Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration's Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults, 37270-37273 [2015-16020]

Download as PDF 37270 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0721. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd.; COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Animal Food Labeling; Declaration of Certifiable Color Additives—21 CFR 501.22(k) OMB Control Number 0910– 0721—Extension This information collection is associated with requirements under 21 CFR 501.22(k) in which animal food manufacturers must declare the presence of certified and noncertified color additives in their animal food products on the product label. The Agency issued this regulation in response to the Nutrition Labeling and Education Act of 1990 (Pub. L. 101–535) to make animal food regulations consistent with the regulations regarding the declaration of color additives on human food labels and to provide animal owners with information on the colors used in animal food. Respondents to this collection are manufacturers of pet food that contain color additives. Manufacturers of certain food or food ingredients do not have products that contain color additives requiring certification (e.g., food for chickens, fish, and some other species, including some pet foods) and would thus be minimally affected by § 501.22(k)(1). However, since we cannot rule out the possibility that they may at some point use a color additive requiring certification, we have consolidated the burden estimates for §§ 501.22(k)(1) and 501.22(k)(2). Additionally, we believe that this burden is more accurately characterized as a third-party disclosure burden because FDA does not require routine submission of pet food labeling to the Agency. In the Federal Register of April 1, 2015 (80 FR 17445), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received but did not respond to any of the four information collection topics solicited and is therefore not addressed by the Agency. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 21 CFR Section/Activity Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 501.22(k); labeling of color additive or make of color additive; labeling of color additives not subject to certification. 3,120 0.83 2,587 .25 (15 minutes) 647 asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Having become effective November 18, 2013, the Agency estimates that the burden associated with the labeling requirements under § 501.22(k) apply only to new product labels. Because the vast majority of animal food products that contain certified color additives are pet foods, we limit our burden estimate to reviewing labels for the use of certified color additives to pet food manufacturers subject to this regulation. Based on A.C. Nielsen Data, FDA estimates that the number of animal food product units subject to § 501.22(k) for which sales of the products are greater than zero is 25,874. Assuming that the flow of new products is 10 percent per year, then 2,587 new animal food products subject to § 501.22(k) will come on the market each year. FDA also estimates that there are about 3,120 manufacturers of pet food subject to either § 501.22(k)(1) or (k)(2). Assuming the approximately 2,587 new products are split equally among the firms, then each firm would prepare labels for approximately 0.83 new products per year (2,587 new products/3,120 firms is approximately 0.83 labels per firm). VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 The Agency expects that firms prepare the required labeling for their products in a manner that takes into account at one time all information required to be disclosed on their product labels. Based on our experience with reviewing pet food labeling, FDA estimates that firms would require less than 0.25 hour (15 minutes) per product to comply with the requirement to include the color additive information pursuant to § 501.22(k). The total burden of this activity is 647 hours (2,587 labels × 0.25 hour/label is approximately 647 hours). DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: June 25, 2015. Leslie Kux, Associate Commissioner for Policy. ACTION: [FR Doc. 2015–16022 Filed 6–29–15; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2015–N–2126] Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Food and Drug Administration’s Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults AGENCY: Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on SUMMARY: E:\FR\FM\30JNN1.SGM 30JNN1 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices the Evaluation of FDA’s Multicultural Youth Tobacco Prevention Campaigns. Submit either electronic or written comments on the collection of information by August 31, 2015. DATES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: 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 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 Evaluation of FDA’s Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and Transgender Young Adults OMB Control Number—0910New 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 public education campaigns to help prevent and reduce tobacco use among lesbian, gay, bisexual and transgender (LGBT) young adults and thereby reduce the public health burden of tobacco. Overall the campaigns will feature events; advertisements on television and radio and in print; digital communications including social media; and other forms of media. In support of the provisions of the Tobacco Control Act that require FDA to protect the public health and to reduce tobacco use, FDA requests OMB approval to collect information needed to evaluate FDA’s campaign to reduce tobacco use among LGBT young adults. Comprehensive evaluation of FDA’s public education campaigns is needed to ensure campaign messages are effectively received, understood, and accepted by those for whom they are intended. