Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications, 12952-12954 [2021-04606]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
12952
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
‘‘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:
Bryan Spells, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1117, Silver Spring,
MD 20993–0002, 240–402–6511, email:
cderdatastandards@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA’s
CDER is issuing this Federal Register
notice to announce the date that support
will begin for version 1.1 of the CDISC
SENDIG–DART and version 1.6 of the
CDISC SDTM and the dates when such
new standard and version update will
be required in certain submissions. The
FDA guidance for industry ‘‘Providing
Regulatory Submissions in Electronic
Format—Standardized Study Data’’
(October 2020) (eStudy Data guidance),
posted on FDA’s Study Data Standards
Resources web page at https://
www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm, implements the electronic
submission requirements of section
745A(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379k–1(a)) for
study data contained in NDAs, ANDAs,
certain BLAs, and certain INDs
submitted to CDER or the Center for
Biologics Evaluation and Research by
specifying the format for electronic
submissions. The eStudy Data guidance
states that a Federal Register notice will
specify any new standards and version
updates to FDA-supported study data
standards that will be added to the
Catalog, when the support for such
standards and version updates begins or
ends, and when the requirement to use
such standards and version updates in
submissions begins or ends.
Support for version 1.1 of the CDISC
SENDIG–DART and version 1.6 of the
CDISC SDTM will begin on March 15,
2021, the transition date. The
requirement for electronic submissions
VerDate Sep<11>2014
20:30 Mar 04, 2021
Jkt 253001
to be submitted using version 1.1 of the
CDISC SENDIG–DART will begin March
15, 2023, for NDAs, ANDAs and certain
BLAs, and March 15, 2024, for certain
INDs. The requirement for electronic
submissions to be submitted using
version 1.6 of the CDISC SDTM will
begin on March 15, 2022.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04609 Filed 3–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0180]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Clearance
for the Collection of Quantitative Data
on Tobacco Products and
Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 generic
clearance for the collection of
quantitative data on tobacco products
and communications.
DATES: Submit either electronic or
written comments on the collection of
information by May 4, 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 May 4, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 4, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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–0180 for ‘‘Generic Clearance for
the Collection of Quantitative Data on
Tobacco Products and
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
E:\FR\FM\05MRN1.SGM
05MRN1
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
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-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: 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.
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
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:30 Mar 04, 2021
Jkt 253001
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
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 the Collection of
Quantitative Data on Tobacco Products
and Communications
OMB Control Number 0910–0810—
Extension
To conduct educational and public
information programs relating to
tobacco use as authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA’s Center for Tobacco
Products will conduct research and use
a variety of media to inform and educate
the public, tobacco retailers, and health
professionals about the health risks of
tobacco use, how to quit using tobacco
products, and FDA’s role in regulating
tobacco.
To ensure that these educational and
public information programs have the
highest potential to be received,
understood, and accepted by those for
whom they are intended, the Center for
Tobacco Products will conduct research
and develop health messages relating to
the control and prevention of disease. In
conducting such research, FDA will use
quantitative methods (i.e., surveys,
experimental studies) for studies about
tobacco products. These studies may be
used to collect information related to
the formative pretesting of tobacco
communication messages and other
materials directed at consumers. This
type of research involves: (1) Assessing
audience knowledge, attitudes,
behaviors, and other characteristics for
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
12953
the purpose of determining the need for
and developing health messages,
communication strategies, and public
information programs; (2) pretesting
these health messages, strategies, and
program components while they are in
developmental form to assess audience
comprehension, reactions, and
perceptions; and (3) adding to the
regulatory science knowledge base.
Quantitative studies play an important
role in exploring areas of research and
gathering information because they can
be used to summarize a population of
interest on key variables or reveal
systematic relationships between
variables.
Formative pretesting is a staple of best
practices in communications research.
Obtaining voluntary feedback from
intended audiences during the
development of messages and materials
is crucial for the success of every
communication program. The purpose
of obtaining information from formative
pretesting is that it allows FDA to
improve materials and strategies while
revisions are still affordable and
possible. Formative pretesting can also
avoid potentially expensive and
dangerous unintended outcomes caused
by audiences interpreting messages in a
way that was not intended by the
drafters. By maximizing the
effectiveness of messages and strategies
for reaching targeted audiences, the
frequency with which tobacco
communication messages need to be
modified should be greatly reduced.
