Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees, 54324-54326 [2023-17154]
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54324
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. This position
may be filled on a rotating, sequential
basis by representatives of different
small business tobacco manufacturers
based on areas of expertise relevant to
the topics being considered by the
Advisory Committee. Nominations will
be accepted for current vacancies
effective with this notice.
DATES: Any small business tobacco
manufacturing industry organization
interested in participating in the
selection of appropriate nonvoting
members to represent industry interests
must send a letter stating that interest to
the FDA by September 11, 2023, (see
sections I and II of this document for
further details). Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
September 11, 2023.
ADDRESSES: All statements of interest
from small business tobacco
manufacturing industry organizations
interested in participating in the
selection process of nonvoting industry
representative nominations should be
sent to CAPT Serina Hunter-Thomas
(see FOR FURTHER INFORMATION CONTACT).
All nominations for nonvoting industry
representatives may be submitted
electronically by accessing the FDA
Advisory Committee Membership
Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website
https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products,
Food and Drug Administration, Center
for Tobacco Products Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–877–287–1373 (choose
Option 5), or by email: TPSAC@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add nonvoting
industry representative(s) to the
following advisory committee:
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of FDA (the
Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
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17:28 Aug 09, 2023
Jkt 259001
to tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
The Committee includes three
nonvoting members who represent
industry interests. These members
include one representative representing
the interests of the tobacco
manufacturing industry, one
representative representing the interests
of tobacco growers, and one
representative representing the interests
of the small business tobacco
manufacturing industry, which may be
filled on a rotating, sequential basis by
representatives of different small
business tobacco manufacturers based
on areas of expertise relevant to the
topics being considered by the Advisory
Committee.
With this notice, nominations are
sought for the following positions: A
pool of individuals, with varying areas
of expertise, to represent the interests of
the small business tobacco
manufacturing industry on a rotating,
sequential basis.
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
Food and Drug Administration
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
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Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17149 Filed 8–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2010–N–0583]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Radioactive Drug
Research Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
11, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0053. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
SUMMARY:
E:\FR\FM\10AUN1.SGM
10AUN1
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Radioactive Drug Research Committees
OMB Control Number 0910–0053—
Extension
This information collection request
supports the implementation of
statutory and regulatory requirements
and associated Agency forms. Sections
201, 505, and 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
355, and 371) establish provisions under
which FDA issues regulations governing
the use of radioactive drugs for basic
scientific research. Specifically, § 361.1
(21 CFR 361.1) sets forth specific
regulations about establishing and
composing radioactive drug research
committees (RDRCs) and their role in
approving and monitoring basic
research studies using
radiopharmaceuticals, including
reporting, recordkeeping, and labeling
requirements. No basic research study
involving any administration of a
radioactive drug to research subjects is
permitted without the authorization of
an FDA-approved RDRC (§ 361.1(d)(7)).
The type of research that may be
undertaken with a radiopharmaceutical
drug must be intended to obtain basic
information and not to carry out a
clinical trial for safety or efficacy. The
types of basic research permitted are
specified in the regulations and include
studies of metabolism, human
physiology, pathophysiology, or
biochemistry.
To assist respondents with the
applicable reporting requirements, we
developed Form FDA 2914 entitled,
‘‘Report on Research Use of Radioactive
Drugs: Membership Summary,’’
available at https://www.fda.gov/media/
73820/download; and Form FDA 2915,
entitled, ‘‘Report on Research Use of
Radioactive Drugs: Study Summary,’’
available at https://www.fda.gov/media/
71805/download.
We also developed the guidance
document entitled, ‘‘Radioactive Drug
Research Committee: Human Research
Without An Investigational New Drug
Application’’ (August 2010), available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/radioactive-drug-researchcommittee-human-research-withoutinvestigational-new-drug-application,
which provides information to help
determine whether research studies may
be conducted under an FDA-approved
RDRC, or whether research studies must
be conducted under an investigational
new drug application (IND). It also
offers answers to frequently asked
questions on conducting research with
radioactive drugs, and provides
information on the membership,
54325
functions, and reporting requirements of
an RDRC approved by FDA. All Agency
guidance documents are issued
consistent with our good guidance
practice regulations at 21 CFR 10.115.
Types of research studies not
permitted under the regulations are also
specified and include those intended for
immediate therapeutic, diagnostic, or
similar purposes or to determine the
safety or effectiveness of the drug in
humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy).
These studies require filing of an IND
under 21 CFR part 312, and the
associated information collections, are
covered in OMB control number 0910–
0014.
The primary purpose of this
collection of information is to determine
whether the research studies are being
conducted in accordance with required
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks. Respondents to
this information collection are the
chairperson or chairpersons of each
individual RDRC, investigators, and
participants in the studies.
In the Federal Register of March 16,
2023 (88 FR 16272), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section; FDA form or activity
Total annual
responses
Average burden
per response
Total
hours
§ 361.1(c)(3) reports and (c)(4) approval; Form FDA
2914 (Membership Summary).
§ 361.1(c)(3) reports; Form FDA 2915 (Study Summary)
§ 361.1(d)(8); adverse events ............................................
