83 FR 63176 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco Among the Lesbian Gay Bisexual Transgender Community
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 235 (December 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 235 (December 7, 2018)
| Page Range | 63176-63178 | |
| FR Document | 2018-26555 |
[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)] [Notices] [Pages 63176-63178] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26555] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2126] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco Among the Lesbian Gay Bisexual Transgender Community 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 January 7, 2019. 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 0910-0808. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Food and Drug Administration's (FDA's) Research and Evaluation Survey for the Public Education Campaign on Tobacco (RESPECT) Among the LGBT Community OMB Control Number 0910-0808--Extension The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and Cosmetic Act (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. In May 2016, FDA began implementing a public education campaign 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. The campaign continues to be implemented in 12 U.S. cities and features events, television and radio and print advertisements, digital communications, including videos, social media, and other forms of media. For the purpose of this notice, these campaign elements will be referred to as ``advertisements'' or ``ads.'' 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. To evaluate the effectiveness of FDA's RESPECT at reducing tobacco use among LGBT young adults aged 18 to 24, FDA contracted with RTI International to conduct Web-based surveys with the target population in the 12 campaign cities and 12 comparison cities. The surveys include measures of tobacco-related knowledge, attitudes, beliefs, intentions, and use as well as measures of audience awareness of and exposure to campaign events and advertisements. The voluntary surveys also collect information on demographic variables, including sexual orientation, age, sex, race/ethnicity, education, and [[Page 63177]] primary language. Baseline data collection for RESPECT was conducted between February and May 2016. Four subsequent waves of data collection were conducted with new (cross-sectional) and returning (longitudinal) respondents. This design facilitated analysis of relationships between individuals' exposure to campaign activities and baseline to followup changes in outcomes of interest between campaign and comparison cities. Information collection for baseline and the first four followups was reviewed and approved by OMB. FDA will continue to implement RESPECT in 12 U.S. cities through April 2019. To complete the evaluation of RESPECT, FDA is requesting an extension of the previously approved information collection in order to conduct two additional waves of data collection with the target population. The proposed sixth and seventh waves of data collection (i.e., fifth and sixth followups after baseline) will coincide with the official end of the campaign, and will serve as an assessment of the campaign at completion. Continued evaluation is necessary in order to determine the campaign's impact on outcomes of interest. As in previous waves, new and returning survey respondents will be invited to complete the online questionnaire. New (or cross-sectional) respondents will be recruited at LGBT social venues and via social media (i.e., Facebook and Twitter). In-person recruitment will take place in a variety of LGBT venues. The owners or managers of potential recruitment sites will be asked a series of questions to determine the appropriateness of its clientele for participation in the study. For the fifth and sixth followups, an estimated 60 new venues (20 annualized) will be assessed at 5 minutes per assessment, for an additional 5 hours (1.67 annualized). A total of 1,980 venues (660 annualized) will be assessed during the evaluation study, for a total of 165 hours (55 annualized). Our goal is to recruit 75 percent of the sample via intercept interviews and 25 percent via social media. To obtain the target number of completed fifth and sixth followup questionnaires, an additional 11,904 adults (3,968 annualized) recruited in person and 2,736 adults (912 annualized) recruited via social media will complete screening questionnaires. For the entire evaluation study, a total of 33,717 adults (11,239 annualized) recruited in person will complete screening questionnaires along with 10,617 adults (3,539 annualized) recruited via social media. The estimated burden to complete the screening questionnaire is 5 minutes (0.083 hour), for a total of 2,799 hours (933 annualized) for in-person recruits and 881 hours (294 annualized) for social media recruits. Based on analysis of response rates from prior waves of data collection, we expect 65 percent of intercept respondents will be deemed eligible and 50 percent of those will complete the fifth followup questionnaire. We expect 30 percent of those recruited via social media will be deemed eligible and complete the fifth followup questionnaire. Lastly, we expect 50 percent of returning (or longitudinal) respondents to complete the fifth and sixth followup questionnaires. We estimate that approximately 2,100 new respondents (700 annualized) and 6,678 returning (2,226 annualized) respondents will complete the fifth and sixth followup questionnaires, for a total of 8,778 responses (2,926 annualized). OMB previously approved 3,156 (1,052 annualized) respondents recruited via social media and 9,456 (3,152 annualized) respondents recruited in person to complete the first four followup questionnaires. Adding the fifth and sixth followups brings the total estimated number of followup questionnaires completed by social media recruits to 5,256 (1,752 annualized) and by in-person recruits to 16,134 (5,378 annualized). At 40 minutes per completed questionnaire, the