National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 64180-64181 [2016-22391]
Download as PDF
64180
Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
guidance was a significant advance in
promoting anticancer drug
development. Since the S9 guidance
was issued, some parties have
experienced challenges implementing
the nonclinical recommendations for
developing anticancer pharmaceuticals
outlined in that guidance. In June 2016,
the ICH Assembly endorsed the current
draft Q&As guidance entitled ‘‘S9
Nonclinical Evaluation for Anticancer
Pharmaceuticals—Questions and
Answers’’ and agreed that the draft
Q&As guidance should be made
available for public comment. The draft
Q&As guidance is the product of the
Safety Implementation Working Group
(IWG) of the ICH. Comments about this
draft will be considered by FDA and the
Safety IWG.
The draft Q&As guidance provides
guidance on implementing the S9
guidance. The Q&As were developed by
the IWG to provide additional clarity for
the nonclinical development of
anticancer pharmaceuticals. Topics
addressed in the draft Q&As guidance
include the patient population covered
by the S9 guidance, recovery groups in
nonclinical studies, development of
antibody-drug conjugates, juvenile
animal studies, and the need for longterm toxicity studies when
pharmaceutical development moves to
patients with earlier stage diseases.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘S9 Nonclinical Evaluation for
Anticancer Pharmaceuticals—Questions
and Answers.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
mstockstill on DSK3G9T082PROD with NOTICES
II. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22375 Filed 9–16–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
21:47 Sep 16, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2489]
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. 6208, 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
(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, under section
351(l)(6)(C) of the PHS Act, to provide
the FDA with notice and a copy of the
complaint within 30 days of service.
FDA is required to publish notice of a
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
FDA has received notice of the
following complaint under section
351(l)(6)(C) of the PHS Act: Amgen v.
Sandoz, 3:16–cv–02581 (N.D. Cal., filed
May 12, 2015).
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: September 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–22376 Filed 9–16–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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
Allergy and Infectious Diseases Special
Emphasis Panel; International Center of
Excellence for Malaria Research.
Date: October 13–14, 2016.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Yong Gao, Ph.D., Scientific
Review Officer, Scientific Review Program,
Division of Extramural Activities, Room
#3G13B, National Institutes of Health/NIAID,
5601 Fishers Lane, MSC 9823, Rockville, MD
20892–7616, (240) 669–5048, yong.gao@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
E:\FR\FM\19SEN1.SGM
19SEN1
Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
Dated: September 13, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–22391 Filed 9–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
mstockstill on DSK3G9T082PROD with NOTICES
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: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: October 27, 2016.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6710 B
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6710 B Rockledge Drive,
Bethesda, MD 20892, (301) 435–6680,
skandasa@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development Initial
Review Group Population Sciences
Subcommittee.
Date: November 3, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Carla T. Walls, Ph.D.,
Scientific Review Administratior, Scientific
Review Branch, National Institute of Child
Health and Human Development, NIH, 6710
B Rockledge Drive, Bethesda, MD 20892,
(301) 435–6898, wallsc@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel.
Date: November 4, 2016.
VerDate Sep<11>2014
21:47 Sep 16, 2016
Jkt 238001
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Carla T. Walls, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, National Institute of Child
Health and Human Development, NIH, 6710
B Rockledge Drive, Bethesda, MD 20892,
(301) 435–6898, wallsc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: September 13, 2016.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
64181
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 13, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–22389 Filed 9–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
[FR Doc. 2016–22394 Filed 9–16–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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
Allergy and Infectious Diseases Special
Emphasis Panel; Global Infectious Disease
Research Administration Development
Award for Low-and Middle-Income Country
Institutions (G11).
Date: October 11, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: B. Duane Price, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
RM 3G50, National Institutes of Health,
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, 240–669–5074,
pricebd@niaid.nih.gov.
PO 00000
Frm 00056
Fmt 4703
Sfmt 9990
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
Allergy and Infectious Diseases Special
Emphasis Panel; Rapid Assessment of Zika
Virus (ZIKV) Complications (R21).
Date: October 13–14, 2016.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Eleazar Cohen, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G62A, National Institute of Health,
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20899823, (240) 669–5081,
ecohen@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 13, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–22392 Filed 9–16–16; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\19SEN1.SGM
19SEN1
Agencies
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64180-64181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22391]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious 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 Allergy and Infectious
Diseases Special Emphasis Panel; International Center of Excellence
for Malaria Research.
Date: October 13-14, 2016.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Road, Bethesda, MD 20852.
Contact Person: Yong Gao, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities, Room
#3G13B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC
9823, Rockville, MD 20892-7616, (240) 669-5048, yong.gao@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
[[Page 64181]]
Dated: September 13, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-22391 Filed 9-16-16; 8:45 am]
BILLING CODE 4140-01-P