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  1. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... notice entitled ``Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications... the draft guidance for industry entitled ``Draft Guidance for Industry; Dietary Supplements:...

  2. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...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

    ... notification requirements for dietary supplements that contain an NDI (62 FR 49886, September 23, 1997). The... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... a draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient...

  3. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and...

  4. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  5. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false General industry guidance. 7.59 Section 7.59 Food... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and...

  6. 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... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and...

  7. 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... POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and Industry Responsibilities § 7.59 General industry guidance. A recall can be disruptive of a firm's operation and...

  8. 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...

  9. 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; Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems... Document: Repetitive Transcranial Magnetic Stimulation Systems.'' This guidance document describes a...

  10. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  11. 77 FR 20025 - Draft Guidance for Industry on Compliance Policy for Reporting Drug Sample Distribution...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Compliance Policy for... guidance for industry entitled ``Compliance Policy on Reporting Drug Sample Distribution Information Under... availability of a draft guidance for industry entitled ``Compliance Policy on Reporting Drug...

  12. 75 FR 48973 - Draft Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ...-1493. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2009 (74 FR 33030... 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...

  13. 36 CFR 223.242 - Supplemental guidance, Memorandum of Agreements and Memorandums of Understanding.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 2 2010-07-01 2010-07-01 false Supplemental guidance... Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE SALE AND DISPOSAL OF NATIONAL FOREST SYSTEM TIMBER... Supplemental guidance, Memorandum of Agreements and Memorandums of Understanding. Consistent with subparts...

  14. 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...

  15. 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... pathway. This draft guidance provides an overview of FDA's approach to quality considerations...

  16. 75 FR 22681 - Supplemental Guidance on Overdraft Protection Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

    ... goals, including building long term customer relationships, cross selling additional products, and... Guidance on Overdraft Protection Programs (Overdraft Guidance) OTS issued February 18, 2005 (70 FR 8428). OTS issued the Overdraft Guidance after notice and comment. See 69 FR 31858 (June 7, 2004)....

  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. 75 FR 54524 - Defense Federal Acquisition Regulation Supplement; Guidance on Personal Services (DFARS Case 2009...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-08

    ... Regulation Supplement; Guidance on Personal Services (DFARS Case 2009-D028) AGENCY: Defense Acquisition... Fiscal Year 2009 to require DoD to develop guidance related to personal services contracts. DATES... posted without change to http://www.regulations.gov , including any personal information provided....

  19. 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

    ... the availability of a guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' Because of increases in the number and complexity of ANDAs and FDA's desire to standardize... new drug applications to ensure the stability of new drug substances and products, FDA believes......

  20. Supplemental risk-assessment guidance for the Superfund program. Part 1. Guidance for Public-Health Risk Assessments. Part 2. Guidance for ecological Risk Assessments. Draft report (Final)

    SciTech Connect

    Not Available

    1989-06-01

    This guidance manual was developed to address the practical aspects and issues pertaining to the Superfund risk-assessment process for both public health and environment concerns. Part 1, Guidance for Public Health Risk Assessments, supplements the Superfund Public Health Evaluation Manual and Superfund Exposure Assessment Manual and the Endangerment Assessment Handbook. Explicit guidance on technical matters which should be followed in developing public health risk assessments for EPA Region 1. The guidance addresses hazard identification, dose-response assessment, exposure assessment, risk characterization, and uncertainty/limitations. Part 2 of the manual, Guidance for Ecological Risk Assessments, addresses the collection of site-specific data needed to support an ecological risk assessment, describes a framework for conducting the assessments, and provides several specific approaches for assessing risks to systems exposed to chemical contamination in different media.

  1. 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

    ... Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement... availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and... glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting...

  2. 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

    ... 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 of... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration...

  3. Taking Comprehensive Competency-Based Guidance to Business and Industry.

    ERIC Educational Resources Information Center

    Ammon, Tina K.

    This chapter discusses the successful implementation of the Arizona Comprehensive Competency-Based Guidance program model, and how lessons learned from this project can be applied to business and industry settings. Also discussed is the Career Decidedness Study, developed to improve counseling skills and the services offered to employees seeking…

  4. 75 FR 59268 - Draft Guidance for Industry: Acidified Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    .... 0910-0037; 73 FR 11649 at 11650, March 4, 2008). In that analysis, we estimated that there are 8,950... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Acidified Foods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration...

  5. 76 FR 81513 - Guidance for Industry: Prevention of Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a... September 8, 2009. In the Federal Register of August 12, 2010 (75 FR 48973), FDA made available a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Prevention of Salmonella...

  6. 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,...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions 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.''...

  8. 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...

  9. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

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

  10. 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

    ... 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 Rheumatoid Arthritis... guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.''...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling; Availability AGENCY... announcing the availability of a draft guidance for industry and review staff entitled...

  12. A SUPPLEMENTAL GUIDANCE MANUAL BASED ON INSTITUTIONAL REASEARCH.

    ERIC Educational Resources Information Center

    NIELSEN, MARJORIE L.

    THE GUIDANCE MANUAL HAS BEEN ORGANIZED TO PROVIDE A STATISTICAL BASIS FOR ANALYZING (1) THE NONSELECTIVE ADMISSION POLICY, (2) THE PERFORMANCE OF NATIVE, EVERETT JUNIOR COLLEGE STUDENTS WHO TRANSFER TO 4-YEAR COLLEGES, (3) THE PERFORMANCE OF TRANSFER STUDENTS TO THE JUNIOR COLLEGE WHO LATER ENROLL AT A 4-YEAR COLLEGE, (4) THE ESTABLISHMENT OF THE…

  13. 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

    ... Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief; Draft Guidance for Industry and FDA... for Pain Relief Intended for Over the Counter Use; Draft Guidance for Industry and FDA Staff''; (5... Output for Pain Relief; Draft Guidance for Industry and FDA Staff''; (6) ``Class II Special...

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

    ERIC Educational Resources Information Center

    US Department of Education, 2009

    2009-01-01

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

  15. 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.

  16. Vitamin D supplementation: less controversy, more guidance needed

    PubMed Central

    Stokes, Caroline S.; Lammert, Frank

    2016-01-01

    Vitamin D is a secosteroid hormone with multiple functions that extend beyond the regulation of intestinal calcium absorption. In recent years, the publication of research articles investigating associations between vitamin D status and health has reached an all-time high, and an increase in supplementation studies has followed. Given the pleiotropic effects of vitamin D, the scientific focus has gone beyond its known classic benefits on skeletal health to include diabetes and cardiovascular, neurological, respiratory, renal, and liver diseases, yet numerous conflicting findings continue to emerge. This review presents some examples of recent work within the context of controversies surrounding vitamin D and highlights key factors that should be considered when designing vitamin D supplementation regimens.

  17. Vitamin D supplementation: less controversy, more guidance needed

    PubMed Central

    Stokes, Caroline S.; Lammert, Frank

    2016-01-01

    Vitamin D is a secosteroid hormone with multiple functions that extend beyond the regulation of intestinal calcium absorption. In recent years, the publication of research articles investigating associations between vitamin D status and health has reached an all-time high, and an increase in supplementation studies has followed. Given the pleiotropic effects of vitamin D, the scientific focus has gone beyond its known classic benefits on skeletal health to include diabetes and cardiovascular, neurological, respiratory, renal, and liver diseases, yet numerous conflicting findings continue to emerge. This review presents some examples of recent work within the context of controversies surrounding vitamin D and highlights key factors that should be considered when designing vitamin D supplementation regimens. PMID:27594987

  18. Vitamin D supplementation: less controversy, more guidance needed.

    PubMed

    Stokes, Caroline S; Lammert, Frank

    2016-01-01

    Vitamin D is a secosteroid hormone with multiple functions that extend beyond the regulation of intestinal calcium absorption. In recent years, the publication of research articles investigating associations between vitamin D status and health has reached an all-time high, and an increase in supplementation studies has followed. Given the pleiotropic effects of vitamin D, the scientific focus has gone beyond its known classic benefits on skeletal health to include diabetes and cardiovascular, neurological, respiratory, renal, and liver diseases, yet numerous conflicting findings continue to emerge. This review presents some examples of recent work within the context of controversies surrounding vitamin D and highlights key factors that should be considered when designing vitamin D supplementation regimens. PMID:27594987

  19. 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...

  20. 77 FR 40068 - Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-06

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

  1. 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

    ... 1995 This guidance refers to previously approved collections of information found in FDA regulations...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... access to the guidance document. Submit electronic comments on the guidance to...

  2. 36 CFR 223.242 - Supplemental guidance, Memorandum of Agreements and Memorandums of Understanding.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 36 Parks, Forests, and Public Property 2 2012-07-01 2012-07-01 false Supplemental guidance... Memorandums of Understanding. Consistent with subparts G and H of this part, regional foresters may issue... G and H within 24 months from December 29, 2008 or those agreements will terminate....

  3. 15 CFR Supplement No. 1 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 2 2011-01-01 2011-01-01 false Guidance on Charging and Penalty... Pt. 766, Supp. 1 Supplement No. 1 to Part 766—Guidance on Charging and Penalty Determinations in... guidance does not apply to enforcement cases for antiboycott violations under part 760 of the EAR....

  4. 15 CFR Supplement No. 1 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 15 Commerce and Foreign Trade 2 2013-01-01 2013-01-01 false Guidance on Charging and Penalty... Pt. 766, Supp. 1 Supplement No. 1 to Part 766—Guidance on Charging and Penalty Determinations in... guidance does not apply to enforcement cases for antiboycott violations under part 760 of the EAR....

  5. 15 CFR Supplement No. 1 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 15 Commerce and Foreign Trade 2 2012-01-01 2012-01-01 false Guidance on Charging and Penalty... Pt. 766, Supp. 1 Supplement No. 1 to Part 766—Guidance on Charging and Penalty Determinations in... guidance does not apply to enforcement cases for antiboycott violations under part 760 of the EAR....

  6. 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...

  7. 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...

  8. 15 CFR Supplement No. 3 to Part 732 - BIS's “Know Your Customer” Guidance and Red Flags

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 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...

  9. 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...

  10. 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

    ... using a systems approach to minimize medication errors relating to product design. The draft guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Safety Considerations for... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication...

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Documenting Statistical Analysis...: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 197 entitled ``Documenting Statistical Analysis Programs and Data Files.'' This guidance is provided to...

  12. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Early Clinical Trials With Live... availability of a document entitled ``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic... submission of INDs for early clinical trials with live biotherapeutic products (LBPs). The guidance...

  13. 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... ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this guidance with labeling recommendations because of concerns that both healthcare providers and patients...

  14. 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...

  15. 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

    ..., 2011 (76 FR 10908), FDA announced the availability of a draft guidance for industry entitled... inpatient setting or an outpatient setting such as a clinic or infusion center. This guidance is intended...

  16. 78 FR 70953 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment... FR 55263), FDA announced the notice of availability for the draft guidance entitled ``Draft Guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on...

  17. 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...

  18. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... (74 FR 68629), FDA announced the availability of a draft guidance entitled ``Tobacco Health Document... 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...

  19. 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

    ... (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance... 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...

  20. 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

    ... (74 FR 13211), FDA announced the availability of the draft guidance entitled ``Guidance for Industry... Health and Human Services Food and Drug Administration Guidance for Industry: Use of Serological Tests To... Management and Budget Review; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce...

  1. 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

    ... and Red Flags No. Supplement No. 3 to Part 732 Commerce and Foreign Trade Regulations Relating to... Customer” Guidance and Red Flags “Know Your Customer” Guidance Various requirements of the EAR are...) Decide whether there are “red flags”. Take into account any abnormal circumstances in a transaction...

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pulmonary Tuberculosis... industry entitled ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' The purpose of the draft... tuberculosis. This guidance applies to the development of a single investigational drug as well as...

  3. 75 FR 63188 - Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Early Clinical Trials With Live... availability of a draft document entitled ``Guidance for Industry: Early Clinical Trials with Live... submission of INDs for early clinical trials with live biotherapeutic products (LBPs). DATES: Although...

  4. 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... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides... healthcare professional for administration to a patient instead of being dispensed directly to the...

  5. 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''...

  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

    ... the Federal Register of October 29, 2007 (72 FR 61171), FDA announced the availability of the draft... 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...

  7. 75 FR 14604 - Guidance for Industry on Anesthetics for Companion Animals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... Federal Register of December 17, 2008, (73 FR 76657), FDA published the notice of availability for a draft... 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...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Abbreviated New Drug Applications...) guidance for industry ``Q3B(R) Impurities in New Drug Products,'' which was announced in August 2006. DATES... and Research, Food and Drug Administration, 10903 New ] Hampshire Ave., Bldg. 51, rm. 2201,...

  9. 15 CFR Supplement No. 2 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., note (2000)), which are codified at 15 CFR 6.4. For violations that occurred before March 9, 2006, the... Determinations in Settlement of Administrative Enforcement Cases Involving Antiboycott Matters No. Supplement No... ADMINISTRATIVE ENFORCEMENT PROCEEDINGS Pt. 766, Supp. 2 Supplement No. 2 to Part 766—Guidance on Charging...