total burden is 3,507 hours (1,169 annualized) for social media respondents and 10,761 hours (3,587 annualized) for in-person respondents. OMB also previously approved 393 hours (approximately 132 annualized) for social media respondents and 1,182 hours (394 annualized) for in-person respondents to complete baseline questionnaires. OMB also approved the pilot test of procedures in bars (6 hours (2 annualized)). As these study components are complete, the corresponding burden will not change. Lastly, the original study design included a media tracking component, which included a burden of 414 hours (138 annualized) for completing a 5-minute screening questionnaire and 999 hours (333 annualized) for completing the media tracking questionnaire. However, this component was dropped from the study; hence, the related burden has been deducted from the total study burden. In the Federal Register of August 2, 2018 (83 FR 37817), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received a total of nine comments from the public, of which five were PRA-related. (Comment) Two commenters indicated support for FDA's efforts to evaluate media campaigns targeting smoking within the LGBT community. (Response) FDA appreciates the public's support of its efforts to meet its mission to promote and protect public health. (Comment) One commenter questioned the need for further data collection on this topic. (Response) FDA disagrees. This collection of information is necessary for FDA to meet its mission to promote and protect public, and in its implementation of the Tobacco Control Act. (Comment) One commenter questioned whether the evaluation is collecting sufficient data on the campaign's impact on the target population's thinking about smoking. (Response) The campaign is intended to influence the target population's attitude towards smoking. To evaluate the effectiveness of the campaign, FDA is asking questions about the target population's tobacco use-related knowledge, attitudes, beliefs, and intentions before and after seeing the campaign's ads to test whether those have changed over time as a result of exposure to the campaign. (Comment) One commenter questioned the utility of collecting data on smoking among LGBT young adults without first gathering information on smoking rates in this population, and also suggested specific modes for participant recruitment. (Response) Multiple peer-reviewed studies have found that LGBT populations of all age groups are significantly more likely to smoke cigarettes and use other tobacco products compared to non-LGBT populations. FDA appreciates the detailed review of the evaluation's recruitment approach. Consistent with the commenter's recommendation, this information collection recruits participants both online via social media platforms and in person at LGBT social venues. This information collection does not recruit on the street or advertise via television. (Comment) Several comments raised questions about the appropriateness of the target population and implementation approach of the public education campaigns being conducted by FDA. (Response) FDA notes that these comments address the content, focus, or implementation of an existing public education campaign, and are therefore outside the scope of this information [[Page 63178]] collection, which is being conducted to evaluate the campaign. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Respondent type and activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Venue Owners and Managers................. 660 1 660 0.083 (5 minutes)........................... 55 General Population: Pilot test of 27 1 27 0.083 (5 minutes)........................... 2 Procedures in Bars. General population--outcome screener (in 11,239 1 11,239 0.083 (5 minutes)........................... 933 person). General population--outcome screener 3,539 1 3,539 0.083 (5 minutes)........................... 294 (social media). LGBT young adults outcome baseline (social 263 1 263 0.5 (30 minutes)............................ 132 media). LGBT young adults outcome baseline (in 788 1 788 0.5 (30 minutes)............................ 394 person). LGBT young adults outcome followup 1,752 1 1,752 0.667 (40 minutes).......................... 1,169 questionnaire (social media). LGBT young adults outcome followup 5,378 1 5,378 0.667 (40 minutes).......................... 3,587 questionnaire (in person). ------------------------------------------------------------------------------------------------------------- Totals................................ .............. .............. .............. ............................................ 6,566 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. To accommodate the additional waves of data collection, FDA requests approval to increase the number of burden hours under the existing control number. The previous number of approved responses was 53,967 (17,989 annualized), and the previous burden was 14,031 hours (4,677 annualized). The fifth and sixth followups add 23,478 responses (7,826 annualized), which include responses to new venues assessments, screening questionnaires, and the followup questionnaires, for a total of 7,074 additional burden hours (2,357 annualized). Removing the media tracking component deducts 6,507 responses (2,169 annualized) and 1,413 burden hours (471 annualized). The totals for the entire evaluation study are increasing by 16,971 responses (5,657 annualized) and 5,661 hours (1,887 annualized) for a new total of 70,938 responses (23,646 annualized) and 19,692 burden hours (approximately 6,566 annualized). Dated: November 30, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26555 Filed 12-6-18; 8:45 am] BILLING CODE 4164-01-P
![63176 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices
*10. FDA, Food Code 2017 2–301.12. Dated: December 3, 2018. Food and Drug Administration’s
Available at https://www.fda.gov/ Leslie Kux, (FDA’s) Research and Evaluation
downloads/Food/GuidanceRegulation/ Survey for the Public Education
Associate Commissioner for Policy.
