Department of Health and Human Services August 12, 2016 – Federal Register Recent Federal Regulation Documents

Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Availability
Document Number: 2016-19306
Type: Notice
Date: 2016-08-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the issuance of a revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The revised draft guidance supersedes FDA's July 2011 draft guidance on the same topic. The revised draft guidance, when finalized, will help industry in evaluating whether to submit a premarket safety notification for a new dietary ingredient (NDI), or for a dietary supplement containing an NDI, and in preparing such premarket safety notifications (also referred to as NDI notifications).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Center Program Application Forms
Document Number: 2016-19301
Type: Notice
Date: 2016-08-12
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, the Health Resources and Services Administration (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 OMB Review; Comment Request
Document Number: 2016-19214
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-19206
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-19194
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2016-19193
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2016-19192
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2016-19191
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2016-19190
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, National Institutes of Health
Request for Comment on Report Entitled: Advancing the Care of Pregnant and Parenting Women With Opioid Use Disorder and Their Infants: A Foundation for Clinical Guidance
Document Number: 2016-19187
Type: Notice
Date: 2016-08-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment, in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on a report entitled: Advancing the Care of Pregnant and Parenting Women with Opioid Use Disorder and their Infants: A Foundation for Clinical Guidance. The report is available at: http://www.regulations.gov/docket?D=SAMHSA-2016-0002. This report describes the formal process agreed on and followed under the guidance of the federal steering committee (FSC). It explains the RAND Corporation (RAND)/University of California Los Angeles (UCLA) Appropriateness Method (RAM), justifies its adoption, and reports the outcomes of its application that will form the basis for the development of clinical guidance. This report will serve as the foundation for the development of clinical guidance to be used by providers caring for women with opioid use disorder and their infants.
Statement of Principles on Industrial Hemp
Document Number: 2016-19146
Type: Notice
Date: 2016-08-12
Agency: Department of Agriculture, Drug Enforcement Administration, Department of Justice, Food and Drug Administration, Department of Health and Human Services, Office of the Secretary
The U.S. Department of Agriculture, in consultation with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, has developed a Statement of Principles on Industrial Hemp to inform the public how Federal law applies to activities associated with industrial hemp that is grown and cultivated in accordance with Section 7606 of the Agricultural Act of 2014. The purpose of this notice is to set forth the statement in its entirety.
340B Drug Pricing Program; Administrative Dispute Resolution
Document Number: 2016-18969
Type: Proposed Rule
Date: 2016-08-12
Agency: Department of Health and Human Services
The Health Resources and Services Administration (HRSA) implements section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This proposed rule will apply to all drug manufacturers and covered entities that participate in the 340B Program. The proposed rule sets forth the requirements and procedures for the 340B Program's administrative dispute resolution process.