The voluntary information collected
will serve the primary purpose of
providing FDA information about the
perceived effectiveness of messages,
advertisements, and materials in
reaching and successfully
communicating with their intended
audiences. Quantitative testing
messages and other materials with a
sample of the target audience will allow
FDA to refine messages, advertisements,
and materials, including questionnaires
or images, directed at consumers while
the materials are still in the
developmental stage.
In addition, quantitative information
is needed by FDA to track changes in
response to policy and regulatory
actions and to expand the tobacco
regulatory science base by providing
information on behavior, knowledge,
and attitudes about tobacco products,
including postmarketing surveillance of
tobacco products.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05MRN1.SGM
05MRN1
12954
Federal Register / Vol. 86, No. 42 / Friday, March 5, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total annual
responses
Average burden
per response
Total hours
Screener ..............................................................
Self-Administered Surveys ..................................
485,580
133,728
1
1
485,580
133,728
0.083 (5 minutes) ...........
0.33 (20 minutes) ...........
40,465
44,576
Total .............................................................
........................
........................
........................
........................................
85,041
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Number of respondents to be included
in each new survey will vary,
depending on the nature of the material
or message being tested and the target
audience. Table 1 provides examples of
the types of activities that may be
administered and estimated burden
levels during the 3-year period. Time to
read, review, or complete the activity is
built into the ‘‘Average Burden per
Response’’ figures. Our estimated
burden for the information collection
reflects an overall increase of 60,000
hours and a corresponding increase of
461,808 responses. We attribute the
adjustment to an increase in the number
of new quantitative studies that are
anticipated underneath this information
collection during the next 3 years
(proposed extension).
Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04606 Filed 3–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–1189]
Canned Tuna Deviating From the
Standard of Identity; Amendment of
Temporary Marketing Permit
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
amending StarKist Seafood Company’s
temporary permit to market test canned
tuna. The temporary permit is amended
to add three additional manufacturing
locations and to increase the amount of
test product. This amendment will
allow the applicant to continue to test
market the test product and collect data
on consumer acceptance of the test
product.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number
of responses
per
respondent
Number
of
respondents
Activity
VerDate Sep<11>2014
20:30 Mar 04, 2021
Jkt 253001
FOR FURTHER INFORMATION CONTACT:
Marjan Morravej, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2371.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 20, 2014 (79 FR
35362), we issued a notice announcing
that we had issued a temporary permit
to StarKist Seafood Company, 225 North
Shore Dr., Pittsburgh, PA 15212, to
market test products identified as
canned tuna products. The permit
allowed for the test product to be
manufactured at Galapesca S.A., Km.
12.5 Via A Duale, Guayaquil, Ecuador,
and StarKist Samoa Co., 368 Atu’u Rd.,
Pago Pago, American Samoa 96799. We
issued the permit to facilitate market
testing of products that deviate from the
requirements of the standard of identity
for canned tuna in 21 CFR 161.190,
which was issued under section 401 of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 341).
In the Federal Register of March 7,
2016 (81 FR 11813), we issued a notice
announcing that we were extending the
temporary market permit issued to
StarKist Seafood Company. The
extension allows the applicants to
continue to measure consumer
acceptance of the products and assess
the commercial feasibility of the
products, in support of a petition to
amend the standard of identity for
canned tuna. The new expiration date of
the permit will be either the effective
date of a final rule amending the
standard of identity for canned tuna that
may result from the petition or 30 days
after denial of the petition.
Under our regulations at 21 CFR
130.17(f), we are amending the
temporary permit issued to StarKist
Seafood Company, to allow the test
product to be manufactured at three
additional plants: Tropical Canning
(Thailand) Public Co., LTD., 1⁄1 M.2
T.Thungyai, Hatyai, Songkhla 90110,
Thailand; ISA Value Co., Ltd., 44/4
Moo1, Petchkasem Road, Yaicha,
Sampran, Nakornpathom 73110,
Thailand; and Tri-Marine (Solomon
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
Islands), Soltuna Ltd., 1 Tuna Dr., Noro,
Western Province, Solomon Islands. We
are also amending the temporary permit
to increase the amount of test product
to be market tested to 213,500,000
pounds (96,841,971 kilograms) in retail
cans of various sizes. All other
conditions and terms of this permit
remain the same.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04607 Filed 3–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the COVID–19 Health Equity
Task Force
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice of meeting.
As required by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services (HHS) is hereby giving notice
that the COVID–19 Health Equity Task
Force (Task Force) will hold a virtual
meeting on March 26, 2021. The
purpose of this meeting is to discuss
equitable vaccine access and
acceptance. This meeting is open to the
public and will be live-streamed at
www.hhs.gov/live. Information about the
meeting will be posted on the HHS
Office of Minority Health website:
www.minorityhealth.hhs.gov/
healthequitytaskforce/ prior to the
meeting.