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. FDA plans to conduct two studies to evaluate the effectiveness of its LGBT young adult tobacco prevention campaign: (1) An outcome evaluation study to evaluate the effectiveness of its LGBT young adult tobacco prevention campaign, and (2) a media tracking questionnaire to assess awareness of and receptivity to campaign messages. The timing of these studies will be designed to follow the multiple, discrete waves of media advertising planned for the campaigns. • Outcome Evaluation Study The outcome evaluation study begins with a baseline survey of LGBT young adults aged 18 to 24 before the campaign launch. The baseline will be followed by three follow-up surveys of the target audience of young adults at PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 37271 approximately 6-month intervals after the campaign’s launch. Information will be collected about young adult awareness of and exposure to campaign events and advertisements and about tobacco-related knowledge, attitudes, beliefs, intentions and use, as well as use of other tobacco products (ecigarettes, hookah, cigars, smokeless tobacco), marijuana and alcohol. Information will also be collected on demographic variables including sexual orientation, age, sex, race/ethnicity, education, and primary language. All information will be collected through in-person and web-based questionnaires. Young adult respondents will be recruited in 30 U.S. cities (15 campaign and 15 comparison cities) from two sources: (1) Intercept surveys in LGBT social venues (e.g., bars and nightclubs) identified using a time location sampling approach, and (2) through social media advertisements on Facebook and Twitter targeted at LGBT 18 to 24-year-olds, living in the same 30 U.S. cities. Participation in the study is voluntary. • Media Tracking Survey The media tracking survey consists of assessments of LGBT young adults aged 18 to 24 conducted once yearly post campaign launch—timing that complements the outcome evaluation’s timing. The media tracking survey will assess awareness of the campaign and receptivity to campaign messages. These data will provide critical evaluation feedback to the campaigns and will be conducted with sufficient frequency to match the cyclical patterns of events and media advertising and variation in exposure to allow for mid-campaign refinements. For the media tracking surveys, we will recruit LGBT young adults aged 18 to 24 from all campaign cities through social media. The information collected is necessary to inform FDA’s efforts and measure the effectiveness and public health impact of the campaigns. Data from the media tracking surveys will be used to estimate awareness of and exposure to the campaigns among young adults in target markets where the campaigns are active. Data from the outcome evaluation study will be used to examine statistical associations between awareness of and exposure to the campaigns and subsequent changes in specific outcomes of interest, which will include knowledge, attitudes, beliefs and intentions related to tobacco use. FDA’s burden estimate is based on prior experience with in-person studies similar to the Agency’s plan presented in this document, as well as previous E:\FR\FM\30JNN1.SGM 30JNN1 37272 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices research using social media advertising to recruit young adult participants. To reduce overall burden hours, participants who screen and complete the baseline outcome evaluation questionnaire will be re-contacted to complete the first follow up campaign evaluation questionnaire, those who complete the first follow up campaign evaluation questionnaire will be recontacted to complete the second follow up campaign evaluation questionnaire, and so on. Re-contacted individuals will not need to complete the screener again. We expect a 50 percent response rate for individuals recruited in person and a 30 percent rate for individuals recruited via social media. In each successive round of data collection, we expect 50 percent of re-contacted individuals to complete the follow up questionnaire, therefore, additional screenings will be conducted for each follow up in order to maintain the target sample size for each follow up questionnaire. To obtain the target number of completed questionnaires (‘‘completes’’) for the outcome evaluation study, 18,376 young adults (11,810 recruited in person and 6,566 recruited via social media) will participate in a screening process (‘‘screener’’). The estimated burden per screener is 5 minutes (0.083), for a total of 1,525 hours (980 hours for participants recruited in person and 545 hours for persons recruited via social media). A total of 12,600 LGBT young adults (9,448 of those screened in person and 3,152 of those screened through social media) will complete questionnaires in 4 rounds of data collection (baseline and three post-campaign rounds). The estimated