Source: https://regulations.justia.com/regulations/fedreg/2016/09/06/2016-21321.html
Timestamp: 2020-05-30 03:56:31
Document Index: 159975970

Matched Legal Cases: ['art 51', 'art 56', 'art 75', 'art 6', 'art 75', 'art 51', 'art 56', 'art 75', 'art 6', 'art 75']

Request for Public Comment on Draft Health Center Program Compliance Manual, 61224-61225 [2016-21321] :: Health Resources And Services Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Health Resources And Services Administration Request for Public Comment on Draft Health Center Program Compliance Manual, 61224-61225 [2016-21321]
Request for Public Comment on Draft Health Center Program Compliance Manual, 61224-61225 [2016-21321]
Download as PDF 61224 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices Senior Executive Service members for the Fiscal Year 2016 review period: Leslie Atkinson, Tonya Bowers, Adriane Burton, Tina Cheatham, Laura Cheever, Cheryl Dammons, Elizabeth DeVoss, Diana Espinosa, Catherine Ganey, Alexandra Garcia, Richard Goodman, Heather Hauck, Avril Houston, Laura Kavanagh, Martin Kramer, Sarah Linde, Rimas Liogys, Michael Lu, Dennis Malcomson, James Macrae, Thomas Morris, Kerry Nesseler, William O’Rourke, Luis Padilla, Deborah Parham Hopson, Wendy Ponton, Patricia Stroup. Dated: August 30, 2016. James Macrae, Acting Administrator. [FR Doc. 2016–21320 Filed 9–2–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Request for Public Comment on Draft Health Center Program Compliance Manual Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Request for public comment on Draft Health Center Program Compliance Manual. AGENCY: HRSA is inviting public comment on the Draft Health Center Program Compliance Manual, hereafter referred to as the Compliance Manual. The purpose of the Compliance Manual is to provide a consolidated web-based resource to assist current and prospective health centers in understanding and demonstrating compliance with requirements of the Health Center Program, a HRSAadministered program authorized under 42 U.S.C. 254b. The Compliance Manual identifies requirements found in the Health Center Program’s authorizing legislation and implementing regulations, as well as certain applicable grant regulations. The Compliance Manual also addresses HRSA’s approach to determining eligibility for and oversight of the Health Center Program. In addition, the Compliance Manual includes the requirements for obtaining deemed Public Health Service (PHS) employee status under the Federally Supported Health Centers Assistance Acts of 1992 and 1995, for purposes of Federal Tort Claims Act (FTCA) liability protections for the performance of medical, surgical, mstockstill on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 dental, and related functions within the scope of deemed PHS employment. DATES: Submit written comments no later than November 22, 2016. ADDRESSES: Written comments should be submitted through the HRSA/Bureau of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/ programrequirements/ draftcompliancemanual/index.html. FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, contact HRSA/BPHC/Office of Policy and Program Development at HCPComplianceManual@hrsa.gov. SUPPLEMENTARY INFORMATION: HRSA provides grants to eligible applicants under section 330(e), (g), (h), and/or (i) of the PHS Act, as amended (42 U.S.C. 254b), to support the delivery of preventive and primary care services to medically underserved communities and vulnerable populations. Nearly 1,400 Health Center Program-funded health centers operate approximately 9,800 service delivery sites that provide care to over 24 million patients in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. HRSA also designates eligible applicants under the Health Center Look-Alike Program (see Sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social Security Act). Look-Alikes do not receive Health Center Program funding but must meet the Health Center Program statutory and regulatory requirements. Note that for the purposes of the Compliance Manual, the term ‘‘health center’’ refers to entities that receive a federal award under section 330 of the PHS Act, as amended, subrecipients, and organizations designated as look-alikes, unless otherwise stated. HRSA also makes determinations of deemed PHS employment status for health centers funded under section 330 and their covered individuals for purposes of providing liability protections under the Health Center Federal Tort Claims Act (FTCA) Program. Section 224(g)–(n) of the PHS Act (42 U.S.C. 233(g)–(n)) authorizes the FTCA Program and affords eligibility for FTCA coverage as the exclusive civil remedy for acts or omissions arising from the performance of medical, surgical, dental, or related functions within the scope of such employment by deemed health centers and by any officers, governing board members, employees, and certain individual contractors of these entities. A favorable FTCA deeming determination requires submission of an application by the Health Center Program awardee in the form and manner specified by HRSA. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 The Compliance Manual includes sections identifying the requirements found in the Health Center Program’s authorizing legislation and program implementing regulations (section 330 of the PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56); certain applicable HHS grant regulations (45 CFR part 75); and the Health Center FTCA Program’s authorizing legislation and implementing regulations (section 224(g)–(n) of the PHS Act, and 42 CFR part 6). Organizations receiving Health Center Program federal awards, including subrecipients, are also subject to all requirements incorporated within documents such as Funding Opportunity Announcements and Notices of Award. The Compliance Manual specifies Health Center Program non-regulatory policy issuances that would be superseded, as well as those that would remain in effect. The first chapter of the Compliance Manual outlines HRSA’s approach to determining organizational eligibility for the Health Center Program, including how to demonstrate nonprofit or public