Department of Health and Human Services December 13, 2017 – Federal Register Recent Federal Regulation Documents

National Library of Medicine; Notice of Meetings
Document Number: 2017-26880
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-26864
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2017-26863
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2017-26862
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2017-26861
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-26831
Type: Notice
Date: 2017-12-13
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 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.
Advisory Committee; Food Advisory Committee; Termination
Document Number: 2017-26829
Type: Rule
Date: 2017-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the termination of the Food Advisory Committee. This document removes the Food Advisory Committee from the Agency's list of standing advisory committees.
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability
Document Number: 2017-26828
Type: Notice
Date: 2017-12-13
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 ``Gluten in Drug Products and Associated Labeling Recommendations.'' This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. This draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals.
Submission for OMB Review; Comment Request
Document Number: 2017-26825
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-26817
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2017-26814
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
National Library of Medicine; Notice of Closed Meetings
Document Number: 2017-26802
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2017-26801
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-26800
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-26799
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-26798
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2017-26797
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-26796
Type: Notice
Date: 2017-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
Document Number: 2017-26795
Type: Notice
Date: 2017-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
Document Number: 2017-26794
Type: Notice
Date: 2017-12-13
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 provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.
Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability
Document Number: 2017-26791
Type: Notice
Date: 2017-12-13
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 ``Refuse to File: NDA and BLA Submissions to CDER.'' The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or supplemental NDA, or a biologics license application (BLA) or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of a refuse- to-file (RTF) action by FDA.
21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website
Document Number: 2017-26790
Type: Notice
Date: 2017-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Opioid Policy Steering Committee: Prescribing Intervention-Exploring a Strategy for Implementation; Public Hearing; Request for Comments
Document Number: 2017-26785
Type: Proposed Rule
Date: 2017-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing entitled, ``Opioid Policy Steering Committee: Prescribing InterventionExploring a Strategy for Implementation.'' The purpose of the public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-26784
Type: Notice
Date: 2017-12-13
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 the proposed extension of the existing information Message Testing for Tobacco Communication Activities (MTTCA). CDC's Office on Smoking and Health has used the MTTCA clearance to support the development and testing of tobacco-related health messages, including messages supporting CDC's National Tobacco Education Campaign (NTEC) called the Tips from Former Smokers[supreg] campaign.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-26783
Type: Notice
Date: 2017-12-13
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 Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communication Campaigns. Thus, CDC seeks to request Office of Management and Budget (OMB) approval to reinstatement OMB Control Number 0920-0800.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2017-26782
Type: Notice
Date: 2017-12-13
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 the National Vital Statistics Report Forms. These are the data collection forms used by State and/or county vital registration offices to report to the Federal government (a) provisional counts of births, deaths, and infant deaths at the end of each month and (b) annual counts of marriages and divorces/ annulments in support of the National Vital Statistics System. This submission contains no changes to the actual data collection forms. However, the number of respondent for the monthly and annual forms have shifted from 91 and 58 respectively to 58 and 91, since the 33 New Mexico Counties only send marriage and divorce information that is now only captured in the annual report.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-26781
Type: Notice
Date: 2017-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-26780
Type: Notice
Date: 2017-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-26779
Type: Notice
Date: 2017-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-26770
Type: Notice
Date: 2017-12-13
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including 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.
New Animal Drugs; Approval of New Animal Drug Applications
Document Number: 2017-26753
Type: Rule
Date: 2017-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.