  10. 15 CFR Supplement No. 2 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., note (2000)), which are codified at 15 CFR 6.4. For violations that occurred before March 9, 2006, the... Determinations in Settlement of Administrative Enforcement Cases Involving Antiboycott Matters No. Supplement No... ADMINISTRATIVE ENFORCEMENT PROCEEDINGS Pt. 766, Supp. 2 Supplement No. 2 to Part 766—Guidance on Charging...

  11. 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

    ...: extension of comment period. SUMMARY: On March 8, 2010, (75 FR 10524), the Nuclear Regulatory Commission (NRC) published for public comment a document entitled: ``NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3... COMMISSION NUREG-0654/FEMA-REP-1, Rev. 1, Supplement 3, Guidance for Protective Action Recommendations...

  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

    ... 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..., Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD...

  13. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff... Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR...

  14. Apollo 16 mission Report. Supplement 1: Apollo 16 guidance, navigation, and control system performance analysis report

    NASA Technical Reports Server (NTRS)

    1972-01-01

    The results are reported of additional studies which were conducted to supplement conclusions drawn in the MSC Mission Report and analyses which were not completed in time to meet the Mission Report dealine. A detailed evaluation of the Abort Guidance System sensor assembly and results from the investigation of the X gyro loop anomaly are included. Further evidence is presented substantiating the excellent LM IMU performance obtained from preliminary indications. A detailed study is presented of the procedural changes implemented on Apollo 16 to diminish the number and duration of interruptions to the CSM DAP attitude maneuver during P20 Option 5 operations.

  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. International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; guidance for industry; availability. Notice.

    PubMed

    2015-01-27

    The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "S10 Photosafety Evaluation of Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Implementation of the Fee... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food Safety... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  18. 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... availability of a draft guidance for industry 211 entitled ``Residual Solvents in Animal ] Drug...

  19. 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

    ... Affecting the Hematopoietic System.'' That draft guidance, when finalized, is intended to supersede the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and FDA Staff: Investigational... Hematopoietic System; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  20. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... HUMAN SERVICES Food and Drug Administration Mobile Medical Applications; 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 the availability of the guidance...

  1. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Standards for Clinical Trial... entitled ``Standards for Clinical Trial Imaging Endpoints.'' The purpose of this draft guidance is to assist sponsors in the use of imaging endpoints in clinical trials of therapeutic drugs and...

  2. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

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

  4. 76 FR 72422 - Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-23

    ... food-producing animals. It does not create or confer any rights for or on any person and does not... of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration...-Producing Animals.'' The draft guidance, when finalized, is intended to provide guidance to industry...

  5. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Assessing the Effects of... Additives; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... Food Ingredients That Are Color Additives.'' The draft guidance, when finalized, will explain...

  6. 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

    ... Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft guidance... 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...

  7. 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

    ... a notice published in the Federal Register of June 22, 2010 (75 FR 35492), FDA announced the... 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...

  8. 75 FR 67987 - Guidance for Industry: Cellular Therapy for Cardiac Disease; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... regarding cellular delivery systems. In the Federal Register of April 2, 2009 (74 FR 14992), FDA announced... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Cellular Therapy for Cardiac Disease... Therapy for Cardiac Disease'' dated October 2010. The guidance document provides sponsors who...

  9. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing...

  10. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  11. 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...

  12. 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 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 draft guidance for...

  13. 75 FR 22812 - Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... April 20, 2010 (75 FR 20606). The notice announced the availability of a guidance entitled ``Tobacco.... SUPPLEMENTARY INFORMATION: In FR Doc. 2010-9134, appearing on page 20606, in the Federal Register of Tuesday... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document...

  14. 75 FR 2145 - Draft Guidance for Industry on Tobacco Health Document Submission; Availability; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-14

    ... Register of December 28, 2009 (74 FR 68629). The notice announced the availability of a draft guidance...., Rockville, MD 20850-3229, 240-276-1717, May.Nelson@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. E9... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Tobacco Health...

  15. 78 FR 68852 - Draft Guidance for Industry on Acrylamide in Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

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

  16. 78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Pre-Launch Activities Importation Requests; 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...

  17. 75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Qualification Process for... entitled ``Qualification Process for Drug Development Tools.'' This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple...

  18. 78 FR 74154 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... Wednesday, September 11, 2013 (78 FR 55727), announcing the availability of the draft guidance for industry... INFORMATION: I. Background In the Federal Register of Wednesday, September 11, 2013 (78 FR 55727),...

  19. 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

    ... tretinoins, beta blockers (especially those entering the brain), reserpine, drugs for smoking cessation, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials; Availability AGENCY: Food and Drug Administration, HHS....

  20. 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...

  1. 76 FR 44013 - Draft Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Implementation of Acceptable Full- Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma; Availability AGENCY: Food and Drug Administration, HHS. ACTION:...

  2. 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

    ... Staff: The Content of Investigational Device Exemption and Premarket Approval Applications for Low... document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of... Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA)...

  3. 77 FR 66621 - Draft Guidance for Industry on Bioequivalence Recommendation for Lenalidomide Capsules; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence...), approved by FDA on December 27, 2005, is a thalidomide analogue indicated for the treatment of:...

  4. 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

    ... Arrangements for Drugs: Quality Agreements; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This... drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality,...

  5. 78 FR 46965 - Draft Guidance for Industry on Bioequivalence Recommendations for Mesalamine Rectal Suppositories...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

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

  6. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  7. 78 FR 73200 - Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  8. 77 FR 35688 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... HUMAN SERVICES Food and Drug Administration Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  9. 78 FR 52777 - Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2007D-0168) Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  10. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fluticasone propionate...; salmeterol xinafoate. Advair Diskus (fluticasone propionate; salmeterol xinafoate), new drug application... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... 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 Drug... to generic drug manufacturers to follow International Conference on Hamonisation (ICH)...

  12. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... Meprobamate Methotrexate Sodium (multiple RLDs) Methylprednisolone Acetate Metoclopramide HCl N Nadolol... Tosylate T Tamoxifen Citrate Telbivudine Temazepam Terbinafine HCl Toremifene Citrate V Voriconazole...

  13. 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...

  14. 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...

  15. 76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... human foods and direct-human-contact animal foods. It does not create or confer any rights for or on any... 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...

  16. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... Systems.'' This draft guidance provides recommendations to developers and manufacturers of TDDS, TMDS, and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Use of Nucleic Acid Tests To... ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From... donor screening test. The guidance recommends the use of an FDA-licensed nucleic acid test ] (NAT)...

  18. 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...

  19. 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...

  20. 78 FR 74154 - Draft Guidance for Industry on Size, Shape, and Other Physical Attributes of Generic Tablets and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-10

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Size, Shape, and Other... guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.'' This guidance discusses FDA recommendations for the size, shape, and other physical attributes...

  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

    ...; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use... Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.'' This guidance document... ``Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use''...

  2. 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

    ... Bioequivalence Data for Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants...

  3. 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

    ... Federal Register of July 19, 2007 (72 FR 39631), FDA announced the availability of the draft guidance... developed this guidance document to assist industry in preparing a Premarket Notification (510(k)) for...

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007... information to the industry in complying with the Reportable Food Registry requirements prescribed by the...

  5. 77 FR 18827 - Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose Injection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... Recommendations for Iron Sucrose Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide...

  6. 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.

  7. 78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... studies on an old system. The draft of this guidance was issued on January 5, 2009 (74 FR 302). The... guidance is also applicable for some 510(k) cleared devices for which transition to a new system presents...; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and...

  8. 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

    ...) System for Drug Establishment Registration.'' This draft guidance specifies the UFI system for... guidance specifies the UFI system as follows. At this time, FDA's preferred UFI for a drug establishment is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Specification of the...

  9. 75 FR 22601 - Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-29

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

  10. 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

    ...; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System... Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' This guidance document... system, but it remains subject to comment in accordance with the agency's good guidance practices...

  11. 78 FR 68460 - Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. SUMMARY: The Food and Drug...

  12. 77 FR 7586 - Draft Guidance for Industry on Bioequivalence Recommendation for Nitroglycerin Metered Spray...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    ... 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ``Bioequivalence... attack or prophylaxis of angina pectoris due to coronary artery disease. Nitromist (nitroglycerin lingual... attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray...

  13. 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,...

  14. 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

    .... Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a final rule requiring shell egg... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 118 Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During...

  15. 78 FR 44483 - Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    .... Background In the Federal Register of July 9, 2009 (74 FR 33030), FDA issued a final rule requiring shell egg... HUMAN SERVICES Food and Drug Administration 21 CFR Part 118 Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During...

  16. 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

    ..., 2009 (74 FR 33030), we issued a final rule requiring shell egg producers to implement measures to... ``Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 118 Guidance for Industry: Questions...

  17. 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

    ... on February 10, 2004 (69 FR 6309). DATES: Submit either electronic or written comments on Agency... Federal Register of January 23, 2002 (67 FR 3060), FDA published a final rule that amended the OTC drug... HUMAN SERVICES Food and Drug Administration (Formerly 2004D-0027) Guidance for Industry on Time...

  18. Industrial Prep, Volume Four, Junior Year--Contents: Mathematics and Guidance.

    ERIC Educational Resources Information Center

    Hackensack Public Schools, NJ.

    As part of a 3-year comprehensive interdisciplinary program in industrial preparation for vocational students, this 11th Grade teaching guide consists of units on technical mathematics and guidance. Designed as supportive material for related physics and English curriculums, the first four sections of Volume 4 on algebra, vectors, simple machines,…

  19. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ..., including CTR, CTT, and Low Glucose Suspend systems. On June 22, 2011 (76 FR 36542), FDA announced the... Staff; the Content of Investigational Device Exemption and Premarket Approval Applications for... document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational...

  20. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced...

  1. 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

    ... 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 Electronic Source Data in... Register of Tuesday, November 20, 2012 (77 FR 69632). The document announced the availability of a...

  2. 78 FR 26785 - Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ...DHQ documents under 21 CFR 601.12. In the Federal Register of October 24, 2011 (76 FR 65735), FDA... Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of... ``Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire...

  3. 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

    ... the Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft... 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...

  4. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of...

  5. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-11

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2007D-0169) Guidance for Industry on Bioequivalence Recommendations for Specific Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of...

  7. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration..., Including Certain First in Human Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  8. 78 FR 15370 - Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-11

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Availability AGENCY: Food and Drug Administration,...

  9. 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... ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted...

  10. 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...

  11. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-02

    ... stability, as well as enhance processability of the solid material inputs in drug product manufacture... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  12. 77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... HUMAN SERVICES Food and Drug Administration Guidances for Industry and Food and Drug Administration... Approval and Premarket Notification (510(k)) Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  13. 77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  14. 77 FR 14022 - Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation-Derived...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ... INFORMATION: I. Background In the Federal Register of March 14, 2011 (76 FR 13629), FDA published the notice... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Chemistry, Manufacturing, and... entitled ``Chemistry, Manufacturing, and Controls (CMC) Information-- Fermentation-Derived...

  15. 75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Federal Register of June 1, 2006 (71 FR 31194), FDA published the notice of withdrawal and revision of... Substance Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug... availability of a guidance for industry 169 entitled ``Drug Substance Chemistry, Manufacturing, and...

  16. 78 FR 42387 - Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-15

    ... Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new.... 78, No. 135 / Monday, July 15, 2013 / Notices#0;#0; ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Circumstances That Constitute Delaying,...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration... Electronic Healthcare Data Sets; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic...

  18. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials... provide guidance to industry on enrichment strategies that can be used in clinical trials intended...

  19. 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

    ... guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a... 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...

  20. 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

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

  1. 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

    ... 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 Scale-Up and Post-Approval... post-approval changes (SUPAC) draft guidance for industry entitled ``SUPAC: Manufacturing...

  2. 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....

  3. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Providing Submissions in Electronic...; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance to industry entitled ``Providing Submissions...

  4. 75 FR 26967 - Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-13

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

  5. 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... systems for aesthetic use into class II (special controls). The guidance document is immediately in...

  6. 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

    ... of May 2, 2006 (71 FR 25844), we announced the availability of a guidance entitled ``Guidance on the... Cosmetic Act; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal... 403(w) of the Federal Food, Drug, and Cosmetic Act,'' dated April 2006, that was announced in...

  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. 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...

  9. 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...

  10. 78 FR 68461 - Guidance for Industry: Studies To Evaluate the Utility of Anti-Salmonella Chemical Food Additives...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

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

  11. 78 FR 70953 - Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ...The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1)'', published in the Federal Register of September 10, 2013 (78 FR 55261). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment......

  12. 78 FR 2676 - Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abuse-Deterrent Opioids-- Evaluation and Labeling; 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...

  13. 77 FR 69634 - Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of guidance...

  14. 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... entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... classification information.'' In the Federal Register of April 29, 2010 (75 FR 22601), FDA announced the...; 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...

  16. 77 FR 35986 - Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-15

    ... certain OTC drugs. FDA is issuing this small entity compliance guide as level 2 guidance consistent with... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved...

