Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications, 50544-50545 [2021-19480]
Download as PDF
50544
Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3037]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for Quantitative Testing for the
Development of Food and Drug
Administration Communications
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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 collection of
information entitled ‘‘Generic Clearance
for Quantitative Testing for the
Development of FDA Communications,’’
which collects individual generic
quantitative information (e.g., surveys,
experimental studies) to test
communications or educational
messages on FDA-regulated food and
cosmetic products, dietary supplements,
and animal food and feed while they are
being developed or are in review.
DATES: Submit either electronic or
written comments on the collection of
information by November 8, 2021.
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 November 8,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 8, 2021.
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.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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,
VerDate Sep<11>2014
19:38 Sep 08, 2021
Jkt 253001
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–
2018–N–3037 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Generic
Clearance for Quantitative Testing for
the Development of FDA
Communications.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential 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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
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.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
E:\FR\FM\09SEN1.SGM
09SEN1
50545
Federal Register / Vol. 86, No. 172 / Thursday, September 9, 2021 / Notices
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 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.
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.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN BY ANTICIPATED DATA COLLECTION METHODS 1
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
lotter on DSK11XQN23PROD with NOTICES1
Number of
disclosures
per
respondent
Number of
respondents
Survey type
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
Dated: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
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
VerDate Sep<11>2014
19:38 Sep 08, 2021
Jkt 253001
vary, depending on the nature of the
compliance efforts and the target
audience.
[FR Doc. 2021–19480 Filed 9–8–21; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
public policies or important private sector
decisions.’’
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50544-50545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19480]
[[Page 50544]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3037]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for Quantitative Testing for the
Development of Food and Drug Administration Communications
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 collection of information entitled
``Generic Clearance for Quantitative Testing for the Development of FDA
Communications,'' which collects individual generic quantitative
information (e.g., surveys, experimental studies) to test
communications or educational messages on FDA-regulated food and
cosmetic products, dietary supplements, and animal food and feed while
they are being developed or are in review.
DATES: Submit either electronic or written comments on the collection
of information by November 8, 2021.
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 November 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 8, 2021. 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.
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 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-2018-N-3037 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Generic Clearance for
Quantitative Testing for the Development of FDA Communications.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential 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-2015-09-18/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.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether
[[Page 50545]]
the proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
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.
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.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden by Anticipated Data Collection Methods \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden
Survey type respondents per disclosures per response Total hours
respondent
----------------------------------------------------------------------------------------------------------------
Cognitive Interviews Screener. 720 1 720 0.083 (5 60
minutes).
Cognitive Interviews.......... 144 1 144 1............... 144
Pre-test Study Screener....... 2,400 1 2,400 0.083 (5 199
minutes).
Pre-test Study................ 480 1 480 0.25 (15 120
minutes).
Self-administered Surveys/ 75,000 1 75,000 0.083 (5 6,225
Experimental Studies Screener. minutes).
Self-administered Surveys/ 15,000 1 15,000 0.25 (15 3,750
Experimental Studies. minutes).
---------------------------------------------------------------------------------
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: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19480 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P