82 FR 49834 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 207 (October 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 207 (October 27, 2017)
| Page Range | 49834-49836 | |
| FR Document | 2017-23450 |
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)] [Notices] [Pages 49834-49836] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23450] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3710] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's Education at the Point of Sale Campaign 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. DATES: Fax written comments on the collection of information by November 27, 2017. 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--NEW and title ``Evaluation of FDA's Education at the Point of Sale Campaign.'' 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. Evaluation of FDA's Education at the Point of Sale Campaign OMB Control Number 0910--NEW The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing a tobacco education intervention at the point of sale to reduce the public health burden of tobacco use. The campaign features advertisements intended to encourage future quit attempts among current smokers in stores that sell tobacco products. In support of the provisions of the Tobacco Control Act that require FDA to protect the public health, FDA requests OMB approval to collect information to evaluate the effectiveness of the point of sale tobacco education campaign. Data from this outcome evaluation study will be used to examine statistical associations between exposure to the campaign and specific outcomes of interest, which include awareness of the campaign and its messaging, tobacco-related attitudes, beliefs and risk perceptions, and motivation to quit smoking. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. Comprehensive evaluation of FDA's public education campaigns will be used to document whether the intended audience is aware of and understands campaign messages, and whether campaign exposure influences tobacco-related attitudes, beliefs and risk perceptions, intentions to use tobacco, and motivation to quit smoking. Participation in the outcome evaluation study will be voluntary. All of the information collected is integral to that evaluation. Evaluation of the Point of Sale Campaign. This outcome evaluation study will consist of four longitudinal data collection periods over 24 months (approximately every 7 months), with the first survey (Wave 1) occurring approximately 3 months after campaign launch. A fourth wave of data collection has been added to the three proposed in the 60-day notice because the campaign has been extended from 18 to 24 months. The additional wave of data collection is necessary to continue to assess the impact of the campaign. To reduce the number of participants needed to detect the effects of the campaign on outcomes of interest, the design of the campaign was changed from two treatment groups and one control group to one treatment group and one control group. The respondent numbers and burden hours below have been revised to reflect the four data collection waves and the change in the number of treatment groups. Information will be collected from adult cigarette smokers, ages 25 to 54, about awareness of and exposure to campaign advertisements, tobacco use, and knowledge, attitudes, and beliefs related to tobacco use. Information will be collected on demographic variables including age, sex, race/ethnicity, and primary language. Participants will also be offered the option to download a smartphone application that will track their exposure to the campaign, and that will ask them to respond to a brief survey about every 6 months over 18 months. FDA's media contractor identified 37 potential counties for the campaign. From this list, FDA's evaluation contractor has selected 30 counties to be included in the evaluation. Of these, 15 counties will receive the intervention (treatment counties), and 15 counties will not receive it (control counties). The number of counties has changed since the 60-day notice because we changed the experimental design to have one treatment group instead of two, which resulted in needing fewer counties. Data will be collected from a longitudinal cohort that will consist of an entirely new sample of adult cigarette smokers. Addresses will be randomly selected from postal carrier routes in the 30 selected U.S. counties to identify households that contain one or more adult smokers between the ages of 25 and 54. Pre-paid pre-addressed paper screening surveys will be mailed to approximately 104,541 households. We estimate that 27,651 (9,217 annualized respondents) households will return the 10-minute screener they received by mail, and 26,258 (8,753 [[Page 49835]] annualized respondents) households will complete a 10-minute in-person field screener conducted by trained field interviewers. Field interviewers will attempt to conduct field screeners for all households that return the mail screener and appear to have one or more eligible participants in the household, and a subsample of the households that do not return the screener. At 10 minutes per screening, the