there is no state agency certified to participate, the Administrator, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue, SE, Washington, DC 20590. (2)...

  20. Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis

    PubMed Central

    Yang, Y. Tony; Cheng, Xi; Bian, John; Bennett, Charles L.

    2016-01-01

    The United States Constitution protects the right of citizens to petition the government for “a redress of grievances.” This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10–13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to “redress grievances.” PMID:27171162

  1. Petitioning the FDA to Improve Pharmaceutical, Device and Public Health Safety by Ordinary Citizens: A Descriptive Analysis.

    PubMed

    Chen, Brian K; Yang, Y Tony; Cheng, Xi; Bian, John; Bennett, Charles L

    2016-01-01

    The United States Constitution protects the right of citizens to petition the government for "a redress of grievances." This right has important implications for citizens desiring to advance the public health by petitioning administrative agencies, such as the Food and Drug Administration, to take safety actions. We examined a total of 1,915 petitions filed between 2001 and 2013 to investigate the outcomes of citizen petitions that address public health concerns. We found that most petitions were filed by manufacturers against other manufacturers. Only 346 (18%) of all petitions were submitted by individuals and non-profit organizations, and 178 (87.3%) of these petitions with a final response were denied. On average, these petitions required 2.85 years for a final agency decision, and many decisions remain pending 10-13 years after their initial submission. The great majority of the approved requests included some form of risk communication, such as labeling changes, boxed warnings or placement of a drug into a Risk Evaluation and Mitigation Strategy. As a policy instrument to improve the safety of medical and food products, the citizen petition process requires sophisticated legal and scientific expertise, and may not represent a viable route for ordinary citizens to petition the FDA to "redress grievances." PMID:27171162

  2. 78 FR 38445 - Hyundai-Kia America Technical Center, Inc., Grant of Petition for Decision of Inconsequential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... National Highway Traffic Safety Administration Hyundai-Kia America Technical Center, Inc., Grant of... Register (77 FR 33807). No comments were received. To view the petition and all supporting documents log... Administration, DOT. ACTION: Grant of Petition. SUMMARY: Hyundai America Technical Center, Inc. on behalf...

  3. 78 FR 9039 - Notice of Petition for Waiver of BSH Corporation From the Department of Energy Residential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-07

    ... of Energy Efficiency and Renewable Energy Notice of Petition for Waiver of BSH Corporation From the... Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of petition for waiver... Efficiency and Renewable Energy (the Assistant Secretary) if it is determined that the basic model for...

  4. 77 FR 19650 - Notice of Petition for Waiver of BSH Corporation From the Department of Energy Residential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ... of Energy Efficiency and Renewable Energy Notice of Petition for Waiver of BSH Corporation From the... Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of petition for waiver... Efficiency and Renewable Energy (the Assistant Secretary) if it is determined that the basic model for...

  5. 77 FR 33450 - Notice of Petition for Waiver of BSH Corporation From the Department of Energy Residential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... Office of Energy Efficiency and Renewable Energy Notice of Petition for Waiver of BSH Corporation From...: Office of Energy Efficiency and Renewable Energy, Department of Energy. ACTION: Notice of petition for... Efficiency and Renewable Energy (the Assistant Secretary) if it is determined that the basic model for...

  6. 75 FR 55791 - Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... AGENCY Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Alliant Energy--WPL Edgewater Generating Station AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of final order on petition to object to Clean Air Act operating permit. SUMMARY: This...

  7. 19 CFR 206.43 - Contents of a petition under section 406(a) of the Trade Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Trade Act. 206.43 Section 206.43 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION... DISRUPTION, TRADE DIVERSION, AND REVIEW OF RELIEF ACTIONS Investigations for Relief From Market Disruption § 206.43 Contents of a petition under section 406(a) of the Trade Act. A petition for relief...

  8. 76 FR 6825 - Notice of Receipt of a Petition To Designate Lands Unsuitable for Mining and To Prepare a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... Office of Surface Mining Reclamation and Enforcement Notice of Receipt of a Petition To Designate Lands Unsuitable for Mining and To Prepare a Petition Evaluation Document and Environmental Impact Statement AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Notice of intent to prepare...

  9. 76 FR 37115 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure... Human Services (HHS). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of employees from the Chapman Valve Manufacturing Company (i.e., Building 23 and...

