Department of Health and Human Services July 10, 2014 – Federal Register Recent Federal Regulation Documents
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Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information starting in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, the final rule requires the submission of this information to FDA instead of USDA.
Extension of Solicitation for Nominations for Membership on the National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is extending the solicitation period for nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). NVPO is taking this action to allow more time for qualified candidates to be identified to be considered for appointment as public members of the NVAC. NVPO is seeking additional candidates that meet the expertise and qualifications needed to constitute a balanced membership as outlined in the Committee's charter and to ensure that the membership will be fairly balanced in terms of the points of view represented and the Committee's function. Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health, in his capacity as Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non- government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
Meeting of the President's Council on Fitness, Sports, and Nutrition
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Fitness, Sports, and Nutrition (PCFSN) will hold its annual meeting. The meeting will be open to the public.
Issuance and Enforcement Guidance for Dog Confinement Agreements
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this issuance and enforcement guidance for dog confinement agreements under 42 CFR 71.51. Under 42 CFR 71.51(c)(2), the CDC Director may authorize admission into the United States of a dog that has not been vaccinated for rabies or that is inadequately immunized if the owner agrees to subsequently vaccinate and properly confine the dog. This guidance describes the factors that HHS/CDC will consider in determining whether it will issue a dog confinement agreement allowing entry of a dog that has not been adequately immunized against rabies, or whether the dog(s) will be denied entry. The notice also describes the steps that an importer may take if his/her imported dog is denied entry.
Meeting of the National Advisory Committee on Children and Disasters
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding its inaugural meeting on August 8, 2014. The meeting is open to the public.
Announcement of Replacement Funding for Title X Family Planning Service Grant to the Massachusetts Department of Public Health
The Office of Population Affairs (OPA) announces that $714,000 in fiscal year 2014 funds are being awarded for a replacement family planning service grant to the Massachusetts Department of Public Health for Berkshire, Franklin, Hampshire, and Hampden counties. This grant will establish and operate voluntary family planning service projects, which shall provide family planning services to all persons desiring such services, with priority for services to persons from low-income families.
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 Health Resources and Services Administration (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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