82 FR 57279 - Food and Drug Administration Fiscal Year 2017 Performance Review Board Members

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 231 (December 4, 2017)

Page Range		57279-57279
FR Document		2017-26015

The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42(f) SES Equivalents performance appraisals, bonus recommendations, and pay adjustments.

Federal Register, Volume 82 Issue 231 (Monday, December 4, 2017)

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Page 57279]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6475]


Food and Drug Administration Fiscal Year 2017 Performance Review 
Board Members

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the names 
of the members who will serve on its Performance Review Board (PRB). 
The purpose of the PRB is to provide fair and impartial review of 
senior executive service (SES), senior professional and Title 42(f) SES 
Equivalents performance appraisals, bonus recommendations, and pay 
adjustments.

DATES: Effective October 30, 2017.

FOR FURTHER INFORMATION CONTACT: Abu Sesay, Office of Human Resources 
Executive and Resources Management Staff, Food and Drug Administration, 
Three White Flint North, 05C68, 11601 Landsdown St., North Bethesda, MD 
20852, 240-402-0440 (not a toll free number).

SUPPLEMENTARY INFORMATION: This action is being taken pursuant to 5 
U.S.C. 4314(c)(4), which requires that members of performance review 
boards be appointed in a manner to ensure consistency, stability, and 
objectivity in performance appraisals and requires that notice of the 
appointment of an individual to serve as a member be published in the 
Federal Register.
    The following persons will serve on the FDA Performance Review 
Board, which oversees the evaluation of performance appraisals of FDA's 
senior executives:

James Sigg, PRB Chair
Tania Tse, PRB Officiator
Glenda Barfell
Janelle Barth
Vincent Bunning
Mary Beth Clarke
Tracey Forfa
Leslie Kux
Diane Maloney
Edward Margerrison
Lynne Rice
William Tootle

    Dated: November 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26015 Filed 12-1-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices 57279

that the data will be: Entered once, then accuracy. The reduction in burden is a through face-to-face meetings and
only updated from that point on; used result of a data collection workgroup webinar presentations. The number of
for both the State Plan and APR; composed of State AT program staff that hours is multiplied by 56 AT State
updated quarterly with reminders; and met to suggest revisions to the current Grants programs, resulting in a total
used to populate the online State AT instrument. The workgroup solicited estimated hour burden of 4,088 hours.
Program listing to ensure currency and feedback from all of the grantees

Number of Responses per Hours per Annual
Respondent/data collection activity respondents respondent response burden hours

State Plan for AT Annual Progress Report (AT APR) .................................. 56 1 73.0 4,088

