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

Agency Information Collection Activities; Proposed Collection; Public Comment Request; Semiannual Performance Measures for the ACL Traumatic Brain Injury State Partnership Program (ICR New)
Document Number: 2017-24525
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to 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 a 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 proposed semiannual performance measures for the ACL Traumatic Brain Injury State Partnership program as reauthorized under the Traumatic Brain Injury Reauthorization Act of 2014.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-24524
Type: Notice
Date: 2017-11-13
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24523
Type: Notice
Date: 2017-11-13
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed work and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Evaluation of the Cancer Survivorship Demonstration Project. This information collection aims to help CDC better understand strategies and best practices to identify and address current cancer survivorship needs and gaps.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report
Document Number: 2017-24495
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Be The Match® Patient Services Survey, OMB No. 0906-0004-Revision
Document Number: 2017-24494
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Advisory Commission on Childhood Vaccines
Document Number: 2017-24493
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act (FACA), notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following Web site: http:// www.hrsa.gov/advisorycommittees/childhoodvaccines/index.html.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Voluntary Partner Surveys To Implement Executive Order 12862 in the Health Resources and Services Administration, OMB No. 0915-0212-Extension
Document Number: 2017-24492
Type: Notice
Date: 2017-11-13
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: Submission to OMB for Review and Approval; Public Comment Request; Assessing Client Factors Associated With Detectable HIV Viral Loads; and Models of Care and the Ryan White HIV/AIDS Program
Document Number: 2017-24491
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
National Advisory Committee on Rural Health and Human Services; Notice of Correction
Document Number: 2017-24490
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register, FR 2017-23562 (October 31, 2017), announcing the charter renewal of the National Advisory Committee on Rural Health and Human Services (NACRHHS).
S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2017-24483
Type: Notice
Date: 2017-11-13
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 entitled ``S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance replaces the existing guidance entitled ``S5(R2) Detection of Toxicity to Reproduction for Human Pharmaceuticals.'' The draft guidance is intended to align with other ICH guidances, elaborate on concepts to consider when designing studies, and identify potential circumstances in which a risk assessment can be made based on preliminary studies. It also clarifies the qualification and potential use of alternative assays.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24473
Type: Notice
Date: 2017-11-13
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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Project NICE: Navigating Insurance Coverage Expansion''. Project NICE will evaluate the efficacy of an in-person health insurance enrollment assistance intervention among Black and Hispanic men who have sex with men (MSM) and Transgender persons living in the Chicago, Illinois metropolitan area.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24472
Type: Notice
Date: 2017-11-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-24436
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-24435
Type: Notice
Date: 2017-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate and Formic Acid
Document Number: 2017-24366
Type: Rule
Date: 2017-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, the Agency) is amending food additive regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid and ammonium formate. This action is in response to a food additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP 2286), which also proposed to amend the animal food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources.
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
Document Number: 2017-23932
Type: Rule
Date: 2017-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.