Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed, 53500-53501 [2023-16924]
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Federal Register / Vol. 88, No. 151 / Tuesday, August 8, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
address questions or concerns that may
arise. Pilot program participants will
also be asked to provide written and
verbal feedback during their training
and after they submit the simulated
registration and listing information.
This feedback will assist OCAC and
OCS in ensuring the electronic
submission portal is usable and
functional to ensure industry will be
able to meet its statutory obligations.
OCAC and OCS estimate that each
individual participant’s involvement
may require about 8 hours over the 2week period. OCAC and OCS are
soliciting applications from members of
the cosmetic product industry who will
be required to register their facilities
and list their products, such as cosmetic
product manufacturers, as well as
entities that may act as authorized
agents for manufacturers. At its
discretion, OCAC and OCS may
withdraw a participant from the pilot
program for not completing the
requested activities within requested
timeframes.
None of the information submitted
during the pilot will fulfill a
participant’s registration and listing
responsibilities pursuant to MoCRA.
Participants will need to submit their
information in the electronic
registration and listing system once it is
available for submissions or through a
paper form to fulfill their registration
and listing responsibilities pursuant to
MoCRA.
Entities that may be eligible to
participate in this voluntary pilot
program for cosmetic product facility
registration and listing are limited to
those firms following the procedures set
out in section III. and that also meet the
two selection criteria that follow:
1. required to submit cosmetic
product facility registration and listing
information to FDA pursuant to MoCRA
by December 29, 2023; and,
2. willing to provide feedback on the
cosmetic product facility registration
and listing electronic submission
process.
III. Applications for Participation
To be considered to participate in the
pilot program, entities should submit a
statement of interest for participation to
eRLC.testing@fda.hhs.gov. The
statement of interest should include the
following information: company and
contact name, contact phone number,
and contact email address, size of the
company (i.e., number of personnel and
the approximate amount of revenue per
year), agreement to the selection criteria
in section II of this document, as well
as the number of cosmetic product(s)
and a description of the cosmetic
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20:00 Aug 07, 2023
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product(s) intended to be submitted in
the pilot program in enough detail to
verify that the cosmetic product(s) are
not drug product(s). A firm can choose
to submit information for a subset of
their products rather than all their
products in the pilot program.
Additionally, although not required
for consideration, FDA is interested in
whether you are a manufacturer or may
act as an authorized agent, and whether
you have previously submitted
registration and listing information to
the Agency for any regulated product.
Once statements of interest for
participation in the pilot are received,
FDA will contact interested applicants
to confirm selection for the pilot
program. FDA will not notify interested
applicants who are not selected for the
pilot program. FDA will select no more
than nine participants, who best meet
the selection criteria and who reflect a
broad spectrum of cosmetic product
manufacturers and processors,
including companies that range in size
and develop a range of products, or are
an authorized agent. In the event a large
number of submissions are received,
FDA may only review a small number
of submissions in order to identify nine
(or fewer) for the pilot program.
Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16772 Filed 8–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1157]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Qualitative Data To Support Social
and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and
Animal Food and Feed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the 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 (PRA).
DATES: Submit written comments
(including recommendations) on the
SUMMARY:
PO 00000
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collection of information by September
7, 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 0910–0891. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
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:
Generic Clearance for Qualitative Data
To Support Social and Behavioral
Research for Food, Dietary
Supplements, Cosmetics, and Animal
Food and Feed
OMB Control Number 0910–0891—
Extension
OMB’s Office of Information and
Regulatory Affairs has issued
memoranda that provides an overview
of administrative flexibilities available
to assist Agencies in complying with
their statutory obligations under the
PRA. Among these flexibilities is use of
a generic clearance for certain
information collection activities. A
generic clearance may be appropriate
when (1) the need for the data collection
can be evaluated in advance, as part of
the review of the proposed plan, but (2)
the Agency cannot determine the details
of the specific individual collections
until a later time. Generic clearances
cover collections that are voluntary,
low-burden, and uncontroversial.
This generic clearance supports
research intended to help the Center for
Food Safety and Applied Nutrition
understand stakeholders’ perceptions,
attitudes, motivations, and behaviors.
To ensure that communications
activities have the highest effect, we
will conduct research and studies
relating to the control and prevention of
disease and the safety and health of the
public. FDA is requesting OMB
approval for the use of this generic
collection of information that allows
E:\FR\FM\08AUN1.SGM
08AUN1
Federal Register / Vol. 88, No. 151 / Tuesday, August 8, 2023 / Notices
FDA to use qualitative social/behavioral
science data collection techniques (i.e.,
individual indepth interviews, small
group discussions, focus groups, and
observations) to better understand
stakeholders’ perceptions, attitudes,
motivations, and behaviors regarding
various issues associated with food and
cosmetic products, dietary supplements,
and animal food and feed.
Understanding these consumers’,
manufacturers’, and producers’
perceptions, attitudes, motivations, and
behaviors plays an important role in
improving FDA’s communications that
impact these various stakeholders and
assists in the development of
quantitative study proposals,
complementing other important
research efforts in the Agency.
To obtain approval for an individual
generic submission collection that meets
the conditions of this generic clearance,
an abbreviated supporting statement
will be submitted to OMB along with
supporting documentation (e.g., a copy
of the interview or moderator guide,
screening questionnaire).
Selection for potential respondents is
done via a screening process to match
the best possible respondent to each
individual generic submission.
Respondents to individual requests
made under the generic clearance, once
approved by OMB, may include a wide
range of consumers and other FDA
53501
stakeholders, such as producers and
manufacturers who are regulated under
FDA-regulated food and cosmetic
products, dietary supplements, and
animal food and feed. Participation is
voluntary.
