Department of Health and Human Services December 19, 2019 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; OCSE-75 Tribal Child Support Enforcement Program Annual Data Report (OMB #0970-0320)
Document Number: 2019-27423
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the form OCSE- 75Tribal Child Support Enforcement Annual Data Report (OMB # 0970- 0320, expiration 03/31/2020). There are no changes requested to the form.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Practitioner Data Bank Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, Health Centers, and Other Eligible Entities
Document Number: 2019-27395
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-27385
Type: Notice
Date: 2019-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 Request. 60-Day Public Comment Request
Document Number: 2019-27376
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Meeting of the National Advisory Council on the National Health Service Corps
Document Number: 2019-27357
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Council on the National Health Service Corps (NACNHSC) will hold public meetings for the 2020 calendar year (CY). Information about NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at: https://nhsc.hrsa.gov/nac/meetings.html.
Bridging for Drug-Device and Biologic-Device Combination Products; Draft Guidance for Industry; Availability
Document Number: 2019-27354
Type: Notice
Date: 2019-12-19
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 ``Bridging for Drug-Device and Biologic-Device Combination Products.'' This draft guidance, when finalized, will represent the Agency's thinking on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or co-packaged combination products and will help to fulfill the performance goals under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). For the purposes of this guidance, the term bridging refers to the process of establishing the scientific relevance of information developed in an earlier phase of the development program or another development program to support the combination product for which an applicant is seeking approval. Once the applicant has established the relevance of such information to (i.e., bridged to) its product, the applicant may be able to leverage that information to streamline the development program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects; Informed Consent; and Institutional Review Boards
Document Number: 2019-27351
Type: Notice
Date: 2019-12-19
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.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-27317
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-27316
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes And Digestive And Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-27315
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-27314
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-27313
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-27312
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-27311
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-27310
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-27309
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations for Membership To Serve on the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and Sexually Transmitted Disease (STD) Prevention and Treatment
Document Number: 2019-27301
Type: Notice
Date: 2019-12-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). CHACHSPT advises the HHS Secretary, the CDC Director, and the HRSA Administrator on objectives, strategies, policies, and priorities for HIV, viral hepatitis, and STD prevention and treatment efforts. These include surveillance of HIV infection, viral hepatitis, other STDs, and related behaviors; epidemiologic, behavioral, health services, and laboratory research on HIV, viral hepatitis, and other STDs; identification of policy issues related to HIV/viral hepatitis/ STD professional education, patient healthcare delivery, and prevention services; agency policies about prevention, treatment, healthcare delivery, and research and training relating to HIV, viral hepatitis and other STDs; strategic issues influencing the ability of CDC and HRSA to fulfill their missions of providing prevention and treatment services; programmatic efforts to prevent and treat HIV, viral hepatitis, and other STDs; and support to the agencies in their development of responses to emerging health needs related to HIV, viral hepatitis, and other STDs.
Listing of Color Additives Exempt From Certification; Soy Leghemoglobin
Document Number: 2019-27173
Type: Rule
Date: 2019-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food Safety on the final rule entitled ``Listing of Color Additives Exempt from Certification; Soy Leghemoglobin,'' which published on August 1, 2019. The final rule amended the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. After reviewing the objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. We are also providing notice that the administrative stay of the effective date for this color additive regulation is now lifted.
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