  17. 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

    ....'' Because of the public health implications of both epidemic and pandemic influenza, the variable nature of... effects under epidemic and pandemic conditions. A draft notice of availability of this guidance was... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Influenza: Developing Drugs...

  18. 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

    ... Use of Bayesian Statistics in Medical Device Clinical Trials.'' This guidance summarizes FDA's current... device clinical trials. DATES: Submit electronic or written comments on agency guidances at any time... Use of Bayesian Statistics in Medical Device Clinical Trials'' to the Division of Small...

  19. 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

    ... Controls Guidance Document: Topical Oxygen Chamber for Extremities'' (71 FR 17476). Interested persons were... Register of April 6, 2006 (71 FR 17390), FDA's Center for Devices and Radiological Health (CDRH) published...; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability...

  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

    ...; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability...: Low Level Laser System for Aesthetic Use.'' This guidance document describes a means by which low level laser systems for aesthetic use may comply with the requirement of special controls for class...

  1. 75 FR 52427 - Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-25

    ... requirements for nutrition labeling of standard menu items for chain retail food establishments and chain... menu items (``chain retail food establishments'') to disclose specific nutrition information about... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Questions and Answers Regarding...

  2. 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.

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

    PubMed

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

    2016-01-01

    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

  4. 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

  5. 29 CFR 2509.08-1 - Supplemental guidance relating to fiduciary responsibility in considering economically targeted...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... bulletin modifies and supersedes the guidance set forth in interpretive bulletin 94-1 (29 CFR 2509.94-1... objectives, and may not select investments on the basis of any factor outside the economic interest of the... Department has issued a regulation, at 29 CFR 2550.404a-1, interpreting the prudence requirements of ERISA...

  6. 29 CFR 2509.08-1 - Supplemental guidance relating to fiduciary responsibility in considering economically targeted...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... bulletin modifies and supersedes the guidance set forth in interpretive bulletin 94-1 (29 CFR 2509.94-1... objectives, and may not select investments on the basis of any factor outside the economic interest of the... Department has issued a regulation, at 29 CFR 2550.404a-1, interpreting the prudence requirements of ERISA...

  7. 29 CFR 2509.08-1 - Supplemental guidance relating to fiduciary responsibility in considering economically targeted...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... bulletin modifies and supersedes the guidance set forth in interpretive bulletin 94-1 (29 CFR 2509.94-1... Department has issued a regulation, at 29 CFR 2550.404a-1, interpreting the prudence requirements of ERISA as... that the prudence requirements of section 404(a)(1)(B) are satisfied if (1) the fiduciary making...

  8. 29 CFR 2509.08-1 - Supplemental guidance relating to fiduciary responsibility in considering economically targeted...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... bulletin modifies and supersedes the guidance set forth in interpretive bulletin 94-1 (29 CFR 2509.94-1... Department has issued a regulation, at 29 CFR 2550.404a-1, interpreting the prudence requirements of ERISA as... interests of plan participants and their beneficiaries. The Department rejects a construction of ERISA...

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... bulletin modifies and supersedes the guidance set forth in interpretive bulletin 94-1 (29 CFR 2509.94-1... Department has issued a regulation, at 29 CFR 2550.404a-1, interpreting the prudence requirements of ERISA as... interests of plan participants and their beneficiaries. The Department rejects a construction of ERISA...

  10. Solicitation of information and recommendations for developing OIG compliance program guidance for the durable medical equipment industry--HHS. Notice.

    PubMed

    1998-08-01

    This Federal Register notice seeks the input and recommendations of interested parties into the OIG's development of a compliance program guidance for the durable medical equipment (DME) industry, its providers and suppliers. Many providers and provider organizations have expressed an interest in better protecting their operations from fraud and abuse. Previously, the OIG has developed compliance program guidances for hospitals, clinical laboratories and home health agencies. In order to provide clear and meaningful guidance to those segments of the health care industry involved in the supply and distribution of DME, we are soliciting comments, recommendations and other suggestions from concerned parties and organizations on how best to develop compliance program guidance and reduce fraud and abuse within the DME industry.

  11. 78 FR 36196 - Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... Hematopoietic System'' dated June 2013. The draft guidance document provides recommendations for manufacturers... Affecting the Hematopoietic System'' dated June 2013. The draft guidance document, when finalized, will... Patients with Disorders Affecting the Hematopoietic System.'' That draft guidance, when finalized,...

  12. 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

    ... Pressure Wound Therapy; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction... Device Intended for Negative Pressure Wound Therapy (NPWT)'' to the Division of Small...

  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

    ... for the Topical Approximation of Skin; Availability AGENCY: Food and Drug Administration, HHS. ACTION... Intended for the Topical Approximation of Skin.'' This guidance document describes a means by which tissue adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply...

  14. 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

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

    PubMed Central

    2006-01-01

    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

  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

    ... draft guidance provides responses to questions FDA has received on the Family Smoking Prevention and... effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  17. 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

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... previously conducted clinical trials with various effective antibiotics. The draft guidance also provides a... of information referred to in the guidance for clinical trial sponsors ``Establishment and...

  18. 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...

  19. 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...

  20. 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...

  1. 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... confirm the species origin of crude heparin in each lot of every shipment before use in the manufacture or... testing crude heparin and for the identification of species origin. The method should be based on...

  2. 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 Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food...

  3. 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

    ... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period... entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological... guidance to industry on enrichment strategies that can be used in clinical trials intended to...

  4. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment Period... entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular... assist in designing early-phase clinical trials of CGT products. In the notice, we requested comments...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design... clinical trials. This guidance is intended to assist the pharmaceutical industry and other investigators... subtype is the ideal primary efficacy assessment tool in clinical trials used to support labeling...

  6. 78 FR 15955 - Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Dispute Resolution: Appeals Above the Division Level; Availability AGENCY: Food and Drug Administration... a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above... staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' In the course of...

  7. 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

    ... 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... Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and...

  8. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Implementation of an Acceptable Full... Donors of Source Plasma; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document...

  9. 75 FR 29768 - Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-27

    ... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 1997D-0318) Guidance for Industry...) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  10. 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

    ... drugs that are intended to be used in combination to treat a disease or condition. A sponsor may elect... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination; Availability AGENCY: Food and Drug Administration, HHS....

  11. 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 Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  12. 76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... INFORMATION: In a notice published in the Federal Register of July 26, 2007 (72 FR 41080), FDA announced the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal...

  13. 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...

  14. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

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

  15. 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... notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The...

  16. 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...

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Limiting the Use of Certain...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,...

  18. 78 FR 45930 - Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... Register of April 13, 2011 (76 FR 20686), FDA announced the availability of a draft guidance for industry...--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and... new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to...

  19. 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...

  20. 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 Generic Drug Facilities, Sites, and Organizations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  1. 78 FR 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  2. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of...

  3. 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... to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related... ANDAs and PASs to ANDAs for which the applicant is seeking approval of a new strength of the...

  4. 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...

  5. 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....

  6. 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...

  7. 75 FR 53972 - Guidance for Industry; Small Entities Compliance Guide-The Index of Legally Marketed Unapproved...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Industry; Small Entities Compliance Guide--The... Species Animal Health Act of 2004 (MUMS). DATES: Submit either electronic or written comments on...

  8. 77 FR 22328 - Guidance for Industry on the Judicious Use of Medically Important Antimicrobial Drugs in Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... Important Antimicrobial Drugs in Food-Producing Animals; Availability AGENCY: Food and Drug Administration... a guidance for industry (GFI 209) entitled ``The Judicious Use of Medically Important Antimicrobial... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit...

  9. 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...

  10. 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

    ... Tobacco to Protect Children and Adolescents'' (75 FR 13225, March 19, 2010, codified at 21 CFR part 1140... Staff; Civil Money Penalties for Tobacco Retailers: Responses to Frequently Asked Questions... Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Civil...

  11. 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)...

  12. 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

    ... necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as...

  13. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

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

  14. 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:...

  15. 78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Investigations--A Risk-Based Approach to Monitoring; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Oversight of Clinical Investigations--A Risk-Based Approach to...

  16. 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

  17. 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. PMID:23543602

  18. 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

    ... control recommendations are listed for the natural toxin action level for diarrhetic shellfish poisoning... the third edition to include ciguatera fish poisoning guidance for northern Gulf of Mexico...

  19. 78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-24

    ... HUMAN SERVICES Food and Drug Administration Global Unique Device Identification Database; Draft Guidance... ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate... device labelers (in most instances, the device manufacturer) will interface with the GUDID, as well...

  20. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine...

  1. 78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... accurate and complete data. In the Federal Register of November 20, 2012 (77 FR 69632), FDA issued a draft... FR 76049)). Most of the comments sought clarification on the topics discussed in the guidance. We... Clinical Investigations,'' as mentioned in the guidance, is discussed in the May 10, 2007 (72 FR...

  2. 77 FR 70167 - Draft Guidance for Industry on Vaginal Microbicides: Development for the Prevention of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ... guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug... collections of information referred to in the guidance for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have been approved under OMB...

  3. 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

    ... Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in...: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and...-resistant Staphylococcus aureus. The definitions of ABSSSI and the designs of ABSSSI clinical trials...

  4. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of draft guidance documents for 11 neurological and physical medicine devices. The document was...

  5. 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

    ... guidance practices regulation. FDA withdrew the 1994 draft on January 5, 2005 (70 FR 824) and is now... Staff; Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications... Administration (FDA) is announcing the availability of the draft guidance document entitled ``Heart...

  6. 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...

  7. 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

    ... (71 FR 3999), FDA issued final guidances on the content and format of the ``Adverse Reactions'' and ``Clinical Studies'' sections of labeling. In the Federal Register of October 19, 2009 (74 FR 53507), FDA... Register of March 3, 2009 (74 FR 9250), FDA issued a draft guidance on the content and format of...

  8. 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

    ... Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has been developed for... residual solvents in new animal drugs (referred to as pharmaceuticals or veterinary medicinal products in this guidance) for the safety of the target animal as well as for the safety of human consumers...

  9. 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

    ..., November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been... (76 FR 70151), FDA published a notice announcing the availability of the draft guidance entitled ``FDA... Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period AGENCY: Food and...

  10. 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....

  11. 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 draft guidance published in the Federal Register of June 9, 2010 (75 FR 32791). The original...

  12. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in......

  13. 75 FR 35018 - Eagle Industrial Power Services (IL), LLC; Supplemental Notice That Initial Market-Based Rate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Eagle Industrial Power Services (IL), LLC; Supplemental Notice That.... This is a supplemental notice in the above-referenced proceeding of Eagle Industrial Power Services...

  14. 75 FR 35016 - EDF Industrial Power Services (NY), LLC; Supplemental Notice That Initial Market-Based Rate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission EDF Industrial Power Services (NY), LLC; Supplemental Notice That Initial... supplemental notice in the above-referenced proceeding of EDF Industrial Power Services (NY), LLC's...

  15. 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

    ... quantitate the anti-seizure drugs lamotrigine and zonisamide in serum. The Therapeutic Drug Monitoring (TDM... TDM Roundtable recommendations. Some of the general concepts in this guidance may also be helpful...

  16. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... (66 FR 28526), FDA issued the first version of this guidance. Since then, substantial scientific and... where needed, such as the sections on chromatography and ligand-binding assays. The changes...

  17. 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

    ... current thinking regarding the overall development program and clinical trial designs for drugs to support... Administration Safety and Innovation Act that FDA review guidances for the conduct of clinical trials...

  18. 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

    ..., 2008 (73 FR 29519), FDA announced the availability of the draft guidance of the same title. FDA... electronic comments to http://www.regulations.gov . FOR FURTHER INFORMATION CONTACT: Paul E. Levine,...

  19. 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

    ... Register of June 26, 2003 (68 FR 38083), FDA announced the availability of the draft guidance entitled... Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr.,...

  20. 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...

  1. 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

    ... Influenza Pandemic.'' In the Federal Register of December 16, 2008 (73 FR 76364), FDA published notice of... 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...

  2. 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.

  3. Economics of resource supplementation: the development of an ethanol fuel industry

    SciTech Connect

    Underwood, D.A.

    1986-01-01

    Technological supplementation is introduced into the intertemporal resource allocation problem. Supplementation allows a renewable resource to be partially substituted for a nonrenewable resource in a fixed production. The reduced input quantity of the nonrenewable in the end product increases its uselife. There is an inverse relationship between the supplementation date and uselife. Using the ethanol fuel industry as an example, supplementation benefits take three forms: (1) the uselife of petroleum to produce gasoline is increased; (2) when petroleum's exponentially growing price exceeds ethanol's constant price, refiners earn an economic profit by pricing fuel at petroleum's opportunity cost; and (3) a harmful externality is reduced as ethanol replaces lead in gasoline. The private switch point occurs when a relative price advantage exists. However, this may not be the optimal switch point. Supplementation prior to the private switch will require a subsidy equal to the input price differential. A unique level of production capacity is required for the optimal switch point. Capacity development requires identification of an investment path. Attempts to compress the investment interval will increase total capacity cost per unit, the final price of ethanol, and hence, the total subsidy cost for any switch point.

