Notice of Availability of Final Policy Document, 43993-43994 [2017-19938]
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<![CDATA[
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
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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
https://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:
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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 https://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:
https://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 https://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
https://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
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]]>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]
-----------------------------------------------------------------------
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
