Science.gov

Sample records for industry supplemental guidance

  1. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New...: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications...

  2. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration... NDI and any other dietary ingredients in the dietary supplement ``have been present in the food supply...

  3. 77 FR 2555 - Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Preparation of Investigational Device... Cartilage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and.... The guidance supplements recommendations regarding IDE and IND submissions contained in other FDA...

  4. CDER photosafety guidance for industry.

    PubMed

    Jacobs, Abigail C; Brown, Paul C; Chen, Conrad; Ellis, Amy; Farrelly, James; Osterberg, Robert

    2004-01-01

    In the Federal Register of January 10, 2000 (65 FR 1399), FDA published a draft guidance entitled "Photosafety Testing." The notice gave interested persons an opportunity to submit comments. As a result of the comments, certain sections of the guidance were reworded to improve clarity. A final guidance was published in May 2003. The final guidance further emphasizes that a flexible approach can be used to address adverse photoeffects and that specific assays are not required. Moreover, it encourages the development of methods that can efficiently be used to evaluate human safety. The guidance describes a consistent, science-based approach for testing of topically and systemically administered drug products.

  5. Data Management-Supplement to Section 106 Tribal Guidance

    EPA Pesticide Factsheets

    The document supplements the Tribal 106 Guidance by providing useful suggestions and tips to tribes about how to establish a data management system that reflects tribal water quality goals and objectives.

  6. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and business...

  7. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Acidified Foods...

  8. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During... ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation''...

  9. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... proposes amendments to the labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in the guidance document entitled ``Guidance for Industry... in the 2010 CJD/vCJD guidance for plasma-derived products, including albumin and products...

  10. 76 FR 81513 - Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Prevention of Salmonella Enteritidis... availability of a guidance for industry entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During... with certain provisions contained in FDA's final rule ``Prevention of Salmonella Enteritidis in...

  11. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Initial Completeness... Amendments of 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... or prior approval supplements to these applications, will be required to undergo an initial...

  12. 76 FR 20688 - Guidance for Industry and Food and Drug Administration Staff; 30-Day Notices, 135-Day Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; 30- Day Notices, 135-Day Premarket Approval Supplements and 75-Day Humanitarian Device Exemption Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration...

  13. The Industrial User Permitting Guidance Manual

    EPA Pesticide Factsheets

    Provides guidance for control authorities to effectively develop and issue control mechanisms to IUs discharging to the POTW and covers developing and implementing control mechanisms for both SIUs and non-SIUs.

  14. 78 FR 37231 - Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing...

  15. Guidance for Industry: Food Producers, Processors, and ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... สองฉบับประกอบคําแนะนําเรื่องความปลอดภัย ของอาหารชื่อ "Food Producers, Processors, and Transporters: Food security preventive measures guidance ...

  16. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug... availability of a revised draft guidance for industry entitled ``Draft Guidance on Risperidone.'' The guidance... drug applications (ANDAs) for risperidone injection. DATES: Although you can comment on any guidance...

  17. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance..., biologics, medical devices, and dietary supplements during an influenza pandemic. The agency makes...

  18. 77 FR 11134 - Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability AGENCY... Medical Products and Dietary Supplements During an Influenza Pandemic.'' The guidance discusses FDA's... devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations to...

  19. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  20. Guidance for Industry: Food Producers, Processors, and ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... ปลอดภัยของอาหารชื่อ "Importers and filers: Food security preventive measures ... ข้อมูลและการวิเคราะห์อุตสาหกรรมอาหาร (Food Industry Information and ...

  1. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... antiretroviral drugs for the treatment of HIV. This draft guidance revises the guidance for industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations [[Page 33849

  2. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false General industry guidance. 7.59 Section 7.59 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENFORCEMENT..., but there are several steps a prudent firm can take in advance to minimize this disruptive...

  3. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false General industry guidance. 7.59 Section 7.59 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENFORCEMENT..., but there are several steps a prudent firm can take in advance to minimize this disruptive...

  4. 78 FR 20116 - Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4; Availability AGENCY: Food and Drug...

  5. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... document provides guidance to sponsors, contract research organizations (CROs), data management centers... Investigations.'' This revised draft document provides guidance to sponsors, CROs, data management centers... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data...

  6. 78 FR 49271 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... About Medical Foods; Second Edition; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' The... Foods; Second Edition.'' This draft guidance is being issued consistent with our good guidance...

  7. 78 FR 32667 - Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This... of patients with rheumatoid arthritis (RA). It also addresses additional considerations for...

  8. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing...

  9. 76 FR 71577 - Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-18

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Medication Guide Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability...) is announcing the availability of a guidance for industry entitled ``Medication Guides--...

  10. 78 FR 18353 - Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Blood Establishment Computer System... ``Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility'' dated April... establishment computer system validation program, consistent with recognized principles of software validation...

  11. 76 FR 59142 - Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Reproductive and Developmental... a guidance for industry entitled ``Reproductive and Developmental Toxicities--Integrating Study... developmental or reproductive risks associated with drug or biological product exposure when a...

  12. General RMP Guidance - Appendix E: Supplemental Risk Management Program Guidance for Ammonia Refrigeration Facilities

    EPA Pesticide Factsheets

    Additional information for food processors, food distributors, refrigerated warehouses, and any other facility with ammonia refrigeration system. Includes guidance on exemptions, threshold quantity, offsite consequence analysis.

  13. 75 FR 10524 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... COMMISSION NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for... document entitled: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action...-4737, or by e-mail to pdr.resource@nrc.gov . NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3,...

  14. 75 FR 27840 - NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ...: 2010-11842] NUCLEAR REGULATORY COMMISSION [NRC-2010-0080] NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3...: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for General... the existing guidance contained in Supplement 3 to NUREG- 0654/FEMA-REP-1, Rev. 1, ``Criteria...

  15. 77 FR 60126 - Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ...; Formerly 2008N-0004] Guidance for Industry on Acute Bacterial Otitis Media: Developing Drugs for Treatment... Media: Developing Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the... treatment of acute bacterial otitis media (ABOM). This guidance finalizes the revised draft guidance of...

  16. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

    ... Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated June 2012. The draft guidance document provides blood establishments that collect... malaria. This guidance replaces the draft guidance entitled ``Guidance for Industry: Recommendations...

  17. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Researchers on the Radioactive...) is announcing the availability of a guidance for industry and researchers entitled ``The Radioactive... guidance provides information to those using radioactive drugs for certain research purposes to help...

  18. 75 FR 875 - Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on New Contrast Imaging Indication... availability of a guidance for industry entitled ``New Contrast Imaging Indication Considerations for Devices..., FDA agreed to publish guidance for medical imaging devices for use with imaging contrast agents...

  19. 75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Anesthetics for Companion Animals... Administration (FDA) is announcing the availability of Guidance for Industry 192 entitled ``Anesthetics for Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug...

  20. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pre-Launch Activities... entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This draft guidance describes FDA's policy... announcing the availability of a draft guidance for industry entitled ``Pre-Launch Activities...

  1. 75 FR 22681 - Supplemental Guidance on Overdraft Protection Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY... is organized into the same broad categories as the Overdraft Guidance: ``Marketing and Consumer... title location Marketing and Consumer Communications Avoid promoting poor account No change--Best...

  2. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-14

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  3. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... subject to comment in accordance with the Agency's good guidance practices. DATES: Submit...

  4. 78 FR 12761 - Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and... ``Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section... certain uses of lecithin derived from soy under the Federal Food, Drug, and Cosmetic Act (the FD&C Act...

  5. 77 FR 11133 - Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ... Infections: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment... treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses...

  6. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

    ... guidance entitled ``Electronic Source Data in Clinical Investigations.'' The document was published with an... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice;...

  7. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY...

  8. 76 FR 60055 - Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products; Availability; Agency Information Collection Activities; Proposed... ``Applications for Premarket Review of New Tobacco Products.'' The draft guidance is intended to assist...

  9. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... Cosmetic Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic...

  10. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial..., Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators..., Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to...

  11. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence... Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in... for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol...

  12. Supplemental Educational Services "Non-Regulatory Guidance" [2009

    ERIC Educational Resources Information Center

    US Department of Education, 2009

    2009-01-01

    Supplemental educational services (SES) are additional academic instruction designed to increase the academic achievement of students in schools in need of improvement. These services may include academic assistance such as tutoring, remediation and other educational interventions, provided that such approaches are consistent with the content and…

  13. Guidance values for microcystins in water and cyanobacterial supplement products (blue-green algal supplements): a reasonable or misguided approach?

    SciTech Connect

    Dietrich, Daniel; Hoeger, Stefan . E-mail: stefan.hoeger@uni-konstanz.de

    2005-03-15

    This article reviews current scientific knowledge on the toxicity and carcinogenicity of microcystins and compares this to the guidance values proposed for microcystins in water by the World Health Organization, and for blue-green algal food supplements by the Oregon State Department of Health. The basis of the risk assessment underlying these guidance values is viewed as being critical due to overt deficiencies in the data used for its generation: (i) use of one microcystin congener only (microcystin-LR), while the other presently known nearly 80 congeners are largely disregarded, (ii) new knowledge regarding potential neuro and renal toxicity of microcystins in humans and (iii) the inadequacies of assessing realistic microcystin exposures in humans and especially in children via blue-green algal food supplements. In reiterating the state-of-the-art toxicology database on microcystins and in the light of new data on the high degree of toxin contamination of algal food supplements, this review clearly demonstrates the need for improved kinetic data of microcystins in humans and for discussion concerning uncertainty factors, which may result in a lowering of the present guidance values and an increased routine control of water bodies and food supplements for toxin contamination. Similar to the approach taken previously by authorities for dioxin or PCB risk assessment, the use of a toxin equivalent approach to the risk assessment of microcystins is proposed.

  14. Supplemental Guidance on Implementing the North County PSD Remand

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  15. 79 FR 19620 - Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2014-04-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Proper Labeling of Honey and Honey Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... industry entitled ``Guidance for Industry: Proper Labeling ] of Honey and Honey Products.'' FDA...

  16. 75 FR 32493 - NUREG-0654/FEMA-REP-, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... SECURITY Federal Emergency Management Agency NUREG-0654/FEMA-REP-, Rev. 1, Supplement 3, Guidance for... be held to discuss the proposed Supplement 3 to NUREG-0654/FEMA-REP-1, Rev.1, Guidance for Protective Action Recommendations for General Emergencies (NUREG Supp 3). NUREG Supp 3 addresses onsite and...

  17. 36 CFR 223.242 - Supplemental guidance, Memorandum of Agreements and Memorandums of Understanding.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., Memorandum of Agreements and Memorandums of Understanding. 223.242 Section 223.242 Parks, Forests, and Public... Supplemental guidance, Memorandum of Agreements and Memorandums of Understanding. Consistent with subparts G... Agreement and Memorandums of Understanding to promote local collaboration, issue resolution, and local...

  18. Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens

    EPA Pesticide Factsheets

    This Supplemental Guidance does not establish any substantive “rules” under the Administrative Procedure Act or any other law and has no binding effect on EPA or any regulated entity, but instead represents a non-binding statement of policy.

  19. 15 CFR Supplement No. 3 to Part 732 - BIS's “Know Your Customer” Guidance and Red Flags

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... ADMINISTRATION REGULATIONS STEPS FOR USING THE EAR Pt. 732, Supp. 3 Supplement No. 3 to Part 732—BIS's “Know Your Customer” Guidance and Red Flags “Know Your Customer” Guidance Various requirements of the EAR are... EAR has occurred or is about to occur. (a) BIS provides the following guidance on how individuals...

  20. 15 CFR Supplement No. 3 to Part 732 - BIS's “Know Your Customer” Guidance and Red Flags

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... ADMINISTRATION REGULATIONS STEPS FOR USING THE EAR Pt. 732, Supp. 3 Supplement No. 3 to Part 732—BIS's “Know Your Customer” Guidance and Red Flags “Know Your Customer” Guidance Various requirements of the EAR are... EAR has occurred or is about to occur. (a) BIS provides the following guidance on how individuals...

  1. 15 CFR Supplement No. 3 to Part 732 - BIS's “Know Your Customer” Guidance and Red Flags

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... ADMINISTRATION REGULATIONS STEPS FOR USING THE EAR Pt. 732, Supp. 3 Supplement No. 3 to Part 732—BIS's “Know Your Customer” Guidance and Red Flags “Know Your Customer” Guidance Various requirements of the EAR are... EAR has occurred or is about to occur. (a) BIS provides the following guidance on how individuals...

  2. 15 CFR Supplement No. 3 to Part 732 - BIS's “Know Your Customer” Guidance and Red Flags

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... ADMINISTRATION REGULATIONS STEPS FOR USING THE EAR Pt. 732, Supp. 3 Supplement No. 3 to Part 732—BIS's “Know Your Customer” Guidance and Red Flags “Know Your Customer” Guidance Various requirements of the EAR are... EAR has occurred or is about to occur. (a) BIS provides the following guidance on how individuals...

  3. 76 FR 82306 - Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Use of Histology in Biomarker... ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance...

  4. 76 FR 21752 - Guidance for Industry on How To Write a Request for Designation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-18

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on How To Write a Request for... Write a Request for Designation (RFD).'' This guidance is intended to clarify the type of information...: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written...

  5. 75 FR 24718 - Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-05

    ... entitled ``Documenting Statistical Analysis Programs and Data Files.'' This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to... guidance entitled ``Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files...

  6. 77 FR 38305 - Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus-Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ... availability of a guidance entitled ``Lupus Nephritis Caused By Systemic Lupus Erythematosus--Developing... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Lupus Nephritis Caused by Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Withdrawal of Guidance AGENCY: Food...

  7. 75 FR 35492 - Guidance for Industry on Lupus Nephritis Caused By Systemic Lupus Erythematosus-Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... availability of a guidance for industry entitled ``Lupus Nephritis Caused By Systemic Lupus Erythematosus... nephritis (LN) caused by systemic lupus erythematosus (SLE). This guidance finalizes the parts of the draft guidance entitled ``Systemic Lupus Erythematosus--Developing Drugs for Treatment'' (the draft...

  8. 78 FR 63218 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chronic Hepatitis C Virus... availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct... guidance revises and replaces a previous draft guidance for industry entitled ``Chronic Hepatitis C Virus...

  9. General RMP Guidance - Appendix F: Supplemental Risk Management Program Guidance for Wastewater Treatment Plants

    EPA Pesticide Factsheets

    Additional information for wastewater treatment plants (WWTPs), including publicly owned treatment works (POTWs) and other industrial treatment systems; about compliance for chlorine, ammonia (anhydrous and aqueous), sulfur dioxide, and digester gas.

  10. 76 FR 14024 - Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Hypertension Indication: Drug... for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive...

  11. 78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric... announcing the availability of a draft guidance for industry and review staff entitled ``Pediatric... is intended to assist applicants and FDA review staff in making decisions about the placement and...

  12. 76 FR 55923 - Draft Guidance for Industry: Submission of Warning Plans for Cigarettes and Smokeless Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Submission of Warning Plans for... Collection; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled...

  13. 77 FR 8883 - Draft Guidance for Industry on Scientific Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Scientific Considerations in... guidance for industry entitled ``Scientific Considerations in Demonstrating Biosimilarity to a Reference... protein product is biosimilar to a reference product for the purpose of submitting a marketing...

  14. 76 FR 10908 - Draft Guidance for Industry on Medication Guides-Distribution Requirements and Inclusion of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Medication Guides--Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication...

  15. 76 FR 68767 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...] [FR Doc No: 2011-28766] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0689] Draft Guidance for Industry and Food and Drug Administration Staff; De...

  16. 76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing... document entitled ``Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated...

  17. 75 FR 52755 - Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Acute Bacterial Skin and Skin... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... the development of antimicrobial drugs for the treatment of acute bacterial skin and skin structure...

  18. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription drug...

  19. 78 FR 21611 - Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application...

  20. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  1. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... document is immediately in effect as the special control for the ovarian adnexal mass assessment score...

  2. Secure Data Transfer Guidance for Industrial Control and SCADA Systems

    SciTech Connect

    Mahan, Robert E.; Fluckiger, Jerry D.; Clements, Samuel L.; Tews, Cody W.; Burnette, John R.; Goranson, Craig A.; Kirkham, Harold

    2011-09-01

    This document was developed to provide guidance for the implementation of secure data transfer in a complex computational infrastructure representative of the electric power and oil and natural gas enterprises and the control systems they implement. For the past 20 years the cyber security community has focused on preventative measures intended to keep systems secure by providing a hard outer shell that is difficult to penetrate. Over time, the hard exterior, soft interior focus changed to focus on defense-in-depth adding multiple layers of protection, introducing intrusion detection systems, more effective incident response and cleanup, and many other security measures. Despite much larger expenditures and more layers of defense, successful attacks have only increased in number and severity. Consequently, it is time to re-focus the conventional approach to cyber security. While it is still important to implement measures to keep intruders out, a new protection paradigm is warranted that is aimed at discovering attempted or real compromises as early as possible. Put simply, organizations should take as fact that they have been, are now, or will be compromised. These compromises may be intended to steal information for financial gain as in the theft of intellectual property or credentials that lead to the theft of financial resources, or to lie silent until instructed to cause physical or electronic damage and/or denial of services. This change in outlook has been recently confirmed by the National Security Agency [19]. The discovery of attempted and actual compromises requires an increased focus on monitoring events by manual and/or automated log monitoring, detecting unauthorized changes to a system's hardware and/or software, detecting intrusions, and/or discovering the exfiltration of sensitive information and/or attempts to send inappropriate commands to ICS/SCADA (Industrial Control System/Supervisory Control And Data Acquisition) systems.

  3. 77 FR 31368 - Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-25

    ... HUMAN SERVICES Food and Drug Administration Guidance on Meetings With Industry and Investigators on the... guidance for industry entitled ``Meetings with Industry and Investigators on the Research and Development... development or marketing of tobacco products. The guidance is intended to assist persons seeking a...

  4. 78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-14

    ... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability... ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug... Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff,'' you may either...

  5. 78 FR 69992 - Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of Ciguatera...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 123 Guidance for Industry on Purchasing Reef... announcing the availability of a guidance for industry entitled ``Guidance for Industry: Purchasing Reef Fish... primary seafood processors who purchase reef fish on how to minimize the risk of ciguatera fish poisoning...

  6. 78 FR 57394 - Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' The recommendations in the draft guidance are intended to help ensure that the labeling is clear, useful, informative, and to the extent possible,......

  7. 78 FR 12760 - Guidance for Industry on Labeling for Human Prescription Drug and Biological Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products--Implementing the PLR Content and Format Requirements.'' This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products. The......

  8. 76 FR 63303 - Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and......

  9. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Acrylamide in Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...: Acrylamide in Foods.'' The draft guidance is intended to provide information that may help growers...

  10. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ... of HIV Infection.'' The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. The... guidance for industry entitled ``Vaginal Microbicides: Development for the Prevention of HIV...

  11. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good... for the manufacturing of drugs. This draft guidance is being issued consistent with FDA's good... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Contract...

  12. 75 FR 22812 - Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission... April 20, 2010 (75 FR 20606). The notice announced the availability of a guidance entitled...

  13. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission... Administration (FDA) is announcing the availability of a guidance entitled ``Tobacco Health Document Submission... the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). DATES: Submit written...

  14. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly...

  15. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  16. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period...

  17. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  18. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical...

  19. 76 FR 49772 - Guidance for Industry: Bar Code Label Requirements-Questions and Answers; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Bar Code Label Requirements--Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for...

  20. 76 FR 68768 - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... No. FDA-2009-D-0427] Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines... Considerations for Therapeutic Cancer Vaccines'' dated October 2011. The guidance document provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine with...

