Department of Health and Human Services November 2012 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 236
Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of guidance for industry 217 entitled ``Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.'' The guidance provides guidance to industry for designing and conducting clinical effectiveness studies and describes criteria that the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs intended for use in poultry and other food-producing animals. The guidance suggests times during the evaluation of effectiveness when sponsors may wish to consult with CVM.
Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE Is Needed.'' The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators, adequacy of research sites, and the determination of whether an investigational new drug (IND) application or investigational device exemption (IDE) is needed in order to assure the protection of the rights and welfare of human subjects in clinical investigations.
International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q11 Development and Manufacture of Drug Substances.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The guidance is intended to harmonize the scientific and technical principles relating to the description and justification of the development and manufacturing process of drug substances (both chemical entities and biotechnological/biological entities) to enable a consistent approach for providing and evaluating this information across the three regions. The discussion of principles in the guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished drug products.
Notice of Allotment Percentages to States for Child Welfare Services State Grants
As required by section 423(c) of the Social Security Act (42 U.S.C. 623(c)), the Department is publishing the allotment percentage for each State under the Title IV-B Subpart 1, Child Welfare Services State Grants Program. Under section 423(a), the allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program.
Medical Devices; Custom Devices; Request for Comments
The Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug Administration (FDA) is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption.
Unique Device Identification System
The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Establishing a List of Qualifying Pathogens That Have the Potential To Pose a Serious Threat to Public Health; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on establishing a list of qualifying pathogens (i.e., those that have the potential to pose a serious threat to public health), as required under the Food and Drug Administration Safety and Innovation Act (FDASIA). This public hearing is being held to obtain comments from the public to determine the methodology that should be used in developing the list of qualifying pathogens, and to elicit suggestions for adding specific pathogens to the list.
Standard Test Procedures Approval Process for Respirators To Be Used in Wildland Fire-Fighting Operations; Standard Test Procedures for Composite Multi-Gas and Particulate Protection and Approval Process for Respirators To Be Used in Wildland Fire-Fighting Operations
The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH) intends to employ existing provisions in 42 CFR Part 84 to test and approve air-purifying respirators (APRs) and powered air-purifying respirators (PAPRs) that provide composite multi-gas and particulate protection for inhalation hazards associated with wildland fire-fighting. NIOSH will evaluate candidate respirators for inhalation protections tailored against exposures identified in the National Fire Protection Association (NFPA) 1984 standard on respirators for wildland fire-fighting (WFF) operations. Under 42 CFR Part 84 requirements, NIOSH approval is necessary for the complete evaluation of WFF respirators pursuant to NFPA 1984 (2011).
Prospective Grant of Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking of giving a co-exclusive license in Africa, and an exclusive license in all territories other than Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Merial Limited, having a place of business in Duluth, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application(s) to be licensed are:
Prospective Grant of Co-Exclusive License: Veterinary Vaccines for Rift Valley Fever Virus
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a co-exclusive license in Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Deltamune Ltd., having a place of business in Centurion, South Africa. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:
Prospective Grant of Exclusive License: Multiple-Valent Opsonophagocytic Assay Selection Panel Arrays
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a worldwide, exclusive license to practice the inventions listed in the patent referred to below to Flow Applications, Inc., having a place of business in Okawville, Illinois. The patent rights in these inventions have been assigned to the government of the United States of America. The patent to be licensed is:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013
This major final rule with comment period addresses changes to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also implements provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it implements statutory changes regarding the termination of non-random prepayment review. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs . (See the Table of Contents for a listing of the specific issues addressed in this final rule with comment period.)
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, To Reduce the Risk of Transmission of Hepatitis B Virus; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus,'' dated October 2012. The guidance document provides recommendations on the use of FDA- licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, the guidance provides notification that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. The guidance is intended for blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. The guidance announced in this notice finalizes the draft guidance of the same title, dated November 2011. The guidance also supplements previous memoranda and guidance from FDA concerning the testing of donations for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc) and the management of donors and donations mentioned in those documents.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Compliance Guidance for Small Business Entities on Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Availability
The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ``Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with the requirements of the final rule that provides new labeling applicable to all over-the- counter (OTC) bronchodilator drug products marketed without an approved application. The guidance describes the bronchodilator labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act.
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the guidance document entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealer's Certificate
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Interstate Shellfish Dealer's Certificate.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with FDA's technical assistance reference manuals provided to State, local, territorial, and tribal jurisdictions, and other Federal Agencies to interpret and promote the application of Hazard Analysis and Critical Control Point (HACCP) principles to reduce the risk of foodborne illness in the operation of retail and food service establishments.
Privacy Act of 1974; System of Records Notice
In accordance with the requirements of the Privacy Act of 1974, the Office of Minority Health, Office of the Assistant Secretary for Health, Office of the Secretary of Health and Human Services (HHS/ OS/OASH/OMH) is establishing a new system of records, ``Think Cultural Health,'' to support its Think Cultural Health Web site Program. The system will provide educational information, training, best practices, and tools to health professionals as one initiative to help them accomplish cultural competency in accordance with national Culturally and Linguistically Appropriate Services (CLAS) Standards. The CLAS standards were originally promulgated by OMH in 2001 and are being revised and enhanced in order to guide health and health care organizations in the provision of culturally and linguistically appropriate services that will improve the health care of all Americans. The system will maintain registration and training records containing personally identifiable information (PII) about individual health professionals who are registrants/users of the Think Cultural Health Web site. The program and the system of records are more thoroughly described in the Supplementary Information section and System of Records Notice (SORN) below.
Submission for OMB Review; Comment Request (30-day): National Institute of Nursing Research (NINR) Summer Genetics Institute Alumni Survey
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This information collection was previously published in the Federal Register on June 29, 2012, page 38840 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_ submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Amanda Greene, Office of Science Policy and Public Liaison, NINR, NIH, Democracy One, 6701 Democracy Blvd., Suite 700, Bethesda, MD 20892 or call non-toll-free number (301) 496-9601 or Email your request, including your address to: amanda.greene@nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
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