Agency Information Collection Revision 60-Day Public Comment Request, 31759-31760 [2024-08799]
Download as PDF
<![CDATA[
31759
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
issued on February 4, 2020 (85 FR 6201)
(2020 draft guidance). In revising this
guidance, FDA considered comments
received on the 2020 draft guidance and
expanded the scope of the 2020 draft
guidance to fulfill the BsUFA III
commitment to publish draft guidance
on promotional labeling and advertising
considerations for interchangeable
biosimilar products. Changes from the
2020 draft guidance include additional
recommendations and an example for
interchangeable biosimilar products. In
addition, editorial changes were made
to improve clarity.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Promotional Labeling and
Advertising Considerations for
Prescription Biological Reference
Products, Biosimilar Products, and
Interchangeable Biosimilar Products:
Questions and Answers.’’ 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. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in FDA’s guidance entitled
‘‘Providing Regulatory Submissions in
Electronic and Non-Electronic Format:
Promotional Labeling and Advertising
Materials for Human Prescription
Drugs,’’ the collections of information in
21 CFR part 314, and the collections of
information resulting from submissions
using Form FDA 2253 (Transmittal of
Advertisements and Promotional
Labeling for Drugs and Biologics for
Human Use) have been approved under
OMB control number 0910–0001. The
collections of information in 21 CFR
601.12 have been approved under OMB
control number 0910–0338; the
collections of information in 21 CFR
202.1 have been approved under OMB
control number 0910–0686; the
collections of information in FDA’s
guidance entitled ‘‘Medical Product
Communications That Are Consistent
With the Food and Drug Administration
Required Labeling: Questions and
Answers’’ have been approved under
OMB control number 0910–0856; the
collections of information in 21 CFR
part 11 pertaining to electronic records
and signatures have been approved
under OMB control number 0910–0303;
and the collections of information
relating to section 351(k) of the Public
Health Service Act relating to biosimilar
and interchangeable product
applications have been approved under
OMB control number 0910–0718.
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/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: April 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08886 Filed 4–24–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0477]
Agency Information Collection
Revision 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
SUMMARY:
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before June 24, 2024.
ADDRESSES: Submit your comments to
Sherrette.Funn@hhs.gov or by calling
(202) 264–0041 and PRA@HHS.GOV.
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0990–0477–60D
and project title for reference, to
Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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: Incident Report
Form.
Type of Collection: Reinstatement
with Change.
OMB No.: 0990–0477.
Abstract: The Office of the Assistant
Secretary for Health, Office for Human
Research Protections (OHRP), is
requesting reinstatement of the OMB
No. 0990–0477, Incident Report Form,
with two new information elements on
the Incident Report form: IORG # for
Reviewing IRB; and, Revising research
policies and procedures as a corrective
action plan category, if it applies. The
purpose of the Incident Report form is
to facilitate organizations or institutions
prompt reporting of specific human
subject protection incidents to OHRP, in
a simplified standardized format, as
required by HHS protection of human
subjects regulations at 45 CFR part 46.
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Forms name
Number of
responses per
respondents
Average
burden per
response
Total burden
hours
Incident Report ................................................................................................
Incident Report ................................................................................................
Incident Report ................................................................................................
25
25
200
1
3
5
30/60
30/60
30/60
12.5
37.5
500
Total ..........................................................................................................
........................
........................
........................
550
VerDate Sep<11>2014
18:54 Apr 24, 2024
Jkt 262001
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
E:\FR\FM\25APN1.SGM
25APN1
31760
Federal Register / Vol. 89, No. 81 / Thursday, April 25, 2024 / Notices
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2024–08799 Filed 4–24–24; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Committee on Minority
Health; Notice of Meeting Cancellation
The Office of Minority Health (OMH)
published a notice in the Federal
Register concerning a meeting of the
Advisory Committee on Minority
Health. The meeting scheduled for
Tuesday, April 30, 2024 at 11 a.m. to
12:30 p.m. (EDT) is cancelled. The
notice for the April 30, 2024 meeting
was published in the Federal Register
on Monday, April 1, 2024 in FR Doc.
2024–06850, on pages 22412–22413.
