Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 65362-65363 [2024-17661]
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Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
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 that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Sundeep Agrawal, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–348–3914; or James
Myers, Center of Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm., 7301, Silver Spring,
MD 20993, 240–402–7911.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘BCG-Unresponsive Nonmuscle
Invasive Bladder Cancer: Developing
Drug and Biological Products for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
development of drugs and biologics for
the treatment of patients with BCGunresponsive NMIBC. This guidance
addresses select statistical and clinical
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trial design issues specific to BCGunresponsive NMIBC. These topics are
further addressed in the International
Council for Harmonisation guidances
for industry entitled ‘‘E9 Statistical
Principles for Clinical Trials’’
(September 1998) and ‘‘E10 Choice of
Control Group and Related Issues in
Clinical Trials’’ (May 2001),
respectively.
This draft guidance reflects proposed
changes to FDA’s guidance entitled
‘‘BCG-Unresponsive Nonmuscle
Invasive Bladder Cancer: Developing
Drugs and Biologics for Treatment,’’
published in February 2018, and
incorporates FDA’s current
recommendations based on the
Agency’s experience as well as the
evolving landscape of drug development
in this space, as noted by external
experts. This guidance, when finalized,
will replace the final guidance titled
BCG-Unresponsive Nonmuscle Invasive
Bladder Cancer: Developing Drugs and
Biologics for Treatment published in
February 2018.
Key changes include the following: (1)
clarification on use of BCG substrains,
(2) considerations for trial design and
conduct in the setting of a recent
worldwide shortage of BCG, (3)
clarification on use of single arm vs.
randomized trial designs (with more
emphasis on randomized control trials),
and (4) clarifications on assessing and
reporting responses and assessing
endpoints for trials.
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 ‘‘BCG-Unresponsive Nonmuscle
Invasive Bladder Cancer: Developing
Drug and Biological Products for
Treatment.’’ 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 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; and the collections
of information pertaining to submission
of a biologics license application under
section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)) 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/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: August 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17733 Filed 8–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–0073; FDA–
2023–N–5656; FDA–2024–N–0802; FDA–
2023–N–3848; FDA–2023–N–5746]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09AUN1.SGM
09AUN1
Federal Register / Vol. 89, No. 154 / Friday, August 9, 2024 / Notices
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
65363
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Irradiation in the Production, Processing and Handling of Food ............................................................................
State Enforcement Notifications ..............................................................................................................................
Veterinary Feed Directive ........................................................................................................................................
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring ..............................................
Record Retention Requirements for the Soy Protein and Reduced Risk of Coronary Heart Disease Health
Claim ....................................................................................................................................................................
Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–17661 Filed 8–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–2979]
Pre-Market Animal Food Ingredient
Review Programs; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA, we, or Agency) is
soliciting comments from the public
regarding the Food Additive Petition
and Generally Recognized as Safe
(GRAS) Notification programs to
determine if changes are needed to
promote their efficiency. Specific
questions and information requests are
included in this notice to help guide
input from stakeholders and other
members of the public.
DATES: Submit either electronic or
written comments on the notice by
December 9, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 9, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–2979 for ‘‘Pre-Market Animal
Food Ingredient Review Programs,
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
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Date approval
expires
0910–0186
0910–0275
0910–0363
0910–0409
7/31/2027
7/31/2027
7/31/2027
7/31/2027
0910–0428
7/31/2027
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 89, Number 154 (Friday, August 9, 2024)]
[Notices]
[Pages 65362-65363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-0073; FDA-2023-N-5656; FDA-2024-N-0802; FDA-
2023-N-3848; FDA-2023-N-5746]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information
[[Page 65363]]
collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Irradiation in the Production, 0910-0186 7/31/2027
Processing and Handling of Food........
State Enforcement Notifications......... 0910-0275 7/31/2027
Veterinary Feed Directive............... 0910-0363 7/31/2027
Regulations for In Vivo 0910-0409 7/31/2027
Radiopharmaceuticals Used for Diagnosis
and Monitoring.........................
Record Retention Requirements for the 0910-0428 7/31/2027
Soy Protein and Reduced Risk of
Coronary Heart Disease Health Claim....
------------------------------------------------------------------------
Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17661 Filed 8-8-24; 8:45 am]
BILLING CODE 4164-01-P