potential burden hours for the mail screener are 4,701 hours (1,567 annualized). At 10 minutes per screening, the potential burden hours for the field screener are 4,464 hours (1,488). The process for locating and screening participants has been updated since the 60-day notice to better reflect the study design. Accounting for nonresponse, we estimate that the mail and field screenings will result in 4,282 (1,427 annualized) adults who meet criteria for participation and complete the full Wave 1 questionnaire. The Wave 1 questionnaire will be completed during an in-person visit to the home, immediately after the field screening is completed, assuming the selected participant is available to complete the questionnaire at that time. If the participant is not available at that time, the interviewer will schedule a time to return to the household and complete the evaluation questionnaire in person. We estimate that the Wave 1 questionnaire will take 40 minutes to complete, resulting in 2,869 (956 annualized) burden hours. Adjusting for loss to follow-up between waves, we anticipate that 3,426 (1,142 annualized) participants will complete the Wave 2 questionnaire, which will take 40 minutes and result in 2,295 (765 annualized) burden hours, that 2,912 (971 annualized) participants will complete the Wave 3 questionnaire, which will take 40 minutes and result in 1,951 (650 annualized) burden hours, and that 2,475 (825 annualized) participants will complete the Wave 4 questionnaire, which will take 40 minutes and result in 1,658 (553 annualized) burden hours. The Waves 2, 3, and 4 questionnaires will be completed online or in person by trained interviewers, depending on participant preference. The total burden hours for Waves 2 to 4 evaluation questionnaires will be 5,904 (1,968 annualized). We anticipate that approximately 54 percent of the participants (2,308 people (769 annualized)) who complete the Wave 1 questionnaire will download a smartphone application that will deliver brief app- based questionnaires to them in between the four waves of evaluation data collection. These participants will complete three questionnaires lasting 5 minutes each (every 6 months over the course of 18 months), resulting in 554 (185 annualized) burden hours. The app will also use geolocation technology to record participants' visits to convenience stores as a measure of passive campaign exposure. In addition, over the course of the study, telephone verification questionnaires will be conducted with a small portion of participants. The purpose of these questionnaires is to ensure that information obtained by field interviewers is correct, to evaluate the performance of field interviewers, to avoid fraud, and to ensure that all relevant incentives were delivered. Trained staff will administer a 5-minute verification questionnaire to a random sample of 10 percent of participants who completed the in-person screening but not the Wave 1 questionnaire (2,198 individuals (733 annualized)), and a random sample of 10 percent of participants who completed the Waves 1 to 4 questionnaires (1,308 individuals (436 annualized)). At 5 minutes per verification questionnaire, this results in 177 burden hours (59 annualized) for the field screener telephone verifications and 105 burden hours (35 annualized) for the four evaluation questionnaire telephone verifications. Some telephone verification questionnaires may be administered in person if it is not possible to reach the individual by phone. This verification process has been added to the information collection request since the 60-day notice to prevent fraudulent data entry by interviewers. In addition to the telephone verification survey, we will also audio record (with participants' consent) interviews with a random sample of approximately 10 percent of respondents to the Wave 1 questionnaire and a random 10 percent of the Waves 2, 3, and 4 respondents who complete the questionnaire in person as an additional quality control measure. These recordings will be used to measure interviewer compliance with study procedures and will be destroyed after they are reviewed. This procedure does not affect participant burden. The total burden hours for the mail and field screeners, four outcome evaluation questionnaires, three app-based questionnaires, and four telephone verification questionnaires is 18,773 (6,258 annualized). In the Federal Register of November 15, 2016 (81 FR 80075), FDA published a 60-day notice requesting public comment on the proposed collection of information. Two comments were received; however, only one was PRA-related. Comment: One comment stated that requiring or compelling retailers to display ``anti-smoking or anti-tobacco advocacy'' is prohibited under the First Amendment. If the campaign is deemed unconstitutional, then there is no need for the information collection. Response: The comment misunderstands how FDA intends to carry out this public education campaign. FDA intends to purchase advertising space from retailers on a voluntary basis and will not require that retailers participate in the campaign. Therefore, the comment raises an issue that is outside the scope of this proposed information collection. