Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications, 51533-51534 [2024-13388]
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Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
(3) Best Practices in the Approval
Process
(4) Target Animal Safety Technical
Section Overview
(5) Effectiveness Technical Section
Overview
(6) Chemistry, Manufacturing, and
Controls Technical Section Overview
(7) Human Food Safety Technical
Section Overview
(8) Environmental Impact Technical
Section Overview
(9) Minor Technical Sections Overview
The conference will also contain Q&A
sessions during which FDA will address
specific questions from the in-person
and virtual audience as time allows.
Future educational conferences will
take a more in-depth approach to these
and other topics based on questions and
comments received during this
conference, as well as questions and
comments submitted to the docket.
lotter on DSK11XQN23PROD with NOTICES1
III. Participating in the Educational
Conference
Registration: This educational
conference is open to the public and
will be available virtually and inperson. When registering, please
provide complete contact information
for each attendee, including name, title,
affiliation (if any), address, email, and
telephone number. Also, please selfidentify as a member of one of the
stakeholder categories: regulated
industry, scientific or academic experts,
veterinary professionals, consumer
advocacy groups, press/media relations,
FDA, other government/congress, or
other.
Early registration is recommended for
persons who wish to attend the
conference. Registrants will receive
confirmation when their registration has
been received and they will be provided
the webcast link. Persons interested in
attending this conference virtually may
register until the start time of the
conference. Persons interested in
attending this conference in person are
encouraged to register online at https://
fda.zoomgov.com/webinar/register/WN_
cSFEyfDpQK6RuGrwPznG9A no later
than July 10, 2024. Onsite registration
will be provided on the day of the
conference on a first-come, first-served
basis, until the room capacity is
reached. Onsite registration will open at
the conference site at 8 a.m. on July 17,
2024. If room capacity is reached,
individuals will be offered the
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17:57 Jun 17, 2024
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opportunity to observe the conference
from an overflow room located at the
conference site.
If you need special accommodations
due to a disability, please contact Walter
Ellenberg (see FOR FURTHER INFORMATION
CONTACT) no later than July 10, 2024.
Transcript: Transcripts of the
educational conference will be available
on FDA’s website at https://
www.fda.gov/industry/animal-druguser-fee-act-adufa/adufa-meetings
approximately 30 days after the
conference. Please be advised that as
soon as a transcript of the educational
conference is available, it will be
accessible at https://
www.regulations.gov, and may also be
viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript
will also be available at https://
www.fda.gov/industry/animal-druguser-fee-act-adufa/adufa-meetings.
Recording of Conference: Please be
advised that as soon as a recording of
this conference is available, it will be
accessible at https://www.fda.gov/
industry/animal-drug-user-fee-actadufa/adufa-meetings.
Dated: June 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13303 Filed 6–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5656]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Enforcement
Notifications
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
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
51533
collection of information by July 18,
2024.
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 0910–0275. 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, 10A–12M, 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:
State Enforcement Notifications—21
CFR 100.2(d)
OMB Control Number 0910–0275—
Extension
This information collection supports
Agency regulations. Specifically, section
310(b) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
337(b)) authorizes a State to enforce
certain sections of the FD&C Act in their
own name and within their own
jurisdiction. However, before doing so,
a State must provide notice to FDA
according to § 100.2 (21 CFR 100.2). The
information required in a letter of
notification under § 100.2(d) enables us
to identify the food against which a
State intends to take action and to
advise that State whether Federal
enforcement action against the food has
been taken or is in process. With certain
narrow exceptions, Federal enforcement
action precludes State action under the
FD&C Act.
In the Federal Register of January 23,
2024 (89 FR 4315), we published a 60day notice soliciting comment on the
proposed collection of information. No
comments were received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\18JNN1.SGM
18JNN1
51534
Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.2(d); notification ............................................................
1
1
1
10
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. The
estimated reporting burden for
§ 100.2(d) is minimal because
enforcement notifications are seldom
used by States. During the last 3 years,
we have not received any new
enforcement notifications; therefore, we
estimate that one or fewer notifications
will be submitted annually. Although
we have not received any new
enforcement notifications in the last 3
years, these information collection
provisions should be extended to
provide for the potential future need of
a State government to submit
enforcement notifications informing us
when it intends to take enforcement
action under the FD&C Act against a
particular food located in the State.