RetailFoodProtection/FoodCode/ Campaign on Tobacco (RESPECT)
UCM595140.pdf. Accessed on May 15, [FR Doc. 2018–26561 Filed 12–6–18; 8:45 am]
Among the LGBT Community
2018. BILLING CODE 4164–01–P
*11. ‘‘Diseases Transmitted through the Food OMB Control Number 0910–0808—
Supply: Pathogens Transmitted by Food Extension
Contaminated by Infected Person Who DEPARTMENT OF HEALTH AND The 2009 Family Smoking Prevention
Handle Food, and Modes of HUMAN SERVICES and Tobacco Control Act (Tobacco
Transmission of Such Pathogens.’’
Control Act) (Pub. L. 111–31) amended
Available at https://www.cdc.gov/ Food and Drug Administration the Federal Food, Drug, and Cosmetic
foodsafety/pdfs/pathogens-by-food-
handlers-508c.pdf.
Act (FD&C Act) to grant FDA authority
*12. Gould, H., et al. ‘‘Surveillance for
[Docket No. FDA–2015–N–2126] to regulate the manufacture, marketing,
Foodborne Disease Outbreaks-United and distribution of tobacco products to
Agency Information Collection protect public health and to reduce
States 1998–2008,’’ Morbidity and
Mortality Weekly Report, Surveillance Activities; Submission for Office of tobacco use by minors. Section
Summaries 62 (2). Management and Budget Review; 1003(d)(2)(D) of the FD&C Act (21
*13. Transcript of the October 20, 2005, Comment Request; Food and Drug U.S.C. 393(d)(2)(D)) supports the
Nonprescription Drugs Advisory Administration’s Research and development and implementation of
Committee Meeting. Available at http:// Evaluation Survey for the Public FDA public education campaigns
wayback.archive-it.org/7993/2017 Education Campaign on Tobacco related to tobacco use. In May 2016,
0404055923/https:/www.fda.gov/ohrms/ Among the Lesbian Gay Bisexual FDA began implementing a public
dockets/ac/05/transcripts/2005- Transgender Community education campaign to help prevent and
4184T1.pdf. Accessed May 15, 2018 reduce tobacco use among Lesbian, Gay,
*14. Comment submitted in Docket No. AGENCY: Food and Drug Administration, Bisexual, and Transgender (LGBT)
FDA–1975–N–0012–0037. Available at young adults and thereby reduce the
https://www.regulations.gov/search
HHS.
public health burden of tobacco. The
Results?rpp=25&po=0&s=FDA-1975-N- ACTION: Notice. campaign continues to be implemented
0012-0037&fp=true&ns=true. Accessed
in 12 U.S. cities and features events,
May 15, 2018. SUMMARY: The Food and Drug
*15. Comment submitted in Docket No.
television and radio and print
Administration (FDA) is announcing advertisements, digital communications,
FDA–1975–N–0012–0038. Available at
https://www.regulations.gov/ that a proposed collection of including videos, social media, and
searchResults?rpp=25&po=0&s=FDA- information has been submitted to the other forms of media. For the purpose
1975-N-0012-0038&fp=true&ns=true. Office of Management and Budget of this notice, these campaign elements
16. ASTM International, ‘‘ASTM E2720, (OMB) for review and clearance under will be referred to as ‘‘advertisements’’
Standard Practice for Evaluation of the Paperwork Reduction Act of 1995. or ‘‘ads.’’
