Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-13631
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2018-13630
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2018-13629
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13628
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13627
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: 2018-13604
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-13593
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Proposed Standards for the Children's Hospitals Graduate Medical Education Payment Program's Quality Bonus System
Document Number: 2018-13592
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA published a notice in the Federal Register on October 11, 2017, soliciting feedback on the establishment of the Children's Hospitals Graduate Medical Education Payment (CHGME) Program's Quality Bonus System (QBS). In particular, HRSA requested feedback on the Fiscal Year (FY) 2019 and beyond multi-step implementation of the system, including demonstration of engagement in state or regional- level initiatives, documentation, and payment structure. This notice summarizes and responds to the comments received during the 60-day comment period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290-Reinstatement With Change
Document Number: 2018-13590
Type: Notice
Date: 2018-06-26
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. The ICR is for reinstatement with change of a previously approved information collection, assigned OMB control number 0915-0290, which expired on March 31, 2015. 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: Proposed Collection: Public Comment Request Information Collection Request Title: Health Resources and Service Administration Uniform Data System, OMB No. 0915-0193-Revision
Document Number: 2018-13587
Type: Notice
Date: 2018-06-26
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-13544
Type: Notice
Date: 2018-06-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-13543
Type: Notice
Date: 2018-06-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Request for Information Regarding the Physician Self-Referral Law
Document Number: 2018-13529
Type: Proposed Rule
Date: 2018-06-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.
Notice; Children's Bureau Proposed Research Priorities for Fiscal Years 2018-2020
Document Number: 2018-13526
Type: Notice
Date: 2018-06-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau (CB) within the Administration on Children, Youth and Families (ACYF) announces the proposed priorities for research on the causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect, and solicits comments regarding the prioritization.
Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer
Document Number: 2018-13486
Type: Notice
Date: 2018-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patent Applications listed in the Summary Information section of this notice to Apexx Oncology, Inc., located in New York, NY.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), June 20, 2018
Document Number: 2018-13503
Type: Notice
Date: 2018-06-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On June 1, 2018, we published a Federal Register notice (83 FR 25461) announcing a new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel), which was scheduled for Wednesday, June 20, 2018. This notice announces the cancellation of the June 20, 2018 meeting.
Prospective Grant of an Exclusive Patent License: Methods of Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B Molecules
Document Number: 2018-13443
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Dental and Craniofacial Research, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patent Applications listed in the Supplementary Information section of this notice to ERYTHRYx Therapeutics, located in Los Angeles, California.
Medicare and Medicaid Programs; Application by The Compliance Team for Continued CMS Approval of Its Rural Health Clinic Accreditation Program
Document Number: 2018-13436
Type: Notice
Date: 2018-06-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Compliance Team (TCT) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of its Ambulatory Surgical Center Accreditation Program
Document Number: 2018-13435
Type: Notice
Date: 2018-06-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Decisions Related to the Development of a Clearinghouse of Evidence-Based Practices in Accordance With the Family First Prevention Services Act of 2018
Document Number: 2018-13420
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families, HHS, solicits comments by July 22, 2018 on initial criteria and potential candidate programs and services for review in a Clearinghouse of evidence-based practices in accordance with the Family First Prevention Services Act of 2018. The Clearinghouse will identify promising, supported, and well-supported practices for mental health and substance abuse prevention and treatment programs, in-home parent skill-based programs, and kinship navigator programs appropriate for children who are candidates for foster care pregnant or parenting foster youth, and the parents or kin caregivers of those children and youth.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-13419
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-13418
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-13417
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-13416
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-13415
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-13414
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2018-13413
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test
Document Number: 2018-13406
Type: Rule
Date: 2018-06-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the next generation sequencing based tumor profiling test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2018-13405
Type: Notice
Date: 2018-06-22
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13391
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-13389
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Availability of Draft Toxicological Profile: Perfluoroalkyls
Document Number: 2018-13385
Type: Notice
Date: 2018-06-21
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of the Draft Toxicological Profile for Perfluoroalkyls for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information, reports, and studies about the health effects of these substances. Although ATSDR considers key studies for this substance during the profile development process, this document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a comment period for this document as a means to best serve public health.
Draft-National Occupational Research Agenda for Healthcare and Social Assistance
Document Number: 2018-13308
Type: Notice
Date: 2018-06-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Healthcare and Social Assistance (HCSA) for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2018-0050 in the search field and click ``Search.''
Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-13297
Type: Notice
Date: 2018-06-21
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 for industry entitled ``Major Depressive Disorder: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder (MDD). Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This draft guidance revises the guidance for industry entitled ``Guidelines for the Clinical Evaluation of Antidepressant Drugs'' issued in September 1977.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-13296
Type: Notice
Date: 2018-06-21
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 Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Draft Guidance for Industry; Availability
Document Number: 2018-13295
Type: Notice
Date: 2018-06-21
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 for industry entitled ``Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This draft guidance is a revision of the guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,'' issued in September 2011.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-13294
Type: Notice
Date: 2018-06-21
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 adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications
Document Number: 2018-13293
Type: Notice
Date: 2018-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-13265
Type: Notice
Date: 2018-06-20
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: 2018-13264
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-13263
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13262
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services, National Institutes of Health
Mitigation Strategies To Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability
Document Number: 2018-13222
Type: Notice
Date: 2018-06-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''
Fees for Sanitation Inspection of Cruise Ships
Document Number: 2018-13216
Type: Notice
Date: 2018-06-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2019. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced inspections and, when necessary, reinspection.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2018-13179
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims; Correction
Document Number: 2018-13152
Type: Proposed Rule
Date: 2018-06-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the proposed rule that appeared in the May 7, 2018 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims''.
Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period
Document Number: 2018-13187
Type: Rule
Date: 2018-06-19
Agency: Agency for International Development, Agencies and Commissions, Department of Transportation, Social Security Administration, National Science Foundation, National Aeronautics and Space Administration, Department of Labor, Department of Housing and Urban Development, Department of Homeland Security, Department of Health and Human Services, Environmental Protection Agency, Department of Energy, Department of Education, Department of Defense, Consumer Product Safety Commission, Department of Commerce, Department of Agriculture, Department of Veterans Affairs
In a final rule published on January 19, 2017, a number of federal departments and agencies revised to the Federal Policy for the Protection of Human Subjects (often referred to as the ``Common Rule''), which each department and agency adopted into regulations in its part of the Code of Federal Regulations (CFR). The Consumer Product Safety Commission (CPSC) adopted the same changes in a final rule published on September 18, 2017. The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. The Department of Housing and Urban Development (HUD) published an interim final rule adopting the same regulatory changes on January 26, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to here as the ``2018 Requirements.'' On April 20, 2018, the federal departments and agencies listed here published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional 6-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances during such continued delay period. Through this final rule, we are adopting the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the ``pre-2018 Requirements'') until January 21, 2019. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019). Those three provisions are: The revised definition of ``research,'' which deems certain activities not to be research covered by the Common Rule; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research. Institutions taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study's duration.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-13149
Type: Notice
Date: 2018-06-19
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-13138
Type: Notice
Date: 2018-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Ryan White HIV/AIDS Program Parts A and B Integrated HIV Planning Implementation Cooperative Agreement to John Snow, Inc. (JSI), U69HA30144
Document Number: 2018-13121
Type: Notice
Date: 2018-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
This noncompetitive supplement award to JSI will support and strengthen current Ryan White HIV/AIDS Program (RWHAP) Part A and Part B priority setting and resource allocation processes to ensure people living with HIV are linked to care, remain engaged in care, and achieve viral suppression.