81 FR 39675 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 117 (June 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 117 (June 17, 2016)
| Page Range | 39675-39677 | |
| FR Document | 2016-14352 |
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)] [Notices] [Pages 39675-39677] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14352] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0717] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns 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 July 18, 2016. 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 0910-0753. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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 General Market Youth Tobacco Prevention Campaigns-- OMB Control Number 0910-0753--Revision 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 youth-targeted public education campaigns to help prevent tobacco use among youth and thereby reduce the public health burden of tobacco. The campaigns feature televised advertisements along with complementary ads on radio, on the Internet, in print, and through other forms of media. 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 beliefs about tobacco, susceptibility to tobacco use, and tobacco use behavior. All of the information collected is integral to that evaluation. FDA is in the process of conducting three studies to evaluate the effectiveness of its youth tobacco prevention campaigns: (1) An outcome evaluation study of its General Market Youth Tobacco Prevention Campaign, (2) an outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, and (3) a media tracking survey. The timing of these studies follows the multiple, discrete waves of media advertising planned for the campaigns. Evaluation of the General Market Youth Tobacco Prevention Campaign The General Market Youth Tobacco Prevention Campaign targets youth who are at-risk for smoking, or who have experimented with but not progressed to regular smoking. The outcome evaluation of the campaign consists of an initial baseline survey of youth aged 11 to 16 before campaigns launch, followed by a number of longitudinal follow-up surveys of the same youth at approximate 8 month intervals. To date, the baseline and three follow-up surveys have been conducted. A baseline survey was also conducted with the parent or legal guardian of each youth, to collect data on household characteristics and media use. Because the cohort aged over the study period, data have been collected from youth aged 11 to 18. Information has been collected about youth awareness of and exposure to campaign advertisements and about youth knowledge, attitudes, and beliefs related to tobacco use. In addition, the surveys have measured tobacco use susceptibility and current use. Information has been collected on demographic variables including age, sex, race/ethnicity, grade level, and primary language. Evaluation of the Rural Male Youth Smokeless Tobacco Campaign Baseline data collection for the Rural Male Youth Smokeless Campaign evaluation will begin in January 2016. The three follow up surveys will begin in August 2016, March 2017, and October 2017. The evaluation of the Rural Male Youth Smokeless Campaign differs from the General Market Campaign evaluation, in that only males in the age range will be considered eligible. Media Tracking Survey The media tracking survey consists of assessments of youth aged 13 to 18 conducted periodically during the campaign period. The tracking survey assesses awareness of the campaign and [[Page 39676]] receptivity to campaign messages. These data provide critical evaluation feedback to the campaigns and are conducted with sufficient frequency to match the cyclical patterns of media advertising and variation in exposure to allow for mid-campaign refinements. All information is being collected through in-person and web-based questionnaires. Youth respondents were recruited from two sources: (1) A probability sample drawn from 90 U.S. media markets gathered using an address-based postal mail sampling of U.S. households for the outcome evaluations, and (2) an Internet panel for the media tracking survey. Participation in the studies is voluntary. The studies are being conducted in support of the provisions of the Tobacco Control Act, which require FDA to protect the public health and to reduce tobacco use by minors. The information being collected is necessary to inform FDA's efforts towards those goals and to measure the effectiveness and public health impact of the campaigns. Data from the outcome evaluation of the General Market and Rural Male Youth Smokeless campaigns is being used to examine statistical associations between exposure to the campaigns and subsequent changes in specific outcomes of interest, which will include knowledge, attitudes, beliefs, and intentions related to tobacco use, as well as behavioral outcomes including tobacco use. Data from the media tracking survey is being used to estimate awareness of and exposure to the campaigns among youth nationally as well as among youth in geographic areas targeted by the campaign. FDA requests OMB approval to collect additional information for the purpose of extending the evaluation of FDA's general market youth tobacco prevention campaign. Specifically, FDA requests