In the Federal Register of April 10,
2023 (88 FR 21193), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
but was not responsive to the four
collection of information topics
solicited and therefore will not be
discussed.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of interview
Total annual
responses
Average burden
per response
Total hours
Individual Indepth Interview Screening ...........................
Individual Indepth Interviews ..........................................
Focus Group/Small Group Participant Screening ..........
Focus Groups/Small Group Discussion .........................
Observation Screening ...................................................
Observations ...................................................................
4,800
400
10,800
3,600
720
144
1
1
1
1
1
1
4,800
400
10,800
3,600
720
144
0.08 (5 minutes) .................
1 ..........................................
0.08 (5 minutes) .................
1.5 .......................................
0.08 (5 minutes) .................
2 ..........................................
384
400
864
5,400
58
288
Total .........................................................................
....................
....................
20,464
.............................................
7,394
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Current estimates are based on both
historical numbers of participants from
past projects as well as estimates for
projects to be conducted in the next 3
years. The collections we have
conducted under this generic collection
of information have informed and
helped us better understand stakeholder
perceptions, attitudes, motivations, and
behaviors to help us improve our
communications to them.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
SUMMARY:
[FR Doc. 2023–16924 Filed 8–7–23; 8:45 am]
BILLING CODE 4164–01–P
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses
per
respondent
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Food and Drug Administration
[Docket No. FDA–2023–D–2439]
QTc Information in Human Prescription
Drug and Biological Product Labeling;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘QTc
Information in Human Prescription
Drug and Biological Product Labeling.’’
This guidance is intended to assist
applicants with incorporating corrected
QT (QTc) interval prolongation-related
information into the labeling of nonantiarrhythmic human prescription drug
and biological products. The guidance
provides recommendations on how and
where to appropriately include the
clinically relevant information on QTc
interval prolongation in the labeling, in
accordance with regulatory
PO 00000
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requirements for the content and format
of human prescription drug labeling.
DATES: Submit either electronic or
written comments on the draft guidance
by October 10, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• 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
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53500-53501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1157]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Qualitative Data To Support Social and Behavioral Research for Food,
Dietary Supplements, Cosmetics, and Animal Food and Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the 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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by September 7, 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 0910-0891. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Generic Clearance for Qualitative Data To Support Social and Behavioral
Research for Food, Dietary Supplements, Cosmetics, and Animal Food and
Feed
OMB Control Number 0910-0891--Extension
OMB's Office of Information and Regulatory Affairs has issued
memoranda that provides an overview of administrative flexibilities
available to assist Agencies in complying with their statutory
obligations under the PRA. Among these flexibilities is use of a
generic clearance for certain information collection activities. A
generic clearance may be appropriate when (1) the need for the data
collection can be evaluated in advance, as part of the review of the
proposed plan, but (2) the Agency cannot determine the details of the
specific individual collections until a later time. Generic clearances
cover collections that are voluntary, low-burden, and uncontroversial.
This generic clearance supports research intended to help the
Center for Food Safety and Applied Nutrition understand stakeholders'
perceptions, attitudes, motivations, and behaviors. To ensure that
communications activities have the highest effect, we will conduct
research and studies relating to the control and prevention of disease
and the safety and health of the public. FDA is requesting OMB approval
for the use of this generic collection of information that allows
[[Page 53501]]
FDA to use qualitative social/behavioral science data collection
techniques (i.e., individual indepth interviews, small group
discussions, focus groups, and observations) to better understand
stakeholders' perceptions, attitudes, motivations, and behaviors
regarding various issues associated with food and cosmetic products,
dietary supplements, and animal food and feed. Understanding these
consumers', manufacturers', and producers' perceptions, attitudes,
motivations, and behaviors plays an important role in improving FDA's
communications that impact these various stakeholders and assists in
the development of quantitative study proposals, complementing other
important research efforts in the Agency.
To obtain approval for an individual generic submission collection
that meets the conditions of this generic clearance, an abbreviated
supporting statement will be submitted to OMB along with supporting
documentation (e.g., a copy of the interview or moderator guide,
screening questionnaire).
Selection for potential respondents is done via a screening process
to match the best possible respondent to each individual generic
submission. Respondents to individual requests made under the generic
clearance, once approved by OMB, may include a wide range of consumers
and other FDA stakeholders, such as producers and manufacturers who are
regulated under FDA-regulated food and cosmetic products, dietary
supplements, and animal food and feed. Participation is voluntary.
In the Federal Register of April 10, 2023 (88 FR 21193), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received but was not
responsive to the four collection of information topics solicited and
therefore will not be discussed.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average burden per
Type of interview respondents per annual response Total hours
respondent responses
----------------------------------------------------------------------------------------------------------------
Individual Indepth Interview 4,800 1 4,800 0.08 (5 minutes)...... 384
Screening.
Individual Indepth Interviews....... 400 1 400 1..................... 400
Focus Group/Small Group Participant 10,800 1 10,800 0.08 (5 minutes)...... 864
Screening.
Focus Groups/Small Group Discussion. 3,600 1 3,600 1.5................... 5,400
Observation Screening............... 720 1 720 0.08 (5 minutes)...... 58
Observations........................ 144 1 144 2..................... 288
---------------------------------------------------------------------------
Total........................... ........... ........... 20,464 ...................... 7,394
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Current estimates are based on both historical numbers of
participants from past projects as well as estimates for projects to be
conducted in the next 3 years. The collections we have conducted under
this generic collection of information have informed and helped us
better understand stakeholder perceptions, attitudes, motivations, and
behaviors to help us improve our communications to them.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16924 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P
