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  1. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New...: Food and Drug Administration, HHS.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 notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient...

  2. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...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

    ... written requests for single copies of this draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration... for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch...

  3. 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.

  4. 75 FR 22681 - Supplemental Guidance on Overdraft Protection Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... plans? Is the relationship between the Overdraft Guidance and the proposed Supplemental Guidance clear... associations to make clear, where applicable, that the payment of an overdraft is discretionary.\\17\\ Consistent... protection may be reinstated after suspension, e.g., when a deposit clears the outstanding overdraft and...

  5. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Prevention of Salmonella... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During...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''...

  6. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...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...

  7. 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...

  8. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... No. FDA-2013-D-0589] Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral...

  9. 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...

  10. 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.

  11. 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 and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and...

  12. 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 ...

  13. 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...

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

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... ตีพิมพ์เอกสารประกอบคําแนะนําเรื่องความปลอดภัยของอาหารชื่อ "Importers and filers: Food security preventive measures guidance" เพื่อครอบคลุม เรื่องการ ...

  15. 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...

  16. 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...

  17. 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)...

  18. 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... Supplements for Manufacturing Method or Process Changes; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  19. 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...

  20. 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...

  1. 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

    ... 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 and... availability of a guidance entitled ``Lupus Nephritis Caused By Systemic Lupus...

  2. 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...

  3. 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...

  4. 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

    ... 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...'s good guidance practices. DATES: Submit either electronic or written comments on this guidance...

  5. 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...

  6. 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...

  7. 76 FR 72951 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Differentiation of Human Papillomaviruses.'' This guidance document provides industry and Agency staff...

  8. 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--...

  9. 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...

  10. 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... a draft guidance for industry entitled ``Quality Considerations in Demonstrating Biosimilarity to a... reference product for the purpose of submitting a marketing application through an abbreviated...

  11. 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.

  12. 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,...

  13. 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...

  14. 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...

  15. 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... Industry: Bar Code Label Requirements--Questions and Answers'' dated August 2011. The guidance announced in... alternative coding technologies to the linear bar code requirement. The guidance announced in this...

  16. 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...

  17. 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...

  18. 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.

  19. 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...

  20. 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...

  1. 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...

  2. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioanalytical Method Validation; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... revising the guidance to reflect advancements in the science and technology of bioanalytical...

  3. 76 FR 65735 - Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of... entitled ``Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire and.... The draft guidance document recognizes the abbreviated donor history questionnaire and...

  4. 78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy... and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy,...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug... availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls...

  7. 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...

  8. 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;...

  9. 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...

  10. 76 FR 31615 - Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Commercially... Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance...

  11. 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.

  12. 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...

  13. 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...

  14. 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.

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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.

  1. 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...

  2. 75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Industry on Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients... comments of a draft revised guidance for industry ( 100) entitled ``Residual Solvents in New Veterinary... veterinary use by the International Cooperation on Harmonisation of Technical Requirements for...

  3. 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 Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability AGENCY... announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of...

  4. 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...

  5. 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

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

  6. 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''...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Marketing Applications; 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...

  13. 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...

  14. 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...

  15. 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.

  16. 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...

  17. 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...

  18. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... and in employing appropriate quality control procedures. Under the draft guidance, processors of non... safe manufacturing, processing, and packing processes and in employing appropriate quality control... Establishment-Specific Written Quality Control Plans and Recordkeeping for Acidified Foods, and...

  19. 75 FR 25271 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy Concerning...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-07

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

  20. 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...

  1. 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...

  2. 75 FR 67987 - Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... No. FDA-2009-D-0132] Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability AGENCY... Disease'' dated October 2010. The guidance document provides sponsors who are developing cellular therapies for the treatment of cardiac disease with recommendations on the design of preclinical...

  3. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abbreviated New Drug... regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current...

  4. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft and Revised Draft Guidances for Industry Describing...). The guidances represent the Agency's current thinking on product-specific design of BE studies...

  5. 78 FR 26785 - Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ...The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated May 2013. The guidance document recognizes the abbreviated donor history questionnaire and accompanying......

  6. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... ``Non- Inferiority Clinical Trials.'' This draft guidance provides sponsors and review staff in the... announcing the availability of a draft guidance for industry entitled ``Non-Inferiority Clinical Trials... clinical trials. It does not create or confer any rights for or on any person and does not operate to...

  7. 76 FR 23823 - Guidance for Industry on Fish and Fishery Products Hazards and Controls, Fourth Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... principles of HACCP. Fish and fishery products are adulterated under section 402(a)(4) of the Federal Food... chapter has been added containing guidance for the control of pathogen survival through processes designed... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Fish and Fishery Products...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug Administration Staff; The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13; Availability AGENCY: Food and Drug...

  9. 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

    ... 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... for heart valves. This draft guidance document is not final, nor is it in effect at this time....

  10. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

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

  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... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  12. 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...

  13. 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

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

  14. 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

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

  15. 76 FR 40921 - Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Radiology 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...

  16. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

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

  17. 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...

  18. 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...

  19. 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...

  20. 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... determined, despite outstanding issues, that the information provided is sufficient to justify human clinical... maintaining appropriate subject protections. Staged approval or staged approval with conditions is most...

  1. 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...

  2. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    ... Recommendations for Pentosan Polysulfate Sodium Capsule; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Bioequivalence Recommendations for Pentosan Polysulfate Sodium.'' The... drug applications (ANDAs) for pentosan polysulfate sodium capsule. DATES: Although you can comment...

  3. 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...

  4. 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...

  5. 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 Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  6. 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...

  7. 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...

  8. 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...

  9. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A... announcing the availability of a guidance for industry entitled ``Non-Penicillin Beta- Lactam Drugs: A CGMP... (APIs) with non-penicillin beta-lactams. This guidance also provides information regarding the...

  10. 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...

  11. 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... document entitled ``Guidance for Industry: Bar Code Label Requirements--Questions and Answers (Question 12... advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing...

  12. 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...

  13. 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...

  14. 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...

  15. 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... revising the guidance entitled ``Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella... Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in...

  16. 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...

  17. 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...

  18. 76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ... the pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs). The guidance is... pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug...

  19. 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...

  20. 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…

  1. 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.

  2. 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...

  3. 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…

  4. 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...

  5. 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...

  6. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and the Use of the Term `Lead Free' in the Labeling of Pottery; and Proper Identification of Ornamental and Decorative Ceramicware.'' FDA is issuing the guidance in response to recent findings of lead......