approval to conduct a fourth follow-up survey with youth who are part of the first longitudinal cohort, and who participated in the baseline and first through third follow-up surveys. Based on earlier response rates, we estimate that 1,607 will participate in this survey, for a total of 6,666 annualized participants (including 5,059 previously approved). At 0.75 hours per survey, this adds 1,205 annualized burden hours to the 3,794 previously approved hours for a total of 5,000 annualized burden hours. Baseline data collection for this cohort, approved for 2,288 participants (1,144 burden hours at 30 minutes per survey) is complete. FDA also requests approval to develop and survey a second longitudinal cohort which will consist of an entirely new sample of youth, ages 11-16 at baseline. Development of the second cohort will involve screening 17,467 individuals in the general population for a total of 30,880 participants, including 13,413 previously approved. At 10 minutes per screening, this adds 2,970 burden hours to the already approved 2,280 hours for a total of 5,250 annualized burden hours. We expect this screening to yield 2,667 youth annually who will complete the baseline survey for the new cohort at 45 minutes per survey, resulting in a total of 2,000 burden hours for youth. Three follow up surveys are planned for this cohort. We expect a total of 6,270 participants to complete follow up surveys for a total burden of 4,703 annualized burden hours. As was done with the first cohort, parents of the 2,667 youth will also complete surveys for a total of 6,009 parent surveys including the 3,342 previously approved. At 10 minutes per survey, this adds 453 hours to the previously approved 568 hours for a total of 1,021 annualized burden hours. FDA also requests approval to extend the media tracking survey. This survey is cross sectional and thus necessitates brief screening prior to data collection. We expect 20,000 participants to complete screener for a total of 60,000 participants (including 40,000 previously approved). At 2 minutes per screener, this adds 600 burden hours to the previously approved 1,200 hours for a total of 1,800 annualized burden hours. We expect the screening process to yield 2,000 participants, for a total of 6,000 including 4,000 previously approved. At 30 minutes per survey, this adds 1,000 burden hours to the already- approved 2,000 for a total of 3,000 annualized burden hours. FDA also requests approval to extend the time period of the evaluation of the Male Rural Youth Smokeless Campaign. No new burden hours will be required to complete this study. Previously approved burden for the evaluation of the Rural Male Youth Smokeless Campaign include 656 annualized participants (328 annualized burden hours at 30 minutes per questionnaire) for the baseline questionnaire and 1,281 annualized participants (961 annualized burden hours at 0.75 hours per questionnaire). In the Federal Register of February 19, 2016 (81 FR 8511), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. Two burden items have been revised since the publication of the 60- day notice. First, number of respondents planned for the General Population Screener and Consent Process has been corrected to annualize the new screening participants over the 3-year extension. Second, the burden per response for the Cohort 2 Youth Baseline has been increased to 45 minutes to better reflect the actual time required for completion as assessed during the previous data collection rounds. 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- General Population.................... Screener and Consent 30,880 1 30,880 0.17 (10 minutes)................ 5,250 Process (Youth and Parent). Parent of Youth Baseline Survey Parent Baseline 6,009 1 6,009 0.17 (10 minutes)................ 1,022 Participants. Questionnaire. Youth Aged 11 to 18 (Experimenters and Youth Baseline 2,288 1 2,288 0.50 (30 minutes)................ 1,144 Non-Triers). Questionnaire (Experimenters & Non- Triers). Youth 1st, 2nd, 3rd, 4th 6,666 1 6,666 0.75 (45 minutes)................ 5,000 Follow-up Questionnaire (Experimenters and Non- Triers) Youth Aged 13 to 17................... Media Tracking Screener.. 60,000 1 60,000 0.03 (2 minutes)................. 1,800 Media Tracking 6,000 1 6,000 0.50 (30 minutes)................ 3,000 Questionnaires 1st, 2nd, and 3rd [[Page 39677]] Male Youth Aged 11 to 18 in U.S. Rural Youth Baseline 656 1 656 0.50 (30 minutes)................ 328 Markets (Male Rural Smokeless). Questionnaire (Male Rural Smokeless). Youth 1st, 2nd, 3rd 1,281 1 1,281 0.75 (45 minutes)................ 961 (Male, Rural Smokeless) Follow-up Questionnaire Cohort 2--Youth Aged 11 to 18......... Cohort 2--Youth Baseline 2,667 1 2,667 0.75 (45 minutes)................ 2,000 Questionnaire. Cohort 2--Youth 1st, 2nd, 6,270 1 6,270 0.75 (45 minutes)................ 4,703 3rd Follow-Up Questionnaire --------------------------------------- ------------ Total............................. 122,717 25,208 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-14352 Filed 6-16-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39675
II. The Paperwork Reduction Act of DATES: Fax written comments on the information collected is integral to that
1995 collection of information by July 18, evaluation.