burden per complete is 30 minutes (0.5 hour) for the baseline questionnaire and 40 minutes (0.667 hour) for each follow up complete, for a total of 7,878 hours (5,906 hours for those recruited in person and 1,972 hours for those recruited via social media). To obtain the target number of completes for the media tracking survey, 5,000 young adults will be recruited via social media ads to complete a screener for all three waves of the media tracking survey. The estimated burden per screener response is 5 minutes (0.083 hour), for a total of 414 hours for all waves of media tracking screener. An estimated 500 LGBT young adults will complete each of the three waves of the media tracking survey (assuming a 30 percent response rate to screeners via social media). The estimated burden per completed media tracking questionnaire is 40 minutes (0.667 hour), for a total of 1,002 hours for the three waves. The total burden for the media tracking survey (screeners and completes) is 1,416 hours. The target number of completed campaign questionnaires (screeners and questionnaires for both the outcome evaluation and media tracking survey) for all respondents is 37,477. The total estimated burden is 10,819 hours. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Number of responses per respondent Average burden per response Total annual responses Type of respondent Activity General population—Recruited in person (50% response rate). Screener—Baseline—outcome study. 4,724 1 4,724 0.083 (5 min.) ...... 392 Screener—First follow up—outcome study. Screener—Second follow up—outcome study. Screener—Third follow up—outcome study. Baseline—outcome evaluation questionnaire. 2,362 1 2,362 0.083 (5 min.) ....... 196 2,362 1 2,362 0.083 (5 min.) ...... 196 2,362 1 2,362 0.083 (5 min.) ...... 196 2,362 1 2,362 0.5 (30 min.) ......... 1181 First follow up young adult outcome evaluation questionnaire. Second follow up young adult outcome evaluation questionnaire. Third follow up young adult outcome evaluation questionnaire. Screener—Baseline—outcome study. 2,362 1 2,362 0.667 (40 min.) ..... 1575 2,362 1 2,362 0.667 (40 min.) ..... 1575 2,362 1 2,362 0.667 (40 min.) ..... 1575 2,627 1 2,627 0.083 (5 min.) ....... 218 Screener—First follow up—outcome study. Screener—Second follow up—outcome study. Screener—Third follow up—outcome study. Baseline—outcome evaluation questionnaire. 1,313 1 1,313 0.083 (5 min.) ....... 109 1,313 1 1,313 0.083 (5 min.) ...... 109 1,313 1 1,313 0.083 (5 min.) ...... 109 788 1 788 0.5 (30 min.) ......... 394 788 1 788 0.667 (40 min.) ..... 526 LGBT young adults aged 18–24 in select media markets—Recruited in person. asabaliauskas on DSK5VPTVN1PROD with NOTICES General population—Recruited via social media (30% response rate). LGBT young adults aged 18–24 in select media markets—Recruited via social media. First follow up young adult outcome evaluation questionnaire. VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1 Total hours Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37273 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Type of respondent LGBT young adults aged 18–24 in the select media markets—Recruited via social media. Number of respondents Activity Second follow up young adult outcome evaluation questionnaire. Third follow up young adult outcome evaluation questionnaire. 1st media tracking screener. Total .......................... BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site. The BE SUMMARY: asabaliauskas on DSK5VPTVN1PROD with NOTICES 1 788 0.667 (40 min.) ..... 526 788 1 788 0.667 (40 min.) ..... 526 1667 .......................................... [FR Doc. 2015–16020 Filed 6–29–15; 8:45 am] ACTION: Total hours 1 1667 0.083 (5 min.) ....... 138 500 1 500 0.667 (40 min.) ..... 334 1667 1 1667 0.083 (5 min.) ....... 138 500 1 500 0.667 (40 min.) ..... 334 1667 1 1667 0.083 (5 min.) ...... 138 500 1 500 0.667 (40 min.) ..... 334 37,477 ........................ ........................ .............................. 10,819 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 24, 2015. Leslie Kux, Associate Commissioner for Policy. AGENCY: Average burden per response Total annual responses 788 1st media tracking questionnaire. 2nd media tracking screener. 2nd media tracking questionnaire. 3rd media tracking screener. 3rd media tracking questionnaire. 1 There Number of responses per respondent VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 recommendations identified in this notice were developed using the process described in that guidance. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by August 31, 2015. ADDRESSES: Submit written requests for single copies of the individual BE guidances to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations. Submit electronic comments on the draft product-specific BE recommendations to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993–0002, 301– 796–5850. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products’’ that explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on March 9, 2015 (80 FR 12502). This notice announces draft product-specific E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37270-37273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2126]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of the Food and Drug Administration's 
Campaign To Reduce Tobacco Use Among Lesbian, Gay, Bisexual, and 
Transgender Young Adults

