Science.gov

Sample records for industry supplemental guidance

  1. 76 FR 39111 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...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 HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements: New... a draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient...

  2. 76 FR 55927 - Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

    ... and Related Issues; Availability,'' that appeared in the Federal Register of July 5, 2011 (76 FR 39111... 5, 2011 (76 FR 39111), FDA published a notice with a 90-day comment period to request comments on... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry; Dietary Supplements:...

  3. 78 FR 73199 - Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-05

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance......

  4. Supplemental Literature Resource for Adult Career Education Counseling and Guidance.

    ERIC Educational Resources Information Center

    Northwest Regional Educational Lab., Portland, OR.

    Following the same format as the original document "Adult Career Education Counseling and Guidance Resource," the guide provides supplemental information on sources relative to the field of adult counseling and guidance. The resource aid, which is directed to the adult educator or counselor as well as graduate students in adult or counselor…

  5. 76 FR 1170 - Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and...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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary......

  6. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Refuse-to-Receive Standards.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on......

  7. 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

    ... February 25, 1998 (63 FR 9570). This guidance describes the user fees authorized, updates the previous... the guidance entitled ``30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day... of a guidance for industry entitled ``30-Day Notices, 135-Day Premarket Approval (PMA)...

  8. Industrial-user-permitting guidance manual

    SciTech Connect

    Not Available

    1989-09-01

    The manual provides publicly-owned treatment works (POTWs) with guidance on the development and issuance of effective industrial user permits. The manual addresses and expands upon minimum requirements and provides guidance on how to establish a permit program, procedures for permit issuance, procedures for writing a permit, and requirements for waste haulers. It is intended to assist new permit writers, experienced permit writers, and legal and administrative personnel who are involved in the implementation of an industrial user permitting program in preparing effective and enforceable industrial user permits. It provides documentation of EPA's recommendations for industrial user permit contents/structure. It contains many examples of sections and conditions of a permit, as well as complete sample permits and fact sheets. It also contains background info on requirements of the issuance process and discusses the necessary legal authority required to implement an effective program. Appendix A: Bibliography; Appendix B: List of State/Regional Pretreatment Coordinators; Appendix C: Glossary of Terms; Appendix D: Sample Sewer Use Ordinance Provisions for Permits; Appendix E: Sample Permit Application Form; Appendix F: Sample IU Permit; Appendix G: Sample Standard Conditions for Permits; Appendix H: IU Management Practices; Appendix I: Fact Sheet: Appendix J: Sample Waste Hauler Permit.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to `Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and......

  10. 78 FR 33848 - Draft Guidance for Industry on Human Immunodeficiency Virus-1 Infection: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Human Immunodeficiency Virus... availability of a draft guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing... guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral...

  11. 21 CFR 7.59 - General industry guidance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General industry guidance. 7.59 Section 7.59 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ENFORCEMENT POLICY Recalls (Including Product Corrections)-Guidance on Policy, Procedures, and...

  12. 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

    ...) ``Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation; Draft Guidance for Industry and FDA Staff''; (9) ``Class II Special Controls Guidance Document: Powered Muscle... II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning;...

  13. 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

    ... 10.115). The guidance represents the Agency's current thinking on postmarketing adverse event... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Postmarketing Adverse Event... announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting...

  14. 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.

  15. 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...

  16. 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…

  17. 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,...

  18. 76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... 216 entitled ``Chemistry, Manufacturing, and Controls (CMC) Information-- Fermentation-Derived... guidance for industry 216 entitled ``Chemistry, Manufacturing, and Controls (CMC)...

  19. 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.

  20. 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

  1. 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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 36 Parks, Forests, and Public Property 2 2013-07-01 2013-07-01 false Supplemental guidance, Memorandum of Agreements and Memorandums of Understanding. 223.242 Section 223.242 Parks, Forests, and Public Property FOREST SERVICE, DEPARTMENT OF AGRICULTURE SALE AND DISPOSAL OF NATIONAL FOREST SYSTEM...

  3. 76 FR 25565 - Defense Federal Acquisition Regulations Supplement; Guidance on Personal Services (DFARS Case...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ... their own procedures. DoD published an interim rule at 75 FR 54524 on September 8, 2010, to implement... published at 75 FR 54524 on September 8, 2010, with the following changes: 0 1. The authority citation for... Regulations Supplement; Guidance on Personal Services (DFARS Case 2009-D028) AGENCY: Defense...

  4. 29 CFR 2509.08-1 - Supplemental guidance relating to fiduciary responsibility in considering economically targeted...

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 false Supplemental guidance relating to fiduciary responsibility in considering economically targeted investments. 2509.08-1 Section 2509.08-1 Labor Regulations Relating to Labor (Continued) EMPLOYEE BENEFITS SECURITY ADMINISTRATION, DEPARTMENT OF LABOR GENERAL INTERPRETIVE BULLETINS RELATING TO THE...

  5. 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

    ... specific protocols. This guidance finalizes the draft guidance issued on September 19, 2011 (76 FR 58018... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Self-Selection Studies for... entitled ``Self-Selection Studies for Nonprescription Drug Products.'' This guidance is intended to...

  6. 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

    ... the draft guidance published in the Federal Register of May 1, 2009 (74 FR 20322). This guidance is... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for... entitled ``Label Comprehension Studies for Nonprescription Drug Products.'' The guidance...

  7. 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...

  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, 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...

  10. 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...

  11. 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...

  12. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical......

  13. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the Center for......

  14. 75 FR 9228 - Draft Guidance for Industry on Non-Inferiority Clinical Trials; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Non-Inferiority Clinical... ``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...

  15. 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

    ..., 2008 (73 FR 59635), FDA announced the availability of the draft guidance of the same title. FDA... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Potency Tests for Cellular and Gene... Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance...

  16. 76 FR 65735 - Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaire...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

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

  17. 75 FR 36421 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Chemistry, Manufacturing, and... reported in annual reports. Specifically, the draft guidance describes chemistry, manufacturing,...

  18. 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...

  19. 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...

  20. 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...

  1. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition.'' The updated guidance supports and complements FDA's regulations for the safe and sanitary processing and importing of fish and fishery products using hazard analysis and critical control point (HACCP)...

  2. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex.'' The purpose of this draft guidance is to make recommendations on the appropriate language to include......

  3. 78 FR 55263 - Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry... Propionate; Salmeterol Xinafoate.'' The recommendations provide specific guidance on the design of....115). The draft guidance, when finalized, will represent the Agency's current thinking on the...

  4. 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... products. The draft guidance describes standards sponsors can use to ensure that clinical trial...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Data in Clinical Investigations.'' This document revises and updates the draft guidance entitled ``Electronic Source Documentation in Clinical Investigations.'' This revised draft document provides guidance to sponsors, contract research organizations (CROs), data......

  6. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).'' This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to......

  7. 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...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance discusses the processes that should be considered to ensure the quality and......

  9. 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

    ..., 2013 (78 FR 18273), FDA made available a draft guidance entitled ``Guidance for Industry: Purchasing... Fish Species Associated With the Hazard of Ciguatera Fish Poisoning; Availability AGENCY: Food and Drug... announcing the availability of a guidance for industry entitled ``Guidance for Industry: Purchasing Reef...

  10. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Expanded Access to Investigational Drugs for Treatment Use--Qs & As.'' This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs......

  11. 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

    ... Federal Register of February 3, 2011 (76 FR 6143), FDA published the notice of availability for a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Target Animal Safety and... guidance for industry ( 215) entitled ``Target Animal Safety and Effectiveness Protocol Development...

  12. 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...

  13. 75 FR 60129 - Draft Guidance for Industry and Investigators on Safety Reporting Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ..., 2003 (68 FR 12406), FDA published a proposed rule to revise its regulations governing pre- and... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Investigators on Safety... Administration (FDA) is announcing the availability of a draft guidance for industry and investigators...

  14. 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

    ... (42 U.S.C. 1320a-7i). This new section requires the submission of certain drug sample information to... 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...

  15. 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...

  16. 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...

  17. 15 CFR Supplement No. 2 to Part 766 - Guidance on Charging and Penalty Determinations in Settlement of Administrative Enforcement Cases...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., 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...

  18. 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

    ... Act of 1990 (28 U.S.C. 2461, note (2000)), which are codified at 15 CFR 6.4. B. Denial of export... Determinations in Settlement of Administrative Enforcement Cases No. Supplement No. 1 to Part 766 Commerce and... Pt. 766, Supp. 1 Supplement No. 1 to Part 766—Guidance on Charging and Penalty Determinations...

  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 Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A (R2) through Q1E. The use of these ICH recommendations will......

  20. 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.

  1. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-14

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Abuse-Deterrent Opioids... Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry... availability of a draft guidance for industry entitled ``Abuse-Deterrent Opioids--Evaluation and...

  3. 75 FR 45640 - Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Residual Drug in Transdermal... guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This... of a draft guidance for industry entitled ``Residual Drug in Transdermal and Related Drug...

  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

    ... Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 1646, Silver Spring... the Internet. A search capability for all Center for Devices and Radiological Health (CDRH) guidance... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and......

  5. 78 FR 15956 - Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  6. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Rheumatoid Arthritis: Developing Drug Products for Treatment.'' This guidance outlines FDA's current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of......

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-14

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without an IND.'' This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies......

  8. 77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending that generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A(R2) through Q1E. The use of these ICH recommendations......

  9. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate......

  10. 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 Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.'' The draft guidance announced in this notice is being issued in accordance with the Food and Drug Administration Safety and......

  11. 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...

  12. 76 FR 46303 - Guidance for Industry and Food and Drug Administration Staff: Investigational New Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,'' dated June 2011. The guidance document provides advice to potential......

  13. 77 FR 67379 - Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-09

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed......

  14. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-20

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Tobacco Health Document Submission; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... (74 FR 68629), FDA announced the availability of a draft guidance entitled ``Tobacco Health...

  15. 78 FR 4417 - Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to... new drug application (NDA), or a device premarket approval application (PMA). DATES: Although you can..., or PMA.'' This document provides guidance to industry and FDA staff on the underlying principles...

  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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture'' dated June 2013. The draft guidance document provides manufacturers of licensed Whole Blood and blood components intended for......

  17. 75 FR 73106 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

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

  18. 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...

  19. 77 FR 10535 - Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...The Food and Drug Administration (FDA) is announcing the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry,......

  20. 76 FR 55927 - Draft Guidance for Industry and Food and Drug Administration Staff; Demonstrating the Substantial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-09

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

  1. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International......