  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

    ... at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects...ComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082193.htm . FDA is issuing this guidance... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Providing Submissions in...

  8. 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)...

  9. 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

    ...; 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 entitled... CDRH and FDA. DATES: Submit either electronic or written comments on this guidance at any time....

  10. 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...

  11. 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

    ... 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...: Demonstrating Substantial Equivalence for Tobacco Products.'' In general, the Federal Food, Drug, and...

  12. 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...

  13. 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...

  14. 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...

  15. 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,...

  16. 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

    ... amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), as well as FDA... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  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 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...

  19. 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

    ...: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of...

  20. 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....

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Investigational New Drug Applications--Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

  2. 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 SERVICES Food and Drug Administration Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic... Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act...

  3. 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

    ... HUMAN SERVICES Food and Drug Administration Revised Guidance for Industry on Impurities: Residual... target animal as well as for the safety of human consumers of products derived from treated food...); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act... ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food,...

  5. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Antibodies to Borrelia Burgdorferi; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  6. 76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  7. 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...

  8. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Glucose Suspend Device Systems; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

  9. 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...

  10. 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...

  11. 76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

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

  12. 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

    ... 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... Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process. FDA...

  13. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... adverse effect on the identity, strength, quality, purity, or potency of the drug product and, therefore... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  14. 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

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

  15. 75 FR 4400 - Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Assessment of Abuse Potential of Drugs; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  16. 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.''...

  17. 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...

  18. 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...

  19. 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...

  20. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  1. 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... of development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C....

  2. 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...

  3. 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... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Determining the... types of safety data to collect in trials conducted late in the development of a drug for...

  4. 77 FR 31858 - Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pathologic Complete Response... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... applicants in designing trials to support marketing approval of drugs to treat breast cancer in...

  5. 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...

  6. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Alzheimer's Disease... a draft guidance for industry entitled ``Alzheimer's Disease: Developing Drugs for the Treatment of... demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease that...

  7. 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

  8. 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.

  9. 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.

  10. 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...

  11. 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......

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Oversight of Clinical... overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial... adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity...

  13. 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... and State drinking water quality standards. Further, this guidance is intended to assist...

  14. 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

    ... and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: External Pacemaker Pulse Generator; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  15. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. FDA-2008-D-0128) Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of Comment Period for Future Revision of Guidance Dated July 2009; Public Conference AGENCY: Food and Drug Administration, HHS....

  16. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... safety and effectiveness of these devices. This draft guidance is not final nor is it in effect at...

  17. 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...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on...

  18. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... adequately addressed in clinical trials. This draft guidance is not final nor is it in effect at this...

  19. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Processing...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... with processing or reprocessing labeling. This draft guidance is not final; nor is it in effect at...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Assays; 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 ``Class...

  1. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  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 Treatment and/or Prophylaxis; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  3. 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...

  4. 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

    ... Register of November 24, 2008 (73 FR 71009), FDA announced the availability of a draft guidance for... Name Review'' (concept paper) (73 FR 58604, October 7, 2008). FDA acknowledges that information in the... HUMAN SERVICES Food and Drug Administration Guidance for Industry on the Contents of a...

  5. 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...

  6. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  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...

  13. 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...

  14. 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...

  15. 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

  16. 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.

  17. 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.

  18. 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

    ... Biological Products: Technical Information to Supplement International Organization for Standardization (ISO... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting devices'') that comply with the ISO 594-2 standard. ] DATES: Although you can comment on any guidance at any...

  19. 76 FR 63167 - Airworthiness Directives; Diamond Aircraft Industries GmbH Airplanes With Supplemental Type...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ...; AD 2011-21-10] RIN 2120-AA64 Airworthiness Directives; Diamond Aircraft Industries GmbH Airplanes... directive (AD) for Diamond Aircraft Industries GmbH Model (Diamond) DA 40 airplanes equipped with cabin air... directive (AD): 2011-21-10 Diamond Aircraft Industries GmbH Airplanes Equipped With Supplemental...

  20. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION:...

  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. 78 FR 12759 - Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-25

    ... Submitting Hepatitis C Virus Resistance Data; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.'' The purpose of this... important for supporting clinical trials of products in development for the treatment of HCV. HCV...

  3. 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

  4. 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.

  5. 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...

  6. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting for Manufacturers; Draft Guidance....115). The draft guidance, when finalized, will represent the Agency's current thinking on...

  7. 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...

  8. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug... Products: Chemistry, Manufacturing, and Control Information '' dated February 2012. The guidance provides... Products: Chemistry, Manufacturing, and Control Information'' dated February 2012. The guidance...

  9. 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...

  10. 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

    ... Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device... Administration Staff; 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing... comment period to request comments on the draft guidance for industry and FDA staff entitled...

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Identification of... written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630... enhancements to FDA's generic drugs program. GDUFA will also significantly improve global supply...

  12. 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)...

  13. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Scale-Up and Post-Approval...: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a scale-up and... Oral Dosage Forms--Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In...

  14. 77 FR 72869 - Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-06

    ... for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks...-Regulated Products.'' This guidance provides the pharmaceutical industry with CDER's current thinking on the... have raised concerns, particularly in vulnerable populations such as pregnant women and...

  15. 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...

  16. 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...

  17. 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...

  18. 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....

  19. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry: Implementation of an Acceptable Full... represents FDA's current thinking on this topic. It does not create or confer any rights for or on any...

  20. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 123 Guidance for Industry on Purchasing Reef... our current thinking on this topic. It does not create or confer any rights for or on any person...

  1. 77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Notification to Food and Drug..., directing FDA to use all available administrative tools to expand the Agency's efforts to combat the problem... required nutrition, or to address other serious medical conditions. Other shortages force providers...

  2. 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...

  3. 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:...

  4. 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

    ... efficiency of the review process. This draft guidance is not final nor is it in effect at this time. DATES... review process between FDA and industry for specific medical device premarket submissions. Further... recommendations for MDUFA III, Title II of the Food and Drug Administration Safety and Innovation Act, Public...

  5. 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...

  6. 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

    ...--Clinical Evaluation of Products for Treatment; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Products for Treatment... who are conducting new product development for the treatment of IBS. DATES: Although you can...

  7. 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...

  8. 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 Whole Blood and Blood Components Intended for Transfusion; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  9. 75 FR 69449 - Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... 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... manufacturer or distributor of a human drug or biologic, or from FDA--intended to alert physicians and...

  10. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  11. 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-Dissemination Review Program; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  12. 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...

