83 FR 22690 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 83, Issue 95 (May 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 95 (May 16, 2018)
| Page Range | 22690-22691 | |
| FR Document | 2018-10457 |
[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)] [Notices] [Pages 22690-22691] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10457] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0987] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). DATES: Fax written comments on the collection of information by June 15, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0796. Also include the FDA docket number found in brackets in the heading of this document. 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Generic Clearance for 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 in-depth 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 understand people's knowledge and perceptions about tobacco-related topics before 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 at FDA. 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 in- depth understanding of individual attitudes, beliefs, motivations, and feelings. Focus group research serves the narrowly defined need for direct and informal public opinion on a specific topic. In the Federal Register of November 17, 2017 (82 FR 54351), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment by a private citizen that was PRA-related. (Comment) The commenter stated that FDA should use the data we have collected in the past instead of collecting new information. The comment does not go in detail or provide any alternatives. (Response) This collection is a valuable tool for conducting research. The studies FDA has conducted through this collection of information have been essential in helping FDA meet its mission as a science-based regulatory agency and implementing the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31). Future submissions submitted under this generic clearance will continue to assist FDA in its mission to protect and promote public health. FDA estimates the burden of this collection of information as follows: [[Page 22691]] Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of interview Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- In-Person Individual IDIs.................... 1,092 1 1,092 1........................................ 1,092 IDI Screener................................. 1,800 1 1,800 .083 (5 minutes)......................... 149 Focus Group Interviews....................... 4,701 1 4,701 1.5...................................... 7,052 Focus Group Screener......................... 3,996 1 3,996 .25 (15 minutes)......................... 999 Usability Testing............................ 2,322 1 2,322 .5 (30 minutes).......................... 1,161 Usability Testing Screener................... 2,028 1 2,028 .083 (5 minutes)......................... 168 ---------------------------------------------------------------------------------------------------------- Total.................................... .............. .............. .............. ......................................... 10,621 -------------------------------------------------------------------------------------------------------------------------------------------------------- \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 a 3-year period. Time to read, view, or listen to the message being tested is built into the ``Hours per Response'' figures. FDA has updated the estimated burden that was published in the 60- day notice. The estimated burden for this collection has increased by 4,437 hours from 6,184 to 10,621. FDA attributes this increase to adding usability testing, and increasing the overall number of studies planned the next 3 years. Dated: May 10, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10457 Filed 5-15-18; 8:45 am] BILLING CODE 4164-01-P
![22690 Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
or Joanne Lipkin at least 7 days in in brackets in the heading of this characteristics of the target audience—
advance of the meeting. document. its perceptions, knowledge, attitudes,
FDA is committed to the orderly FOR FURTHER INFORMATION CONTACT: beliefs, and behaviors—and use these in
conduct of its advisory committee Amber Sanford, Office of Operations, the development of appropriate survey/
meetings. Please visit our website at Food and Drug Administration, Three research questions, study stimuli, or
https://www.fda.gov/Advisory White Flint North, 10A–12M, 11601 communications; (2) more efficiently
Committees/AboutAdvisoryCommittees/ Landsdown St., North Bethesda, MD and effectively design survey/research
ucm111462.htm for procedures on 20852, 301–796–8867, PRAStaff@ questions and study stimuli; and (3)
public conduct during advisory fda.hhs.gov. more efficiently and effectively design
committee meetings. experimental studies.
SUPPLEMENTARY INFORMATION: In
Notice of this meeting is given under FDA is requesting approval of this
the Federal Advisory Committee Act (5 compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed new generic clearance for collecting
U.S.C. app. 2). information through the use of
collection of information to OMB for
Dated: May 10, 2018. review and clearance. qualitative methods (i.e., individual
Leslie Kux, interviews, small group discussions,
Generic Clearance for the Collection of and focus groups) for studies involving
Associate Commissioner for Policy.
Qualitative Data on Tobacco Products all tobacco products regulated by FDA.