  2. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of this guidance is to assist sponsors in prospectively assessing the occurrence of treatment-emergent suicidal ideation and behavior in clinical trials of drug and biological......

  3. 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... guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs... current thinking on the design of BE studies to support ANDAs for iron sucrose injection. It does...

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

  5. 78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

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

  6. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Electronic Source Documentation in Clinical Investigations.'' This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical......

  7. 78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... Federal Register of November 29, 2012 (77 FR 71194), FDA announced the availability of the draft guidance... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated March 2013. The draft guidance document provides revised recommendations for screening and testing of donors and management......

  9. 76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA)...

  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

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

  11. 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

    ... provide recommendations to industry on the design of self- selection studies for nonprescription drug... guidance discusses general concepts to be considered in the design and conduct of a self-selection...

  12. 77 FR 71194 - Draft Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... Investigational Cellular and Gene Therapy Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... document entitled ``Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene... for Biologics Research and Evaluation (CBER), Office of Cellular, Tissue, and Gene Therapies...

  13. 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

    ... 16, 2002 (67 FR 2226), FDA announced the availability of a guidance entitled ``Guidance for Industry... the Federal Register of August 14, 2006 (71 FR 46484), FDA announced the availability of a draft... the revised 2002 guidance as a level 2 guidance document for immediate implementation (71 FR...

  14. 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... Enteritidis in Shell Eggs During Production, Storage, and Transportation; Availability AGENCY: Food and Drug... availability of a draft guidance entitled ``Prevention of Salmonella Enteritidis in Shell Eggs...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

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

  16. 75 FR 55797 - Draft Guidance for Industry on Chronic Hepatitis C Virus Infection: Developing Direct-Acting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-14

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

  17. Industrial Education Manual for Guidance to Teachers, Counsellors and Administrators.

    ERIC Educational Resources Information Center

    Alberta Dept. of Education, Edmonton.

    This manual is designed to provide ready access to information about the industrial education program in Alberta to junior and senior high school teachers, counselors, and administrators. The manual is organized in 10 sections. The first three sections introduce the concept of industrial education, define it, and set forth the objectives of the…

  18. 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 describes a means by which focused ultrasound stimulator systems for aesthetic use may comply with...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...: Norovirus Serological Reagents.'' This guidance document describes a means by which norovirus serological... by following the recommendations in the guidance document or by some other means that...

  20. 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

    ... Federal Register of July 31, 2012 (77 FR 45357), FDA announced the availability of the draft guidance... accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for...

  1. 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... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories; Availability AGENCY:...

  2. 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... of transmission of T. cruzi infection by detecting antibodies to T. cruzi in plasma and serum samples from individual human donors. The guidance document does not apply to the collection of source...

  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

    ... regulations require that certain human drug and biological product labels contain a bar code (Sec. 201.25 (21... Guidance (October 5, 2006, 71 FR 58739). In this guidance, FDA is proposing to amend our response to... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Bar Code Label...

  4. 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

    ... guidance is to enhance human subject protection and the quality of clinical trial data by focusing sponsor..., 2011 (76 FR 53683), FDA announced the availability of the draft guidance entitled ``Oversight of... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Oversight of...

  5. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation Report.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines two ICH......

  6. 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...

  7. 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

    ...The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced......

  8. 76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-03

    ... Staff; De Novo Classification Process (Evaluation of Automatic Class III Designation); Availability...) is announcing the availability of the draft guidance entitled ``De Novo Classification Process... staff and industry on the process for the submission and review of petitions submitted under the...

  9. 77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-23

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  10. 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,...

  11. 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...

  12. 77 FR 74671 - Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ..., 2003, FDA issued an interim final rule (68 FR 58894) to implement amendments to the FD&C Act made by... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) AGENCY: Food and Drug Administration, HHS. ACTION: Notice....

  13. 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: Notice. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of the...

  14. 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.... In the Federal Register of July 21, 2011 (76 FR 43689), FDA announced the availability of the...

  15. 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... comment on those recommendations. In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced...

  16. 76 FR 41803 - Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-15

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

  17. 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...

  18. 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...

  19. 77 FR 20026 - Draft Guidance for Industry: Modified Risk Tobacco Product Applications; Availability; Agency...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-03

    ... product; Sample product labels and labeling; All documents (including underlying scientific information... proposes to label and market the product, consumers will not be misled into believing that the product is... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Modified Risk Tobacco...

  20. 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

    ..., metabolism, and excretion), and pharmacodynamics (i.e., all of the effects of the drug on various physiologic... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability AGENCY: Food and Drug Administration,...

  1. 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

    ... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced the...-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-12623, appearing on page 30175, in the... HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and...

  2. 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... abbreviated licensure pathway under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k... application (i.e., a facility in which the proposed biological product is ] manufactured, processed,...

  3. 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... August 22, 2008 (73 FR 49684), which in turn revised the draft guidance for industry entitled ``Acute... for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data...

  4. 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..., 7519 Standish Pl., Rockville, MD 20855, 240-453-6864, sharon.benz@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of Wednesday, September 11, 2013 (78 FR 55727),...

  5. 78 FR 21128 - Molecular Diagnostic Instruments With Combined Functions; Draft Guidance for Industry and Food...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... draft guidance document provides industry and Agency staff with FDA's current thinking on regulation of...-resistant Staphylococcus aureus, Hepatitis C virus, and genetic markers of cystic fibrosis. These types of... meant to communicate FDA's policy regarding molecular diagnostic instruments with combined...

  6. 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...

  7. 76 FR 4360 - Guidance for Industry on Process Validation: General Principles and Practices; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-25

    ... to be used during process validation. In the Federal Register of November 18, 2008 (73 FR 68431), FDA... to submit comments by January 20, 2009. In the Federal Register of February 13, 2009 (74 FR 7237... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Process Validation:...

  8. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System'' dated June 2013.......

  9. 76 FR 72952 - Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-28

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

  10. 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,…

  11. 76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-06

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry and Food and Drug Administration Staff...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... predicate tobacco product. Manufacturers of tobacco products first introduced or delivered for...

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on ``Target Animal Safety and... guidance for industry ( 215) entitled ``Target Animal Safety and Effectiveness Protocol Development and... for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation...

  13. 77 FR 12852 - Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-02

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks associated with exposure to......

  14. 76 FR 66073 - Guidance for Industry on What You Need to Know About Administrative Detention of Foods; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-25

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on What You Need to Know About.... SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry... part 1, subpart K (21 CFR part 1, subpart K), (76 FR 25538), that pertain to the criteria for...

  15. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Meetings with Industry and Investigators on the Research and Development of Tobacco Products.'' This guidance describes FDA's current policies and recommendations with respect to Agency meetings with tobacco manufacturers, importers, researchers, and/or investigators relating to their......

  16. 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....

  17. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Evaluating the Safety of Flood-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...

  18. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Formal Dispute Resolution: Appeals Above the Division Level.'' This guidance is intended to provide recommendations for industry on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for......

  19. 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

    ... Guidance for Industry: Studies to Evaluate the Utility of Anti-Salmonella Chemical Food Additives in Feeds... HUMAN SERVICES Food and Drug Administration Guidance for Industry: Studies To Evaluate the Utility of Anti- Salmonella Chemical Food Additives in Feeds; Request for Comments AGENCY: Food and...

  20. 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

    ..., and ease of reading. The draft of this guidance issued on September 28, 2010 (75 FR 59726) and the... supersedes the guidance with the same name that issued on April 3, 2007 (72 FR 15888). II. Significance of...; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ...; 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 describes a means by which the ovarian adnexal mass assessment score test system may comply with...

  2. 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...

  3. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.'' This guidance summarizes FDA's current thoughts on the appropriate use of Bayesian statistical methods in the design and analysis of medical device clinical...

  4. 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

  5. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory.'' This guidance is intended to advise food manufacturers that once a boil-water advisory has been issued they should stop using the water subject to the advisory until the water again meets the......

  6. 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...

  7. 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

    ... FR 3054), a draft version of this guidance was made available for public comment. On September 27... of an SNI by opening a docket to receive information (73 FR 14988, March 20, 2008). We received 59... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Standards for Securing the...

  8. 77 FR 20825 - Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-06

    ... 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...

  9. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This guidance provides applicants preparing or submitting new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's)......

  10. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical... entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.'' The draft guidance provides sponsors... Evaluation and Research (CBER) with information regarding adaptive design clinical trials when used in...

  11. 76 FR 3144 - Draft Guidance for Industry on Size of Beads in Drug Products Labeled for Sprinkle; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-19

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current......

  12. 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...

  13. 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

    ... (76 FR 44013), FDA announced the availability of the draft guidance of the same title dated July 2011...- Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening... ``Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor...

  14. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic Format--Summary Level Clinical Site Data for CDER's Inspection Planning.'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of......

  15. 78 FR 35940 - Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ...The FDA is announcing the availability of a guidance for industry entitled ``Codevelopment of Two or More New Investigational Drugs for Use in Combination.'' This guidance is intended to assist sponsors in the codevelopment of two or more investigational drugs that have not been previously developed for any indication (i.e., ``new investigational drugs'') to be used in combination to treat a......

  16. 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...

  17. 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

    ...; Class II Special Controls Guidance Document: Tissue Adhesive With Adjunct Wound Closure Device Intended... entitled ``Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device... adhesives with adjunct wound closure devices intended for the topical approximation of skin may comply...

  18. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

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

  19. 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...

  20. 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

    ..., Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg... CONTACT: Samie Allen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New... HUMAN SERVICES Food and Drug Administration Guidance for Industry and......

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-16

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

  3. 78 FR 19495 - Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

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

  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. 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

  6. 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

    ... clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements..., suite 200N, Rockville, MD 20852-1448, 301-827-6210. I. Background The PMA regulation (21 CFR...

  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... required to comply with, but is not necessarily limited to, the requirements set forth in 29 CFR...

  8. 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... required to comply with, but is not necessarily limited to, the requirements set forth in 29 CFR...

  9. 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... Department has issued a regulation, at 29 CFR 2550.404a-1, interpreting the prudence requirements of ERISA as... required to comply with, but is not necessarily limited to, the requirements set forth in 29 CFR...

  10. 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... required to comply with, but is not necessarily limited to, the requirements set forth in 29 CFR...

  11. Do You Read Me? Industrial Supplement: Reading Development Activities Guide.

    ERIC Educational Resources Information Center

    Kendall, Elizabeth L.; Chenoweth, Roberta

    This activity guide is one of four supplements to be used with "Do You Read Me? Prevocational-Vocational Reading Development Activities" (ED 210 454). Each supplement deals with a different occupational category. Games, puzzles, and other activities are offered to aid in developing the word recognition, vocabulary, and comprehension skills of…

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Generic Drug User Fee... 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...