  4. 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. PMID:16466091

  5. 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,...

  6. 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

    ... regarding the overall development program and clinical trial designs for drugs to support an indication for... Innovation Act of 2012 that FDA review guidances for the conduct of clinical trials with respect to... for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data...

  7. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

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

  8. 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

    ... clinical trial designs to support approval of drugs. DATES: Although you can comment on any guidance at any... trial sponsors ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have been... margin based on historical observational data compared to the results of previously conducted...

  9. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... tobacco smoke; Scientific evidence is not available and, using the best available scientific methods... application and the scientific evidence FDA recommends you submit to support your application. The draft... guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing...

  10. 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

    ... September 30, 2008 (73 FR 58604, October 7, 2008); the comment period closed on January 5, 2009. FDA held.../biological products that provide image contrast enhancement. The final guidance announced in this document... developers of medical imaging devices and imaging drug/ biological products that provide image...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... Recommendations for Iron Sucrose; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... entitled ``Bioequivalence Recommendations for Iron Sucrose.'' The recommendations provide specific...

  13. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title dated... Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues,...

  14. 78 FR 55727 - Draft Guidance for Industry on Recommendations for Preparation and Submission of Animal Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-11

    ... Preparation and Submission of Animal Food Additive Petitions; Availability AGENCY: Food and Drug... Submission of Animal Food Additive Petitions.'' This draft guidance describes the types of information that...) submitted for food additives intended for use in food for animals. It is intended to help the...

  15. 76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ..., 2011 (76 FR 70150). In the notice, FDA requested comments on the draft guidance that addresses the.... Background In the Federal Register of November 10, 2011 (76 FR 70150), FDA published a notice announcing the... mitigation strategies, under the investigational device exemption (IDE) requirements. The Agency is...

  16. 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...

  17. 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

    ... to protect children and adolescents. One provision restricts the use of a trade or brand name of a... children and adolescents under the age of 18. This guidance document will be implemented immediately, but... (75 FR 13225), FDA published final regulations restricting the sale and distribution of cigarettes...

  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

    ... (21 CFR part 312, subpart I) went into effect on October 13, 2009 (74 FR 40900). These regulations... implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring,...

  19. 75 FR 13562 - Revised Draft Guidance for Industry on Pharmacokinetics in Patients With Impaired Renal Function...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-22

    ... 15, 1998 (63 FR 27094), FDA announced the availability of a guidance entitled ``Pharmacokinetics in... its metabolites, changes in renal metabolism can also occur. Renal impairment can also adversely affect some pathways of hepatic and/or gut drug metabolism and has been associated with other...

  20. 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

    ... the quality of the premarket submission. The draft of this guidance was issued October 25, 2007. DATES... Code of Federal Regulations, subchapter H. In the Federal Register of October 25, 2007 (72 FR 60682...://www.regulations.gov or the CBER Internet site at...

  1. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice... Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act.'' FDA is... information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is...

  2. 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

    ... 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 persons submitting applications for new tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C...

  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

    ... The draft guidance refers to previously approved collections of information found in FDA regulations.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document... donor history information from frequent donors of blood and blood components that is consistent with...

  4. 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....

  5. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-07

    ...) application for the injector alone. For a combination product that includes the injector, the marketing...) or a PMA application for the injector alone. For a combination product that includes the injector... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance...

  6. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... guidance published in the Federal Register on July 12, 2011 (76 FR 40921), and the comment period closed on...; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology... for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.''...

  7. 76 FR 51038 - Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... during product design and development--as well as during manufacturing and product life-cycle management... development--as well as during manufacturing and product life-cycle management--to ensure that the amount of... August 3, 2010 (75 FR 45640), FDA announced the availability of the draft version of this guidance....

  8. 77 FR 71008 - Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... June 22, 2010. In a notice published in the Federal Register of June 8, 2010 (75 FR 32481), FDA... Rotational Warning Plans for Smokeless Tobacco Products; Withdrawal of Guidance AGENCY: Food and Drug... Smokeless Tobacco Products,'' that was announced in the Federal Register on June 8, 2010. DATES:...

  9. 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),...

  10. 77 FR 20030 - Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... the HPHC list requirement (76 FR 5387, January 31, 2011). The guidance is available on the Internet at..., on August 12, 2011, FDA issued a document (the HPHC notice; 76 FR 50226) in the Federal Register... Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug,...

  11. 76 FR 68768 - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... studies of these products. The guidance also provides recommendations for the design of clinical trials... provides recommendations for the design of clinical trials for cancer vaccines conducted under an IND... recommendations for the design of clinical trials for cancer vaccines conducted under an IND to support...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

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

  13. 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

    ... accordance with ICH E2C (see 62 FR 27470 (May 19, 1997) and 69 FR 5551 (Feb. 5, 2004)) instead of a PADER... with an existing PSUR waiver to substitute the PBRER for the PSUR without submitting a new waiver...Information/Guidances/default.htm ,...

  14. 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

    ..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not... detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  15. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time. DATES... Assisting in the Diagnosis of C. difficile Associated Disease'' issued on May 31, 1990. It is updated to... C. difficile nucleic acids (e.g., C. difficile toxin B gene by nucleic acid amplification...

  16. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ..., published in the Federal Register of August 7, 2001 (66 FR 41247). The draft guidance is being issued..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism..., including Source Plasma, with recommendations intended to assist with determining which reporting...

  17. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... of the classification. On December 2, 2011 (76 FR 75551), FDA announced the availability of the draft... 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...

  18. 75 FR 75483 - Guidance for Industry: Recommendations for Blood Establishments: Training of Back-Up Personnel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... guidance, the H1N1 influenza pandemic has waned in the United States and disruptions in the blood supply..., and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus'' dated November 2009... in Response to Pandemic (H1N1) 2009 Virus'' (November 2009). At that time, we anticipated that...

  19. 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

    ... Helicobacter pylori; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food... detecting Helicobacter pylori (H. pylori). This draft guidance is not final nor is it in effect at this time... Detection of Antibodies to Helicobacter pylori,'' to suggest information that submitters provide that...

  20. 77 FR 74195 - Draft Guidance for Industry and Food and Drug Administration Staff; Design Considerations for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Staff; Design Considerations for Devices Intended for Home Use; Availability AGENCY: Food and Drug... availability of the draft guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This document is intended to assist manufacturers in designing and developing home use medical devices...

  1. 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...

  2. 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

    ... the FD&C Act, FDA is issuing this draft guidance, announcing its determination that submission types... files and advertising and promotional labeling submissions. However, FDA accepts and strongly encourages the submission of master files and advertising and promotional labeling materials electronically,...

  3. 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... pharmaceutical industry on the elements of process validation for the manufacture of human and animal drug and... broad spectrum of the pharmaceutical industry. In response to comments received on the draft...

  4. 15 CFR Supplement No. 2 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Determinations in Settlement of Administrative Enforcement Cases Involving Antiboycott Matters No. Supplement No... Penalty Determinations in Settlement of Administrative Enforcement Cases Involving Antiboycott Matters (a... enforcement program. BIS carefully considers each settlement offer in light of the facts and circumstances...

  5. 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

    ... Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia Species Detection... Guidance Document: In 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...

  6. 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.

  7. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... industry entitled ``Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations ] for... Plasma HIV- RNA Measurements--Clinical Considerations for Accelerated and Traditional Approval''...

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

    PubMed

    Arpinelli, Fabio; Bamfi, Francesco

    2006-01-01

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

  9. 78 FR 36769 - EDF Industrial Power Services (OH), LLC; Supplemental Notice That Initial Market-Based Rate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission EDF Industrial Power Services (OH), LLC; Supplemental Notice That Initial... notice in the above-referenced proceeding, of EDF Industrial Power Services (OH), LLC's application...

  10. 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...

  11. 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

    ... Preparedness Program Manual and Supplement 4 to NUREG-0654/FEMA-REP-1, Rev.1 (74 FR 23198 published on May 18... comments, see the ``Announcement of Issuance for Public Comment, Availability'' (at 75 FR 10524, on March 8... of availability, titled ``Announcement of Issuance for Public Comment, Availability'' (75 FR...

  12. 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…

  13. 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…

  14. 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

  15. 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... availability of the draft guidance entitled ``Implanted Blood Access Devices for Hemodialysis.'' This guidance was developed to support the reclassification of the Implanted Blood Access Devices for...

  16. 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

    ... manufactured, and should have an independent air handling system. A draft version of this guidance was... practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on...

  17. 76 FR 81510 - Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... Notifications .'' FDA developed this draft guidance document to provide a contemporary perspective on how FDA... This draft guidance serves to update FDA's perspective on the Agency's approach to the 510(k)...

  18. 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

    ... Federal Register of August 15, 2012 (77 FR 48990), we made available a draft guidance entitled ``Guidance..., as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response...

  19. 75 FR 53971 - Guidance for Industry and Food and Drug Administration Staff; Impact-Resistant Lenses: Questions...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-02

    ...; Impact-Resistant Lenses: Questions and Answers; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on...

  20. 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.

  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

    ... Drug Administration Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for... entitled ``Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for...

  2. 76 FR 64228 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

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

  3. 75 FR 59726 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

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

  4. 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

    ... reducing the risk of CFP. DATES: Submit either electronic or written comments on FDA guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to Division of Seafood Safety/Office of... written comments on the guidance to the Division of Dockets Management (HFA-305), Food and...

  5. 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; Use of ``Light,'' ``Mild,'' ``Low,'' or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  6. 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

    ... decompensated cirrhosis and those co-infected with human immunodeficiency virus (HIV). The guidance also... experienced, patients without cirrhosis, patients with compensated and decompensated cirrhosis, and...

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

    PubMed

    2016-07-19

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

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

    PubMed

    2016-07-19

    The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance. PMID:27459749

  9. 76 FR 78670 - Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

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

  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

    ... either electronic or written comments on the draft guidance by September 14, 2012. ADDRESSES: Submit... Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002; or Office of Communication, Outreach and... section for information on electronic access to the guidance. Submit electronic comments on the...

  11. 75 FR 73107 - Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... this draft guidance is to assist clinical trial sponsors and investigators in the development of... bacterial pneumonia (VABP). The science of clinical trial design and our understanding of these diseases... Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors...

  12. 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

    ... labeling in a future guidance. In the Federal Register of July 14, 2009 (74 FR 34021), FDA announced the... Identifiers Into Solid Oral Dosage Form Drug Products for Anticounterfeiting; Availability AGENCY: Food and... Into Solid Oral Dosage Form Drug Products for Anticounterfeiting.'' This guidance...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food and... Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.'' This draft guidance advises... of new animal drugs for use in companion animals. The intent of the guidance is to...

  15. 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...

  16. 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

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 10, 2010 (75 FR 32952), FDA announced... 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...

  17. 77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-27

    ... guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at... professionals, hospital purchasing departments, and manufacturers of enteral feeding tubes regarding luer lock... Misconnections With Small-Bore Connectors Intended for Enteral Applications,'' you may either send an...

  18. 76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document... 14, 2011 (76 FR 41506), FDA published a notice announcing the availability of the draft guidance... Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and...

  19. 76 FR 5386 - Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-31

    ... same title dated January 2001 (January 31, 2001, 66 FR 8410). The draft guidance, when finalized, will... of Whole Blood and Blood Components Intended for Transfusion; Availability AGENCY: Food and Drug... Blood and Blood Components Intended for Transfusion'' dated January 2011. The draft guidance...

  20. 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

    ... TV ads will be subject to a 45-calendar day review clock by FDA. DATES: Although you can comment on... on this draft guidance before it begins work on the final version of the guidance, submit either... table 1 of this document. There is a 45-day review clock for TV ads submitted under section 503B....

  1. 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

    ... 8, 2013 (78 FR 9396), FDA announced the availability of the draft guidance of the same title. FDA...; 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...

  2. 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

    ... individual case safety reports to regulatory authorities, automated data mining techniques, more attention to... 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:...

  3. 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

    ... Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to... we believe that an alternative regulatory program, comprised of alternative technology such as two dimensional symbology, could render the use of linear bar codes unnecessary for patient safety and...

  4. 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

    ... packets containing beads). In the Federal Register of January 19, 2011 (76 FR 3144), FDA announced the... recommendations in this guidance are based on literature on chewing and swallowing particle size and on...

  5. 75 FR 22814 - Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... (70 FR 43439), FDA announced the availability of the draft guidance of the same title. FDA received... INFORMATION CONTACT: Paul Levine, Center for Biologics Evaluation and Research (HFM-17), Food and...

  6. 77 FR 7584 - Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

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

  7. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

    ... Staff; Total Product Life Cycle: Infusion Pump--Premarket Notification Submissions; Availability AGENCY... announcing the availability of the draft guidance document entitled ``Total Product Life Cycle: Infusion Pump... Life Cycle: Infusion Pump-- Premarket Notification Submissions'' to the Division of Small...

  8. 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

    ... Means to Distribute Certain Product Information'' (71 FR 26102, May 3, 2006). That guidance referred to... information. \\1\\ Mazor K, S. Andrade, J. Auger, et al., ``Communicating Safety Information to Physicians:...