  1. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the Center for Veterinary Medicine (CVM) thinks... represent the Agency's current thinking on evaluating the effectiveness of anticoccidial drugs in food...

  2. 75 FR 70011 - Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ... approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary) or... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Mammography Quality Standards Act...: Modifications and Additions to Policy Guidance Help System 13; Availability AGENCY: Food and Drug...

  3. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... Recommendations for Metronidazole Vaginal Gel; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Bioequivalence Recommendations for Metronidazole Vaginal Gel.'' The... abbreviated new drug applications (ANDAs) for metronidazole vaginal gel. DATES: Although you can comment on...

  4. 75 FR 9905 - Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-04

    ...: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of... a document entitled ``Guidance for Industry: Characterization and Qualification of Cell Substrates... vaccines for the characterization and qualification of cell substrates, viral seeds, and other...

  5. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  6. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration (formerly 2003D-0571) Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  7. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Fluticasone... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate...

  8. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...

  9. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Availability AGENCY: Food and Drug Administration, HHS...

  10. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  11. 78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  12. 77 FR 8885 - Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  13. 77 FR 64999 - Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in... fishery/seafood product categories. We also added the word ``nutritional'' to the pet supplements category... ``pet nutritional supplements.'' The guidance announced in this notice finalizes the draft guidance...

  14. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... in Human Foods and Direct-Human-Contact Animal Foods; Availability AGENCY: Food and Drug... Direct-Human-Contact Animal Foods.'' The draft guidance, when finalized, is intended for firms that manufacture, process, pack, or hold human foods or direct-human-contact animal foods intended for distribution...

  15. 75 FR 6210 - Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Contents of a Complete Submission for the Evaluation of Proprietary Names'' (proprietary names submission guidance). This guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary......

  16. 76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Non-Penicillin Beta-Lactam... guidance for industry entitled ``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This... non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers...

  17. 76 FR 25696 - Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Dosage Delivery Devices for Orally.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... intended to provide guidance to firms that are manufacturing, marketing, or distributing orally...

  18. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and...

  19. 75 FR 55797 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chronic Hepatitis C Virus... availability of a draft guidance for industry entitled ``Chronic Hepatitis C Virus Infection: Developing Direct... specific steps in the hepatitis C virus (HCV) replication cycle. The guidance outlines the types of...

  20. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ... Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical... (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of... Products.'' This draft guidance provides the pharmaceutical industry with CDER's current thinking on...

  1. 78 FR 63220 - Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Acute Bacterial Skin and Skin... guidance for industry entitled ``Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for... drugs to treat acute bacterial skin and skin structure infections (ABSSSI). This guidance finalizes the...

  2. 78 FR 15017 - Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-08

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: What You Need To Know About... availability of a guidance for industry entitled ``What You Need to Know About Administrative Detention of... Act of 1996 (SBREFA). The title of the October 2011 guidance was ``What You Need to Know...

  3. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... the industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designations may be eligible for marketing approval under the Humanitarian Device Exemption...

  4. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ... educate regulated industry and FDA Staff on how, when, and why to use classification product codes for... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration...

  5. 77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Novo Classifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance document... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  6. 78 FR 13071 - Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...- Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening... ``Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History... guidance document recognizes the standardized full-length and abbreviated donor history questionnaires...

  7. A Critical Analysis of the Vocational Guidance Practices Employed by Industrial Arts Teachers in Selected Junior High Schools in the United States.

    ERIC Educational Resources Information Center

    Miller, Dudley B.

    The purpose of this study was to investigate the: (1) formal guidance preparation of industrial arts teachers, (2) vocational guidance resources available to industrial arts teachers, (3) opinions of industrial arts teachers toward vocational guidance, and (4) vocational guidance functions performed by industrial arts teachers. A nationwide sample…

  8. Stereo optical guidance system for control of industrial robots

    NASA Technical Reports Server (NTRS)

    Powell, Bradley W. (Inventor); Rodgers, Mike H. (Inventor)

    1992-01-01

    A device for the generation of basic electrical signals which are supplied to a computerized processing complex for the operation of industrial robots. The system includes a stereo mirror arrangement for the projection of views from opposite sides of a visible indicia formed on a workpiece. The views are projected onto independent halves of the retina of a single camera. The camera retina is of the CCD (charge-coupled-device) type and is therefore capable of providing signals in response to the image projected thereupon. These signals are then processed for control of industrial robots or similar devices.

  9. Educators-in-Industry; Career Guidance Programs Handbook.

    ERIC Educational Resources Information Center

    General Electric Co., Fairfield, CT. Corporate Educational Relations Operation.

    Unemployment of those aged 16 to 23 is due largely to inadequate job preparation. Most educators have little exposure to the world of work outside of education, and may unknowingly provide incorrect, restrictive or out-of-date information to students. This Educators-in-Industry Handbook is designed to provide G.E. plant representatives with…

  10. 77 FR 35689 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... Evaluation of Drugs for Treatment; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for...

  11. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ...; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities; Availability... Drug Administration Staff; Class II Special Controls Guidance Documents: Topical Oxygen Chamber for... Guidance Document: Topical Oxygen Chamber for Extremities'' to the Division of Small...

  12. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Electrocardiograph Electrodes.'' The special controls identify the following risks to health... Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph...

  13. 75 FR 13766 - Guidance for Industry on the Content and Format of the Dosage and Administration Section of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear......

  14. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration... the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for...

  15. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ...; User Fees for 513(g) Requests for Information; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information.'' This guidance document describes the user fees associated with 513(g) requests...

  16. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... No. FDA-2012-D-1092] Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry... guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to inform... and Radiological Health's (CDRH) proposed approach on the safety of toy laser products. This draft...

  17. 76 FR 41506 - Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff on In Vitro.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance.... This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight...

  18. 76 FR 72952 - Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Nonclinical Evaluation of Late... commonly associated with XRT (e.g., brain necrosis, paralysis, pulmonary fibrosis, liver or kidney failure... tolerance doses of most human organs for conventional fractionated XRT are known, and are routinely used...

  19. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Tobacco Health Document... entitled ``Tobacco Health Document Submission.'' The notice published with an inadvertent error in the... CONTACT: May Nelson, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  20. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...) for iron sucrose injection. DATES: Although you can comment on any guidance at any time (see 21 CFR 10...

  1. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ...; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY... announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j) Reports... products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended...

  2. 76 FR 34715 - Draft Guidance for Industry; Considering Whether an FDA-Regulated Product Involves the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ...-Regulated Product Involves the Application of Nanotechnology; Availability AGENCY: Food and Drug... the Application of Nanotechnology''. This guidance is intended to provide industry with FDA's current... nanotechnology. The points to consider are intended to be broadly applicable to all FDA-regulated products, with...

  3. 77 FR 8884 - Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  4. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  5. 76 FR 67746 - Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... (Revision)'' VICH GL18(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH... industry associations to promote the international harmonization of regulatory requirements. FDA has...

  6. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0387) Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies--Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

  7. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on... entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The...

  8. 76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

    ... Differentiation of Influenza Viruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Influenza Viruses.'' FDA is issuing this guidance to inform industry and Agency staff of its... diagnostic devices intended for the detection or detection and differentiation of influenza viruses. DATES...

  9. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... regulations governing financial disclosure by clinical investigators, part 54 (21 CFR part 54), and to provide... Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Availability AGENCY... FDA Staff: Financial Disclosure by Clinical Investigators.'' This draft guidance is intended to assist...

  10. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  11. 75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  12. 75 FR 35493 - Guidance for Industry on Systemic Lupus Erythematosus-Developing Medical Products for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... Systemic Lupus Erythematosus--Developing Medical Products for Treatment; Availability AGENCY: Food and Drug... availability of a guidance for industry entitled ``Systemic Lupus Erythematosus--Developing Medical Products..., therapeutic biological products, and medical devices for the treatment of systemic lupus erythematosus......

  13. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked... the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions.''...

  14. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... six of them from the premarket notification requirements of the Federal Food, Drug, and Cosmetic...

  15. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Federal Food, Drug, and Cosmetic Act (the FD&C Act), procedural information on how to fulfill section...

  16. 76 FR 6685 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommended Warning for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... about the potential adverse health effects from the use of powder on medical gloves and is...

  17. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions...

  18. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  19. 76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... if: ``through either chemical reaction or intermolecular forces or both, the product mediates a... Issues; and Interpretation of the Term ``Chemical Action'' in the Definition of Device Under Section 201...'' and ``Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the...

  20. 76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and Submission; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  1. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions... Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug Administration... to requests for an extension to allow interested persons additional time to submit comments. DATES...

  2. 78 FR 2676 - Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... their development. This draft guidance is intended to provide industry with a framework for evaluating... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry...-deterrent properties of opioid analgesic products should be studied and evaluated, and what claims regarding...

  3. 78 FR 42085 - Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.'' This draft guidance is intended to provide information to industry on how to submit initial and amended pediatric study plans (PSPs) as required under the......

  4. 75 FR 75482 - Draft Guidance for Industry on Residual Solvents in Animal Drug Products; Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Solvents in Animal... guidance for industry 211 entitled ``Residual Solvents in Animal Drug Products; Questions and Answers... Chapter Residual Solvents that applies to both human and veterinary drugs and to compendial and...

  5. 76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of... Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

  6. 75 FR 26967 - Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water...

  7. 77 FR 57094 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities, Sites...

  8. 75 FR 75809 - Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... Health and Human Services Food and Drug Administration Guidance for Industry: Use of Serological Tests To...; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry: Use of... Components Intended for Transfusion; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  9. 76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are... HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption...

  10. 78 FR 63477 - Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... investigators who conduct studies using active controls and have a basic understanding of statistical principles... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Active Controls in Studies To... the availability of a guidance for industry 204 entitled ``Active Controls in Studies to...

  11. 77 FR 59000 - Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Pre-Storage Leukocyte Reduction of... availability of a document entitled ``Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole Blood... blood establishments with recommendations for pre-storage leukocyte reduction of Whole Blood and...

  12. 76 FR 5386 - Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Pre-Storage Leukocyte Reduction... availability of a draft document entitled ``Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole... provides blood establishments with recommendations for pre- storage leukocyte reduction of Whole Blood...

  13. Human factors engineering in oil and gas--a review of industry guidance.

    PubMed

    Robb, Martin; Miller, Gerald

    2012-01-01

    Oil and gas exploration and production activities are carried out in hazardous environments in many parts of the world. Recent events in the Gulf of Mexico highlight those risks and underline the importance of considering human factors during facility design. Ergonomic factors such as machinery design, facility and accommodation layout and the organization of work activities have been systematically considered over the past twenty years on a limited number of offshore facility design projects to a) minimize the occupational risks to personnel, b) support operations and maintenance tasks and c) improve personnel wellbeing. During this period, several regulators and industry bodies such as the American Bureau of Shipping (ABS), the American Society of Testing and Materials (ASTM), the UK's Health and Safety Executive (HSE), Oil and Gas Producers (OGP), and Norway's Petroleum Safety Authority (PSA) have developed specific HFE design standards and guidance documents for the application of Human Factors Engineering (HFE) to the design and operation of Oil and Gas projects. However, despite the existence of these guidance and recommended design practise documents, and documented proof of their value in enhancing crew safety and efficiency, HFE is still not well understood across the industry and application across projects is inconsistent. This paper summarizes the key Oil and Gas industry bodies' HFE guidance documents, identifies recurring themes and current trends in the use of these standards, provides examples of where and how these HFE standards have been used on past major offshore facility design projects, and suggests criteria for selecting the appropriate HFE strategy and tasks for future major oil and gas projects. It also provides a short history of the application of HFE to the offshore industry, beginning with the use of ASTM F 1166 to a major operator's Deepwater Gulf of Mexico facility in 1990 and the application of HFE to diverse world regions. This

  14. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ...; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems... Document: Repetitive Transcranial Magnetic Stimulation Systems.'' This guidance document describes a means by which a repetitive transcranial magnetic stimulation (rTMS) system may comply with the requirement...

  15. Draft guidance for industry; exports and imports under the FDA Export Reform and Enhancement Act of 1996--FDA. Notice.

    PubMed

    1998-06-12

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, "FDA Draft Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996." The draft guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, food additives, and devices as well as the importation of components, parts, accessories, or other articles for incorporation or further processing into articles intended for export.

  16. Memoranda about Implementation of the Cancer Guidelines and Accompanying Supplemental Guidance - Science Policy Council Cancer Guidelines Implementation Workgroup Communication I and II

    EPA Pesticide Factsheets

    Memoranda from the Chair of EPA's Science Policy Council to the Science Policy Council and the Science Policy Council Steering Committee regarding Implementation of the Cancer Guidelines and Accompanying Supplemental Guidance.

  17. 78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... Anti- Salmonella Chemical Food Additives in Feeds; Request for Comments AGENCY: Food and Drug... Chemical Food Additives in Feeds,'' and is seeking comments on this guidance before revisions are made... Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds...

  18. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability AGENCY: Food and Drug... availability of a guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or...

  19. 76 FR 35450 - Draft Guidance for Industry on Clinical Trial Endpoints for the Approval of Non-Small Cell Lung...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Availability AGENCY: Food and Drug... Cell Lung Cancer Drugs and Biologics.'' This draft guidance provides recommendations to applicants on... draft guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell...

  20. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.'' This guidance... developing drugs for the treatment of early Alzheimer's disease. It does not create or confer any rights...

  1. 78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance...

  2. 76 FR 20689 - Guidance for Industry on Influenza: Developing Drugs for Treatment and/or Prophylaxis; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs for... entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' This guidance is intended to... treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both seasonal and...

  3. 78 FR 66366 - Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-05

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility......

  4. 75 FR 71133 - Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: The Safety of Imported Traditional... guidance entitled ``The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of... traditional pottery, and labeling considerations for food use and non food use pottery that may contain lead...

  5. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design... clinical trials. This guidance is intended to assist the pharmaceutical industry and other investigators... on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your...

  6. 77 FR 51814 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to assess user fees to... safe and effective generic drugs to the public and reduce costs to industry. GDUFA enables FDA to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User...

  7. 76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

    ... Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best...

  8. 78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... Changes: Manufacturing Equipment Addendum; Availability AGENCY: Food and Drug Administration, HHS. ACTION... post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing Equipment... Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999...

  9. 78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... HUMAN SERVICES Food and Drug Administration Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  10. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ...; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY...-Field Digital Mammography System.'' This guidance document describes a means by which a full-field digital mammography (FFDM) system may comply with special controls that apply to these class II...

  11. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ...; Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative... II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative... apparatus devices intended for NPWT may comply with the requirement of special controls for class II devices...

  12. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ...; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays... Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This guidance document describes a means by which the herpes simplex virus types 1 and 2 serological assay device type may comply with the...

  13. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ...; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability...: Contact Cooling System for Aesthetic Use.'' This guidance document describes a means by which contact.... Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify contact cooling...

  14. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ...; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY... Oxygen Chamber for Extremities.'' This guidance document was developed as a special control to support the reclassification of the topical oxygen chamber for extremities (TOCE) from class III...

  15. 75 FR 6209 - Guidance for Industry and Food and Drug Administration; Guidance for the Use of Bayesian...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ... thoughts on the appropriate use of Bayesian statistical methods in the design and analysis of medical... outlines FDA's current thinking on the use of Bayesian statistical methods in medical device clinical... guidance represents the agency's current thinking on ``Guidance for the Use of Bayesian Statistics...

  16. Robot Guidance Using Machine Vision Techniques in Industrial Environments: A Comparative Review

    PubMed Central

    Pérez, Luis; Rodríguez, Íñigo; Rodríguez, Nuria; Usamentiaga, Rubén; García, Daniel F.

    2016-01-01

    In the factory of the future, most of the operations will be done by autonomous robots that need visual feedback to move around the working space avoiding obstacles, to work collaboratively with humans, to identify and locate the working parts, to complete the information provided by other sensors to improve their positioning accuracy, etc. Different vision techniques, such as photogrammetry, stereo vision, structured light, time of flight and laser triangulation, among others, are widely used for inspection and quality control processes in the industry and now for robot guidance. Choosing which type of vision system to use is highly dependent on the parts that need to be located or measured. Thus, in this paper a comparative review of different machine vision techniques for robot guidance is presented. This work analyzes accuracy, range and weight of the sensors, safety, processing time and environmental influences. Researchers and developers can take it as a background information for their future works. PMID:26959030

  17. Robot Guidance Using Machine Vision Techniques in Industrial Environments: A Comparative Review.

    PubMed

    Pérez, Luis; Rodríguez, Íñigo; Rodríguez, Nuria; Usamentiaga, Rubén; García, Daniel F

    2016-03-05

    In the factory of the future, most of the operations will be done by autonomous robots that need visual feedback to move around the working space avoiding obstacles, to work collaboratively with humans, to identify and locate the working parts, to complete the information provided by other sensors to improve their positioning accuracy, etc. Different vision techniques, such as photogrammetry, stereo vision, structured light, time of flight and laser triangulation, among others, are widely used for inspection and quality control processes in the industry and now for robot guidance. Choosing which type of vision system to use is highly dependent on the parts that need to be located or measured. Thus, in this paper a comparative review of different machine vision techniques for robot guidance is presented. This work analyzes accuracy, range and weight of the sensors, safety, processing time and environmental influences. Researchers and developers can take it as a background information for their future works.

  18. 75 FR 61473 - New Hampshire Industries, Inc.; Supplemental Notice That Initial Market-Based Rate Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission New Hampshire Industries, Inc.; Supplemental Notice That Initial Market... supplemental notice in the above-referenced proceeding of New Hampshire Industries, Inc.'s application for...

  19. Data Assessment and Reporting-Supplement to Section 106 Tribal Guidance

    EPA Pesticide Factsheets

    This document is intended to complement the Tribal 106 Guidance and provide additional detail to tribes concerning the reporting information requested by EPA. It addresses the water quality assessment component of a Tribal Assessment Report.

  20. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This... a guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological...

  1. 77 FR 59929 - Guidance for Industry on Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... Disease: Developing Antimicrobial Drugs for Treatment.'' This guidance addresses FDA's current thinking...). The guidance represents the Agency's current thinking on developing drugs for the treatment of...

  2. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ...). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic vaccination..., therapeutic vaccination, and xenotransplantation. The guidance is intended to clarify current...

  3. Dose uniformity of scored and unscored tablets: Application of the FDA Tablet Scoring Guidance for Industry.

    PubMed

    Ciavarella, Anthony; Khan, Mansoor; Gupta, Abhay; Faustino, Patrick

    2016-06-20

    This FDA laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units <905>, which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5-2.1 standard deviation (SD) of the % label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3-9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting "can affect how much drug is present in the split tablet and available for absorption" as stated in the guidance (1). Copyright © 2016, Parenteral Drug Association.

  4. Randomized trials assessing calcium supplementation in healthy children: relationship between industry sponsorship and study outcomes.

    PubMed

    Nkansah, Nancy; Nguyen, Thao; Iraninezhad, Hoda; Bero, Lisa

    2009-10-01

    To explore the relationship between industry sponsorship of Ca supplementation studies in healthy children and study outcomes. An electronic search for published randomized controlled trials (RCT) was conducted. We collected data on study design features aimed at reducing bias, statistical significance of results, authors' conclusions and financial sponsorship of study. We used Fischer's exact test to examine associations between sponsorship and study results and conclusions. Healthy children between the ages of 9 and 18 years. Nineteen trials met our inclusion criteria. Seventeen out of nineteen studies reported a statistically significant improvement of supplementation on bone mineral density. Subjects in eight of the seventeen studies had a baseline daily Ca intake of 800-1300 mg. There was no significant association between study design features and the results or conclusions of the studies. Three studies received government funding, two of which (66.7%) concluded in favour of additional supplementation. Sixteen studies were either industry-funded or had mixed industry funding, thirteen (81.3%) of which had a conclusion supporting Ca supplementation in children. There was no significant association between study sponsorship and authors' conclusions. The majority of RCT assessing the effects of Ca supplementation in healthy children are industry-funded and support Ca supplementation. The clinical significance of the outcomes measured in Ca supplementation studies should be considered when examining associations between study design and results. Further non-industry funded research is needed to thoroughly assess the impact of funding on authors' conclusions in nutrition research.

