Department of Health and Human Services September 22, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
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.
Medicare and Medicaid Programs; Continued Approval of the American Osteopathic Association/Healthcare Facilities Accreditation Program's (AOA/HFAP's) Ambulatory Surgical Center Accreditation Program
This final notice announces our decision to approve the American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
Statistical Approaches To Evaluate Analytical Similarity; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Statistical Approaches to Evaluate Analytical Similarity.'' This draft guidance, when finalized, will provide advice on the evaluation of analytical similarity to sponsors interested in developing biosimilar products. Specifically, this draft guidance describes the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan for the proposed biosimilar, and the statistical approaches recommended for evaluating analytical similarity.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys
The Food and Drug Administration (FDA or we) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping
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.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions
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 (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 requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.
Zinpro Corp.; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA) is announcing that Zinpro Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of chromium DL- methionine as a nutritional source of chromium in cattle feed.
Notice of Availability of a Revised Environmental Assessment for HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, Georgia
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability and opportunity for public review and comment of a revised Environmental Assessment (EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The revised EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.
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