Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 54351-54353 [2017-24924]

Download as PDF Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES draft guidance in lieu of specific examples because the Agency does not yet possess a wide body of experience regarding the evaluation of devices used with RMATs, given the recent establishment of the RMAT designation program in the Cures Act. As we gain more experience with such devices, we intend to incorporate such information into the final guidance. To that end, although you are welcome to comment on any aspect of the guidance, we encourage commenters to support their comments with information related to specific marketed devices or types of devices that are used in the recovery, isolation, and delivery of RMATs. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a document entitled ‘‘Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry.’’ Among other things, that document provides information about the RMAT designation program. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Evaluation of Devices Used with Regenerative Medicine Advanced Therapies. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 807 have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910–0231; and the collections of information in 21 CFR part 1271 have been approved under OMB control number 0910–0543. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: November 13, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24836 Filed 11–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0987] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA 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 Qualitative Data on Tobacco Products and Communications. DATES: Submit either electronic or written comments on the collection of information by January 16, 2018. 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 January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 16, 2018. 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: Electronic Submissions Submit electronic comments in the following way: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 54351 • 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– 2014–N–0987 for ‘‘Generic Clearance for the Collection of Qualitative 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. • 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 E:\FR\FM\17NON1.SGM 17NON1 54352 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. 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. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), 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 Qualitative Data on Tobacco Products and Communications OMB Control Number 0910–0796— Extension Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational and public information programs. In conducting studies relating to the regulation and communications related to tobacco products, FDA will need to employ formative qualitative research including focus groups, usability testing, and/or indepth interviews (IDIs) to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve three major purposes. First, formative research will provide critical knowledge about target audiences. FDA must first understand people’s knowledge and perceptions about tobacco related topics prior to developing survey/research questions as well as stimuli for experimental studies. Second, by collecting communications usability information, FDA will be able to serve and respond to the ever-changing demands of consumers of tobacco products. Additionally, we will be able to determine the best way to present messages. Third, initial testing will allow FDA to assess consumer understanding of survey/research questions and study stimuli. Focus groups and/or IDIs with a sample of the target audience will allow FDA to refine the survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, analyze, and interpret information gathered through this generic clearance in order to: (1) Better understand characteristics of the target audience— its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/ research questions, study stimuli, or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies. FDA is requesting approval of this new generic clearance for collecting information through the use of qualitative methods (i.e., individual interviews, small group discussions, and focus groups) for studies involving all tobacco products regulated by FDA. This information will be used as a first step to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Focus groups play an important role in gathering information because they allow for an indepth understanding of individuals’ attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic. FDA estimates the burden of this collection of information as follows: sradovich on DSK3GMQ082PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 In-Person Individual Indepth Interviews ............. Indepth Interview (IDI) Screener ........................ Focus Group Interviews ..................................... Focus Group Screener ....................................... Usability Testing ................................................. VerDate Sep<11>2014 18:32 Nov 16, 2017 Number of responses per respondent Number of respondents Type of interview Jkt 244001 PO 00000 1,092 1,800 4,701 3,996 2,322 Frm 00037 Fmt 4703 Total annual responses 1 1 1 1 1 Sfmt 4703 1,092 1,800 4,701 3,996 2,322 E:\FR\FM\17NON1.SGM Average burden per response 1 .................................. 0.083 (5 minutes) ........ 1.5 ............................... 0.25 (15 minutes) ........ 0.50 (30 minutes) ........ 17NON1 Total hours 1,092 150 7,052 999 1,161 Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54353 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of responses per respondent Number of respondents Type of interview Total annual responses Average burden per response Total hours Usability Testing Screener ................................. 2,028 1 2,028 0.083 (5 minutes) ........ 168 Total ............................................................ .......................... .......................... ........................ ..................................... 10,622 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of respondents to be included in each new pretest may vary, depending on the nature of the material or message being tested and the target audience. Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the ‘‘Hours per Response’’ figures. The burden for this collection has decreased by 18,437 hours from 29,059 to 10,622. FDA attributes this decrease to assessing the planned studies for the next 3 years. Dated: November 9, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–24924 Filed 11–16–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] Medical Gas Regulation; Public Workshops; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshops; request for comments. ACTION: The Food and Drug Administration (FDA, the Agency, or we) is announcing two public workshops entitled ‘‘Medical Gas Regulation: Workshop I’’ and ‘‘Medical Gas Regulation: Workshop II.’’ The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases. DATES: The first public workshop will be held on December 15, 2017, from 9 a.m. to 5 p.m. The second public workshop will be held on February 9, 2018, from 9 a.m. to 5 p.m. However, depending on the level of public participation, the workshops may end early. FDA may announce additional public workshop dates in the future, if needed. sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:32 Nov 16, 2017 Jkt 244001 Submit either electronic or written comments on these public workshops by March 15, 2018, for Workshop I, and by May 10, 2018, for Workshop II. See the SUPPLEMENTARY INFORMATION section for registration dates and information. ADDRESSES: The public workshops will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 B–C (sections B and C of the ‘‘Great Room’’), Silver Spring, MD 20993–0002. Entrance for public workshop participants (non-FDA employees) is through Building 1 where routine security-check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments may not be considered. For timely consideration, we request that electronic comments on workshop topics be submitted before or within 90 days after each workshop (i.e., comments should be submitted by or before March 15, 2018, for Workshop I, and May 10, 2018, for Workshop II). FDA will have one shared docket for all workshops. The https:// www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 10, 2018. 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 the relevant 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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– 2017–N–0001 for ‘‘Medical Gas Regulation.’’ 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. • 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 E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54351-54353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24924]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Qualitative
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
Qualitative Data on Tobacco Products and Communications.