  10. 76 FR 37114 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure... Human Services (HHS). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of employees from the Dow Chemical Company in Madison, Illinois, to the...

  11. 76 FR 70147 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure... Human Services (HHS). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of employees from the Piqua Organic Moderated Reactor, Piqua, Ohio, to the...

  12. 76 FR 37115 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure... Human Services (HHS). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel Company located at 110 Hopkins...

  13. 76 FR 37115 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-24

    ... HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure... Human Services (HHS). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of employees from the Wah Chang facility in Albany, Oregon, to the Special...

  14. 76 FR 70148 - Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Determination Concerning a Petition To Add a Class of Employees to the Special Exposure... Human Services (HHS). ACTION: Notice. SUMMARY: HHS gives notice of a determination concerning a petition to add a class of employees from the Norton Co. (or a subsequent owner), Worcester, Massachusetts,...

  15. 76 FR 51468 - BMW of North America, LLC, a subsidiary of BMW AG, Receipt of Petition for Decision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ..., (65 FR 19477-78). The petition, supporting materials, and all comments received before the close of... National Highway Traffic Safety Administration BMW of North America, LLC, a subsidiary of BMW AG, Receipt... Administration, DOT. ACTION: Receipt of Petition for Inconsequential Noncompliance. SUMMARY: BMW of North...

  16. 78 FR 48769 - Mercedes-Benz USA, LLC and Daimler AG, Receipt of Petition for Decision of Inconsequential...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... Register published on April 11, 2000, (65 FR 19477-78). The petition, supporting materials, and all... Administration, DOT. ACTION: Receipt of petition. SUMMARY: Mercedes-Benz USA, LLC (MBUSA) \\1\\ on behalf of itself... passenger vehicles (MPVs), do not fully comply with paragraph S5.1.1.6 of Federal Motor Vehicle...

  17. 25 CFR 83.11 - Independent review, reconsideration and final action.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... review, reconsideration and final action. (a)(1) Upon publication of the Assistant Secretary's... received by the Board no later than 90 days after the date of publication of the Assistant Secretary's... Secretary's decision shall be final for the Department 90 days after publication of the final...

  18. 25 CFR 83.11 - Independent review, reconsideration and final action.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... review, reconsideration and final action. (a)(1) Upon publication of the Assistant Secretary's... received by the Board no later than 90 days after the date of publication of the Assistant Secretary's... Secretary's decision shall be final for the Department 90 days after publication of the final...

  19. A successful petition to delist a hazardous waste

    SciTech Connect

    Finch, A.J.; Cormier, S.L.

    1997-12-31

    The prospect of a favorable ruling in an effort to have a hazardous waste delisted is remote, and few have been granted. This paper recounts the successful procedure used to have materials from a hazardous waste site delisted. Other property owners with sites affected with hazardous wastes will find the methodology discussed here instructive if they are contemplating a delisting petition. The regulatory agency with jurisdiction was the Michigan Department of Environmental Quality through its Waste Management Division (MDEQ WMD). The state has accepted authority for this function from the USEPA. The materials from discontinued electroplating operations were considered hazardous based on their contact with a listed F006 waste sludge generated from the electroplating operations. The sludge had been stored in surface impoundments. To initiate the delisting procedure, the requirements of a USEPA document were followed: Petition to Delist Hazardous Wastes, a Guidance Manual. The MDEQ WMD sanctioned the use of this guidance. This document is issued by the Office of Solid Waste. In observing the guidance, the following actions were taken: (1) Collection of soil samples from the area proposed for delisting; (2) Evaluation of data and the feasibility of preparing a delisting petition; (3) Development of the petition. In developing the details of the petition, the data from the site were scrutinized. Analytical results of metals in the soil samples were compared with pre-established maximum allowable concentrations that had been calculated in a closure plan. These values were also compared with delisting levels calculated by USEPA`s Composite Model for Landfills (EPACML). The data indicated that the levels of chemical constituents were below the appropriate regulatory criteria. Therefore, the petition was launched. This paper discusses their effective procedure and contents of each section of the delisting petition.

  20. 16 CFR 1051.10 - Granting petitions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Granting petitions. 1051.10 Section 1051.10... § 1051.10 Granting petitions. (a) The Commission shall either grant or deny a petition within a.... The Commission may also grant a petition in part or deny it in part. If the Commission grants...