agency status. The chapter also describes organizational eligibility requirements that apply only to look-alikes. The second chapter clarifies HRSA/BPHC’s oversight process by providing information on how HRSA will address areas of noncompliance and impose enforcement actions, including those for serious violations that may lead to the suspension of grant activities or termination of grant funding by HRSA under 45 CFR part 75. The Compliance Manual contains 18 chapters on Health Center Program requirements, each of which: (a) Cites the applicable statutory and regulatory authorities; (b) lists statutory and regulatory requirements; (c) describes how health centers would demonstrate compliance to HRSA; and d) includes examples of areas in which health centers have discretion or that may be helpful for health centers to consider when implementing the requirements. The final chapter specifies the FTCA requirements for obtaining deemed PHS employment status, including how a health center would demonstrate compliance with the FTCA requirements in its annual deeming application. Please note that deemed employment status does not confer FTCA coverage in all cases, as health center providers also must comply with applicable legal eligibility requirements and covered actions must be undertaken within the scope of such deemed PHS employment (for more information, see the Federal Tort Claims Act Health Center Policy Manual at http:// E:\FR\FM\06SEN1.SGM 06SEN1 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices bphc.hrsa.gov/ftca/healthcenters/ ftcahcpolicymanual.html). When FTCA matters become the subject of litigation, the U.S. Department of Justice and the federal courts may assume significant roles in certifying or determining whether or not a given activity falls within the scope of employment, for purposes of FTCA coverage. Dated: August 30, 2016. James Macrae, Acting Administrator. [FR Doc. 2016–21321 Filed 9–2–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. mstockstill on DSK3G9T082PROD with NOTICES The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and thediscussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group; Skeletal Biology Development and Disease Study Section. Date: September 28–29, 2016. Time: 7:30 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn San Francisco Fisherman’s Wharf, 1300 Columbus Avenue, San Francisco, CA 94133. Contact Person: Aruna K Behera, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301–435– 6809, beheraak@csr.nih.gov. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group; Vector Biology Study Section. Date: October 5, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Cambria Suites Rockville, 1 Helen Heneghan Way, Rockville, MD 20850. Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD 20892, 301–402– 5671, zhengli@csr.nih.gov. VerDate Sep<11>2014 17:04 Sep 02, 2016 Jkt 238001 Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Alcohol and Motivated Behavior. Date: October 5–6, 2016. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Michael Selmanoff, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5164, MSC 7844, Bethesda, MD 20892, 301–435– 1119, selmanom@csr.nih.gov. Name of Committee: Molecular, Cellular and Developmental Neuroscience Integrated Review Group; Biophysics of Neural Systems Study Section. Date: October 5, 2016. Time: 8:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Monaco Baltimore, 2 North Charles Street, Baltimore, MD 212013. Contact Person: Geoffrey G Schofield, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040–A, MSC 7850, Bethesda, MD 20892, 301–435– 1235, geoffreys@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: August 30, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–21232 Filed 9–2–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 61225 Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; SBIR Direct Phase II, Bioreactors for Reparative Medicine. Date: September 28, 2016. Time: 1:00 p.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892–7924, 301–435– 0725, creazzotl@mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Phase I and Phase II, Bioreactors for Reparative Medicine (SBIR). Date: September 28, 2016. Time: 1:30 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892–7924, 301–435– 0725, creazzotl@mail.nih.gov. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Phase I and Phase II, Bioreactors for Reparative Medicine (STTR). Date: September 28, 2016. Time: 12:30 p.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Tony L. Creazzo, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7180, Bethesda, MD 20892–7924, 301–435– 0725, creazzotl@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: August 30, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–21233 Filed 9–2–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\06SEN1.SGM 06SEN1
[Pages 61224-61225]
[FR Doc No: 2016-21321]
Request for Public Comment on Draft Health Center Program
ACTION: Request for public comment on Draft Health Center Program
SUMMARY: HRSA is inviting public comment on the Draft Health Center
Program Compliance Manual, hereafter referred to as the Compliance
Manual. The purpose of the Compliance Manual is to provide a
consolidated web-based resource to assist current and prospective
health centers in understanding and demonstrating compliance with
requirements of the Health Center Program, a HRSA-administered program
authorized under 42 U.S.C. 254b. The Compliance Manual identifies
requirements found in the Health Center Program's authorizing
legislation and implementing regulations, as well as certain applicable
grant regulations. The Compliance Manual also addresses HRSA's approach
to determining eligibility for and oversight of the Health Center
Program. In addition, the Compliance Manual includes the requirements
for obtaining deemed Public Health Service (PHS) employee status under
the Federally Supported Health Centers Assistance Acts of 1992 and
1995, for purposes of Federal Tort Claims Act (FTCA) liability
protections for the performance of medical, surgical, dental, and
related functions within the scope of deemed PHS employment.