[FR Doc. 2018–10414 Filed 5–15–18; 8:45 am]
and Communications This information will be used as a first
BILLING CODE 4164–01–P
OMB Control Number 0910–0796— step to explore concepts of interest and
Extension assist in the development of quantitative
DEPARTMENT OF HEALTH AND study proposals, complementing other
Under section 1003(d)(2)(D) of the important research efforts at FDA. This
HUMAN SERVICES Federal Food, Drug, and Cosmetic Act information may also be used to help
(21 U.S.C. 393(d)(2)(D)), FDA is identify and develop communication
Food and Drug Administration authorized to conduct educational and messages, which may be used in
public information programs. education campaigns. Focus groups play
[Docket No. FDA–2014–N–0987] In conducting studies relating to the an important role in gathering
regulation and communications related
Agency Information Collection information because they allow for an
to tobacco products, FDA will need to
Activities; Submission for Office of in-depth understanding of individual
employ formative qualitative research
Management and Budget Review; attitudes, beliefs, motivations, and
including focus groups, usability
Comment Request; Generic Clearance feelings. Focus group research serves
testing, and/or in-depth interviews
for the Collection of Qualitative Data the narrowly defined need for direct and
(IDIs) to assess knowledge and
on Tobacco Products and informal public opinion on a specific
perceptions about tobacco-related topics
Communications topic. In the Federal Register of
with specific target audiences. The
November 17, 2017 (82 FR 54351), FDA
AGENCY: Food and Drug Administration, information collected will serve three
published a 60-day notice requesting
HHS. major purposes. First, formative
research will provide critical knowledge public comment on the proposed
ACTION: Notice. collection of information. FDA received
about target audiences. FDA must
understand people’s knowledge and one comment by a private citizen that
SUMMARY: The Food and Drug
perceptions about tobacco-related topics was PRA-related.
Administration (FDA) is announcing
that a proposed collection of before developing survey/research (Comment) The commenter stated that
information has been submitted to the questions as well as stimuli for FDA should use the data we have
Office of Management and Budget experimental studies. Second, by collected in the past instead of
(OMB) for review and clearance under collecting communications usability collecting new information. The
the Paperwork Reduction Act of 1995 information, FDA will be able to serve comment does not go in detail or
(PRA). and respond to the ever-changing provide any alternatives.
demands of consumers of tobacco (Response) This collection is a
DATES: Fax written comments on the products. Additionally, we will be able valuable tool for conducting research.
collection of information by June 15, to determine the best way to present The studies FDA has conducted through
2018. messages. Third, initial testing will this collection of information have been
ADDRESSES: To ensure that comments on allow FDA to assess consumer essential in helping FDA meet its
the information collection are received, understanding of survey/research mission as a science-based regulatory
OMB recommends that written questions and study stimuli. Focus agency and implementing the Family
comments be faxed to the Office of groups and/or IDIs with a sample of the Smoking Prevention and Tobacco
Information and Regulatory Affairs, target audience will allow FDA to refine Control Act (Pub. L. 111–31). Future
OMB, Attn: FDA Desk Officer, Fax: 202– the survey/research questions and study submissions submitted under this
395–7285, or emailed to oira_ stimuli while they are still in the generic clearance will continue to assist
submission@omb.eop.gov. All developmental stage. FDA will collect, FDA in its mission to protect and
comments should be identified with the analyze, and interpret information promote public health.
OMB control number 0910–0796. Also gathered through this generic clearance FDA estimates the burden of this
sradovich on DSK3GMQ082PROD with NOTICES
include the FDA docket number found in order to: (1) Better understand collection of information as follows:
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![Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices 22691
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
Type of interview responses per annual burden per Total hours
respondents respondent responses response
In-Person Individual IDIs ........................................... 1,092 1 1,092 1 ............................... 1,092
IDI Screener ............................................................... 1,800 1 1,800 .083 (5 minutes) ...... 149
Focus Group Interviews ............................................. 4,701 1 4,701 1.5 ............................ 7,052
Focus Group Screener .............................................. 3,996 1 3,996 .25 (15 minutes) ...... 999
Usability Testing ........................................................ 2,322 1 2,322 .5 (30 minutes) ........ 1,161
Usability Testing Screener ......................................... 2,028 1 2,028 .083 (5 minutes) ...... 168
Total .................................................................... ........................ ........................ ........................ .................................. 10,621
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be comments or requesting information, subrecipient’s types and number of
included in each new pretest may vary, please include the document identifier services provided, estimated costs of
depending on the nature of the material 0990—New—30D and project title for services, service coordination between
or message being tested and the target reference. grantees or subrecipients and other
audience. Table 1 provides examples of services providers, and type and
SUPPLEMENTARY INFORMATION: Interested
the types of studies that may be strength of relationships between
persons are invited to send comments
administered and estimated burden grantees and subrecipients. This
regarding this burden estimate or any
levels during a 3-year period. Time to information will enable HHS to
other aspect of this collection of
read, view, or listen to the message understand the structure of the grantee/
information, including any of the
being tested is built into the ‘‘Hours per subrecipient network and inform
following subjects: (1) The necessity and
Response’’ figures. recommendations for more efficient
utility of the proposed information
FDA has updated the estimated network management and distribution
collection for the proper performance of of support.
