National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 35307-35308 [2021-14173]
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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
trials conducted exclusively in patients
with CNS metastases.
CNS metastases are associated with
significant morbidity and mortality and
development of therapeutic products for
patients with CNS metastases is needed.
FDA has participated in efforts to
facilitate drug development for patients
with CNS metastases, including a March
2019 ‘‘Workshop on Product
Development for CNS Metastases.’’
Stakeholders at this meeting stated there
is a need for further FDA guidance on
specific topics, including identifying
optimal study endpoints. Study design
challenges for CNS metastases include
uncertainty regarding optimal
endpoints, lack of standardized
response assessments, understanding
how CNS metastases are evaluated in
the context of the entire burden of
metastatic disease to characterize a
drug’s potential benefit (e.g., timing of
CNS radiographic assessments relative
to other sites of metastases), and
interpreting radiographic response in
the setting of recent radiation therapy or
surgery. This guidance is intended to
provide recommendations on these
study design challenges.
In the Federal Register of August 27,
2020 (85 FR 53007), FDA announced the
availability of the draft guidance
‘‘Evaluating Cancer Drugs in Patients
with Central Nervous System
Metastases’’ dated August 2020. FDA
received several comments on the draft
guidance and those comments were
considered as the guidance was
finalized. A summary of changes
includes: Clarification on the number of
stratification factors the protocol should
specify in order to minimize bias,
confirmation of the version of Response
Evaluation Criteria in Solid Tumours
(RECIST) that should be referred to
when evaluating CNS disease,
clarification that both CNS and
systematic duration of response should
be captured and the addition of a 6month timepoint, and the addition of
progression-free survival in patients
with brain metastasis as another
measurement to be reported when CNS
is a common metastatic site. In addition,
editorial changes were made to improve
clarity. The guidance announced in this
notice finalizes the draft guidance dated
August 27, 2020.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Evaluating Cancer
Drugs in Patients with Central Nervous
System Metastases.’’ 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
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it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601 have
been approved under 0910–0338; and
the collections of information in 21 CFR
201.56 and 201.57 have been approved
under OMB control number 0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances or https://
www.regulations.gov.
Dated: June 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14194 Filed 7–1–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
35307
(plasminogen, human-tvmh),
manufactured by Prometic
Bioproduction, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that RYPLAZIM (plasminogen, humantvmh), manufactured by Prometic
Bioproduction, Inc., meets the criteria
for a priority review voucher.
RYPLAZIM (plasminogen, human-tvmh)
is indicated for the treatment of patients
with plasminogen deficiency type 1
(hypoplasminogenemia).
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/industry/
developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For
further information about RYPLAZIM
(plasminogen, human-tvmh), go to the
Center for Biologics Evaluation and
Research Cellular and Gene Therapy
Products website at https://
www.fda.gov/vaccines-blood-biologics/
cellular-gene-therapy-products/
approved-cellular-and-gene-therapyproducts.
Dated: June 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–14191 Filed 7–1–21; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that RYPLAZIM
SUMMARY:
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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, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
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; HIV Vaccine Research and
Design (HIVRAD) Program (P01 Clinical Trial
Not Allowed).
Date: July 29, 2021.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G11A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: J. Bruce Sundstrom, Ph.D.,
Scientific Review Officer, Scientific Review
Program, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G11A,
Rockville, MD 20852, 240–669–5045,
sundstromj@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: June 28, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–14173 Filed 7–1–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Toxicology Program Board of
Scientific Counselors; Announcement
of Meeting; Request for Comments
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This notice announces the
next meeting of the National Toxicology
Program (NTP) Board of Scientific
Counselors (BSC). The BSC, a federally
chartered, external advisory group
composed of scientists from the public
and private sectors, will review and
provide advice on programmatic
activities. This meeting is a virtual
meeting and is open to the public.
Written comments will be accepted and
registration is required to present oral
comments. Information about the
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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meeting and registration are available at
https://ntp.niehs.nih.gov/go/165.
DATES:
Meeting: Scheduled for August 4,
2021, 12:30 p.m.–5:00 p.m. Eastern
Daylight Time (EDT).
Written Public Comment
Submissions: Deadline is July 28, 2021.
Registration for Oral Comments:
Deadline is July 28, 2021.
ADDRESSES:
Meeting web page: The preliminary
agenda, registration, and other meeting
materials are available at https://
ntp.niehs.nih.gov/go/165.
