National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 14898 [2022-05562]
Download as PDF
<![CDATA[
14898
Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, 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:
jspears on DSK121TN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance document entitled
‘‘Human Gene Therapy Products
Incorporating Human Genome Editing;
Draft Guidance for Industry.’’ The draft
guidance document provides
recommendations to sponsors
developing human gene therapy
products incorporating GE of human
somatic cells. Specifically, the guidance
provides recommendations regarding
information that should be provided in
an IND application in order to assess the
safety and quality of the investigational
GE product as required in 21 CFR
312.23. This includes information on
product design, product manufacturing,
product testing, preclinical safety
assessment and clinical trial design.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of another human gene
therapy draft guidance document
entitled ‘‘Considerations for the
Development of Chimeric Antigen
Receptor (CAR) T Cell Products; Draft
Guidance for Industry.’’
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Human Gene Therapy Products
Incorporating Human Genome Editing.’’
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
VerDate Sep<11>2014
17:16 Mar 15, 2022
Jkt 256001
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 parts 210 and
211 have been approved under OMB
control number 0910–0073; the
collections of information in 21 CFR
part 1271 have been approved under
OMB control number 0910–0543.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/
biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/ or
https://www.regulations.gov.
Dated: March 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05538 Filed 3–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney 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
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.
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR19–319: NIDDK
Central Repositories Non-renewable Sample
Access (X01).
Date: May 6, 2022.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Blvd.,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Najma S. Begum, Ph.D.
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health
Room, 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: March 11, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–05562 Filed 3–15–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney 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
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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Characterization of
Islet-derived Extracellular Vesicles for
Improved Detection, Monitoring,
Classification, and Treatment of Type 1
Diabetes Special Emphasis Panel.
Date: April 6, 2022.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Page 14898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05562]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney 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
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 Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; PAR19-319: NIDDK Central
Repositories Non-renewable Sample Access (X01).
Date: May 6, 2022.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892 (Telephone Conference Call).
Contact Person: Najma S. Begum, Ph.D. Scientific Review Officer,
Review Branch, DEA, NIDDK, National Institutes of Health Room, 7349,
6707 Democracy Boulevard, Bethesda, MD 20892-5452, (301) 594-8894,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: March 11, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-05562 Filed 3-15-22; 8:45 am]
BILLING CODE 4140-01-P