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish a notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on

[[Page 37271]]

the Evaluation of FDA's Multicultural Youth Tobacco Prevention 
Campaigns.

DATES: Submit either electronic or written comments on the collection 
of information by August 31, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to https://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information 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.

Evaluation of FDA's Campaign To Reduce Tobacco Use Among Lesbian, Gay, 
Bisexual, and Transgender Young Adults 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 public education campaigns to help prevent and reduce 
tobacco use among lesbian, gay, bisexual and transgender (LGBT) young 
adults and thereby reduce the public health burden of tobacco. Overall 
the campaigns will feature events; advertisements on television and 
radio and in print; digital communications including social media; and 
other forms of media.
    In support of the provisions of the Tobacco Control Act that 
require FDA to protect the public health and to reduce tobacco use, FDA 
requests OMB approval to collect information needed to evaluate FDA's 
campaign to reduce tobacco use among LGBT young adults. Comprehensive 
evaluation of FDA's public education campaigns is needed to ensure 
campaign messages are effectively received, understood, and accepted by 
those for whom they are intended. Evaluation is an essential 
organizational practice in public health and a systematic way to 
account for and improve public health actions.
    FDA plans to conduct two studies to evaluate the effectiveness of 
its LGBT young adult tobacco prevention campaign: (1) An outcome 
evaluation study to evaluate the effectiveness of its LGBT young adult 
tobacco prevention campaign, and (2) a media tracking questionnaire to 
assess awareness of and receptivity to campaign messages. The timing of 
these studies will be designed to follow the multiple, discrete waves 
of media advertising planned for the campaigns.
 Outcome Evaluation Study
    The outcome evaluation study begins with a baseline survey of LGBT 
young adults aged 18 to 24 before the campaign launch. The baseline 
will be followed by three follow-up surveys of the target audience of 
young adults at approximately 6-month intervals after the campaign's 
launch. Information will be collected about young adult awareness of 
and exposure to campaign events and advertisements and about tobacco-
related knowledge, attitudes, beliefs, intentions and use, as well as 
use of other tobacco products (e-cigarettes, hookah, cigars, smokeless 
tobacco), marijuana and alcohol. Information will also be collected on 
demographic variables including sexual orientation, age, sex, race/
ethnicity, education, and primary language.
    All information will be collected through in-person and web-based 
questionnaires. Young adult respondents will be recruited in 30 U.S. 
cities (15 campaign and 15 comparison cities) from two sources: (1) 
Intercept surveys in LGBT social venues (e.g., bars and nightclubs) 
identified using a time location sampling approach, and (2) through 
social media advertisements on Facebook and Twitter targeted at LGBT 18 
to 24-year-olds, living in the same 30 U.S. cities. Participation in 
the study is voluntary.
 Media Tracking Survey
    The media tracking survey consists of assessments of LGBT young 
adults aged 18 to 24 conducted once yearly post campaign launch--timing 
that complements the outcome evaluation's timing. The media tracking 
survey will assess awareness of the campaign and receptivity to 
campaign messages. These data will provide critical evaluation feedback 
to the campaigns and will be conducted with sufficient frequency to 
match the cyclical patterns of events and media advertising and 
variation in exposure to allow for mid-campaign refinements. For the 
media tracking surveys, we will recruit LGBT young adults aged 18 to 24 
from all campaign cities through social media.
    The information collected is necessary to inform FDA's efforts and 
measure the effectiveness and public health impact of the campaigns. 
Data from the media tracking surveys will be used to estimate awareness 
of and exposure to the campaigns among young adults in target markets 
where the campaigns are active. Data from the outcome evaluation study 
will be used to examine statistical associations between awareness of 
and exposure to the campaigns and subsequent changes in specific 
outcomes of interest, which will include knowledge, attitudes, beliefs 
and intentions related to tobacco use.
    FDA's burden estimate is based on prior experience with in-person 
studies similar to the Agency's plan presented in this document, as 
well as previous

[[Page 37272]]

research using social media advertising to recruit young adult 
participants. To reduce overall burden hours, participants who screen 
and complete the baseline outcome evaluation questionnaire will be re-
contacted to complete the first follow up campaign evaluation 
questionnaire, those who complete the first follow up campaign 
evaluation questionnaire will be re-contacted to complete the second 
follow up campaign evaluation questionnaire, and so on. Re-contacted 
individuals will not need to complete the screener again. We expect a 
50 percent response rate for individuals recruited in person and a 30 
percent rate for individuals recruited via social media. In each 
successive round of data collection, we expect 50 percent of re-
contacted individuals to complete the follow up questionnaire, 
therefore, additional screenings will be conducted for each follow up 
in order to maintain the target sample size for each follow up 
questionnaire.
    To obtain the target number of completed questionnaires 
(``completes'') for the outcome evaluation study, 18,376 young adults 
(11,810 recruited in person and 6,566 recruited via social media) will 
participate in a screening process (``screener''). The estimated burden 
per screener is 5 minutes (0.083), for a total of 1,525 hours (980 
hours for participants recruited in person and 545 hours for persons 
recruited via social media). A total of 12,600 LGBT young adults (9,448 
of those screened in person and 3,152 of those screened through social 
media) will complete questionnaires in 4 rounds of data collection 
(baseline and three post-campaign rounds). The estimated burden per 
complete is 30 minutes (0.5 hour) for the baseline questionnaire and 40 
minutes (0.667 hour) for each follow up complete, for a total of 7,878 
hours (5,906 hours for those recruited in person and 1,972 hours for 
those recruited via social media).
    To obtain the target number of completes for the media tracking 
survey, 5,000 young adults will be recruited via social media ads to 
complete a screener for all three waves of the media tracking survey. 
The estimated burden per screener response is 5 minutes (0.083 hour), 
for a total of 414 hours for all waves of media tracking screener. An 
estimated 500 LGBT young adults will complete each of the three waves 
of the media tracking survey (assuming a 30 percent response rate to 
screeners via social media). The estimated burden per completed media 
tracking questionnaire is 40 minutes (0.667 hour), for a total of 1,002 
hours for the three waves. The total burden for the media tracking 
survey (screeners and completes) is 1,416 hours.
    The target number of completed campaign questionnaires (screeners 
and questionnaires for both the outcome evaluation and media tracking 
survey) for all respondents is 37,477. The total estimated burden is 
10,819 hours.