Virtual Meeting: The URL for viewing
the virtual meeting will be provided on
the meeting web page the day before the
meeting.
FOR FURTHER INFORMATION CONTACT: Dr.
Sheena Scruggs, Designated Federal
Official for the BSC, Office of Policy,
Review, and Outreach, Division of NTP,
NIEHS, P.O. Box 12233, K2–03,
Research Triangle Park, NC 27709.
Phone: 984–287–3355, Fax: 301–451–
5759, Email: sheena.scruggs@nih.gov.
Hand Deliver/Courier address: 530
Davis Drive, Room K2126, Morrisville,
NC 27560.
SUPPLEMENTARY INFORMATION: The BSC
will provide input to the NTP on
programmatic activities and issues. The
preliminary agenda topics include
presentations from two of the Division
of the National Toxicology Program
(DNTP)’s research program areas. The
preliminary agenda, roster of BSC
members, background materials, public
comments, and any additional
information, when available, will be
posted on the BSC meeting web page
(https://ntp.niehs.nih.gov/go/165) or
may be requested in hardcopy from the
Designated Federal Official for the BSC.
Following the meeting, summary
minutes will be prepared and made
available on the BSC meeting web page.
Meeting Attendance Registration: The
meeting is open to the public with time
scheduled for oral public comments.
Registration is not required to view the
virtual meeting; the URL for the virtual
meeting is provided on the BSC meeting
web page (https://ntp.niehs.nih.gov/go/
165) the day before the meeting. TTY
users should contact the Federal TTY
Relay Service at 800–877–8339.
Requests should be made at least five
business days in advance of the event.
Written Public Comments: NTP
invites written public comments.
Guidelines for public comments are
available at https://ntp.niehs.nih.gov/
ntp/about_ntp/guidelines_public_
comments_508.pdf.
The deadline for submission of
written comments is July 28, 2021.
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Written public comments should be
submitted through the meeting web
page. Persons submitting written
comments should include name,
affiliation, mailing address, phone,
email, and sponsoring organization (if
any). Written comments received in
response to this notice will be posted on
the NTP web page, and the submitter
will be identified by name, affiliation,
and sponsoring organization (if any).
Oral Public Comment Registration:
The agenda allows for two formal public
comment periods—one comment period
for each program area (up to 3
commenters, up to 5 minutes per
speaker, per topic). Persons wishing to
make an oral comment are required to
register online at https://
ntp.niehs.nih.gov/go/165 by July 28,
2021. Oral comments will be received
only during the formal comment periods
indicated on the preliminary agenda.
Oral comments will only be by
teleconference line. The access number
for the teleconference line will be
provided to registrants by email prior to
the meeting. Registration is on a firstcome, first-served basis. Each
organization is allowed one time slot
per topic. After the maximum number of
speakers per comment period is
exceeded, individuals registered to
provide oral comment will be placed on
a wait list and notified should an
opening become available. Commenters
will be notified approximately one week
before the meeting about the actual time
allotted per speaker.
If possible, oral public commenters
should send a copy of their slides and/
or statement or talking points to NTPMeetings@icf.com by July 28, 2021.
Meeting Materials: The preliminary
meeting agenda is available on the
meeting web page (https://
ntp.niehs.nih.gov/go/165) and will be
updated one week before the meeting.
Individuals are encouraged to access the
meeting web page to stay abreast of the
most current information regarding the
meeting.
Background Information on the BSC:
The BSC is a technical advisory body
comprised of scientists from the public
and private sectors that provides
primary scientific oversight to the NTP.
Specifically, the BSC advises the NTP
on matters of scientific program content,
both present and future, and conducts
periodic review of the program for the
purpose of determining and advising on
the scientific merit of its activities and
their overall scientific quality. Its
members are selected from recognized
authorities knowledgeable in fields such
as toxicology, pharmacology, pathology,
epidemiology, risk assessment,
carcinogenesis, mutagenesis, cellular
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[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35307-35308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14173]
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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, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
[[Page 35308]]
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; HIV Vaccine Research and Design
(HIVRAD) Program (P01 Clinical Trial Not Allowed).
Date: July 29, 2021.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G11A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: J. Bruce Sundstrom, Ph.D., Scientific Review
Officer, Scientific Review Program, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, 5601 Fishers
Lane, Room 3G11A, Rockville, MD 20852, 240-669-5045,
[email protected].
(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: June 28, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-14173 Filed 7-1-21; 8:45 am]
BILLING CODE 4140-01-P