  5. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

    PubMed

    2006-10-11

    This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably

  6. Environmental performance measurement: Design, implementation, and review guidance for the utility industry. Final report

    SciTech Connect

    Fiksel, J.; McDaniel, J.; Parker, B.

    1998-08-01

    Many utilities formally track their environmental performance and report it to internal decision-makers and external stakeholders. Their environmental performance measurement (EPM) process captures both the environmental impacts and benefits attributable to their company, and the financial costs and benefits of their environmental management efforts. This report presents a framework intended to assist utilities in creating and implementing EPM processes that support both their business and environmental objectives. The three-phase framework--Plan, Implement, Review--describes the development, use and improvement of the EPM process. Specific guidance is provided for each step in the process so that readers can begin immediately developing or improving their process for measuring and reporting environmental information. The EPM framework builds on a variety of company experiences in the electric utility and other industries, previous research supported by EPRI on environmental performance measurement, and a series of benchmarking interviews with several major electric utility companies.

  7. Dose Uniformity of Scored and Unscored Tablets: Application of the FDA Tablet Scoring Guidance for Industry.

    PubMed

    Ciavarella, Anthony B; Khan, Mansoor A; Gupta, Abhay; Faustino, Patrick J

    This U.S. Food and Drug Administration (FDA) laboratory study examines the impact of tablet splitting, the effect of tablet splitters, and the presence of a tablet score on the dose uniformity of two model drugs. Whole tablets were purchased from five manufacturers for amlodipine and six for gabapentin. Two splitters were used for each drug product, and the gabapentin tablets were also split by hand. Whole and split amlodipine tablets were tested for content uniformity following the general chapter of the United States Pharmacopeia (USP) Uniformity of Dosage Units <905>, which is a requirement of the new FDA Guidance for Industry on tablet scoring. The USP weight variation method was used for gabapentin split tablets based on the recommendation of the guidance. All whole tablets met the USP acceptance criteria for the Uniformity of Dosage Units. Variation in whole tablet content ranged from 0.5 to 2.1 standard deviation (SD) of the percent label claim. Splitting the unscored amlodipine tablets resulted in a significant increase in dose variability of 6.5-25.4 SD when compared to whole tablets. Split tablets from all amlodipine drug products did not meet the USP acceptance criteria for content uniformity. Variation in the weight for gabapentin split tablets was greater than the whole tablets, ranging from 1.3 to 9.3 SD. All fully scored gabapentin products met the USP acceptance criteria for weight variation. Size, shape, and the presence or absence of a tablet score can affect the content uniformity and weight variation of amlodipine and gabapentin tablets. Tablet splitting produced higher variability. Differences in dose variability and fragmentation were observed between tablet splitters and hand splitting. These results are consistent with the FDA's concerns that tablet splitting can have an effect on the amount of drug present in a split tablet and available for absorption. Tablet splitting has become a very common practice in the United States and throughout

  8. 77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-09

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' This guidance addresses FDA's... an indication for the treatment of acute bacterial sinusitis (ABS). This guidance finalizes...

  9. 77 FR 59928 - Draft Guidance for Industry on Complicated Intra-Abdominal Infections: Developing Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ... previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a... resistance to most antibacterial drugs on in vitro susceptibility testing. ] This draft guidance is being...

  10. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... degradation products and updates the draft guidance ``ANDAs: Impurities in Drug Products'' announced in... final guidance to: (1) Update information on listing of degradation products, setting acceptance criteria, and qualifying degradation products (thresholds and procedures) in abbreviated new...

  11. 78 FR 101 - Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Reviews for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  12. 77 FR 48990 - Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  13. 77 FR 32124 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... Evaluation of Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry and investigators who are developing drugs for the...

  14. 75 FR 22599 - Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the act... techniques, when appropriate, and other forms of information technology. Title: Draft Guidance for Industry...

  15. 78 FR 38349 - Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-26

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Expedited Programs for Serious Conditions--Drugs and Biologics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  16. 78 FR 9396 - Draft Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil Money... responses to questions FDA has received regarding the issuance of civil money penalties for violations of...

  17. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  18. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  19. 77 FR 7166 - Draft Guidance for Industry on Determining the Extent of Safety Data Collection Needed in Late...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Determining the Extent of...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... certain aspects of a drug's safety profile will be sufficiently well-established that comprehensive...

  20. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Naming of Drug Products Containing Salt Drug Substances.'' The United States Pharmacopeial (U.S.P.) Convention has adopted a monograph naming policy that changed the nomenclature for compendial drug products that contain a salt. Under the new policy, drug names and strengths for......

  1. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration (FDA...

  2. 78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-02

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the...

  3. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

  4. 76 FR 65734 - Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ...-Affected Food Crops for Human Consumption; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Guidance for Industry: Evaluating the Safety of Flood-Affected Food Crops for Human Consumption... information on how to evaluate the safety of flood-affected food crops for human consumption. DATES:...

  5. 78 FR 63476 - Draft Guidance for Industry: Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and... ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From... donors of HCT/Ps, with recommendations for donor testing for West Nile Virus (WNV) using an FDA-licensed...

  6. 75 FR 22814 - Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ...: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV... availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) for Human... Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on...

  7. 78 FR 74154 - Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  8. 77 FR 14811 - Draft Guidance for Industry on Direct-to-Consumer Television Advertisements-the Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Direct-to-Consumer Television Advertisements--the Food and Drug Administration Amendments Act of 2007 Direct-to-Consumer Television Ad Pre... entitled ``Direct-to- Consumer Television Advertisements--FDAAA DTC Television Ad Pre- Dissemination Review...

  9. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    .../ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability AGENCY... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling... ``Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

  10. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0344) Draft Guidance for Industry on Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling... entitled ``Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and...

  11. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  12. 77 FR 37059 - Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food and Drug Administration... of a New Animal Drug for Use in Companion Animals.'' This draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal...

  13. 75 FR 54347 - Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-07

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Bar Code Label Requirements-- Questions and Answers (Question 12 Update); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft...

  14. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and... clinical studies conducted outside of the United States to support future U.S. marketing applications (Ref...

  15. 78 FR 60292 - Draft Guidance for Industry on Abbreviated New Drug Application Submissions-Refuse-to-Receive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug Application Submissions--Refuse-to-Receive Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  16. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... February 15, 2007'' to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate...

  17. 77 FR 37058 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ...] [FR Doc No: 2012-15025] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2012-D-0304] Draft Guidance for Industry and Food and Drug Administration Staff; Class II...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  18. 75 FR 15440 - Guidance for Industry on Standards for Securing the Drug Supply Chain-Standardized Numerical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  19. 77 FR 45357 - Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ] SUMMARY: The Food and Drug Administration (FDA) is...

  20. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  1. 78 FR 56719 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for Action Level for Arsenic in Apple Juice; A Quantitative Assessment of Inorganic Arsenic in Apple Juice; Extension of Comment Period AGENCY: Food and Drug Administration...

  2. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... System; the European Union Notified Body Accreditation System; the Therapeutics Goods Administration of... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Third Parties and Food and Drug... manufacturer whose establishment has been audited under one of the regulatory systems implemented by the...

  3. 76 FR 44935 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...] [FR Doc No: 2011-18923] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0453] Draft Guidance for Industry and Food and Drug Administration Staff; 510(k... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

  4. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... No: 2011-2315] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA... Development and Submission,'' Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry...

  5. 76 FR 69274 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration (FDA) is reopening until November 28...

  6. 78 FR 66743 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific guidance... iron sucrose injection. The draft guidance is a revised version of a previously issued draft guidance...

  7. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ..., Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated August 2013. The guidance document provides blood establishments that collect... malaria. This guidance finalizes the draft guidance of the same title dated June 2012, and supersedes...

  8. Appendix F: Supplemental Risk Management Program Guidance for Wastewater Treatment Plants

    EPA Pesticide Factsheets

    Detail for wastewater treatment plants (WWTPs), including publicly owned treatment works (POTWs) and other industrial treatment systems, on complying with part 68 with respect to chlorine, ammonia (anhydrous and aqueous), sulfur dioxide, and digester gas.

  9. 29 CFR 2509.08-1 - Supplemental guidance relating to fiduciary responsibility in considering economically targeted...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... employees in a metropolitan area's construction industry wants to invest in a large loan for a construction... interests of plan participants and their beneficiaries. The Department rejects a construction of ERISA that... the risk of nonpayment. Moreover, the loan's expected return is equal to or greater than construction...

  10. Drug-drug interaction studies: regulatory guidance and an industry perspective.

    PubMed

    Prueksaritanont, Thomayant; Chu, Xiaoyan; Gibson, Christopher; Cui, Donghui; Yee, Ka Lai; Ballard, Jeanine; Cabalu, Tamara; Hochman, Jerome

    2013-07-01

    Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents.

  11. Press releases issued by supplements industry organisations and non-industry organisations in response to publication of clinical research findings: a case-control study.

    PubMed

    Wang, Michael T M; Gamble, Greg; Bolland, Mark J; Grey, Andrew

    2014-01-01

    Dietary supplement use is increasing despite lack of evidence of benefits, or evidence of harm. Press releases issued by the supplements industry might contribute to this situation by using 'spin' (strategies to hype or denigrate findings) to distort the results of clinical studies. We assessed press releases issued in response to publication of clinical studies on dietary supplements. We analyzed 47 supplements industry press releases and 91 non-industry press releases and news stories, generated in response to 46 clinical studies of dietary supplements published between 1/1/2005 and 5/31/2013. The primary outcome was 'spin' content and direction. We also assessed disposition towards use of dietary supplements, reporting of study information, and dissemination of industry press releases. More supplements industry press releases (100%) contained 'spin' than non-industry media documents (55%, P<0.001). Hyping 'spin' scores were higher in industry than non-industry media documents for studies reporting benefit of supplements (median 'spin' score 3.3, 95% CI 1.0-5.5 vs 0.5, 0-1.0; P<0.001). Denigratory 'spin' scores were higher in industry than non-industry media documents for studies reporting no effect (6.0, 5.0-7.0 vs 0, 0-0; P<0.001) or harm (6.0, 5.5-7.5 vs 0, 0-0.5; P<0.001) from a supplement. Industry press releases advocated supplement use in response to >90% of studies that reported no benefit, or harm, of the supplement. Industry press releases less frequently reported study outcomes, sample size, and estimates of effect size than non-industry media documents (all P<0.001), particularly for studies that reported no benefit of supplements. Industry press releases were referenced by 148 news stories on the websites of 6 organizations that inform manufacturers, retailers and consumers of supplements. Dietary supplements industry press releases issued in response to clinical research findings are characterized by 'spin' that hypes results that are favourable to

  12. Press Releases Issued by Supplements Industry Organisations and Non-Industry Organisations in Response to Publication of Clinical Research Findings: A Case-Control Study

    PubMed Central

    Wang, Michael T. M.; Gamble, Greg; Bolland, Mark J.; Grey, Andrew

    2014-01-01

    Background Dietary supplement use is increasing despite lack of evidence of benefits, or evidence of harm. Press releases issued by the supplements industry might contribute to this situation by using ‘spin’ (strategies to hype or denigrate findings) to distort the results of clinical studies. We assessed press releases issued in response to publication of clinical studies on dietary supplements. Methods and Findings We analyzed 47 supplements industry press releases and 91 non-industry press releases and news stories, generated in response to 46 clinical studies of dietary supplements published between 1/1/2005 and 5/31/2013. The primary outcome was ‘spin’ content and direction. We also assessed disposition towards use of dietary supplements, reporting of study information, and dissemination of industry press releases. More supplements industry press releases (100%) contained ‘spin’ than non-industry media documents (55%, P<0.001). Hyping ‘spin’ scores were higher in industry than non-industry media documents for studies reporting benefit of supplements (median ‘spin’ score 3.3, 95% CI 1.0–5.5 vs 0.5, 0–1.0; P<0.001). Denigratory ‘spin’ scores were higher in industry than non-industry media documents for studies reporting no effect (6.0, 5.0–7.0 vs 0, 0–0; P<0.001) or harm (6.0, 5.5–7.5 vs 0, 0–0.5; P<0.001) from a supplement. Industry press releases advocated supplement use in response to >90% of studies that reported no benefit, or harm, of the supplement. Industry press releases less frequently reported study outcomes, sample size, and estimates of effect size than non-industry media documents (all P<0.001), particularly for studies that reported no benefit of supplements. Industry press releases were referenced by 148 news stories on the websites of 6 organizations that inform manufacturers, retailers and consumers of supplements. Conclusions Dietary supplements industry press releases issued in response to clinical research

  13. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

    ... draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies... design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)...

  14. 78 FR 15956 - Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... guidance and made appropriate changes. The Agency also held an Advisory Committee for Pharmaceutical... and labeled by: (1) Providing a harmonized approach to chemistry, manufacturing, and controls...

  15. 78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... therapy, therapeutic vaccination, xenotransplantation, and certain biologic-device combination products... product areas covered by this guidance include cellular therapy, gene therapy, therapeutic...

  16. 76 FR 53909 - Draft Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-30

    ... cutting a higher- strength tablet into smaller portions.) Specifically, this draft guidance recommends... breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this draft...

  17. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide guidance to FDA... process. This draft guidance is not final nor is it in effect at this time. DATES: Although you can... predicate device, may remain in class III even if the risks it presents are relatively low. This is the...

  18. 75 FR 57963 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ...-13 (\\13\\C) urea breath and blood tests, and the urease test. This draft guidance has been updated... technologies outside the scope of the old guidance, such as H. pylori urea breath tests and H. pylori antigen... detection of H. pylori bacteria in human blood, serum, urine, stool, or breath specimens. FDA believes these...

  19. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Clostridium difficile; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... Clostridium difficile.'' This draft guidance document describes FDA's recommendations concerning 510(k... Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time....

  20. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... therapeutic biologics regulated by the Center for Drug Evaluation and Research. This draft guidance may apply to some studies related to the veterinary drug approval process (Investigational New Animal Drugs...)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is...

  1. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

    ... of the Developing World: Developing Drugs for Treatment or Prevention; Availability AGENCY: Food and... Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist... developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug...

  2. 78 FR 52203 - Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents... Adolescents.'' This guidance is intended to help small entities and other stakeholders comply with FDA's... adolescents. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES...

  3. 76 FR 16424 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents... Smokeless Tobacco to Protect Children and Adolescents.'' This revised draft guidance replaces the original... Tobacco to Protect Children and Adolescents.'' DATES: Although you can comment on any guidance at any time...

  4. 78 FR 66744 - Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... electronic or written comments on the draft guidance by February 4, 2014. ADDRESSES: Submit written requests.... Submit electronic comments on the draft guidance to http://www.regulations.gov . Submit written comments... immunodeficiency virus/acquired immunodeficiency syndrome; and (3) new drugs that are active in the treatment of...

  5. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act..., and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance...

  6. 75 FR 3238 - Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart Valves... for heart valves. This draft guidance document is not final, nor is it in effect at this time. DATES...

  7. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... HUMAN SERVICES Food and Drug Administration Global Unique Device Identification Database; Draft Guidance... ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate... information on the database elements that must be submitted to the GUDID and their definitions. We intend...

  8. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug...-crystal solid-state forms. This guidance also provides information about the data the applicant should...

  9. 78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... considers your comment on this draft guidance before it begins work on the final version of the guidance..., to set forth criteria for charging for an investigational drug for the three types of expanded access.... Consistent with the goal of clarifying the requirements for charging for an investigational drug and the...

  10. 78 FR 20925 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... FDA's Web site. The BE recommendations identified in this notice were developed using the process... the public on FDA's Web site at...

  11. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... FDA's Web site. The BE recommendations identified in this notice were developed using the process... FDA's Web site at...

  12. 76 FR 41157 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-13

    ... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production... Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance... rule entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and...

  13. 78 FR 36196 - Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for...: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord.../umbilical cord blood, for hematopoietic and immunologic reconstitution. The guidance document is intended to...

  14. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... reference listed drugs and dosage forms) For a complete history of previously published Federal Register... access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceCompliance...

  15. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... Risedronate sodium T Tacrolimus Thalidomide Tinidazole For a complete history of previously published Federal... Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance...

  16. 77 FR 39710 - Draft Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... Contain Acetaminophen; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Over-the-Counter Human Use--Labeling for Products That Contain Acetaminophen.'' The draft guidance is... antirheumatic (IAAA) drug products that contain [[Page 39711

  17. 75 FR 32953 - Guidance for Industry and Food and Drug Administration Staff; Use of “Light,” “Mild,” “Low,” or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Use...

  18. Progress report on the guidance for industry for statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.

    PubMed

    Lin, K K

    2000-11-01

    The U.S. Food and Drug Administration (FDA) is in the process of preparing a draft Guidance for Industry document on the statistical aspects of carcinogenicity studies of pharmaceuticals for public comment. The purpose of the document is to provide statistical guidance for the design of carcinogenicity experiments, methods of statistical analysis of study data, interpretation of study results, presentation of data and results in reports, and submission of electronic study data. This article covers the genesis of the guidance document and some statistical methods in study design, data analysis, and interpretation of results included in the draft FDA guidance document.

  19. 76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices; Availability AGENCY: Food and Drug... Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture- Based... monitoring blood culture systems. This draft guidance is not final nor is it in effect at this time. DATES...

  20. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug... Submission of Animal Food Additive Petitions.'' This draft guidance describes the types of information that FDA's Center for Veterinary Medicine (CVM) recommends for inclusion in food additive petitions (FAPs...

  1. 76 FR 23824 - Guidance for Industry: “Computer Crossmatch” (Computerized Analysis of the Compatibility Between...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... Analysis of the Compatibility Between the Donor's Cell Type and the Recipient's Serum or Plasma Type... Crossmatch' (Computerized Analysis of the Compatibility between the Donor's Cell Type and the Recipient's... donor's cell type and the recipient's serum or plasma type. The guidance describes practices that...

  2. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... applications intended for use on mobile platforms (mobile applications or ``mobile apps''). At this time, the FDA intends to apply regulatory requirements to only a small subset of mobile apps referred to in this guidance as mobile medical applications (mobile medical apps). DATES: Submit either electronic or written...

  3. 77 FR 75439 - Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... Reporting Requirements for INDs and BA/BE Studies--Small Entity Compliance Guide.'' These guidances are... and BA/BE Studies'' and ``Safety Reporting Requirements for INDs and BA/BE Studies--Small Entity... requirements for IND safety reporting and safety reporting for BA and BE studies. In addition, the Small...

  4. 75 FR 32481 - Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

    ... Rotational Warning Plans for Smokeless Tobacco; Availability AGENCY: Food and Drug Administration, HHS... Tobacco Products.'' The guidance is intended to provide information relating to FDA's enforcement policy concerning section 3 of the Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco Act),...

  5. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It... traceability of electronic source data and source records maintained at the site for FDA inspection....

  6. 75 FR 33311 - Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... describes a new process for making available recommendations on how to design product- specific... FDA Web site. FDA believes that making this information available on the Internet will streamline the... guidance describes a new process for making available recommendations on how to design product-specific...

  7. 77 FR 16842 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-22

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... that would be used to make product-specific BE recommendations available to the public on FDA's Web... the public on FDA's Web site at...

  8. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... provide product-specific guidance on the design of BE studies to support abbreviated new drug applications... that would be used to make product-specific BE recommendations available to the public on FDA's Web... the public on FDA's Web site at...