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of
         Type of respondent                 Activity           Number of     responses per   Total annual        Average  burden per        Total hours
                                                              respondents     respondent       responses              response
--------------------------------------------------------------------------------------------------------------------------------------------------------
General population--Recruited in     Screener--Baseline--o           4,724               1           4,724  0.083 (5 min.)..............             392
 person (50% response rate).          utcome study.
                                     Screener--First                 2,362               1           2,362  0.083 (5 min.)..............             196
                                      follow up--outcome
                                      study.
                                     Screener--Second                2,362               1           2,362  0.083 (5 min.)..............             196
                                      follow up--outcome
                                      study.
                                     Screener--Third                 2,362               1           2,362  0.083 (5 min.)..............             196
                                      follow up--outcome
                                      study.
LGBT young adults aged 18-24 in      Baseline--outcome               2,362               1           2,362  0.5 (30 min.)...............            1181
 select media markets--Recruited in   evaluation
 person.                              questionnaire.
                                     First follow up young           2,362               1           2,362  0.667 (40 min.).............            1575
                                      adult outcome
                                      evaluation
                                      questionnaire.
                                     Second follow up                2,362               1           2,362  0.667 (40 min.).............            1575
                                      young adult outcome
                                      evaluation
                                      questionnaire.
                                     Third follow up young           2,362               1           2,362  0.667 (40 min.).............            1575
                                      adult outcome
                                      evaluation
                                      questionnaire.
General population--Recruited via    Screener--Baseline--o           2,627               1           2,627  0.083 (5 min.)..............             218
 social media (30% response rate).    utcome study.
                                     Screener--First                 1,313               1           1,313  0.083 (5 min.)..............             109
                                      follow up--outcome
                                      study.
                                     Screener--Second                1,313               1           1,313  0.083 (5 min.)..............             109
                                      follow up--outcome
                                      study.
                                     Screener--Third                 1,313               1           1,313  0.083 (5 min.)..............             109
                                      follow up--outcome
                                      study.
LGBT young adults aged 18-24 in      Baseline--outcome                 788               1             788  0.5 (30 min.)...............             394
 select media markets--Recruited      evaluation
 via social media.                    questionnaire.
                                     First follow up young             788               1             788  0.667 (40 min.).............             526
                                      adult outcome
                                      evaluation
                                      questionnaire.

[[Page 37273]]

 
                                     Second follow up                  788               1             788  0.667 (40 min.).............             526
                                      young adult outcome
                                      evaluation
                                      questionnaire.
                                     Third follow up young             788               1             788  0.667 (40 min.).............             526
                                      adult outcome
                                      evaluation
                                      questionnaire.
LGBT young adults aged 18-24 in the  1st media tracking               1667               1            1667  0.083 (5 min.)..............             138
 select media markets--Recruited      screener.
 via social media.
                                     1st media tracking                500               1             500  0.667 (40 min.).............             334
                                      questionnaire.
                                     2nd media tracking               1667               1            1667  0.083 (5 min.)..............             138
                                      screener.
                                     2nd media tracking                500               1             500  0.667 (40 min.).............             334
                                      questionnaire.
                                     3rd media tracking               1667               1            1667  0.083 (5 min.)..............             138
                                      screener.
                                     3rd media tracking                500               1             500  0.667 (40 min.).............             334
                                      questionnaire.
                                                           ------------------------------------------------                              ---------------
    Total..........................  .....................          37,477  ..............  ..............  ............................          10,819
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16020 Filed 6-29-15; 8:45 am]
BILLING CODE 4164-01-P
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