Dated: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13388 Filed 6–17–24; 8:45 am]
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0987]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative Data
on Tobacco Products and
Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, us, 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 July 18,
2024.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:57 Jun 17, 2024
Jkt 262001
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 0910–0796. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
ADDRESSES:
OMB Control Number 0910–0796—
Extension
This information collection supports
FDA’s programs. Under section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA is authorized to
conduct educational and public
information programs.
In conducting studies relating to the
regulation and communications related
to tobacco products, FDA will need to
employ formative qualitative research
including but not limited to focus
groups, usability and/or psychometric
testing, in-depth interviews (IDIs),
cognitive interviews and asynchronous
qualitative discussions (e.g., online
journaling or web-based discussion
boards), naturalistic observation and
ethnographic studies to assess
knowledge and perceptions about
tobacco-related topics with specific
target audiences. The information
collected will serve four major
purposes. First, foundational research
will provide critical knowledge and
insights about intended audiences. FDA
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
must first understand people’s
knowledge of, perceptions of, and
reactions to tobacco related topics prior
to developing survey/research questions
as well as stimuli for experimental
studies. Second, formative research will
provide information about people’s
responses, thoughts, and feelings
regarding potential creative messaging,
or stimuli. Third, by collecting
communications usability information,
FDA will be able to serve and respond
to the ever-changing demands of
consumers of tobacco products.
Additionally, we will be able to
determine the best way to communicate
with intended audiences around
tobacco prevention and cessation.
Fourth, cognitive testing will allow FDA
to assess consumer understanding of
survey/research questions and study
stimuli. Focus groups and/or IDIs with
a sample of the intended audience will
allow FDA to refine the survey/research
questions and study stimuli while they
are still in the developmental stage.
FDA will collect, and interpret
information gathered through this
generic clearance to: (1) better
understand characteristics of the
intended audience—its perceptions,
knowledge, attitudes, beliefs, and
behaviors—and use these in the
development of appropriate survey/
research questions, study stimuli, or
communications; (2) more efficiently
and effectively design survey/research
questions and study stimuli; and (3)
more efficiently and effectively design
experimental studies.
FDA is requesting approval of an
extension of this generic clearance for
collecting information using qualitative
methods (e.g., interviews, focus groups,
asynchronous discussion boards, etc.)
for studies involving all tobacco
products regulated by FDA. This
information will be used to explore
concepts of interest and assist in the
development of quantitative study
proposals, complementing other
important research efforts in the
Agency. This information may also be
used to help identify and develop
communication messages, which may
be used in education campaigns.
Qualitative research plays an important
role in gathering information because it
allows for an in-depth understanding of
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51533-51534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5656]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications
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 July 18, 2024.
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 0910-0275. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
State Enforcement Notifications--21 CFR 100.2(d)
OMB Control Number 0910-0275--Extension
This information collection supports Agency regulations.
Specifically, section 310(b) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 337(b)) authorizes a State to enforce certain
sections of the FD&C Act in their own name and within their own
jurisdiction. However, before doing so, a State must provide notice to
FDA according to Sec. 100.2 (21 CFR 100.2). The information required
in a letter of notification under Sec. 100.2(d) enables us to identify
the food against which a State intends to take action and to advise
that State whether Federal enforcement action against the food has been
taken or is in process. With certain narrow exceptions, Federal
enforcement action precludes State action under the FD&C Act.
In the Federal Register of January 23, 2024 (89 FR 4315), we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 51534]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
100.2(d); notification............................................. 1 1 1 10 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. The estimated reporting burden for Sec. 100.2(d) is minimal
because enforcement notifications are seldom used by States. During the
last 3 years, we have not received any new enforcement notifications;
therefore, we estimate that one or fewer notifications will be
submitted annually. Although we have not received any new enforcement
notifications in the last 3 years, these information collection
provisions should be extended to provide for the potential future need
of a State government to submit enforcement notifications informing us
when it intends to take enforcement action under the FD&C Act against a
particular food located in the State.
Dated: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13388 Filed 6-17-24; 8:45 am]
BILLING CODE 4164-01-P
