Notice of Availability of Final Policy Document, 43993-43994 [2017-19938]

Download as PDF Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices Robert Sargis, Reports Clearance Officer. emanual.pdf. All Health Center Program non-regulatory policy issuances that remain in effect after release of the Compliance Manual are listed in Appendix A of the Compliance Manual. With the exception of these policies, the Compliance Manual supersedes other previous Health Center Program nonregulatory policy issuances related to Health Center Program compliance or eligibility requirements. [FR Doc. 2017–20022 Filed 9–19–17; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: The Health Center Program Compliance Manual (Compliance Manual) has been developed as a comprehensive, significantly streamlined, and web-based guidance document to assist health centers in understanding and demonstrating compliance with Health Center Program requirements. As such, this guidance document will reduce burden for current and prospective health centers and look-alikes and further strengthen HRSA’s oversight of the Health Center and Health Center Federal Tort Claims Act (FTCA) Programs. It also responds to recommendations contained within the Government Accountability Office report, Health Center Program: Improved Oversight Needed to Ensure Grantee Compliance with Requirements, GAO–12–546, for increased transparency, clarity, and consistency in Health Center Program oversight. The Bureau of Primary Health Care (BPHC) released a draft Compliance Manual on August 23, 2016, for a 90-day public comment period. Individuals and groups submitted over 700 comments regarding the draft Compliance Manual. After thorough review and consideration of all comments received, HRSA made a substantial number of updates to the Compliance Manual to incorporate suggestions and requests for further clarification. HRSA has also posted a summary of comments for each corresponding section and chapter of the Compliance Manual and HRSA’s responses to these comments. HRSA’s ‘‘Summary of Comments and HRSA Responses on the Draft Health Center Program Compliance Manual’’ is available online at https:// bphc.hrsa.gov/programrequirements/ pdf/healthcentercompliancemanualcomments.pdf. The Compliance Manual, which was effective August 28, 2017, is available online at https:// bphc.hrsa.gov/programrequirements/ pdf/healthcentercomplianc sradovich on DSKBBY8HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:28 Sep 19, 2017 Jkt 241001 For questions regarding this notice, contact HRSA/BPHC at https://www.hrsa.gov/ about/contact/bphc.aspx. FOR FURTHER INFORMATION CONTACT: Notice of Availability of Final Policy Document SUPPLEMENTARY INFORMATION: Executive Orders 12866, 13563 and 13771 Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a ‘‘significant regulatory action’’ as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as ‘‘economically significant’’); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a ‘‘significant’’ regulatory action is subject to review by the Office of Management and Budget (OMB). PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 43993 Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations. OMB’s interim guidance issued on February 2, 2017, explains that for fiscal year 2017 the above requirements only apply to each new ‘‘significant regulatory action that imposes costs.’’ It has been determined that the Compliance Manual is not a ‘‘significant regulatory action that imposes costs’’ and thus does not trigger the above requirements of Executive Order 12866 or of Executive Order 13771. Background HRSA provides grants to eligible applicants under section 330(e), (g), (h), and/or (i) of the Public Health Service (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 10,400 service delivery sites that provide care to nearly 26 million patients in every U.S. state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. 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, grant subrecipients, and organizations designated as look-alikes, unless otherwise stated within the Compliance Manual. Look-alikes, as described in Sections 1861(aa)(4)(B) and 1905(l)(2)(B) of the Social Security Act (42 U.S.C. 1395x(aa)(4)(B) and 42 U.S.C. 1396d(l)(2)(B)(iii)), do not receive a Health Center Program award but must meet the Health Center Program statutory and regulatory requirements. Organizations designated as look-alikes are eligible for payment as a Federally Qualified Health Center under Medicare, Medicaid, and the State Children’s Health Insurance Program (CHIP), as well as participation in the 340B Drug Pricing Program and the National Health Service Corps Program. E:\FR\FM\20SEN1.SGM 20SEN1 43994 Federal Register / Vol. 82, No. 181 / Wednesday, September 20, 2017 / Notices HRSA also makes determinations of deemed PHS employment status for health centers funded under section 330 (including subrecipients), which also extends to certain statutorily eligible ‘‘covered individuals,’’ for purposes of providing liability protections under the Health Center Federal Tort Claims Act (FTCA) Program. A favorable FTCA deeming determination requires approval by HRSA of an application submitted by the Health Center Program awardee in the form and manner specified by HRSA. Health centers may also sponsor individual health professional volunteers for such protections. Sections 224(g)–(n) and (q) of the PHS Act (42 U.S.C. 233(g)–(n), and (q)) authorize the Health Center FTCA Program and afford eligibility for FTCA coverage as the exclusive civil remedy for acts or omissions arising within the scope of deemed federal employment in the performance of medical, surgical, dental, or related functions. The Compliance Manual restates the Health Center Program’s statutory and regulatory requirements and provides guidance on how health centers would demonstrate compliance with such requirements to HRSA. However, the Compliance Manual also allows health centers to submit alternative means of demonstrating compliance with the specified Health Center Program requirements. All means of demonstrating compliance are subject to HRSA review and approval. Organizations receiving Health Center Program federal awards, including subrecipients, continue to be subject to all requirements incorporated within terms and conditions stated in Notices of Funding Opportunity, Notices of Award, and other applicable laws, regulations, and policies, as well as the distinct statutory, regulatory, and policy requirements of other federal programs in which they participate. Dated: September 13, 2017. George Sigounas, Administrator. [FR Doc. 2017–19938 Filed 9–19–17; 8:45 am] sradovich on DSKBBY8HB2PROD with NOTICES BILLING CODE 4165–15–P VerDate Sep<11>2014 18:28 Sep 19, 2017 Jkt 241001 DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615–0121] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery U.S. Citizenship and Immigration Services, Department of Homeland Security. ACTION: 60-Day notice. AGENCY: The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments. DATES: Comments are encouraged and will be accepted for 60 days until November 20, 2017. ADDRESSES: All submissions received must include the OMB Control Number 1615–0121 in the body of the letter, the agency name and Docket ID USCIS– 2014–0008. To avoid duplicate submissions, please use only one of the following methods to submit comments: (1) Online. Submit comments via the Federal eRulemaking Portal Web site at http://www.regulations.gov under eDocket ID number USCIS–2014–0008; (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW., Washington, DC 20529–2140. FOR FURTHER INFORMATION CONTACT: USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529–2140, telephone number 202–272–8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800–375–5283 (TTY 800–767– 1833). SUPPLEMENTARY INFORMATION: Comments You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS–2014–0008 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. E:\FR\FM\20SEN1.SGM 20SEN1

