82 FR 54351 - Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 221 (November 17, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 221 (November 17, 2017)
| Page Range | 54351-54353 | |
| FR Document | 2017-24924 |
[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)] [Notices] [Pages 54351-54353] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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, [email protected]. 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
![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54351
draft guidance in lieu of specific RegulatoryInformation/Guidances/ • Federal eRulemaking Portal:
examples because the Agency does not default.htm or https:// https://www.regulations.gov. Follow the
yet possess a wide body of experience www.regulations.gov. instructions for submitting comments.
regarding the evaluation of devices used Dated: November 13, 2017. Comments submitted electronically,
with RMATs, given the recent Anna K. Abram,
including attachments, to https://
establishment of the RMAT designation www.regulations.gov will be posted to
Deputy Commissioner for Policy, Planning,
program in the Cures Act. the docket unchanged. Because your
Legislation, and Analysis.
As we gain more experience with comment will be made public, you are
such devices, we intend to incorporate [FR Doc. 2017–24836 Filed 11–16–17; 8:45 am]
solely responsible for ensuring that your
such information into the final BILLING CODE 4164–01–P
comment does not include any
guidance. To that end, although you are confidential information that you or a
welcome to comment on any aspect of third party may not wish to be posted,
the guidance, we encourage commenters DEPARTMENT OF HEALTH AND such as medical information, your or
to support their comments with HUMAN SERVICES anyone else’s Social Security number, or
information related to specific marketed Food and Drug Administration confidential business information, such
devices or types of devices that are used as a manufacturing process. Please note
in the recovery, isolation, and delivery [Docket No. FDA–2014–N–0987] that if you include your name, contact
of RMATs. information, or other information that
Elsewhere in this issue of the Federal Agency Information Collection identifies you in the body of your
Register, FDA is announcing the Activities; Proposed Collection; comments, that information will be
availability of a document entitled Comment Request; Generic Clearance posted on https://www.regulations.gov.
‘‘Expedited Programs for Regenerative for the Collection of Qualitative Data • If you want to submit a comment
Medicine Therapies for Serious on Tobacco Products and with confidential information that you
Conditions; Draft Guidance for Communications do not wish to be made available to the
Industry.’’ Among other things, that AGENCY: Food and Drug Administration, public, submit the comment as a
document provides information about HHS. written/paper submission and in the
the RMAT designation program. manner detailed (see ‘‘Written/Paper
This draft guidance is being issued ACTION: Notice.
Submissions’’ and ‘‘Instructions’’).
consistent with FDA’s good guidance SUMMARY: The Food and Drug
practices regulation (21 CFR 10.115). Written/Paper Submissions
Administration (FDA or Agency) is
The draft guidance, when finalized, will announcing an opportunity for public Submit written/paper submissions as
represent the current thinking of FDA comment on the proposed collection of follows:
on Evaluation of Devices Used with • Mail/Hand delivery/Courier (for
certain information by the Agency.
Regenerative Medicine Advanced written/paper submissions): Dockets
Under the Paperwork Reduction Act of
Therapies. It does not establish any Management Staff (HFA–305), Food and
1995 (PRA), Federal Agencies are
rights for any person and is not binding Drug Administration, 5630 Fishers
required to publish notice in the
on FDA or the public. You can use an Lane, Rm. 1061, Rockville, MD 20852.
Federal Register concerning each • For written/paper comments
alternative approach if it satisfies the proposed collection of information,
requirements of the applicable statutes submitted to the Dockets Management
including each proposed extension of an Staff, FDA will post your comment, as
and regulations. This guidance is not existing collection of information, and
subject to Executive Order 12866. well as any attachments, except for
to allow 60 days for public comment in information submitted, marked and
II. Paperwork Reduction Act of 1995 response to the notice. This notice identified, as confidential, if submitted
solicits comments on the Generic as detailed in ‘‘Instructions.’’
This draft guidance refers to
Clearance for the Collection of Instructions: All submissions received
previously approved collections of
Qualitative Data on Tobacco Products must include the Docket No. FDA–
information found in FDA regulations.
and Communications. 2014–N–0987 for ‘‘Generic Clearance for
These collections of information are
subject to review by the Office of DATES: Submit either electronic or the Collection of Qualitative Data on
Management and Budget (OMB) under written comments on the collection of Tobacco Products and
the Paperwork Reduction Act of 1995 information by January 16, 2018. Communications.’’ Received comments,
(44 U.S.C. 3501–3520). The collections ADDRESSES: You may submit comments those filed in a timely manner (see
of information in 21 CFR part 807 have as follows. Please note that late, ADDRESSES), will be placed in the docket
been approved under OMB control untimely filed comments will not be and, except for those submitted as
number 0910–0120; the collections of considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly
information in 21 CFR part 812 have be submitted on or before January 16, viewable at https://www.regulations.gov
been approved under OMB control 2018. The https://www.regulations.gov or at the Dockets Management Staff
number 0910–0078; the collections of electronic filing system will accept between 9 a.m. and 4 p.m., Monday
information in 21 CFR part 814 have comments until midnight Eastern Time through Friday.