  13. 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...

  14. 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

    ... Administration (FDA) is correcting a notice that appeared in the Federal Register of April 25, 2011 (76 FR 22906...., Bldg. 66, Rm. G424, Silver Spring, MD 20993-0002, 301-796-6438. SUPPLEMENTARY INFORMATION: In FR Doc...; Class II Special Controls; Guidance Document: Topical Oxygen Chamber for Extremities;...

  15. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... special controls for class II devices. In the Federal Register of October 4, 2007 (72 FR 56771), and... associated with electrocardiograph electrodes: Adverse tissue reaction to the skin- contacting electrode... either electronic or written comments on this guidance at any time. General comments on agency...

  16. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ...-Field Digital Mammography System.'' This guidance document describes a means by which a full-field...-796-2533. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of May 30, 2008 (73 FR... class II (special controls). Also, in the Federal Register of May 30, 2008 (73 FR 31128), FDA...

  17. QUESTIONS AND ANSWERS: EPA'S GUIDELINES FOR CARCINOGEN RISK ASSESSMENT AND SUPPLEMENTAL GUIDANCE FROM ASSESSING SUSCEPTIBILITY FROM EARLY-LIFE EXPOSURE TO CARCINOGENS

    EPA Science Inventory

    March 29, 2005
    EPA's Guidelines for Carcinogen Risk Assessment
    And Supplemental Guidance from Assessing Susceptibility from Early-life
    Exposure to Carcinogens

    Questions and Answers

    The following questions ...

  18. 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

  19. The Music Industry Conference Guide for Music Educators. A Supplement to the Music Educators Journal.

    ERIC Educational Resources Information Center

    Music Educators Journal, 1988

    1988-01-01

    This supplement is a comprehensive guide to the music industry designed for music teachers. Included are tips for contacting music businesses and suggestions on ordering music, robes, instruments, computer software, and other supplies. Includes an annotated directory of Music Industry Conference members. (JDH)

  20. 75 FR 73108 - Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

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

  1. 76 FR 21752 - Guidance for Industry on How To Write a Request for Designation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-18

    ... Write a Request for Designation (RFD).'' This guidance is intended to clarify the type of information... the type of information OCP recommends that a sponsor include in an RFD. The goal of this guidance...

  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

    ....'' This guidance addresses nonclinical development, early phases of clinical development, phase 3 trial... 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. 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

    .... This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on... electronic radiation emitting products. The scope of the guidance document includes devices described in...

  4. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Device Reporting for Manufacturers.'' This draft guidance describes and explains the current FDA regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events. This draft guidance is intended......

  5. 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...

  6. 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

    ... (77 FR 58999), FDA published a draft and on June 20, 2013 (78 FR 37231), published a final guidance... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... guidances Q1A (R2) through Q1E. DATES: Although you can comment on any guidance at any time (see 21 CFR...

  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

    ... the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for... for Paliperidone Palmitate.'' The guidance provides specific recommendations on the design of...). The draft guidance, when finalized, will represent the Agency's current thinking on the design of...

  8. 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

    .... The guidance is intended for any HCT/P establishment that performs a manufacturing step and is... 1271, subpart E. The guidance is intended for any HCT/P establishment that performs a manufacturing... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title...

  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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g); Requests for Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability...

  10. 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...

  11. 78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-15

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

  13. 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

    ... Physical Attributes of Generic Tablets and Capsules; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size, Shape, and Other Physical Attributes of Generic Tablets and...

  14. 78 FR 75570 - Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... Federal Register of April 13, 2012 (77 FR 22327), FDA published the notice of availability for a draft... HUMAN SERVICES Food and Drug Administration Guidance for Industry on New Animal Drugs and New Animal... entitled ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated...

  15. 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

    ... INFORMATION: I. Background In the Federal Register of June 20, 2012 (77 FR 37059), FDA published the notice of... Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food and... Effectiveness of a New Animal Drug for Use in Companion Animals.'' This guidance advises industry on the use...

  16. 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

    ... Generic Drug Facilities, Sites, and Organizations; Availability; Correction AGENCY: Food and Drug... notice that appeared in the Federal Register of Monday, August 27, 2012 (77 FR 51811). The document announced a draft guidance for industry entitled ``Self-Identification of Generic Drug Facilities,...

  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

    ... Products (HCT/Ps)'' dated April 2008 (April 28, 2008; 73 FR 22958), with respect to HCT/Ps. The testing... Reduce the Risk of Transmission of West Nile Virus From Donors of Human Cells, Tissues, and Cellular and... ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus...

  18. 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

    ... (76 FR 45820), FDA published a notice establishing fee rates for FY 2012 for domestic and foreign... Provisions of the FDA Food Safety Modernization Act; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Implementation of the Fee Provisions of Section 107 of the FDA Food...

  19. 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...

  20. 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

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

  1. 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...

  2. 78 FR 38058 - Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-25

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

  3. 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...

  4. 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...

  5. 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...

  6. 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

    ... appropriate dose ranges. On November 13, 2001 (66 FR 56830), FDA issued a draft of this guidance. Comments... pharmacokinetic information, including absorption, distribution, metabolism, and elimination findings....

  7. APPLICATION OF COMBUSTION MODIFICATIONS TO INDUSTRIAL COMBUSTION EQUIPMENT (DATA SUPPLEMENT A)

    EPA Science Inventory

    The supplement provides raw data from a study of the effects of combustion modifications on air pollutant emissions from a variety of industrial combustion equipment. Tested were 22 units, including refinery process heaters; clay and cement kilns; steel and aluminum furnaces; boi...

  8. APPLICATION OF COMBUSTION MODIFICATIONS TO INDUSTRIAL COMBUSTION EQUIPMENT (DATA SUPPLEMENT B)

    EPA Science Inventory

    The supplement provides raw data from a study of the effects of combustion modifications on air pollutant emissions from a variety of industrial combustion equipment. Tested were 22 units, including refinery process heaters; clay and cement kilns; steel and aluminum furnaces; boi...

  9. 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

    ... 2007'' and gave interested parties an opportunity to submit comments by July 27, 2009 (74 FR 27803... FR 46434). This draft guidance is the second edition of that guidance entitled ``Questions and... Registry is to provide a ``reliable mechanism to track patterns of adulteration in food would...

  10. 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......

  11. 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... Companion Animals.'' This guidance makes recommendations for the development of anesthetic new animal drug products for companion animals. The guidance discusses the contents of the target animal...

  12. 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... -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications.'' This draft guidance...

  13. 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... Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for...

  14. 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

    ... closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing risks... Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability AGENCY: Food and... Labels and Carton Labeling Design to Minimize Medication Errors.'' The draft guidance focuses on...

  15. 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...

  16. 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...

  17. 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... Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti... Hepatitis B Core Antigen (Anti- HBc),'' dated May 2010. The guidance document provides recommendations...

  18. 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... definitions of ABSSSI and the recommendations for clinical drug development. DATES: Although you can...

  19. 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... endpoint and a non-inferiority trial design. The efficacy endpoint of clinical success represents the... of information referred to in the guidance for clinical trial sponsors ``Establishment and...

  20. 78 FR 72899 - Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

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

  1. 75 FR 70011 - Guidance for Industry, Mammography Quality Standards Act Inspectors, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-16

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System 13.'' This document is intended to assist mammography facilities and their personnel in meeting the requirements of the Mammography Quality Standards Act (MQSA)...

  2. 78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... ``Electronic Source Data in Clinical Investigations.'' This document provides guidance to sponsors, contract... 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....

  3. 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

    .... Specifically, the guidance addresses study population enrollment and efficacy endpoints for LN trials. In the Federal Register of March 29, 2005 (70 FR 15868), FDA announced the availability of a draft guidance..., efficacy endpoints, and response criteria in SLE. FDA received a number of comments on the draft...

  4. 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

    ... 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 application...Library system by clicking on the appropriate link in the above list. They are also available for...

  5. 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

    ... 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 (IL... accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list....

  6. 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... adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to...

  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

    ... August 3, 2010 (75 FR 45640), FDA announced the availability of the draft version of this guidance. The... prolonged pharmacological effect of the drug. Also, some children have died from inadvertent exposure...

  8. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... higher brain areas such as the visual cortex or the lateral geniculate nucleus. In the Federal Register of April 17, 2009 (74 FR 17872), FDA announced the availability of the draft guidance. Comments...

  9. 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

    ... guidance entitled ``Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical... mitigation strategies, under the IDE requirements. Early feasibility studies allow for limited early clinical... of an early feasibility study IDE application and explains the requirements applicable...

  10. 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

    ... Information Incorporated Into Human Prescription Drug and Biological Products Labeling; Availability AGENCY... Information Incorporated into Human Prescription Drug and Biological Products Labeling.'' This draft guidance... content of pediatric information in human prescription drug and biological products labeling in...

  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

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

  12. 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... should consider, especially during device design and development, and provides recommendations...

  13. 75 FR 36425 - Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... Code of Federal Regulations, subchapter H. In the Federal Register of October 25, 2007 (72 FR 60682... receive a hard copy. Please use the document number 1587 to identify the guidance you are requesting....

  14. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ...; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability AGENCY... Treatment of Urinary Incontinence.'' This guidance document describes FDA's recommendations for clinical investigations of medical devices indicated for the treatment of urinary incontinence. DATES: Submit...

  15. 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

  16. 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.

  17. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Medical Device Classification Product Codes.'' This document describes how device product codes are used in a variety of FDA program areas to regulate and track medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research......

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... 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...

  19. 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

    ... April 5, 2010 (75 FR 17093), FDA published a notice announcing the availability of draft special... for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  20. 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

    ... July 28, 2010 (75 FR 44267). The document reopened the comment period for a notice of availability of..., Silver Spring, MD 20993, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2010-18406, appearing on... Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...

  1. 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

    ... draft guidance published in the Federal Register of June 9, 2010 (75 FR 32791). The original draft... Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31; 123 Stat. 1776... the authority to regulate tobacco products. Section 102 of the Tobacco Control Act requires FDA...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ... Federal Register of May 22, 2001 (66 FR 28182) (the 2001 final guidance), has been developed for... requirements for the approval of human pharmaceutical and biological products among the European Union, Japan... medicinal products in the European Union, Japan, and the United States, and includes input from...

  3. 76 FR 67746 - Revised Guidance for Industry on Impurities: Residual Solvents in New Veterinary Medicinal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-02

    ... marketing applications in this guidance) submitted to the European Union, Japan, and the United States... among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary... of veterinary medicinal products in the European Union, Japan, and the United States, and...