  9. 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

    ... Research and Development of Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS... of Tobacco Products.'' This guidance describes FDA's current policies and recommendations with respect to Agency meetings with tobacco manufacturers, importers, researchers, and/or...

  10. 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

    ... clarification on related issues such as user fee exemptions for orphan drugs. In the Federal Register of March 14, 2011 (76 FR 13629), FDA announced the availability of a revised draft guidance entitled...

  11. 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. PMID:24112316

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

    NASA Astrophysics Data System (ADS)

    Schwarzman, A. B.

    2011-12-01

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

  13. 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

    ... 3, 2007 (72 FR 137). The comment period closed on April 2, 2007. Over 25 companies, numerous... HUMAN SERVICES Food and Drug Administration (formerly Docket No. 2006D-0504) Radio Frequency Wireless...) is announcing the availability of the guidance entitled ``Radio Frequency Wireless Technology...

  14. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-03

    ... for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE... guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration... Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,...

  15. 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

    ... overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial... methods, responsibilities, and requirements for each clinical trial. The plan should provide those... plans to the appropriate CDER review division and request input from the division's clinical...

  16. 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...

  17. 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...

  18. 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

    ... regulations in 21 CFR part 1, subpart K (76 FR 25538), that pertain to the criteria for ordering... Administrative Detention of Foods,'' (76 FR 66073, October 25, 2011). The guidance was intended to provide... February 5, 2013 (78 FR 7994), FDA issued a final rule adopting the IFR as final without changes. The...

  19. 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

    ... FR 50483), FDA announced the availability of the draft guidance. Interested persons were invited to...; Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and de... entitled ``Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-08

    ...-contact animal foods. It does not create or confer any rights for or on any person and does not operate to... 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,...

  1. 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

    ... Federal Register of September 12, 2006 (71 FR 53696), FDA announced the availability of a draft guidance... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating...

  2. 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

    ... Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is not final...) Requests for Information Under the Federal Food, Drug, and Cosmetic Act'' to the Division of...

  3. 76 FR 33309 - Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

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

  4. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ..., 2010 (75 FR 22599), FDA announced the availability of the draft guidance. Comments on the draft... the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS... Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act.''...

  5. 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

    ... November 28, 2011 (76 FR 72950), FDA announced the availability of the draft guidance of the same title...) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for... screen blood donors for HBV DNA. FDA is also providing these blood establishments with...

  6. 77 FR 75174 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... submitted to and reviewed by CDER as described in the Federal Register of June 26, 2003 (68 FR 38067....'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset... of the individual study site (summary level clinical site dataset). The summary level clinical...

  7. 77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-10

    ... Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food... announcing the availability of the draft guidance entitled ``Pediatric Information for X-ray Imaging Device... should be ] provided in premarket notifications for x-ray imaging devices with indications for use...

  8. 75 FR 8968 - Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... design clinical trials (i.e., clinical, statistical, regulatory) call for special consideration, when to interact with FDA while planning and conducting adaptive design studies, what information to include in the... study. The draft guidance is intended to assist sponsors in planning and conducting adaptive...

  9. 76 FR 35665 - Draft Guidance for Industry on Enforcement Policy for Over-the-Counter Sunscreen Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... sunscreen final rule published in the Federal Register of May 21, 1999 (64 FR 27666) (the 1999 final rule) that was stayed before becoming effective (69 FR 53801, September 3, 2004); The draft guidance states... FR 27666 at 27689 through 27693) or a proposed rule that published in the Federal Register of...

  10. 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

    ... Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device... Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device.'' The recommendations in this...

  11. 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...

  12. 78 FR 48172 - Minimizing Risk for Children's Toy Laser Products; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... specifically address children's toy laser products. FDA recently issued a proposed rule (78 FR 37723) that... HUMAN SERVICES Food and Drug Administration Minimizing Risk for Children's Toy Laser Products; Draft... availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This...

  13. 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.

  14. 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.

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

    PubMed

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

    2015-10-01

    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

  16. 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

  17. 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…

  18. Industrial Arts Resource Supplement to the Consumer Education Curriculum Guide for Ohio.

    ERIC Educational Resources Information Center

    Ohio State Dept. of Education, Columbus. Div. of Vocational Education.

    The consumer education guide for industrial arts teachers was developed by a group of experienced teachers using the Consumer Education Curriculum Guide for Ohio, Grades K-12 as a reference. The guide is organized in six sections, each dealing with one of the following basic concepts: (1) the economic system, (2) income procurement, (3) consumer…

  19. 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

    ... for Industry and FDA,'' dated July 2001. In the Federal Register of December 28, 2011 (76 FR 81511... HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health Appeals Processes... ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes...

  20. 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…

  1. Use of nutritional supplements in sports: risks, knowledge, and behavioural-related factors.

    PubMed

    Molinero, O; Márquez, S

    2009-01-01

    A large number of recreational and elite athletes use nutritional supplements in hopes of improving performance. These aids can be costly and potentially harmful, and the advertised ergogenic gains are often based on little or no scientific evidence. Due to the lack of regulation of the dietary supplement industry, an abundance of supplement products of dubious value, content, and quality are now available around the world. Many supplement products contain substances that are prohibited in sport or that have been associated with significant morbidity and mortality. For athletes, lack of knowledge or misinformation has been established despite numerous sources of information being available, and the reasons for, and implications of, unsupervised and unrestricted supplement use require further attention. In addition to the necessity of an appropriate regulation of dietary supplements, nutritional education and scientifically sound guidance for athletes is required. Intervention and prevention efforts should be particularly targeted to adolescents.

  2. The role of population pharmacokinetics in drug development in light of the Food and Drug Administration's 'Guidance for Industry: population pharmacokinetics'.

    PubMed

    Williams, P J; Ette, E I

    2000-12-01

    Population pharmacokinetics (PPK) has evolved from a discipline primarily applied to therapeutic drug monitoring to one that plays a significant role in clinical pharmacology in general and drug development in particular. In February 1999 the US Food and Drug Administration issued a 'Guidance for Industry: Population Pharmacokinetics' that sets out the mechanisms and philosophy of PPK and outlines its role in drug development. The application of PPK to the drug development process plays an important role in the efficient development of safe and effective drugs. PPK knowledge is essential for mapping the response surface, explaining subgroup differences, developing and evaluating competing dose administration strategies, and as an aid in designing future studies. The mapping of the response surface is done to maximise the benefit-risk ratio, so that the impact of the input profile and dose magnitude on beneficial and harmful pharmacological effects can be understood and applied to individual patients. PPK combined with simulation methods provides a tool for estimating the expected range of concentrations from competing dose administration strategies. Once extracted, this knowledge can be applied to labelling or used to assess various future study designs. PPK should be implemented across all phases of drug development. For preclinical studies, PPK can be applied to allometric scaling and toxicokinetic analyses, and is useful for determining 'first time in man' doses and explaining toxicological results. Phase I studies provide initial understanding of the structural model and the effect of possible covariates, and may later be used to evaluate PPK differences between patients and healthy individuals. Phase II studies provide the greatest opportunity to map the response surface. With these PPK models it is possible to gain an improved understanding of the role of the dose on the response surface and of the range of expected responses. In phase III and IV studies, PPK

  3. 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).

  4. Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

    PubMed

    Villafranco, John E; Bond, Katie

    2009-01-01

    Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims. PMID:19998572

  5. Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

    PubMed

    Villafranco, John E; Bond, Katie

    2009-01-01

    Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims.

  6. 76 FR 27274 - Defense Federal Acquisition Regulation Supplement; Technical Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-11

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Part 225 Defense Federal Acquisition Regulation Supplement... Supplement (DFARS) to direct contracting officers to additional guidance on supporting contingency...

  7. 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.

  8. 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.

  9. Vitamin supplementation in pregnancy.

    PubMed

    2016-07-01

    Ensuring that a woman is well-nourished, both before and during pregnancy, is crucial for the health of the woman and that of the unborn child.(1) Maternal deficiency in key nutrients has been linked to pre-eclampsia, restricted fetal growth, neural tube defects, skeletal deformity and low birth weight.(1,2) Many nutritional supplements containing vitamins, minerals and other micronutrients are heavily marketed to women for all stages of pregnancy. However, much of the evidence for vitamin supplementation in pregnancy comes from studies carried out in low-income countries,(3) where women are more likely to be undernourished or malnourished than within the UK population. The challenges lie in knowing which supplements are beneficial and in improving uptake among those at most need. Here we summarise current UK guidance for vitamin supplementation in pregnancy and review the evidence behind it. PMID:27405305

  10. 76 FR 35896 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-20

    ... Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical... of information technology. Guidance for Industry on Formal Dispute Resolution: Scientific and... that encourage open and prompt discussion of disputes and lead to their resolution. The...

  11. 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

  12. 77 FR 16237 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division... in the guidance for industry on formal dispute resolution. DATES: Submit either electronic or written... technology. Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division...

  13. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-18

    ... Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion... solicits comments on ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump... technology. Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion...

  14. Feed intake, digestibility, nitrogen utilization, and body weight change of sheep consuming wheat straw supplemented with local agricultural and agro-industrial by-products.

    PubMed

    Nurfeta, Ajebu

    2010-06-01

    Effects of supplementing sheep consuming wheat straw with local agro-industrial by-products on feed intake, growth, digestibility and nitrogen utilization were determined. Thirty 1-year-old local wethers, with a mean (+/-SD) live weight of 19.8 (+/-1.06) kg, were assigned to five treatments: wheat straw + atella (T1), wheat straw + atella + poultry litter (T2), wheat straw + atella + coffee pulp (T3), wheat straw + atella + coffee pulp + poultry litter (T4), hay + concentrate (T5). A 7-day digestibility experiment and a 112-day growth trial were conducted. Total dry matter (DM) and organic matter (OM) intake as well as body weight gain was similar for all treatments. The highest (P < 0.05) nitrogen (N) intake was in sheep fed T1 and T4 diets, while the lowest was in those fed T2 and T5 diets. Sheep fed T1 and T2 diets had greater (P < 0.05) DM and OM digestibility than those fed T4 and T5 diets. The highest (P < 0.05) digestibility of N was for the T2, T4, and T5 diets, while the lowest was for the T1 diet. The highest N retention was in T4 diet, whereas the lowest was in T3 diet. In conclusion, in urban and peri-urban areas where atella, poultry litter, or coffee pulp are available, smallholder farmers could feed the mixtures as a supplement to straw with a good performance without using concentrate feeds.

  15. 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.

  16. Unified powered flight guidance

    NASA Technical Reports Server (NTRS)

    Brand, T. J.; Brown, D. W.; Higgins, J. P.

    1973-01-01

    A complete revision of the orbiter powered flight guidance scheme is presented. A unified approach to powered flight guidance was taken to accommodate all phases of exo-atmospheric orbiter powered flight, from ascent through deorbit. The guidance scheme was changed from the previous modified version of the Lambert Aim Point Maneuver Mode used in Apollo to one that employs linear tangent guidance concepts. This document replaces the previous ascent phase equation document.

  17. Dietary Supplements

    MedlinePlus

    Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, ... possible Tell your health care provider about any dietary supplements you use Do not take a bigger dose ...

  18. Corporate information management guidance

    SciTech Connect

    1997-08-01

    At the request of the Department of Energy`s (DOE) Information Management (IM) Council, IM representatives from nearly all Headquarters (HQ) organizations have been meeting over the past year as the Corporate Guidance Group (CGG) to develop useful and sound corporate information management (IM) guidance. The ability of the Department`s IM community to develop such unified guidance continues to be critical to the success of future Departmental IM planning processes and the establishment of a well-coordinated IM environment between Headquarters and field organizations. This report, with 26 specific corporate IM guidance items documented and unanimously agreed to, as well as 12 items recommended for further development and 3 items deferred for future consideration, represents a highly successful effort by the IM community. The effort has proven that the diverse DOE organizations can put aside individual preferences and work together towards a common and mutually beneficial goal. In examining most areas and issues associated with information management in the Department, they have developed specific, far-reaching, and useful guidance. The IM representatives recommend that the documented guidance items provided in this report and approved by the DOE IM Council be followed by all IM organizations. The representatives also strongly recommend that the guidance process developed by the CGG be the single process for developing corporate IM guidance.

  19. 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.

  20. Guidance for Total Development.

    ERIC Educational Resources Information Center

    Van Hoose, William H.

    Elementary guidance, deriving much of its content from the developmental phenomena of middle childhood, is viewed as the maximization of human potentiality in the total range of the population. Included in the list of elementary school guidance objectives are (1) aiding academic development, (2) helping children develop health self-concepts, (3)…

  1. 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

    ... Interim Staff Guidance (ISG) ESP/ DC/COL-ISG-015 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML093561416). This ISG supplements the guidance provided to the NRC staff in Section 1.0... COMMISSION Office of New Reactors; Final Interim Staff Guidance on Post- Combined License Commitments...