been approved under OMB control at the end of January 16, 2018. • Confidential Submissions—To
number 0910–0231; and the collections Comments received by mail/hand submit a comment with confidential
of information in 21 CFR part 1271 have delivery/courier (for written/paper information that you do not wish to be
made publicly available, submit your
sradovich on DSK3GMQ082PROD with NOTICES
been approved under OMB control submissions) will be considered timely
number 0910–0543. if they are postmarked or the delivery comments only as a written/paper
service acceptance receipt is on or submission. You should submit two
III. Electronic Access before that date. copies total. One copy will include the
Persons with access to the internet information you claim to be confidential
may obtain the draft guidance at either Electronic Submissions with a heading or cover note that states
https://www.fda.gov/BiologicsBlood Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Vaccines/GuidanceCompliance following way: CONFIDENTIAL INFORMATION.’’ The
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![Federal Register / Vol. 82, No. 221 / Friday, November 17, 2017 / Notices 54353
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Type of interview responses per Total hours
respondents responses per response
respondent
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 Submit either electronic or written confidential information that you or a
included in each new pretest may vary, comments on these public workshops third party may not wish to be posted,
depending on the nature of the material by March 15, 2018, for Workshop I, and such as medical information, your or
or message being tested and the target by May 10, 2018, for Workshop II. See anyone else’s Social Security number, or
audience. Table 1 provides examples of the SUPPLEMENTARY INFORMATION section confidential business information, such
the types of studies that may be for registration dates and information. as a manufacturing process. Please note
administered and estimated burden ADDRESSES: The public workshops will that if you include your name, contact
levels during the 3-year period. Time to be held at FDA’s White Oak Campus, information, or other information that
read, view, or listen to the message 10903 New Hampshire Ave., Bldg. 31 identifies you in the body of your
being tested is built into the ‘‘Hours per Conference Center, Rm. 1503 B–C comments, that information will be
Response’’ figures. (sections B and C of the ‘‘Great Room’’), posted on https://www.regulations.gov.
The burden for this collection has Silver Spring, MD 20993–0002. • If you want to submit a comment
decreased by 18,437 hours from 29,059 Entrance for public workshop with confidential information that you
to 10,622. FDA attributes this decrease participants (non-FDA employees) is do not wish to be made available to the
to assessing the planned studies for the through Building 1 where routine public, submit the comment as a
next 3 years. security-check procedures will be written/paper submission and in the
performed. For parking and security manner detailed (see ‘‘Written/Paper
Dated: November 9, 2017.
information, please refer to https:// Submissions’’ and ‘‘Instructions’’).
Anna K. Abram,
Deputy Commissioner for Policy, Planning, www.fda.gov/AboutFDA/ Written/Paper Submissions
Legislation, and Analysis. WorkingatFDA/BuildingsandFacilities/ Submit written/paper submissions as
[FR Doc. 2017–24924 Filed 11–16–17; 8:45 am] WhiteOakCampusInformation/ follows:
BILLING CODE 4164–01–P
ucm241740.htm. • Mail/Hand delivery/Courier (for
You may submit comments as written/paper submissions): Dockets
follows. Please note that late, untimely Management Staff (HFA–305), Food and
DEPARTMENT OF HEALTH AND filed comments may not be considered. Drug Administration, 5630 Fishers
HUMAN SERVICES For timely consideration, we request Lane, Rm. 1061, Rockville, MD 20852.
that electronic comments on workshop • For written/paper comments
Food and Drug Administration topics be submitted before or within 90 submitted to the Dockets Management
days after each workshop (i.e., Staff, FDA will post your comment, as
[Docket No. FDA–2017–N–0001]
comments should be submitted by or well as any attachments, except for
Medical Gas Regulation; Public before March 15, 2018, for Workshop I, information submitted, marked and
Workshops; Request for Comments and May 10, 2018, for Workshop II). identified, as confidential, if submitted
FDA will have one shared docket for all as detailed in ‘‘Instructions.’’
AGENCY: Food and Drug Administration, workshops. The https:// Instructions: All submissions received
HHS. www.regulations.gov electronic filing must include the Docket No. FDA–
ACTION: Notice of public workshops; system will accept comments until 2017–N–0001 for ‘‘Medical Gas
request for comments. midnight Eastern Time at the end of Regulation.’’ Received comments, those
May 10, 2018. Comments received by filed in a timely manner (see
SUMMARY: The Food and Drug mail/hand delivery/courier (for written/ ADDRESSES), will be placed in the docket
Administration (FDA, the Agency, or paper submissions) will be considered and, except for those submitted as
we) is announcing two public timely if they are postmarked or the ‘‘Confidential Submissions,’’ publicly
workshops entitled ‘‘Medical Gas delivery service acceptance receipt is on viewable at https://www.regulations.gov
Regulation: Workshop I’’ and ‘‘Medical or before the relevant date. or at the Dockets Management Staff
Gas Regulation: Workshop II.’’ The topic between 9 a.m. and 4 p.m., Monday
to be discussed is potential areas of Electronic Submissions
through Friday.
Federal drug regulation that should be Submit electronic comments in the • Confidential Submissions—To
revised with respect to medical gases. following way: submit a comment with confidential
DATES: The first public workshop will • Federal eRulemaking Portal: information that you do not wish to be
be held on December 15, 2017, from 9 https://www.regulations.gov. Follow the made publicly available, submit your
a.m. to 5 p.m. The second public instructions for submitting comments.
sradovich on DSK3GMQ082PROD with NOTICES
comments only as a written/paper
workshop will be held on February 9, Comments submitted electronically, submission. You should submit two
2018, from 9 a.m. to 5 p.m. However, including attachments, to https:// copies total. One copy will include the
depending on the level of public www.regulations.gov will be posted to information you claim to be confidential
participation, the workshops may end the docket unchanged. Because your with a heading or cover note that states
early. FDA may announce additional comment will be made public, you are ‘‘THIS DOCUMENT CONTAINS
public workshop dates in the future, if solely responsible for ensuring that your CONFIDENTIAL INFORMATION.’’ The
needed. comment does not include any Agency will review this copy, including
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Document Created: 2017-11-17 05:14:49
Document Modified: 2017-11-17 05:14:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by January 16, 2018. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 82 FR 54351 |
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