Agency Emergency Information Collection Clearance Request for Public Comment, 48432-48433 [2021-18636]
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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
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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:
E:\FR\FM\30AUN1.SGM
30AUN1
48433
Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
Policy for Extramural Research
Administration, 6705 Rockledge Drive,
8th Floor Room 803, Bethesda,
Maryland 20892, or call a non-toll-free
number 301–435–0941 or Email your
request, including your address to
ProjectClearanceBranch@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) The necessity and utility of
the proposed information collection for
the proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
SUPPLEMENTARY INFORMATION:
technology to minimize the information
collection burden.
Title of the Collection: NIH COVID–19
Vaccine Attestation Intake Form.
Type of Collection: Emergency.
OMB Number: 0925–NEW.
Abstract: The U.S. Office of Personnel
Management (OPM) approved the U.S.
Department of Health and Human
Services’ (HHS) request for a variation
to a strict application of 5 CFR 339.205
under 5 CFR.1 to promote the efficiency
of the Government. Under this variation,
HHS may use the authority under 5 CFR
339.205 to mandate COVID–19
vaccinations authorized under
Emergency Use Authorizations (EUA)
for its patient-facing health care
personnel, including its health care
applicants and employees, who work in
Indian Health Service (IHS) medical
facilities, National Institutes of Health
(NIH) clinical research facilities, or
other HHS facilities that provide direct
patient care or clinical research. In
addition, the Safer Federal Workforce
Task Force created by President Biden’s
Executive Order 13991 has instructed
Federal Agencies to inquire about the
COVID–19 vaccination status of federal
employees and on-site contractors. The
NIH now has a COVID–19 vaccination
requirement for persons working in
Building 10 on the Bethesda campus,
those with patient contact, or probable
patient contact. The proposed
information collection will be used to
ensure compliance with these
requirements, generate the list of
persons required to be tested on a
routine basis, and will provide
important information regarding safety
frameworks, guidance, and procedures.
The purpose of the information
collection is to promote the safety of the
federal workplace consistent with the
above-referenced authorities, the
COVID–19 Workplace Safety: Agency
Model Safety Principles established by
the Safer Federal Workforce Task Force,
and guidance from the Centers for
Disease Control and Prevention (CDC)
and the Occupational Safety and Health
Administration (OSHA).
ESTIMATED ANNUALIZED BURDEN TABLE
Type of
collection
Number of
respondents
Average
burden per
response
(in hours)
Total burden
hours
NIH COVID–19 Vaccine Attestation intake form .............................................
31,000
1
5/60
2,583
Total ..........................................................................................................
........................
31,000
........................
2,583
Dated: August 24, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2021–18636 Filed 8–27–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of
Meetings
khammond on DSKJM1Z7X2PROD with NOTICES
Number
responses
per
respondent
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Advisory
Allergy and Infectious Diseases Council.
The meeting will be open to the
public. The open session will be
videocast and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov).
Individuals who need special
assistance, such as sign language
interpretation or other reasonable
VerDate Sep<11>2014
18:40 Aug 27, 2021
Jkt 253001
accommodations, should notify the
Contact Person listed below in advance
of the meeting.
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 Advisory
Allergy and Infectious Diseases Council
Date: September 13, 2021
Open: 10:30 a.m. to 11:30 a.m.
Agenda: Report of Institute Director
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 4G30
Rockville, MD 20892 (Virtual Meeting).
Closed: 11:45 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Health, 5601 Fishers Lane, Room 4G30
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Matthew J. Fenton, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 4F50, Bethesda, MD,
20892 301–496–7291, fentonm@
niaid.nih.gov.
Name of Committee: National Advisory
Allergy and Infectious Diseases Council
Acquired Immune Deficiency Syndrome
Subcommittee.
Date: September 13, 2021.
Open 8:30 a.m. to 10:15 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 4G30,
Rockville, MD 20832 (Virtual Meeting).
Open: 1:00 p.m. to 4:00 p.m.
Agenda: Report of Division Director and
Division Staff.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 4G30,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Matthew J. Fenton, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 4F50, Bethesda, MD
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 86, Number 165 (Monday, August 30, 2021)]
[Notices]
[Pages 48432-48433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18636]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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.
ADDRESSES: 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.
FOR FURTHER INFORMATION CONTACT: 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
[[Page 48433]]
Policy for Extramural Research Administration, 6705 Rockledge Drive,
8th Floor Room 803, Bethesda, Maryland 20892, or call a non-toll-free
number 301-435-0941 or Email your request, including your address to
[email protected]. Formal requests for additional
plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written comments and/or suggestions
from the public and affected agencies are invited to address one or
more of the following points: (1) The necessity and utility of the
proposed information collection for the proper performance of the
agency's functions; (2) the accuracy of the estimated burden; (3) ways
to enhance the quality, utility, and clarity of the information to be
collected; and (4) the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
Title of the Collection: NIH COVID-19 Vaccine Attestation Intake
Form.
Type of Collection: Emergency.
OMB Number: 0925-NEW.
Abstract: The U.S. Office of Personnel Management (OPM) approved
the U.S. Department of Health and Human Services' (HHS) request for a
variation to a strict application of 5 CFR 339.205 under 5 CFR.1 to
promote the efficiency of the Government. Under this variation, HHS may
use the authority under 5 CFR 339.205 to mandate COVID-19 vaccinations
authorized under Emergency Use Authorizations (EUA) for its patient-
facing health care personnel, including its health care applicants and
employees, who work in Indian Health Service (IHS) medical facilities,
National Institutes of Health (NIH) clinical research facilities, or
other HHS facilities that provide direct patient care or clinical
research. In addition, the Safer Federal Workforce Task Force created
by President Biden's Executive Order 13991 has instructed Federal
Agencies to inquire about the COVID-19 vaccination status of federal
employees and on-site contractors. The NIH now has a COVID-19
vaccination requirement for persons working in Building 10 on the
Bethesda campus, those with patient contact, or probable patient
contact. The proposed information collection will be used to ensure
compliance with these requirements, generate the list of persons
required to be tested on a routine basis, and will provide important
information regarding safety frameworks, guidance, and procedures.
The purpose of the information collection is to promote the safety
of the federal workplace consistent with the above-referenced
authorities, the COVID-19 Workplace Safety: Agency Model Safety
Principles established by the Safer Federal Workforce Task Force, and
guidance from the Centers for Disease Control and Prevention (CDC) and
the Occupational Safety and Health Administration (OSHA).
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of collection respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
NIH COVID-19 Vaccine Attestation intake form.... 31,000 1 5/60 2,583
---------------------------------------------------------------
Total....................................... .............. 31,000 .............. 2,583
----------------------------------------------------------------------------------------------------------------
Dated: August 24, 2021.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2021-18636 Filed 8-27-21; 8:45 am]
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