  13. 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...

  14. 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...

  15. 75 FR 1060 - Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-08

    ... Doc No: 2010-87] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0568] Draft Guidance for Industry on Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products; Availability AGENCY: Food and Drug Administration,...

  16. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... 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... and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to...

  17. 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...

  18. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... FDA may no longer be adequate, as animal drug effects can change over time and less apparent effects... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Data Elements for Submission... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  19. 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)...

  20. 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

    ... 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... regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) relating to tobacco products...

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Draft 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...

  3. 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...

  4. 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...

  5. 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

    ...: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans... Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study... draft guidance for industry entitled ``Pediatric Study Plans: Content of and Process for...

  6. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of... collected from a donor who should have been deferred due to possible malaria risk. Finally, the guidance... other terms used to assess a donor's risk of malaria based on history of travel or residence;...

  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

    ... January 24, 2006 (71 FR 3998), FDA announced the availability of final guidances on the content and format... of March 23, 2010 (75 FR 13766), FDA announced the availability of final guidance on the content and..., 2011 (76 FR 63303), FDA announced the availability of final guidance on the content and format of...

  8. 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

  9. 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.

  10. 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)...

  11. 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...

  12. 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...

  13. 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

    ... of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in.... Send one self-addressed adhesive label to assist that office in processing your requests. See the... Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing...

  14. 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

    ..., to set forth criteria for charging for an investigational drug for the three types of expanded access... types of costs that can be recovered, FDA is providing a draft guidance in a question and answer format...ComplianceRegulatoryInformation/Guidances/default.htm ,...

  15. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices...

  16. 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... use of the product to minimize medication errors. DATES: Although you can comment on any guidance...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical... comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug... http://www.regulations.gov . Submit written comments to the Division of Dockets Management...

  18. 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... on this draft guidance before it begins work on the final version of the guidance, submit either... access under a treatment protocol or treatment investigational new drug application (IND). These... CFR part 56 (21 CFR 312.305(c)(4)). 21 CFR part 56 requires, among other things, that an IRB...

  19. 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....

  20. 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...

  1. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    .... On June 22, 2011 (76 FR 36542), FDA announced the availability of the draft guidance document...) Device Systems.'' On December 6, 2011 (76 FR 76166), FDA announced the availability of the draft guidance...; The Content of Investigational Device Exemption and Premarket Approval Applications for...

  2. 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

    ... Federal Register of January 24, 2006 (71 FR 3999), FDA issued final guidances on the content and format of...-63304] [FR Doc No: 2011-26297] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration... October 19, 2009 (74 FR 53507), FDA issued a final guidance on determining established pharmacologic...

  3. 78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant... New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood..., Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and...

  4. 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

    ... developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug... current thinking on this topic. It does not create or confer any rights for or on any person and does...

  5. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... our current thinking of how the GUDID will operate. The guidance includes both information about how... represent the Agency's current thinking on the GUDID. It does not create or confer any rights for or on...

  6. 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

    ... responsible for cIAIs, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria, and there are also mixed infections. This draft guidance includes recommendations for an...

  7. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... form in some foods during certain types of high-temperature cooking. The draft guidance is intended to.... Acrylamide is a chemical that can form in some foods during certain types of high-temperature cooking, and...

  8. 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

    ... Staff; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration... of the draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the... classification product codes for medical devices regulated by the Center for Devices and Radiological...

  9. 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

    ... Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug Administration, HHS... guidance document entitled ``Product Name Placement, Size, and Prominence in Advertising and Promotional..., size, prominence, and frequency in promotional labeling and advertising for prescription human...

  10. 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... Research's (CDER's) current thinking on the appropriate regulatory classification of pharmaceutical...

  11. 76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... Staff; Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies... guidance, FDA intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early...

  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,...

  13. 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...

  14. 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...

  15. 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...

  16. 76 FR 36307 - Guidance for Industry on Topical Acne Drug Products for Over-the-Counter Human Use-Revision of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 333 Guidance for Industry on Topical Acne Drug... availability of a guidance for small business entities entitled ``Topical Acne Drug Products for Over-the... ingredient in over-the-counter (OTC) topical acne drug products and provides new labeling...

  17. 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.

  18. 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.

  19. 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

    ... HUMAN SERVICES Food and Drug Administration (formerly 1999D-4396) Guidance for Clinical Investigators... recommendations made by the Office of the Inspector General (OIG), Department of Health and Human Services, in... represents FDA's current thinking on this topic. It does not create or confer any rights for or on any...

  20. 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...

  1. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ...) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics... circumstances under which the Agency intends to grant a PLAIR. An applicant who has an NDA, ANDA, or a BLA... the underlying NDA or ANDA within 6 months and the conditions of the PLAIR are otherwise met....

  2. 75 FR 73109 - Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... this guidance is to provide information on FDA's current thinking regarding appropriate use of noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this... Agency's current thinking on this topic. It does not create or confer any rights for or on any person...

  3. 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

    ... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies (OCTGT). The product areas covered by this guidance are cellular therapy, gene therapy, therapeutic...

  4. 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

    ... (TEA) to determine whether a condition is eligible for inclusion in the OTC drug monograph system and... designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the... regulation in Sec. 330.14, an applicant must first submit a TEA to show that the drug product is eligible...

  5. 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,...

  6. 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

    ... investigations of medical devices indicated for the treatment of urinary incontinence. DATES: Submit either... search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices...; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability...

  7. 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...

  8. 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

    ... the Center for Veterinary Medicine (CVM) for the evaluation of safety and effectiveness in new animal... single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food... Nevius, Center for Veterinary Medicine (HFV-163), Food and Drug Administration, 7500 Standish...

  9. 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...

  10. 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...

  11. 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

    ... Cigarettes and Smokeless Tobacco Products; Availability; Agency Information Collection Activities; Proposed... ``Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.'' This draft guidance document is... Cigarette Labeling and Advertising Act, as amended by the Family Smoking Prevention and Tobacco Control...

  12. 75 FR 22813 - Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti... Hepatitis B Core Antigen (Anti- HBc),'' dated May 2010. The guidance document provides recommendations to... previous tests that were repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc)...

  13. 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....

  14. 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...

  15. 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),...

  16. 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...

  17. 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...

  18. 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

    ... FDA's Center for Veterinary Medicine (CVM) recommends for inclusion in food additive petitions (FAPs... for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine... CONTACT: Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration,...