2016. FDA is in the process of conducting
This draft guidance refers to three studies to evaluate the
previously approved collections of ADDRESSES: To ensure that comments on
the information collection are received, effectiveness of its youth tobacco
information found in FDA regulations. prevention campaigns: (1) An outcome
These collections of information are OMB recommends that written
comments be faxed to the Office of evaluation study of its General Market
subject to review by the Office of Youth Tobacco Prevention Campaign,
Management and Budget (OMB) under Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: (2) an outcome evaluation of the Rural
the Paperwork Reduction Act of 1995 Male Youth Smokeless Tobacco
(44 U.S.C. 3501–3520). The collection of 202–395–7285, or emailed to oira_
submission@omb.eop.gov. All Campaign, and (3) a media tracking
information in investigational new drug survey. The timing of these studies
applications is approved under OMB comments should be identified with the
OMB control number 0910–0753. Also follows the multiple, discrete waves of
control number 0910–0014; the media advertising planned for the
collection of information (including include the FDA docket number found
in brackets in the heading of this campaigns.
prescription drug labeling) in new drug
applications and abbreviated new drug document. Evaluation of the General Market Youth
applications, as well as supplements to FOR FURTHER INFORMATION CONTACT: FDA Tobacco Prevention Campaign
these applications, is approved under PRA Staff, Office of Operations, Food The General Market Youth Tobacco
OMB control number 0910–0001; the and Drug Administration, 8455 Prevention Campaign targets youth who
collection of biologics license Colesville Rd., COLE–14526, Silver are at-risk for smoking, or who have
applications is approved under OMB Spring, MD 20993–0002, PRAStaff@ experimented with but not progressed to
control number 0910–0338; and the fda.hhs.gov. regular smoking. The outcome
format and content of prescription drug SUPPLEMENTARY INFORMATION: In evaluation of the campaign consists of
labeling is approved under OMB control compliance with 44 U.S.C. 3507, FDA an initial baseline survey of youth aged
number 0910–0572. has submitted the following proposed 11 to 16 before campaigns launch,
collection of information to OMB for followed by a number of longitudinal
III. Electronic Access
review and clearance. follow-up surveys of the same youth at
Persons with access to the Internet approximate 8 month intervals. To date,
Evaluation of FDA’s General Market the baseline and three follow-up surveys
may obtain the draft guidance at either
Youth Tobacco Prevention have been conducted. A baseline survey
http://www.fda.gov/Drugs/
Campaigns—OMB Control Number was also conducted with the parent or
GuidanceCompliance
0910–0753—Revision legal guardian of each youth, to collect
RegulatoryInformation/Guidances/
default.htm or http:// The 2009 Family Smoking Prevention data on household characteristics and
www.regulations.gov. and Tobacco Control Act (Tobacco media use. Because the cohort aged over
Control Act) (Pub. L. 111–31) amends the study period, data have been
Dated: June 13, 2016.
the Federal Food, Drug, and Cosmetic collected from youth aged 11 to 18.