56
1
56
1 .............................
56
37
10
10
1
370
10
3 .............................
0.5 (30 mins) ..........
1,110
5
Total ............................................................................
..........................
..........................
..........................
................................
1,171
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
ddrumheller on DSK120RN23PROD with NOTICES1
21 CFR section; and activity
Number of
records per
recordkeepers
Total annual
records
Average burden per
recordkeeping
Total
Hours
§ 361.1(c)(2); RDRC maintains meeting minutes involving
use in human research subjects.
§ 361.1(d)(5); RDRC obtains consent of human research
subjects.
56
10.61
594
4.239 ......................
2,518
Total ............................................................................
..........................
..........................
..........................
................................
2,518
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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E:\FR\FM\10AUN1.SGM
10AUN1
54326
Federal Register / Vol. 88, No. 153 / Thursday, August 10, 2023 / Notices
The burden attributed to
recordkeeping activities is assumed to
be distributed among the individual
elements and averaged among
respondents. In the burden estimate, we
assume an average burden per record of
10 hours for the RDRC respondents to
maintain meeting minutes and 0.75
hours (45 minutes) for a subset of the
respondents (37 RDRCs) to obtain
consent of human research subjects.
Section 361.1(f) sets forth labeling
requirements for radioactive drugs.
These requirements are not in the
burden estimate because they are
information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Our estimated burden for the
information collection reflects an
overall decrease of 703 hours and a
corresponding decrease of 158
responses. We attribute this adjustment
to a decrease in the average burden per
response, from 3.5 hours to 3 hours per
response, associated with the public
reporting burden for Form FDA 2915.
The decrease is based on our program
experience and matches the burden
hours reflected on the form. In addition,
this adjustment is also attributable to
the Agency receiving fewer submissions
over the last few years.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–17154 Filed 8–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0918]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Labeling
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
11, 2023.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:28 Aug 09, 2023
Jkt 259001
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0381. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10 a.m.–12 p.m.,
11601 Landsdown St., North Bethesda,
MD 20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food Labeling Requirements
OMB Control Number 0910–0381—
Revision
This information collection supports
statutory and regulatory requirements
that govern food labeling, and
information collection
recommendations discussed in
associated Agency guidance. Sections 4,
5, and 6 of the Fair Packaging and
Labeling Act (FPLA) (15 U.S.C. 1453,
1454, and 1455) and sections 201, 301,
402, 403, 409, 411, 701, and 721 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321, 331, 342,
343, 348, 350, 371, and 379e), establish
provisions under which a food product
shall be deemed to be misbranded if,
among other things, its label or labeling
fails to bear certain required information
concerning the food product, is false or
misleading in any particular, or bears
certain types of unauthorized claims.
Implementing regulations are codified
in parts 101, 102, 104, and 105 (21 CFR
parts 101, 102, 104, and 105). While
regulations in part 101 set forth general
food labeling provisions, requirements
pertaining to the common or usual name
for nonstandardized foods; guidelines
for nutritional quality to prescribe the
minimum level or range of nutrient
composition appropriate for a given
class of food; and requirements for foods
for special dietary use are found in parts
102, 104, and 105, respectively. The
requirements are intended to ensure the
safety of food products produced or sold
in the United States and enable
consumers to be knowledgeable about
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
the foods they purchase and include
corresponding information disclosure
requirements, along with the reporting
and recordkeeping provisions, subject to
enforcement by FDA.
We provide information resources
regarding food labeling under the FD&C
Act and its amendments on our website
at https://www.fda.gov/food/foodlabeling-nutrition. Food labeling is
required for most prepared foods, such
as breads, cereals, canned and frozen
foods, snacks, desserts, drinks, etc.
Nutrition labeling for raw produce
(fruits and vegetables) and fish is
voluntary. We refer to these products as
‘‘conventional’’ foods. For detailed
information on dietary supplement
labeling requirements visit our website
at https://www.fda.gov/food/dietarysupplements. Nutrition labeling
provides information for use by
consumers in selecting a nutritious diet.
Other information enables consumers to
comparison shop. Ingredient
information also enables consumers to
avoid substances to which they may be
sensitive. Petitions or other requests
submitted to us provide the basis for us
to permit new labeling statements or to
grant exemptions from certain labeling
requirements. Recordkeeping
requirements enable us to monitor the
basis upon which certain label
statements are made for food products
and whether those statements are in
compliance with the requirements of the
FD&C Act or the FPLA. Requirements
include general content and format for
the labeling of food packaging,
including nutrition and ingredient
information. Additional regulations
provide for specific nutrient content
claims.