  19. 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

    ... for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The... for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine..., Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville,...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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

    ... Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401... the FD&C Act, FDA is issuing this draft guidance, announcing its determination that submission types... Persons with access to the Internet may obtain the document at either...

  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. 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...

  7. 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...

  8. 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...

  9. 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.

  10. 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.

  11. 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.

  12. 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

    ... Quality.'' This draft guidance is intended to alert manufacturers of active pharmaceutical ingredients... to protect public health. FDA developed this draft guidance to alert manufacturers to the risks...

  13. 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.

  14. 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...

  15. 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

    ... http://www.regulations.gov . Identify comments with the docket number found in brackets in the heading... Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21... receive a hard copy. Please use the document number 1709 to identify the guidance you are requesting....

  16. 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...

  17. 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…

  18. 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…

  19. 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...

  20. 75 FR 5356 - Office of New Reactors; Final Interim Staff Guidance on Post-Combined License Commitments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

    ...) Accession No. ML093561416). This ISG supplements the guidance provided to the NRC staff in Section 1.0... guidance provided in Section C.III.4 of Regulatory Guide (RG) 1.206, ``Regulatory Guide for Combined... License Commitments,'' (ADAMS Accession No. ML091671355) to solicit public and industry comment. The...

  1. 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

  2. 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...

  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. 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.

  5. 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

    ... guidance: Interpretation of findings; study time frame; identification and handling of confounding and the use of statistical techniques to address confounding; exposure ascertainment; study design;...

  6. 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

    ... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program; Availability... (FDA) is announcing the availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary... guidance document entitled ``Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot...

  7. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-20

    ... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability...) is announcing the availability of the draft guidance entitled ``Medical Device ISO 13485:2003... written requests for single copies of the draft guidance document entitled ``Medical Device ISO...

  8. 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...

  9. 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...

  10. 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...

  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. 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

    ..., 2006 (71 FR 3998), FDA issued final guidances on the format and content of the ``Adverse Reactions...,'' ``Contraindications,'' and ``Boxed Warning'' sections of labeling. In the Federal Register of March 3, 2009 (74 FR... of labeling. The labeling requirements (71 FR 3922) and these guidances are intended to...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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... Studies Using Electronic Healthcare Data Sets.'' The draft guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies using electronic...

  19. 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...

  20. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-04

    ... enrichment. The guidance also discusses general clinical trial design considerations, provides examples of potential clinical trial designs, and discusses regulatory considerations when using enrichment strategies... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment...

  1. 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...

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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...

  7. 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

    ... Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the..., 10903 New Hampshire Ave., Bldg. 51, rm. 6216, Silver Spring, MD 20993-0002, 301-796-3602; or Stephen... guidance represents the Agency's current thinking on user fee waivers and reductions for drug products....

  8. 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

    ... Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm..., will represent the Agency's current thinking on tablet size, shape, and other physical attributes of... collections recommended in this guidance that are new or that would represent material modifications to...

  9. 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

    ... antibodies to Trypanosoma cruzi. These tests are intended for use as donor screening tests to reduce the risk of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples... recommendations for HCT/P donor screening and testing for T. cruzi antibodies contained in the draft guidance...

  10. 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

    ... and Research. This draft guidance is not final nor is it in effect at this time. DATES: Although you... Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401..., Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville...

  11. 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

    ... to stakeholder requests for specific guidance on FDA's current views on how manufacturers and... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD...

  12. 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...

  13. 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...

  14. 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...

  15. 75 FR 78259 - Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-15

    ... to apply to vaccines, gene or cellular therapies, blood products, or medical devices. DATES: Although... vaccines, gene or cellular therapies, or blood products. This draft guidance is being issued consistent... development of resistance. In settings in which combination therapy provides significant...

  16. 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...

  17. 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...

  18. 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...

  19. 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

    ..., Drug, and Cosmetic Act (FD&C Act). This guidance contains FDA's determination that information about..., Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch... Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,...

  20. 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,...

  1. 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...

  2. 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…

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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…

  8. 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

  9. 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…

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying...

  15. 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.

  16. 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.

  17. 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).

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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...

  3. 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…

  4. 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)...

  5. 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...

  6. 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.

  7. 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.

  8. Sports Supplements

    MedlinePlus

    ... for Parents for Kids for Teens Teens Home Body Mind Sexual Health Food & Fitness Diseases & Conditions Infections Q& ... Sports Supplements? How Some Common Supplements Affect the Body Will Supplements ... improving your sports performance is probably on your mind. Lots of people wonder if taking sports supplements ...

  9. 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...

  10. 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 ...

  11. 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.

  12. 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 ...

  13. 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 ...

  14. 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.

  15. 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.

  16. 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…

  17. 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…

  18. 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…

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 76 FR 46819 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-03

    ... Register of June 11, 1998 (63 FR 32102), FDA announced the availability of a guidance entitled ``Guidance... Collection; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim... nutrient content claims based on authoritative statements of scientific bodies of the U.S....

  9. 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 ...

  10. 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...

  11. 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…

  12. 76 FR 2328 - National Organic Program: Notice of Draft Guidance Concerning “Made With Organic (Specified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-13

    ... Agricultural Marketing Service National Organic Program: Notice of Draft Guidance Concerning ``Made With Organic (Specified Ingredients or Food Groups)'' Products: Product Composition and Use of Percentage...: This notice announces draft guidance for the organic industry to address the labeling, composition...

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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)

  18. 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. ...

  19. 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...

  20. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... Pump--Premarket Notification Submissions AGENCY: Food and Drug Administration, HHS. ACTION: Notice... 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...

  1. 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.

  2. 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

  3. The National Nanotechnology Initiative: Research and Development Leading to a Revolution in Technology and Industry. Supplement to the President’s 2011 Budget

    DTIC Science & Technology

    2010-02-01

    emphasize the use of carbon nanotube threads and yarns to produce conductive wires, impact- and bullet-proof panels, support struts, electromagnetic...of carbon nanotubes with an electronic grade junction to a silicon semiconductor substrate for ultra-lightweight, uncooled infrared detectors, (2...being pursued. • Advanced sensing platforms: Work on the development of multimodal carbon nanotube sensing platforms continues with industry partners

  4. 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.

  5. 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.

  6. 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…

  7. 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…

  8. 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…

  9. 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).

  10. 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…

  11. 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.

  12. 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.…

  13. 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.

  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. 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.

  18. 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.

  19. 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."