  1. Comparison of growth, serum biochemistries and n-6 fatty acid metabolism in rats fed diets supplemented with high-gamma-linolenic acid safflower oil or borage oil for 90 days.

    PubMed

    Tso, Patrick; Caldwell, Jody; Lee, Dana; Boivin, Gregory P; DeMichele, Stephen J

    2012-06-01

    Recently, steps have been taken to further developments toward increasing gamma-linolenic acid (GLA) concentration and lowering costs in plant seed oils using transgenic technology. Through identification and expression of a fungal delta-6 desaturase gene in the high linoleic acid safflower plant, the seeds from this genetic transformation produce oil with >40% GLA (high GLA safflower oil (HGSO)). The aim of the study was to compare the effects of feeding HGSO to a generally recognized as safe source of GLA, borage oil, in a 90 day safety study in rats. Weanling male and female Sprague-Dawley rats were fed a semi-synthetic, fat free, pelleted diet (AIN93G) supplemented with a 10% (wt/wt) oil blend containing HGSO or borage oil, with equivalent GLA levels. Results demonstrated that feeding diets containing HGSO or borage oil for 90 days had similar biologic effects with regard to growth characteristics, body composition, behavior, organ weight and histology, and parameters of hematology and serum biochemistries in both sexes. Metabolism of the primary n-6 fatty acids in plasma and organ phospholipids was similar, despite minor changes in females. We conclude that HGSO is biologically equivalent to borage oil and provides a safe alternative source of GLA in the diet. PMID:22265940

  2. 77 FR 42492 - Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-19

    ... the petition submitted by Environmental Policy & Law Center on behalf of Sierra Club and Valley Watch... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION... Kentucky Syngas, LLC; Muhlenberg County, KY AGENCY: Environmental Protection Agency (EPA). ACTION:...

  3. 75 FR 42084 - Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for JP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... Pulliam Power Plant AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of final order on... the Wisconsin Public Service Corporation's, JP Pulliam Power Plant (JP Pulliam) issued by the... order for the JP Pulliam Power Plant petition is available electronically at:...

  4. 75 FR 26839 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www..., 2010. Pamela Hamilton-Powell, Director, Office of Rulemaking. Petition for Exemption Docket No.:...

  5. 75 FR 60859 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments received, go... Washington, DC, on September 28, 2010. Pamela Hamilton-Powell, Director, Office of Rulemaking. Petition...

  6. 75 FR 26843 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-12

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Washington, DC, on May 7, 2010. Pamela Hamilton-Powell, Director, Office of Rulemaking. Petition...

  7. 77 FR 44309 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Rulemaking. Petition for Exemption Docket No.: FAA-2012-0533. Petitioner: I-TEC. Section of 14 CFR...

  8. 77 FR 71865 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... Liu, Director, Office of Rulemaking, Petition for Exemption Docket No.: FAA-2012-1137. Petitioner:...

  9. 78 FR 7851 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www..., DC, on January 24, 2013. Lirio Liu, Director, Office of Rulemaking. Petition For Exemption Docket...

  10. 78 FR 13745 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... February 19, 2013. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket No.:...

  11. 78 FR 13746 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To.... Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket No.: FAA-2013-0101....

  12. 78 FR 46672 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments... published pursuant to 14 CFR 11.85. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption...

  13. 78 FR 60996 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background..., on September 27, 2013. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket...

  14. 78 FR 69929 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-21

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... November 15, 2013. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket No.:...

  15. 78 FR 57676 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www..., on September 13, 2013. Lirio Liu, Director, Office of Rulemaking. ] Petition for Exemption Docket...

  16. 78 FR 17746 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to ] http://www..., on March 14, 2013. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket No.:...

  17. 77 FR 65764 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78). Docket: To.... Issued in Washington, DC, on October 23, 2012. Lirio Liu, Director, Office of Rulemaking. Petition...

  18. 77 FR 71864 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... November 29, 2012. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket No.:...

  19. 78 FR 46673 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... Register published on April 11, 2000 (65 FR 19477-78). Docket: To read background documents or comments..., DC, on June 26, 2013. Lirio Liu, Director, Office of Rulemaking. Petition for Exemption Docket...

  20. 77 FR 72432 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... (65 FR 19477-78). Docket: To read background documents or comments received, go to http://www... November 30, 2012. Lirio Liu, Acting Director, Office of Rulemaking. Petition for Exemption Docket No.:...