Dated: November 24, 2017. (42 U.S.C. 262(k)), added by the BPCI SUMMARY: The Food and Drug
Mary Lazare, Act, describes the requirements for a Administration (FDA) is announcing the
Principal Deputy Administrator. BLA for a proposed biosimilar product names of the members who will serve
[FR Doc. 2017–26018 Filed 12–1–17; 8:45 am] or a proposed interchangeable product on its Performance Review Board (PRB).
BILLING CODE 4154–01–P (351(k) BLA). Section 351(l) of the PHS The purpose of the PRB is to provide
Act, also added by the BPCI Act, fair and impartial review of senior
describes certain procedures for executive service (SES), senior
DEPARTMENT OF HEALTH AND exchanging patent information and professional and Title 42(f) SES
HUMAN SERVICES resolving patent disputes between a Equivalents performance appraisals,
351(k) BLA applicant and the holder of bonus recommendations, and pay
Food and Drug Administration the BLA reference product. If a 351(k) adjustments.
[Docket No. FDA–2017–N–4853] applicant is served with a complaint for
DATES: Effective October 30, 2017.
a patent infringement described in
Receipt of Notice That a Patent section 351(l)(6) of the PHS Act, the FOR FURTHER INFORMATION CONTACT: Abu
Infringement Complaint Was Filed applicant is required to provide FDA Sesay, Office of Human Resources
Against a Biosimilar Applicant with notice and a copy of the complaint Executive and Resources Management
within 30 days of service. FDA is Staff, Food and Drug Administration,
AGENCY: Food and Drug Administration, Three White Flint North, 05C68, 11601
required to publish notice of a
HHS. Landsdown St., North Bethesda, MD
complaint received under section
ACTION: Notice. 351(l)(6)(C) of the PHS Act in the 20852, 240–402–0440 (not a toll free
Federal Register. number).
SUMMARY: The Food and Drug
Administration (FDA) is publishing FDA received notice of the following SUPPLEMENTARY INFORMATION: This
notice that an applicant for a proposed complaint under section 351(l)(6)(C) of action is being taken pursuant to 5
biosimilar product notified FDA that a the PHS Act: U.S.C. 4314(c)(4), which requires that
patent infringement action was filed in AbbVie, Inc., et al. v. Boehringer members of performance review boards
connection with the applicant’s Ingelheim Intl. GMBH., et al., 17–cv– be appointed in a manner to ensure
biologics license application (BLA). 01065 (D. Del., filed August 2, 2017). consistency, stability, and objectivity in
Under the Public Health Service Act This complaint involves the product performance appraisals and requires
(PHS Act), an applicant for a proposed Humira. that notice of the appointment of an
biosimilar product or interchangeable FDA has only a ministerial role in individual to serve as a member be
product must notify FDA within 30 days publishing notice of a complaint published in the Federal Register.
after the applicant was served with a received under section 351(l)(6)(C) of The following persons will serve on
complaint in a patent infringement the PHS Act, and does not perform a the FDA Performance Review Board,
action described under the PHS Act. substantive review of the complaint. which oversees the evaluation of
FDA is required to publish notice of the Dated: November 28, 2017. performance appraisals of FDA’s senior
complaint in the Federal Register. Leslie Kux, executives:
FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. James Sigg, PRB Chair
Daniel Orr, Center for Drug Evaluation [FR Doc. 2017–26013 Filed 12–1–17; 8:45 am] Tania Tse, PRB Officiator
and Research, Food and Drug BILLING CODE 4164–01–P Glenda Barfell
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6246, Silver Spring, Janelle Barth
MD 20993–0002, 240–402–0979, DEPARTMENT OF HEALTH AND Vincent Bunning
daniel.orr@fda.hhs.gov. HUMAN SERVICES Mary Beth Clarke
SUPPLEMENTARY INFORMATION: The Tracey Forfa
Biologics Price Competition and Food and Drug Administration Leslie Kux
Innovation Act of 2009 (BPCI Act) was Diane Maloney
enacted as part of the Patient Protection [Docket No. FDA–2017–N–6475] Edward Margerrison
and Affordable Care Act (Pub. L. 111–
sradovich on DSK3GMQ082PROD with NOTICES

Lynne Rice
148) on March 23, 2010. The BPCI Act Food and Drug Administration Fiscal
Year 2017 Performance Review Board William Tootle
amended the PHS Act and created an
abbreviated licensure pathway for Members Dated: November 28, 2017.
biological products shown to be Leslie Kux,
AGENCY: Food and Drug Administration,
biosimilar to, or interchangeable with, Associate Commissioner for Policy.
HHS.
an FDA-licensed biological reference [FR Doc. 2017–26015 Filed 12–1–17; 8:45 am]
ACTION: Notice.
product. Section 351(k) of the PHS Act BILLING CODE 4164–01–P

VerDate Sep<11>2014 18:22 Dec 01, 2017 Jkt 244001 PO 00000 Frm 00085 Fmt 4703 Sfmt 9990 E:\FR\FM\04DEN1.SGM 04DEN1

Document Created: 2017-12-02 00:40:05
Document Modified: 2017-12-02 00:40:05

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.
Dates		Effective October 30, 2017.
Contact		Abu Sesay, Office of Human Resources Executive and Resources Management Staff, Food and Drug Administration, Three White Flint North, 05C68, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-0440 (not a toll free number).
FR Citation		82 FR 57279

82 FR 57279 - Food and Drug Administration Fiscal Year 2017 Performance Review Board Members

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 231 (December 4, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration