80_FR_37395 80 FR 37270 - 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

80 FR 37270 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 125 (June 30, 2015)

Page Range37270-37273
FR Document2015-16020

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

Federal Register, Volume 80 Issue 125 (Tuesday, June 30, 2015) 
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37270-37273]
From the Federal Register Online  [www.thefederalregister.org]
[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 http://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, [email protected].

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

37270 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices Information and Regulatory Affairs, Animal Food Labeling; Declaration of chickens, fish, and some other species, OMB, Attn: FDA Desk Officer, FAX: Certifiable Color Additives—21 CFR including some pet foods) and would 202–395–7285, or emailed to oira_ 501.22(k) OMB Control Number 0910– thus be minimally affected by submission@omb.eop.gov. All 0721—Extension § 501.22(k)(1). However, since we comments should be identified with the This information collection is cannot rule out the possibility that they OMB control number 0910–0721. Also associated with requirements under 21 may at some point use a color additive include the FDA docket number found CFR 501.22(k) in which animal food requiring certification, we have in brackets in the heading of this manufacturers must declare the consolidated the burden estimates for document. presence of certified and noncertified §§ 501.22(k)(1) and 501.22(k)(2). color additives in their animal food Additionally, we believe that this FOR FURTHER INFORMATION CONTACT: FDA products on the product label. The burden is more accurately characterized PRA Staff, Office of Operations, Food Agency issued this regulation in as a third-party disclosure burden and Drug Administration, 8455 response to the Nutrition Labeling and because FDA does not require routine Colesville Rd.; COLE–14526, Silver Education Act of 1990 (Pub. L. 101–535) submission of pet food labeling to the Spring, MD 20993–0002, PRAStaff@ to make animal food regulations Agency. fda.hhs.gov. consistent with the regulations In the Federal Register of April 1, regarding the declaration of color 2015 (80 FR 17445), FDA published a SUPPLEMENTARY INFORMATION: In additives on human food labels and to compliance with 44 U.S.C. 3507, FDA 60-day notice requesting public provide animal owners with has submitted the following proposed comment on the proposed collection of information on the colors used in collection of information to OMB for information. One comment was received animal food. Respondents to this collection are but did not respond to any of the four review and clearance. manufacturers of pet food that contain information collection topics solicited color additives. Manufacturers of certain and is therefore not addressed by the food or food ingredients do not have Agency. products that contain color additives FDA estimates the burden of this requiring certification (e.g., food for collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual 21 CFR Section/Activity burden per Total hours respondents per disclosures disclosure respondent 501.22(k); labeling of color additive or make of color addi- 3,120 0.83 2,587 .25 647 tive; labeling of color additives not subject to certification. (15 minutes) 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Having become effective November The Agency expects that firms DEPARTMENT OF HEALTH AND 18, 2013, the Agency estimates that the prepare the required labeling for their HUMAN SERVICES burden associated with the labeling products in a manner that takes into requirements under § 501.22(k) apply account at one time all information Food and Drug Administration only to new product labels. Because the required to be disclosed on their [Docket No. FDA–2015–N–2126] vast majority of animal food products product labels. Based on our experience that contain certified color additives are with reviewing pet food labeling, FDA Agency Information Collection pet foods, we limit our burden estimate estimates that firms would require less Activities; Proposed Collection; to reviewing labels for the use of than 0.25 hour (15 minutes) per product Comment Request; Evaluation of the certified color additives to pet food to comply with the requirement to Food and Drug Administration’s manufacturers subject to this regulation. include the color additive information Campaign To Reduce Tobacco Use Based on A.C. Nielsen Data, FDA pursuant to § 501.22(k). The total Among Lesbian, Gay, Bisexual, and estimates that the number of animal Transgender Young Adults burden of this activity is 647 hours food product units subject to § 501.22(k) (2,587 labels × 0.25 hour/label is AGENCY: Food and Drug Administration, for which sales of the products are approximately 647 hours). HHS. greater than zero is 25,874. Assuming ACTION: Notice. that the flow of new products is 10 Dated: June 25, 2015. percent per year, then 2,587 new animal Leslie Kux, SUMMARY: The Food and Drug food products subject to § 501.22(k) will Associate Commissioner for Policy. Administration (FDA) is announcing an come on the market each year. FDA also [FR Doc. 2015–16022 Filed 6–29–15; 8:45 am] opportunity for public comment on the estimates that there are about 3,120 proposed collection of certain asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 4164–01–P manufacturers of pet food subject to information by the Agency. Under the either § 501.22(k)(1) or (k)(2). Assuming Paperwork Reduction Act of 1995 (the the approximately 2,587 new products PRA), Federal Agencies are required to are split equally among the firms, then publish a notice in the Federal Register each firm would prepare labels for concerning each proposed collection of approximately 0.83 new products per information and to allow 60 days for year (2,587 new products/3,120 firms is public comment in response to the approximately 0.83 labels per firm). notice. This notice solicits comments on VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37271 the Evaluation of FDA’s Multicultural Evaluation of FDA’s Campaign To approximately 6-month intervals after Youth Tobacco Prevention Campaigns. Reduce Tobacco Use Among Lesbian, the campaign’s launch. Information will Gay, Bisexual, and Transgender Young be collected about young adult DATES: Submit either electronic or awareness of and exposure to campaign Adults OMB Control Number—0910- written comments on the collection of New events and advertisements and about information by August 31, 2015. tobacco-related knowledge, attitudes, The 2009 Family Smoking Prevention ADDRESSES: Submit electronic and Tobacco Control Act (Tobacco beliefs, intentions and use, as well as comments on the collection of Control Act) (Pub. L. 111–31) amends use of other tobacco products (e- information to http:// cigarettes, hookah, cigars, smokeless the Federal Food, Drug, and Cosmetic www.regulations.gov. Submit written tobacco), marijuana and alcohol. Act (the FD&C Act) to grant FDA comments on the collection of Information will also be collected on authority to regulate the manufacture, information to the Division of Dockets demographic variables including sexual marketing, and distribution of tobacco Management (HFA–305), Food and Drug orientation, age, sex, race/ethnicity, products to protect public health and to Administration, 5630 Fishers Lane, Rm. education, and primary language. reduce tobacco use by minors. Section All information will be collected 1061, Rockville, MD 20852. All 1003(d)(2)(D) of the FD&C Act (21 comments should be identified with the through in-person and web-based U.S.C. 393(d)(2)(D)) supports the questionnaires. Young adult docket number found in brackets in the development and implementation of heading of this document. respondents will be recruited in 30 U.S. FDA public education campaigns cities (15 campaign and 15 comparison FOR FURTHER INFORMATION CONTACT: FDA related to tobacco use. Accordingly, cities) from two sources: (1) Intercept PRA Staff, Office of Operations, Food FDA is currently developing and surveys in LGBT social venues (e.g., and Drug Administration, 8455 implementing public education bars and nightclubs) identified using a Colesville Rd., COLE–14526, Silver campaigns to help prevent and reduce time location sampling approach, and Spring, MD 20993–0002, PRAStaff@ tobacco use among lesbian, gay, (2) through social media advertisements fda.hhs.gov. bisexual and transgender (LGBT) young on Facebook and Twitter targeted at adults and thereby reduce the public LGBT 18 to 24-year-olds, living in the SUPPLEMENTARY INFORMATION: Under the health burden of tobacco. Overall the same 30 U.S. cities. Participation in the PRA (44 U.S.C. 3501–3520), Federal campaigns will feature events; study is voluntary. Agencies must obtain approval from the advertisements on television and radio Office of Management and Budget and in print; digital communications • Media Tracking Survey (OMB) for each collection of including social media; and other forms The media tracking survey consists of information they conduct or sponsor. of media. assessments of LGBT young adults aged ‘‘Collection of information’’ is defined In support of the provisions of the 18 to 24 conducted once yearly post in 44 U.S.C. 3502(3) and 5 CFR Tobacco Control Act that require FDA to campaign launch—timing that 1320.3(c) and includes Agency requests protect the public health and to reduce complements the outcome evaluation’s or requirements that members of the tobacco use, FDA requests OMB timing. The media tracking survey will public submit reports, keep records, or approval to collect information needed assess awareness of the campaign and provide information to a third party. to evaluate FDA’s campaign to reduce receptivity to campaign messages. These Section 3506(c)(2)(A) of the PRA (44 tobacco use among LGBT young adults. data will provide critical evaluation U.S.C. 3506(c)(2)(A)) requires Federal Comprehensive evaluation of FDA’s feedback to the campaigns and will be Agencies to provide a 60-day notice in public education campaigns is needed conducted with sufficient frequency to the Federal Register concerning each to ensure campaign messages are match the cyclical patterns of events proposed collection of information effectively received, understood, and and media advertising and variation in before submitting the collection to OMB accepted by those for whom they are exposure to allow for mid-campaign for approval. To comply with this intended. Evaluation is an essential refinements. For the media tracking requirement, FDA is publishing notice organizational practice in public health surveys, we will recruit LGBT young of the proposed collection of and a systematic way to account for and adults aged 18 to 24 from all campaign information set forth in this document. improve public health actions. cities through social media. FDA plans to conduct two studies to The information collected is With respect to the following evaluate the effectiveness of its LGBT necessary to inform FDA’s efforts and collection of information, FDA invites young adult tobacco prevention measure the effectiveness and public comments on these topics: (1) Whether campaign: (1) An outcome evaluation health impact of the campaigns. Data the proposed collection of information study to evaluate the effectiveness of its from the media tracking surveys will be is necessary for the proper performance LGBT young adult tobacco prevention used to estimate awareness of and of FDA’s functions, including whether campaign, and (2) a media tracking exposure to the campaigns among young the information will have practical questionnaire to assess awareness of and adults in target markets where the utility; (2) the accuracy of FDA’s receptivity to campaign messages. The campaigns are active. Data from the estimate of the burden of the proposed timing of these studies will be designed outcome evaluation study will be used collection of information, including the to follow the multiple, discrete waves of to examine statistical associations validity of the methodology and media advertising planned for the between awareness of and exposure to assumptions used; (3) ways to enhance the campaigns and subsequent changes asabaliauskas on DSK5VPTVN1PROD with NOTICES campaigns. the quality, utility, and clarity of the in specific outcomes of interest, which information to be collected; and (4) • Outcome Evaluation Study will include knowledge, attitudes, ways to minimize the burden of the The outcome evaluation study begins beliefs and intentions related to tobacco collection of information on with a baseline survey of LGBT young use. respondents, including through the use adults aged 18 to 24 before the FDA’s burden estimate is based on of automated collection techniques, campaign launch. The baseline will be prior experience with in-person studies when appropriate, and other forms of followed by three follow-up surveys of similar to the Agency’s plan presented information technology. the target audience of young adults at in this document, as well as previous VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

