Department of Health and Human Services January 5, 2017 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA or the Agency) 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 FDA regulations requiring that the Agency receives prior notice before food is imported or offered for import into the United States.
Emerging Tick-Borne Diseases and Blood Safety; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Emerging Tick-Borne Diseases and Blood Safety.'' The purpose of the public workshop is to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions. The workshop has been planned in partnership with AABB; America's Blood Centers; National Heart, Lung, and Blood Institute, National Institutes of Health (NIH); the U.S. Department of Defense; and the U.S. Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies.
[Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comments.
Reference Amounts Customarily Consumed: List of Products for Each Product Category; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Reference Amounts Customarily Consumed: List of Products for Each Product Category.'' The draft guidance, when finalized, will provide examples of products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion established in our regulations.
Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals.'' The draft guidance, when finalized, will provide questions and answers on topics related to compliance, labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format for Nutrition and Supplement Facts labels.
Proposed Changes to the Black Lung Clinics Program for Consideration for the FY 2017 Funding Opportunity Announcement Development
The Federal Office of Rural Health Policy (FORHP) in HRSA published a 30-day public notice in the Federal Register on August 22, 2016 soliciting feedback on a range of issues pertaining to the Black Lung Clinics Program (BLCP). In particular, FORHP requested feedback on how to best determine the needs of coal miners and their families, given the available data, and how to better equip future BLCP grantees to meet those needs. This notice responds to the comments received during this 30-day public notice.
Draft Guidance for Industry: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #243 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH GL56). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements in order to establish appropriate Maximum Residue Limits (MRLs) or other safe limits in honey following the treatment of honeybees with veterinary drug products, or to justify withdrawal periods in honey for registration purposes when an MRL already exists. Use of veterinary drug products in honeybee production is considered as a minor use in minor species in most jurisdictions.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on National Program of Cancer Registries Program Evaluation Instrument.
Proposed Data Collections Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Evaluation of the National Tobacco Prevention and Control Public Education Campaign (The Campaign). The primary objectives of the Campaign are to encourage smokers to quit smoking and to encourage nonsmokers to communicate with smokers about the dangers of smoking. The goal of this evaluation is to gauge the effectiveness of these efforts.
Food and Drug Administration Tribal Consultation Policy; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of the FDA Tribal Consultation Policy. The purpose of the FDA Tribal Consultation Policy is to further the government-to- government relationship between FDA and American Indian and Alaskan Native Tribes (Indian Tribes) and facilitate tribal consultation with FDA. The FDA Tribal Consultation Policy provides background on FDA's mission and organizational structure and elaborates on the principles and guidelines in the U.S. Department of Health and Human Services (HHS) Tribal Consultation Policy. This policy finalizes the draft FDA Tribal Consultation Policy issued in February 2016.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This final rule will apply to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. This final rule sets forth the calculation of the 340B ceiling price and application of civil monetary penalties (CMPs).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The National Health Service Corps Loan Repayment Program
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
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