Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications, 4625-4626 [2022-01730]
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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
estimates that one establishment will
initially submit one report annually at 2
hours per report, for a total of 2 hours.
Submissions under section 904(c) of
the FD&C Act are for any new product
that is not yet on the market (e.g., if on
the market due to deeming compliance
period), deemed product manufacturers
should have submitted under section
904(a)(1) of the FD&C Act. This includes
any statutorily regulated product that
would receive a marketing authorization
and any new deemed product not
subject to the deeming compliance
period. For deemed product categories,
while we anticipate receiving a large
number of premarket applications, there
is a portion of these applicants who will
have reported their ingredients under
section 904(a)(1) of the FD&C Act as
most of these submissions are expected
to be for products subject to the
deeming compliance period.
Based on FDA’s experience and the
number of new products authorized to
be introduced or delivered for
introduction into interstate commerce
submitted over the past 3 years, FDA
estimates that 35 establishments will
each submit 10 reports (1 every 6
months). FDA also estimates that the
confirmation or updating of product
(ingredient) listing information
(required by section 904(c) of the FD&C
Act) is expected to take 0.40 hours (24
minutes) for a total 140 burden hours.
FDA estimates that obtaining a data
universal numbering system (DUNS)
number will take 30 minutes. FDA
assumes that all new establishment
facilities that will be required to
initially register under section 905 of
the FD&C Act would obtain a DUNS
number. FDA estimates that up to 100
establishments that would need to
obtain this number each year. The total
industry burden to obtain a DUNS
number is 50 hours.
FDA estimates the total burden for
this collection to be 764 hours. We have
adjusted our burden estimate, which has
resulted in a decrease of 66 hours to the
currently approved burden. Based on
data we reviewed from the past 3 years,
we note a decrease in the number of
establishments submitting a renewal
registration listing, an increase of the
number of applications received for
deemed products and potential
modifications to those, and by
projecting the number of remaining
establishments that have not registered
and submitted product ingredient
listings, we revised the number of
respondents and burden hours in this
information collection.
VerDate Sep<11>2014
18:03 Jan 27, 2022
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4625
Dated: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Generic Clearance for Quantitative
Testing for the Development of FDA
Communications
[FR Doc. 2022–01798 Filed 1–27–22; 8:45 am]
OMB Control Number 0910–0865—
Extension
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3037]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for Quantitative Testing for the
Development of Food and Drug
Administration Communications
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
(PRA).
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by February
28, 2022.
DATES:
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 0910–0865. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
This notice requests extension of
OMB approval of the FDA information
collection for a generic clearance that
allows FDA to use quantitative social/
behavioral science data collection
techniques (i.e., surveys and
experimental studies) to test consumers’
reactions to FDA communications or
educational messaging about FDAregulated food and cosmetic products,
dietary supplements, and animal food
and feed. To ensure that
communications activities and
educational campaigns have the highest
potential to be received, understood,
and accepted by those for whom they
are intended, it is important to assess
communications while they are under
development. Understanding
consumers’ attitudes, motivations, and
behaviors in response to potential
communications and education
messaging plays an important role in
improving FDA’s communications.
If the following conditions are not
met, FDA will submit an information
collection request to OMB for approval
through the normal PRA process:
• The collections are voluntary;
• The collections are low burden for
participants (based on considerations of
total burden hours, total number of
participants, or burden hours per
participant) and are low cost for both
the participants and the Federal
Government;
• The collections are
noncontroversial;
• Personally identifiable information
(PII) is collected only to the extent
necessary 1 and is not retained;
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions; 2
and
• Information gathered will yield
qualitative findings; the collections will
not be designed or expected to yield
statistical data or used as though the
results are generalizable to the
population of study.
1 For example, collections that collect PII to
provide remuneration for participants of focus
groups and cognitive laboratory studies will be
submitted under this request. All Privacy Act
requirements will be met.
2 As defined in OMB and Agency Information
Quality Guidelines, ‘‘influential’’ means that ‘‘an
agency can reasonably determine that
dissemination of the information will have or does
have a clear and substantial impact on important
public policies or important private sector
decisions.’’
E:\FR\FM\28JAN1.SGM
28JAN1
4626
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
To obtain approval for an individual
generic collection submission 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 survey or experimental design
and stimuli for testing).
FDA will submit individual
quantitative collections under this
generic clearance to OMB. Individual
quantitative collections will also
undergo review by FDA’s Research
Involving Human Subjects Committee,
senior leadership in the Center for Food
Safety and Applied Nutrition, and PRA
specialists.
Respondents to this collection of
information 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.
In the Federal Register of September
9, 2021 (86 FR 50544), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and, therefore, will not be
discussed in this document.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
Number of
respondents
Survey type
Average
burden per
response
Total annual
disclosures
Total
hours
Cognitive Interviews Screener ...................................