FOR FURTHER INFORMATION CONTACT:
Violet Woo, Designated Federal Officer,
OMH’s Advisory Committee on
Minority Health, OMH, HHS, Tower
Building, 1101 Wootton Parkway, Suite
100, Rockville, Maryland 20852.
Telephone: (240) 453–6816; Email:
OMH-ACMH@hhs.gov.
Violet Woo,
Designated Federal Officer, Advisory
Committee on Minority Health.
BILLING CODE 4150–29–P
BILLING CODE 4140–01–P
National Institute of Nursing Research;
Notice of Meeting
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
lotter on DSK11XQN23PROD with NOTICES1
[FR Doc. 2024–08832 Filed 4–24–24; 8:45 am]
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 1009 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
Environmental Health Sciences Special
Emphasis Panel: Superfund Hazardous
Substances Research and Training Program
(SRP) Conflict Panel Review.
18:54 Apr 24, 2024
Dated: April 19, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–08896 Filed 4–24–24; 8:45 am]
VerDate Sep<11>2014
Date: May 30–31, 2024.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Science, 530 Davis Drive, Keystone
Building, Durham, NC 27713 (Virtual
Meeting).
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, (984) 287–3340, worth@niehs.nih.gov.
(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)
Jkt 262001
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council for Nursing Research.
This will be a hybrid meeting held inperson and virtually and will be open to
the public as indicated below.
Individuals who plan to attend inperson or view the virtual meeting and
need special assistance or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
can be accessed from the NIH Videocast
at the following link: https://videocast.
nih.gov/watch=54495
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
PO 00000
Frm 00047
Fmt 4703
Sfmt 9990
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Nursing Research.
Date: May 23, 2024.
Open: May 23, 2024, 9:00 a.m. to 4:15 p.m.
Agenda: Call to Order and Opening
Remarks, NINR Director’s Report, Discussion
of NINR Programs, Council Open Discussion.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Room 6C6,
Bethesda, MD 20892 (Hybrid Meeting).
Closed: May 23, 2024, 4:15 p.m. to 4:45
p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Room 6C6,
Bethesda, MD 20892.
Contact Person: Elizabeth Tarlov, Ph.D.,
RN Director, Division of Extramural Science
Programs (DESP), National Institute of
Nursing Research, 31 Center Drive, Bethesda,
MD 20892, (301) 594–1580, elizabeth.tarlov@
nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of an organization may
submit a letter of intent, a brief description
of the organization represented and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and
presentations may be limited to five minutes.
Both printed and electronic copies are
requested for the record. In addition, 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.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.ninr.nih.gov/aboutninr/nacnr, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: April 22, 2024.
Patricia B. Hansberger,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–08889 Filed 4–24–24; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\25APN1.SGM
25APN1
]]>Agencies
[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31759-31760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08799]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0477]
Agency Information Collection Revision 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before June 24, 2024.
ADDRESSES: Submit your comments to [email protected] or by calling
(202) 264-0041 and [email protected].
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0477-60D and
project title for reference, to Sherrette A. Funn, email:
[email protected], [email protected] or call (202) 264-0041 the Reports
Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (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: Incident Report Form.
Type of Collection: Reinstatement with Change.
OMB No.: 0990-0477.
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections (OHRP), is requesting reinstatement of
the OMB No. 0990-0477, Incident Report Form, with two new information
elements on the Incident Report form: IORG # for Reviewing IRB; and,
Revising research policies and procedures as a corrective action plan
category, if it applies. The purpose of the Incident Report form is to
facilitate organizations or institutions prompt reporting of specific
human subject protection incidents to OHRP, in a simplified
standardized format, as required by HHS protection of human subjects
regulations at 45 CFR part 46.
Annualized Burden Hour Table
----------------------------------------------------------------------------------------------------------------
Number of
Forms name Number of responses per Average burden Total burden
respondents respondents per response hours
----------------------------------------------------------------------------------------------------------------
Incident Report................................. 25 1 30/60 12.5
Incident Report................................. 25 3 30/60 37.5
Incident Report................................. 200 5 30/60 500
---------------------------------------------------------------
Total....................................... .............. .............. .............. 550
----------------------------------------------------------------------------------------------------------------
[[Page 31760]]
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-08799 Filed 4-24-24; 8:45 am]
BILLING CODE 4150-36-P
