Center for Scientific Review; Notice of Closed Meetings, 29570-29571 [2017-13571]
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29570
Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–3199 for ‘‘Program for
Enhanced Review Transparency and
Communication for Original 351(k)
Biologics License Applications in
BsUFA II.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Azada Hafiz, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1148, Silver Spring,
VerDate Sep<11>2014
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MD 20993, 240–402–6073, Fax: 301–
847–8443, Azada.Hafiz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The timely review of 351(k)
applications is central to FDA’s mission
to protect and promote the public
health. The BsUFA was first enacted by
Congress in 2012 and authorizes FDA to
collect user fees for 351(k) applications.
FDA dedicates BsUFA user fees to the
efficient review of 351(k) applications
and to facilitate the development of safe
and effective biosimilar biological
products for the American public. FDA
dedicates the additional fee resources to
hire reviewers and support staff and
upgrade its information technology
systems. With the availability of these
additional fee resources, FDA was able
to agree to certain review performance
goals, including a complete review of
351(k) applications and taking
regulatory action within specified
timeframes. The current authorization of
the program (BsUFA I) expires in
September 2017.
As directed by statute, FDA prepared
recommendations for the
reauthorization of BsUFA for a new 5year period by conducting negotiations
with the regulated industry and holding
regular consultations with public
stakeholders including patient
advocates, consumer advocates, and
healthcare professionals. Following
these discussions, related public
meetings, and Agency requests for
public comment, FDA transmitted
proposed recommendations for BsUFA
II for fiscal years 2018–2022. FDA’s
BsUFA II recommendations include an
FDA commitment to implement a new
review program for 351(k) applications
to promote the efficiency and
effectiveness of the first-cycle review
process and minimize the number of
review cycles necessary for approval of
these complex applications. The
Program is described in detail in section
I.B of the document entitled ‘‘Biosimilar
Biological Product Reauthorization
Performance Goals and Procedures
Fiscal Years 2018 Through 2022’’
available at https://www.fda.gov/
downloads/forindustry/userfees/
biosimilaruserfeeactbsufa/
ucm521121.pdf.
II. BsUFA II Program for Enhanced
Review Transparency and
Communication for Original 351(k)
BLAs
FDA recognizes that increasing
communication between the Agency
and applicants during FDA’s review has
the potential to increase efficiency in
the review process. To enhance review
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transparency and improve
communication between the FDA
review team and the applicant, FDA has
proposed for BsUFA II a new review
model (the Program), for the review of
all 351(k) applications. The Program
will allow for additional
communication between FDA review
teams and the applicants of biosimilar
biological products in the form of a
Biological Product Development Type 4
(pre-351(k) BLA) meetings, mid-cycle
communications, and late-cycle
meetings. To accommodate this
increased interaction during regulatory
review and to address the need for
additional time to review these complex
applications, FDA’s review clock will
begin after the 60-day administrative
filing review period for applications
reviewed under the Program.
The goal of the Program is to improve
the efficiency and effectiveness of the
first-cycle review process by increasing
communications during application
review. This will provide sponsors with
the opportunity to clarify previous
submissions and provide additional
data and analyses that are readily
available, potentially avoiding the need
for an additional review cycle when
concerns can be promptly resolved
without compromising FDA’s standards
for approval.
Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13609 Filed 6–28–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR16–274:
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices
Adverse Drug Reaction Scientific Review
Panel.
Date: July 26, 2017.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Alexander D Politis, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3210,
MSC 7808, Bethesda, MD 20892, (301) 435–
1150, politisa@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Mechanisms of Bacterial
Virulence and Pathogenesis.
Date: July 27–28, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Guangyong Ji, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3211,
MSC 7808, Bethesda, MD 20892, 301–435–
1146, jig@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Synthetic and Biological
Chemistry.
Date: July 27, 2017.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Mike Radtke, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4176,
MSC 7806, Bethesda, MD 20892, 301–435–
1728, radtkem@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Nutrient and Lipid Regulation.
Date: July 27, 2017.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Gary Hunnicutt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, ≤6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, 301–435–
0229, gary.hunnicutt@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodegeneration: Mechanisms
and Pathways.
Date: July 27, 2017.
Time: 12:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
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Contact Person: Laurent Taupenot, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7850, Bethesda, MD 20892, 301–435–
1203, laurent.taupenot@nih.gov.
Name of Committee: Biology of
Development and Aging Integrated Review
Group; International and Cooperative
Projects—1 Study Section.
Date: July 28, 2017.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 23, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–13571 Filed 6–28–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, Time-Sensitive
Obesity Review.
Date: July 21, 2017.
Time: 1:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
PO 00000
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29571
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Michele L. Barnard, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7353, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, (301) 594–8898,
barnardm@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: June 23, 2017.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–13572 Filed 6–28–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Vascular and Hematology.
Date: July 24–25, 2017.
Time: 10:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Anshumali Chaudhari,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
MSC 7802, Bethesda, MD 20892, (301) 435–
1210, chaudhaa@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group;
NeuroAIDS and other End-Organ Diseases
Study Section.
Date: July 25–26, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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Agencies
[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29570-29571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13571]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR16-274:
[[Page 29571]]
Adverse Drug Reaction Scientific Review Panel.
Date: July 26, 2017.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Alexander D Politis, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3210, MSC 7808, Bethesda, MD
20892, (301) 435-1150, politisa@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in Mechanisms of Bacterial Virulence
and Pathogenesis.
Date: July 27-28, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-
1146, jig@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Synthetic and Biological Chemistry.
Date: July 27, 2017.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Mike Radtke, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301-435-
1728, radtkem@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Nutrient and Lipid Regulation.
Date: July 27, 2017.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Gary Hunnicutt, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, >6701 Rockledge Drive, Room 6164, MSC 7892, Bethesda, MD
20892, 301-435-0229, gary.hunnicutt@nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neurodegeneration: Mechanisms and Pathways.
Date: July 27, 2017.
Time: 12:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Laurent Taupenot, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188, MSC 7850, Bethesda, MD
20892, 301-435-1203, laurent.taupenot@nih.gov.
Name of Committee: Biology of Development and Aging Integrated
Review Group; International and Cooperative Projects--1 Study
Section.
Date: July 28, 2017.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892.
Contact Person: Seetha Bhagavan, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD
20892, (301) 237-9838, bhagavas@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: June 23, 2017.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2017-13571 Filed 6-28-17; 8:45 am]
BILLING CODE 4140-01-P