  20. 78 FR 56752 - Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... COMMISSION Interim Staff Guidance Specific Environmental Guidance for Integral Pressurized Water Reactors Reviews AGENCY: Nuclear Regulatory Commission. ACTION: Draft Interim Staff Guidance; request for comment... comment on, draft Interim Staff Guidance (ISG) ESP/COL-ISG-027, ``Interim Staff Guidance...

  1. 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.

  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. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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…

  9. 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…

  10. 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.

  11. 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...

  12. 10 CFR 431.14 - Sources for information and guidance.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 3 2013-01-01 2013-01-01 false Sources for information and guidance. 431.14 Section 431.14 Energy DEPARTMENT OF ENERGY ENERGY CONSERVATION ENERGY EFFICIENCY PROGRAM FOR CERTAIN COMMERCIAL AND INDUSTRIAL EQUIPMENT Electric Motors Test Procedures, Materials Incorporated and Methods...

  13. 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.…

  14. 75 FR 48179 - Comprehensive List of Guidance Documents at the Food and Drug Administration

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-09

    ... at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection 8/2009 Guidance... Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion... Test Results Indicating Infection with HCV 8/24/2007 Guidance for Industry: Class II Special...

  15. Guidance for the New Millenium?

    ERIC Educational Resources Information Center

    McLaren, David J.

    1996-01-01

    Reviews the "Guidance Arrangements" consultation document issued with "Higher Still" (proposed new Scottish upper secondary curricula). Argues that the paper ignores the full implications for educational change in Higher Still and misses the opportunity for timely modernization of school guidance. Advocates a cross-curricular…

  16. Guidance in the Secondary School

    ERIC Educational Resources Information Center

    Kumar, V. Jurist Lional

    2010-01-01

    Secondary School Students face a lot of problems in their body as well as in mind due to puberty that tends to adolescence stage. Adolescence has peculiar characters of their own. They need proper Guidance and Counselling to tackle their own problems. Guidance is described as a counselling service to assist the individual in achieving self…

  17. Restructuring Guidance and Counseling Programs.

    ERIC Educational Resources Information Center

    Snyder, Beverly A.; Daly, Timothy P.

    1993-01-01

    Briefly reviews counseling profession's call for revitalization and transformation in school counseling and guidance programs. Summarizes one school system's efforts during late 1980s and early 1990s to transform its program from services and crisis orientation into a comprehensive developmental model based on Myrick's developmental guidance and…

  18. Guidance Services in Spanish Universities

    ERIC Educational Resources Information Center

    Vidal, Javier; Diez, Gloria; Vieira, Maria J.

    2003-01-01

    Since the 80s, higher education in Spain has undergone important modifications such as greater autonomy, expansion in the number of students and the introduction of more flexible programmes. In this context, guidance services have proliferated in an unstructured way. This paper presents a description of guidance services in Spanish universities…

  19. Final OSWER Vapor Intrusion Guidance

    EPA Science Inventory

    EPA is preparing to finalize its guidance on assessing and addressing vapor intrusion, which is defined as migration of volatile constituents from contaminated media in the subsurface (soil or groundwater) into the indoor environment. In November 2002, EPA issued draft guidance o...

  20. Marxist Guidance: A Dialectic Lesson

    ERIC Educational Resources Information Center

    Drapela, Victor J.

    1971-01-01

    Based on primary sources published in the Soviet Bloc, this article compares the stated goals of Marxist guidance with actual outcomes, and identifies the foundations of guidance in the Soviet Bloc in terms of Marxist philosophy and social doctrine. Current symptoms of ideological unrest in socialist society as exemplified by the suppressed reform…

  1. GUIDANCE AWARENESS IN ELEMENTARY EDUCATION.

    ERIC Educational Resources Information Center

    MOREAU, GEORGE H., ED.

    THE PURPOSE OF THE WORKSHOP IN ELEMENTARY SCHOOL GUIDANCE WAS TWOFOLD--(1) TO SHOW HOW GUIDANCE PROCEDURES AND TECHNIQUES CENTER ABOUT AND INVOLVE THE CHILD AS HE ADAPTS TO A NEW TYPE OF SCHOOL SETTING AND LEARNING PROCESS, AND (2) TO CREATE AN AWARENESS OF THE NEED FOR ALL AREAS OF COUNSELING AT THE ELEMENTARY SCHOOL LEVEL. OF THE ELEVEN PAPERS…

  2. Automated Guidance for Student Inquiry

    ERIC Educational Resources Information Center

    Gerard, Libby F.; Ryoo, Kihyun; McElhaney, Kevin W.; Liu, Ou Lydia; Rafferty, Anna N.; Linn, Marcia C.

    2016-01-01

    In 4 classroom experiments we investigated uses for technologies that automatically score student generated essays, concept diagrams, and drawings in inquiry curricula. We used the automatic scores to assign typical and research-based guidance and studied the impact of the guidance on student progress. Seven teachers and their 897 students…

  3. Discussing Diverse Perspectives on Guidance

    ERIC Educational Resources Information Center

    Gonzalez-Mena, Janet; Shareef, Intisar

    2005-01-01

    Ideas about discipline and guidance get extremely complex when they intersect with culture and oppression. Some groups of people who are targets of racism have to protect their children from the oppressive practices of racist individuals and institutions. Their methods of guidance and discipline may be different from those of groups for whom…

  4. 78 FR 78974 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-27

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products AGENCY: Food and Drug...

  5. 78 FR 37548 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-21

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products AGENCY: Food and Drug Administration, HHS. ACTION:...

  6. 78 FR 19637 - National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service National Organic Program: Notice of Draft Guidance on Classification of Materials and Materials for Organic Crop Production AGENCY: Agricultural... operations, material evaluation programs, and other organic industry stakeholders. The first set of...

  7. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions LLC

    2008-01-12

    The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package (also known as the "RH-TRU 72-B cask") and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: "...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application." It further states: "...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application." Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) §71.8, "Deliberate Misconduct." Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, "Packaging and Transportation of Radioactive Material," certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, "Reporting of Defects and Noncompliance," regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a

  8. Autonomous landing guidance program

    NASA Astrophysics Data System (ADS)

    Brown, John A.