  2. Guidance for Industry: Preparation of Premarket Submissions ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    ... 确定这些数据的方法。如果难以取得分子量,申请人应提供聚合体的其他属性; 这些属性应为分子量的应变量,例如固有粘度或相对粘度、或熔体流动指数 ...

  3. 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.

  4. Guidance for Industry: Cosmetics Processors and ...

    Center for Food Safety and Applied Nutrition (CFSAN)

    Page 1. إرﺷﺎدات ﻟﻠﺼﻨﺎﻋﺔ : إرﺷﺎدات ﻟﺘﺪاﺑﻴﺮ اﻟ ﺤﻤﺎﻳﺔ اﻟﻮﻗﺎﺋﻴﺔ ﻟﻬﻴﺌﺎت ﻣﻌﺎﻟﺠﺔ وﻧﻘﻞ ﻣﻨﺘﺠﺎت اﻟﺘﺠﻤﻴﻞ ﺗ ﺤﺘﻮي ﻋﻠﻰ ﺗﻮﺻﻴﺎت ﻏﻴﺮ ﻣُﻠﺰﻣﺔ ﺗﺸﺮﻳﻦ اﻟﺜﺎﻧﻲ / ﻧﻮﻓﻤﺒﺮ 2003 ؛ ﺗﻤﺖ ...

  5. Regional Employment by Industry, 1940-1970. Decennial Series for United States, Regions, States, Counties. A Supplement to the Survey of Current Business.

    ERIC Educational Resources Information Center

    Ashby, Lowell D.; Cartwright, David W.

    The volume presents employment by industry from the decennial censuses of population for 1940, 1950, 1960, and 1970. Thirty-five identified civilian industries are presented for each area for 1970, 1960, and 1950, together with 30 groups for 1940. Introductory material deals with the definition of employment, industrial classification of civilian…

  6. 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...

  7. 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…

  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. Vocational Guidance and the Labour Market: Guidance to Transform or Guidance to Domesticate?

    ERIC Educational Resources Information Center

    Kann, Ulla

    1988-01-01

    Explores the conflict in guidance arising from the desire to consider the needs of society while guaranteeing individual freedom of choice. Discusses the theoretical basis of vocational guidance. Gives examples of "domestication" and "transformation" approaches to guidance and discusses the consequences of viewing guidance as a change strategy.(KO)

  10. Dietary supplements for aquatic sports.

    PubMed

    Derave, Wim; Tipton, Kevin D

    2014-08-01

    Many athletes use dietary supplements, with use more prevalent among those competing at the highest level. Supplements are often self-prescribed, and their use is likely to be based on an inadequate understanding of the issues at stake. Supplementation with essential micronutrients may be useful when a diagnosed deficiency cannot be promptly and effectively corrected with food-based dietary solutions. When used in high doses, some supplements may do more harm than good: Iron supplementation, for example, is potentially harmful. There is good evidence from laboratory studies and some evidence from field studies to support health or performance benefits from appropriate use of a few supplements. The available evidence from studies of aquatic sports is small and is often contradictory. Evidence from elite performers is almost entirely absent, but some athletes may benefit from informed use of creatine, caffeine, and buffering agents. Poor quality assurance in some parts of the dietary supplements industry raises concerns about the safety of some products. Some do not contain the active ingredients listed on the label, and some contain toxic substances, including prescription drugs, that can cause health problems. Some supplements contain compounds that will cause an athlete to fail a doping test. Supplement quality assurance programs can reduce, but not entirely eliminate, this risk.

  11. 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. ...

  12. Dietary Supplements

    MedlinePlus

    ... are not intended to treat, diagnose, prevent, or cure diseases. Do not take supplements instead of your ... Partners Women's Health Topics Mammography Women and Diabetes HPV, HIV, Birth Control Heart Health for Women Pregnancy ...

  13. 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)

  14. 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…

  15. 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.…

  16. 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.

  17. 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. PMID:11066951

  18. Enhancing Access to Vocational Guidance.

    ERIC Educational Resources Information Center

    Clayton, Pam

    1998-01-01

    Issues in vocational guidance for adults include lack of provision, especially for unemployed or disadvantaged people and the need to publicize existing excellent guidance services and demonstrate their usefulness to this population. (SK)

  19. An Appraisal of the Industrial Cooperative Education Program Based on Responses from Students and Employers. Supplemental Report No. 3: The Women Students.

    ERIC Educational Resources Information Center

    Freeman, Nancy S.

    As part of a study appraising the industrial cooperative education program at Macomb County Community College (MCCC), 54 women enrolled from 1970 to 1975 in Design and Mechanical Technology and Graphic and Commercial Arts programs, and their employers were surveyed. A comparison of the 30 women in the cooperative programs and the 24 non co-op…

  20. 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…

  1. Trajectory shaping rendezvous guidance

    NASA Astrophysics Data System (ADS)

    Klumpp, A. R.

    The Space Station will bring a great increase in rendezvous traffic. Formerly, rendezvous has been expensive in terms of time and crew involvement. Multiple trajectory adjustments on separate orbits have been required to meet safety, lighting, and geometry requirements. This paper describes a new guidance technique in which the approach trajectory is shaped by a sequence of velocity increments in order to satisfy multiple constraints within a single orbit. The approach phase is planned before the mission, leaving a group of free parameters that are optimized by onboard guidance. Fuel penalties are typically a few percent, compared to unshaped Hohmann transfers, and total fuel costs can be less than those of more time-consuming ways of meeting the same requirements.

  2. 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.

  3. 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.

  4. Glutamine supplementation.

    PubMed

    Wernerman, Jan

    2011-07-18

    Intravenous glutamine supplementation is standard care when parenteral nutrition is given for critical illness. There are data of a reduced mortality when glutamine supplementation is given. In addition, standard commercial products for parenteral nutrition do not contain any glutamine due to glutamine instability in aqueous solutions. For the majority of critical ill patients who are fed enterally, the available evidence is insufficient to recommend glutamine supplementation. Standard formulation of enteral nutrition contains some glutamine: 2-4 g/L. However, this dose is insufficient to normalize glutamine plasma concentration.Plasma concentration of glutamine is low in many patients with critical illness and a low level is an independent risk factor for mortality. A low plasma glutamine concentration is the best indicator of glutamine depletion. Data are emerging about how the endogenous production of glutamine is regulated. We know that skeletal muscle is the major producer of glutamine and that a part of the profound depletion of skeletal muscle seen in critical illness is a reflection of the need to produce glutamine.Glutamine is utilized in rapidly dividing cells in the splanchnic area. Quantitatively most glutamine is oxidized, but the availability of glutamine in surplus is important for the de novo synthesis of nucleotides and necessary for cell division and protein synthesis. More knowledge about the regulation of the endogenous production of glutamine is needed to outline better guidelines for glutamine supplementation in the future.

  5. Sports Supplements

    MedlinePlus

    ... specialist. The doc will be able to offer alternatives to supplements based on your body and sport. Reviewed by: Mary L. Gavin, MD Date reviewed: January 2015 previous 1 • 2 • 3 For Teens For Kids For Parents MORE ON THIS TOPIC Sports Center Energy Drinks and Food Bars: Power or Hype? A ...

  6. INDUSTRIAL ARTS HANDBOOK.

    ERIC Educational Resources Information Center

    JOHNSON, ALLEN

    TO AID TEACHERS, GUIDANCE COUNSELORS, AND ADMINISTRATORS, AS WELL AS THE STUDENT HIMSELF, THE HANDBOOK OFFERED PURPOSES AND COURSE DESCRIPTIONS IN THE FIELD OF INDUSTRIAL ARTS. IT APPLIED TO ELEMENTARY, JUNIOR HIGH, AND SENIOR HIGH SCHOOL STUDENTS. INDUSTRIAL ARTS PROVIDED AN OPPORTUNITY FOR STUDENTS TO DISCOVER THEIR APTITUDES AND ABILITIES IN…

  7. 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.

  8. 76 FR 2681 - Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... AGENCY Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and... guidelines to implement its EIS filing responsibilities. The purpose of the EPA Filing System Guidelines is to provide guidance to Federal agencies on filing EISs, including draft, final, and supplemental...

  9. 77 FR 51530 - Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-24

    ... AGENCY Amended Environmental Impact Statement Filing System Guidance for Implementing 40 CFR 1506.9 and... guidelines to implement its EIS filing responsibilities. The purpose of the EPA Filing System Guidelines is to provide guidance to Federal agencies on filing EISs, including draft, final, and supplemental...

  10. Guidance of Nonlinear Systems

    NASA Technical Reports Server (NTRS)

    Meyer, George

    1997-01-01

    The paper describes a method for guiding a dynamic system through a given set of points. The paradigm is a fully automatic aircraft subject to air traffic control (ATC). The ATC provides a sequence of way points through which the aircraft trajectory must pass. The way points typically specify time, position, and velocity. The guidance problem is to synthesize a system state trajectory which satisfies both the ATC and aircraft constraints. Complications arise because the controlled process is multi-dimensional, multi-axis, nonlinear, highly coupled, and the state space is not flat. In addition, there is a multitude of possible operating modes, which may number in the hundreds. Each such mode defines a distinct state space model of the process by specifying the state space coordinatization, the partition of the controls into active controls and configuration controls, and the output map. Furthermore, mode transitions must be smooth. The guidance algorithm is based on the inversion of the pure feedback approximations, which is followed by iterative corrections for the effects of zero dynamics. The paper describes the structure and modules of the algorithm, and the performance is illustrated by several example aircraft maneuvers.

  11. Guidance of Nonlinear Systems

    NASA Technical Reports Server (NTRS)

    Meyer, George; Null, Cynthia H. (Technical Monitor)

    1996-01-01

    The paper describes a method for guiding a dynamic system through a given set of points. The paradigm is a fully automatic aircraft subject to air traffic control (ATC). The ATC provides a sequence of way points through which the aircraft trajectory must pass. The way points typically specify time, position, and velocity. The guidance problem is to synthesize a system state trajectory which satisfies both the ATC and aircraft constraints. Complications arise because the controlled process is multi-dimensional, multi-axis, nonlinear, highly coupled, and the state space is not flat. In addition, there is a multitude of possible operating modes, which may number in the hundreds. Each such mode defines a distinct state space model of the process by specifying the state space coordination, the partition of the controls into active controls and configuration controls, and the output map. Furthermore, mode transitions must be smooth. The guidance algorithm is based on the inversion of the pure feedback approximations, which is followed by iterative corrections for the effects of zero dynamics. The paper describes the structure and modules of the algorithm, and the performance is illustrated by several example aircraft maneuvers.

  12. Controls and guidance: Space

    NASA Technical Reports Server (NTRS)

    Dibattista, John D.

    1988-01-01

    The Space Controls and Guidance Research and Technology Program is directed toward enabling the next generation of space transportation systems, large future spacecraft, and space systems such as the Space Station to have large communication antennas and high precision segmented reflector astrophysical telescopes. The new generation of transportation vehicles has demanding requirements to provide for an order of magnitude reduction in cost as well as an increase in capability. The future orbital facilities have demanding control requirements for pointing and stabilization, momentum management, build-up and growth accomodation, and disturbance management. To address these advanced requirements, the research and development program is designed to provide the generic technology base to support the implementation of advanced guidance, navigation, and control. The area of computational controls will be stressed in order to develop cost effective, high speed, high fidelity control system simulation and analysis and synthesis tools. The trust of this work will be to develop methods and software to enable analysis and real-time hardware-in-the-loop simulation of complex spacecraft for control design certification. To address future orbital facilities requirements, an advanced technology program is underway in system identification, distributed control, integrated controls/structures design methods, and advanced sensors and actuators. Because the behavior of large, light weight per unit area deployable/assembled spacecraft is greatly influenced by the ground environment, the testing and verification activity is both ground- and space-based.

  13. Bilinear tangent yaw guidance

    NASA Technical Reports Server (NTRS)

    Brusch, R. G.

    1979-01-01

    This paper presents a parametric yaw steering law which has been used to provide closed-loop yaw guidance for the launch of the HEAO (High Energy Astronomy Observatory) satellite mission using the Atlas/Centaur launch vehicle. This bilinear tangent steering law provides near optimal yaw steering for maneuvers requiring insertion into orbits with a specified inclination and node. Bilinear tangent steering is shown to be optimal in both the pitch and yaw planes when a uniform gravitational field is assumed. The conditions under which the general bilinear tangent laws degenerate into linear tangent and constant attitude laws are presented. The flight computer implementation of these laws in a rotating coordinate system using real-time integration of the equations of motion is detailed. Explicit solution of the parametric guidance equations requires the inflight solution of (2x2) two-point boundary value problems in the pitch and yaw planes. Excellent results are obtained even for very large (greater than 50 deg) out-of-plane steering angles.

  14. Partial stabilization-based guidance.

    PubMed

    Shafiei, M H; Binazadeh, T

    2012-01-01

    A novel nonlinear missile guidance law against maneuvering targets is designed based on the principles of partial stability. It is demonstrated that in a real approach which is adopted with actual situations, each state of the guidance system must have a special behavior and asymptotic stability or exponential stability of all states is not realistic. Thus, a new guidance law is developed based on the partial stability theorem in such a way that the behaviors of states in the closed-loop system are in conformity with a real guidance scenario that leads to collision. The performance of the proposed guidance law in terms of interception time and control effort is compared with the sliding mode guidance law by means of numerical simulations.

