Department of Health and Human Services August 17, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request; Voluntary Qualified Importer Program Guidance for Industry
Document Number: 2016-19643
Type: Notice
Date: 2016-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2016-19611
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-19598
Type: Notice
Date: 2016-08-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Indian Health Outreach and Education II Program; Correction
Document Number: 2016-19597
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on July 15, 2016, for the Fiscal Year 2016 National Indian Health Outreach and Education II Program. The notice contained an incorrect Announcement Number.
Regulatory Classification of Pharmaceutical Co-Crystals; Draft Guidance for Industry; Availability
Document Number: 2016-19596
Type: Notice
Date: 2016-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co- Crystals'' issued in April 2013.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2016-19589
Type: Notice
Date: 2016-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee of the Pediatric Advisory Committee. 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 comment on this document.
Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability
Document Number: 2016-19588
Type: Notice
Date: 2016-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The guidance finalizes the draft guidance of the same title dated January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007 (2007 Donor Eligibility Guidance).
Prospective Grant of Exclusive Patent License: Development of T Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the Treatment of Cancer
Document Number: 2016-19549
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA to practice the inventions embodied in the following patent applications:
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2016-19548
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2016-19547
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-19546
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2016-19545
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2016-19544
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2016-19543
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2016-19542
Type: Notice
Date: 2016-08-17
Agency: Department of Health and Human Services, National Institutes of Health
Substances Generally Recognized as Safe
Document Number: 2016-19164
Type: Rule
Date: 2016-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.
World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements
Document Number: 2016-18679
Type: Proposed Rule
Date: 2016-08-17
Agency: Department of Health and Human Services
In 2011 and 2012, the Secretary, Department of Health and Human Services (HHS), promulgated regulations designed to govern the World Trade Center (WTC) Health Program (Program), including the processes by which eligible responders and survivors may apply for enrollment in the Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions, as well as a process to add new conditions to the List of WTC-Related Health Conditions. After using the regulations for a number of years, the Administrator of the WTC Health Program has identified potential improvements to certain existing provisions, including, but not limited to, appeals of enrollment, certification, and treatment decisions, as well as the procedures for the addition of health conditions for WTC Health Program coverage. He has also identified the need to add new regulatory provisions, including, but not limited to, standards for the disenrollment of a WTC Health Program member and decertification of a certified WTC-related health condition.