Department of Health and Human Services February 21, 2017 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-03370
Type: Notice
Date: 2017-02-21
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-03369
Type: Notice
Date: 2017-02-21
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.
Pediatric Postmarketing Pharmacovigilance and Drug Utilization Reviews; Establishment of a Public Docket; Request for Comments
Document Number: 2017-03365
Type: Notice
Date: 2017-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments related to the pediatric postmarketing pharmacovigilance and drug utilization reviews of products posted between September 17, 2016, and February 24, 2017, on the FDA Web site, but will not be presented at the March 6-7, 2017, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2017-03364
Type: Notice
Date: 2017-02-21
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration
Document Number: 2017-03342
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Nurse Faculty Loan Program-Revised Program Specific Data Form, OMB No. 0915-0378-Revision
Document Number: 2017-03339
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
World Trade Center Health Program; Petition 014-Autoimmune Diseases; Finding of Insufficient Evidence
Document Number: 2017-03336
Type: Proposed Rule
Date: 2017-02-21
Agency: Department of Health and Human Services
On September 29, 2016, the Administrator of the World Trade Center (WTC) Health Program received a petition to add autoimmune diseases, including rheumatoid arthritis, to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 014 is not substantially different from Petitions 007, 008, 009, 011, and 013, which also requested the addition of autoimmune diseases, including various subtypes. The Administrator has published responses to the five previous petitions in the Federal Register and has determined that Petition 014 does not provide additional evidence of a causal relationship between 9/11 exposures and autoimmune diseases, including rheumatoid arthritis. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; The National Health Service Corps and NURSE Corps Interest Capture Form
Document Number: 2017-03335
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Nurse Faculty Loan Program, Annual Performance Report Financial Data Form
Document Number: 2017-03316
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)
Document Number: 2017-03311
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services
This notice announces the next two meeting dates for the Physician-Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') which will be held in Washington, DC. All meetings will be open to the public.
Q11 Development and Manufacture of Drug Substances-Questions and Answers (Regarding the Selection and Justification of Starting Materials); International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2017-03309
Type: Notice
Date: 2017-02-21
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 entitled ``Q11 Development and Manufacture of Drug SubstancesQuestions and Answers (regarding the selection and justification of starting materials).'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances''. The draft guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The question-and-answer (Q&A) draft guidance focuses on chemical entity drug substances, and provides recommendation on the information that should be provided in marketing authorization applications and/or Master Files to justify the starting materials.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-03306
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-03282
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-03281
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-03280
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-03278
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2017-03277
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-03276
Type: Notice
Date: 2017-02-21
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: 2017-03275
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2017-03274
Type: Notice
Date: 2017-02-21
Agency: Department of Health and Human Services, National Institutes of Health