  15. Beyond Discipline to Guidance: A Primer on the Guidance Alternative.

    ERIC Educational Resources Information Center

    Gartrell, Dan

    As early childhood teachers apply principles of guidance rather than punishment in their classrooms, they face the challenge of avoiding a slippage into traditional discipline practices and transcending the punitive aspects of discipline. Guidance is designed to teach children democratic life skills and therefore goes beyond discipline. Teachers…

  16. 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.

  17. The Talos guidance system

    NASA Astrophysics Data System (ADS)

    Gulick, J.; Hyatt, W. C.; Martin, O. M., Jr.

    1982-06-01

    A description is given of the design principles and performance capabilities of the Talos surface-to-air missile's homing system, which over the course of its development came to be virtually unjammable, as well as the associated antiradiation seeker, which enables the Talos to operate against radar signal-emitting targets. The interferometric homing system chosen employs widely spaced, airframe-fixed antennas compatible with ramjet inlet geometry and simpler than the alternative gimballed dish antenna. Early Talos missile guidance systems used scanning interferometry, but for subsequent models a continuous wave interferometer was developed, followed by a monopulse seeker. Attention is given to the use of the Talos system as a long range antiradiation missile for radar suppression in the Vietnam conflict.

  18. 75 FR 59102 - Defense Federal Acquisition Regulation Supplement; Part 204, Administrative Matters

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-27

    ... guidance on mapping PII and supplementary PII numbers stored in the Electronic Document Access system to... Defense Acquisition Regulations System 48 CFR Part 204 Defense Federal Acquisition Regulation Supplement; Part 204, Administrative Matters AGENCY: Defense Acquisition Regulations System, Department of...

  19. 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...

  20. 15 CFR Supplement No. 1 to Part 734 - Questions and Answers-Technology and Software Subject to the EAR

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Software Subject to the EAR No. Supplement No. 1 to Part 734 Commerce and Foreign Trade Regulations... Supplement No. 1 to Part 734—Questions and Answers—Technology and Software Subject to the EAR This Supplement... to the EAR. It is intended to give the public guidance in understanding how BIS interprets this...

  1. 15 CFR Supplement No. 1 to Part 734 - Questions and Answers-Technology and Software Subject to the EAR

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Software Subject to the EAR No. Supplement No. 1 to Part 734 Commerce and Foreign Trade Regulations... Supplement No. 1 to Part 734—Questions and Answers—Technology and Software Subject to the EAR This Supplement... to the EAR. It is intended to give the public guidance in understanding how BIS interprets this...

  2. 15 CFR Supplement No. 1 to Part 734 - Questions and Answers-Technology and Software Subject to the EAR

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Software Subject to the EAR No. Supplement No. 1 to Part 734 Commerce and Foreign Trade Regulations... Supplement No. 1 to Part 734—Questions and Answers—Technology and Software Subject to the EAR This Supplement... to the EAR. It is intended to give the public guidance in understanding how BIS interprets this...

  3. 15 CFR Supplement No. 1 to Part 734 - Questions and Answers-Technology and Software Subject to the EAR

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Software Subject to the EAR No. Supplement No. 1 to Part 734 Commerce and Foreign Trade Regulations... Supplement No. 1 to Part 734—Questions and Answers—Technology and Software Subject to the EAR This supplement... to the EAR. It is intended to give the public guidance in understanding how BIS interprets this...

  4. Guidance: Agent of the Counterculture.

    ERIC Educational Resources Information Center

    Patouillet, Raymond A.; Marin, Roselyn L.

    1979-01-01

    This article was an introduction to a convention program presented at the Florida Personnel and Guidance Association Convention (Tampa, Nov., 1977) by Raymond Patouillet, shortly before his sudden death. It encapsulates his guidance philosophy, his understanding of the human condition, and his faith in the crucial role of the caring profession.…

  5. Innovative Approaches to Career Guidance.

    ERIC Educational Resources Information Center

    Freeman, Andrew R.

    A key part of a broad-based approach to career education in Australian schools is vocational/career guidance. Various vocational guidance programs have been developed for specific groups in Australian society, including work experience, caravans, and micrographics technology for the handicapped; pre-employment courses and a family education center…

  6. 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…

  7. Considerations for Middle School Guidance

    ERIC Educational Resources Information Center

    Knudsen, Grace

    1971-01-01

    Middle school guidance appears to be neglected. Yet this is a time of searching when pupils who are able to relate are usually willing to be helped. The characteristics of both elementary and secondary school guidance need to be evaluated in order to provide continuity in the junior high schools. (Author/BY)

  8. 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…

  9. 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…

  10. A Guide to Career Guidance.

    ERIC Educational Resources Information Center

    Nejedlo, Robert J., Ed.

    The nineteen articles in this guidebook are by former consultants for vocational guidance workshops at Northern Illinois University. Articles are organized in five parts: identifying students' career guidance needs, providing students with helpful career information, assisting students pursuing career programs, preparing students for career…

  11. Signaling from Axon Guidance Receptors

    PubMed Central

    Bashaw, Greg J.; Klein, Rüdiger

    2010-01-01

    Determining how axon guidance receptors transmit signals to allow precise pathfinding decisions is fundamental to our understanding of nervous system development and may suggest new strategies to promote axon regeneration after injury or disease. Signaling mechanisms that act downstream of four prominent families of axon guidance cues—netrins, semaphorins, ephrins, and slits—have been extensively studied in both invertebrate and vertebrate model systems. Although details of these signaling mechanisms are still fragmentary and there appears to be considerable diversity in how different guidance receptors regulate the motility of the axonal growth cone, a number of common themes have emerged. Here, we review recent insights into how specific receptors for each of these guidance cues engage downstream regulators of the growth cone cytoskeleton to control axon guidance. PMID:20452961

  12. Signaling from axon guidance receptors.

    PubMed

    Bashaw, Greg J; Klein, Rüdiger

    2010-05-01

    Determining how axon guidance receptors transmit signals to allow precise pathfinding decisions is fundamental to our understanding of nervous system development and may suggest new strategies to promote axon regeneration after injury or disease. Signaling mechanisms that act downstream of four prominent families of axon guidance cues--netrins, semaphorins, ephrins, and slits--have been extensively studied in both invertebrate and vertebrate model systems. Although details of these signaling mechanisms are still fragmentary and there appears to be considerable diversity in how different guidance receptors regulate the motility of the axonal growth cone, a number of common themes have emerged. Here, we review recent insights into how specific receptors for each of these guidance cues engage downstream regulators of the growth cone cytoskeleton to control axon guidance. PMID:20452961

  13. Clinical use of glutamine supplementation.

    PubMed

    Wernerman, Jan

    2008-10-01

    Endogenous production of glutamine may become insufficient during critical illness. The shortage of glutamine is reflected as a decrease in plasma concentration, which is a prognostic factor for poor outcome in sepsis. Because glutamine is a precursor for nucleotide synthesis, rapidly dividing cells are most likely to suffer from a shortage. Therefore, exogenous glutamine supplementation is necessary. In particular, when i.v. nutrition is given, extra glutamine supplementation becomes critical, because most present formulations for i.v. use do not contain any glutamine for technical reasons. The major part of endogenously produced glutamine comes from skeletal muscle. For patients staying a long time in the intensive care unit (ICU), the muscle mass decreases rapidly, which leaves a tissue of diminishing size to maintain the export of glutamine. The metabolic and nutritional adaptation in long-staying ICU patients is poorly studied and is one of the fields that needs more scientific evidence for clinical recommendations. To date, there is evidence to support the clinical use of glutamine supplementation in critically ill patients, in hematology patients, and in oncology patients. Strong evidence is presently available for i.v. glutamine supplementation to critically ill patients on parenteral nutrition. This must be regarded as the standard of care. For patients on enteral nutrition, more evidence is needed. To guide administration of glutamine, there are good arguments to use measurement of plasma glutamine concentration for guidance. This will give an indication for treatment as well as proper dosing. Most patients will have a normalized plasma glutamine concentration by adding 20-25 g/24 h. Furthermore, there are no reported adverse or negative effects attributable to glutamine supplementation.

  14. 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

  15. 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.…

  16. 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.

  17. 75 FR 18514 - Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ... constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry... used to develop draft guidance for industry on practices for naming, labeling, and packaging of drugs... http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm ). In that letter,...

  18. 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.

  19. 76 FR 20679 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY:...

  20. 76 FR 4116 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-24

    ... Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j...(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products. DATES: Submit either... 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products (OMB Control Number...

  1. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... HUMAN SERVICES Food and Drug Administration Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and... entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This...

  2. Cumulated UDC Supplement, 1965-1975. Volume IV: Classes 63/676 (63 Agriculture, Forestry and Fisheries, 64 Household and Domestic Economy, 65 Management. Communications, 66 Chemical Technology, 67/676 Various Industries; Leather, Pulp and Paper, Textiles, etc.).

    ERIC Educational Resources Information Center

    International Federation for Documentation, The Hague (Netherlands). Committee on Classification Research.

    In continuation of the "Cumulated UDC Supplement - 1964" published by the International Federation for Documentation, this document provides a cumulative supplement to the Universal Decimal Classification for 1965-1975. This fourth of a five volume series lists new classification subdivisions added to the system in the following subject areas: (1)…

  3. Publication of OIG compliance program guidance for clinical laboratories--HHS. Notice.

    PubMed

    1998-08-24

    This Federal Register notice sets forth the OIG's recently-issued Compliance Program Guidance for Clinical Laboratories. The OIG had previously developed and published a model compliance plan for the clinical laboratory industry on March 3, 1997. This Compliance Program Guidance for Clinical Laboratories is intended to be more consistent with compliance program guidances issued by the OIG with respect to the hospital industry and to home health agencies, and serves to clarify various aspects of the original model plan. As with previously-issued compliance program guidances, we believe that the development of this guidance for clinical laboratories will continue as a positive step towards promoting a higher level of ethical and lawful conduct throughout the entire health care community.

  4. 75 FR 29183 - Office of the Chief Financial Officer; Department of Agriculture Implementation of OMB Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... part 417 on nonprocurement debarment and suspension at 2 CFR Chapter 4 that adopts and supplements the..., Conservation, and Energy Act of 2008, Public Law 110-246 (7 U.S.C. 2209j), which requires the Secretary to... final guidance for governmentwide nonprocurement debarment and suspension (70 FR 51863). This...

  5. 76 FR 34180 - National Organic Program; Notice of Draft Guidance for Accredited Certifying Agents and Certified...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-13

    ... Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure... and Sources of Vitamins and Minerals For Organic Livestock Feed, Feed Supplements, and Feed Additives... (NOP 5029)'', and ``Evaluating Allowed Ingredients and Sources of Vitamins and Minerals For...

  6. 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.

  7. Measuring Client Progression in Adult Guidance

    ERIC Educational Resources Information Center

    Hearne, Lucy

    2007-01-01

    Currently, in the field of guidance, relevant stakeholders including guidance practitioners, educators and policy makers, have identified progression for adults in education and employment as one of the key outcomes of educational guidance. Lifelong guidance is now inextricably linked with lifelong learning as a mechanism to enhance individual…

  8. 33 CFR 385.5 - Guidance memoranda.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., Circulars, Manuals, or Pamphlets, or other appropriate form of guidance. (2) Guidance on the following six... for development of six program-wide guidance memoranda. The Corps of Engineers and the South Florida... agencies, develop the six guidance memoranda described in paragraph (a) of this section for approval by...

  9. Vocational Guidance: A Primary Function of Education.

    ERIC Educational Resources Information Center

    Roehrs, Hermann

    1992-01-01

    Perceives vocational orientation/guidance as a school responsibility. Discusses changing work attitudes, vocational guidance as counseling for life, parents' roles, work experience for 14-16 year olds, continuity between vocational guidance and competent career choice, vocational ethics, and midcareer and retirement guidance. Cites research on…

  10. Information Paper 18: Guidance in Secondary Schools.

    ERIC Educational Resources Information Center

    Ashton, Terry

    1986-01-01

    Traces impetus for introduction of structured guidance into Scottish secondary schools. Identifies 1968 "Orange Paper" as first attempt to set out rationale for guidance. Describes how guidance is organized; outlines tasks of guidance teachers; and presents current developments, training requirements, and trends. (NEC)

  11. Guidelines for Comprehensive Guidance and Counseling Services.

    ERIC Educational Resources Information Center

    Stefkovich, Jacqueline; And Others

    These guidelines are designed to assist local school districts and their Boards of Education in developing and implementing comprehensive guidance and counseling services in thier school systems. The components of the comprehensive guidance program are comprehensive guidance services, certified personnel, and comprehensive guidance facilities.…

  12. 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…

  13. [Guidance of volume transmission theory on treatment of "bipolar lesions"].

