Department of Health and Human Services November 23, 2016 – Federal Register Recent Federal Regulation Documents

Food Labeling
Document Number: 2016-28367
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
Food Labeling
Document Number: 2016-28364
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
Food Labeling
Document Number: 2016-28363
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-28225
Type: Notice
Date: 2016-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28211
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Request for Nominations of Potential Reviewers To Serve on the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)
Document Number: 2016-28207
Type: Notice
Date: 2016-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Breast Cancer in Young Women, Centers for Disease Control and Prevention: Notice of Charter Renewal
Document Number: 2016-28206
Type: Notice
Date: 2016-11-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-28155
Type: Notice
Date: 2016-11-23
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: ``The Consumer Assessment of Healthcare Providers and Systems (CAHPS) Patient-Centered Medical Home (PCMH) Items Demonstration Study.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3rd, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2016-28149
Type: Notice
Date: 2016-11-23
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: 2016-28148
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended Notice of Meeting
Document Number: 2016-28146
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-28145
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2016-28144
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-28143
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-28142
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-28141
Type: Notice
Date: 2016-11-23
Agency: Department of Health and Human Services, National Institutes of Health
Nonprescription Sunscreen Drug Products-Safety and Effectiveness Data; Guidance for Industry; Availability
Document Number: 2016-28124
Type: Notice
Date: 2016-11-23
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 guidance for industry entitled ``Nonprescription Sunscreen Drug ProductsSafety and Effectiveness Data.'' This guidance addresses FDA's current thinking on the safety and effectiveness data needed to determine whether a nonprescription sunscreen active ingredient or combination of active ingredients evaluated under the Sunscreen Innovation Act (SIA) is generally recognized as safe and effective (GRASE) and not misbranded when used under specified conditions. The guidance also addresses FDA's current thinking about an approach to safety-related final formulation testing that the Agency anticipates adopting in the future.
Contract Manufacturing Arrangements for Drugs: Quality Agreements; Guidance for Industry; Availability
Document Number: 2016-28122
Type: Notice
Date: 2016-11-23
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 guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This guidance describes FDA's current thinking on defining, establishing, and documenting manufacturing activities of the parties involved in contract drug manufacturing subject to current good manufacturing practice (CGMP) requirements. In particular, we describe how parties involved in contract drug manufacturing can use quality agreements to delineate their manufacturing activities to ensure compliance with CGMP.
Nonprescription Sunscreen Drug Products-Format and Content of Data Submissions; Guidance for Industry; Availability
Document Number: 2016-28121
Type: Notice
Date: 2016-11-23
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 guidance for industry entitled ``Nonprescription Sunscreen Drug ProductsFormat and Content of Data Submissions.'' This guidance addresses FDA's current thinking on the format and content of information provided to support a request for a determination whether a nonprescription sunscreen active ingredient is generally recognized as safe and effective (GRASE), as provided under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA).
Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
Document Number: 2016-28120
Type: Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.
Evaluation of the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates; Request for Scientific Data, Information, and Comments
Document Number: 2016-27950
Type: Notice
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is requesting scientific data, information, and comments that would help us evaluate the beneficial physiological effects to human health of isolated or synthetic non-digestible carbohydrates that are added to foods. We are requesting such scientific data, information, and comments to help us determine whether a particular isolated or synthetic non-digestible carbohydrate should be added to our definition of ``dietary fiber'' for purposes of being declared as dietary fiber on a Nutrition Facts or Supplement Facts label.
Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition; Draft Guidance for Industry; Availability
Document Number: 2016-27949
Type: Proposed Rule
Date: 2016-11-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30).'' The draft guidance, when finalized, will describe our views on the scientific evidence needed and the approach to evaluating the scientific evidence on the physiological effects of isolated or synthetic non-digestible carbohydrates that are added to foods that are beneficial to human health.