burden that was published in the 60-day
the agency’s functions; (2) the accuracy TVAP, as authorized by the
notice. The estimated burden for this
of the estimated burden; (3) ways to Trafficking Victims Protection Act of
collection has increased by 4,437 hours
enhance the quality, utility, and clarity 2000, provides comprehensive case
from 6,184 to 10,621. FDA attributes
of the information to be collected; and management services to foreign-born
this increase to adding usability testing,
(4) the use of automated collection victims of human trafficking residing in
and increasing the overall number of
techniques or other forms of information the United States. Since its inception,
studies planned the next 3 years.
technology to minimize the information TVAP funding and infrastructure have
Dated: May 10, 2018. collection burden. remained relatively unchanged: Services
Leslie Kux, Title of the Collection: Trafficking are paid on a per capita basis, and funds
Associate Commissioner for Policy. Victim Assistance Program Social are managed through three primary
[FR Doc. 2018–10457 Filed 5–15–18; 8:45 am] Network Analysis—Network Survey. grantees that enter into cooperative
BILLING CODE 4164–01–P Type of Collection: New. agreements with service providers
OMB No. 0990–NEW—Office of the (subrecipients). Given the changing
Assistant Secretary for Planning and landscape and the greater understanding
DEPARTMENT OF HEALTH AND Evaluation—Administration for of the nature and extent of trafficking,
HUMAN SERVICES Children and Families’ Trafficking HHS is undertaking a program
[Document Identifier: OS–0990—New]
Victim Assistance Program. assessment to understand whether any
Abstract efficiencies can be gained in the
Agency Information Collection program administration and structure.
Request. 30-Day Public Comment The Office of the Assistant Secretary To supplement an earlier fiscal year
Request for Planning and Evaluation (ASPE), in 2018 assessment to solicit qualitative
partnership with the Administration for feedback from a range of program
AGENCY: Office of the Secretary, HHS. Children and Families (ACF), U.S. stakeholders, the information collected
ACTION: Notice. Department of Health and Human for this program survey aims to help
Services (HHS) is requesting Office of HHS determine if efficiencies can be
SUMMARY: In compliance with the Management and Budget (OMB) gained through improved coordination
requirement of the Paperwork approval for a new information among TVAP grantees, TVAP
Reduction Act of 1995, the Office of the collection request titled, ‘‘Trafficking subrecipients, and other service
Secretary (OS), Department of Health Victim Assistance Program (TVAP) providers.
and Human Services, is publishing the Social Network Analysis—Network Data will be collected through an
following summary of a proposed Survey.’’ Under the guidance of ASPE electronic survey of fiscal year 2016
collection for public comment. and ACF, a contractor is carrying out TVAP grantees and subrecipients. Key
DATES: Comments on the ICR must be this assessment. The data collected and staff at grantee sites and subrecipient
sradovich on DSK3GMQ082PROD with NOTICES
received on or before June 15, 2018. analyzed under this submission will organizations will complete a self-
ADDRESSES: Submit your comments to help HHS better understand the type administered online survey that will
OIRA_submission@omb.eop.gov or via and extent of the relationship between include questions about each
facsimile to (202) 395–5806. the TVAP grantees, TVAP subrecipients, respondent’s services provided,
FOR FURTHER INFORMATION CONTACT: and other service providers operating in estimated costs of services, service
Sherrette Funn, Sherrette.Funn@hhs.gov TVAP subrecipient areas. It will also coordination between grantees or
or (202) 795–7714. When submitting help illuminate each grantee’s and subrecipients, and type and strength of
VerDate Sep<11>2014 17:34 May 15, 2018 Jkt 244001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1](https://thefederalregister.org/doc/83_FR_22785/page/2.svg)
Document Created: 2018-11-02 09:13:27
Document Modified: 2018-11-02 09:13:27
| 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 | Fax written comments on the collection of information by June 15, 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 | 83 FR 22690 |
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