DATES: Submit either electronic or written comments on the collection
of information by January 16, 2018.

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 January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 16, 2018. 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-2014-N-0987 for ``Generic Clearance for the Collection of
Qualitative 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.
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

[[Page 54352]]

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.gpo.gov/fdsys/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.

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.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 Qualitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0796--Extension
Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational
and public information programs.
In conducting studies relating to the regulation and communications
related to tobacco products, FDA will need to employ formative
qualitative research including focus groups, usability testing, and/or
indepth interviews (IDIs) to assess knowledge and perceptions about
tobacco-related topics with specific target audiences. The information
collected will serve three major purposes. First, formative research
will provide critical knowledge about target audiences. FDA must first
understand people's knowledge and perceptions about tobacco related
topics prior to developing survey/research questions as well as stimuli
for experimental studies. Second, by collecting communications
usability information, FDA will be able to serve and respond to the
ever-changing demands of consumers of tobacco products. Additionally,
we will be able to determine the best way to present messages. Third,
initial testing will allow FDA to assess consumer understanding of
survey/research questions and study stimuli. Focus groups and/or IDIs
with a sample of the target audience will allow FDA to refine the
survey/research questions and study stimuli while they are still in the
developmental stage. FDA will collect, analyze, and interpret
information gathered through this generic clearance in order to: (1)
Better understand characteristics of the target audience--its
perceptions, knowledge, attitudes, beliefs, and behaviors--and use
these in the development of appropriate survey/research questions,
study stimuli, or communications; (2) more efficiently and effectively
design survey/research questions and study stimuli; and (3) more
efficiently and effectively design experimental studies.
FDA is requesting approval of this new generic clearance for
collecting information through the use of qualitative methods (i.e.,
individual interviews, small group discussions, and focus groups) for
studies involving all tobacco products regulated by FDA. This
information will be used as a first step to explore concepts of
interest and assist in the development of quantitative study proposals,
complementing other important research efforts in the Agency. This
information may also be used to help identify and develop communication
messages, which may be used in education campaigns. Focus groups play
an important role in gathering information because they allow for an
indepth understanding of individuals' attitudes, beliefs, motivations,
and feelings. Focus group research serves the narrowly defined need for
direct and informal public opinion on a specific topic.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of interview Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
In-Person Individual Indepth 1,092 1 1,092 1.............. 1,092
Interviews.
Indepth Interview (IDI) 1,800 1 1,800 0.083 (5 150
Screener. minutes).
Focus Group Interviews....... 4,701 1 4,701 1.5............ 7,052
Focus Group Screener......... 3,996 1 3,996 0.25 (15 999
minutes).
Usability Testing............ 2,322 1 2,322 0.50 (30 1,161
minutes).

[[Page 54353]]

Usability Testing Screener... 2,028 1 2,028 0.083 (5 168
minutes).
----------------------------------------------------------------------------------
Total.................... ............... ............... .............. ............... 10,622
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

The number of respondents to be included in each new pretest may
vary, depending on the nature of the material or message being tested
and the target audience. Table 1 provides examples of the types of
studies that may be administered and estimated burden levels during the
3-year period. Time to read, view, or listen to the message being
tested is built into the ``Hours per Response'' figures.
The burden for this collection has decreased by 18,437 hours from
29,059 to 10,622. FDA attributes this decrease to assessing the planned
studies for the next 3 years.

Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24924 Filed 11-16-17; 8:45 am]
BILLING CODE 4164-01-P

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