Agencies

[Federal Register Volume 82, Number 181 (Wednesday, September 20, 2017)]
[Notices]
[Pages 43993-43994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Notice of Availability of Final Policy Document

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Health Center Program Compliance Manual (Compliance 
Manual) has been developed as a comprehensive, significantly 
streamlined, and web-based guidance document to assist health centers 
in understanding and demonstrating compliance with Health Center 
Program requirements. As such, this guidance document will reduce 
burden for current and prospective health centers and look-alikes and 
further strengthen HRSA's oversight of the Health Center and Health 
Center Federal Tort Claims Act (FTCA) Programs. It also responds to 
recommendations contained within the Government Accountability Office 
report, Health Center Program: Improved Oversight Needed to Ensure 
Grantee Compliance with Requirements, GAO-12-546, for increased 
transparency, clarity, and consistency in Health Center Program 
oversight.
    The Bureau of Primary Health Care (BPHC) released a draft 
Compliance Manual on August 23, 2016, for a 90-day public comment 
period. Individuals and groups submitted over 700 comments regarding 
the draft Compliance Manual. After thorough review and consideration of 
all comments received, HRSA made a substantial number of updates to the 
Compliance Manual to incorporate suggestions and requests for further 
clarification. HRSA has also posted a summary of comments for each 
corresponding section and chapter of the Compliance Manual and HRSA's 
responses to these comments. HRSA's ``Summary of Comments and HRSA 
Responses on the Draft Health Center Program Compliance Manual'' is 
available online at https://bphc.hrsa.gov/programrequirements/pdf/healthcentercompliancemanual-comments.pdf. The Compliance Manual, which 
was effective August 28, 2017, is available online at https://bphc.hrsa.gov/programrequirements/pdf/healthcentercompliancemanual.pdf. 
All Health Center Program non-regulatory policy issuances that remain 
in effect after release of the Compliance Manual are listed in Appendix 
A of the Compliance Manual. With the exception of these policies, the 
Compliance Manual supersedes other previous Health Center Program non-
regulatory policy issuances related to Health Center Program compliance 
or eligibility requirements.

FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, 
contact HRSA/BPHC at https://www.hrsa.gov/about/contact/bphc.aspx.