  9. 77 FR 50372 - Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production... Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The guidance contains... prevent Salmonella Enteritidis (SE) from contaminating eggs on the farm and from further growth during...

  10. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... applications (ANDAs) for mesalamine rectal suppositories. The draft guidance is a revised version of a..., USP) Rectal Suppositories, new drug application 021252, 500 milligram (mg) and 1,000 mg strengths were... pharmacokinetic endpoints and comparative in vitro studies (melting point, differential scanning...

  11. 77 FR 74852 - Draft Guidance for Industry on Certification of Designated Medical Gases; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-18

    ... ``Certification Process for Designated Medical Gases.'' This draft guidance describes the new certification process created by the Food and Drug Administration Safety and Innovation Act (FDASIA) for certain medical gases and explains how FDA plans to implement that process. DATES: Although you can comment on...

  12. 78 FR 57859 - Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... determine the potential for a drug to disrupt the endocrine system. This draft guidance also discusses... compounds that have the potential to interfere with some aspect of the endocrine system of an organism or its progeny. Any component of the endocrine system can be a target of endocrine disruptors, although...

  13. 77 FR 56851 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    ... the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation...'s Web site and announced periodically in the Federal Register. The public is encouraged to submit... being posted on FDA's Web site concurrently with publication of this notice. II. Drug Products for Which...

  14. 76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ... copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research... Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD... FURTHER INFORMATION CONTACT: Brian Hasselbalch, Center for Drug Evaluation and Research, Food and Drug...

  15. 77 FR 3779 - Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... in this guidance pertain to product names in traditional print media promotion (e.g., journal ads... office), broadcast media promotion (e.g., television advertisements, radio advertisements), and electronic and computer-based promotional labeling and advertisements, such as Internet promotion, social...

  16. 78 FR 20926 - Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-08

    ... Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk... ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will...

  17. 75 FR 32791 - Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-09

    ... Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents... Smokeless Tobacco To Protect Children and Adolescents.'' The draft guidance is intended to help small... smokeless tobacco in order to protect children and adolescents. DATES: Although you can comment on any...

  18. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance... adverse event reporting obligations for manufacturers and importers. FDA published ``Medical Device...

  19. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not...

  20. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ... Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  1. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' This draft guidance provides updated... Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act.'' The...

  2. 75 FR 54889 - Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

    ... guidance addresses FDA's current thinking regarding the importance of suicidality assessment in psychiatric... current thinking regarding the importance of suicidality assessment in psychiatric and nonpsychiatric drug... patients about the occurrence of suicidal thinking and behavior, rather than relying on patients to report...

  3. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and... extended-release injectable suspension. DATES: Although you can comment on any guidance at any time (see 21... paliperidone palmitate extended-release injectable suspension. New drug application 022264 for INVEGA...

  4. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

    ... Behavior: Prospective Assessment of Occurrence in Clinical Trials; Availability AGENCY: Food and Drug... of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials...

  5. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide... to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in...

  6. 78 FR 24211 - Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-24

    ... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on safety aspects of the container label and carton labeling design for prescription drug and biological products...

  7. 75 FR 63189 - Draft Guidance for Industry on Investigational New Drug Applications-Determining Whether Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug... ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without... requirements. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure...

  8. 78 FR 310 - Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-03

    ... Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the... Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance... of applications for certain human pharmaceutical products and is being issued for public comment. In...

  9. 76 FR 60504 - Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22...

  10. Resource Conservation and Recovery Act (RCRA) in Focus: Hazardous Waste Generator Guidance by Industry

    EPA Pesticide Factsheets

    Publications providing an overview of the RCRA regulations affecting specific industry sectors. These documents present the lifecycle of a typical waste for each industry and focuses on recycling and pollution prevention.

  11. Industry experience in promoting weekly iron-folic acid supplementation in the Philippines.

    PubMed

    Garcia, Josel; Datol-Barrett, Eva; Dizon, Maynilad

    2005-12-01

    After participating in a pilot project under a government-industry partnership to promote the adoption of weekly iron-folic acid supplementation among women of reproductive age in the Philippines in 1998, United Laboratories (UNILAB), the Philippines' largest private pharmaceutical company, decided in April 2002 to launch a weekly iron-folic acid supplement for pregnant and non-pregnant women under the brand name Femina. The business objective set for the Femina brand was to build the category of preventive iron-folic acid supplements in line with the Philippine Department of Health's advocacy on weekly supplementation as an alternate to daily dosing to reduce the prevalence of anemia in the country. The brand was supported with an integrated mix of traditional advertising media with complementary direct-to-consumer educational programs that aimed to create awareness of iron-deficiency anemia, its causes and effects, and the role of weekly intake of iron-folic acid in preventing the condition. Aggressive marketing support for 1 year was successful in creating awareness among the target women. Significant lessons derived from consumers identified opportunity areas that can be further addressed in developing advocacy programs on weekly iron supplementation implemented on a nationwide scale in the future.

  12. PRN 93-11: Supplemental Guidance for PR Notice 93-7 - Labeling Revisions Required by the WPS

    EPA Pesticide Factsheets

    This pesticide registration notice augments the guidance provided by PR notice 97-3 to provide options that you may choose to allow efficient production and distribution of products that comply with PR Notice 93-7.

  13. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

    PubMed Central

    Arpinelli, Fabio; Bamfi, Francesco

    2006-01-01

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs. PMID:17076891

  14. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company.

    PubMed

    Arpinelli, Fabio; Bamfi, Francesco

    2006-10-31

    The importance of the patients point of view on their health status is widely recognised. Patient-reported outcomes is a broad term encompassing a large variety of different health data reported by patients, as symptoms, functional status, Quality of Life and Health-Related Quality of Life. Measurements of Health-Related Quality of Life have been developed during many years of researches, and a lot of validated questionnaires exist. However, few attempts have been made to standardise the evaluation of instruments characteristics, no recommendations are made about interpretation on Health-Related Quality of Life results, especially regarding the clinical significance of a change leading a therapeutic approach. Moreover, the true value of Health-Related Quality of Life evaluations in clinical trials has not yet been completely defined. An important step towards a more structured and frequent use of Patient-Reported Outcomes in drug development is represented by the FDA Guidance, issued on February 2006. In our paper we aim to report some considerations on this Guidance. Our comments focus especially on the characteristics of instruments to use, the Minimal Important Difference, and the methods to calculate it. Furthermore, we present the advantages and opportunities of using the Patient-Reported Outcomes in drug development, as seen by a pharmaceutical company. The Patient-Reported Outcomes can provide additional data to make a drug more competitive than others of the same pharmacological class, and a well demonstrated positive impact on the patient' health status and daily life might allow a higher price and/or the inclusion in a reimbursement list. Applying extensively the FDA Guidance in the next trials could lead to a wider culture of subjective measurement, and to a greater consideration for the patient's opinions on his/her care. Moreover, prescribing doctors and payers could benefit from subjective information to better define the value of drugs.

  15. Benefits of supplementing an industrial waste anaerobic digester with energy crops for increased biogas production.

    PubMed

    Nges, Ivo Achu; Escobar, Federico; Fu, Xinmei; Björnsson, Lovisa

    2012-01-01

    Currently, there is increasing competition for waste as feedstock for the growing number of biogas plants. This has led to fluctuation in feedstock supply and biogas plants being operated below maximum capacity. The feasibility of supplementing a protein/lipid-rich industrial waste (pig manure, slaughterhouse waste, food processing and poultry waste) mesophilic anaerobic digester with carbohydrate-rich energy crops (hemp, maize and triticale) was therefore studied in laboratory scale batch and continuous stirred tank reactors (CSTR) with a view to scale-up to a commercial biogas process. Co-digesting industrial waste and crops led to significant improvement in methane yield per ton of feedstock and carbon-to-nitrogen ratio as compared to digestion of the industrial waste alone. Biogas production from crops in combination with industrial waste also avoids the need for micronutrients normally required in crop digestion. The batch co-digestion methane yields were used to predict co-digestion methane yield in full scale operation. This was done based on the ratio of methane yields observed for laboratory batch and CSTR experiments compared to full scale CSTR digestion of industrial waste. The economy of crop-based biogas production is limited under Swedish conditions; therefore, adding crops to existing industrial waste digestion could be a viable alternative to ensure a constant/reliable supply of feedstock to the anaerobic digester. Copyright © 2011 Elsevier Ltd. All rights reserved.

  16. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium...; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the... availability of a draft guidance entitled ``Class II Special Controls Guidance Document: Nucleic Acid-Based...

  17. 77 FR 33210 - EDF Industrial Power Services (CA), LLC; Supplemental Notice That Initial Market-Based Rate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... Energy Regulatory Commission EDF Industrial Power Services (CA), LLC; Supplemental Notice That Initial... notice in the above-referenced proceeding of EDF Industrial Power Services (CA), LLC's application for... request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions...

  18. 75 FR 29350 - Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... on the new Safety Reporting Portal. The agency is also seeking comments from industry on the... portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. After receipt of reports through the electronic portal, FDA is...

  19. Practical Guidance for Strengthening Private Industry Councils. Research and Evaluation Report Series 91-C.

    ERIC Educational Resources Information Center

    CSR, Inc., Washington, DC.

    This document is divided into three volumes. Volume I describes what exemplary Private Industry Councils (PICS) do, Volume II explains why they are effective, and Volume III tells how to implement exemplary practice. Volume I contains case studies of 10 exemplary PICs organized by 7 topics areas (history and structure, policies and program…

  20. A Survey of Career Guidance Needs of Industrial Design Students in Taiwanese Universities

    ERIC Educational Resources Information Center

    Yang, Ming-Ying; You, Manlai

    2010-01-01

    School pupils in Taiwan spend most of their time in studying and having examinations, and consequently many of them decide what major to study in universities rather hastily. Industrial design (ID) programs in universities nowadays recruit students from general and vocational senior high schools through a variety of channels. As a consequence, ID…

  1. A Survey of Career Guidance Needs of Industrial Design Students in Taiwanese Universities

    ERIC Educational Resources Information Center

    Yang, Ming-Ying; You, Manlai

    2010-01-01

    School pupils in Taiwan spend most of their time in studying and having examinations, and consequently many of them decide what major to study in universities rather hastily. Industrial design (ID) programs in universities nowadays recruit students from general and vocational senior high schools through a variety of channels. As a consequence, ID…

  2. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... industry entitled ``Bioequivalence Recommendations for Rifaximin,'' one for the 200- milligram (mg) strength (rifaximin-200) and one for the 550-mg strength (rifaximin-550). The recommendations provide..., one for rifaximin-200 and one for rifaximin-550. Xifaxan (rifaximin) 200-mg tablets, approved by...

  3. Implementation guidance for industrial-level security systems using radio frequency alarm links

    SciTech Connect

    Swank, R.G.

    1996-07-12

    Spread spectrum (SS) RF transmission technologies have properties that make the transmitted signal difficult to intercept, interpret, and jam. The digital code used in the modulation process results in a signal that has high reception reliability and supports multiple use of frequency bands and selective addressing. These attributes and the relatively low installation cost of RF systems make SSRF technologies candidate for communications links in security systems used for industrial sites, remote locations, and where trenching or other disturbances of soil or structures may not be desirable or may be costly. This guide provides a description of such a system and presents implementation methods that may be of engineering benefit.

  4. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ..., and Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug... Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of the... placement, size, prominence, and frequency in promotional labeling and advertising for prescription...

  5. Textual synthesis of policies and guidance statements for remote healthcare practitioners on managing medical emergencies in the oil and gas industry: a systematic review protocol.

    PubMed

    Osakwe, Kennedy A; Cooper, Kay; Stewart, Derek; Wainwright, Cherry L; Klein, Susan

    2017-08-01

    The objective of this review is to collate, synthesize and present the available evidence on the policies and guidance statements for remote healthcare practitioners on managing medical emergencies in the offshore oil and gas industry.More specifically, the review seeks to answer the following questions.

  6. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug... Pulse Generator.'' This draft guidance document describes a means by which external pacemaker pulse generators may comply with the requirement of special controls for class II devices. This draft guidance is...

  7. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological... Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This draft guidance document describes a means by which the herpes simplex virus (HSV) serological assay device type...

  8. Benefits of supplementing an industrial waste anaerobic digester with energy crops for increased biogas production

    SciTech Connect

    Nges, Ivo Achu; Escobar, Federico; Fu Xinmei; Bjoernsson, Lovisa

    2012-01-15

    Highlights: Black-Right-Pointing-Pointer This study demonstrates the feasibility of co-digestion food industrial waste with energy crops. Black-Right-Pointing-Pointer Laboratory batch co-digestion led to improved methane yield and carbon to nitrogen ratio as compared to mono-digestion of industrial waste. Black-Right-Pointing-Pointer Co-digestion was also seen as a means of degrading energy crops with nutrients addition as crops are poor in nutrients. Black-Right-Pointing-Pointer Batch co-digestion methane yields were used to predict co-digestion methane yield in full scale operation. Black-Right-Pointing-Pointer It was concluded that co-digestion led an over all economically viable process and ensured a constant supply of feedstock. - Abstract: Currently, there is increasing competition for waste as feedstock for the growing number of biogas plants. This has led to fluctuation in feedstock supply and biogas plants being operated below maximum capacity. The feasibility of supplementing a protein/lipid-rich industrial waste (pig manure, slaughterhouse waste, food processing and poultry waste) mesophilic anaerobic digester with carbohydrate-rich energy crops (hemp, maize and triticale) was therefore studied in laboratory scale batch and continuous stirred tank reactors (CSTR) with a view to scale-up to a commercial biogas process. Co-digesting industrial waste and crops led to significant improvement in methane yield per ton of feedstock and carbon-to-nitrogen ratio as compared to digestion of the industrial waste alone. Biogas production from crops in combination with industrial waste also avoids the need for micronutrients normally required in crop digestion. The batch co-digestion methane yields were used to predict co-digestion methane yield in full scale operation. This was done based on the ratio of methane yields observed for laboratory batch and CSTR experiments compared to full scale CSTR digestion of industrial waste. The economy of crop-based biogas

  9. New Source Review (NSR) Program Supplemental Transitional Guidance on Applicability of New Part D NSR Permit Requirements

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  10. 76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This draft guidance... changes, and enforcement of the requirements for safety labeling changes. This draft guidance is being... collection to OMB for approval. To comply with this requirement, FDA is publishing this notice of the...

  11. 76 FR 13629 - Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401... Food, Drug, and Cosmetic Act (the FD&C Act). This revised draft guidance describes the types of waivers...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  12. 77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-11

    ... and combines two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852....

  13. 78 FR 54899 - Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... and Innovation Act (FDASIA). DATES: Although you can comment on any guidance at any time (see 21 CFR...

  14. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability AGENCY: Food and... the availability of the draft guidance entitled ``Evaluation of Sex Differences in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex differences in...

  15. 76 FR 69040 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection; Availability AGENCY... Vitro Diagnostic Devices for Yersinia Species Detection.'' This draft guidance document describes a means by which in vitro diagnostic devices for Yersinia species (spp.) detection may comply with the...

  16. 75 FR 32952 - Draft Guidance for Industry and Food and Drug Administration Staff; “‘Harmful and Potentially...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... the Federal Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS... Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance... Cosmetic Act.'' This draft guidance, when finalized, will discuss the meaning of the term ``harmful and...

  17. 76 FR 5387 - Guidance for Industry and Food and Drug Administration Staff; “`Harmful and Potentially Harmful...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... Food, Drug, and Cosmetic Act''; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' This guidance provides written guidance to... Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act.'' The Agency...

  18. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification Submissions; Availability AGENCY... announcing the availability of the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump... external infusion pumps. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  19. 78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... monitoring activities and includes additional strategies to ensure study quality. This guidance is being... assists sponsors in developing risk-based monitoring strategies and plans for clinical investigations of... oversight on the most important aspects of study conduct and reporting. The guidance makes clear that...

  20. 76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-29

    ... developing risk-based monitoring strategies and plans for investigational studies of medical products....'' This guidance is intended to assist sponsors in developing risk-based monitoring strategies and plans... device exemption (IDE) studies. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  1. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... this draft guidance is to assist clinical trial sponsors and investigators in the development of... bacterial pneumonia (VABP). The science of clinical trial design and our understanding of these diseases... recommendations for clinical development. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  2. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ... the Committee on Energy and Commerce of the U.S. House of Representatives setting out the goals of... considers your comment on this draft guidance before it begins work on the final version of the guidance... comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of...

  3. E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability. Notice.

    PubMed

    2016-07-19

    The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.

  4. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... (especially ruminant material) contaminants. This draft guidance on crude heparin recommends strategies to... contamination of heparin with the bovine spongiform encephalopathy (BSE) agent derived from ruminant materials... contaminated with OSCS or any non- porcine origin material, especially ruminant material (unless...

  5. 78 FR 55261 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... development and/or testing of generic drug products regarding the requirements and commitments of GDUFA. DATES... launch of the GDUFA program, FDA has revised the draft guidance and is issuing it again in draft...

  6. 76 FR 62073 - Guidance for Industry on Implementation of the Fee Provisions of the FDA Food Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ... Modernization Act.'' FDA is issuing this guidance to provide answers to common questions that might arise about... to common questions that might arise about the new fee provisions and FDA's plans for...

  7. 76 FR 63304 - Guidance for Industry on Incorporation of Physical-Chemical Identifiers Into Solid Oral Dosage...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ... Solid Oral Dosage Form Drug Products for Anticounterfeiting; Availability AGENCY: Food and Drug... Oral Dosage Form Drug Products for Anticounterfeiting.'' This guidance provides recommendations on... Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting.'' For the purpose of...

  8. 78 FR 14097 - Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... current thinking in regards to information that should be included in a premarket submission for a non... guidance represents the Agency's current thinking on non-invasive pulse oximeters intended for prescription...

  9. Nutravigilance: principles and practices to enhance adverse event reporting in the dietary supplement and natural products industry.

    PubMed

    Schmitz, Stephen M; Lopez, Hector L; MacKay, Douglas

    2014-03-01

    Nutravigilance is defined as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects related to the use of a food, dietary supplement, or medical food". The nutravigilance approach is derived from well-defined principles of pharmacovigilance in the drug and biologics industries, which have been developed and refined over a number of years through expert recommendations. While the primary purpose of nutravigilance is to protect customer/patient safety, it also serves to reduce product liability risks for manufacturers and marketing agents of such products. Compliance with the current FDA adverse event reporting requirements is suboptimal, and FDA oversight and enforcement activities have recently increased. In order to better protect customer and product safety, dietary supplement manufacturers must significantly change their current approach, and demonstrate a proactive, systematic, risk-based, scientific approach to product safety, similar to one utilized successfully in the pharmaceutical industry. While this article focuses on FDA regulations, the principles are widely relevant to the supplement industry in the rest of the world.

  10. How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration.

    PubMed

    Furlong, Pat; Bridges, John F P; Charnas, Lawrence; Fallon, Justin R; Fischer, Ryan; Flanigan, Kevin M; Franson, Timothy R; Gulati, Neera; McDonald, Craig; Peay, Holly; Sweeney, H Lee

    2015-06-24

    Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community-led by Parent Project Muscular Dystrophy-created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking involved a broad coalition of more than 80 stakeholders collaborating across nine time zones to produce a document in only 6 months. We hope that other rare disease communities and advocacy organizations can use our experience as a model for developing their own draft guidance documents.

  11. Dietary supplements and cancer prevention: balancing potential benefits against proven harms.

    PubMed

    Martínez, María Elena; Jacobs, Elizabeth T; Baron, John A; Marshall, James R; Byers, Tim

    2012-05-16

    Nutritional supplementation is now a multibillion-dollar industry, and about half of all US adults take supplements. Supplement use is fueled in part by the belief that nutritional supplements can ward off chronic disease, including cancer, although several expert committees and organizations have concluded that there is little to no scientific evidence that supplements reduce cancer risk. To the contrary, there is now evidence that high doses of some supplements increase cancer risk. Despite this evidence, marketing claims by the supplement industry continue to imply anticancer benefits. Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk.