Cognitive Interviews ...................................................
Pre-test Study Screener ............................................
Pre-test Study ............................................................
Self-administered Surveys/Experimental Studies
Screener.
Self-administered Surveys/Experimental Studies ......
720
144
2,400
480
75,000
1
1
1
1
1
720
144
2,400
480
75,000
0.083 (5 minutes) ....
1 ...............................
0.083 (5 minutes) ....
0.25 (15 minutes) ....
0.083 (5 minutes) ....
60
144
199
120
6,225
15,000
1
15,000
0.25 (15 minutes) ....
3,750
Total ....................................................................
........................
........................
........................
..................................
10,498
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
total estimated annual burden is 10,498
hours. 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 number of participants to
be included in each new survey will
vary, depending on the nature of the
compliance efforts and the target
audience.
Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01730 Filed 1–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0520]
jspears on DSK121TN23PROD with NOTICES1
Number of
disclosures
per
respondent
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in
Ruminant Feed
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
ACTION:
Electronic Submissions
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the recordkeeping
requirements regarding animal proteins
prohibited in ruminant feed.
DATES: Submit either electronic or
written comments on the collection of
information by March 29, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 29,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 29, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
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
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
E:\FR\FM\28JAN1.SGM
28JAN1
]]>Agencies
[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4625-4626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01730]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3037]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
Quantitative Testing for the Development of Food and Drug
Administration Communications
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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by February 28, 2022.
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 0910-0865. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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 Quantitative Testing for the Development of FDA
Communications
OMB Control Number 0910-0865--Extension
This notice requests extension of OMB approval of the FDA
information collection for a generic clearance that allows FDA to use
quantitative social/behavioral science data collection techniques
(i.e., surveys and experimental studies) to test consumers' reactions
to FDA communications or educational messaging about FDA-regulated food
and cosmetic products, dietary supplements, and animal food and feed.
To ensure that communications activities and educational campaigns have
the highest potential to be received, understood, and accepted by those
for whom they are intended, it is important to assess communications
while they are under development. Understanding consumers' attitudes,
motivations, and behaviors in response to potential communications and
education messaging plays an important role in improving FDA's
communications.
If the following conditions are not met, FDA will submit an
information collection request to OMB for approval through the normal
PRA process:
The collections are voluntary;
The collections are low burden for participants (based on
considerations of total burden hours, total number of participants, or
burden hours per participant) and are low cost for both the
participants and the Federal Government;
The collections are noncontroversial;
Personally identifiable information (PII) is collected
only to the extent necessary \1\ and is not retained;
---------------------------------------------------------------------------
\1\ For example, collections that collect PII to provide
remuneration for participants of focus groups and cognitive
laboratory studies will be submitted under this request. All Privacy
Act requirements will be met.
---------------------------------------------------------------------------
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; \2\ and
---------------------------------------------------------------------------
\2\ As defined in OMB and Agency Information Quality Guidelines,
``influential'' means that ``an agency can reasonably determine that
dissemination of the information will have or does have a clear and
substantial impact on important public policies or important private
sector decisions.''
---------------------------------------------------------------------------
Information gathered will yield qualitative findings; the
collections will not be designed or expected to yield statistical data
or used as though the results are generalizable to the population of
study.
[[Page 4626]]
To obtain approval for an individual generic collection submission
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 survey or experimental design and
stimuli for testing).
FDA will submit individual quantitative collections under this
generic clearance to OMB. Individual quantitative collections will also
undergo review by FDA's Research Involving Human Subjects Committee,
senior leadership in the Center for Food Safety and Applied Nutrition,
and PRA specialists.
Respondents to this collection of information 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.
In the Federal Register of September 9, 2021 (86 FR 50544), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and, therefore, will not be discussed in this document.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden by Anticipated Data Collection Methods \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Survey type Number of disclosures Total annual Average burden per response Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cognitive Interviews Screener................ 720 1 720 0.083 (5 minutes)........................ 60
Cognitive Interviews......................... 144 1 144 1........................................ 144
Pre-test Study Screener...................... 2,400 1 2,400 0.083 (5 minutes)........................ 199
Pre-test Study............................... 480 1 480 0.25 (15 minutes)........................ 120
Self-administered Surveys/Experimental 75,000 1 75,000 0.083 (5 minutes)........................ 6,225
Studies Screener.
Self-administered Surveys/Experimental 15,000 1 15,000 0.25 (15 minutes)........................ 3,750
Studies.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 10,498
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 total estimated annual burden is 10,498 hours. 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 number of participants to be included in each new
survey will vary, depending on the nature of the compliance efforts and
the target audience.
Dated: January 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01730 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