    1996-05-01

    The Autonomous Landing Guidance program is partly funded by the US Government under the Technology Reinvestment Project. The program consortium consists of avionics and other equipment vendors, airlines and the USAF. A Sextant Avionique HUD is used to present flight symbology in cursive form as well as millimeter wave radar imagery from Lear Astronics equipment and FLIR Systems dual-channel, forward-looking, infrared imagery. All sensor imagery is presented in raster form. A future aim is to fuse all imagery data into a single presentation. Sensor testing has been accomplished in a Cessna 402 operated by the Maryland Advanced Development Laboratory. Development testing is under way in a Northwest Airlines simulator equipped with HUD and image simulation. Testing is also being carried out using United Airlines Boeing 727 and USAF C-135C (Boeing 707) test aircraft. The paper addresses the technology utilized in sensory and display systems as well as modifications made to accommodate the elements in the aircraft. Additions to the system test aircraft include global positioning systems, inertial navigation systems and extensive data collection equipment. Operational philosophy and benefits for both civil and military users are apparent. Approach procedures have been developed allowing use of Category 1 ground installations in Category 3 conditions.

  9. Herbal Products and Supplements

    MedlinePlus

    ... of dietary supplement that contains one or more herbs.Herbal health products and supplements are available in ... wort.Are herbal health products and supplements safe?Herbs aren't necessarily safer than the ingredients in ...

  10. Pandemic influenza guidance for corporations.

    PubMed

    2011-06-01

    The purpose of this guidance document is to assist members of the American College of Occupational and Environmental Medicine (ACOEM), and the organizations for which they work, in managing the impact of a pandemic of influenza or other contagious respiratory disease on patients, employees, and business. This guidance document outlines actions to take before and during an influenza pandemic on the basis of two main strategies: (1) reducing the spread of the virus within facilities; and (2) providing medical care and medical surveillance to client/patient populations. Facilities in which ACOEM members serve include government agencies and the military, universities, and corporations, which generally have multiple locations/sites and their own medical staff, with members responsible for medical care and disease control. This guidance is for organizations with outpatient occupational medicine services, to be used as appropriate. Medical centers should also use guidance that addresses additional employee and external patient care needs.1–3 The ACOEM fully supports implementation of occupational influenza programs that conform with guidance from the Centers for Disease Control and Prevention (CDC), with other guidance from the US Department of Health and Human Services (DHHS), and Occupational Safety and Health Administration (OSHA) regulations and guidance.

  11. General RMP Guidance - Appendix D: OSHA Guidance on PSM

    EPA Pesticide Factsheets

    OSHA's Process Safety Management (PSM) Guidance on providing complete and accurate written information concerning process chemicals, process technology, and process equipment; including process hazard analysis and material safety data sheets.

  12. Uprated fine guidance sensor study

    NASA Technical Reports Server (NTRS)

    1984-01-01

    Future orbital observatories will require star trackers of extremely high precision. These sensors must maintain high pointing accuracy and pointing stability simultaneously with a low light level signal from a guide star. To establish the fine guidance sensing requirements and to evaluate candidate fine guidance sensing concepts, the Space Telescope Optical Telescope Assembly was used as the reference optical system. The requirements review was separated into three areas: Optical Telescope Assembly (OTA), Fine Guidance Sensing and astrometry. The results show that the detectors should be installed directly onto the focal surface presented by the optics. This would maximize throughput and minimize point stability error by not incoporating any additional optical elements.

  13. RH Packaging Program Guidance

    SciTech Connect

    Washington TRU Solutions, LLC

    2003-08-25

    The purpose of this program guidance document is to provide technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the SARP and/or C of C shall govern. The C of C states: ''...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, ''Operating Procedures,'' of the application.'' It further states: ''...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, ''Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M&O) contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC approved, users need to be familiar with 10 CFR {section} 71.11, ''Deliberate Misconduct.'' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the RH-TRU 72-B packaging. This Program Guidance standardizes instructions for all users. Users shall follow these instructions. Following these instructions assures that operations are safe and meet the requirements of the SARP. This document is available on the Internet at: ttp://www.ws/library/t2omi/t2omi.htm. Users are responsible for ensuring they are using the current revision and change notices. Sites may prepare their own document using the word

  14. SPLC Sustainable Purchasing Guidance Profile

    EPA Pesticide Factsheets

    To help you find the resource that is right for your organization, EPA conducted a scan of the landscape and developed summary profiles of some of the leading sources of sustainable purchasing guidance around the globe.

  15. Guidance Documents for Marine Fuel

    EPA Pesticide Factsheets

    The following guidance documents apply to marine fuel used in ocean-going vessels. All vessels that operate in the North American Emission Control Area (ECA) must generally use fuel with 1,000 ppm sulfur or less.

  16. Chesapeake Bay Program Grant Guidance

    EPA Pesticide Factsheets

    Grant Guidance and appendices for the Chesapeake Bay Program that describes how the U.S. Environmental Protection Agency’s (EPA) Region 3’s Chesapeake Bay Program Office (CBPO) administers grant and cooperative agreement funds.

  17. Inert Ingredients Overview and Guidance

    EPA Pesticide Factsheets

    This Web page provides information on inert ingredients approved for use in pesticide products and the guidance documents that are available to assist in obtaining approval for a new inert ingredient.

  18. Enforcement Response Policies and Guidance

    EPA Pesticide Factsheets

    EPA's Enforcement Response Policies relating to violations or noncompliance with the environmental statutes and regulations. The listing is not inclusive of all policy and guidance that may be relied upon in developing enforcement actions.

  19. BASINS User Information and Guidance

    EPA Pesticide Factsheets

    This page provides links to guidance on how to use BASINS, including the User’s Manual, tutorials and training, technical notes, case studies, and publications that highlight the use of BASINS in various watershed analyses.

  20. Determinants of the 25-hydroxyvitamin D response to vitamin D supplements

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Supplemental vitamin D is now widely recommended but little guidance is provided on how or when to take vitamin D supplements. The process of vitamin D replacement is complicated by the fact that the increment in 25-hydroxyvitamin D (25OHD) in response to a given dose varies greatly from person to p...

  1. 76 FR 76318 - Defense Federal Acquisition Regulation Supplement; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-07

    ... Acquisition Regulation Supplement (DFARS) to provide needed editorial changes and guidance to contracting... reference. 6. Makes minor editorial corrections at 225.403(c) and 227.7203- 15(c)(1) through (4). 7. Makes... editorial footnote to the charter for the Armed Services Board of Contract Appeals in Appendix A to...