  12. 77 FR 51811 - Draft Guidance for Industry on Self-Identification of Generic Drug Facilities, Sites, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... explains who is required to self- identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify. DATES: Although you can... and compliance. This guidance is intended to assist human generic drug facilities, sites, and...

  13. 76 FR 82303 - Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... ``Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools'' to provide an... internet and social media promotion, particularly when using tools that are associated with space... encounter through emerging electronic media. DATES: Although you can comment on any guidance at any...

  14. 78 FR 18273 - Draft Guidance for Industry on Purchasing Reef Fish Species Associated With the Hazard of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and...: Purchasing Reef Fish Species Associated With the Hazard of Ciguatera Fish Poisoning.'' The draft guidance, when finalized, will advise primary seafood processors who purchase reef fish how to minimize the...

  15. 77 FR 35986 - Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Register on October 28, 2008 (final rule). The guidance describes certain requirements of the final rule in plain language and provides answers to common questions on how to comply with the rule. FDA prepared...

  16. 75 FR 52427 - Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... Machine Labeling Laws; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws.'' Section... vending machine operators. FDA is issuing this guidance to clarify section 4205's effect on State and...

  17. 78 FR 72900 - Guidance for Industry and Food and Drug Administration Staff; Civil Money Penalties for Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

    ...; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions; Availability... (FDA) is announcing the availability of the guidance entitled ``Civil Money Penalties for Tobacco... questions that FDA has received regarding the issuance of civil money penalties for violations of...

  18. 77 FR 68133 - Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-15

    ... Reduce the Risk of Transmission of Hepatitis B Virus; Availability AGENCY: Food and Drug Administration... Transmission of Hepatitis B Virus,'' dated October 2012. The guidance document provides recommendations on the use of FDA- licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV...

  19. 78 FR 35940 - Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... treat a disease or condition. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie many complex diseases, such as cancer, cardiovascular disease, and... disease or condition. The guidance provides recommendations and advice on how to address certain...

  20. 77 FR 14022 - Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... Human Foods and Direct-Human-Contact Animal Foods; Availability AGENCY: Food and Drug Administration... Direct- Human-Contact Animal Foods.'' The document provides guidance to firms that manufacture, process, pack, or hold human foods or direct-human- contact animal foods intended for distribution to consumers...

  1. 75 FR 53973 - Guidance for Industry; Small Entities Compliance Guide-Designation of New Animal Drugs for Minor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... written requests for single copies of the SECG to the Communications Staff (HFV-12), Center for Veterinary..., chickens, turkeys, dogs, and cats) in the United States or to major species afflicted with uncommon... single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine,...

  2. 76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-18

    ... Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability.... Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with the requirement of special controls for class II devices...

  3. 77 FR 63837 - Draft Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-17

    ... solely on the paper version. This draft guidance is not final nor is it in effect at this time. DATES... rather than relying solely on the paper version. The eCopy Program is not intended to impact (reduce or... approval. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a...

  4. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ... licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on... provides sponsors of NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in...). The draft guidance, when finalized, will represent the Agency's current thinking on size of beads in...

  5. 77 FR 12311 - Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size... submitting NDAs, ANDAs, and BLAs CDER's current thinking on appropriate size ranges for beads in drug... guidance represents the Agency's current thinking on the size of beads in drug products labeled...

  6. 76 FR 26307 - Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-06

    ... Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants in... the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA... subjects: Types of ANDA submissions covered by the regulations on BE studies; Recommended format...

  7. 78 FR 44573 - Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... Format--Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers... Electronic Format--Postmarket Non-Expedited ICSRs; Technical Questions and Answers.'' The guidance provides... to FDA postmarket non-expedited individual case safety reports (ICSRs) on adverse drug...

  8. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... 20993-0002. Regarding human biological products: Stephen Ripley, Center for Biologics Evaluation and... be prescriptive with regard to choice of study design or type of analysis and does not endorse any particular type of data resource or methodology. Finally, the guidance does not provide a framework for...

  9. 77 FR 48159 - Draft Guidance for Industry and Food and Drug Administration Staff; Refuse To Accept Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... Staff; Refuse To Accept Policy for 510(k)s; Availability AGENCY: Food and Drug Administration, HHS... draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to... (510(k)) submission is administratively complete, which determines whether it should be accepted...

  10. 78 FR 39737 - Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... bacteria). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure... against a single genus or species of bacteria). Efforts to develop new antibacterial drugs have diminished in the past few decades. Because bacteria continue to develop resistance to available antibacterial...

  11. National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Portland Cement Manufacturing Industry Subpart LLL Rule Guidance

    EPA Pesticide Factsheets

    This Spring 2016 document is intended for the use of EPA staff, State and Local regulatory agencies and their staff, and industry plant managers for the NESHAP for the Portland Cement Manufacturing Industry.

  12. Supplemental Journal Article Materials: A progress report on an information industry initiative

    NASA Astrophysics Data System (ADS)

    Schwarzman, A. B.

    2011-12-01

    Who could possibly quibble with the idea of publishing supplemental materials to a journal article? Making them available makes it possible for the Earth and space scientists to demonstrate supporting evidence, such as multimedia, computer programs, and datasets; gives the authors the opportunity to present in-depth studies that would not otherwise be available; and enables the readers to replicate experiments and verify their results. However, the scholarly publishing ecosystem is now being threatened by a veritable tsunami of supplemental materials that have to be peer reviewed, identified, described, and made discoverable and citeable; such materials also have to be archived, preserved, and perpetually converted to the contemporary formats to be available to a future researcher. Moreover, the readers often have no clear indication of how critical a particular supplemental material is to the scientific conclusions of the article and thus are not sure whether they should spend their time reading/viewing/running it. In some cases it is not even clear what the material actually supplements. While one segment of the research community argues that even more supplemental materials should be made available, another segment increasingly voices its concern stating categorically that a research article is not a data dump or an FTP site. From the publisher's perspective, dealing with supplemental materials in a responsible fashion is becoming an increasingly costly proposition. Faced with formidable challenges of managing supplemental materials, the information profession community in 2010 formed a joint NISO/NFAIS Working Group to develop Recommended Practices for curating supplemental materials during their life cycle, including but not limited to their selection, peer review, editing, production, presentation, providing context, identification, linking, citing, hosting, discovery, metadata and markup, packaging, accessibility, and preservation. The Recommended Practices

  13. Joint Explorations Program. A Supplement to Home Economics/Industrial Arts 7.

    ERIC Educational Resources Information Center

    Manitoba Dept. of Education, Winnipeg.

    This Joint Explorations Program for Home Economics/Industrial Arts, middle years, is a guide and support document related to the curriculum guides for Home Economics 7-9, and Industrial Arts 7-9. Developed as part of the overall revision of the Home Economics and Industrial Arts programs for the junior high schools of Manitoba, the guide provides…

  14. 76 FR 14025 - Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-15

    ... provide to industry considerations for developing plans for these types of emergencies, as well as to... provide to industry considerations for developing plans for these types of emergencies, as well as to... therapeutic biologic products regulated by CDER, and any components of those products. These considerations...

  15. Do dietary supplements have beneficial health effects in industrialized nations: what is the evidence?

    PubMed

    Marik, Paul E; Flemmer, Mark

    2012-03-01

    Dietary supplements are regularly used by at least half of the American population, yet the health benefits of these agents are unclear. A systematic review to determine the benefits and risks of dietary supplements in Westernized societies. MEDLINE, Embase, Cochrane Register of Controlled Trials and citation review of relevant articles. Randomized, placebo-controlled clinical trials in non-pregnant Westernized adults that evaluated clinical outcomes of nutritional supplements. Data were abstracted on study design, study size, study setting, patient population, dietary intervention and clinical outcomes. The outcome of each study was classified as non-beneficial, beneficial or harmful according to whether the end-point(s) of interest reached statistical significance. Sixty-three studies met the criteria for our systematic review. No benefit was recorded in 45 studies, with 10 of these showing a trend towards harm and with two showing a trend towards benefit. Four studies reported harm with increased cancer deaths (n=2) and increased fractures (n=2). Two studies reported both a harmful as well as a beneficial outcome. A beneficial outcome was reported in 12 studies; 6 which studied vitamin D and three which investigated omega-3 fatty acids. While a benefit was reported in one study each which investigated Vitamin E, folic acid and Ginkgo biloba this benefit was not confirmed by larger and more adequately powered studies. With the possible exceptions of Vitamin D and omega-3 fatty acids there is no data to support the widespread use of dietary supplements in Westernized populations; indeed, many of these supplements may be harmful.

  16. Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.

    PubMed

    Finley, John Weldon; Finley, John Wescott; Ellwood, Kathleen; Hoadley, James

    2014-01-01

    Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

  17. Analysis of concentrating PV-T systems for the commercial/industrial sector. Volume III. Technical issues and design guidance

    SciTech Connect

    Schwinkendorf, W.E.

    1984-09-01

    This report provide appropriate guidance for addressing the major technical issues associated with the design and installation of a photovoltaic-thermal (PV-T) system. Nomographs are presented for developing preliminary sizing and costing, and issues associated with specific components and the overall design of the electrical and mechanical system are discussed. SAND82-7157/2 presents a review of current PV-T technology and operating systems and a study of potential PV-T applications. Detailed PV-T system designs for three selected applications and the results of a trade-off study for these applications are presented in SAND82-7157/4. A summary of the major results of this entire study and conclusions concerning PV-T systems and applications is presented in SAND82-7157/1.

  18. 78 FR 59624 - Guidance for Industry #223: Small Entity Compliance Guide-Declaring Color Additives in Animal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... Compliance Guide--Declaring Color Additives in Animal Foods; Availability AGENCY: Food and Drug... Color Additives in Animal Foods.'' This small entity compliance guide (SECG) aids industry in complying... regulations regarding the declaration of certified color additives on the labels of animal food including...

  19. Government-industry partnership in weekly iron-folic acid supplementation for women of reproductive age in the Philippines: impact on iron status.

    PubMed

    Angeles-Agdeppa, Imelda; Paulino, Lourdes S; Ramos, Adelisa C; Etorma, Unita Marie; Cavalli-Sforza, Tommaso; Milani, Silvano

    2005-12-01

    The effectiveness of weekly iron-folic acid supplements promoted through a government-industry partnership was assessed in pregnant and non-pregnant women in the Philippines. Compliance to both weekly and daily supplementation increased during the year-long study period, but was highest with weekly supplementation. Serum ferritin and hematocrit increased significantly, whereas the hemoglobin level showed minimal change, probably because of lack of other heme-forming nutrients such as vitamin A. Serum ferritin increments were significantly higher in women taking the iron-folic acid supplements for more than 6 weeks. Weekly iron-folic acid supplementation should be recommended as a preventive strategy to control iron deficiency among reproductive-age women in the Philippines.

  20. Manpower Requirements and Resources in S.C. Industry and Occupation. Supplemental Report 1971.

    ERIC Educational Resources Information Center

    South Carolina State Employment Security Commission, Columbia. Research Dept.

    South Carolina's population growth over 1970-1975 is expected to average 22,000 per year, paralleling the growth rate of the last five-year period. Nonfarm wage and salary employment is expected to increase at an average annual rate of 2.4%, with the corresponding national rate being 2.0%. The fastest growing industrial sectors will be…

  1. Marine-Based Nutraceuticals: An Innovative Trend in the Food and Supplement Industries

    PubMed Central

    Suleria, Hafiz Ansar Rasul; Osborne, Simone; Masci, Paul; Gobe, Glenda

    2015-01-01

    Recent trends in functional foods and supplements have demonstrated that bioactive molecules play a major therapeutic role in human disease. Nutritionists and biomedical and food scientists are working together to discover new bioactive molecules that have increased potency and therapeutic benefits. Marine life constitutes almost 80% of the world biota with thousands of bioactive compounds and secondary metabolites derived from marine invertebrates such as tunicates, sponges, molluscs, bryozoans, sea slugs and many other marine organisms. These bioactive molecules and secondary metabolites possess antibiotic, antiparasitic, antiviral, anti-inflammatory, antifibrotic and anticancer activities. They are also inhibitors or activators of critical enzymes and transcription factors, competitors of transporters and sequestrants that modulate various physiological pathways. The current review summaries the widely available marine-based nutraceuticals and recent research carried out for the purposes of isolation, identification and characterization of marine-derived bioactive compounds with various therapeutic potentials. PMID:26473889

  2. The University for Industry and Local Information, Advice and Guidance Partnerships. Report on a NICEC/CRAC Policy Consultation Held in Association with the National Advisory Council for Careers and Educational Guidance (Cambridge, England, February 24-25, 1999). Conference Briefing.

    ERIC Educational Resources Information Center

    Watts, Tony

    The University for Industry (UFI) and local information, advice, and guidance (IAG) partnerships are two key aspects of the British Government's lifelong learning strategy. UFI's key role is to expand the demand for and supply of learning and to exploit the learning potential of information and communication technologies. The main UFI activities…

  3. Policy & Guidance

    EPA Pesticide Factsheets

    Policy documents represent EPA's official interpretation or view of specific issues. Guidance documents are published to further clarify regulations and to assist in implementation of environmental regulations.

  4. Guidance for Facilities on Risk Management Programs (RMP)

    EPA Pesticide Factsheets

    Includes supplemental guidance specific to ammonia refrigeration, wastewater treatment, propane storage, warehouses, chemical distributors, offsite consequence analysis, retail agriculture, applicability of program levels, prevention, emergency response.

  5. Image Guidance

    EPA Pesticide Factsheets

    Guidance that explains the process for getting images approved in One EPA Web microsites and resource directories. includes an appendix that shows examples of what makes some images better than others, how some images convey meaning more than others

  6. National Emission Standards for Hazardous Air Pollutants (NESHAP) for Major Sources: Industrial, Commercial, and Institutional Boilers - Guidance for Calculating Emission Credits Resulting from Implementation of Energy Conservation Measures

    EPA Pesticide Factsheets

    The purpose of this July 2012 document is to provide guidance for developing a consistent approach to documenting efficiency credits generated from energy conservation measures in the Implementation Plan for boilers covered by the Boiler MACT rule.

  7. Culture of human mesenchymal stem cells using a candidate pharmaceutical grade xeno-free cell culture supplement derived from industrial human plasma pools.

    PubMed

    Díez, José M; Bauman, Ewa; Gajardo, Rodrigo; Jorquera, Juan I

    2015-03-13

    Fetal bovine serum (FBS) is an animal product used as a medium supplement. The animal origin of FBS is a concern if cultured stem cells are to be utilized for human cell therapy. Therefore, a substitute for FBS is desirable. In this study, an industrial, xeno-free, pharmaceutical-grade supplement for cell culture (SCC) under development at Grifols was tested for growth of human mesenchymal stem cells (hMSCs), cell characterization, and differentiation capacity. SCC is a freeze-dried product obtained through cold-ethanol fractionation of industrial human plasma pools from healthy donors. Bone marrow-derived hMSC cell lines were obtained from two commercial suppliers. Cell growth was evaluated by culturing hMSCs with commercial media or media supplemented with SCC or FBS. Cell viability and cell yield were assessed with an automated cell counter. Cell surface markers were studied by indirect immunofluorescence assay. Cells were cultured then differentiated into adipocytes, chondrocytes, osteoblasts, and neurons, as assessed by specific staining and microscopy observation. SCC supported the growth of commercial hMSCs. Starting from the same number of seeded cells in two consecutive passages of culture with medium supplemented with SCC, hMSC yield and cell population doubling time were equivalent to the values obtained with the commercial medium and was consistent among lots. The viability of hMSCs was higher than 90%, while maintaining the characteristic phenotype of undifferentiated hMSCs (positive for CD29, CD44, CD90, CD105, CD146, CD166 and Stro-1; negative for CD14 and CD19). Cultured hMSCs maintained the potential for differentiation into adipocytes, chondrocytes, osteoblasts, and neurons. The tested human plasma-derived SCC sustains the adequate growth of hMSCs, while preserving their differentiation capacity. SCC can be a potential candidate for cell culture supplement in advanced cell therapies.

  8. Milk production, intake, digestion, blood parameters, and ingestive behavior of cows supplemented with by-products from the biodiesel industry.

    PubMed

    Gonzaga Neto, Severino; Oliveira, Ronaldo Lopes; de Lima, Francisco Helton Sá; de Medeiros, Ariosvaldo Nunes; Bezerra, Leilson Rocha; Viégas, Júlio; do Nascimento, Nilton Guedes; de Freitas Neto, Marcondes Dias

    2015-01-01

    This study aimed to evaluate the intake, digestion, blood parameters, and feeding behavior of crossbred dairy cows (Holstein × Gir) managed on Panicum maximum Jacq. cv. Tanzania-1 and provided supplementation with groundnut cake, sunflower cake, or palm kernel cake (to replace soybean meal). Sixteen cows were randomly assigned in a Latin square design with four treatments and four experimental periods. The consumption of nutrients from the pasture did not vary between experimental treatments. Cows receiving the palm kernel cake supplement had a reduced crude protein, non-fibrous carbohydrate, and total digestible nutrient intake and an increase in the average consumption of ether extract. There was also a reduction in the digestibility of dry matter. The inclusion of supplements in the diet did not influence the average time spent eating, ruminating, or resting. The mean values of respiratory and heart rates showed thermal comfort during the trial period. There was a reduction in blood urea nitrogen with palm kernel cake supplementation, and the values of total protein, albumin, and glucose were also significantly different with this supplement. It is recommended that cakes of groundnut cake and sunflower cake seed be used for a total replacement of soybean meal supplements for lactating cows, but the use of palm kernel cake is not recommended.

  9. 78 FR 38683 - Availability of Guidance: Establishments Guidance for the Selection of a Commercial or Private...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-27

    ... that meet the guidance provided in the International Organization for Standardization (ISO) 17025... laboratories seeking to implement the ISO 17025 standards. FSIS has developed its guidance to assist industry... an explanation that laboratories that meet the guidance provided in the ISO 17025 accreditation...

  10. 76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-05

    ... Regulatory Commission (NRC) is issuing Supplement 3, ``Guidance for Protective Action Strategies,'' to NUREG... Evacuation Time Estimate Studies;'' all dated November, 2011. These documents update implementation guidance...) studies. This document provides guidance for addressing new EP requirements for nuclear power plants based...

  11. National Emission Standards for Hazardous Air Pollutants for Major Sources. Industrial, Commercial, and Institutional Boilers; Guidance for Calculating Emission Credits Resulting from Implementation of Energy Conservation Measures

    SciTech Connect

    Papar, Riyaz; Wright, Anthony; Cox, Daryl

    2012-07-01

    The purpose of this document is to provide guidance for developing a consistent approach to documenting efficiency credits generated from energy conservation measures in the Implementation Plan for boilers covered by the Boiler MACT rule (i.e., Subpart DDDDD of CFR Part 63).

  12. Environmental technologies industry and global markets. A supplement to environmental technologies export: Strategic framework for US leadership. Export trade information

    SciTech Connect

    Not Available

    1994-04-01

    The present report outlines the background and issues supporting the national strategy which was developed to deploy U.S. Government resources most effectively to increase environmental technologies exports and to enhance the trade competitiveness of the U.S. environmental technologies sector. The document is a supplement to the strategic framework.

  13. Zinc, magnesium, and calcium ion supplementation confers tolerance to acetic acid stress in industrial Saccharomyces cerevisiae utilizing xylose.

