Center for Scientific Review; Notice of Closed Meetings, 59405-59406 [2021-23382]
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Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
an approved drug from sale under
§ 314.81(b)(3)(iii).
We estimate 1,000 firms will expend
40 hours to prepare, review, and
approve a standard operating procedure
(SOP), for a total of 40,000 hours
annually. Although we expect most
respondents will have already prepared
and implemented an SOP for the
electronic submission of drug
establishment registration and drug
listing information, we retain an
estimate for new firms that will do so,
as recommended in the guidance.
Finally, we estimate 12,800
respondents are now subject to the
reporting provisions introduced by the
CARES Act under section 3112(e), and
assume it will take 15 minutes to
prepare and submit the requisite
information, as shown in our 60-day
notice. However, we have reduced this
figure by 1,780 to 11,020 to reflect
proposed reporting exemptions
pertaining to: (1) Blood and blood
components for transfusion and (2) cell
and gene therapy products, where one
lot treats a single patient. Consistent
with section 510(j)(3)(B) of the FD&C
Act, we have proposed to exempt these
biological product categories from the
reporting requirements in section
510(j)(3)(A) of the FD&C Act. If our
proposed order is not finalized, we will
adjust our estimate accordingly upon
reevaluation of the information
collection.
Overall, the information collection
reflects an increase which we attribute
to the new reporting required by section
510(j) of the FD&C Act, as amended by
the CARES Act. We have otherwise
retained the currently approved burden
estimates for the provisions in part 207.
Dated: October 21, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23395 Filed 10–26–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
lotter on DSK11XQN23PROD with NOTICES1
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
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
SUMMARY:
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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 RETHYMIC (allogeneic
processed thymus tissue-agdc),
manufactured by Enzyvant
Therapeutics, GmbH, 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.
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 RETHYMIC (allogeneic processed
thymus tissue-agdc), manufactured by
Enzyvant Therapeutics, GmbH, meets
the criteria for a priority review
voucher. RETHYMIC (allogeneic
processed thymus tissue-agdc) is
indicated for immune reconstitution in
pediatric patients with congenital
athymia. RETHYMIC (allogeneic
processed thymus tissue-agdc) is not
indicated for the treatment of patients
with severe combined
immunodeficiency (SCID).
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 RETHYMIC
(allogeneic processed thymus tissueagdc), go to the Center for Biologics
Evaluation and Research Cellular and
Gene Therapy Products website at
https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products.
SUPPLEMENTARY INFORMATION:
Dated: October 19, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–23336 Filed 10–26–21; 8:45 am]
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59405
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; Member
Conflict: In Toxicology, Pharmacology and
Hepatology.
Date: December 2, 2021.
Time: 9:00 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: Santanu Banerjee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2106,
Bethesda, MD 20892, (301) 435–5947,
banerjees5@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Special Topics in Nephrology and
Urology.
Date: December 2, 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: Stacey Nicole Williams,
Ph.D., Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–867–5309,
stacey.williams@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cancer Genomics.
Date: December 2, 2021.
Time: 10:00 a.m. to 5:00 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: Jian Cao, M.D., Scientific
Review Officer, Center for Scientific Review,
6701 Rockledge Drive, Room 4196, MSC
7844, Bethesda, MD 20892, (301) 827–5902,
caojn@csr.nih.gov.
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59406
Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Pain
Management and Substance Use Disorder
Research.
Date: December 2, 2021.
Time: 2:00 p.m. to 5:00 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: Abu Saleh Mohammad
Abdullah, Ph.D., Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 1003–L, Bethesda, MD 20892, (301)
827–4043, abuabdullah.abdullah@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: October 22, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–23382 Filed 10–26–21; 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
lotter on DSK11XQN23PROD with NOTICES1
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; PAR Panel:
Workforce Diversity in Basic Cancer
Research.
Date: November 30, 2021.
Time: 10:00 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: Rolf Jakobi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7806, Bethesda, MD 20892, 301–495–
1718, jakobir@mail.nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Infectious Diseases and
Immunology Panel C.
Date: December 1–2, 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: Kumud Singh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301–761–7830,
kumud.singh@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Sleep, Circadian Rhythms, Glucose
Regulation, and Cognition.
Date: December 1, 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: Janita N. Turchi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 402–4005, turchij@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cancer Prevention and
Immunotherapy.
Date: December 1, 2021.
Time: 12:00 p.m. to 5:00 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: Laura Asnaghi, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Room 6200, MSC 7804,
Bethesda, MD 20892, (301) 443–1196,
laura.asnaghi@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: October 22, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–23383 Filed 10–26–21; 8:45 am]
meeting of the National Advisory
Environmental Health Sciences Council.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Special Open Session
of the National Advisory Environmental
Health Sciences Council.
Date: November 29, 2021.
Time: 3:30 p.m. to 5:00 p.m.
Agenda: Concept: Climate Change and
Health Initiative.
Place: National Institute of Environmental
Health Science, Research Triangle Park, NC,
https://www.niehs.nih.gov/news/webcasts/
(Virtual Meeting).
Contact Person: J. Patrick Mastin, Ph.D.,
Deputy Division Director, Division of
Extramural Research and Training, National
Institute of Environmental Health Science,
Research Triangle Park, NC 27709, (984) 287–
3285, mastin@niehs.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.niehs.nih.gov/about/boards/naehsc/
index.cfm, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 21, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–23371 Filed 10–26–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HOMELAND
SECURITY
National Institutes of Health
U.S. Customs and Border Protection
National Institute of Environmental
Health Sciences; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
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Guarantee of Payment
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
AGENCY:
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[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59405-59406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23382]
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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; Member Conflict: In Toxicology, Pharmacology and Hepatology.
Date: December 2, 2021.
Time: 9:00 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: Santanu Banerjee, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, (301)
435-5947, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Special Topics in Nephrology and Urology.
Date: December 2, 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: Stacey Nicole Williams, Ph.D., Scientific Review
Officer, Center for Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, 301-867-5309, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Cancer Genomics.
Date: December 2, 2021.
Time: 10:00 a.m. to 5:00 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: Jian Cao, M.D., Scientific Review Officer,
Center for Scientific Review, 6701 Rockledge Drive, Room 4196, MSC
7844, Bethesda, MD 20892, (301) 827-5902, [email protected].
[[Page 59406]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Pain Management and Substance Use Disorder Research.
Date: December 2, 2021.
Time: 2:00 p.m. to 5:00 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: Abu Saleh Mohammad Abdullah, Ph.D., Scientific
Review Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1003-L, Bethesda, MD 20892, (301)
827-4043, [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: October 22, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-23382 Filed 10-26-21; 8:45 am]
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