Food and Drug Administration Fiscal Year 2017 Performance Review Board Members, 57279 [2017-26015]
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57279
Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
that the data will be: Entered once, then
only updated from that point on; used
for both the State Plan and APR;
updated quarterly with reminders; and
used to populate the online State AT
Program listing to ensure currency and
accuracy. The reduction in burden is a
result of a data collection workgroup
composed of State AT program staff that
met to suggest revisions to the current
instrument. The workgroup solicited
feedback from all of the grantees
through face-to-face meetings and
webinar presentations. The number of
hours is multiplied by 56 AT State
Grants programs, resulting in a total
estimated hour burden of 4,088 hours.
Respondent/data collection activity
Number of
respondents
Responses per
respondent
Hours per
response
Annual
burden hours
State Plan for AT Annual Progress Report (AT APR) ..................................
56
1
73.0
4,088
Dated: November 24, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017–26018 Filed 12–1–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4853]
Receipt of Notice That a Patent
Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6246, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:22 Dec 01, 2017
Jkt 244001
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required to provide FDA
with notice and a copy of the complaint
within 30 days of service. FDA is
required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
FDA received notice of the following
complaint under section 351(l)(6)(C) of
the PHS Act:
AbbVie, Inc., et al. v. Boehringer
Ingelheim Intl. GMBH., et al., 17–cv–
01065 (D. Del., filed August 2, 2017).
This complaint involves the product
Humira.
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act, and does not perform a
substantive review of the complaint.
Dated: November 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26013 Filed 12–1–17; 8:45 am]
BILLING CODE 4164–01–P
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:
PO 00000
Fmt 4703
DATES:
Effective October 30, 2017.
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).
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
Dated: November 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26015 Filed 12–1–17; 8:45 am]
Notice.
Frm 00085
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.
SUMMARY:
BILLING CODE 4164–01–P
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[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Notices]
[Page 57279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