    PubMed

    Ismail, Ku Syahidah Ku; Sakamoto, Takatoshi; Hasunuma, Tomohisa; Zhao, Xin-Qing; Kondo, Akihiko

    2014-12-01

    Lignocellulosic biomass is a potential substrate for ethanol production. However, pretreatment of lignocellulosic materials produces inhibitory compounds such as acetic acid, which negatively affect ethanol production by Saccharomyces cerevisiae. Supplementation of the medium with three metal ions (Zn(2+) , Mg(2+) , and Ca(2+) ) increased the tolerance of S. cerevisiae toward acetic acid compared to the absence of the ions. Ethanol production from xylose was most improved (by 34%) when the medium was supplemented with 2 mM Ca(2+) , followed by supplementation with 3.5 mM Mg(2+) (29% improvement), and 180 μM Zn(2+) (26% improvement). Higher ethanol production was linked to high cell viability in the presence of metal ions. Comparative transcriptomics between the supplemented cultures and the control suggested that improved cell viability resulted from the induction of genes controlling the cell wall and membrane. Only one gene, FIT2, was found to be up-regulated in common between the three metal ions. Also up-regulation of HXT1 and TKL1 might enhance xylose consumption in the presence of acetic acid. Thus, the addition of ionic nutrients is a simple and cost-effective method to improve the acetic acid tolerance of S. cerevisiae.

  14. Industry

    SciTech Connect

    Bernstein, Lenny; Roy, Joyashree; Delhotal, K. Casey; Harnisch, Jochen; Matsuhashi, Ryuji; Price, Lynn; Tanaka, Kanako; Worrell, Ernst; Yamba, Francis; Fengqi, Zhou; de la Rue du Can, Stephane; Gielen, Dolf; Joosen, Suzanne; Konar, Manaswita; Matysek, Anna; Miner, Reid; Okazaki, Teruo; Sanders, Johan; Sheinbaum Parado, Claudia

    2007-12-01

    This chapter addresses past, ongoing, and short (to 2010) and medium-term (to 2030) future actions that can be taken to mitigate GHG emissions from the manufacturing and process industries. Globally, and in most countries, CO{sub 2} accounts for more than 90% of CO{sub 2}-eq GHG emissions from the industrial sector (Price et al., 2006; US EPA, 2006b). These CO{sub 2} emissions arise from three sources: (1) the use of fossil fuels for energy, either directly by industry for heat and power generation or indirectly in the generation of purchased electricity and steam; (2) non-energy uses of fossil fuels in chemical processing and metal smelting; and (3) non-fossil fuel sources, for example cement and lime manufacture. Industrial processes also emit other GHGs, e.g.: (1) Nitrous oxide (N{sub 2}O) is emitted as a byproduct of adipic acid, nitric acid and caprolactam production; (2) HFC-23 is emitted as a byproduct of HCFC-22 production, a refrigerant, and also used in fluoroplastics manufacture; (3) Perfluorocarbons (PFCs) are emitted as byproducts of aluminium smelting and in semiconductor manufacture; (4) Sulphur hexafluoride (SF{sub 6}) is emitted in the manufacture, use and, decommissioning of gas insulated electrical switchgear, during the production of flat screen panels and semiconductors, from magnesium die casting and other industrial applications; (5) Methane (CH{sub 4}) is emitted as a byproduct of some chemical processes; and (6) CH{sub 4} and N{sub 2}O can be emitted by food industry waste streams. Many GHG emission mitigation options have been developed for the industrial sector. They fall into three categories: operating procedures, sector-wide technologies and process-specific technologies. A sampling of these options is discussed in Sections 7.2-7.4. The short- and medium-term potential for and cost of all classes of options are discussed in Section 7.5, barriers to the application of these options are addressed in Section 7.6 and the implication of

  15. National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers; Guidance for Calculating Efficiency Credits Resulting from Implementation of Energy Conservation Measures

    SciTech Connect

    Cox, Daryl; Papar, Riyaz; Wright, Dr. Anthony

    2013-02-01

    The purpose of this document is to provide guidance for developing a consistent approach to documenting efficiency credits generated from energy conservation measures in the Implementation Plan for boilers covered by the Boiler MACT rule (i.e., subpart DDDDD of CFR part 63). This document divides Boiler System conservation opportunities into four functional areas: 1) the boiler itself, 2) the condensate recovery system, 3) the distribution system, and 4) the end uses of the steam. This document provides technical information for documenting emissions credits proposed in the Implementation Plan for functional areas 2) though 4). This document does not include efficiency improvements related to the Boiler tune-ups.

  16. National Emission Standards for Hazardous Air Pollutants for Major Sources: Industrial, Commercial, and Institutional Boilers; Guidance for Calculating Emission Credits Resulting from Implementation of Energy Conservation Measures

    SciTech Connect

    Cox, Daryl; Papar, Riyaz; Wright, Dr. Anthony

    2012-07-01

    The purpose of this document is to provide guidance for developing a consistent approach to documenting efficiency credits generated from energy conservation measures in the Implementation Plan for boilers covered by the Boiler MACT rule (i.e., subpart DDDDD of CFR part 63). This document divides Boiler System conservation opportunities into four functional areas: 1) the boiler itself, 2) the condensate recovery system, 3) the distribution system, and 4) the end uses of the steam. This document provides technical information for documenting emissions credits proposed in the Implementation Plan for functional areas 2) though 4). This document does not include efficiency improvements related to the Boiler tune-ups.

  17. Draft Evaluation, Measurement and Verification Guidance for Demand-Side Energy Efficiency

    EPA Pesticide Factsheets

    EPA is sharing draft Evaluation, Measurement and Verification Guidance for Demand-Side Energy Efficiency for public comment. This guidance is not a regulatory document, and is intended to supplement information provided in the Clean Power Plan.

  18. Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

    PubMed

    Villafranco, John E; Bond, Katie

    2009-01-01

    Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims.

  19. Green gold: The potential and pitfalls for North American medicinal plants in the US botanical supplements industry

    Treesearch

    Aswini Pai; Matthew Skeels

    2010-01-01

    Complementary and alternative medicine (CAM) has become an implicit part of a lifestyle industry in the United States. The World Health Organization (WHO) reports that at least 41% of the population in the US has used CAM at least once in their lives (WHO 2002). Globalization, an influx of various immigrant cultures, and growing wariness of western allopathic medicine...

  20. 75 FR 39949 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug... notice solicits comments on the information collection in the guidance for industry on special protocol...

  1. 78 FR 69093 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... a stability protocol, product characterization and relevant manufacturing data. Description of... Collection; Comment Request; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug... notice solicits comments on the information collection in the guidance for industry on special...

  2. A GUIDANCE PROJECT TO INVESTIGATE CHARACTERISTICS, BACKGROUND, AND JOB EXPERIENCES OF SUCCESSFUL AND UNSUCCESSFUL ENTRY WORKERS IN THREE SELECTED INDUSTRIES. FINAL REPORT.

    ERIC Educational Resources Information Center

    GORMAN, ROBERT E.

    FIFTEEN CERTIFIED SECONDARY SCHOOL COUNSELORS PARTICIPATED IN AN ON-THE-JOB INVESTIGATION OF THREE SELECTED INDUSTRIES IN MONTANA--MINING, LUMBERING, AND CONSTRUCTION. THE PURPOSES WERE TO (1) PROVIDE THE PARTICIPATING COUNSELORS WITH ON-THE-JOB KNOWLEDGE ESSENTIAL FOR ENGAGING IN MORE EFFECTIVE VOCATIONAL COUNSELING OF SECONDARY SCHOOL STUDENTS…

  3. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion... solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump... technology. Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion...

  4. GUIDANCE FOR CONDUCTING HEALTH RISK ...

    EPA Pesticide Factsheets

    While some potential environmental hazards involve significant exposure to only a single compound, most instances of environmental contamination involve concurrent or sequential exposures to a mixture of compounds that may induce similar or dissimilar effects over exposure periods ranging from short-term to lifetime. Multichemical exposures are ubiquitous, including air and soil pollution from municipal incinerators, leakage from hazardous waste facilities and uncontrolled waste sites, and drinking water containing chemical substances formed during disinfection. To address concerns over health risks from multichemical exposures, EPA issued Guidelines for Health Risk from Exposure to Chemical Mixtures in 1986. Those Guidelines described broad concepts related to mixtures exposure and toxicity and included few specific procedures. Since then, EPA has published additional mixtures guidance documents such as 1989 guidance for the Superfund program on hazardous waste and the 1990 Technical Support Document on Health Risk Assessment of Chemical Mixtures. Because the science of environmental risk assessment continues to evolve, EPA's Risk Assessment Forum established a Technical Work Panel to ensure that the advances in the area of chemical mixtures health risk assessment are reflected in the Agency's guidance materials. This document has been developed by the Technical Work Panel to supplement the earlier guidances and is organized according to the type of data avail

  5. Controls and guidance: Aeronautics

    NASA Technical Reports Server (NTRS)

    Dibattista, John D.

    1988-01-01

    The overall objective is to provide a validated technology base leading to the development and exploitation of new concepts, analysis and design methodologies, and flight systems for future civil and military aircraft. This will provide increased efficiency, effectiveness, reliability, and safety. The program is organized into generic elements and vehicle-specific elements. The generic elements are control theory, guidance and display concepts, and flight crucial systems. Vehicle-specific elements are generic hypersonics, subsonic transport/commuter/general aviation, rotorcraft, and fighter/attack. Research in the control theory element is directed toward the improved flight control analysis and design methodologies for highly integrated, robust flight control designs. Flight Crucial Systems research is directed toward the development of design, assessment, and validation methodologies for flight crucial systems. The generic hypersonics research concentrates on the integration of flight control, propulsion control, sensors, and displays. The Aeronautical Controls and Guidance Program involves analytical and experimental research by in-house, university, and industry personnel. Extensive use of ground-based simulation is a characteristic of the program with selected flight experiments in a variety of aircraft.

  6. GROUP GUIDANCE IN JUNIOR COLLEGE--A FRAME OF REFERENCE.

    ERIC Educational Resources Information Center

    WITHERSPOON, FREDDA D.

    THIS GROUP GUIDANCE PROGRAM IS DESIGNED TO PROVIDE (1) A CHANCE FOR SELF-ASSESSMENT OF PERSONAL STRENGTHS AND WEAKNESSES, (2) IMPROVEMENT OF ATTITUDES IN HUMAN RELATIONS, (3) IMPROVEMENT OF STUDY HABITS AND TECHNIQUES, AND (4) REALISTIC ASSESSMENT OF VOCATIONAL ABILITIES. GROUP GUIDANCE IS INTENDED TO SUPPLEMENT, NOT SUPPLANT, INDIVIDUAL…

  7. 45 CFR 73a.735-104 - Advice and guidance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Advice and guidance. 73a.735-104 Section 73a.735-104 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-104 Advice and guidance. (a) The...

  8. 45 CFR 73a.735-104 - Advice and guidance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 45 Public Welfare 1 2013-10-01 2013-10-01 false Advice and guidance. 73a.735-104 Section 73a.735-104 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-104 Advice and guidance. (a) The...

  9. 45 CFR 73a.735-104 - Advice and guidance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 45 Public Welfare 1 2014-10-01 2014-10-01 false Advice and guidance. 73a.735-104 Section 73a.735-104 Public Welfare Department of Health and Human Services GENERAL ADMINISTRATION STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-104 Advice and guidance. (a) The...

  10. 45 CFR 73a.735-104 - Advice and guidance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 45 Public Welfare 1 2011-10-01 2011-10-01 false Advice and guidance. 73a.735-104 Section 73a.735-104 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-104 Advice and guidance. (a) The...

  11. 45 CFR 73a.735-104 - Advice and guidance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 45 Public Welfare 1 2012-10-01 2012-10-01 false Advice and guidance. 73a.735-104 Section 73a.735-104 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-104 Advice and guidance. (a) The...

  12. Feed intake, digestibility, nitrogen utilization, and body weight change of sheep consuming wheat straw supplemented with local agricultural and agro-industrial by-products.

    PubMed

    Nurfeta, Ajebu

    2010-06-01

    Effects of supplementing sheep consuming wheat straw with local agro-industrial by-products on feed intake, growth, digestibility and nitrogen utilization were determined. Thirty 1-year-old local wethers, with a mean (+/-SD) live weight of 19.8 (+/-1.06) kg, were assigned to five treatments: wheat straw + atella (T1), wheat straw + atella + poultry litter (T2), wheat straw + atella + coffee pulp (T3), wheat straw + atella + coffee pulp + poultry litter (T4), hay + concentrate (T5). A 7-day digestibility experiment and a 112-day growth trial were conducted. Total dry matter (DM) and organic matter (OM) intake as well as body weight gain was similar for all treatments. The highest (P < 0.05) nitrogen (N) intake was in sheep fed T1 and T4 diets, while the lowest was in those fed T2 and T5 diets. Sheep fed T1 and T2 diets had greater (P < 0.05) DM and OM digestibility than those fed T4 and T5 diets. The highest (P < 0.05) digestibility of N was for the T2, T4, and T5 diets, while the lowest was for the T1 diet. The highest N retention was in T4 diet, whereas the lowest was in T3 diet. In conclusion, in urban and peri-urban areas where atella, poultry litter, or coffee pulp are available, smallholder farmers could feed the mixtures as a supplement to straw with a good performance without using concentrate feeds.

  13. 76 FR 72005 - NUREG-1556, Volume 2, Revision 1, “Consolidated Guidance About Materials Licenses Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... COMMISSION NUREG-1556, Volume 2, Revision 1, ``Consolidated Guidance About Materials Licenses Program... Guidance About Materials Licenses: Program- Specific Guidance About Industrial Radiography Licenses, Draft Report for Comment.'' The document has been updated to include safety culture, security of...

  14. Methane production from cattle manure supplemented with crude glycerin from the biodiesel industry in CSTR and IBR.

    PubMed

    Castrillón, L; Fernández-Nava, Y; Ormaechea, P; Marañón, E

    2013-01-01

    The aim of the present research work was to optimise biogas production from cattle manure by adding crude glycerin from the biodiesel industry. For this purpose, 6%v/v crude glycerin (the optimum amount according to previous research) was added to ground manure and the mixture was sonicated to enhance biodegradability prior to anaerobic co-digestion at 55 °C. Two different reactors were used: continuously stirred (CSTR) and induced bed (IBR). The methanol and pure glycerin contents of the crude glycerin used in this study were 5.6% and 49.4% (w/w), respectively. The best results when operating in CSTR were obtained for an organic loading rate (OLR) of 5.4 kg COD/m(3) day, obtaining 53.2m(3) biogas/t wet waste and 80.7% COD removal. When operating in IBR, the best results were obtained for an OLR of 6.44 kg COD/m(3)day, obtaining 89.6% COD removal and a biogas production of 56.5m(3)/t wet waste.

  15. Current Educational Topics, No. I: I. Illiteracy in the United States and in Europe; II. Industrial Supervisors in Georgia; III. New Phases of Education in Buffalo, N. Y.; IV. Juvenile Labor Bureaus and Vocational Guidance in Great Britain; V. The Educational Museum of the St. Louis Public Schools. Bulletin, 1912, No. 11. Whole Number 482

    ERIC Educational Resources Information Center

    Boykin, James C. Ed.

    1912-01-01

    Contained herein are results and report of study on the current educational topics of: (1) Illiteracy in the United states and in Europe; (2) Industrial Supervisors in Georgia; (3) the New Phases of Education in Buffalo, N.Y; (4) Juvenile labor Bureaus and Vocational Guidance in Great Britain; and (5) a review of the Educational Museum of the St.…

  16. Unified powered flight guidance

    NASA Technical Reports Server (NTRS)

    Brand, T. J.; Brown, D. W.; Higgins, J. P.

    1973-01-01

    A complete revision of the orbiter powered flight guidance scheme is presented. A unified approach to powered flight guidance was taken to accommodate all phases of exo-atmospheric orbiter powered flight, from ascent through deorbit. The guidance scheme was changed from the previous modified version of the Lambert Aim Point Maneuver Mode used in Apollo to one that employs linear tangent guidance concepts. This document replaces the previous ascent phase equation document.

  17. 78 FR 23271 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-18

    ... Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for... collection associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome... are indicated to treat hypertension. DATES: Submit either electronic or written comments on...

  18. 75 FR 13547 - Agency Information Collection Activities; Proposed Collection: Comment Request: Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... Collection: Comment Request: Guidance for Industry Entitled Hypertension Indication: Drug Labeling for... on the information collection associated with the guidance ``Hypertension Indication: Drug Labeling... outcome claims for drugs that are indicated to treat hypertension. DATES: Submit written or...

  19. The Dietary Supplement and Health Education Act and supplements: dietary and nutritional supplements need no more regulations.

    PubMed

    Wollschlaeger, Bernd

    2003-01-01

    The Dietary Supplement and Health Education Act (DSHEA) of 1994 was intended to ensure consumer access to safe dietary supplements, e.g., herbs, minerals, and vitamins. It granted the Food and Drug Administration (FDA) considerable enforcement authority to regulate dietary supplement industry. This article discusses relevant components of the DSHEA, explains the division of regulatory responsibilities between the FDA and the Federal Trade Commission (FTC), and refutes the often cited allegation that the herb and dietary supplement industry are unregulated.

  20. Guidance for Industry: Preparation of Premarket Submissions ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... 用乘以消耗因数(CF)求得膳食中食品接触物质的浓度。然后用膳食浓度乘 以每人每天消耗的食品总量求得估计日摄入量。美国食品和药品管理局假设 ...

  1. Guidance for Industry: Food Producers, Processors, and ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... เอกสารไว้สองฉบับประกอบคําแนะนําเรื่องความปลอดภัย ของอาหารชื่อ "Food Producers, Processors, and Transporters: Food security preventive measures ...

  2. Refine Pilot Industry Organizational Relocation Plan Guidance

    DTIC Science & Technology

    1981-10-01

    NGINEERS Paul J. Parham It ’ ,WO,* &,S_71*WA George R. Pedersen for Federal Emergency Management Agency: .. L f C " Washington, D.C. 20472 AN"O 1932 Ij...8217 iv! 2 -3 193 Prepared Under Contract Number EMW-C-0433 A FEMA Review Notice This report has been reviewed in the Federal Emergency Management Agency...and approved for publication. Approval does not signify that the contents necessarily reflect the views and policies of the Federal Emergency Management

  3. Guidance for Industry: Cosmetics Processors and ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    اﻟﻮﻗﺎﺋﻴﺔ ﺤﻤﺎﻳﺔ إرﺷﺎدات ﻟﺘﺪاﺑﻴﺮ اﻟ : إرﺷﺎدات ﻟﻠﺼﻨﺎﻋﺔ ﻟﻬﻴﺌﺎت ﻣﻌﺎﻟﺠﺔ وﻧﻘﻞ ﻣﻨﺘﺠﺎت اﻟﺘﺠﻤﻴﻞ ﺤﺘﻮي ﻋﻠﻰ ﺗﻮﺻﻴﺎت ﻏﻴﺮ ﻣُﻠﺰﻣﺔ ﺗ 2007 أآﺘﻮﺑﺮ / ؛ ﺗﻤﺖ ﻣﺮاﺟﻌﺘﻬﺎ ﻓﻲ ﺗﺸﺮﻳﻦ اﻷول 2003 ﻧﻮﻓﻤﺒﺮ / ﺗﺸﺮﻳﻦ اﻟﺜﺎﻧﻲ ...

  4. Optical guidance system for industrial vehicles

    DOEpatents

    Dyer, Robert D.; Eschbach, Eugene A.; Griffin, Jeffrey W.; Lind, Michael A.; Buck, Erville C.; Buck, Roger L.