SUPPLEMENTARY INFORMATION: 

Executive Orders 12866, 13563 and 13771

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 is supplemental to and reaffirms the principles, 
structures, and definitions governing regulatory review as established 
in Executive Order 12866, emphasizing the importance of quantifying 
both costs and benefits, of reducing costs, of harmonizing rules, and 
of promoting flexibility. Section 3(f) of Executive Order 12866 defines 
a ``significant regulatory action'' as an action that is likely to 
result in a rule: (1) Having an annual effect on the economy of $100 
million or more in any 1 year, or adversely and materially affecting a 
sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or Tribal 
governments or communities (also referred to as ``economically 
significant''); (2) creating a serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raising novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set forth 
in the Executive Order. A regulatory impact analysis (RIA) must be 
prepared for major rules with economically significant effects ($100 
million or more in any 1 year), and a ``significant'' regulatory action 
is subject to review by the Office of Management and Budget (OMB).
    Executive Order 13771, entitled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017. Section 2(a) of 
Executive Order 13771 requires an agency, unless prohibited by law, to 
identify at least two existing regulations to be repealed when the 
agency publicly proposes for notice and comment or otherwise 
promulgates a new regulation. In furtherance of this requirement, 
section 2(c) of Executive Order 13771 requires that the new incremental 
costs associated with new regulations shall, to the extent permitted by 
law, be offset by the elimination of existing costs associated with at 
least two prior regulations. OMB's interim guidance issued on February 
2, 2017, explains that for fiscal year 2017 the above requirements only 
apply to each new ``significant regulatory action that imposes costs.'' 
It has been determined that the Compliance Manual is not a 
``significant regulatory action that imposes costs'' and thus does not 
trigger the above requirements of Executive Order 12866 or of Executive 
Order 13771.

Background

    HRSA provides grants to eligible applicants under section 330(e), 
(g), (h), and/or (i) of the Public Health Service (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 10,400 service delivery sites that provide care 
to nearly 26 million patients in every U.S. state, the District of 
Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. 
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, grant subrecipients, and organizations 
designated as look-alikes, unless otherwise stated within the 
Compliance Manual. Look-alikes, as described in Sections 1861(aa)(4)(B) 
and 1905(l)(2)(B) of the Social Security Act (42 U.S.C. 1395x(aa)(4)(B) 
and 42 U.S.C. 1396d(l)(2)(B)(iii)), do not receive a Health Center 
Program award but must meet the Health Center Program statutory and 
regulatory requirements. Organizations designated as look-alikes are 
eligible for payment as a Federally Qualified Health Center under 
Medicare, Medicaid, and the State Children's Health Insurance Program 
(CHIP), as well as participation in the 340B Drug Pricing Program and 
the National Health Service Corps Program.

[[Page 43994]]

    HRSA also makes determinations of deemed PHS employment status for 
health centers funded under section 330 (including subrecipients), 
which also extends to certain statutorily eligible ``covered 
individuals,'' for purposes of providing liability protections under 
the Health Center Federal Tort Claims Act (FTCA) Program. A favorable 
FTCA deeming determination requires approval by HRSA of an application 
submitted by the Health Center Program awardee in the form and manner 
specified by HRSA. Health centers may also sponsor individual health 
professional volunteers for such protections. Sections 224(g)-(n) and 
(q) of the PHS Act (42 U.S.C. 233(g)-(n), and (q)) authorize the Health 
Center FTCA Program and afford eligibility for FTCA coverage as the 
exclusive civil remedy for acts or omissions arising within the scope 
of deemed federal employment in the performance of medical, surgical, 
dental, or related functions.
    The Compliance Manual restates the Health Center Program's 
statutory and regulatory requirements and provides guidance on how 
health centers would demonstrate compliance with such requirements to 
HRSA. However, the Compliance Manual also allows health centers to 
submit alternative means of demonstrating compliance with the specified 
Health Center Program requirements. All means of demonstrating 
compliance are subject to HRSA review and approval.
    Organizations receiving Health Center Program federal awards, 
including subrecipients, continue to be subject to all requirements 
incorporated within terms and conditions stated in Notices of Funding 
Opportunity, Notices of Award, and other applicable laws, regulations, 
and policies, as well as the distinct statutory, regulatory, and policy 
requirements of other federal programs in which they participate.

    Dated: September 13, 2017.
George Sigounas,
Administrator.
[FR Doc. 2017-19938 Filed 9-19-17; 8:45 am]
 BILLING CODE 4165-15-P