Leslie Kux, Act (the FD&C Act) to grant FDA Information has been collected about
Associate Commissioner for Policy. authority to regulate the manufacture, youth awareness of and exposure to
[FR Doc. 2016–14354 Filed 6–16–16; 8:45 am] marketing, and distribution of tobacco campaign advertisements and about
BILLING CODE 4164–01–P products to protect public health and to youth knowledge, attitudes, and beliefs
reduce tobacco use by minors. Section related to tobacco use. In addition, the
1003(d)(2)(D) of the FD&C Act (21 surveys have measured tobacco use
DEPARTMENT OF HEALTH AND U.S.C. 393(d)(2)(D)) supports the susceptibility and current use.
HUMAN SERVICES development and implementation of Information has been collected on
FDA public education campaigns demographic variables including age,
Food and Drug Administration related to tobacco use. Accordingly, sex, race/ethnicity, grade level, and
FDA is currently developing and primary language.
[Docket No. FDA–2013–N–0717] implementing youth-targeted public
education campaigns to help prevent Evaluation of the Rural Male Youth
Agency Information Collection tobacco use among youth and thereby Smokeless Tobacco Campaign
Activities; Submission for Office of reduce the public health burden of Baseline data collection for the Rural
Management and Budget Review; tobacco. The campaigns feature Male Youth Smokeless Campaign
Comment Request; Evaluation of the televised advertisements along with evaluation will begin in January 2016.
Food and Drug Administration’s complementary ads on radio, on the The three follow up surveys will begin
General Market Youth Tobacco Internet, in print, and through other in August 2016, March 2017, and
Prevention Campaigns forms of media. October 2017. The evaluation of the
Evaluation is an essential Rural Male Youth Smokeless Campaign
AGENCY: Food and Drug Administration, organizational practice in public health differs from the General Market
HHS. and a systematic way to account for and Campaign evaluation, in that only males
ACTION: Notice. improve public health actions. in the age range will be considered
Comprehensive evaluation of FDA’s
sradovich on DSK3TPTVN1PROD with NOTICES
eligible.
SUMMARY: The Food and Drug public education campaigns will be
Administration (FDA) is announcing used to document whether the intended Media Tracking Survey
that a proposed collection of audience is aware of and understands The media tracking survey consists of
information has been submitted to the campaign messages; and whether assessments of youth aged 13 to 18
Office of Management and Budget campaign exposure influences beliefs conducted periodically during the
(OMB) for review and clearance under about tobacco, susceptibility to tobacco campaign period. The tracking survey
the Paperwork Reduction Act of 1995. use, and tobacco use behavior. All of the assesses awareness of the campaign and
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![Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39677
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of responses Total annual
Type of respondent Activity burden per Total hours
respondents per responses response
respondent
Male Youth Aged 11 to 18 in U.S. Youth Baseline Questionnaire (Male 656 1 656 0.50 (30 minutes) ...... 328
Rural Markets (Male Rural Smoke- Rural Smokeless).
less).
Youth 1st, 2nd, 3rd (Male, Rural 1,281 1 1,281 0.75 (45 minutes) ...... 961
Smokeless) Follow-up Questionnaire
Cohort 2—Youth Aged 11 to 18 ........... Cohort 2—Youth Baseline Question- 2,667 1 2,667 0.75 (45 minutes) ...... 2,000
naire.
Cohort 2—Youth 1st, 2nd, 3rd Follow- 6,270 1 6,270 0.75 (45 minutes) ...... 4,703
Up Questionnaire
Total ............................................... 122,717 25,208
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 13, 2016. one film badge or TLD dosimeter) during the FOR FURTHER INFORMATION CONTACT:
Leslie Kux, period from March 1, 1970, through Stuart L. Hinnefeld, Director, Division
December 31, 1974, and were employed for of Compensation Analysis and Support,
Associate Commissioner for Policy.
a number of work days aggregating at least
[FR Doc. 2016–14352 Filed 6–16–16; 8:45 am] 250 work days, occurring either solely under NIOSH, 1090 Tusculum Avenue, MS C–
BILLING CODE 4164–01–P employment during the period from March 1, 46, Cincinnati, OH 45226–1938,
1970, through December 31, 1974, or in Telephone 1–877–222–7570.
combination with work days within the Information requests can also be
DEPARTMENT OF HEALTH AND parameters established for one or more other submitted by email to DCAS@CDC.GOV.
