National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting, 71650 [2021-27340]
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
products with a USP monograph are
required to meet the applicable criteria
from these USP General Chapters (see
section 501(b) of the FD&C Act).
Noncompendial products should also be
‘‘essentially free from visible
particulates’’ as defined in USP General
Chapter <790>.
Applying acceptance criteria, such as
the criterion outlined in USP General
Chapter <790>, is an important
component of the overall visible
particulate control program, but meeting
these acceptance criteria alone is not
sufficient to ensure compliance with the
applicable CGMP requirements
identified above, which cover a broader
array of manufacturing practices than
product inspection. Full compliance
with CGMP requirements is needed to
ensure the continued supply of pure,
safe, and effective injectable products.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Inspection of Injectable Products for
Visible Particulates.’’ 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 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 parts 211, 314,
and 601 have been approved under
OMB control numbers 0910–0139,
0910–0001, and 0910–0308,
respectively.
jspears on DSK121TN23PROD with NOTICES1
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
VerDate Sep<11>2014
17:39 Dec 16, 2021
Jkt 256001
Dated: December 14, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27351 Filed 12–16–21; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
BILLING CODE 4164–01–P
National Human Genome Research
Institute; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel.
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: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Brain Initiative
RFAs (EB–19–002; EB–20–001) Review SEP.
Date: February 11, 2022.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Democracy II, 6707 Democracy Blvd.,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Songtao Liu, MD,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Blvd., Suite 920, Bethesda, MD
20892, (301) 827–3025, songtao.liu@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, National Institute of
Biomedical Imaging and Bioengineering,
National Institutes of Health, HHS)
Dated: December 10, 2021.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: Center for Inherited
Disease Research Access Committee CIDR
Member Conflict Meeting.
Date: January 14, 2022.
Time: 12:00 p.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, Suite 3100, Room 3184,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Rudy Pozzatti, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, Bldg. 6700B Rockledge Dr., Rm.
3184, 6700B Rockledge Dr., Bethesda, MD
20817, (301) 402–0838, pozzattr@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: December 13, 2021.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–27341 Filed 12–16–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; NIH Electronic Application
System for NIH Certificates of
Confidentiality
AGENCY:
[FR Doc. 2021–27340 Filed 12–16–21; 8:45 am]
HHS.
BILLING CODE 4140–01–P
ACTION:
PO 00000
National Institutes of Health,
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
SUMMARY:
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[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Page 71650]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27340]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering;
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Institute
of Biomedical Imaging and Bioengineering Special Emphasis Panel.
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: National Institute of Biomedical Imaging and
Bioengineering Special Emphasis Panel; Brain Initiative RFAs (EB-19-
002; EB-20-001) Review SEP.
Date: February 11, 2022.
Time: 10:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications and/or
proposals.
Place: National Institutes of Health, Democracy II, 6707
Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Songtao Liu, MD, Scientific Review Officer,
National Institute of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707 Democracy Blvd., Suite 920,
Bethesda, MD 20892, (301) 827-3025, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.866,
National Institute of Biomedical Imaging and Bioengineering,
National Institutes of Health, HHS)
Dated: December 10, 2021.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-27340 Filed 12-16-21; 8:45 am]
BILLING CODE 4140-01-P