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of responses Total Type of respondent Activity respondents per annual Average burden per response Total hours respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Households (adults 18 and up)......... Mail screener............ 9,217 1 9,217 0.17 (10 minutes)................ 1,567 Field screener........... 8,753 1 8,753 0.17 (10 minutes)................ 1,488 Telephone verification, 733 1 733 0.08 (5 minutes)................. 59 field screener. Adult smokers, ages 25 to 54.......... Wave 1 questionnaire..... 1,427 1 1,427 0.67 (40 minutes)................ 956 Wave 2-4 questionnaires.. 2,938 1 2,938 0.67 (40 minutes)................ 1,968 Telephone verification, 436 1 436 0.08 (5 minutes)................. 35 questionnaires 1-4. Study participants (opt in)........... App-based questionnaire.. 769 3 2,308 0.08 (5 minutes)................. 185 -------------------------------------------------------------------------------------- Total............................. ......................... ........... ........... ........... ................................. 6,258 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 49836]] Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23450 Filed 10-26-17; 8:45 am] BILLING CODE 4164-01-P
![49834 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
As reflected in table 1, we estimate White Flint North, 10A–12M, 11601 Evaluation of the Point of Sale
two manufacturers will submit two Landsdown St., North Bethesda, MD Campaign. This outcome evaluation
requests annually for tier-one DR, and 20852, 301–796–8867, PRAStaff@ study will consist of four longitudinal
that there will be one appeal of these fda.hhs.gov. data collection periods over 24 months
requests to the DR panel (tier-two DR). SUPPLEMENTARY INFORMATION: In (approximately every 7 months), with
We estimate also that it will take compliance with 44 U.S.C. 3507, FDA the first survey (Wave 1) occurring
manufacturers approximately 30 hours has submitted the following proposed approximately 3 months after campaign
to prepare and submit each request for collection of information to OMB for launch. A fourth wave of data collection
a tier-one DR, and approximately 8 has been added to the three proposed in
review and clearance.
hours to prepare and submit each the 60-day notice because the campaign
request for a tier-two DR. Based on our Evaluation of FDA’s Education at the has been extended from 18 to 24
experience with this collection we have Point of Sale Campaign OMB Control months. The additional wave of data
not changed our estimate since our last Number 0910—NEW collection is necessary to continue to
request for OMB approval. The 2009 Family Smoking Prevention assess the impact of the campaign. To
Dated: October 24, 2017. and Tobacco Control Act (Tobacco reduce the number of participants
Control Act) (Pub. L. 111–31) amends needed to detect the effects of the
Anna K. Abram,
the Federal Food, Drug, and Cosmetic campaign on outcomes of interest, the
Deputy Commissioner for Policy, Planning, design of the campaign was changed
Legislation, and Analysis. Act (the FD&C Act) to grant FDA
authority to regulate the manufacture, from two treatment groups and one
[FR Doc. 2017–23444 Filed 10–26–17; 8:45 am]
marketing, and distribution of tobacco control group to one treatment group
BILLING CODE 4164–01–P and one control group. The respondent
products to protect public health and to
numbers and burden hours below have
reduce tobacco use by minors. Section
been revised to reflect the four data
DEPARTMENT OF HEALTH AND 1003(d)(2)(D) of the FD&C Act (21
collection waves and the change in the
HUMAN SERVICES U.S.C. 393(d)(2)(D)) supports the
number of treatment groups.
development and implementation of Information will be collected from
Food and Drug Administration FDA public education campaigns adult cigarette smokers, ages 25 to 54,
[Docket No. FDA–2016–N–3710] related to tobacco use. Accordingly, about awareness of and exposure to
FDA is currently developing and campaign advertisements, tobacco use,
Agency Information Collection implementing a tobacco education and knowledge, attitudes, and beliefs
Activities; Submission for Office of intervention at the point of sale to related to tobacco use. Information will
Management and Budget Review; reduce the public health burden of be collected on demographic variables
Comment Request; Evaluation of the tobacco use. The campaign features including age, sex, race/ethnicity, and
Food and Drug Administration’s advertisements intended to encourage primary language. Participants will also
Education at the Point of Sale future quit attempts among current be offered the option to download a
Campaign smokers in stores that sell tobacco smartphone application that will track
products. their exposure to the campaign, and that
AGENCY: Food and Drug Administration, In support of the provisions of the
HHS. will ask them to respond to a brief
Tobacco Control Act that require FDA to survey about every 6 months over 18
ACTION: Notice. protect the public health, FDA requests months.