Effectiveness of Decontamination In support of the provisions of the
Procedures for Air-Permeable Materials DATES: Fax written comments on the Tobacco Control Act that require FDA to
when Challenged with Biological collection of information by January 7, protect the public health and to reduce
Aerosols Containing Human Pathogenic 2019. tobacco use, FDA requests OMB
Viruses.’’ Available at https:// approval to collect information needed
www.astm.org/search/fullsite- ADDRESSES: To ensure that comments on
to evaluate FDA’s campaign to reduce
search.html?query= the information collection are received,
tobacco use among LGBT young adults.
E2720&toplevel=products-and- OMB recommends that written
Comprehensive evaluation of FDA’s
services&sublevel=standards-and- comments be faxed to the Office of public education campaigns is needed
publications. Accessed on May 15, 2018. Information and Regulatory Affairs, to ensure campaign messages are
17. ASTM International, ‘‘ASTM E1052, OMB, Attn: FDA Desk Officer, Fax: 202– effectively received, understood, and
Standard Test Method to Assess the 395–7285, or emailed to oira_
Activity of Microbicides against Viruses accepted by those for whom they are
submission@omb.eop.gov. All intended. Evaluation is an essential
in Suspension.’’ Available at https://
www.astm.org/search/fullsite-
comments should be identified with the organizational practice in public health
search.html?query= OMB control number 0910–0808. Also and a systematic way to account for and
e1052&resStart=0&resLength= include the FDA docket number found improve public health actions.
10&toplevel=products-and- in brackets in the heading of this To evaluate the effectiveness of FDA’s
services&sublevel=standards-and- document. RESPECT at reducing tobacco use
publications&. Accessed on May 15, among LGBT young adults aged 18 to
2018. FOR FURTHER INFORMATION CONTACT: 24, FDA contracted with RTI
*18. Petition Denial Response Letter from Amber Sanford, Office of Operations, International to conduct Web-based
FDA to PCPC and SDA. No. FDA–1975– Food and Drug Administration, Three surveys with the target population in
0012–0042. Available at https:// White Flint North, 10A–12M, 11601 the 12 campaign cities and 12
www.regulations.gov/document?D=FDA- Landsdown St., North Bethesda, MD comparison cities. The surveys include
1975-N-0012-0042. Accessed on May 15,
20852, 301–796–8867, PRAStaff@ measures of tobacco-related knowledge,
2018.
amozie on DSK3GDR082PROD with NOTICES
19. Steinman, J., ‘‘Some Principles of
fda.hhs.gov. attitudes, beliefs, intentions, and use as
Virucidal Testing,’’ Journal of Hospital well as measures of audience awareness
SUPPLEMENTARY INFORMATION: In of and exposure to campaign events and
Infection, 48:S15–S17, 2001.
*20. Comment submitted in Docket No.
compliance with 44 U.S.C. 3507, FDA advertisements. The voluntary surveys
FDA–1975–N–0012–0494. Available at has submitted the following proposed also collect information on demographic
https://www.regulations.gov/document? collection of information to OMB for variables, including sexual orientation,
D=FDA-1975-N-0012-0494. review and clearance. age, sex, race/ethnicity, education, and
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![63178 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Notices
collection, which is being conducted to FDA estimates the burden of this
evaluate the campaign. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Respondent type and activity responses per burden per Total hours
respondents responses
respondent response
Venue Owners and Managers ............................ 660 1 660 0.083 (5 minutes) ........... 55
General Population: Pilot test of Procedures in 27 1 27 0.083 (5 minutes) ........... 2
Bars.
General population—outcome screener (in per- 11,239 1 11,239 0.083 (5 minutes) ........... 933
son).