DATES: Submit written comments no later than November 22, 2016.
ADDRESSES: Written comments should be submitted through the HRSA/Bureau
of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/programrequirements/draftcompliancemanual/index.html.
FOR FURTHER INFORMATION CONTACT: For questions regarding this notice,
contact HRSA/BPHC/Office of Policy and Program Development at
HCPComplianceManual@hrsa.gov.
SUPPLEMENTARY INFORMATION: HRSA provides grants to eligible applicants
under section 330(e), (g), (h), and/or (i) of the PHS Act, as amended
(42 U.S.C. 254b), to support the delivery of preventive and primary
populations. Nearly 1,400 Health Center Program-funded health centers
operate approximately 9,800 service delivery sites that provide care to
over 24 million patients in every U.S. state, the District of Columbia,
Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. HRSA also
designates eligible applicants under the Health Center Look-Alike
Program (see Sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social
Security Act). Look-Alikes do not receive Health Center Program funding
but must meet the Health Center Program statutory and regulatory
requirements. Note that for the purposes of the Compliance Manual, the
term ``health center'' refers to entities that receive a federal award
under section 330 of the PHS Act, as amended, subrecipients, and
organizations designated as look-alikes, unless otherwise stated.
HRSA also makes determinations of deemed PHS employment status for
health centers funded under section 330 and their covered individuals
for purposes of providing liability protections under the Health Center
Federal Tort Claims Act (FTCA) Program. Section 224(g)-(n) of the PHS
Act (42 U.S.C. 233(g)-(n)) authorizes the FTCA Program and affords
eligibility for FTCA coverage as the exclusive civil remedy for acts or
omissions arising from the performance of medical, surgical, dental, or
related functions within the scope of such employment by deemed health
centers and by any officers, governing board members, employees, and
certain individual contractors of these entities. A favorable FTCA
deeming determination requires submission of an application by the
Health Center Program awardee in the form and manner specified by HRSA.
The Compliance Manual includes sections identifying the
legislation and program implementing regulations (section 330 of the
PHS Act, as amended, 42 CFR part 51c, and 42 CFR part 56); certain
applicable HHS grant regulations (45 CFR part 75); and the Health
Center FTCA Program's authorizing legislation and implementing
regulations (section 224(g)-(n) of the PHS Act, and 42 CFR part 6).
Organizations receiving Health Center Program federal awards, including
subrecipients, are also subject to all requirements incorporated within
documents such as Funding Opportunity Announcements and Notices of
Award. The Compliance Manual specifies Health Center Program non-
regulatory policy issuances that would be superseded, as well as those
that would remain in effect.
The first chapter of the Compliance Manual outlines HRSA's approach
to determining organizational eligibility for the Health Center
Program, including how to demonstrate non-profit or public agency
status. The chapter also describes organizational eligibility
requirements that apply only to look-alikes. The second chapter
clarifies HRSA/BPHC's oversight process by providing information on how
HRSA will address areas of noncompliance and impose enforcement
actions, including those for serious violations that may lead to the
suspension of grant activities or termination of grant funding by HRSA
under 45 CFR part 75.
The Compliance Manual contains 18 chapters on Health Center Program
requirements, each of which: (a) Cites the applicable statutory and
regulatory authorities; (b) lists statutory and regulatory
requirements; (c) describes how health centers would demonstrate
compliance to HRSA; and d) includes examples of areas in which health
centers have discretion or that may be helpful for health centers to
consider when implementing the requirements.
The final chapter specifies the FTCA requirements for obtaining
deemed PHS employment status, including how a health center would
demonstrate compliance with the FTCA requirements in its annual deeming
application. Please note that deemed employment status does not confer
FTCA coverage in all cases, as health center providers also must comply
with applicable legal eligibility requirements and covered actions must
be undertaken within the scope of such deemed PHS employment (for more
information, see the Federal Tort Claims Act Health Center Policy
Manual at http://
bphc.hrsa.gov/ftca/healthcenters/ftcahcpolicymanual.html). When FTCA
matters become the subject of litigation, the U.S. Department of
Justice and the federal courts may assume significant roles in
certifying or determining whether or not a given activity falls within
the scope of employment, for purposes of FTCA coverage.