SUMMARY: The Food and Drug OMB approval to collect information to FDA’s media contractor identified 37
Administration (FDA) is announcing evaluate the effectiveness of the point of potential counties for the campaign.
that a proposed collection of sale tobacco education campaign. Data From this list, FDA’s evaluation
information has been submitted to the from this outcome evaluation study will contractor has selected 30 counties to be
Office of Management and Budget be used to examine statistical included in the evaluation. Of these, 15
(OMB) for review and clearance under associations between exposure to the counties will receive the intervention
the Paperwork Reduction Act of 1995. campaign and specific outcomes of (treatment counties), and 15 counties
interest, which include awareness of the will not receive it (control counties).
DATES: Fax written comments on the
campaign and its messaging, tobacco- The number of counties has changed
collection of information by November
related attitudes, beliefs and risk since the 60-day notice because we
27, 2017.
perceptions, and motivation to quit changed the experimental design to
ADDRESSES: To ensure that comments on smoking. have one treatment group instead of
the information collection are received, Evaluation is an essential two, which resulted in needing fewer
OMB recommends that written organizational practice in public health counties.
comments be faxed to the Office of and a systematic way to account for and Data will be collected from a
Information and Regulatory Affairs, improve public health actions. longitudinal cohort that will consist of
OMB, Attn: FDA Desk Officer, Fax: 202– Comprehensive evaluation of FDA’s an entirely new sample of adult
395–7285, or emailed to oira_ public education campaigns will be cigarette smokers. Addresses will be
submission@omb.eop.gov. All used to document whether the intended randomly selected from postal carrier
comments should be identified with the audience is aware of and understands routes in the 30 selected U.S. counties
OMB control number 0910—NEW and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
campaign messages, and whether to identify households that contain one
title ‘‘Evaluation of FDA’s Education at campaign exposure influences tobacco- or more adult smokers between the ages
the Point of Sale Campaign.’’ Also, related attitudes, beliefs and risk of 25 and 54. Pre-paid pre-addressed
include the FDA docket number found perceptions, intentions to use tobacco, paper screening surveys will be mailed
in brackets in the heading of this and motivation to quit smoking. to approximately 104,541 households.
document. Participation in the outcome evaluation We estimate that 27,651 (9,217
FOR FURTHER INFORMATION CONTACT: study will be voluntary. All of the annualized respondents) households
Amber Sanford, Office of Operations, information collected is integral to that will return the 10-minute screener they
Food and Drug Administration, Three evaluation. received by mail, and 26,258 (8,753
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![49836 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
Dated: October 24, 2017. Comments submitted electronically, its consideration of comments. The
Anna K. Abram, including attachments, to https:// second copy, which will have the
Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to claimed confidential information
Legislation, and Analysis. the docket unchanged. Because your redacted/blacked out, will be available
[FR Doc. 2017–23450 Filed 10–26–17; 8:45 am] comment will be made public, you are for public viewing and posted on
BILLING CODE 4164–01–P solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND third party may not wish to be posted, contact information to be made publicly
HUMAN SERVICES such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
Food and Drug Administration confidential business information, such in the body of your comments and you
[Docket No. FDA–2017–N–6145] as a manufacturing process. Please note must identify this information as
that if you include your name, contact ‘‘confidential.’’ Any information marked
Agency Information Collection information, or other information that as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; identifies you in the body of your except in accordance with 21 CFR 10.20
Comment Request; Dispute Resolution comments, that information will be and other applicable disclosure law. For
Procedures for Science-Based posted on https://www.regulations.gov. more information about FDA’s posting
Decisions on Products Regulated by • If you want to submit a comment of comments to public dockets, see 80
the Center for Veterinary Medicine with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. written/paper submission and in the 23389.pdf.