  4. 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...

  5. 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... the Federal Register of July 13, 2011 (76 FR 41157), we made available a draft guidance entitled... Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During...

  6. 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...

  7. 75 FR 54889 - Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-09

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

  8. 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

    ... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability... Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.'' This draft... zonisamide assays. This draft guidance is not final nor is it in effect at this time. DATES: Although you...

  9. 77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... otherwise. In the Federal Register of October 14, 2010 (75 FR 63188), FDA announced the availability of the... Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability AGENCY: Food and Drug... Products: Chemistry, Manufacturing, and Control Information '' dated February 2012. The guidance...

  10. 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

    ... Federal Register on April 27, 2009, (74 FR 19094), FDA announced the availability of the draft guidance of... application would typically be a premarket notification submission (510(k)) or a premarket approval (PMA...) or a PMA application for the injector alone. For a combination product that includes the...

  11. 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

    ... Register of October 21, 2009 (74 FR 54053), FDA announced the availability of the draft guidance documents...-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data--Premarket Approval (PMA...-- Premarket Approval (PMA) and Premarket Notification (510(k)) Submissions'' to the Division of...

  12. 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

    ... if an animal food ingredient is already the subject of an approved FAP. Who to contact for more... 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...

  13. 77 FR 3779 - Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... media, emails, CD-ROMs, and DVDs. In the Federal Register of March 12, 1999 (64 FR 12341), FDA announced... Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug Administration, HHS... guidance document entitled ``Product Name Placement, Size, and Prominence in Advertising and...

  14. 76 FR 49772 - Guidance for Industry: Bar Code Label Requirements-Questions and Answers; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-11

    ... August 2011. In the Federal Register of February 26, 2004 (69 FR 9120), FDA published a final rule (the..., in the Federal Register of April 27, 2006 (71 FR 24856), FDA announced the availability of a guidance... several months later, as discussed in the Federal Register of October 5, 2006 (71 FR 58739). Since...

  15. 75 FR 32481 - Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-08

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

  16. 77 FR 10536 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a......

  17. 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...

  18. 78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... during the development phase of a biosimilar biological product. This draft guidance describes the Agency... development and review of biosimilar biological products. \\1\\ See http://www.fda.gov/downloads/Drugs... between sponsors or applicants and FDA for biosimilar biological product development (BPD) programs. It...

  19. 78 FR 50421 - Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... deferral recommendations. In the Federal Register of July 6, 2012 (77 FR 40068), FDA announced the..., Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria...-Transmitted Malaria'' dated August 2013. The guidance document provides blood establishments that...

  20. 76 FR 32863 - Guidance for Industry and Investigators on Enforcement of Safety Reporting Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... Requirements for Bioavailability and Bioequivalence Studies in Humans'' (75 FR 59935, September 29, 2010... Bioequivalence Studies in Humans'' (75 FR 59935) and issued related draft guidance ``Safety Reporting Requirements for INDs and BA/BE Studies'' (75 FR 60129, Docket No. FDA-2010-D-0482). The final rule amended...

  1. 77 FR 75439 - Guidances for Industry and Investigators on Safety Reporting Requirements for Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... September 29, 2010 (75 FR 59935). FDA has prepared the Small Entity Compliance Guide in accordance with the... entitled ``Safety Reporting Requirements for INDs and BA/BE Studies'' on September 29, 2010 (75 FR 60129... final rule (76 FR 32863; June 7, 2011). At this time, the Agency is withdrawing this guidance....

  2. 78 FR 37230 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-20

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 74669). This notice announces draft product-specific recommendations, either new or revised, that... provide product-specific guidance on the design of BE studies to support abbreviated new drug...

  3. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Design... study design principles relevant to the development of medical device clinical studies that can be...

  4. 77 FR 74669 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... FR 56851). This notice announces draft product-specific recommendations, either new or revised, that... provide product-specific guidance on the design of BE studies to support abbreviated new drug...

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

  6. 78 FR 19271 - Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... guidance provides specific recommendations on the design of bioequivalence (BE) studies to support... finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs...

  7. 77 FR 58399 - Draft Guidance for Industry on Bioequivalence Recommendations for Pentosan Polysulfate Sodium...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-20

    .... SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311; FDA-2007-D- 0433... recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new... on the design of BE studies to support ANDAs for pentosan polysulfate sodium capsule. It does...

  8. 77 FR 7585 - Draft Guidance for Industry on Bioequivalence Recommendations for Rifaximin Tablets; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-13

    .... Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a... specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications... represent the Agency's current thinking on the design of BE studies to support ANDAs for rifaximin-200...

  9. 78 FR 66745 - Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-06

    ... INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the... recommendations for comment. Recommendations were last announced in the Federal Register on June 20, 2013 (78 FR... provide product-specific guidance on the design of BE studies to support abbreviated new drug...

  10. 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... efficacy endpoint and noninferiority trial design. The efficacy endpoint, based on resolution of clinical... trial sponsors ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have...

  11. 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

    ... overall development program and clinical trial designs for drugs to support an indication for the... information referred to in the guidance for clinical trial sponsors entitled ``Establishment and Operation of Clinical Trial Data Monitoring Committees'' have been approved under 0910-0581. III. Comments...

  12. 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... sponsors in the overall clinical development program of drugs to support an indication for the treatment of... Administration Safety and Innovation Act that FDA review guidances for the conduct of clinical trials...

  13. 78 FR 72897 - Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-04

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

  14. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... 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...

  15. 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...

  16. 78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-24

    ... approval of the HDE application. In the Federal Register of December 13, 2011 (76 FR 77542), FDA issued for... guidance to the Office of Orphan Products (OOPD), Food and Drug Administration, 10903 New Hampshire Ave..., MD 20852. FOR FURTHER INFORMATION CONTACT: Eric Chen, Office of Orphan Products Development...

  17. 78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... transplantation. The guidance provides detailed information on the types of studies FDA recommends for validation... information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s. The... designing and conducting studies for validation of nucleic acid-based HLA test kits and preparing a...

  18. 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... publishing a notice announcing the established list of HPHCs as required by section 904(e) of the FD&C...

  19. 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... that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity. (Emphasis added) Thus, withdrawal of this guidance on enforcement policy will...

  20. 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.''...

  1. 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... ADDRESSES section, the second sentence is corrected to read: ``Send one self-addressed adhesive label...

  2. 75 FR 50770 - Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ..., Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Final Monograph'' (74 FR 19385, April 29, 2009).\\1\\ The guidance describes the organ-specific labeling requirements in plain language and... accordance with the Small Business Regulatory Fairness Act. \\1\\ As amended November 25, 2009 (74 FR...

  3. 78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ...)) regulated by the Center for Veterinary Medicine. This guidance was originally issued in 2001. FDA is...), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855... John Kadavil, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish...

  4. 76 FR 569 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-05

    ... Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus... Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft guidance is not final nor is it in effect... for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA)...

  5. 77 FR 33210 - EDF Industrial Power Services (CA), LLC; Supplemental Notice That Initial Market-Based Rate...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission EDF Industrial Power Services (CA), LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization This is a supplemental notice in the above-referenced...

  6. 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

    ... an endpoint for which there is a well-defined treatment effect. The guidance also provides the... endpoints for ABSSSI were included in this guidance. In addition, this guidance reflects recent...

  7. 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...

  8. 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

    ... 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 for...Library system by clicking on the appropriate link in the above list. They are also available for...

  9. 75 FR 5356 - Office of New Reactors; Final Interim Staff Guidance on Post-Combined License Commitments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-02

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

  10. 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…

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ..., Reductions, and Refunds for Drug and Biological Products; Availability AGENCY: Food and Drug Administration... and Biological Products.'' This revised draft guidance provides recommendations to applicants... Drug and Biological Products.'' This revised draft guidance provides recommendations for...

  12. 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

  13. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Class II Special Controls 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 may comply with the requirement of special controls for class II......

  14. 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

    ... the guidance, submit either electronic or written comments on the draft guidance by August 27, 2013... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the... approach satisfies the requirements of the applicable statute and regulations. III. Electronic...

  15. 76 FR 81511 - Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-28

    ... before it begins work on the final version of the guidance, submit either electronic or written comments... information on electronic access to the guidance. Submit electronic comments on the draft guidance to http... the requirements of the applicable statute and regulations. III. Electronic Access Persons...

  16. 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...

  17. 78 FR 69691 - Draft Guidance for Industry on Product Name Placement, Size, and Prominence in Advertising and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Federal Register of January 25, 2012 (77 FR 3779), FDA announced the availability of a guidance entitled..., and Prominence in Advertising and Promotional Labeling; Availability AGENCY: Food and Drug... Advertising and Promotional Labeling.'' When finalized, the draft guidance will replace the guidance of...

  18. 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...

  19. 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

    ... manufacturers of the raw materials necessary for manufacturing of an MNP. The purpose of this guidance is to..., Prioritization of manufactured products based on medical necessity, Developing training, manufacturing and... guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115)....

  20. 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...

  1. 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.

  2. 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

    ... imputed to a firm so as to make it liable for a violation. This makes it important for firms to establish... has an important role to play in preventing exports and reexports contrary to the national security... manufacturing equipment would be of little use in a country without an electronics industry. 4. The customer...

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

    PubMed

    2016-07-19

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

  4. 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

    .... This guidance does not address endpoints for drugs to prevent or decrease the incidence of lung cancer... 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...

  5. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Assay Migration Studies for In Vitro Diagnostic Devices.'' This guidance presents a least burdensome regulatory approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a previously approved assay is migrating (i.e., transitioning) to a new system for......

  6. 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

    ... Register of June 29, 2010 (75 FR 37450), FDA published the notice of availability for a draft guidance... thinking on the use of medically important antimicrobial drugs in animal agriculture. DATES: Submit either... announcing: (1) The availability of a draft guidance entitled ``New Animal Drugs and New Animal...

  7. 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...

  8. 76 FR 50483 - Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider When...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... begins work on the final version of the guidance, submit electronic or written comments on the draft... section for information on electronic access to the guidance. Submit electronic comments on the draft... the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a...

  9. 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

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Impact-Resistant Lenses: Questions and Answers.'' This guidance document answers manufacturer, importer, and consumer questions on impact-resistant lenses, including questions on test procedures, lens testing apparatus, record maintenance, and exemptions to...

  10. 78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Types of Communication During the Review of Medical Device Submissions.'' The purpose of this guidance is to update the Agency's approach to Interactive Review to reflect FDA's implementation of the Medical Device User Fee Act of 2007 (MDUFA II) Commitment Letters and of undertakings agreed......

