Department of Health and Human Services December 13, 2019 – Federal Register Recent Federal Regulation Documents

Solicitation of Nominations for Appointment to the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2019-26921
Type: Notice
Date: 2019-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on CLIAC. CLIAC, consisting of 20 members including the Chair, represents a diverse membership across laboratory specialties, professional roles (laboratory management, technical specialists, physicians, nurses) and practice settings (academic, clinical, public health), and includes a consumer representative. In addition, the Committee includes three ex officio members (or designees), including the Director, CDC; the Administrator, Centers for Medicare and Medicaid Services (CMS); and the Commissioner, Food and Drug Administration (FDA). A nonvoting representative from the Advanced Medical Technology Association (AdvaMed) serves as the industry liaison. The Designated Federal Officer or their designee and the Executive Secretary are present at all meetings to ensure meetings are within applicable statutory, regulatory and HHS General Administration manual directives.
Advisory Committee on Breast Cancer in Young Women (ACBCYW); Meeting
Document Number: 2019-26919
Type: Notice
Date: 2019-12-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio and web conference lines (80 audio and web conference lines available). The public is welcome to listen to the meeting by accessing the call-in number, 1-888-606-5944, and the passcode 8340472, (80 lines are available). The web conference access is https://adobeconnect.cdc.gov/rwa641n3jrry/. Online Registration Required: All ACBCYW Meeting participants must register for the meeting online at least 5 business days in advance at https://www.cdc.gov/cancer/breast/ what_cdc_is_doing/conference.htm. Please complete all the required fields before submitting your registration and submit no later than January 31, 2020.
Request for Information on the Development of the Fiscal Year 2021-2025 Trans-NIH Strategic Plan for Sexual & Gender Minority Health Research
Document Number: 2019-26915
Type: Notice
Date: 2019-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on the development of the fiscal years (FY) 2021-2025 Trans-NIH Strategic Plan for Sexual and Gender Minority Health Research. This plan will describe future directions in sexual and gender minority (SGM) health and research to optimize NIH's research investments.
Submission for OMB Review; Generic Program-Specific Performance Progress Report (0970-0490)
Document Number: 2019-26913
Type: Notice
Date: 2019-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
This Notice describes the proposal to extend data collection under the Administration for Children and Families (ACF) Generic Program-Specific Performance Progress Report (PPR) (0970-0490). This overarching generic allows ACF program offices to collect performance and progress data from recipients and sub-recipients who receive funding from ACF under a discretionary grant or cooperative agreement. This information is required under 45 CFR 75.342, monitoring and reporting program performance. The generic program-specific PPR was originally approved in January 2017.
Request for Information: Family Caregiving Advisory Council; Correction
Document Number: 2019-26880
Type: Notice
Date: 2019-12-13
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) published a document in the Federal Register on December 9, 2019, requesting information to the Advisory Council to Support Grandparents Raising Grandchildren seeking information to be used in the development of the Initial Report, as required by the Supporting Grandparents Raising Grandchildren Act (SGRG). The ACL wishes to change a line in the titling of the notice in order to avoid confusion for potential commenters.
Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs; Draft Guidance for Industry; Availability
Document Number: 2019-26877
Type: Notice
Date: 2019-12-13
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 ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.'' This draft guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA on or after August 18, 2020, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). This guidance addresses the implementation of amendments made by FDARA to the FD&C Act regarding molecularly targeted oncology drugs.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Bureau of Primary Health Care Uniform Data System, OMB No. 0915-0193-Revision
Document Number: 2019-26876
Type: Notice
Date: 2019-12-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of 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. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-26864
Type: Notice
Date: 2019-12-13
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 ``Evaluation of Patient-Centered Outcomes Research Trust Fund Training Program.''
Opportunity to Co-Sponsor Office of Disease Prevention and Health Promotion Healthy Aging Summit and Regional Workshops
Document Number: 2019-26821
Type: Notice
Date: 2019-12-13
Agency: Department of Health and Human Services
The Office of Disease Prevention and Health Promotion (ODPHP) announces the opportunity for non-Federal public and private sector organizations and entities to co-sponsor the 2020 Healthy Aging Regional Workshops (Workshops) and/or the 2021 Healthy Aging Summit (HAS). Opportunity A: 2020 Healthy Aging Regional Workshop co-sponsorship will involve executing a single or series of financially self- sustaining (no federal funds will be provided to the co-sponsor) meetings or workshops to convene healthy-aging stakeholders to support regional action planning and dissemination of information on healthy aging, aging in place, and age-friendly public health systems. Opportunity B: 2021 Healthy Aging Summit co-sponsorship will involve executing a single financially self-sustaining (no federal funds will be provided to the co-sponsor) conference and related activities focused on health promotion and disease prevention research across the lifespan. This Summit will identify critical research needs and highlight the latest science of creating livable communities and improving healthy aging. This co-sponsorship opportunity is not a grant or contract award program and each partner will be responsible for financially supporting its own activities. Potential co-sponsors must have demonstrated interest in and experience with coordinating healthy aging-focused activities, be capable of managing the day-to-day operations associated with the proposed activities, and be willing to participate substantively in the execution of the co-sponsored activity.
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