Center for Scientific Review; Notice of Closed Meetings, 36286-36287 [2021-14617]
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Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
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an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the 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 biological 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 biologic product AJOVY
(fremanezumab-vfrm). AJOVY is
indicated for the preventive treatment of
migraine in adults. Subsequent to this
approval, the USPTO received a patent
term restoration application for AJOVY
(U.S. Patent No. 8,007,794) from Teva
Pharmaceuticals International GmbH,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated July 14, 2020, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of AJOVY 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
AJOVY is 3,216 days. Of this time, 2,882
days occurred during the testing phase
of the regulatory review period, while
334 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 (21 U.S.C. 355(i))
became effective: November 26, 2009.
The applicant claims November 19,
2009, as the date the investigational new
drug application (IND) became effective.
However, FDA records indicate that the
IND effective date was November 26,
2009, which was 30 days after FDA
receipt of the IND.
2. The date the application was
initially submitted with respect to the
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human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): October 16, 2017. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
AJOVY (BLA 761089) was initially
submitted on October 16, 2017.
3. The date the application was
approved: September 14, 2018. FDA has
verified the applicant’s claim that BLA
761089 was approved on September 14,
2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,454 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: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14652 Filed 7–8–21; 8:45 am]
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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,
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;
Neurodevelopmental and Neurological
Disorders.
Date: August 3, 2021.
Time: 10:00 a.m. to 1:00 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: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Eye Disease and Infections.
Date: August 5, 2021.
Time: 11:00 a.m. to 4:00 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: Alessandra C. Rovescalli,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205,
MSC 7846, Bethesda, MD 20892, (301) 435–
1021, rovescaa@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cognitive and Neuropathological
Signatures of Alzheimer’s Disease, Brain
Injury and Aging.
Date: August 5, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Samuel C. Edwards, Ph.D.,
Chief, BDCN IRG, Center for Scientific
Review, National Institutes of Health, 6701
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36287
Federal Register / Vol. 86, No. 129 / Friday, July 9, 2021 / Notices
Rockledge Drive, Room 5210, MSC 7846,
Bethesda, MD 20892, (301) 435–1246,
edwardss@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: July 2, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–14617 Filed 7–8–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Collection; 30-Day Comment
Request: Generic Clearance To Collect
Stakeholder Feedback on the Research
Domain Criteria (RDoC) Initiative,
(NIMH)
National Institutes of Health,
HHS.
ACTION:
This
proposed information collection was
previously published in the Federal
Register on May 5, 2021, pages 23974–
23975 (Vol. 86, No. 85) and allowed 60
days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institute of Mental Health
(NIMH), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection Title: Generic
Clearance to Collect Stakeholder
Feedback on the Research Domain
Criteria (RDoC) Initiative, 0925–0756,
EXTENSION, exp., date 07/31/2021,
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH).
SUPPLEMENTARY INFORMATION:
National Institutes of Health
AGENCY:
Need and Use of Information
Collection: This request serves as notice
that the National Institute of Mental
Health (NIMH) plans to collect
stakeholder feedback to assess the
strengths and weaknesses of the
Research Domain Criteria (RDoC)
initiative. NIMH launched RDoC in
2009 to implement Strategy 1.4 of the
2008 NIMH Strategic Plan: ‘‘Develop
new ways of classifying disorders based
on dimensions of observable behaviors
and brain functions.’’ Rather than
beginning with a syndrome and then
working ‘‘down’’ to clarify mechanisms,
the aim of RDoC is to guide research
that begins with disruptions in
neurobiological and behavioral
mechanisms, and then works across
systems to clarify connections among
such disruptions and clinical
symptoms. NIMH has developed social
media platforms and tools for the RDoC
initiative, including a dedicated RDoC
twitter account (https://twitter.com/
nimh_rdoc), the RDoC website, which
also houses the RDoC matrix (https://
www.nimh.nih.gov/research-priorities/
rdoc/index.shtml), and several
educational and training resources
(including webinars) to educate the field
and interface with scientists who may
have questions about RDoC (https://
www.nimh.nih.gov/research-priorities/
rdoc/rdoc-educational-and-trainingresources.shtml). The evaluation
approach will be conducted using
surveys centered around current content
(i.e., website, twitter, and webinars), as
well as open ended surveys that will
cover the scientific content of RDoC.
The information collected will be used
by NIMH staff to determine success of
the RDoC initiative, develop future
directions and endeavors, and to help
guide programmatic priorities for RDoC
and the Institute.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
490.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Andrew Hooper,
NIMH Project Clearance Liaison,
Science Policy and Evaluation Branch,
Office of Science Policy, Planning and
Communications, NIMH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Bethesda, Maryland 20892, call
(301) 480–8433, or email your request,
including your mailing address, to
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUMMARY:
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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Instrument type
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Workshops .......................................................................................................
Interviews .........................................................................................................
Surveys ............................................................................................................
Focus Groups ..................................................................................................
Assessment Forms ..........................................................................................
50
10
100
10
100
1
1
1
1
1
8
30/60
30/60
1
15/60
400
5
50
10
25
Total ..........................................................................................................
270
270
........................
490
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]]>Agencies
[Federal Register Volume 86, Number 129 (Friday, July 9, 2021)]
[Notices]
[Pages 36286-36287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14617]
-----------------------------------------------------------------------
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, 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; Neurodevelopmental and Neurological Disorders.
Date: August 3, 2021.
Time: 10:00 a.m. to 1:00 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: Samuel C. Edwards, Ph.D., Chief, BDCN IRG,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-
1246, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Eye Disease and Infections.
Date: August 5, 2021.
Time: 11:00 a.m. to 4:00 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: Alessandra C. Rovescalli, Ph.D., Scientific
Review Officer, National Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Rm 5205, MSC 7846, Bethesda, MD 20892,
(301) 435-1021, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Cognitive and Neuropathological Signatures
of Alzheimer's Disease, Brain Injury and Aging.
Date: August 5, 2021.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Samuel C. Edwards, Ph.D., Chief, BDCN IRG,
Center for Scientific Review, National Institutes of Health, 6701
[[Page 36287]]
Rockledge Drive, Room 5210, MSC 7846, Bethesda, MD 20892, (301) 435-
1246, [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: July 2, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-14617 Filed 7-8-21; 8:45 am]
BILLING CODE 4140-01-P
