Department of Health and Human Services November 9, 2017 – Federal Register Recent Federal Regulation Documents

Colorcon, Inc.; Filing of Color Additive Petition
Document Number: 2017-24421
Type: Proposed Rule
Date: 2017-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-24420
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24418
Type: Notice
Date: 2017-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24417
Type: Notice
Date: 2017-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24416
Type: Notice
Date: 2017-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
Document Number: 2017-24415
Type: Notice
Date: 2017-11-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the labeling of natural rubber latex condoms.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
Document Number: 2017-24410
Type: Notice
Date: 2017-11-09
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Health and Diet Survey, as Used by the Food and Drug Administration
Document Number: 2017-24409
Type: Notice
Date: 2017-11-09
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.
Blood Products Advisory Committee Advisory Committee; Notice of Meeting
Document Number: 2017-24408
Type: Notice
Date: 2017-11-09
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 Blood Products Advisory Committee (the Committee). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues related to blood and products derived from blood. The meeting will be open to the public.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24404
Type: Notice
Date: 2017-11-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Rapid Response Suicide Investigation Data Collection.'' CDC will use information collected to respond to urgent requests for CDC assistance.
National Cancer Institute; Notice of Meeting
Document Number: 2017-24402
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2017-24401
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
Draft Report on Carcinogens Monograph on Antimony Trioxide; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2017-24400
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Antimony Trioxide. The Office of the Report on Carcinogens, Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) prepared the monograph. This peer-review meeting is by webcast only and is open to the public. Registration is requested for oral comment and is required to access the webcast. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/38853.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance To Support the Safe To Sleep® Campaign (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Document Number: 2017-24399
Type: Notice
Date: 2017-11-09
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.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Document Number: 2017-24398
Type: Notice
Date: 2017-11-09
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.
Proposed Data Collection Submitted for Public Comment and Recommendations-Assessments To Inform Program Refinement for HIV, Other STD, and Pregnancy Prevention Among Middle and High-School Aged Youth
Document Number: 2017-24388
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) requested publication of a document in the Federal Register. Document 2017-24317, Proposed Data Collection Submitted for Public Comment and RecommendationsAssessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth, has been scheduled to publish on November 8, 2017. The document provided the incorrect docket number (CDC-2018-0093).
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2017-24379
Type: Notice
Date: 2017-11-09
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 Tobacco Products Scientific Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
National Eye Institute; Notice of Closed Meeting
Document Number: 2017-24373
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24372
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, National Institutes of Health
Evaluating Drug Effects on the Ability To Operate a Motor Vehicle; Guidance for Industry; Availability
Document Number: 2017-24367
Type: Notice
Date: 2017-11-09
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 ``Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.'' The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Driving is a complex activity involving a wide range of cognitive, perceptual, and motor activities. Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving is a public health priority. This guidance finalizes the draft guidance issued on January 16, 2015, of the same name.
Proposed Collection; 60-Day Comment Request; CareerTrac
Document Number: 2017-24362
Type: Notice
Date: 2017-11-09
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of 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. The purpose of this notice is to allow 60 days for public comment. The Fogarty International Center (FIC), National Institute of Environmental Health Sciences (NIEHS), including the Superfund Research Program (SRP) within NIEHS, National Institute of General Medical Science (NIGMS), and 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.
Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategy Submissions; Draft Guidance for Industry; Availability
Document Number: 2017-24353
Type: Notice
Date: 2017-11-09
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 ``Use of a Drug Master File for Shared System REMS Submissions.'' The draft guidance provides information to applicants who are part of a shared system Risk Evaluation and Mitigation Strategy (REMS) on using an electronic Type V Drug Master File (DMF). FDA recommends that applicants who are part of a shared system REMS use a Type V DMF for their REMS submissions to improve the efficiency of the submission and review process.
Menu Labeling: Supplemental Guidance for Industry; Availability
Document Number: 2017-24246
Type: Proposed Rule
Date: 2017-11-09
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 for industry entitled ``Menu Labeling: Supplemental Guidance for Industry.'' The draft guidance, when finalized, will address concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments. It includes expanded and new interpretations of policy, and identifies places where FDA intends to be more flexible in its approach. This draft guidance also includes many graphical depictions in order to convey our thinking on various topics and to provide examples of options for implementation. It addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.