    1990-01-01

    An automatically guided vehicle system for steering a vehicle. Optical sensing detects an image of a segment of track mounted above the path of the vehicle. Electrical signals corresponding to the position of the track are generated. A control circuit then converts these signals into movements for the steering of the vehicle.

  5. HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION

    SciTech Connect

    OHARA,J.; BROWN,W.; STUBLER,W.; HIGGINS,J.; WACHTEL,J.; PERSENSKY,J.J.

    2000-07-30

    The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ``Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1.

  6. Industrial Arts Student Organizations.

    ERIC Educational Resources Information Center

    Dixon, James D.

    1980-01-01

    A national survey attempted to identify (1) the number and size of student organizations in industrial arts, (2) the perceptions that principals and guidance personnel had of the student organizations, and (3) the activities offered to student organization members. (LRA)

  7. College Guidance Aspects of the Educational Opportunity Program.

    ERIC Educational Resources Information Center

    Bell, David G.

    San Francisco Valley State College began laying the groundwork for the admission of some 225 educationally and economically disadvantaged students a year ago. The first step was to undo previous guidance, which had guided males into industrial arts areas and females into bedmaking. A new approach was needed by guidance personnel. Through…

  8. A Rationale for Guidance in the Elementary School.

    ERIC Educational Resources Information Center

    Witmer, J. M.

    The growth of guidance programs in elementary schools has been rapid in recent years as industrialization, urbanization, population growth and mobility, and occupational specialization have called for individualized education beginning in the early years. This paper discusses (a) the relationship of elementary guidance to instruction, with…

  9. Corporate information management guidance

    SciTech Connect

    1997-08-01

    At the request of the Department of Energy`s (DOE) Information Management (IM) Council, IM representatives from nearly all Headquarters (HQ) organizations have been meeting over the past year as the Corporate Guidance Group (CGG) to develop useful and sound corporate information management (IM) guidance. The ability of the Department`s IM community to develop such unified guidance continues to be critical to the success of future Departmental IM planning processes and the establishment of a well-coordinated IM environment between Headquarters and field organizations. This report, with 26 specific corporate IM guidance items documented and unanimously agreed to, as well as 12 items recommended for further development and 3 items deferred for future consideration, represents a highly successful effort by the IM community. The effort has proven that the diverse DOE organizations can put aside individual preferences and work together towards a common and mutually beneficial goal. In examining most areas and issues associated with information management in the Department, they have developed specific, far-reaching, and useful guidance. The IM representatives recommend that the documented guidance items provided in this report and approved by the DOE IM Council be followed by all IM organizations. The representatives also strongly recommend that the guidance process developed by the CGG be the single process for developing corporate IM guidance.

  10. Aiding Vertical Guidance Understanding

    NASA Technical Reports Server (NTRS)

    Feary, Michael; McCrobie, Daniel; Alkin, Martin; Sherry, Lance; Polson, Peter; Palmer, Everett; McQuinn, Noreen

    1998-01-01

    A two-part study was conducted to evaluate modern flight deck automation and interfaces. In the first part, a survey was performed to validate the existence of automation surprises with current pilots. Results indicated that pilots were often surprised by the behavior of the automation. There were several surprises that were reported more frequently than others. An experimental study was then performed to evaluate (1) the reduction of automation surprises through training specifically for the vertical guidance logic, and (2) a new display that describes the flight guidance in terms of aircraft behaviors instead of control modes. The study was performed in a simulator that was used to run a complete flight with actual airline pilots. Three groups were used to evaluate the guidance display and training. In the training, condition, participants went through a training program for vertical guidance before flying the simulation. In the display condition, participants ran through the same training program and then flew the experimental scenario with the new Guidance-Flight Mode Annunciator (G-FMA). Results showed improved pilot performance when given training specifically for the vertical guidance logic and greater improvements when given the training and the new G-FMA. Using actual behavior of the avionics to design pilot training and FMA is feasible, and when the automated vertical guidance mode of the Flight Management System is engaged, the display of the guidance mode and targets yields improved pilot performance.

  11. Ascent Guidance Comparisons

    NASA Technical Reports Server (NTRS)

    Hanson, John M.; Shrader, M. Wade; Cruzen, Craig A.

    1995-01-01

    This paper contains results from ascent guidance studies conducted at the NASA Marshall Space Flight Center. The studies include investigation of different guidance schemes for a variety of potential launch vehicles. Criteria of a successful ascent guidance scheme are low operations cost, satisfaction of load indicator constraints, and maximization of performance. Results show that open-loop designs as a function of altitude or velocity are preferable to designs that are functions of time. Optimized open-loop trajectories can increase performance while maintaining load indicators within limits. Closed-loop atmospheric schemes that involve linear tangent steering or feedback of velocity terms for trajectory modification did not yield any improvement. Early release of vacuum closed-loop guidance, including use during solid rocket booster operation, yields some improvements. Evaluation of a closed-loop optimization scheme for flying through the atmosphere shows no advantages over open-loop optimization. Dispersion study results for several potential guidance schemes and launch vehicles are included in the paper and are not a discriminator between guidance schemes. The primary cost driver is mission operations philosophy, not choice of guidance scheme. More autonomous guidance schemes can help in movement towards a philosophy that would reduce operations costs.

  12. Geographical and Occupational Mobility of Workers in the Aircraft and Electronics Industries, Regional Trade Union Seminar (Paris, 21st-22nd September, 1966). Final Report and Supplement.

    ERIC Educational Resources Information Center

    Organisation for Economic Cooperation and Development, Paris (France). Social Affairs Div.

    The trade unions in the European aerospace and electronics industries have become concerned with the sweeping and rapid economic and technical changes taking place in the industries. This seminar enabled trade union representatives from Belgium, France, the Netherlands, and the United Kingdom aerospace industry and the electronics sector working…

  13. Shuttle entry guidance revisited

    NASA Technical Reports Server (NTRS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  14. Shuttle entry guidance

    NASA Technical Reports Server (NTRS)

    Harpold, J. C.; Graves, C. A., Jr.

    1978-01-01

    This paper describes the design of the entry guidance for the Space Shuttle Orbiter. This guidance provides the steering commands for trajectory control from initial penetration of the earth's atmosphere until the terminal area guidance is activated at an earth-relative speed of 2500 fps. At this point, the Orbiter is at a distance of about 50 nmi from the runway threshold, and at an altitude of about 80,000 ft. The entry guidance design is based on an analytic solution of the equations of motion defining the drag acceleration profile that meets the terminal criteria of the entry flight while maintaining the flight within systems and operational constraints. Guidance commands, which are based on a control law that ensures damping of oscillatory type trajectory motion, are computed to steer the Orbiter to this drag acceleration profile.

  15. Shuttle entry guidance revisited

    NASA Astrophysics Data System (ADS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-08-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  16. Shuttle entry guidance revisited

    NASA Technical Reports Server (NTRS)

    Mease, Kenneth D.; Kremer, Jean-Paul

    1992-01-01

    The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

  17. RMP Guidance for Propane Storage Facilities - Main Text

    EPA Pesticide Factsheets

    This document is intended as comprehensive Risk Management Program guidance for larger propane storage or distribution facilities who already comply with propane industry standards. Includes sample RMP, and release calculations.

  18. Federal Guidance for Radiation Protection

    EPA Pesticide Factsheets

    EPA produces federal guidance technical reports, which standardize dose and risk assessment and issues radiation protection guidance to federal agencies. This page provides links to federal guidance policy recommendations and technical reports.

  19. "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and for the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use;'" availability. Food and Drug Administration, HHS. Notice.

    PubMed

    1999-05-10

    The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h, 'Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use.'" This guidance document is intended to assist applicants in the preparation of the content and format of the chemistry, manufacturing, and controls (CMC) section and the establishment description section of a biologics license application (BLA), revised Form FDA 356h, for human blood and blood components intended for transfusion or for further manufacture. In addition, this guidance document provides assistance for the completion of the BLA. This action is part of FDA's continuing effort to achieve the objectives of the President's "Reinventing Government" initiatives and the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to reduce unnecessary burdens for industry without diminishing public health protection.

  20. Supplementing national menu labeling.

    PubMed

    Hodge, James G; White, Lexi C

    2012-12-01

    The US Food and Drug Administration's forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants' menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., "heart-healthy" graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence.

  1. EPA Policy and Guidance

    EPA Pesticide Factsheets

    The policy establishes the principles for accessible Electronic and Information Technology (EIT) and complying with Section 508 requirements. The guidance defines EIT and the technical and functional performance criteria necessary for compliance.

  2. Pollinator Risk Assessment Guidance

    EPA Pesticide Factsheets

    This Guidance is part of a long-term strategy to advance the science of assessing the risks posed by pesticides to honey bees, giving risk managers the means to further improve pollinator protection in our regulatory decisions.

  3. Vitamin supplementation in pregnancy.

    PubMed

    2016-07-01

    Ensuring that a woman is well-nourished, both before and during pregnancy, is crucial for the health of the woman and that of the unborn child.(1) Maternal deficiency in key nutrients has been linked to pre-eclampsia, restricted fetal growth, neural tube defects, skeletal deformity and low birth weight.(1,2) Many nutritional supplements containing vitamins, minerals and other micronutrients are heavily marketed to women for all stages of pregnancy. However, much of the evidence for vitamin supplementation in pregnancy comes from studies carried out in low-income countries,(3) where women are more likely to be undernourished or malnourished than within the UK population. The challenges lie in knowing which supplements are beneficial and in improving uptake among those at most need. Here we summarise current UK guidance for vitamin supplementation in pregnancy and review the evidence behind it. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. Dietary supplements.

    PubMed

    Massey, Patrick B

    2002-01-01

    The amount of published information on dietary supplements mushroomed in the 1990s. In fewer than 5 years, publications increased at least 100-fold in the medical literature alone. Dietary supplements are an uncharted territory that warrants complete and accurate exploration. One should not be surprised that disease and illness may respond to dietary supplements. Nutrition is the foundation to good health, and dietary supplements may prove to be some of the most powerful medicines ever discovered. An especially exciting discovery is that dietary supplements may enhance the effects of specific drugs. This discovery may lead to more effective and safer protocols for the treatment of cancer, heart and lung disease, and a host of chronic medical conditions. Information about dietary supplements is becoming more common in the popular medical literature and is creating increased curiosity and an increased awareness. The explosion of the dietary supplement market is compelling physicians to become aware of dietary supplements. Whether or not they are used in clinical practice is a decision for the individual physician. Given the increasing number of patients who are using dietary supplements, however, it is imperative that physicians have a good understanding of this topic. Considering the increasing complexity and magnitude of this topic, physician specialization may be essential. There are many good reference books, review articles, and internet sites on specific supplements that probably should be part of every physician's reference library. The accompanying box provides a brief list of such sources.

  5. Comprehensive Guidance Programs That Work.

    ERIC Educational Resources Information Center

    Gysbers, Norman C.; And Others

    This monograph describes how the comprehensive guidance model is transforming elementary-secondary school guidance and counseling programs in schools across the country. It incorporates the ideas and experiences of 12 guidance program developers in the actual use of the comprehensive guidance model in diverse school and cultural settings. The book…

  6. Adult Education: Participation, Guidance and Progression. Interchange No. 29.

    ERIC Educational Resources Information Center

    Munn, Pamela

    The Scottish Office Education Department commissioned four interlinked studies of adult education between October 1991 and November 1993. The studies were designed to do the following: provide an overview of provision, progression, and guidance opportunities for adult learners in Scotland; supplement this overview with in-depth pictures of…

  7. Anticipatory guidance through DVD.

    PubMed

    Franz, Sandra; McMahon, Pamela M; Calongne, Laurinda; Steele-Moses, Susan K

    2014-03-01

    The major purpose of the study was to determine if a 5-minute DVD is an effective method for communicating anticipatory guidance to parents at their child's 4-month well-child visit. A total of 84 caregivers were randomly assigned to receive anticipatory guidance through standard care (written anticipatory guidance handout and free talk) or DVD (DVD format + standard care). Participants completed a brief questionnaire immediately before and after their visit. As anticipated, knowledge scores improved significantly from pre-test to post-test. There was also a significant interaction between format used for anticipatory guidance and time. Specifically, there was greater improvement in knowledge over time for parents in the DVD group as compared with the standard care group. Additionally, the mean knowledge level of those in the DVD group as compared with those in the standard care group trended toward significance. Finally, visit length was shortened by nearly 3 minutes in the DVD group, and close to 100% of all respondents, regardless of anticipatory guidance format, indicated that they were very satisfied with their visit and amount of information learned.

  8. INTERIM EPA GUIDANCE FOR GEOSPATIAL-RELATED QUALITY ASSURANCE PROJECT PLANS

    EPA Science Inventory

    This guidance supplements EPA Guidance for Quality,Assurance Project Plans (EPA QA/G-5), in that the focus here is on collection and use of geospatial rather than other environmental data (e.g., strictly chemical or biological data), including unique aspects of data storage, retr...

  9. INTERIM EPA GUIDANCE FOR GEOSPATIAL-RELATED QUALITY ASSURANCE PROJECT PLANS

    EPA Science Inventory

    This guidance supplements EPA Guidance for Quality,Assurance Project Plans (EPA QA/G-5), in that the focus here is on collection and use of geospatial rather than other environmental data (e.g., strictly chemical or biological data), including unique aspects of data storage, retr...

  10. Guidance publication proves timely.

    PubMed

    Baillie, Jonathan

    2011-05-01

    The importance of properly identifying, assessing, and managing risk in all areas of engineering practice, the fact that genuine innovation is almost impossible without a certain element of risk-taking, and the need to acknowledge and respond to public concerns, however much some may be ill-founded, over the risks inherent in technological and engineering advances, are highlighted in a new risk guidance document, Guidance on Risk for the Engineering Profession, published by the Engineering Council in London last month. HEJ editor Jonathan Baillie reports.

  11. Annual Compliance Certification Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the Title V air operating permit regulations. This document is part of the Title V Policy and Guidance Database available at www2.epa.gov/title-v-operating-permits/title-v-operating-permit-policy-and-guidance-document-index. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  12. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country.

    PubMed

    Terrin, Gianluca; Berni Canani, Roberto; Passariello, Annalisa; Messina, Francesco; Conti, Maria Giulia; Caoci, Stefano; Smaldore, Antonella; Bertino, Enrico; De Curtis, Mario

    2013-12-01

    Zinc plays a pivotal role in the pathogenesis of many diseases and in body growth. Preterm neonates have high zinc requirements. The objective of the study was to investigate the efficacy of zinc supplementation in reducing morbidity and mortality in preterm neonates and to promote growth. This was a prospective, double-blind, randomized controlled study of very-low-birth-weight preterm neonates randomly allocated on the seventh day of life to receive (zinc group) or not receive (control group) oral zinc supplementation. Total prescribed zinc intake ranged from 9.7 to 10.7 mg/d in the zinc group and from 1.3 to 1.4 mg/d in the placebo control group. The main endpoint was the rate of neonates with ≥ 1 of the following morbidities: late-onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, periventricular leucomalacia, and retinopathy of prematurity. Secondary outcomes were mortality and body growth. We enrolled 97 neonates in the zinc group and 96 in the control group. Morbidities were significantly lower in the zinc group (26.8% compared with 41.7%; P = 0.030). The occurrence of necrotizing enterocolitis was significantly higher in the control group (6.3% compared with 0%; P = 0.014). Mortality risk was higher in the placebo control group (RR: 2.37; 95% CI: 1.08, 5.18; P = 0.006). Daily weight gain was similar in the zinc (18.2 ± 5.6 g · kg⁻¹ · d⁻¹) and control (17.0 ± 8.7 g · kg⁻¹ · d⁻¹) groups (P = 0.478). Oral zinc supplementation given at high doses reduces morbidities and mortality in preterm neonates. This trial was registered in the Australian New Zealand Clinical Trial Register as ACTRN12612000823875.

  13. 76 FR 20679 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation... drug approvals or biologics licenses for fast track designation as provided in the guidance for industry on fast track drug development programs. DATES: Submit either electronic or written comments on...

  14. Dietary Supplements

    MedlinePlus

    ... other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do. Some supplements can play an important role in health. For example, calcium and vitamin D are important for keeping bones ...

  15. Guidance on lobbying restrictions

    EPA Pesticide Factsheets

    The purpose of this guidance is to remind nonprofit organizations, universities, and other non-government recipients of EPA grants that, with very limited exceptions, you may not use Federal grant funds or cost-sharing funds to conduct lobbying activities.

  16. Vocational Guidance for Everyone

    ERIC Educational Resources Information Center

    Holland, John L.

    1974-01-01

    Describes some of the current problems of vocational guidance, summarizes relevant knowledge and theory in the field, and offers some practical plans for a coordinated, theoretically compatible group of vocational programs, services, and experiences for a high school. (Author/JM)

  17. PIV Logon Configuration Guidance

    SciTech Connect

    Lee, Glen Alan

    2016-03-04

    This document details the configurations and enhancements implemented to support the usage of federal Personal Identity Verification (PIV) Card for logon on unclassified networks. The guidance is a reference implementation of the configurations and enhancements deployed at the Los Alamos National Laboratory (LANL) by Network and Infrastructure Engineering – Core Services (NIE-CS).

  18. Click Here for Guidance.

    ERIC Educational Resources Information Center

    Trotter, Andrew

    2003-01-01

    School guidance counselors can use computers to enhance students' abilities to get into top colleges. One high school counselor has established a Web site with online forms requesting that transcripts be sent to colleges and search tools for finding financial assistance; an Internet discussion forum for seniors to discuss college admissions; and…

  19. Vocational Development and Guidance.

    ERIC Educational Resources Information Center

    Tennyson, W. Wesley; And Others

    The vocational education volume considers questions of career development, the role of guidance in the school, vocational training, the relation of self-concept to vocational choice, and occupational information. Twenty-six papers deal with theories of vocational behavior, the success of vocational education programs, and testing information.…

  20. Regulatory guidance document

    SciTech Connect

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

  1. The Counseling & Guidance Curriculum.

    ERIC Educational Resources Information Center

    Ediger, Marlow

    Counseling and guidance services are vital in any school curriculum. Counselors may themselves be dealing with students of diverse abilities and handicaps. Counselors may have to work with students affected by drug addiction, fetal alcohol syndrome, homelessness, poverty, Acquired Immune Deficiency Syndrome (AIDS) and divorce. Students may present…

  2. Foundations of Career Guidance.

    ERIC Educational Resources Information Center

    Ruff, Eldon E.

    The paper traces the evolution of career guidance from 1909 to the present. The predominant views before 1950 were almost entirely nondevelopmental, but in response to questions raised at a series of major national conferences in the 1960's and the national impact of the career education concept, the 1970's have seen a flurry of writings and…

  3. Guidelines for Guidance Services.

    ERIC Educational Resources Information Center

    Manitoba Dept. of Education and Training, Winnipeg.