    PubMed

    Shao, Xuanming; Han, Jie; Sun, Dayong; Ji, Xiaofei

    2015-10-01

    As the key organ of human, the brain has projection area corresponding to every part of the body, indicating that the damage on human body will locate a corresponding projection area in the brain. The primary injury on the distal end will produce secondary lesion in the projection area of brain, featuring as "bipolar lesions". The volume transmission (VT) theory and propagated sensation along meridians (PSAM) in TCM provide core guidance for the treatment of "bipolar lesions". The tendency to lesion of PSAM is achieved through volume transmission, which is also called "propagated sensation tendency to lesion of VT". From three aspects, VT can treat bipolar lesions, formatting a ring closed path. With VT as main treatment and wiring transmission as supplemented treatment, it has a more comprehensive guidance for treatment, and this theory may play an essential guiding role in the future treatment development for diseases. PMID:26790226

  14. [Guidance of volume transmission theory on treatment of "bipolar lesions"].

    PubMed

    Shao, Xuanming; Han, Jie; Sun, Dayong; Ji, Xiaofei

    2015-10-01

    As the key organ of human, the brain has projection area corresponding to every part of the body, indicating that the damage on human body will locate a corresponding projection area in the brain. The primary injury on the distal end will produce secondary lesion in the projection area of brain, featuring as "bipolar lesions". The volume transmission (VT) theory and propagated sensation along meridians (PSAM) in TCM provide core guidance for the treatment of "bipolar lesions". The tendency to lesion of PSAM is achieved through volume transmission, which is also called "propagated sensation tendency to lesion of VT". From three aspects, VT can treat bipolar lesions, formatting a ring closed path. With VT as main treatment and wiring transmission as supplemented treatment, it has a more comprehensive guidance for treatment, and this theory may play an essential guiding role in the future treatment development for diseases.

  15. The guidance system for Ariane

    NASA Astrophysics Data System (ADS)

    Angus, Alex M.; Gordon, Colin S.; Brunschvig, Alain

    1991-05-01

    The various subsystems that comprise the complete Ariane guidance system are described along with a brief background of earlier developmental instruments and their applications. The Centrale Inertielle is a part of the control and guidance system of the Ariane launcher whose function is to provide a space-stable datum allowing measurement of acceleration and attitude relative to that datum. Consideration is given to the inertial platform, the electronics unit, thermal requirements, coarse alignment and fine-leveling, and the Vehicle Equipment Bay (VEB). The VEB is the main component of the electrical system and is designed to support all the equipment handling the following functions: guidance, navigation and control, sequencer and pyro management, localization and safety management, and telemetry.

  16. Autonomous Guidance, Navigation and Control

    NASA Astrophysics Data System (ADS)

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

    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.

  17. 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.

  18. Technical guidance for siting criteria development

    SciTech Connect

    Aldrich, D.C.; Sprung, J.L.; Alpert, D.J.; Diegert, K.; Ostmeyer, R.M.; Ritchie, L.T.; Strip, D.R.; Johnson, J.D.; Hansen, K.; Robinson, J.

    1982-12-01

    Technical guidance to support the formulation and comparison of possible siting criteria for nuclear power plants has been developed in four areas: (1) consequences of hypothetical severe nuclear-power-plant accidents, (2) characteristics of population distributions about current reactor sites, (3) site availability within the continental United States, and (4) socioeconomic impacts of reactor siting. The impact on consequences of source-term magnitude, meteorology, population distribution, and emergency response have been analyzed. Population distributions about current sites were analyzed to identify statistical characteristics, time trends, and regional differences. A site-availability data bank was constructed for the continential United States. The data bank contains information about population densities, seismicity, topography, water availability, and land-use restrictions. Finally, the socioeconomic impacts of rural-industrialization projects, energy boomtowns, and nuclear power plants were examined to determine their nature, magnitude, and dependence on site demography and remoteness.

  19. 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.

  20. Guidance for evidence-informed policies about health systems: rationale for and challenges of guidance development.

    PubMed

    Bosch-Capblanch, Xavier; Lavis, John N; Lewin, Simon; Atun, Rifat; Røttingen, John-Arne; Dröschel, Daniel; Beck, Lise; Abalos, Edgardo; El-Jardali, Fadi; Gilson, Lucy; Oliver, Sandy; Wyss, Kaspar; Tugwell, Peter; Kulier, Regina; Pang, Tikki; Haines, Andy

    2012-01-01

    In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

  1. Standards, Guidance and Practices for Improved Data Quality

    SciTech Connect

    Martin B. Sattison

    2010-06-01

    Since the mid 1980s, the Idaho National Laboratory (INL) has been involved with numerous projects to collect operational reactor data, develop data tools, and trend and analyze that data for the U.S. Nuclear Regulatory Commission (NRC). Because the data are used in subsequent risk analyses, the NRC must have confidence in the quality of the data delivered. The NRC tasked the INL to establish a comprehensive data quality assurance program. A key element of that effort was to establish a set of requirements based on industry and government standards, guidance and good practices. This paper discusses where these were found, the process of extracting the requirements and recommendations from the source materials, and the consolidation of them into a concise set of 22 standards, guidance and practices for technical data quality. While this set was created specifically for the data programs within the NRC’s Office of Research, they have broad application to many high-technology industries.

  2. Emerging Supplements in Sports

    PubMed Central

    Mason, Bryan C.; Lavallee, Mark E.

    2012-01-01

    Context: Nutritional supplements advertised as ergogenic are commonly used by athletes at all levels. Health care professionals have an opportunity and responsibility to counsel athletes concerning the safety and efficacy of supplements on the market. Evidence Acquisition: An Internet search of common fitness and bodybuilding sites was performed to identify supplement promotions. A search of MEDLINE (2000–August, 2011) was performed using the most commonly identified supplements, including glutamine, choline, methoxyisoflavone, quercetin, zinc/magnesium aspartate, and nitric oxide. The search terms supplement, ergogenic aid, and performance were also used. Results: Six common and newer supplements were identified, including glutamine, choline, methoxyisoflavone, quercetin, zinc/magnesium aspartate, and nitric oxide. Conclusions: Controlled studies have not determined the effects of these supplements on performance in athletes. Scientific evidence is not available to support the use of these supplements for performance enhancement. PMID:23016081

  3. Multivitamin/Mineral Supplements

    MedlinePlus

    ... Nutrient recommendations: Dietary Reference Intakes (DRI) Online DRI tool Daily Value (DV) tables For more advice on buying dietary supplements: Office of Dietary Supplements Frequently Asked Questions: Which brand(s) ...

  4. 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)

  5. 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 ...

  6. Project Inspire: Vocational Guidance Institute.

    ERIC Educational Resources Information Center

    National Alliance of Businessmen, Washington, DC.

    Two introductory speeches suggest the general social and interracial climate in the United States. It is against this backdrop that Project Inspire is described. Its purpose is the development of a vocational guidance component within the broader school curriculum. Its major objective is elevating the awareness level of students to the work world…

  7. Axon guidance: FLRTing promotes attraction.

    PubMed

    Lowery, Laura Anne

    2014-03-01

    A recent study demonstrates a new mechanism by which crosstalk between multiple guidance cues is integrated during axon pathfinding. FLRT3 is a novel co-receptor for Robo1 that acts as a context-dependent modulator of Netrin-1 attraction in thalamocortical axons.

  8. 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…

  9. Teacher Guidance of Knowledge Construction

    ERIC Educational Resources Information Center

    Schwarz, Baruch; Dreyfus, Tommy; Hadas, Nurit; Hershkowitz, Rina

    2004-01-01

    This paper focuses on how teachers guide construction of knowledge in classrooms. We suggest that guidance hinges on the kind of dialogue teachers choose to engage students in. We propose several classroom dialogue types relevant for the construction of knowledge and suggest that critical dialogue is particularly effective for knowledge…

  10. Developing Local Lifelong Guidance Strategies.

    ERIC Educational Resources Information Center

    Watts, A. G.; Hawthorn, Ruth; Hoffbrand, Jill; Jackson, Heather; Spurling, Andrea

    1997-01-01

    Outlines the background, rationale, methodology, and outcomes of developing local lifelong guidance strategies in four geographic areas. Analyzes the main components of the strategies developed and addresses a number of issues relating to the process of strategy development. Explores implications for parallel work in other localities. (RJM)

  11. Humanizing Education Through Guidance Counseling.

    ERIC Educational Resources Information Center

    Accola, W. V.

    A computerized information retrieval system has been designed to support the secondary school counseling effort. The system, entitled Total Guidance Information Support System (TGISS), runs on an IBM System/360 Model 65 facility and uses the IBM 2848 Display Control Unit. The software consists of an interactive communications program developed in…

  12. DOE Waste Treatability Group Guidance

    SciTech Connect

    Kirkpatrick, T.D.

    1995-01-01

    This guidance presents a method and definitions for aggregating U.S. Department of Energy (DOE) waste into streams and treatability groups based on characteristic parameters that influence waste management technology needs. Adaptable to all DOE waste types (i.e., radioactive waste, hazardous waste, mixed waste, sanitary waste), the guidance establishes categories and definitions that reflect variations within the radiological, matrix (e.g., bulk physical/chemical form), and regulated contaminant characteristics of DOE waste. Beginning at the waste container level, the guidance presents a logical approach to implementing the characteristic parameter categories as part of the basis for defining waste streams and as the sole basis for assigning streams to treatability groups. Implementation of this guidance at each DOE site will facilitate the development of technically defined, site-specific waste stream data sets to support waste management planning and reporting activities. Consistent implementation at all of the sites will enable aggregation of the site-specific waste stream data sets into comparable national data sets to support these activities at a DOE complex-wide level.

  13. Iodine Supplementation in Pregnancy and the Dilemma of Ambiguous Recommendations

    PubMed Central

    Andersen, Stine Linding; Laurberg, Peter

    2016-01-01

    Iodine requirements are increased during pregnancy, predominantly caused by an increase in renal iodide clearance and in the use of iodine for thyroid hormone production. Because iodine deficiency (ID) in pregnancy may be associated with neurodevelopmental deficits in the offspring, a pertinent question is at what level of iodine intake pregnant women should be advised to take iodine-containing supplements. The consensus reached by the WHO/UNICEF/ICCIDD in 2007 was that pregnant women should not be recommended to take iodine-containing supplements if the population in general had been iodine sufficient for at least 2 years. However, guidance on this differs between scientific societies. This review discusses iodine supplementation in pregnancy. Based on current evidence, the recommendations given by WHO/UNICEF/ICCIDD in 2007 provide a valid guidance on the use of iodine supplements in pregnant women. Women living in a population with a median urinary iodine concentration (UIC) at or above 100 µg/l are not in need of iodine supplementation in pregnancy. On the other hand, if the population median UIC is below 100 µg/l, pregnant women should take iodine-containing supplements until the population in general has been iodine sufficient for at least 2 years by way of universal salt iodization. PMID:27099837

  14. Iodine Supplementation in Pregnancy and the Dilemma of Ambiguous Recommendations.

    PubMed

    Andersen, Stine Linding; Laurberg, Peter

    2016-03-01

    Iodine requirements are increased during pregnancy, predominantly caused by an increase in renal iodide clearance and in the use of iodine for thyroid hormone production. Because iodine deficiency (ID) in pregnancy may be associated with neurodevelopmental deficits in the offspring, a pertinent question is at what level of iodine intake pregnant women should be advised to take iodine-containing supplements. The consensus reached by the WHO/UNICEF/ICCIDD in 2007 was that pregnant women should not be recommended to take iodine-containing supplements if the population in general had been iodine sufficient for at least 2 years. However, guidance on this differs between scientific societies. This review discusses iodine supplementation in pregnancy. Based on current evidence, the recommendations given by WHO/UNICEF/ICCIDD in 2007 provide a valid guidance on the use of iodine supplements in pregnant women. Women living in a population with a median urinary iodine concentration (UIC) at or above 100 µg/l are not in need of iodine supplementation in pregnancy. On the other hand, if the population median UIC is below 100 µg/l, pregnant women should take iodine-containing supplements until the population in general has been iodine sufficient for at least 2 years by way of universal salt iodization. PMID:27099837

  15. 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. PMID:27426934

  16. 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.

  17. 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…

  18. A guidance concept for hypersonic aerospacecrafts

    NASA Astrophysics Data System (ADS)

    Ishimoto, Shinji

    In this paper a guidance concept for hypersonic re-entry flights is presented. The method uses a closed-form guidance technique based on a drag acceleration reference profile. A guidance law for range control is developed. It employs a physical relation between vehicle energy and range instead of a prediction-correction technique used for Shuttle entry guidance. Simulation results show that the algorithm provides good performance.

  19. US FDA patient-reported outcome guidance: great expectations and unintended consequences.

    PubMed

    Fehnel, Sheri; DeMuro, Carla; McLeod, Lori; Coon, Cheryl; Gnanasakthy, Ari

    2013-08-01

    Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.

  20. 48 CFR 225.7302 - Guidance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Guidance. 225.7302 Section 225.7302 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM, DEPARTMENT OF... Guidance. For guidance on the role of the contracting officer in FMS programs that will require...