37272 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices research using social media advertising To obtain the target number of To obtain the target number of to recruit young adult participants. To completed questionnaires (‘‘completes’’) completes for the media tracking survey, reduce overall burden hours, for the outcome evaluation study, 5,000 young adults will be recruited via participants who screen and complete 18,376 young adults (11,810 recruited in social media ads to complete a screener the baseline outcome evaluation person and 6,566 recruited via social for all three waves of the media tracking questionnaire will be re-contacted to media) will participate in a screening survey. The estimated burden per complete the first follow up campaign process (‘‘screener’’). The estimated screener response is 5 minutes (0.083 evaluation questionnaire, those who burden per screener is 5 minutes hour), for a total of 414 hours for all complete the first follow up campaign (0.083), for a total of 1,525 hours (980 waves of media tracking screener. An evaluation questionnaire will be re- hours for participants recruited in estimated 500 LGBT young adults will contacted to complete the second follow person and 545 hours for persons complete each of the three waves of the up campaign evaluation questionnaire, recruited via social media). A total of media tracking survey (assuming a 30 12,600 LGBT young adults (9,448 of percent response rate to screeners via and so on. Re-contacted individuals will those screened in person and 3,152 of social media). The estimated burden per not need to complete the screener again. those screened through social media) completed media tracking questionnaire We expect a 50 percent response rate for will complete questionnaires in 4 is 40 minutes (0.667 hour), for a total of individuals recruited in person and a 30 rounds of data collection (baseline and 1,002 hours for the three waves. The percent rate for individuals recruited via three post-campaign rounds). The total burden for the media tracking social media. In each successive round estimated burden per complete is 30 survey (screeners and completes) is of data collection, we expect 50 percent minutes (0.5 hour) for the baseline 1,416 hours. of re-contacted individuals to complete questionnaire and 40 minutes (0.667 The target number of completed the follow up questionnaire, therefore, hour) for each follow up complete, for campaign questionnaires (screeners and additional screenings will be conducted a total of 7,878 hours (5,906 hours for questionnaires for both the outcome for each follow up in order to maintain those recruited in person and 1,972 evaluation and media tracking survey) the target sample size for each follow up hours for those recruited via social for all respondents is 37,477. The total questionnaire. media). estimated burden is 10,819 hours. TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Type of respondent Activity responses per burden per Total hours respondents responses respondent response General population—Re- Screener—Baseline—out- 4,724 1 4,724 0.083 (5 min.) ...... 392 cruited in person (50% come study. response rate). Screener—First follow 2,362 1 2,362 0.083 (5 min.) ....... 196 up—outcome study. Screener—Second follow 2,362 1 2,362 0.083 (5 min.) ...... 196 up—outcome study. Screener—Third follow 2,362 1 2,362 0.083 (5 min.) ...... 196 up—outcome study. LGBT young adults aged Baseline—outcome eval- 2,362 1 2,362 0.5 (30 min.) ......... 1181 18–24 in select media uation questionnaire. markets—Recruited in person. First follow up young 2,362 1 2,362 0.667 (40 min.) ..... 1575 adult outcome evalua- tion questionnaire. Second follow up young 2,362 1 2,362 0.667 (40 min.) ..... 1575 adult outcome evalua- tion questionnaire. Third follow up young 2,362 1 2,362 0.667 (40 min.) ..... 1575 adult outcome evalua- tion questionnaire. General population—Re- Screener—Baseline—out- 2,627 1 2,627 0.083 (5 min.) ....... 218 cruited via social media come study. (30% response rate). Screener—First follow 1,313 1 1,313 0.083 (5 min.) ....... 109 up—outcome study. Screener—Second follow 1,313 1 1,313 0.083 (5 min.) ...... 109 up—outcome study. Screener—Third follow 1,313 1 1,313 0.083 (5 min.) ...... 109 asabaliauskas on DSK5VPTVN1PROD with NOTICES up—outcome study. LGBT young adults aged Baseline—outcome eval- 788 1 788 0.5 (30 min.) ......... 394 18–24 in select media uation questionnaire. markets—Recruited via social media. First follow up young 788 1 788 0.667 (40 min.) ..... 526 adult outcome evalua- tion 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

Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37273 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Average Number of Total annual Type of respondent Activity responses per burden per Total hours respondents responses respondent response Second follow up young 788 1 788 0.667 (40 min.) ..... 526 adult outcome evalua- tion questionnaire. Third follow up young 788 1 788 0.667 (40 min.) ..... 526 adult outcome evalua- tion questionnaire. LGBT young adults aged 1st media tracking 1667 1 1667 0.083 (5 min.) ....... 138 18–24 in the select screener. media markets—Re- cruited via social media. 1st media tracking ques- 500 1 500 0.667 (40 min.) ..... 334 tionnaire. 2nd media tracking 1667 1 1667 0.083 (5 min.) ....... 138 screener. 2nd media tracking ques- 500 1 500 0.667 (40 min.) ..... 334 tionnaire. 3rd media tracking 1667 1 1667 0.083 (5 min.) ...... 138 screener. 3rd media tracking ques- 500 1 500 0.667 (40 min.) ..... 334 tionnaire. 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. recommendations identified in this Hampshire Ave., Bldg. 75, Rm. 4730, Leslie Kux, notice were developed using the process Silver Spring, MD 20993–0002, 301– Associate Commissioner for Policy. described in that guidance. 796–5850. [FR Doc. 2015–16020 Filed 6–29–15; 8:45 am] DATES: Although you can comment on SUPPLEMENTARY INFORMATION: BILLING CODE 4164–01–P any guidance at any time (see 21 CFR I. Background 10.115(g)(5)), to ensure that the Agency considers your comments on these draft In the Federal Register of June 11, DEPARTMENT OF HEALTH AND and revised draft guidances before it 2010 (75 FR 33311), FDA announced the HUMAN SERVICES begins work on the final versions of the availability of a guidance for industry guidances, submit either electronic or entitled ‘‘Bioequivalence Food and Drug Administration written comments on the draft and Recommendations for Specific [Docket No. FDA–2007–D–0369] revised draft product-specific BE Products’’ that explained the process recommendations listed in this notice that would be used to make product- Product-Specific Bioequivalence by August 31, 2015. specific BE recommendations available Recommendations; Draft and Revised to the public on FDA’s Web site at ADDRESSES: Submit written requests for Draft Guidances for Industry; http://www.fda.gov/Drugs/Guidance single copies of the individual BE Availability ComplianceRegulatoryInformation/ guidances to the Division of Drug Guidances/default.htm. AGENCY: Food and Drug Administration, Information, Center for Drug Evaluation As described in that guidance, FDA HHS. and Research, Food and Drug adopted this process as a means to Administration, 10001 New Hampshire develop and disseminate product- ACTION: Notice. Ave., Hillandale Bldg., 4th Floor, Silver specific BE recommendations and SUMMARY: The Food and Drug Spring, MD 20993–0002. Send one self- provide a meaningful opportunity for Administration (FDA or Agency) is addressed adhesive label to assist that the public to consider and comment on announcing the availability of office in processing your requests. See those recommendations. Under that additional draft and revised draft the SUPPLEMENTARY INFORMATION section process, draft recommendations are product-specific bioequivalence (BE) for electronic access to the draft posted on FDA’s Web site and recommendations. The guidance recommendations. announced periodically in the Federal recommendations provide product- Submit electronic comments on the Register. The public is encouraged to specific guidance on the design of BE draft product-specific BE submit comments on those studies to support abbreviated new drug recommendations to http:// recommendations within 60 days of applications (ANDAs). In the Federal www.regulations.gov. Submit written their announcement in the Federal asabaliauskas on DSK5VPTVN1PROD with NOTICES Register of June 11, 2010, FDA comments to the Division of Dockets Register. FDA considers any comments announced the availability of a guidance Management (HFA–305), Food and Drug received and either publishes final for industry entitled ‘‘Bioequivalence Administration, 5630 Fishers Lane, rm. recommendations or publishes revised Recommendations for Specific 1061, Rockville, MD 20852. draft recommendations for comment. Products’’ that explained the process FOR FURTHER INFORMATION CONTACT: Recommendations were last announced that would be used to make product- Xiaoqiu Tang, Center for Drug in the Federal Register on March 9, specific BE recommendations available Evaluation and Research, Food and 2015 (80 FR 12502). This notice to the public on FDA’s Web site. The BE Drug Administration, 10903 New announces draft product-specific VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1


Document Created: 2018-02-22 11:17:27
Document Modified: 2018-02-22 11:17:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by August 31, 2015.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 37270 
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