ACTION: Notice. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
SUMMARY: The Food and Drug
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing an opportunity for public received, go to https://
Submit written/paper submissions as www.regulations.gov and insert the
comment on the proposed collection of follows: docket number, found in brackets in the
certain information by the Agency. • Mail/Hand delivery/Courier (for heading of this document, into the
Under the Paperwork Reduction Act of written/paper submissions): Dockets
1995 (PRA), Federal Agencies are ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
required to publish notice in the Drug Administration, 5630 Fishers
Federal Register concerning each Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
proposed collection of information, • For written/paper comments
including each proposed extension of an FOR FURTHER INFORMATION CONTACT: Ila
submitted to the Dockets Management
existing collection of information, and Staff, FDA will post your comment, as S. Mizrachi, Office of Operations, Food
to allow 60 days for public comment in well as any attachments, except for and Drug Administration, Three White
response to the notice. This notice information submitted, marked and Flint North, 10A–12M, 11601
solicits comments on the information identified, as confidential, if submitted Landsdown St., North Bethesda, MD
collection provisions of the dispute as detailed in ‘‘Instructions.’’ 20852, 301–796–7726, PRAStaff@
resolution procedures for science-based Instructions: All submissions received fda.hhs.gov.
decisions on products regulated by the must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
Center for Veterinary Medicine (CVM). 2017–N–6145 for ‘‘Dispute Resolution PRA (44 U.S.C. 3501–3520), Federal
DATES: Submit either electronic or Procedures for Science-Based Decisions Agencies must obtain approval from the
written comments on the collection of on Products Regulated by the Center for Office of Management and Budget
information by December 26, 2017. Veterinary Medicine.’’ Received (OMB) for each collection of
ADDRESSES: You may submit comments comments, those filed in a timely information they conduct or sponsor.
as follows. Please note that late, manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
untimely filed comments will not be in the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
considered. Electronic comments must submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
be submitted on or before December 26, Submissions,’’ publicly viewable at or requirements that members of the
2017. The https://www.regulations.gov https://www.regulations.gov or at the public submit reports, keep records, or
electronic filing system will accept Dockets Management Staff between 9 provide information to a third party.
comments until midnight Eastern Time a.m. and 4 p.m., Monday through Section 3506(c)(2)(A) of the PRA (44
at the end of December 26, 2017. Friday. U.S.C. 3506(c)(2)(A)) requires Federal
Comments received by mail/hand • Confidential Submissions—To Agencies to provide a 60-day notice in
delivery/courier (for written/paper submit a comment with confidential the Federal Register concerning each
submissions) will be considered timely information that you do not wish to be proposed collection of information,
if they are postmarked or the delivery made publicly available, submit your including each proposed extension of an
asabaliauskas on DSKBBXCHB2PROD with NOTICES
service acceptance receipt is on or comments only as a written/paper existing collection of information,
before that date. submission. You should submit two before submitting the collection to OMB
copies total. One copy will include the for approval. To comply with this
Electronic Submissions information you claim to be confidential requirement, FDA is publishing notice
Submit electronic comments in the with a heading or cover note that states of the proposed collection of
following way: ‘‘THIS DOCUMENT CONTAINS information set forth in this document.
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The With respect to the following
https://www.regulations.gov. Follow the Agency will review this copy, including collection of information, FDA invites
instructions for submitting comments. the claimed confidential information, in comments on these topics: (1) Whether
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Document Created: 2017-10-27 02:06:04
Document Modified: 2017-10-27 02:06:04
| 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 November 27, 2017. | |
| 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 49834 |
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