  11. 75 FR 71133 - Guidance for Industry: The Safety of Imported Traditional Pottery Intended for Use With Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-22

    ... findings of lead contamination of imported traditional pottery labeled as ``Lead Free.'' The guidance... contamination of non- lead glazed (NLG) pottery will not occur and also reminds manufacturers of existing... Decorative Ceramicware.'' FDA is issuing the guidance in response to recent findings of lead contamination...

  12. 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...

  13. 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...

  14. 75 FR 21632 - Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-26

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

  15. 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... oxygen saturation (SpO 2 ) and pulse rate. This document supersedes the General Guidance Document... received with recommendations related to organization, terminology, references to standards, labeling,...

  16. 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...

  17. 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...

  18. 76 FR 22903 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing That a Tobacco...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-25

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.'' This draft guidance provides information on how a manufacturer may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. In this......

  19. 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...

  20. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... 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...

  2. 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

    ... and achievable with the use of good manufacturing practices. It also describes FDA's intended sampling... to be protective of human health and to be achievable with the use of good manufacturing practices... with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized,...

  3. 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

    ... 23, 2011 (76 FR 16425), FDA made available a draft guidance entitled ``Testing for Salmonella Species... 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,...

  4. 77 FR 32124 - Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ...) measures as primary endpoints for IBS clinical trials, and sets forth provisional endpoints and trial... endpoints and trial design recommendations set forth in the guidance. This guidance was published as a draft... for maintenance treatment to prevent sign or symptom recurrence. The section on trial endpoints...

  5. 76 FR 72005 - NUREG-1556, Volume 2, Revision 1, “Consolidated Guidance About Materials Licenses Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ...-Specific Guidance About Industrial Radiography Licenses;'' Draft Guidance for Comment AGENCY: Nuclear... Regulatory Commission (NRC) is revising its licensing guidance for industrial radiography licensees. The NRC... Guidance About Materials Licenses: Program- Specific Guidance About Industrial Radiography Licenses,...

  6. 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

    ... describes a means by which implanted blood access devices may comply with the requirement of special... identified in the guidance document or by some other means that provides equivalent assurances of safety...

  7. 76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... 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...

  8. 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... blood components intended for transfusion, including recommendations for validation and quality control... for transfusion, including recommendations for validation and quality control monitoring of...

  9. 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...

  10. 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

  11. 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

  12. 77 FR 22327 - Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... concerns regarding the development of antimicrobial resistance in human and animal bacterial pathogens when... those products consistent with FDA's GFI 209, ``The Judicious Use of Medically Important Antimicrobial... of a final guidance entitled ``The Judicious Use of Medically Important Antimicrobial Drugs in...

  13. 78 FR 39737 - Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

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

  14. 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

    ... advertisements (TV ads) provision of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). (The term ``pre... ``Prereview of Television Advertisements.'') The draft guidance describes which TV ads FDA intends to make... submit their TV ads to FDA for pre-dissemination review in compliance with the FD&C Act. These...

  15. 75 FR 28257 - Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-20

    ... Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program; Availability... Voluntary Audit Report Submission Program.'' This draft guidance is intended to provide information on the... Voluntary Audit Report Submission Program'' to the Division of Small Manufacturers, International,...

  16. 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... recommendations on design considerations for incorporating physical-chemical identifiers (PCIDs) into solid oral... provides recommendations to pharmaceutical manufacturers on the following topics: (1) Design...

  17. 77 FR 68133 - Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-15

    ... 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV... Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor...

  2. 75 FR 29352 - Draft Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-25

    ... Reaction, Lack of Effectiveness, Product Defect Report,'' as required by FDA regulations. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency... FDA may no longer be adequate, as animal drug effects can change over time and less apparent...

  3. 78 FR 63221 - Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... the Federal Register of May 25, 2010 (75 FR 29352), FDA published the notice of availability for a...-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product... either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written...

  4. 76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability... Medical Device Design.'' The recommendations in this guidance are intended to improve the safety and... Factors and Usability Engineering to Optimize Medical Device Design'' to the Division of...

  5. 78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... Federal Register of February 16, 2011 (76 FR 9027), FDA issued a draft version of this guidance entitled... includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA... be prescriptive with regard to choice of study design or type of analysis and does not endorse...

  6. 75 FR 13765 - Draft Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Products for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-23

    ... of primary endpoints for IBS clinical trials, interim recommendations for IBS clinical trial design... guidance recommends interim strategies for IBS clinical trial design and endpoints, and discusses the...--Clinical Evaluation of Products for Treatment; Availability AGENCY: Food and Drug Administration,...

  7. 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...

  8. 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

    ... Products'' that appeared in the Federal Register of December 17, 2012 (77 FR 74670). In the document, FDA... the Federal Register of December 17, 2012 (77 FR 74670), FDA announced the availability of this draft... enrichment. The guidance also discusses general clinical trial design considerations, provides examples...

  9. 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...

  10. 76 FR 18226 - Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ... Federal Register of July 15, 2009 (74 FR 34358), FDA announced the availability of a draft guidance for... Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Availability... Clinical Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.''...

  11. 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...

  12. 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.''...

  13. 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...

  14. 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

    ... protective of human health and achievable with the use of good manufacturing practices. It also describes FDA...: Action Level'' that appeared in the Federal Register of July 15, 2013 (78 FR 42086). The draft guidance...-1639. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 15, 2013 (78 FR...

  15. 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

    ... guidance describes the importance of implementing appropriate steps during the manufacturing process to... manufacturing process to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin... critical aspect of manufacturing non-penicillin beta-lactam drugs is preventing cross-contamination...

  16. 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...

  17. 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...

  18. 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

    ... and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The... 2, 2013 (78 FR 39736), FDA published a notice announcing the availability of a draft guidance... of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Extension of Comment...

  19. 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

    ... the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA... announced the availability of the draft version of this guidance (74 FR 17872). The public comment period... Bioequivalence Data for Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration,...

  20. 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...

  1. 78 FR 9396 - Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-08

    ... before the onset of overt dementia. DATES: Although you can comment on any guidance at any time (see 21... patients in the early stages of Alzheimer's disease (AD) that occur before the onset of overt dementia.... The design of clinical trials that are specifically focused on the treatment of patients...

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

    ERIC Educational Resources Information Center

    Manitoba Dept. of Education, Winnipeg.

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

  3. RCRA Subtitle C TSD facilities and solvent recovery facilities: Section 313 of the Emergency Planning and Community Right-to-Know Act. Toxic chemical release inventory; Industry guidance

    SciTech Connect

    1999-01-01

    The purpose of this guidance document is to assist facilities in SIC code 4953 that are regulated under the Resource Conservation and Recovery Act (RCRA), Subtitle C and facilities in SIC code 7389 that are primarily engaged in solvent recovery services on a contract or fee basis. This document explains the EPCRA Section 313 and PPA Section 6607 reporting requirements (collectively referred to as the EPCRA Section 313) reporting requirements, and discusses specific release and other waste management activities encountered at many facilities in these industries. The objectives of this manual are to: clarify EPCRA Section 313 requirements for industry; increase the accuracy and completeness of the data being reported by RCRA Subtitle C TSD and solvent recovery facilities; and reduce the level of effort expended by those facilities that prepare an EPCRA Section 313 report.

  4. ENGINEERING ASSESSMENT REPORT--HAZARDOUS WASTE COFIRING IN INDUSTRIAL BOILERS. VOLUME 2. DATA SUPPLEMENT

    EPA Science Inventory

    This report documents results of 42 hazardous waste combustion tests performed on 11 full-scale industrial boilers. The report discusses the boiler operating conditions, measured organic and other gaseous emissions, and the achieved destruction efficiency of principal organic haz...

  5. 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.

  6. 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

  7. 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

  8. ENVIRONMENTAL ASSESSMENT OF A COAL/WATER SLURRY FIRED INDUSTRIAL BOILER. VOLUME 2. DATA SUPPLEMENT

    EPA Science Inventory

    The report gives results of comprehensive emission measurements and analyses for a 7.6 kg/s (60,000 lb/hr) watertube industrial boiler firing a coal/water slurry. Measurements included continuous monitoring of flue gas; quantitation of semivolatile organics and 73 trace elements;...

  9. ENVIRONMENTAL ASSESSMENT OF A WOOD-WASTE-FIRED INDUSTRIAL WATERTUBE BOILER. VOLUME 2. DATA SUPPLEMENT

    EPA Science Inventory

    The two-volume report gives results from field tests of a wood-waste-fired industrial watertube boiler. Two series of tests were performed: one firing dry (11% moisture) wood waste, and the other firing green (34% moisture) wood waste. Emission measurements included: continuous m...

  10. 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…

  11. 77 FR 9945 - Draft Guidance for Industry on Providing Submissions in Electronic Format-Standardized Study Data...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061... refers submitters to FDA's Study Data Standards Resource Web page at http://www.fda.gov/ForIndustry/Data... regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see...

  12. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug... 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request,...

  13. 75 FR 14602 - Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Opening of Comment Period for Future... industry published in the Federal ] Register July 30, 2009, entitled ``Drug-Induced Liver Injury... Liver Diseases (AASLD) and the Pharmaceutical and Research Manufacturers of America, is sponsoring...

  14. Guidance Matters

    ERIC Educational Resources Information Center

    Gartrell, Dan

    2005-01-01

    In this column, the author shares and comments on early childhood educators' use of guidance to foster young children's development and learning. He defines guidance as the commitment a teacher makes to teaching children how to solve their problems, rather than punishing them for having problems they haven't yet learned how to solve. The focus of…

  15. 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…

  16. 7 CFR 1794.7 - Guidance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Analysis, Stop 1522, 1400 Independence Avenue, SW., Washington, DC 20250-1522. (b) Water and waste program... appropriate State Director. State Directors may provide supplemental guidance to meet state and local laws...

  17. Internet Guidance.

    ERIC Educational Resources Information Center

    Savage, Frank X.

    1999-01-01

    States that children need proper guidance and boundaries to reap the benefits of the Internet. Focuses on two issues: how parents can protect their children from the Internet's potential dangers and how they can help their children use the Internet to get work done. Includes suggestions for teachers to help parents meet these challenges. (VWC)

  18. GUIDANCE DOCUMENTS

    EPA Science Inventory

    Defn: Guidance Document - A peer-reviewed document stating overarching principles and practices to be followed (also includes handbook documents).

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... applicable to all OTC topical acne products marketed under the monograph (75 FR 9767, March 4, 2010) (final rule). The guidance describes the requirements of the final rule in plain language and provides...