SUMMARY:
The Task Force meeting will be
held on Friday, March 26, 2021, from
approximately 12 p.m. to 3 p.m. ET
(times are tentative and subject to
change). The confirmed time and
agenda will be posted on the COVID–19
Health Equity Task Force website:
www.minorityhealth.hhs.gov/
DATES:
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 86, Number 42 (Friday, March 5, 2021)]
[Notices]
[Pages 12952-12954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04606]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0180]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Quantitative
Data on Tobacco Products and Communications
AGENCY: Food and Drug Administration, 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 generic clearance for the collection of
quantitative data on tobacco products and communications.
DATES: Submit either electronic or written comments on the collection
of information by May 4, 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 May 4, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 4, 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-0180 for ``Generic Clearance for the Collection of
Quantitative Data on Tobacco Products and 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
[[Page 12953]]
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: 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: 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 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 the Collection of Quantitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0810--Extension
To conduct educational and public information programs relating to
tobacco use as authorized by section 1003(d)(2)(D) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's Center for
Tobacco Products will conduct research and use a variety of media to
inform and educate the public, tobacco retailers, and health
professionals about the health risks of tobacco use, how to quit using
tobacco products, and FDA's role in regulating tobacco.
To ensure that these educational and public information programs
have the highest potential to be received, understood, and accepted by
those for whom they are intended, the Center for Tobacco Products will
conduct research and develop health messages relating to the control
and prevention of disease. In conducting such research, FDA will use
quantitative methods (i.e., surveys, experimental studies) for studies
about tobacco products. These studies may be used to collect
information related to the formative pretesting of tobacco
communication messages and other materials directed at consumers. This
type of research involves: (1) Assessing audience knowledge, attitudes,
behaviors, and other characteristics for the purpose of determining the
need for and developing health messages, communication strategies, and
public information programs; (2) pretesting these health messages,
strategies, and program components while they are in developmental form
to assess audience comprehension, reactions, and perceptions; and (3)
adding to the regulatory science knowledge base. Quantitative studies
play an important role in exploring areas of research and gathering
information because they can be used to summarize a population of
interest on key variables or reveal systematic relationships between
variables.
Formative pretesting is a staple of best practices in
communications research. Obtaining voluntary feedback from intended
audiences during the development of messages and materials is crucial
for the success of every communication program. The purpose of
obtaining information from formative pretesting is that it allows FDA
to improve materials and strategies while revisions are still
affordable and possible. Formative pretesting can also avoid
potentially expensive and dangerous unintended outcomes caused by
audiences interpreting messages in a way that was not intended by the
drafters. By maximizing the effectiveness of messages and strategies
for reaching targeted audiences, the frequency with which tobacco
communication messages need to be modified should be greatly reduced.
The voluntary information collected will serve the primary purpose
of providing FDA information about the perceived effectiveness of
messages, advertisements, and materials in reaching and successfully
communicating with their intended audiences. Quantitative testing
messages and other materials with a sample of the target audience will
allow FDA to refine messages, advertisements, and materials, including
questionnaires or images, directed at consumers while the materials are
still in the developmental stage.
In addition, quantitative information is needed by FDA to track
changes in response to policy and regulatory actions and to expand the
tobacco regulatory science base by providing information on behavior,
knowledge, and attitudes about tobacco products, including
postmarketing surveillance of tobacco products.
FDA estimates the burden of this collection of information as
follows:
[[Page 12954]]
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener.................................. 485,580 1 485,580 0.083 (5 minutes)........................... 40,465
Self-Administered Surveys................. 133,728 1 133,728 0.33 (20 minutes)........................... 44,576
-------------------------------------------------------------------------------------------------------------
Total................................. .............. .............. .............. ............................................ 85,041
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Number of respondents to be included in each new survey will vary,
depending on the nature of the material or message being tested and the
target audience. Table 1 provides examples of the types of activities
that may be administered and estimated burden levels during the 3-year
period. Time to read, review, or complete the activity is built into
the ``Average Burden per Response'' figures. Our estimated burden for
the information collection reflects an overall increase of 60,000 hours
and a corresponding increase of 461,808 responses. We attribute the
adjustment to an increase in the number of new quantitative studies
that are anticipated underneath this information collection during the
next 3 years (proposed extension).
Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04606 Filed 3-4-21; 8:45 am]
BILLING CODE 4164-01-P
