Department of Health and Human Services August 27, 2019 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; 30-Day Comment Request Introduction to Cancer Research Careers (ICRC) Application (NCI)
Document Number: 2019-18426
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Delta States Rural Development Network Grant Program; OMB No. 0915-0386-Extension
Document Number: 2019-18425
Type: Notice
Date: 2019-08-27
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: Submission for OMB Review; Comment Request
Document Number: 2019-18415
Type: Notice
Date: 2019-08-27
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2019-18410
Type: Notice
Date: 2019-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) 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. At least one portion of the meeting will be closed to the public. Members will participate via teleconference.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evidence-Based Telehealth Network Program Measures, OMB No. 0906-xxxx-NEW
Document Number: 2019-18388
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-18383
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Reallotment of Fiscal Year 2018 Funds for the Low Income Home Energy Assistance Program (LIHEAP)
Document Number: 2019-18374
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given of a preliminary determination that funds from the fiscal year (FY) 2018 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to States, Territories, Tribes, and Tribal Organizations that received FY 2019 direct LIHEAP grants. No subgrantees or other entities may apply for these funds.
Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2019-18363
Type: Notice
Date: 2019-08-27
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 ``Male Breast Cancer: Developing Drugs for Treatment.'' This draft guidance provides recommendations regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of male patients with breast cancer. Specifically, this draft guidance recommends the inclusion of male patients in clinical trials of breast cancer drugs and provides recommendations on clinical development when males have either not been included in clinical trials for drugs to treat breast cancer or when inclusion of males in those trials is very limited. The development of drugs for male breast cancer may provide clinical data and additional FDA-approved treatment options to improve the clinical management of breast cancer in male patients.
Request for Information: Regarding Revisions to the PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation
Document Number: 2019-17759
Type: Notice
Date: 2019-08-27
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health in the Department of Health and Human Services (HHS) seeks public comment regarding proposed revisions to the 2013 PHS Guideline for Reducing Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Organ Transplantation.
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