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

    PubMed

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

    2015-01-01

    This study aimed to evaluate the intake, digestion, blood parameters, and feeding behavior of crossbred dairy cows (Holstein × Gir) managed on Panicum maximum Jacq. cv. Tanzania-1 and provided supplementation with groundnut cake, sunflower cake, or palm kernel cake (to replace soybean meal). Sixteen cows were randomly assigned in a Latin square design with four treatments and four experimental periods. The consumption of nutrients from the pasture did not vary between experimental treatments. Cows receiving the palm kernel cake supplement had a reduced crude protein, non-fibrous carbohydrate, and total digestible nutrient intake and an increase in the average consumption of ether extract. There was also a reduction in the digestibility of dry matter. The inclusion of supplements in the diet did not influence the average time spent eating, ruminating, or resting. The mean values of respiratory and heart rates showed thermal comfort during the trial period. There was a reduction in blood urea nitrogen with palm kernel cake supplementation, and the values of total protein, albumin, and glucose were also significantly different with this supplement. It is recommended that cakes of groundnut cake and sunflower cake seed be used for a total replacement of soybean meal supplements for lactating cows, but the use of palm kernel cake is not recommended. PMID:25319453

    1. Zinc, magnesium, and calcium ion supplementation confers tolerance to acetic acid stress in industrial Saccharomyces cerevisiae utilizing xylose.

      PubMed

      Ismail, Ku Syahidah Ku; Sakamoto, Takatoshi; Hasunuma, Tomohisa; Zhao, Xin-Qing; Kondo, Akihiko

      2014-12-01

      Lignocellulosic biomass is a potential substrate for ethanol production. However, pretreatment of lignocellulosic materials produces inhibitory compounds such as acetic acid, which negatively affect ethanol production by Saccharomyces cerevisiae. Supplementation of the medium with three metal ions (Zn(2+) , Mg(2+) , and Ca(2+) ) increased the tolerance of S. cerevisiae toward acetic acid compared to the absence of the ions. Ethanol production from xylose was most improved (by 34%) when the medium was supplemented with 2 mM Ca(2+) , followed by supplementation with 3.5 mM Mg(2+) (29% improvement), and 180 μM Zn(2+) (26% improvement). Higher ethanol production was linked to high cell viability in the presence of metal ions. Comparative transcriptomics between the supplemented cultures and the control suggested that improved cell viability resulted from the induction of genes controlling the cell wall and membrane. Only one gene, FIT2, was found to be up-regulated in common between the three metal ions. Also up-regulation of HXT1 and TKL1 might enhance xylose consumption in the presence of acetic acid. Thus, the addition of ionic nutrients is a simple and cost-effective method to improve the acetic acid tolerance of S. cerevisiae. PMID:24924214

    2. 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).

    3. 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

    4. 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.

    5. 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.

    6. 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

    7. 45 CFR 73a.735-104 - Advice and guidance.

      Code of Federal Regulations, 2010 CFR

      2010-10-01

      ... 45 Public Welfare 1 2010-10-01 2010-10-01 false Advice and guidance. 73a.735-104 Section 73a.735-104 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION STANDARDS OF CONDUCT: FOOD AND DRUG ADMINISTRATION SUPPLEMENT General Provisions § 73a.735-104 Advice and guidance. (a)...

    8. 76 FR 80946 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2011-12-27

      ... Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for... solicits comments on the FDA guidance for industry on ``Postmarketing Adverse Event Reporting for... recommendations on postmarketing serious adverse event reporting for nonprescription (over-the-counter)...

    9. 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

    10. A GUIDANCE PROJECT TO INVESTIGATE CHARACTERISTICS, BACKGROUND, AND JOB EXPERIENCES OF SUCCESSFUL AND UNSUCCESSFUL ENTRY WORKERS IN THREE SELECTED INDUSTRIES. FINAL REPORT.

      ERIC Educational Resources Information Center

      GORMAN, ROBERT E.

      FIFTEEN CERTIFIED SECONDARY SCHOOL COUNSELORS PARTICIPATED IN AN ON-THE-JOB INVESTIGATION OF THREE SELECTED INDUSTRIES IN MONTANA--MINING, LUMBERING, AND CONSTRUCTION. THE PURPOSES WERE TO (1) PROVIDE THE PARTICIPATING COUNSELORS WITH ON-THE-JOB KNOWLEDGE ESSENTIAL FOR ENGAGING IN MORE EFFECTIVE VOCATIONAL COUNSELING OF SECONDARY SCHOOL STUDENTS…

    11. Elementary School Guidance Bibliography.

      ERIC Educational Resources Information Center

      Biasco, Frank

      This bibliography lists articles and books dealing with elementary school guidance. The bibliography is arranged alphabetically by author. No annotations are given. Approximately 70 titles are given, covering most phases of elementary guidance. (KJ)

    12. Enhanced treatment of wastewater from the vitamin C biosynthesis industry using a UASB reactor supplemented with zero-valent iron.

      PubMed

      Shi, Rongjiu; Xu, Hui; Zhang, Ying

      2011-12-01

      The effects of zero-valent iron (Fe0) on the performance of a mesophilic upflow anaerobic sludge blanket (UASB) reactor treating high-strength wastewater from the vitamin C biosynthesis industry (VCW) was investigated during a 200-day period. The results showed that the chemical oxygen demand (COD) removal efficiency, CH4 content in biogas, specific methanogenic activity of sludge, and phosphate removal efficiency were significantly improved up to 81.8-96.1%, 76.5-79.6%, 1.71-2.87 g CH4-COD g(-1) VSS d(-1) and 68.5-85.2%, respectively, at elevated organic loading rates (OLRs) in the Fe0-amended reactor (RFe). In contrast, the corresponding values of 65.3-83.4%, 69.1-70.8%, 1.12-1.95 g CH4-COD g(-1) VSS d(-1) and 1.4-1.6%, respectively, were recorded in the control (R0). Elevated ferrous concentration of nearly 400 mg L(-1) in sludge was detected in RFe, whereas in the effluent of both reactors it was low (< 1.0 mg L(-1)). Batch tests further showed that Fe0 significantly enhanced the biodegradability of the VCW as shown by an increase in BOD/COD ratio from 0.41 to 0.65, and could serve as the electron donor for methanogenesis by anaerobic sludge, which were responsible for the differences between RFe and R0. The results suggest this integrated Fe0-microbial system is promising in facilitating the anaerobic digestion of VCW in UASB reactors. PMID:22439574

    13. 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.

    14. Current Educational Topics, No. I: I. Illiteracy in the United States and in Europe; II. Industrial Supervisors in Georgia; III. New Phases of Education in Buffalo, N. Y.; IV. Juvenile Labor Bureaus and Vocational Guidance in Great Britain; V. The Educational Museum of the St. Louis Public Schools. Bulletin, 1912, No. 11. Whole Number 482

      ERIC Educational Resources Information Center

      Boykin, James C. Ed.

      1912-01-01

      Contained herein are results and report of study on the current educational topics of: (1) Illiteracy in the United states and in Europe; (2) Industrial Supervisors in Georgia; (3) the New Phases of Education in Buffalo, N.Y; (4) Juvenile labor Bureaus and Vocational Guidance in Great Britain; and (5) a review of the Educational Museum of the St.…

    15. The revised HSE fatigue guidance

      SciTech Connect

      Stacey, A.; Sharp, J.V.

      1995-12-31

      Fatigue cracking has been a principal cause of damage to North Sea structures and consequently considerable attention has been given to the development of guidance for the prediction of fatigue performance. The fatigue guidance of the Offshore Safety Division of the Health and Safety Executive (HSE) was recently revised and published, following a significant offshore industry review in the period 1987 to 1990, and is based on the results of a considerable amount of research and development work on the fatigue behavior of welded tubular and plated joints. As a result of this review, the revised fatigue guidance incorporates several new clauses and recommendations. The revised recommendations apply to joint classification, basic design S-N curves for welded joints and cast or forged steel components, the thickness effect, the effects of environment and the treatment of low and high stress ranges. Additionally, a new appendix on the derivation of stress concentration factors is included. The new clauses cover high strength steels, bolts and threaded connectors, moorings, repaired joints and the use of fracture mechanics analysis. This paper presents an overview of the revisions to the fatigue guidance, the associated background technical information and aspects of the fatigue behavior of offshore structures which are considered to require further investigation. 67 refs., 7 figs., 8 tabs.

    16. Metal mining facilities. Section 313 of the Emergency Planning and Community Right-to-Know Act, toxic chemical release inventory: Industry guidance

      SciTech Connect

      1999-01-01

      This document is intended to assist establishments and facilities designated by the Standard Industrial Classification (SIC) Major Group 10 (except SIC codes 1011, 1081, and 1094) in making compliance determinations under the EPCRA Section 313 reporting requirements and preparing Form R(s) or the Form A certification statement(s) as required. Chapter 1 serves as an introduction to TRI reporting and provides a brief background on the Emergency Planning and Community Right-to-Know Act and information on where to obtain additional compliance assistance. Chapter 2 begins with how to determine if a facility must report. Chapter 2 concludes with a discussion on how to address trade secrets in reporting and the kinds of records that should be kept to support reporting. Chapter 3 discusses how to calculate the activity thresholds (manufacture, process, and otherwise use) for the EPCRA Section 313 chemicals. Chapter 3 concludes with a discussion of how to determine whether EPCRA Section 313 chemicals exceed a reporting threshold, including focused discussions on issues specific to metal mining facilities. Chapter 4 discusses how to calculate the release and other waste management amounts for those EPCRA Section 313 chemicals for which a report must be prepared. This chapter provides a step-by-step approach designed to minimize the risk of overlooking an activity involving an EPCRA Section 313 chemical and any potential sources or types of releases and other waste management activities that a facility may conduct.

    17. Electricity generating facilities. Section 313 of the Emergency Planning and Community Right-to-Know Act, toxic chemical release inventory: Industry guidance

      SciTech Connect

      1999-01-01

      This document is intended to assist establishments and facilities designated by the Standard Industrial Classification (SIC) codes 4911 (limited to facilities that combust coal and/or oil for the purpose of generating electricity for distribution in commerce), 4931 (limited to facilities that combust coal and/or oil for the purpose of generating electricity for distribution in commerce), and 4939 (limited to facilities that combust coal and/or oil for the purpose of generating electricity for distribution in commerce) in making compliance determinations under the EPCRA Section 313 reporting requirements and preparing Form R(s) or the Form A certification statement(s) as required. Chapter 1 serves as an introduction to TRI reporting and provides a brief background on the Emergency Planning and Community Right-to-Know Act and information on where to obtain additional compliance assistance. Chapter 2 begins with how to determine if a facility must report. Chapter 2 concludes with a discussion on how to address trade secrets in reporting and the kinds of records that should be kept to support reporting. Chapter 3 discusses how to calculate the activity thresholds (manufacture, process, and otherwise use) for the EPCRA Section 313 chemicals. Chapter 3 concludes with a discussion of how to determine whether EPCRA Section 313 chemicals exceed a reporting threshold, including focused discussions on issues specific to electricity generating facilities. Chapter 4 discusses how to calculate the release and other waste management amounts for those EPCRA Section 313 chemicals for which a report must be prepared. This chapter provides a step-by-step approach designed to minimize the risk of overlooking an activity involving an EPCRA Section 313 chemical and any potential sources or types of releases and other waste management activities that a facility may conduct.

