Center for Scientific Review; Notice of Closed Meetings, 32951-32952 [2021-13184]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices
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 § 10.20 (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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
VerDate Sep<11>2014
17:13 Jun 22, 2021
Jkt 253001
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, TURALIO
(pexidartinib), indicated for treatment of
adult patients with symptomatic
tenosynovial giant cell tumor associated
with severe morbidity or functional
limitations and not amenable to
improvement with surgery. Subsequent
to this approval, the USPTO received
patent term restoration applications for
TURALIO (U.S. Patent Nos. 7,893,075;
8,461,169; and 9,169,250) from
Plexxikon Inc. and the USPTO
requested FDA’s assistance in
determining the patents’ eligibility for
patent term restoration. In a letter dated
May 8, 2020, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of TURALIO
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
TURALIO is 3,637 days. Of this time,
3,394 days occurred during the testing
phase of the regulatory review period,
while 243 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: August 19,
2009. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on August 19, 2009.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: December 3, 2018.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
TURALIO (NDA 211810) was initially
submitted on December 3, 2018.
3. The date the application was
approved: August 2, 2019. FDA has
verified the applicant’s claim that NDA
211810 was approved on August 2,
2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
32951
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,664 days, 1,244
days or 810 days of patent term
extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13186 Filed 6–22–21; 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, 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,
E:\FR\FM\23JNN1.SGM
23JNN1
32952
Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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; Small
Business: SBIR/STTR Commercialization
Readiness Pilot (CRP) Program.
Date: July 15, 2021.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Allen Richon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7892, Bethesda, MD 20892, 301–379–
9351, allen.richon@nih.hhs.gov.
Name of Committee: Infectious Diseases
and Immunology B Integrated Review Group;
HIV Coinfections and HIV Associated
Cancers Study Section.
Date: July 15, 2021.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jingsheng Tuo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3196,
Bethesda, MD 20892, 301–451–5953, tuoj@
csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Infectious Diseases and Immunology Panel C.
Date: July 15–16, 2021.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shahrooz Vahedi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 810G,
Bethesda, MD 20892, (301) 496–9322,
vahedis@mail.nih.gov.
Name of Committee: Infectious Diseases
and Immunology B Integrated Review Group;
HIV Immunopathogenesis and Vaccine
Development Study Section.
Date: July 15–16, 2021.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in Reproductive Biology.
VerDate Sep<11>2014
17:13 Jun 22, 2021
Jkt 253001
Date: July 16, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Yunshang Piao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
Bethesda, MD 20892, (301) 402–8402,
piaoy3@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Infectious
Diseases and Immunology Research
Enhancement Review.
Date: July 19, 2021.
Time: 9:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
MSC 7808, Bethesda, MD 20892, 301–996–
5819, zhengli@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Human Complex Mental Function.
Date: July 19, 2021.
Time: 1:00 p.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Pamela Jeter, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 10J08,
Bethesda, MD 20892, (301) 435–2591,
pamela.jeter@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Topics in infectious diseases
vaccines, therapeutics and vector biology.
Date: July 20, 2021.
Time: 9:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Gagan Pandya, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 3200,
MSC 7808, Bethesda, MD 20892, 301–435–
1167, pandyaga@mail.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 17, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–13184 Filed 6–22–21; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Center for Substance Abuse
Treatment; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Treatment
(CSAT) National Advisory Council
(NAC) will meet on August 12, 2021,
1:00 p.m.–4:30 p.m. (EDT).
The meeting is open to the public and
will include consideration of minutes
from the SAMHSA CSAT NAC meeting
of March 31, 2021; an update on CSAT
activities; a discussion with SAMHSA
leadership; and discussion of recovery
and recovery support. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the Council. Written
submissions should be forwarded to the
contact person on or before August 6,
2021. Oral presentations from the public
will be scheduled at the conclusion of
the meeting. Individuals interested in
making oral presentations must notify
the contact person on or before August
6, 2021. Five minutes will be allotted for
each presentation.
The meeting will be conducted via
WebEx and telephone only, and
registration is required to participate
during this me. To attend virtually, or
to obtain the call-in number and access
code, submit written or brief oral
comments, or request special
accommodations for persons with
disabilities, please register on-line at
https://snacregister.samhsa.gov/
MeetingList.aspx, or communicate with
the CSAT National Advisory Council
Designated Federal Officer; Tracy Goss
(see contact information below).
Meeting information and a roster of
Council members may be obtained by
accessing the SAMHSA Committee
website at https://www.samhsa.gov/
about-us/advisory-councils/csatnational-advisory-council or by
contacting the CSAT National Advisory
Council Designated Federal Officer.
Council Name: SAMHSA’s Center for
Substance Abuse Treatment National
Advisory Council.
Date/Time/Type: August 12, 2021,
1:00 p.m.–4:30 p.m. EDT, OPEN.
Place: SAMHSA, 5600 Fishers Lane,
Rockville, Maryland 20857.
Contact: Tracy Goss, Designated
Federal Officer, CSAT National
Advisory Council, 5600 Fishers Lane,
Rockville, Maryland 20857 (mail),
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Notices]
[Pages 32951-32952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13184]
-----------------------------------------------------------------------
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, 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,
[[Page 32952]]
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; Small Business: SBIR/STTR Commercialization Readiness Pilot
(CRP) Program.
Date: July 15, 2021.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Allen Richon, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6184, MSC 7892, Bethesda, MD 20892, 301-379-
9351, [email protected].
Name of Committee: Infectious Diseases and Immunology B
Integrated Review Group; HIV Coinfections and HIV Associated Cancers
Study Section.
Date: July 15, 2021.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jingsheng Tuo, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3196, Bethesda, MD 20892, 301-451-5953,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowship: Infectious Diseases and Immunology Panel C.
Date: July 15-16, 2021.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shahrooz Vahedi, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 810G, Bethesda, MD 20892, (301)
496-9322, [email protected].
Name of Committee: Infectious Diseases and Immunology B
Integrated Review Group; HIV Immunopathogenesis and Vaccine
Development Study Section.
Date: July 15-16, 2021.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shiv A. Prasad, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD
20892, 301-443-5779, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in Reproductive Biology.
Date: July 16, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Yunshang Piao, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6184, Bethesda, MD 20892, (301) 402-8402,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Infectious Diseases and Immunology Research Enhancement
Review.
Date: July 19, 2021.
Time: 9:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Liangbiao Zheng, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD
20892, 301-996-5819, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Human Complex Mental Function.
Date: July 19, 2021.
Time: 1:00 p.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Pamela Jeter, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 10J08, Bethesda, MD 20892, (301) 435-2591,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Topics in infectious diseases vaccines,
therapeutics and vector biology.
Date: July 20, 2021.
Time: 9:30 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Gagan Pandya, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, RM 3200, MSC 7808, Bethesda, MD 20892, 301-435-
1167, [email protected].
(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 17, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-13184 Filed 6-22-21; 8:45 am]
BILLING CODE 4140-01-P