  2. SPAR-H Step-by-Step Guidance

    SciTech Connect

    April M. Whaley; Dana L. Kelly; Ronald L. Boring; William J. Galyean

    2012-06-01

    Step-by-step guidance was developed recently at Idaho National Laboratory for the US Nuclear Regulatory Commission on the use of the Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method for quantifying Human Failure Events (HFEs). This work was done to address SPAR-H user needs, specifically requests for additional guidance on the proper application of various aspects of the methodology. This paper overviews the steps of the SPAR-H analysis process and highlights some of the most important insights gained during the development of the step-by-step directions. This supplemental guidance for analysts is applicable when plant-specific information is available, and goes beyond the general guidance provided in existing SPAR-H documentation. The steps highlighted in this paper are: Step-1, Categorizing the HFE as Diagnosis and/or Action; Step-2, Rate the Performance Shaping Factors; Step-3, Calculate PSF-Modified HEP; Step-4, Accounting for Dependence, and; Step-5, Minimum Value Cutoff.

  3. Resources for Guidance Program Improvement. Volume 2.

    ERIC Educational Resources Information Center

    Frenza, Mary C., Comp.; and Others

    This guide, for guidance personnel and teachers, is designed to provide ready access to current, practical programs, activities, and references for improving guidance programs. The resources are organized in four sections representing areas of basic concern for guidance personnel. Section 1 presents selected portions of guidance programs from…

  4. Resources for Guidance Program Improvement. Volume I.

    ERIC Educational Resources Information Center

    Walz, Garry R., Comp.; And Others

    Designed for use by counselors, guidance directors, school administrators, school board members, and anyone interested in the improvement of school guidance programs, this resource book provides a collection of over 100 guidance program models and individual guidance practices. The format consists of references (bibliographic information with…

  5. Industrial Education Resources.

    ERIC Educational Resources Information Center

    Alaska State Dept. of Education, Juneau. Div. of Adult and Vocational Education.

    This guide was developed as a supplement to the Alaska Department of Education's industrial education curriculum. The special topics included in it focus on competencies from the curriculum for which materials were not readily available to Alaskan teachers and provide information that may not be sufficiently covered by existing curricula. Each…

  6. Laboratory and Industrial Ventilation

    NASA Technical Reports Server (NTRS)

    1972-01-01

    This handbook supplements the Facilities Engineering Handbook (NHB 7320.1) and provides additional policies and criteria for uniform application to ventilation systems. It expands basic requirements, provides additional design and construction guidance, and places emphasis on those design considerations which will provide for greater effectiveness in the use of these systems. The provisions of this handbook are applicable to all NASA field installations and the Jet Propulsion Laboratory. Since supply of this handbook is limited, abstracts of the portion or portions applicable to a given requirement will be made for the individual specific needs encountered rather than supplying copies of the handbook as has been past practice.

  7. Vitamin D supplementation guidelines.

    PubMed

    Pludowski, Pawel; Holick, Michael F; Grant, William B; Konstantynowicz, Jerzy; Mascarenhas, Mario R; Haq, Afrozul; Povoroznyuk, Vladyslav; Balatska, Nataliya; Barbosa, Ana Paula; Karonova, Tatiana; Rudenka, Ema; Misiorowski, Waldemar; Zakharova, Irina; Rudenka, Alena; Łukaszkiewicz, Jacek; Marcinowska-Suchowierska, Ewa; Łaszcz, Natalia; Abramowicz, Pawel; Bhattoa, Harjit P; Wimalawansa, Sunil J

    2017-02-12

    Research carried out during the past two-decades extended the understanding of actions of vitamin D, from regulating calcium and phosphate absorption and bone metabolism to many pleiotropic actions in organs and tissues in the body. Most observational and ecological studies report association of higher serum 25-hydroxyvitamin D [25(OH)D] concentrations with improved outcomes for several chronic, communicable and non-communicable diseases. Consequently, numerous agencies and scientific organizations have developed recommendations for vitamin D supplementation and guidance on optimal serum 25(OH)D concentrations. The bone-centric guidelines recommend a target 25(OH)D concentration of 20ng/mL (50nmol/L), and age-dependent daily vitamin D doses of 400-800IU. The guidelines focused on pleiotropic effects of vitamin D recommend a target 25(OH)D concentration of 30ng/mL (75nmol/L), and age-, body weight-, disease-status, and ethnicity dependent vitamin D doses ranging between 400 and 2000IU/day. The wise and balanced choice of the recommendations to follow depends on one's individual health outcome concerns, age, body weight, latitude of residence, dietary and cultural habits, making the regional or nationwide guidelines more applicable in clinical practice. While natural sources of vitamin D can raise 25(OH)D concentrations, relative to dietary preferences and latitude of residence, in the context of general population, these sources are regarded ineffective to maintain the year-round 25(OH)D concentrations in the range of 30-50ng/mL (75-125nmol/L). Vitamin D self-administration related adverse effects, such as hypercalcemia and hypercalciuria are rare, and usually result from taking extremely high doses of vitamin D for a prolonged time.

  8. Ultrasound guidance for vascular access.

    PubMed

    Abboud, Paul-André C; Kendall, John L

    2004-08-01

    The evidence that supports the general application of US guidance for venous access in the ED has reached a critical mass. The increasing familiarity of emergency physicians with US and the recent focus on patient safety and clinical outcomes has intensified attention on the capacity for US to improve patient care in the ED. US guidance can increase the safety and efficiency of venous access procedures and offers improved outcomes. The potential for these improvements is compelling, especially among certain types of ED patients such as those with difficult or complicated access. Varying levels of evidence support the use of US guidance over the traditional landmark approach for venous access in adult and pediatric populations and for central and peripheral veins. Many different techniques may be applied, depending on the clinical situation and equipment available.

  9. Autonomous Guidance, Navigation and Control

    NASA Technical Reports Server (NTRS)

    Bordano, A. J.; Mcswain, G. G.; Fernandes, S. T.

    1991-01-01

    The NASA Autonomous Guidance, Navigation and Control (GN&C) Bridging program is reviewed to demonstrate the program plan and GN&C systems for the Space Shuttle. The ascent CN&C system is described in terms of elements such as the general-purpose digital computers, sensors for the navigation subsystem, the guidance-system software, and the flight-control subsystem. Balloon-based and lidar wind soundings are used for operations assessment on the day of launch, and the guidance software is based on dedicated units for atmospheric powered flight, vacuum powered flight, and abort-specific situations. Optimization of the flight trajectories is discussed, and flight-control responses are illustrated for wavelengths of 500-6000 m. Alternate sensors are used for load relief, and adaptive GN&C systems based on alternate gain synthesis are used for systems failures.

