81 FR 61223 - Senior Executive Service Performance Review Board
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 172 (September 6, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 172 (September 6, 2016)
| Page Range | 61223-61224 | |
| FR Document | 2016-21320 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Notices] [Pages 61223-61224] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21320] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Senior Executive Service Performance Review Board AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In this notice, the Health Resources and Services Administration (HRSA) located within the Department of Health and Human Services (HHS) publishes a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA. FOR FURTHER INFORMATION CONTACT: Dora Ober, Executive Resources, Office of Human Resources, 5600 Fishers Lane, Rm 12N06C, Rockville, Maryland 20857, Telephone (301) 443-0759. SUPPLEMENTARY INFORMATION: Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register. The following persons may be named to serve on the HRSA Performance Review Board, which will oversee the evaluation of performance appraisals of [[Page 61224]] 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
![Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61223
DEPARTMENT OF HEALTH AND in brackets in the heading of this The second purpose of this regulation
HUMAN SERVICES document. is to enhance the efficiency of Agency
FOR FURTHER INFORMATION CONTACT: FDA management and operations by
Food and Drug Administration providing procedures for classifying and
PRA Staff, Office of Operations, Food
[Docket No. FDA–2009–N–0380] and Drug Administration, Three White determining which Agency component
Flint North 10A–12M, 11601 is designated to have primary
Agency Information Collection Landsdown St., North Bethesda, MD jurisdiction for any drug, device, or
Activities; Submission for Office of 20852, PRAStaff@fda.hhs.gov. biological product where such
Management and Budget Review; jurisdiction is unclear or in dispute.
SUPPLEMENTARY INFORMATION: In
Comment Request; Product The regulation establishes a
Jurisdiction: Assignment of Agency compliance with 44 U.S.C. 3507, FDA
procedure by which an applicant may
Component for Review of Premarket has submitted the following proposed
obtain an assignment or designation
Applications collection of information to OMB for
determination. The regulation requires
review and clearance.
AGENCY: Food and Drug Administration, that the request include the identity of
HHS. Product Jurisdiction: Assignment of the applicant, a comprehensive
Agency Component for Review of description of the product and its
ACTION: Notice. Premarket Applications—21 CFR Part proposed use, and the applicant’s
SUMMARY: The Food and Drug 3—OMB Control Number 0910–0523— recommendation as to which Agency
Administration (FDA) is announcing Extension component should have primary
that a proposed collection of This regulation relates to Agency jurisdiction, with an accompanying
information has been submitted to the management and organization and has statement of reasons. The information
Office of Management and Budget two purposes. The first is to implement submitted would be used by FDA as the
(OMB) for review and clearance under section 503(g) of the Federal Food, Drug, basis for making the assignment or
the Paperwork Reduction Act of 1995. and Cosmetic Act (21 U.S.C. 353(g)), as designation decision. Most information
DATES: Fax written comments on the added by the Safe Medical Devices Act required by the regulation is already
collection of information by October 6, of 1990 (Pub. L. 101–629), and amended required for premarket applications
2016. by the Medical Device User Fee and affecting drugs, devices, biological
ADDRESSES: To ensure that comments on Modernization Act of 2002 (Pub. L. 107– products, and combination products.
the information collection are received, 250), by specifying how FDA will The respondents will be businesses or
OMB recommends that written determine the organizational component other for-profit organizations.
comments be faxed to the Office of within FDA assigned to have primary In the Federal Register of January 28,
Information and Regulatory Affairs, jurisdiction for the premarket review 2016 (81 FR4921), FDA published a 60-
OMB, Attn: FDA Desk Officer, FAX: and regulation of products that are day notice requesting public comment
202–395–7285, or emailed to oira_ comprised of any combination of: (1) A on the proposed collection of
submission@omb.eop.gov. All drug and a device; (2) a device and a information. No comments were
comments should be identified with the biological product; (3) a biological received.