    18. Dietary Supplements

      MedlinePlus

      Dietary supplements are vitamins, minerals, herbs, and many other products. They can come as pills, capsules, powders, drinks, and energy bars. Supplements do not have to go through the testing that drugs do. Some ...

    19. 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 ...

    20. Supplementing National Menu Labeling

      PubMed Central

      White, Lexi C.

      2012-01-01

      The US Food and Drug Administration’s forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants’ menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., “heart-healthy” graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence. PMID:23078494

    1. Supplementing national menu labeling.

      PubMed

      Hodge, James G; White, Lexi C

      2012-12-01

      The US Food and Drug Administration's forthcoming national menu labeling regulations are designed to help curb the national obesity epidemic by requiring calorie counts on restaurants' menus. However, posted calories can be easily ignored or misunderstood by consumers and fail to accurately describe the healthiness of foods. We propose supplemental models that include nutritional information (e.g., fat, salt, sugar) or specific guidance (e.g., "heart-healthy" graphics). The goal is to empower restaurant patrons with better data to make healthier choices, and ultimately to reduce obesity prevalence. PMID:23078494

    2. 78 FR 23271 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-04-18

      ... Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for... collection associated with the guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome... are indicated to treat hypertension. DATES: Submit either electronic or written comments on...

    3. HOW HIGH SCHOOL COUNSELORS CAN ASSIST STUDENTS TO SUCCESSFULLY ENTER GOVERNMENT AND INDUSTRY, WORKSHOP ON VOCATIONAL AND OCCUPATIONAL GUIDANCE IN THE SIXTIES AND SEVENTIES (MAY 8-9, 1964).

      ERIC Educational Resources Information Center

      PHILLIPS, P. BERTRAND; AND OTHERS

      APPROXIMATELY 200 COUNSELORS AND PRINCIPALS FROM 85 HIGH SCHOOLS ENROLLING 76,610 PUPILS THROUGHOUT SEVEN SOUTHERN STATES ATTENDED A 2-DAY CONFERENCE TO EXAMINE AND EVALUATE GUIDANCE PROGRAMS AND TO SUGGEST IMPROVEMENTS. A FOLLOWUP STUDY OF THE CONFERENCE, INDICATED THAT 88 PERCENT OF THE RESPONDENTS HAD IMPROVED THEIR VOCATIONAL GUIDANCE PROGRAMS…

    4. Stressor Identification Guidance Document

      EPA Science Inventory

      EPA has made availabile the Stressor Identification Guidance Document (EPA 822-B-00-025) published under the authority of Section 304(a)(2) of the Clean Water Act (CWA). This technical guidance doc...

    5. 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.

    6. Evaluating Guidance Activities.

      ERIC Educational Resources Information Center

      Sanborn, Marshall P.

      This report discusses one of the consistent problems in school counseling and guidance-that of furnishing concrete evidence concerning the effects of counseling and guidance activities on the development of children. The following causal factors are discussed: (1) the difficulty of pinning down abstractly stated goals in an operational manner at…

    7. 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.

    8. Ascent Guidance Comparisons

      NASA Technical Reports Server (NTRS)

      Hanson, John M.; Shrader, M. Wade; Cruzen, Craig A.

      1995-01-01

      This paper contains results from ascent guidance studies conducted at the NASA Marshall Space Flight Center. The studies include investigation of different guidance schemes for a variety of potential launch vehicles. Criteria of a successful ascent guidance scheme are low operations cost, satisfaction of load indicator constraints, and maximization of performance. Results show that open-loop designs as a function of altitude or velocity are preferable to designs that are functions of time. Optimized open-loop trajectories can increase performance while maintaining load indicators within limits. Closed-loop atmospheric schemes that involve linear tangent steering or feedback of velocity terms for trajectory modification did not yield any improvement. Early release of vacuum closed-loop guidance, including use during solid rocket booster operation, yields some improvements. Evaluation of a closed-loop optimization scheme for flying through the atmosphere shows no advantages over open-loop optimization. Dispersion study results for several potential guidance schemes and launch vehicles are included in the paper and are not a discriminator between guidance schemes. The primary cost driver is mission operations philosophy, not choice of guidance scheme. More autonomous guidance schemes can help in movement towards a philosophy that would reduce operations costs.

    9. 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)…

    10. HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION

      SciTech Connect

      OHARA,J.; BROWN,W.; STUBLER,W.; HIGGINS,J.; WACHTEL,J.; PERSENSKY,J.J.

      2000-07-30

      The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ``Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1.

    11. Shuttle entry guidance revisited

      NASA Technical Reports Server (NTRS)

      Mease, Kenneth D.; Kremer, Jean-Paul

      1992-01-01

      The Shuttle entry guidance concept is reviewed which is aimed at tracking a reference drag trajectory that leads to the specified range and velocity for the initiation of the terminal energy management phase. An approximate method of constructing the domain of attraction is proposed, and its validity is ascertained by simulation. An alternative guidance law yielding global exponential tracking in the absence of control saturation is derived using a feedback linearization method. It is noted that the alternative guidance law does not improve on the stability and performance of the current guidance law, for the operating domain and control capability of the Shuttle. It is suggested that the new guidance law with a larger operating domain and increased lift-to-drag capability would be superior.

    12. Shuttle entry guidance

      NASA Technical Reports Server (NTRS)

      Harpold, J. C.; Graves, C. A., Jr.

      1978-01-01

      This paper describes the design of the entry guidance for the Space Shuttle Orbiter. This guidance provides the steering commands for trajectory control from initial penetration of the earth's atmosphere until the terminal area guidance is activated at an earth-relative speed of 2500 fps. At this point, the Orbiter is at a distance of about 50 nmi from the runway threshold, and at an altitude of about 80,000 ft. The entry guidance design is based on an analytic solution of the equations of motion defining the drag acceleration profile that meets the terminal criteria of the entry flight while maintaining the flight within systems and operational constraints. Guidance commands, which are based on a control law that ensures damping of oscillatory type trajectory motion, are computed to steer the Orbiter to this drag acceleration profile.

    13. 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 ...

    14. 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.

    15. 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 ...

    16. 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…

    17. Dietary supplements.

      PubMed

      Maughan, Ron J; King, Doug S; Lea, Trevor

      2004-01-01

      For the athlete training hard, nutritional supplements are often seen as promoting adaptations to training, allowing more consistent and intensive training by promoting recovery between training sessions, reducing interruptions to training because of illness or injury, and enhancing competitive performance. Surveys show that the prevalence of supplement use is widespread among sportsmen and women, but the use of few of these products is supported by a sound research base and some may even be harmful to the athlete. Special sports foods, including energy bars and sports drinks, have a real role to play, and some protein supplements and meal replacements may also be useful in some circumstances. Where there is a demonstrated deficiency of an essential nutrient, an increased intake from food or from supplementation may help, but many athletes ignore the need for caution in supplement use and take supplements in doses that are not necessary or may even be harmful. Some supplements do offer the prospect of improved performance; these include creatine, caffeine, bicarbonate and, perhaps, a very few others. There is no evidence that prohormones such as androstenedione are effective in enhancing muscle mass or strength, and these prohormones may result in negative health consequences, as well as positive drug tests. Contamination of supplements that may cause an athlete to fail a doping test is widespread. PMID:14971436

    18. 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...

    19. 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…

    20. 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....

    1. 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. ...

    2. 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 ...

    3. 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)

    4. Dietary Supplements

      MedlinePlus

      ... take these supplements off the market. The Federal Trade Commission looks into reports of ads that might ... 504-5414 http://fnic.nal.usda.gov Federal Trade Commission 600 Pennsylvania Avenue, NW Washington, DC 20580 ...

    5. 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)

    6. Creating Strong Supplemental Educational Services Programs. Innovations in Education

      ERIC Educational Resources Information Center

      US Department of Education, 2004

      2004-01-01

      This report, the second in a series, was developed to give district leaders guidance as they implement supplemental services under the No Child Left Behind (NCLB) Supplemental Educational Services (SES) provision. This provision gives parents of elegible children the opportunity and the funding to choose a private tutor or other academic support…

    7. 77 FR 23631 - Defense Federal Acquisition Regulation Supplement; Technical Amendments

      Federal Register 2010, 2011, 2012, 2013, 2014

      2012-04-20

      ... Defense Federal Acquisition Regulation Supplement; Technical Amendments AGENCY: Defense Acquisition... amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial....html . Additional guidance on the fuel card programs is available at http://www.energy.dla.mil ....

    8. Exploring Goals. Career Guidance.

      ERIC Educational Resources Information Center

      Mesa Public Schools, AZ.

      Materials contained in this career guidance unit are designed to enable senior high school students to relate their abilities scores from the Developed Abilities Performance (DAP) instrument to actual vocational areas and Long Range [occupational] Goals (LRG) for later indepth study. The length of the unit is six 55-minute periods. Instructional…

    9. 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.

    10. Differentiating Classroom Guidance

      ERIC Educational Resources Information Center

      Akos, Patrick; Cockman, Caroline R.; Strickland, Cindy A.

      2007-01-01

      To differentiate is to make different, distinct, or specialized (Costello, 1994). Differentiation has become popular in education as an instructional philosophy aimed at equitably meeting the learning needs of all students in the classroom. Differentiated planning and delivery of classroom guidance is also necessary for appropriate school…

    11. The Counseling & Guidance Curriculum.

      ERIC Educational Resources Information Center

      Ediger, Marlow

      Counseling and guidance services are vital in any school curriculum. Counselors may themselves be dealing with students of diverse abilities and handicaps. Counselors may have to work with students affected by drug addiction, fetal alcohol syndrome, homelessness, poverty, Acquired Immune Deficiency Syndrome (AIDS) and divorce. Students may present…

    12. Primary Guidance Activities.

      ERIC Educational Resources Information Center

      Hauck, Ruth, Comp.