  10. Information architecture. Volume 3: Guidance

    SciTech Connect

    1997-04-01

    The purpose of this document, as presented in Volume 1, The Foundations, is to assist the Department of Energy (DOE) in developing and promulgating information architecture guidance. This guidance is aimed at increasing the development of information architecture as a Departmentwide management best practice. This document describes departmental information architecture principles and minimum design characteristics for systems and infrastructures within the DOE Information Architecture Conceptual Model, and establishes a Departmentwide standards-based architecture program. The publication of this document fulfills the commitment to address guiding principles, promote standard architectural practices, and provide technical guidance. This document guides the transition from the baseline or defacto Departmental architecture through approved information management program plans and budgets to the future vision architecture. This document also represents another major step toward establishing a well-organized, logical foundation for the DOE information architecture.

  11. New supplements to infant formulas.

    PubMed

    Eshach Adiv, Orly; Berant, Moshe; Shamir, Raanan

    2004-12-01

    Foods, which, in addition to their nutritional attributes, contain also elements that are considered to be health-promoting, have been termed "functional foods". In this regard, human milk has gained recognition as being the ultimate functional food for infants - by its biological compatibility, nutritional value and the undisputed added value of its health promoting qualities. Intensive research activity has recently evolved in a quest to identify and define the components of human milk that might confer disease-preventing and health-enhancing properties and to determine the instances and clinical conditions in which these factors become particularly important. The outcome of such research would also provide a rationale for advocating the supplementation of commercial infant formulas with such substances. In effect, the body of data accumulated from scientific and clinical studies on nucleotides, probiotics, prebiotics and long-chain polyunsaturated fatty acids in human milk and as additives to infant formula, has become regarded as convincing enough by the infant formula industry so as to launch into the market formulas supplemented with one or more of these factors - in an effort to emulate human milk and its beneficial effects. The following review is intended for the reader to obtain a general idea of the new supplements that have been introduced to infant formulas. We summarize the pertinent experimental and clinical observations concerning each of the supplements, pointing out their potential specific benefits, their possible disadvantages and the issues that still remain unresolved.

  12. Guidance for state attainment plans

    SciTech Connect

    Strait, R.

    1994-06-01

    Title I of the Clean Air act Amendments of 1990 significantly changed requirements for regulatory agencies to prepare state implementation plans that demonstrate attainment of the ozone National Ambient Air Quality Standards. State agencies now are required to submit plans that show how they will meet the standards by their attainment date. EPA has published a series of guidance documents to assist states in preparing their plans. In addition, the agency is developing software to assist states in projecting emissions and tracking reductions. This article summarizes the guidance documents and software program.

  13. Overview of Needs, Programs, and Implementations of Vocational Counseling and Guidance.

    ERIC Educational Resources Information Center

    Kunze, Karl R.

    The author begins by overviewing some recent criticisms of the vocational guidance field: (1) too little collaboration with industrial personnel; (2) an emphasis on processing masses of people rather than on the individual; and (3) the need for a systems approach to counseling. His impressions, from the vantage point of industry (i.e. the…

  14. Managing particulates in cell therapy: Guidance for best practice.

    PubMed

    Clarke, Dominic; Stanton, Jean; Powers, Donald; Karnieli, Ohad; Nahum, Sagi; Abraham, Eytan; Parisse, Jean-Sebastien; Oh, Steve

    2016-09-01

    The intent of this article is to provide guidance and recommendations to cell therapy product sponsors (including developers and manufacturers) and their suppliers in the cell therapy industry regarding particulate source, testing, monitoring and methods for control. This information is intended to help all parties characterize the processes that generate particulates, understand product impact and provide recommendations to control particulates generated during manufacturing of cell therapy products.

  15. Reading Guidance: Death and Grief.

    ERIC Educational Resources Information Center

    Smith, Alice Gullen

    1989-01-01

    Gives guidelines for the librarian using reading guidance (similar to bibliotherapy). Provides a nine-item annotated bibliography of novels for children and adolescents on the subject of death and grief. Appends an embryo list of categories suitable for content analysis of any file librarians might wish to keep on books suitable for use in this…

  16. THE STRESSOR IDENTIFICATION GUIDANCE DOCUMENT

    EPA Science Inventory

    THE STRESSOR IDENTIFICATION GUIDANCE DOCUMENT

    Susan M. Cormier, ORD/NRMRL, Susan B. Norton, ORD/NCEA, Glenn W. Suter, II ORD/NCEA, William Swietlik, OW lOST

    Science Question(s):

    MYP Science Question: How can multiple and possibly related causes of biological ...

  17. Atmospheric guidance techniques and performance

    NASA Technical Reports Server (NTRS)

    Harpold, J. C.; Gavert, D. E.

    1982-01-01

    The Orbiter entry guidance system controls the Space Shuttle Orbiter from the initial atmospheric penetration point to the point at which an earth relative velocity of 2500 feet/second is reached. At the latter point, control of the Orbiter is transferred to the terminal area energy management system. The entry guidance system is based on the concept that the range to be flown during entry is a unique function of the drag deceleration profile flown throughout the entry. The range prediction during entry is based on analytic equations which are simple drag deceleration functions of earth relative velocity above Mach 10.5 and energy with respect to the earth below Mach 10.5. Flight through the entry corridor is accomplished by linking these simple drag deceleration functions together in series in order to define a drag deceleration reference profile. The results of the first three Space Shuttle missions have not only verified the entry guidance concept but have also demonstrated the stability of the guidance system.

  18. Theater As A Guidance Technique

    ERIC Educational Resources Information Center

    Wolpert, William

    1973-01-01

    Guidance-drama activity provides (a) crisp definitions of selected issues; (b) potent modeling from the characters in the play, the students actively engaged in the play, and the students involved in the discussions that follow the play; and (c) a technique for peer-led discussions on sensitive issues. This article gives precise definition to the…

  19. Guidance: Interim Municipal Settlement Policy

    EPA Pesticide Factsheets

    Interim guidance and fact sheets regarding settlements involving municipalities or municipal waste under Section 122 CERCLA as amended by SARA. Interim policy sets forth the criteria by which EPA generally determines whether to exercise enforcement discretion to pursue MSW generators and transporters as PRPs.

  20. Abortion Information: A Guidance Viewpoint

    ERIC Educational Resources Information Center

    Wolleat, Patricia L.

    1975-01-01

    A number of questions relating to providing abortion information to teenagers can be raised from legal, ethical and philosophical standpoints. The purpose of this article is to examine abortion information-giving from the perspective of counseling and guidance theory and practice. (Author)