OMB control number 0910–0523. Also product and a drug; or (4) a drug, a FDA estimates the burden of this
include the FDA docket number found device, and a biological product. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR part responses per burden per Total hours
respondents responses
respondent response
3 ........................................................................................... 84 1 84 24 2,016
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These burden estimates are based on DEPARTMENT OF HEALTH AND Review Board that oversees the
the number of applications FDA HUMAN SERVICES evaluation of performance appraisals for
received over the past fiscal year. Senior Executive Service members
Health Resources and Services within HRSA.
Dated: August 30, 2016.
Administration FOR FURTHER INFORMATION CONTACT: Dora
Leslie Kux,
Ober, Executive Resources, Office of
Associate Commissioner for Policy. Senior Executive Service Performance
Human Resources, 5600 Fishers Lane,
[FR Doc. 2016–21228 Filed 9–2–16; 8:45 am] Review Board
Rm 12N06C, Rockville, Maryland
BILLING CODE 4164–01–P AGENCY: Health Resources and Services 20857, Telephone (301) 443–0759.
Administration (HRSA), Department of SUPPLEMENTARY INFORMATION: Title 5,
Health and Human Services (HHS). U.S.C. Section 4314(c)(4) of the Civil
Service Reform Act of 1978, Public Law
mstockstill on DSK3G9T082PROD with NOTICES
ACTION: Notice.
95–454, requires that the appointment
SUMMARY: In this notice, the Health of Performance Review Board Members
Resources and Services Administration be published in the Federal Register.
(HRSA) located within the Department The following persons may be named to
of Health and Human Services (HHS) serve on the HRSA Performance Review
publishes a list of persons who may be Board, which will oversee the
named to serve on the Performance evaluation of performance appraisals of
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![61224 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Senior Executive Service members for dental, and related functions within the The Compliance Manual includes
the Fiscal Year 2016 review period: scope of deemed PHS employment. sections identifying the requirements
Leslie Atkinson, Tonya Bowers, DATES: Submit written comments no found in the Health Center Program’s
Adriane Burton, Tina Cheatham, Laura later than November 22, 2016. authorizing legislation and program
Cheever, Cheryl Dammons, Elizabeth ADDRESSES: Written comments should implementing regulations (section 330
DeVoss, Diana Espinosa, Catherine be submitted through the HRSA/Bureau of the PHS Act, as amended, 42 CFR
Ganey, Alexandra Garcia, Richard of Primary Health Care (BPHC) Web site part 51c, and 42 CFR part 56); certain
Goodman, Heather Hauck, Avril at http://bphc.hrsa.gov/ applicable HHS grant regulations (45
Houston, Laura Kavanagh, Martin programrequirements/ CFR part 75); and the Health Center
Kramer, Sarah Linde, Rimas Liogys, draftcompliancemanual/index.html. FTCA Program’s authorizing legislation
Michael Lu, Dennis Malcomson, James FOR FURTHER INFORMATION CONTACT: For
and implementing regulations (section
Macrae, Thomas Morris, Kerry Nesseler, questions regarding this notice, contact 224(g)–(n) of the PHS Act, and 42 CFR
William O’Rourke, Luis Padilla, HRSA/BPHC/Office of Policy and part 6). Organizations receiving Health
Deborah Parham Hopson, Wendy Program Development at Center Program federal awards,
Ponton, Patricia Stroup. HCPComplianceManual@hrsa.gov. including subrecipients, are also subject
Dated: August 30, 2016. to all requirements incorporated within
SUPPLEMENTARY INFORMATION: HRSA
James Macrae,
documents such as Funding
provides grants to eligible applicants
Opportunity Announcements and
Acting Administrator. under section 330(e), (g), (h), and/or (i)
Notices of Award. The Compliance
[FR Doc. 2016–21320 Filed 9–2–16; 8:45 am] of the PHS Act, as amended (42 U.S.C.
Manual specifies Health Center Program
BILLING CODE 4165–15–P 254b), to support the delivery of
non-regulatory policy issuances that
preventive and primary care services to
would be superseded, as well as those
medically underserved communities
that would remain in effect.