    The purpose of this booklet is to provide direction and assistance to school divisions as they develop responsive, effective, and accountable guidance services and programs at the school level. The guidelines presented provide a broad conceptual framework of definitions and goals and outline expectations for service standards. Models and…

  4. Vocational Development and Guidance.

    ERIC Educational Resources Information Center

    Tennyson, W. Wesley; And Others

    The vocational education volume considers questions of career development, the role of guidance in the school, vocational training, the relation of self-concept to vocational choice, and occupational information. Twenty-six papers deal with theories of vocational behavior, the success of vocational education programs, and testing information.…

  5. Quality in Careers Guidance.

    ERIC Educational Resources Information Center

    Plant, Peter

    This paper examines quality issues in career guidance, counseling, and information services in Europe and elsewhere from a range of different perspectives related to economic, ethical, and/or effectiveness criteria. Selected examples from the European Union member states, Canada, and the United States are used to illustrate how quality is…

  6. Secondary Guidance Manual.

    ERIC Educational Resources Information Center

    Bennett, Charlotte; And Others

    This manual outlines the philosophy and organization of the secondary counseling program of the Moore Public Schools (Oklahoma). The school district has made efforts in counseling American Indian students. This document presents the goals and objectives for secondary guidance programs that provide such services as orientation, information,…

  7. The National Nanotechnology Initiative. Research and Development Leading to a Revolution in Technology ad Industry. Supplement to the President’s 2009 Budget

    DTIC Science & Technology

    2008-09-30

    Kariampuzha Bureau of Industry and Security (BIS/DOC) Kelly Gardner Consumer Product Safety Commission (CPSC) Mary Ann Danello Treye A...and Security (BIS, Department of Commerce) Consumer Product Safety Commission (CPSC) Department of Education (DOEd) Department of Labor (DOL...Department of the Interior) U.S. Patent and Trademark Office (USPTO, Department of Commerce)  Created a culture of interdisciplinary research

  8. Environmental impact statement/environmental impact report for the proposed marathon industrial/commercial business center tract 5167, Hayward California. Supplement. Draft report

    SciTech Connect

    Not Available

    1987-06-01

    Joint State Federal environmental impact document concerning a regulatory permit application by Marathon U.S. Realties, Inc. under Section 10 of the River and Harbor Act of 1899 and Section 404 of the Clean Water Act. The proposed project involves a nonwater-oriented industrial, business development with public utilities, and habitat mitigation.

  9. Supplements of interest for sport-related injury and sources of supplement information among college athletes.

    PubMed

    Malinauskas, B M; Overton, R F; Carraway, V G; Cash, B C

    2007-01-01

    This study examined incidence of sport-related injury, interest in supplements to treat injury, and sources of supplement information among 145 college athletes (89 males, 56 females). A survey was used to assess sport-related injuries, interest in three categories of supplements to treat injury, and sources of supplement information among college athletes who used athletic training room and weight training facilities. Pearson chi2 was used to evaluate differences in frequency distribution of responses by sex. Sport-related injuries were experienced by 91% of athletes (93% males, 88% females). Overall, 17% of participants were interested in supplements to improve circulation, 34% for joint and soft tissue repair, and 22% to reduce inflammation. Significant sex differences were not found for any supplements in any categories evaluated. Males were more likely than females to rely on strength coaches (37%, 20%) for supplement information. Athletic trainers (71% of athletes), coaches (60%), and physicians (41%) were the primary professionals, and the internet (79%), magazines (68%), and television (52%) the most popular sources of media for supplement information. The majority of athletes experience injury during their college athletic career and 17% to 34% express an interest in supplements for injury treatment. Athletes would benefit from scientifically sound guidance to identify appropriate supplements for injury treatment and internet sites for supplement information. Future research should identify if athletes are more likely to increase supplement use when they are injured or if supplement use is more prevalent among athletes who are prone to injury.

  10. Dietary supplements for aquatic sports.

    PubMed

    Derave, Wim; Tipton, Kevin D

    2014-08-01

    Many athletes use dietary supplements, with use more prevalent among those competing at the highest level. Supplements are often self-prescribed, and their use is likely to be based on an inadequate understanding of the issues at stake. Supplementation with essential micronutrients may be useful when a diagnosed deficiency cannot be promptly and effectively corrected with food-based dietary solutions. When used in high doses, some supplements may do more harm than good: Iron supplementation, for example, is potentially harmful. There is good evidence from laboratory studies and some evidence from field studies to support health or performance benefits from appropriate use of a few supplements. The available evidence from studies of aquatic sports is small and is often contradictory. Evidence from elite performers is almost entirely absent, but some athletes may benefit from informed use of creatine, caffeine, and buffering agents. Poor quality assurance in some parts of the dietary supplements industry raises concerns about the safety of some products. Some do not contain the active ingredients listed on the label, and some contain toxic substances, including prescription drugs, that can cause health problems. Some supplements contain compounds that will cause an athlete to fail a doping test. Supplement quality assurance programs can reduce, but not entirely eliminate, this risk.

  11. Ethical guidance in the era of managed care: an analysis of the American College of Healthcare Executives' Code of Ethics.

    PubMed

    Higgins, W

    2000-01-01

    Market competition and the rise of managed care are transforming the healthcare system from a physician-dominated cottage industry into a manager-dominated corporate enterprise. The managed care revolution is also undermining the safe-guards offered by medical ethics and raising serious public concerns. These trends highlight the growing importance of ethical standards for managers. The most comprehensive ethical guidance for health service managers is contained in the American College of Healthcare Executives' (ACHE) Code of Ethics. An analysis of the ACHE Code suggests that it does not adequately address several ethical concerns associated with managed care. The ACHE may wish to develop a supplemental statement regarding ethical issues in managed care. A supplemental statement that provides more specific guidance in the areas of financial incentives to reduce utilization, social mission, consumer/patient information, and the health service manager's responsibility to patients could be extremely valuable in today's complex and rapidly changing environment. More specific ethical guidelines would not ensure individual or organizational compliance. However, they would provide professional standards that could guide decision making and help managers evaluate performance in managed care settings.

  12. Nepali Supplements.

    ERIC Educational Resources Information Center

    Peace Corps, Washington, DC.

    This volume is intended as a supplement to Nepali language instruction. It contains songs, numerals, dialogues in Devanagari script, a Nepali-English, English-Nepali glossary, and an English-Nepali surveyor technical glossary. (AM)

  13. Calcium supplements

    MedlinePlus

    ... TYPES OF CALCIUM SUPPLEMENTS Forms of calcium include: Calcium carbonate: Over-the-counter (OTC) antacid products, such as Tums and Rolaids, contain calcium carbonate. These sources of calcium do not cost much. ...

  14. Supplementary Guidance for Conducting Health Risk ...

    EPA Pesticide Factsheets

    This document is a supplement to the EPA Guidelines for the Health Risk Assessment of Chemical Mixtures of 1986. The 1986 Guidelines represent the Agency's science policy and are a procedural guide for evaluating data on the health risks from exposures to chemical mixtures. The emphasis is on dose response and risk characterization. The principles and concepts put forth in the Guidelines remain in effect. However, where the Guidelines describe broad principles and include few specific procedures, the present guidance is a supplement that is intended to provide more detail on these principles and their applications.After an overview of the background and scope, this supplementary guidance puts forth the risk assessment paradigm for mixtures. This paradigm begins with problem formulation, then briefly discusses hazard identification, dose-response assessment, exposure, and risk characterization. The document is organized according to the type of data available. Procedures are described for assessment using data on the mixture of concern, data on a toxicologically similar mixture, and data on the mixture component chemicals. The state of the science varies dramatically for these three approaches. The whole-mixture procedures are most advanced for assessing carcinogenic risk, mainly because of the long use of in vitro mutagenicity tests to indicate carcinogenic potency. In vitro test procedures for noncancer endpoints are still in the pionee

  15. Vocational Guidance and Human Development.

    ERIC Educational Resources Information Center

    Herr, Edwin L., Ed.

    New knowledge and practices in the area of vocational guidance and human growth and development that have occurred since 1964 as well as future directions for guidance, both nationally and internationally, are covered in this second volume of a decennial volume series sponsored by the National Vocational Guidance Association to up-date the…

  16. When Instructional Guidance is Needed

    ERIC Educational Resources Information Center

    Chen, Ouhao; Kalyuga, Slava; Sweller, John

    2016-01-01

    Studying worked examples providing problem solutions to learners usually leads to better test performance than solving the equivalent problems without guidance, demonstrating the worked-example effect. The generation effect occurs when learners who generate answers without guidance learn better than those who read answers that provide guidance.…

  17. When Instructional Guidance is Needed

    ERIC Educational Resources Information Center

    Chen, Ouhao; Kalyuga, Slava; Sweller, John

    2016-01-01

    Studying worked examples providing problem solutions to learners usually leads to better test performance than solving the equivalent problems without guidance, demonstrating the worked-example effect. The generation effect occurs when learners who generate answers without guidance learn better than those who read answers that provide guidance.…

  18. Employee commute options guidance

    SciTech Connect

    Not Available

    1992-12-01

    The Clean Air Act Amendments of 1990 (CAAA) require severe and extreme ozone nonattainment areas and serious carbon monoxide nonattainment areas to establish programs aimed at reducing commute trips to the worksites of large employers. The concerns that lead to the inclusion of the Employee Commute Options (ECO) provision in the Act are that more people are driving than ever before and they are driving longer distances. The purpose of the guidance is to inform the affected State and local jurisdictions of the Clean Air Act requirement, to provide guidance on preparing an approvable State Implementation Plan (SIP) revision, and to discuss various approaches which may help areas achieve Clean Air Act targets through implementation strategies that are the least burdensome and costly to both affected employers and employees.

  19. Creatine supplementation.

    PubMed

    Hall, Matthew; Trojian, Thomas H

    2013-01-01

    Creatine monohydrate is a dietary supplement that increases muscle performance in short-duration, high-intensity resistance exercises, which rely on the phosphocreatine shuttle for adenosine triphosphate. The effective dosing for creatine supplementation includes loading with 0.3 g·kg·d for 5 to 7 days, followed by maintenance dosing at 0.03 g·kg·d most commonly for 4 to 6 wk. However loading doses are not necessary to increase the intramuscular stores of creatine. Creatine monohydrate is the most studied; other forms such as creatine ethyl ester have not shown added benefits. Creatine is a relatively safe supplement with few adverse effects reported. The most common adverse effect is transient water retention in the early stages of supplementation. When combined with other supplements or taken at higher than recommended doses for several months, there have been cases of liver and renal complications with creatine. Further studies are needed to evaluate the remote and potential future adverse effects from prolonged creatine supplementation.

  20. Environmental guidance regulatory bulletin

    SciTech Connect

    1997-01-31

    This document describes the background on expanding public participation in the Resource Conservation and Recovery Act and DOE`s response. The bulletin also describes the changes made by the final rule to existing regulations, guidance provided by EPA in the preamble and in the revised RCRA Public Participation Manual, the relationship between public participation and environmental justice, and DOE`s recent public participation and environmental justice initiatives.

  1. Probabilistic Extra-Tropical Storm Surge Guidance

    NASA Astrophysics Data System (ADS)

    Liu, H.; Taylor, A. A.

    2016-02-01

    The National Weather Service's (NWS) Meteorological Development Laboratory (MDL) developed the Extra-Tropical Storm Surge (ETSS) model in 1995 by applying the Sea Lake and Overland Surges from Hurricanes (SLOSH) model to Extra-Tropical storms. Over the last two years, MDL, with Hurricane Sandy Supplemental funding, has enhanced the ETSS model to meet the anticipated requirements of a potential extra-tropical storm surge watch. The latest such enhancement, implemented in October 2015, enabled ETSS to operationally provide deterministic inundation guidance four times a day based on storm surge and tide in all of its model domains. Storm surge guidance has various uncertainties associated with it such as (a) the atmospheric forcing (wind speed, wind direction and atmospheric pressure), (b) the initial water conditions, (c) the included physical processes, (d) the numerical scheme, etc. While some of these can be reduced by enhancing the storm surge model, others, such as atmospheric forcing, rely on external inputs. Uncertainty in atmospheric forcing is particularly challenging as it is the main source of uncertainty in storm surge based inundation guidance. Ensemble techniques are necessary to produce quantitative estimates of storm surge based inundation risk. To create such an ensemble technique, MDL has developed the Probabilistic Extra-Tropical Storm Surge (PETSS) model by using atmospheric inputs from the 21 Global Ensemble Forecast System ensemble members. This paper describes the details of this effort and provides statistical verification of the PETSS products for several case studies.

  2. GUIDE TO INDUSTRIAL ASSESSMENTS FOR POLLUTION PREVENTION AND ENERGY EFFICIENCY

    EPA Science Inventory

    This document presents an overview of industrial assessments and the general framework for conducting an assessment. It describes combined assessments for pollution prevention and energy, "industrial assessments," providing guidance to those performing assessments at industrial o...

  3. GUIDE TO INDUSTRIAL ASSESSMENTS FOR POLLUTION PREVENTION AND ENERGY EFFICIENCY

    EPA Science Inventory

    This document presents an overview of industrial assessments and the general framework for conducting an assessment. It describes combined assessments for pollution prevention and energy, "industrial assessments," providing guidance to those performing assessments at industrial o...

  4. Shuttle ascent guidance and control.

    NASA Technical Reports Server (NTRS)

    Lovingood, J. A.; Blair, J. C.; Geissler, E. O.

    1972-01-01

    The requirements of a unified optimal guidance scheme are discussed, giving attention to a general formulation, aspects of self-targeting, problems of optimum guidance within the atmosphere, and a unified concept for all flight phases. Since no previous guidance scheme meets these requirements, the shuttle demands a fundamentally new approach. A new unified optimal guidance scheme, called Mascot, was developed. The capabilities of Mascot include the real-time solution of general trajectory-optimization problems and the unification of guidance for all flight phases.

  5. Guidance for Using Formal Methods in a Certification Context

    NASA Technical Reports Server (NTRS)

    Brown, Duncan; Delseny, Herve; Hayhurst, Kelly; Wiels, Virginie

    2010-01-01

    This paper discusses some of the challenges to using formal methods in a certification context and describes the effort by the Formal Methods Subgroup of RTCA SC-205/EUROCAE WG-71 to propose guidance to make the use of formal methods a recognized approach. This guidance, expected to take the form of a Formal Methods Technical Supplement to DO-178C/ED-12C, is described, including the activities that are needed when using formal methods, new or modified objectives with respect to the core DO-178C/ED-12C document, and evidence needed for meeting those objectives.

  6. International Conference on Harmonisation; guidance on Q10 Pharmaceutical Quality System; availability. Notice.

    PubMed

    2009-04-08

    The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q10 Pharmaceutical Quality System." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System. The guidance is intended to provide a comprehensive approach to an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH guidances on "Q8 Pharmaceutical Development" and "Q9 Quality Risk Management."

  7. Development of a Naval Supply Systems Command Acquisition Supplement - A Business Practice Improvement

    DTIC Science & Technology

    2015-09-01

    SUPPLEMENT — A BUSINESS PRACTICE IMPROVEMENT September 2015 By: Annette Stevenson Advisors: Charles K. Pickar Clarence M. Belton...COMMAND ACQUISITION SUPPLEMENT —A BUSINESS PRACTICE IMPROVEMENT 5. FUNDING NUMBERS 6. AUTHOR(S) Stevenson, Annette 7. PERFORMING ORGANIZATION NAME(S) AND...its contracting workforce. NAVSUP’s supplemental guidance to the Federal Acquisition Regulation (FAR), Defense Federal Acquisition Regulation

  8. PSD Increment Consumption Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  9. Hypervelocity Orbital Intercept Guidance

    DTIC Science & Technology

    1988-04-14

    Professor Charles E. Fosha, Jr. Terminal guidance of a hypervelocity exo-atmospheric orbital interceptor with free end-time is examined. The pursuer is...stochastic nonlinear systems with free end-time was developed by Tse and 29 Bar-Shalom [5]. This method differs from the optimal control formulation...Vol. AC-18, No. 2, April 1973, pp. 98-108. 5. Tse, E., and Y. Bar-Shalom, "Adaptive Dual Control For Stochastic Nonlinear Systems with Free End- Time

  10. Guidance on Determining LAER

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  11. PSD Guidance Document

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  12. NSR Program Transitional Guidance

    EPA Pesticide Factsheets

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  13. Sports Supplements

    MedlinePlus

    ... For example, teen athletes who use medications like human growth hormone (hGH) that haven't been prescribed for them can have problems with growth, and may develop diabetes and heart problems. Lots of sports organizations have developed policies on sports supplements. The National ...

  14. Weight Loss Nutritional Supplements

    NASA Astrophysics Data System (ADS)

    Eckerson, Joan M.

    Obesity has reached what may be considered epidemic proportions in the United States, not only for adults but for children. Because of the medical implications and health care costs associated with obesity, as well as the negative social and psychological impacts, many individuals turn to nonprescription nutritional weight loss supplements hoping for a quick fix, and the weight loss industry has responded by offering a variety of products that generates billions of dollars each year in sales. Most nutritional weight loss supplements are purported to work by increasing energy expenditure, modulating carbohydrate or fat metabolism, increasing satiety, inducing diuresis, or blocking fat absorption. To review the literally hundreds of nutritional weight loss supplements available on the market today is well beyond the scope of this chapter. Therefore, several of the most commonly used supplements were selected for critical review, and practical recommendations are provided based on the findings of well controlled, randomized clinical trials that examined their efficacy. In most cases, the nutritional supplements reviewed either elicited no meaningful effect or resulted in changes in body weight and composition that are similar to what occurs through a restricted diet and exercise program. Although there is some evidence to suggest that herbal forms of ephedrine, such as ma huang, combined with caffeine or caffeine and aspirin (i.e., ECA stack) is effective for inducing moderate weight loss in overweight adults, because of the recent ban on ephedra manufacturers must now use ephedra-free ingredients, such as bitter orange, which do not appear to be as effective. The dietary fiber, glucomannan, also appears to hold some promise as a possible treatment for weight loss, but other related forms of dietary fiber, including guar gum and psyllium, are ineffective.

  15. Comprehensive Career Guidance. Career Guidance Curriculum. Staff Development K-6.

    ERIC Educational Resources Information Center

    Straub, Vicki W.; Moore, Earl J.

    One of six staff development training manuals for career guidance infusion in the elementary school curriculum (K-6), this manual focuses on the curriculum design of a comprehensive career guidance program. It is divided into the following five major sections: (1) a list of the major goals and activities covered in the manual; (2) an overview…

  16. From Industry to Assignment: Developing Curriculum through Industry Liaison.

    ERIC Educational Resources Information Center

    Scribner, Jean

    Responding to the increasing use of the DACUM (Developing A Curriculum) process as a means of meeting industry demands for relevant curricula, this paper describes an approach supplementing DACUM with direct contact with industry. Following introductory material on the increasing emphasis on meeting industry's needs for training, discussions are…

  17. Endangerment assessment guidance

    SciTech Connect

    Not Available

    1985-11-22

    The directive clarifies the requirement that an endangerment assessment be developed to support all administrative and judicial enforcement actions under Section 106 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and Section 7003 of the Resource Conservation and Recovery Act (RCRA). Before taking enforcement action under these provisions to abate the hazards or potential hazards at a site, the Environmental Protection Agency (EPA) must be able to properly document and justify its assertion that an imminent and substantial endangerment to public health or welfare or the environment may exist. The endangerment assessment provides this documentation and justification. The endangerment assessment is not necessary to support Section 104 actions. It also provides guidance on the content, timing, level of detail, format, and resources required for the preparation of endangerment assessments.

  18. 10 CFR 431.104 - Sources for information and guidance.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 3 2014-01-01 2014-01-01 false Sources for information and guidance. 431.104 Section 431.104 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT Commercial Water Heaters, Hot Water Supply Boilers and Unfired Hot Water...

  19. Historical Development of Guidance and Counseling and Implications for the Future

    ERIC Educational Resources Information Center

    Aubrey, Roger F.

    1977-01-01

    The author traces the development of guidance and counseling from the nineteenth century to the present with implications for the future. The impact of the progressive movement, vocational guidance, industrialization, psychometrics, and Carl Rogers are highlighted. The 1950's are singled out as the decade having the greatest effect on counselors.…

  20. Historical Development of Guidance and Counseling and Implications for the Future

    ERIC Educational Resources Information Center

    Aubrey, Roger F.

    1977-01-01

    The author traces the development of guidance and counseling from the nineteenth century to the present with implications for the future. The impact of the progressive movement, vocational guidance, industrialization, psychometrics, and Carl Rogers are highlighted. The 1950's are singled out as the decade having the greatest effect on counselors.…