The information collection includes
Form FDA 3570 entitled, ‘‘Small
Business Nutrition Labeling Exemption
Notice,’’ for use as applicable and
available for download from our website
at https://www.fda.gov/food/labelingnutrition-guidance-documentsregulatory-information/small-businessnutrition-labeling-exemption-noticemodel-form. We have also developed
the following guidance documents to
assist respondents with various aspects
of the information collection:
• ‘‘Guidance for Industry:
Notification of a Health Claim or
Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body’’ (June 1998). The guidance
document is available from our website
at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industrynotification-health-claim-or-nutrientcontent-claim-based-authoritativestatement. The guidance document
E:\FR\FM\10AUN1.SGM
10AUN1
Agencies
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54324-54326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17154]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0583]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Radioactive Drug
Research Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 11, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0053. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three
[[Page 54325]]
White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD
20852, 240-994-7399, [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Radioactive Drug Research Committees
OMB Control Number 0910-0053--Extension
This information collection request supports the implementation of
statutory and regulatory requirements and associated Agency forms.
Sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 355, and 371) establish provisions under which FDA
issues regulations governing the use of radioactive drugs for basic
scientific research. Specifically, Sec. 361.1 (21 CFR 361.1) sets
forth specific regulations about establishing and composing radioactive
drug research committees (RDRCs) and their role in approving and
monitoring basic research studies using radiopharmaceuticals, including
reporting, recordkeeping, and labeling requirements. No basic research
study involving any administration of a radioactive drug to research
subjects is permitted without the authorization of an FDA-approved RDRC
(Sec. 361.1(d)(7)). The type of research that may be undertaken with a
radiopharmaceutical drug must be intended to obtain basic information
and not to carry out a clinical trial for safety or efficacy. The types
of basic research permitted are specified in the regulations and
include studies of metabolism, human physiology, pathophysiology, or
biochemistry.
To assist respondents with the applicable reporting requirements,
we developed Form FDA 2914 entitled, ``Report on Research Use of
Radioactive Drugs: Membership Summary,'' available at https://www.fda.gov/media/73820/download; and Form FDA 2915, entitled, ``Report
on Research Use of Radioactive Drugs: Study Summary,'' available at
https://www.fda.gov/media/71805/download.
We also developed the guidance document entitled, ``Radioactive
Drug Research Committee: Human Research Without An Investigational New
Drug Application'' (August 2010), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radioactive-drug-research-committee-human-research-without-investigational-new-drug-application, which provides information to help determine whether
research studies may be conducted under an FDA-approved RDRC, or
whether research studies must be conducted under an investigational new
drug application (IND). It also offers answers to frequently asked
questions on conducting research with radioactive drugs, and provides
information on the membership, functions, and reporting requirements of
an RDRC approved by FDA. All Agency guidance documents are issued
consistent with our good guidance practice regulations at 21 CFR
10.115.
Types of research studies not permitted under the regulations are
also specified and include those intended for immediate therapeutic,
diagnostic, or similar purposes or to determine the safety or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an IND under 21 CFR part 312, and the associated information
collections, are covered in OMB control number 0910-0014.
The primary purpose of this collection of information is to
determine whether the research studies are being conducted in
accordance with required regulations and that human subject safety is
assured. If these studies were not reviewed, human subjects could be
subjected to inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson or
chairpersons of each individual RDRC, investigators, and participants
in the studies.
In the Federal Register of March 16, 2023 (88 FR 16272), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; FDA form or activity Number of responses per Total annual Average burden per response Total
respondents respondent responses hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 361.1(c)(3) reports and (c)(4) approval; 56 1 56 1.......................................... 56
Form FDA 2914 (Membership Summary).
Sec. 361.1(c)(3) reports; Form FDA 2915 37 10 370 3.......................................... 1,110
(Study Summary).
Sec. 361.1(d)(8); adverse events............. 10 1 10 0.5 (30 mins).............................. 5
--------------------------------------------------------------------------------------------------------
Total...................................... ............... ............... ............... ........................................... 1,171
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; and activity Number of records per Total annual Average burden per recordkeeping Total
recordkeepers recordkeepers records Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 361.1(c)(2); RDRC maintains meeting 56 10.61 594 4.239...................................... 2,518
minutes involving use in human research
subjects.
Sec. 361.1(d)(5); RDRC obtains consent of
human research subjects.
--------------------------------------------------------------------------------------------------------
Total...................................... ............... ............... ............... ........................................... 2,518
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 54326]]
The burden attributed to recordkeeping activities is assumed to be
distributed among the individual elements and averaged among
respondents. In the burden estimate, we assume an average burden per
record of 10 hours for the RDRC respondents to maintain meeting minutes
and 0.75 hours (45 minutes) for a subset of the respondents (37 RDRCs)
to obtain consent of human research subjects.
Section 361.1(f) sets forth labeling requirements for radioactive
drugs. These requirements are not in the burden estimate because they
are information supplied by the Federal Government to the recipient for
the purposes of disclosure to the public (5 CFR 1320.3(c)(2)).
Our estimated burden for the information collection reflects an
overall decrease of 703 hours and a corresponding decrease of 158
responses. We attribute this adjustment to a decrease in the average
burden per response, from 3.5 hours to 3 hours per response, associated
with the public reporting burden for Form FDA 2915. The decrease is
based on our program experience and matches the burden hours reflected
on the form. In addition, this adjustment is also attributable to the
Agency receiving fewer submissions over the last few years.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17154 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P