Department of Health and Human Services May 27, 2016 – Federal Register Recent Federal Regulation Documents

Request for Information on the Development of the FY 2018 Trans-NIH Plan for HIV-Related Research
Document Number: 2016-12578
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health (NIH) invites feedback from investigators in academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, and other interested constituents and the community on the development of the fiscal year 2018 Trans-NIH Plan for HIV-Related Research. This plan is designed to identify and articulate possible future directions to maximize benefits of investments in HIV/AIDS research.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-12555
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-12532
Type: Notice
Date: 2016-05-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-12506
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request a Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Document Number: 2016-12505
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, 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 March 9, 2016 P. 12514 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. The National Cancer Institute, NCI, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)
Document Number: 2016-12504
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health, 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 March 11, 2016 (Vol. 81, P. 12914) 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. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2016-12503
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-12502
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 2016-12501
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2016-12500
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-12499
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-12486
Type: Notice
Date: 2016-05-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Mitigation Strategies To Protect Food Against Intentional Adulteration
Document Number: 2016-12373
Type: Rule
Date: 2016-05-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).
Food Labeling: Revision of the Nutrition and Supplement Facts Labels
Document Number: 2016-11867
Type: Rule
Date: 2016-05-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases, health-related conditions, physiological endpoints, and/or maintaining a healthy dietary pattern that reflects current public health conditions in the United States, and corresponds to new information on consumer understanding and consumption patterns. The final rule updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the Nutrition Facts label.
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments
Document Number: 2016-11865
Type: Rule
Date: 2016-05-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is issuing a final rule to define a single-serving container; require dual-column labeling for certain containers; update, modify, and establish several reference amounts customarily consumed (RACCs); amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. We are taking this action to provide consumers with more accurate and up-to-date information on serving sizes.
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