      Designed for the primary grades, the guidance activities in this document cover thirty-three topical areas: capabilities, changes, cooperation, criticism, differences, family, feelings, free time, friends, following directions, handicaps, honesty, improving environment, kindness, patience, paying attention, problem solving, rejection,…

    13. Developmental Guidance Program Implementation.

      ERIC Educational Resources Information Center

      Vernon, Ann; Strub, Richard

      This packet of materials was developed for workshops provided to teams of school counselors and administrators for the purpose of developing knowledge and competencies in the delivery of a comprehensive, sequential, developmental guidance program. Section I contains a rationale, definition, and description of program components. In section II…

    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. 1999 Guidance, Navigation, and Control Highlights

      NASA Technical Reports Server (NTRS)

      Polites, Michael E.

      1999-01-01

      This article summarizes the highlights of recent events and developments in guidance, navigation, and control in space, aircraft, and weapons. This article is about 1,200 words long. Information for the article was collected from other NASA Centers, DoD, and industry. All information was previously cleared by the originating organizations. Information for the article was also gathered from Aviation Week and Space Technology, Space News, and similar sources.

    17. 2000 Guidance, Navigation, and Control Highlights

      NASA Technical Reports Server (NTRS)

      Polites, Michael E.

      2000-01-01

      This article summarizes the highlights of recent events and developments in guidance, navigation, and control in space, aircraft, and weapons. This article is about 1,200 words long. Information for the article was collected from other NASA centers, DoD, and industry. All information was previously cleared by the originating organizations. Information for the article was also gathered from Aviation Week and Space Technology, Space News, and similar sources.

    18. 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

    19. 78 FR 16676 - Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-03-18

      ..., 2010 (75 FR 21632), FDA published a notice seeking comment on the proposed information collection... 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...

    20. 75 FR 39949 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-07-13

      ... adequate evaluation of the protocol, including: (1) The role of the study in the overall development of the... Collection; Comment Request; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug... notice solicits comments on the information collection in the guidance for industry on special...

    1. 78 FR 69093 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2013-11-18

      ... adequate evaluation of the protocol, including: (1) The role of the study in the overall development of the... Collection; Comment Request; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug... notice solicits comments on the information collection in the guidance for industry on special...

    2. Needed Concepts in Elementary Guidance.

      ERIC Educational Resources Information Center

      Warner, Tom, Ed.

      School administrators and developmental guidance is the topic of the first speech. Developmental guidance, concerned with personalizing the educational experience, should be available to each child to gain self-understanding. Major responsibilities of the elementary guidance department are pupil appraisal, consultation, and developmental…

    3. New Interpretations of Guidance Role

      ERIC Educational Resources Information Center

      Kerlan, Julius H.; Ryan, Charles W.

      1972-01-01

      A panoramic view of Guidance Division general sessions and workshops covering some exemplary career guidance programs, as well as such topics as career choice, leadership, evaluation, and program development and management. Presented at the Guidance division session of the American Vocational Association 1971 annual meeting. (Editor/MU)

    4. Glutamine supplementation.

      PubMed

      Wernerman, Jan

      2011-01-01

      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. PMID:21906372

    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. Calcium supplements

      MedlinePlus

      ... SHOULD TAKE CALCIUM SUPPLEMENTS? Calcium is an important mineral for the human body. It helps build and protect your teeth ... absorb calcium. You can get vitamin D from sunlight exposure to your skin and from your diet. Ask your provider whether ...

    7. 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.

    8. 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.

    9. 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.

    10. 75 FR 22681 - Supplemental Guidance on Overdraft Protection Programs

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-04-29

      ... an ``opt out'' strategy for consumers. See, e.g., 74 FR at 59038 (``Due to various factors such as... OTS-2010-0008, by any of the following methods: E-mail: regs.comments@ots.treas.gov . Please include... appointment. To make an appointment for access, call (202) 906-5922, send an e-mail to public.info...

    11. 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.

    12. 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…

    13. Station-keeping guidance

      NASA Technical Reports Server (NTRS)

      Gustafson, D. E.; Kriegsman, B. A.

      1972-01-01

      The station-keeping guidance system is described, which is designed to automatically keep one orbiting vehicle within a prescribed zone fixed with respect to another orbiting vehicle. The active vehicle, i.e. the one performing the station-keeping maneuvers, is referred to as the shuttle. The other passive orbiting vehicle is denoted as the workshop. The passive vehicle is assumed to be in a low-eccentricity near-earth orbit. The primary navigation sensor considered is a gimballed tracking radar located on board the shuttle. It provides data on relative range and range rate between the two vehicles. Also measured are the shaft and trunnion axes gimbal angles. An inertial measurement unit (IMU) is provided on board the orbiter. The IMU is used at all times to provide an attitude reference for the vehicle. The IMU accelerometers are used periodically to monitor the velocity-correction burns applied to the shuttle during the station-keeping mode. The guidance system is capable of station-keeping the shuttle in any arbitrary position with respect to the workshop by periodically applying velocity-correction pulses to the shuttle.

    14. 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.

    15. 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.

    16. 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. PMID:21963401

    17. 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…

    18. 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.

    19. Guidance for the New Millenium?

      ERIC Educational Resources Information Center

      McLaren, David J.

      1996-01-01

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

    20. Push drill guidance indication apparatus

      SciTech Connect

      Bockhorst, R.W.; Elenburg, J.H.

      1984-06-05

      The present invention relates to a program controlled apparatus for providing rapid calibration and update of sensor parameters in a push drill guidance apparatus which is remotely controllable from microprocessor circuitry. A special calibration program is set into nonvolatile memory for coaction with the control processor to compute sensor parameters for storage and recall during normal programmed guidance operation.

    1. 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…

    2. Discussing Diverse Perspectives on Guidance

      ERIC Educational Resources Information Center

      Gonzalez-Mena, Janet; Shareef, Intisar

      2005-01-01

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

    3. 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…

    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. Marxist Guidance: A Dialectic Lesson

      ERIC Educational Resources Information Center

      Drapela, Victor J.

      1971-01-01

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

    7. 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

    8. Biodiesel Supplement

      Technology Transfer Automated Retrieval System (TEKTRAN)

      1. What are the greatest challenges facing the biodiesel industry today? The greatest challenges are probably related to the amount of feedstock being available if the current expansion in biodiesel production and use continues. This challenge is addressed below under question 2 regarding the hur...

    9. Diabetes and Dietary Supplements

      MedlinePlus

      ... R S T U V W X Y Z Diabetes and Dietary Supplements: In Depth Share: On This ... health product or practice. Are dietary supplements for diabetes safe? Some dietary supplements may have side effects, ...

    10. 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...

    11. 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

    12. RH Packaging Program Guidance

      SciTech Connect

      Washington TRU Solutions LLC

      2006-11-07

      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 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 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. 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 conspicuous location where the activities subject to

    13. 75 FR 17147 - International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-04-05

      ... Federal Register of August 14, 2009 (74 FR 41144), FDA published a ] notice announcing the availability of... Register of February 21, 2008 (73 FR 9575). When implemented, the annex will provide guidance for industry..., and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance...

    14. 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.

    15. 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.

    16. RH Packaging Program Guidance

      SciTech Connect

      Washington TRU Solutions, LLC

      2003-08-25

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

    17. Video guidance sensor

      NASA Technical Reports Server (NTRS)

      Howard, Richard

      1991-01-01

      A Martin-Marietta study comparing the application of laser, video, or RF sensors was conducted in 1982. The study concluded that video was the most attractive sensor (the video also could be used for operator monitoring). The Retro-Reflector field Tracker from the Solar Array Flight Experiment was chosen as a 'first generation' sensor and integrated with guidance algorithms for evaluation on the air-bearing vehicle. Results indicated that this sensor was not applicable for the noise environment posed by the multi-layer insulation used on most spacecraft. A 'second generation' sensor was developed to be used with a modified RMS target. This sensor utilized two sets of laser diodes to acquire three optically filtered targets. The targets were illuminated first with a 780 nanometer diode, followed by illumination with a 830 nm diode. The second digitized picture was subtracted from the first to get a low-noise image. The centroids of the retroreflectors were used then to uniquely derive target attitude and range. The sensor presently operates to 80 feet and within +/- 40 degrees in pitch and yaw. Sensor operability is a concern if the sun is within a +/- 40 degree cone angle to the target. The present sensor performance characteristics are less than 1 percent range error and less than 1 degree angle error. Future sensor development is anticipated to extend the operating range to 150 feet and reduce the cone angle of sensor inoperability to within +/- 10 degrees of direct sunlight. Performance improvements also are anticipated. TRW currently is developing a system that utilizes dual cameras with simultaneous diode illumination. Although further development is being pursued, the basic system has proven sound, and the sensor is essentially ready for application.

    18. 75 FR 6038 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

      Federal Register 2010, 2011, 2012, 2013, 2014

      2010-02-05

      ... appropriate, and other forms of information technology. ] Guidance for Industry on How to Submit Information... electronically is limited by its current information technology capabilities and the requirements of the... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities;...

    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. GUIDANCE DOCUMENT ON ENVIRONMENTAL MODELS

      EPA Science Inventory

      This guidance provides recommendations intended to assist in the development, evaluation and application of high quality environmental models that the Environmental Protection Agency uses to address environmental problems and to support regulatory activities. These guidelines wi...

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

      Technology Transfer Automated Retrieval System (TEKTRAN)

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

    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. 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.

    4. 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…

    5. 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)

    6. Books for Professionals: Discipline and Guidance.

      ERIC Educational Resources Information Center

      King, Margaret A.

      1994-01-01

      Reviews two books that promote a view of discipline as teaching and guidance. "Guiding Young Children" (Verna Hildebrand) offers specific child guidance techniques and a discussion of general issues affecting child guidance. "Constructive Guidance and Discipline: Preschool and Primary Education" (Majorie V. Fields and Cindy Boesser) focuses on…

    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. 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.

    9. Autonomous Guidance, Navigation and Control

      NASA Technical Reports Server (NTRS)

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

      1991-01-01

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

    10. 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.

    11. 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.

    12. 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) ...

    13. Children and Dietary Supplements

      MedlinePlus

      ... NCCIH Clinical Digest for health professionals Children and Dietary Supplements Share: September 2012 © Matthew Lester Research has shown that many children use herbs and other dietary supplements. However, there are little data available on their ...

    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. 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

    16. 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.

    17. Theater As A Guidance Technique

      ERIC Educational Resources Information Center

      Wolpert, William

      1973-01-01

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

    18. 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…

    19. 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 ...

    20. 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…