DEPARTMENT OF HEALTH AND and vulnerable populations. Nearly The first chapter of the Compliance
HUMAN SERVICES 1,400 Health Center Program-funded Manual outlines HRSA’s approach to
health centers operate approximately determining organizational eligibility
Health Resources and Services 9,800 service delivery sites that provide for the Health Center Program,
Administration care to over 24 million patients in every including how to demonstrate non-
U.S. state, the District of Columbia, profit or public agency status. The
Request for Public Comment on Draft Puerto Rico, the U.S. Virgin Islands, and
Health Center Program Compliance chapter also describes organizational
the Pacific Basin. HRSA also designates eligibility requirements that apply only
Manual eligible applicants under the Health to look-alikes. The second chapter
AGENCY: Health Resources and Services Center Look-Alike Program (see clarifies HRSA/BPHC’s oversight
Administration (HRSA), Department of Sections 1861(aa)(4)(B) and 1905(l)(2)(B) process by providing information on
Health and Human Services (HHS). of the Social Security Act). Look-Alikes how HRSA will address areas of
ACTION: Request for public comment on do not receive Health Center Program noncompliance and impose
Draft Health Center Program funding but must meet the Health enforcement actions, including those for
Compliance Manual. Center Program statutory and regulatory serious violations that may lead to the
requirements. Note that for the purposes suspension of grant activities or
SUMMARY: HRSA is inviting public of the Compliance Manual, the term termination of grant funding by HRSA
comment on the Draft Health Center ‘‘health center’’ refers to entities that under 45 CFR part 75.
Program Compliance Manual, hereafter receive a federal award under section The Compliance Manual contains 18
referred to as the Compliance Manual. 330 of the PHS Act, as amended, chapters on Health Center Program
The purpose of the Compliance Manual subrecipients, and organizations requirements, each of which: (a) Cites
is to provide a consolidated web-based designated as look-alikes, unless the applicable statutory and regulatory
resource to assist current and otherwise stated. authorities; (b) lists statutory and
prospective health centers in HRSA also makes determinations of regulatory requirements; (c) describes
understanding and demonstrating deemed PHS employment status for how health centers would demonstrate
compliance with requirements of the health centers funded under section 330 compliance to HRSA; and d) includes
Health Center Program, a HRSA- and their covered individuals for examples of areas in which health
administered program authorized under purposes of providing liability centers have discretion or that may be
42 U.S.C. 254b. The Compliance Manual protections under the Health Center helpful for health centers to consider
identifies requirements found in the Federal Tort Claims Act (FTCA) when implementing the requirements.
Health Center Program’s authorizing Program. Section 224(g)–(n) of the PHS The final chapter specifies the FTCA
legislation and implementing Act (42 U.S.C. 233(g)–(n)) authorizes the requirements for obtaining deemed PHS
regulations, as well as certain applicable FTCA Program and affords eligibility for employment status, including how a
grant regulations. The Compliance FTCA coverage as the exclusive civil health center would demonstrate
Manual also addresses HRSA’s remedy for acts or omissions arising compliance with the FTCA
approach to determining eligibility for from the performance of medical, requirements in its annual deeming
and oversight of the Health Center surgical, dental, or related functions application. Please note that deemed
Program. In addition, the Compliance within the scope of such employment employment status does not confer
Manual includes the requirements for by deemed health centers and by any FTCA coverage in all cases, as health
mstockstill on DSK3G9T082PROD with NOTICES
obtaining deemed Public Health Service officers, governing board members, center providers also must comply with
(PHS) employee status under the employees, and certain individual applicable legal eligibility requirements
Federally Supported Health Centers contractors of these entities. A favorable and covered actions must be undertaken
Assistance Acts of 1992 and 1995, for FTCA deeming determination requires within the scope of such deemed PHS
purposes of Federal Tort Claims Act submission of an application by the employment (for more information, see
(FTCA) liability protections for the Health Center Program awardee in the the Federal Tort Claims Act Health
performance of medical, surgical, form and manner specified by HRSA. Center Policy Manual at http://
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Document Created: 2018-02-09 12:04:09
Document Modified: 2018-02-09 12:04:09
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Dora Ober, Executive Resources, Office of Human Resources, 5600 Fishers Lane, Rm 12N06C, Rockville, Maryland 20857, Telephone (301) 443-0759. | |
| FR Citation | 81 FR 61223 |
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