Department of Health and Human Services November 2, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26493
Type: Notice
Date: 2016-11-02
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 any of the following subjects: 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.
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
Document Number: 2016-26491
Type: Notice
Date: 2016-11-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.
Organization and Functional Statement; Part GFG; California Area Office; Proposed Functional Statement
Document Number: 2016-26488
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, Indian Health Service
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26454
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-26452
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26451
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26450
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Public Health Service Applications and Pre-Award Reporting Requirements (Office of the Director)
Document Number: 2016-26448
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (Office of the Director)
Document Number: 2016-26447
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; 30-Day Comment Request, National Institutes of Health Electronic Application System for Certificates of Confidentiality
Document Number: 2016-26445
Type: Notice
Date: 2016-11-02
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. This proposed information collection was previously published in the Federal Register on August 18, 2016 (81 FR 55207-55208) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-26427
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements
Document Number: 2016-26408
Type: Notice
Date: 2016-11-02
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 (Section 3506(c)(2)(A) 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.
Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used To Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments
Document Number: 2016-26407
Type: Proposed Rule
Date: 2016-11-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive comments, particularly data and other information, on the appropriate reference amount customarily consumed (RACC) and product category for flavored nut butter spreads (e.g., cocoa, cookie, and coffee flavored), and products that can be used to fill cupcakes and other desserts, such as cakes and pastries. We are taking this action in part because we have recently issued a final rule updating certain RACCs, and we have also received a citizen petition asking that we either issue a guidance recognizing that ``nut cocoa-based spreads'' fall within the ``Honey, jams, jellies, fruit butter, molasses'' category for purposes of RACC determination; or amend the regulation to establish a new RACC category for ``nut cocoa- based spreads'' with an RACC of 1 tablespoon (tbsp.). We also are taking this action in response to a request to amend our serving size regulations to establish an RACC and product category for cupcake filling.
Animal Drug User Fees and Fee Waivers and Reductions; Draft Revised Guidance for Industry; Availability
Document Number: 2016-26406
Type: Notice
Date: 2016-11-02
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 revised guidance for industry (GFI) #170 entitled ``Animal Drug User Fees and Fee Waivers and Reductions.'' This draft revised guidance document describes the types of fees the Food and Drug Administration (FDA or the Agency) is authorized to collect under the Animal Drug User Fee Act of 2003 (ADUFA), as amended, and how to request waivers and reductions from these fees.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2016-26402
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims
Document Number: 2016-26399
Type: Notice
Date: 2016-11-02
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation
Document Number: 2016-26398
Type: Notice
Date: 2016-11-02
Agency: Food and Drug Administration, Department of Health and Human Services
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 (the PRA).
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-26390
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization 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.
National Cancer Institute; Notice of Meeting
Document Number: 2016-26389
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-26388
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute Of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-26387
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-26386
Type: Notice
Date: 2016-11-02
Agency: Department of Health and Human Services, National Institutes of Health
Family Violence Prevention and Services Programs
Document Number: 2016-26063
Type: Rule
Date: 2016-11-02
Agency: Department of Health and Human Services, Administration for Children and Families
This rule will better prevent and protect survivors of family violence, domestic violence, and dating violence, by clarifying that all survivors must have access to services and programs funded under the Family Violence Prevention and Services Act. More specifically, the rule enhances accessibility and non-discrimination provisions, clarifies confidentiality rules, promotes coordination among community- based organizations, State Domestic Violence Coalitions, States, and Tribes, as well as incorporates new discretionary grant programs. Furthermore, the rule updates existing regulations to reflect statutory changes made to the Family Violence Prevention and Services Act, and updates procedures for soliciting and awarding grants. The rule also increases clarity and reduces potential confusion over statutory and regulatory standards. The rule codifies standards already used by the program in the Funding Opportunity Announcements and awards, in technical assistance, in reporting requirements, and in sub-regulatory guidance.