HUMAN SERVICES classes of employees in the Special Exposure
Cohort. SUPPLEMENTARY INFORMATION:
Designation of a Class of Employees Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
This designation will become
for Addition to the Special Exposure 7384l(14)(C).
effective on July 3, 2016, unless
Cohort
Congress provides otherwise prior to the
AGENCY: National Institute for effective date. After this effective date, On June 3, 2016, as provided for
Occupational Safety and Health HHS will publish a notice in the under 42 U.S.C. 73841(14)(C), the
(NIOSH), Centers for Disease Control Federal Register reporting the addition Secretary of HHS designated the
and Prevention, Department of Health of this class to the SEC or the result of following class of employees as an
and Human Services (HHS). any provision by Congress regarding the addition to the SEC:
ACTION: Notice. decision by HHS to add the class to the All employees of the Department of
SEC. Energy, its predecessor agencies, and their
SUMMARY: HHS gives notice of a
John Howard, contractors and subcontractors who worked
decision to designate a class of
Director, National Institute for Occupational in any area at the Lawrence Livermore
employees from the Idaho National
Safety and Health. National Laboratory in Livermore, California,
Laboratory site in Scoville, Idaho, as an
[FR Doc. 2016–14327 Filed 6–16–16; 8:45 am] during the period from January 1, 1974,
addition to the Special Exposure Cohort
through December 31, 1989, for a number of
(SEC) under the Energy Employees BILLING CODE 4163–19–P
work days aggregating at least 250 work days,
Occupational Illness Compensation occurring either solely under this
Program Act of 2000. employment, or in combination with work
FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND
HUMAN SERVICES days within the parameters established for
Stuart L. Hinnefeld, Director, Division one or more other classes of employees in the
of Compensation Analysis and Support, Designation of a Class of Employees Special Exposure Cohort.
NIOSH, 1090 Tusculum Avenue, MS C– for Addition to the Special Exposure
46, Cincinnati, OH 45226–1938, This designation will become
Cohort
Telephone 1–877–222–7570. effective on July 3, 2016, unless
Information requests can also be AGENCY: National Institute for Congress provides otherwise prior to the
submitted by email to DCAS@CDC.GOV. Occupational Safety and Health effective date. After this effective date,
SUPPLEMENTARY INFORMATION: (NIOSH), Centers for Disease Control HHS will publish a notice in the
Authority: 42 U.S.C. 7384q(b). 42 U.S.C. and Prevention, Department of Health Federal Register reporting the addition
7384l(14)(C). and Human Services (HHS). of this class to the SEC or the result of
On June 3, 2016, as provided for ACTION: Notice. any provision by Congress regarding the
under 42 U.S.C. 7384l(14)(C),the decision by HHS to add the class to the
Secretary of HHS designated the SUMMARY: HHS gives notice of a SEC.
decision to designate a class of
sradovich on DSK3TPTVN1PROD with NOTICES
following class of employees as an John Howard,
addition to the SEC: employees from the Lawrence
Livermore National Laboratory site in Director, National Institute for Occupational
All employees of the Department of Safety and Health.
Energy, its predecessor agencies, and their
Livermore, California, as an addition to
[FR Doc. 2016–14326 Filed 6–16–16; 8:45 am]
contractors and subcontractors who worked the Special Exposure Cohort (SEC)
at the Idaho National Laboratory (INL) in under the Energy Employees BILLING CODE 4163–19–P
Scoville, Idaho, and were monitored for Occupational Illness Compensation
external radiation at INL (e.g., having at least Program Act of 2000.
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Document Created: 2016-06-17 01:05:10
Document Modified: 2016-06-17 01:05:10
| 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 July 18, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 39675 |
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