National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 48432 [2021-18564]
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48432
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
specified the electronic format for
submitting certain submission types to
the Agency, such content must be
submitted electronically and in the
format specified by FDA. According to
the guidance for industry ‘‘Providing
Regulatory Submissions in Electronic
Format—Certain Human Pharmaceutical
Product Applications and Related
Submissions Using the eCTD
Specifications’’ (available at https://
www.fda.gov/media/135373/download),
submissions subject to section 745A(a)
of the FD&C Act must be submitted in
eCTD format using the version of eCTD
currently supported by FDA (unless
such submission is exempt from the
electronic submission requirements or if
FDA has granted a waiver). The version
of eCTD currently supported by FDA is
specified in the Data Standards Catalog
(available at https://www.fda.gov/
industry/fda-resources-data-standards/
study-data-standards-resources).
As described in the guidance for
industry ‘‘Providing Regulatory
Submissions in Electronic and NonElectronic Format—Promotional
Labeling and Advertising Materials for
Human Prescription Drugs’’ (The
Promotional Labeling Guidance)
(available at https://www.fda.gov/
media/128163/download), certain types
of promotional-material-related
submissions, including postmarketing
submissions of promotional materials
using Form FDA 2253 (required by
§ 314.81(b)(3)(i) (21 CFR 314.81(b)(3)(i))
and 21 CFR 601.12(f)(4)) (called 2253
submissions), fall within the scope of
section 745A(a) of the FD&C Act and
are, therefore, subject to the mandatory
electronic submission requirements
(unless such submission is exempt from
the electronic submission requirements
or if FDA has granted a waiver). The
Promotional Labeling Guidance
provides that 2253 submissions are
required to be accompanied by a
completed fillable Form FDA 2253.
When submitting Form FDA 2253, firms
must submit the most current product
labeling, as required in § 314.81(b)(3)(i),
under eCTD section 1.14.6, as described
in the Promotional Labeling Guidance.
Electronic Common Technical
Document validations 1551 (‘‘2253
submission does not include Product
Labeling’’) and 1553 (‘‘The only valid
FDA Form to include in a 2253
submission is FDA Form 2253’’)
describe parts of the eCTD
specifications that were not followed
correctly (see the Specifications for
eCTD Validation Criteria, pp. 29 and 30,
respectively). Submissions to CDER that
are subject to section 745A(a) of the
FD&C Act and fail to pass either eCTD
VerDate Sep<11>2014
18:40 Aug 27, 2021
Jkt 253001
validation 1551 or 1553 will begin being
rejected on October 18, 2021.
Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18587 Filed 8–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, 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; NIAID 2021 DMID Omnibus
BAA (HHS–NIH–NIAID–BAA2021–01)
Research Area 001: Advanced Development
of Vaccine Candidates for Biodefense and
Emerging Infectious Diseases (1).
Date: September 20, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Frank S. De Silva, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3E72A, Rockville, MD
20852, (240) 669–5023, fdesilva@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases, Special
Emphasis Panel; NIAID 2021 DMID Omnibus
BAA (HHS–NIH–NIAID–BAA2021–01)
Research Area 001: Advanced Development
of Vaccine Candidates for Biodefense and
Emerging Infectious Diseases (2).
Date: September 22, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Frank S. De Silva, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3E72A, Rockville, MD
20852, (240) 669–5023, fdesilva@
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: August 24, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–18564 Filed 8–27–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Agency Emergency Information
Collection Clearance Request for
Public Comment
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments on the information
collection request must be received on
or before 10 days of this published
notice.
SUMMARY:
When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted
within 10 days. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
ADDRESSES:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Mikia P. Currie, Office of
FOR FURTHER INFORMATION CONTACT:
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30AUN1
]]>Agencies
[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Page 48432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, 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; NIAID 2021 DMID Omnibus BAA (HHS-
NIH-NIAID-BAA2021-01) Research Area 001: Advanced Development of
Vaccine Candidates for Biodefense and Emerging Infectious Diseases
(1).
Date: September 20, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Frank S. De Silva, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20852, (240) 669-5023, [email protected].
Name of Committee: National Institute of Allergy and Infectious
Diseases, Special Emphasis Panel; NIAID 2021 DMID Omnibus BAA (HHS-
NIH-NIAID-BAA2021-01) Research Area 001: Advanced Development of
Vaccine Candidates for Biodefense and Emerging Infectious Diseases
(2).
Date: September 22, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Frank S. De Silva, Ph.D., Scientific Review
Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3E72A,
Rockville, MD 20852, (240) 669-5023, [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: August 24, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-18564 Filed 8-27-21; 8:45 am]
BILLING CODE 4140-01-P