General population—outcome screener (social 3,539 1 3,539 0.083 (5 minutes) ........... 294
media).
LGBT young adults outcome baseline (social 263 1 263 0.5 (30 minutes) ............. 132
media).
LGBT young adults outcome baseline (in per- 788 1 788 0.5 (30 minutes) ............. 394
son).
LGBT young adults outcome followup question- 1,752 1 1,752 0.667 (40 minutes) ......... 1,169
naire (social media).
LGBT young adults outcome followup question- 5,378 1 5,378 0.667 (40 minutes) ......... 3,587
naire (in person).
Totals ............................................................ ........................ ........................ ........................ ........................................ 6,566
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
To accommodate the additional waves DEPARTMENT OF HEALTH AND that the Agency considers your
of data collection, FDA requests HUMAN SERVICES comment before it begins work to
approval to increase the number of implement the program.
burden hours under the existing control Food and Drug Administration
ADDRESSES: You may submit comments
number. The previous number of [Docket No. FDA–2018–N–4000] as follows:
approved responses was 53,967 (17,989
annualized), and the previous burden Framework for a Real-World Evidence Electronic Submissions
was 14,031 hours (4,677 annualized). Program; Availability Submit electronic comments in the
The fifth and sixth followups add AGENCY: Food and Drug Administration, following way:
23,478 responses (7,826 annualized), HHS. • Federal eRulemaking Portal:
which include responses to new venues ACTION: Notice of availability. https://www.regulations.gov. Follow the
assessments, screening questionnaires, instructions for submitting comments.
and the followup questionnaires, for a SUMMARY: The Food and Drug Comments submitted electronically,
total of 7,074 additional burden hours Administration (FDA or Agency) is including attachments, to https://
(2,357 annualized). Removing the media establishing a public docket to collect www.regulations.gov will be posted to
tracking component deducts 6,507 comments on a framework created by the docket unchanged. Because your
responses (2,169 annualized) and 1,413 the Center for Drug Evaluation and comment will be made public, you are
burden hours (471 annualized). The Research and the Center for Biologic solely responsible for ensuring that your
totals for the entire evaluation study are Evaluation and Research for comment does not include any
implementing a program to evaluate the confidential information that you or a
increasing by 16,971 responses (5,657
potential use of real-world evidence third party may not wish to be posted,
annualized) and 5,661 hours (1,887
(RWE) in regulatory decision making. such as medical information, your or
annualized) for a new total of 70,938
This framework is entitled ‘‘Framework anyone else’s Social Security number, or
responses (23,646 annualized) and for the Real-World Evidence Program.’’ confidential business information, such
19,692 burden hours (approximately The 21st Century Cures Act (Cures Act) as a manufacturing process. Please note
6,566 annualized). was enacted on December 13, 2016, and that if you include your name, contact
Dated: November 30, 2018. requires that FDA establish a framework information, or other information that
Leslie Kux, for implementing a program to evaluate identifies you in the body of your
Associate Commissioner for Policy.
the potential use of RWE to help comments, that information will be
support the approval of a new posted on https://www.regulations.gov.
[FR Doc. 2018–26555 Filed 12–6–18; 8:45 am]
indication for a drug approved under • If you want to submit a comment
BILLING CODE 4164–01–P
the Federal Food, Drug, and Cosmetic with confidential information that you
Act (FD&C Act) and to help support or do not wish to be made available to the
satisfy postapproval study requirements. public, submit the comment as a
amozie on DSK3GDR082PROD with NOTICES
FDA has created this framework to written/paper submission and in the
satisfy the Cures Act mandate and is manner detailed (see ‘‘Written/Paper
establishing a docket to receive public Submissions’’ and ‘‘Instructions’’).
comments.
Written/Paper Submissions
DATES: Submit either electronic or
written comments on the draft Submit written/paper submissions as
document by February 5, 2019 to ensure follows:
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Document Created: 2018-12-07 01:52:50
Document Modified: 2018-12-07 01:52:50
| 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 January 7, 2019. | |
| Contact | Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected] | |
| FR Citation | 83 FR 63176 |
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