Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns, 46021-46022 [2019-18938]

Download as PDF Federal Register / Vol. 84, No. 170 / Tuesday, September 3, 2019 / Notices nominations must be compounded using a bulk drug substance rather than the approved drug product. IV. Other Issues Raised in Nominations khammond on DSKBBV9HB2PROD with NOTICES Some of the bulk drug substance nominations included in this notice state that there could be a benefit gained from providing drug products containing each of these bulk drug substances that do not require dilution or reconstitution prior to administration. More broadly, as explained above, when a bulk drug substance is a component of an approved drug, FDA asks whether there is a basis to conclude that an attribute of each approved drug product makes each one medically unsuitable to treat certain patients for their condition, an interpretation that protects patients and the integrity of the drug approval process. The nominations do not show that the approved drug product, when not manufactured in the ready-to-use form, is medically unsuitable for certain patients. Nor do the nominations establish that drug products in the relevant concentrations, including ready-to-use products, cannot be prepared from the approved drug products. Rather, they propose to compound a ready-to-use product from bulk drug substances to seek improved efficiency for prescribers or healthcare providers, or to address the possibility that the approved drug might be mishandled by a medical professional, neither of which falls within the meaning of clinical need to compound a drug product using a bulk drug substance. Some of the nominations for the substances in this notice include statements that these substances should be added to the 503B Bulks List because compounding from the bulk drug substance could help outsourcing facilities address drug shortages and supply disruptions of approved drugs. As noted above, section 503B of the FD&C Act contains a separate provision for compounding from bulk drug substances to address a drug shortage, and we do not interpret the other priceand supply-related issues advanced by the nominations to be within the meaning of ‘‘clinical need’’ for compounding with a bulk drug substance.51 51 Please see the final guidance entitled ‘‘Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act’’ (503B Bulks Evaluation Guidance) (84 FR 7390); available at https://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/ Guidances/UCM602276.pdf and the Federal Register notice entitled ‘‘List of Bulk Drug VerDate Sep<11>2014 16:24 Aug 30, 2019 Jkt 247001 Some of the nominations for the substances in this notice assert that it would be preferable to compound a drug product using a bulk drug substance rather than using an approved drug product; however, they do not take the position or provide support for the position that a bulk drug substance must be used to prepare these concentrations.52 V. Conclusion For the reasons stated above, we find no basis to conclude that there is a clinical need for outsourcing facilities to compound drug products using the bulk drug substances dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide. We therefore propose to not include dipyridamole, ephedrine sulfate, famotidine, hydralazine hydrochloride, methacholine chloride, sodium bicarbonate, sodium tetradecyl sulfate, trypan blue, and vecuronium bromide on the 503B Bulks List. Dated: August 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–18932 Filed 8–30–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0717] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaigns AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the SUMMARY: Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act’’ available at https:// www.federalregister.gov/documents/2019/03/04/ 2019-03810/list-of-bulk-drug-substances-for-whichthere-is-a-clinical-need-under-section-503b-of-thefederal. 52 For example, the nominations do not take the position or provide support for the position that a drug product prepared by starting with the approved drug would be unsuitable for administration. PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 46021 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 October 3, 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 oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0753. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.–12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301–796–8867, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Evaluation of the Food and Drug Administration’s General Market Youth Tobacco Prevention Campaigns OMB Control Number 0910–0753— Extension Overview of the Evaluation Studies The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111–31) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing youth-targeted public education campaigns to help prevent tobacco use among youth and thereby reduce the public health burden of tobacco. The campaigns feature televised advertisements along with complementary ads on radio, on the internet, in print, and through other forms of media. Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. Comprehensive evaluation of FDA’s E:\FR\FM\03SEN1.SGM 03SEN1 46022 Federal Register / Vol. 84, No. 170 / Tuesday, September 3, 2019 / Notices public education campaigns will be used to document whether the intended audience is aware of and understands campaign messages; and whether campaign exposure influences beliefs about tobacco, susceptibility to tobacco use, and tobacco use behavior. All the information collected is integral to that evaluation. FDA conducted three studies to evaluate the effectiveness of its youth tobacco prevention campaigns: (1) An outcome evaluation study of its General Market Youth Tobacco Prevention Campaign, (2) an outcome evaluation of the Rural Male Youth Smokeless Tobacco Campaign, and (3) a media tracking survey. The timing of these studies follows the multiple, discrete waves of media advertising planned for the campaigns. The outcome evaluation of the smokeless tobacco campaign and the media tracking survey are now complete, while evaluation of the General Market Youth Tobacco Prevention campaign is ongoing. The General Market Youth Tobacco Prevention Campaign The General Market Youth Tobacco Prevention Campaign targets youth who are at risk for smoking, or who have experimented with smoking but not progressed to regular smoking. The campaign evaluation consists of surveys conducted with two cohorts of youth and their parents or guardians. Each cohort consists of an initial baseline survey of youth aged 11 to 16, and followup surveys of the same youth at approximate 8-month intervals. At baseline, surveys are also conducted with the parent or legal guardian of each youth to collect data on household characteristics and media use. Because youth age over the study period, the age range of youth and young adults among whom we collect data over the study period are aged 11 to 18. Data collection associated with the first cohort, including a baseline survey and four followup surveys, is complete. We have also completed baseline and first followup data collection for the second cohort. We are planning two additional followup surveys of youth in the second cohort. Methods Used for the Evaluation Study All information for the General Market campaign evaluation is being collected through in-person and webbased questionnaires. Youth respondents were recruited from a probability sample drawn from 90 U.S. media markets gathered using an address-based postal mail sampling of U.S. households. Participation in the study is voluntary. Purpose of the Evaluation Studies The studies are being conducted in support of the provisions of the Tobacco Control Act, which require FDA to protect the public health and reduce tobacco use by minors. The information being collected is necessary to inform FDA’s efforts towards those goals and to measure the effectiveness and public health impact of the campaigns. Data from the outcome evaluation of the General Market and Rural Male Youth Smokeless campaigns are being used to examine statistical associations between exposure to the campaigns and subsequent changes in specific outcomes of interest, which include knowledge, attitudes, beliefs, and intentions related to tobacco use, as well as behavioral outcomes including tobacco use. Data from the media tracking survey are being used to estimate awareness of and exposure to the campaigns among youth nationally as well as among youth in geographic areas targeted by the campaign. In the Federal Register of May 17, 2019 (84 FR 22499), FDA published a 60-day notice requesting public comment on the proposed collection of information. Four comments were received that were not PRA related. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Total annual responses Screener and Consent Process (Parent Permission). Telephone Verification Survey .............................. 6,270 1 6,270 .125 (7.5 minutes) ........ 784 627 1 627 .1333 (8 minutes) ......... 84 Recruitment Materials—Panel Maintenance Letter, Lead Letter, Survey Invitation Email, Q&As; Study Description; Email Reminders, Reminder Letter, Notifications. Youth Assent under 18 .......................................... Youth Consent 18 and up ..................................... Cohort 2—Youth 1st, 2nd, 3rd Followup Questionnaire. 6,270 1 6,270 .20 (12 minutes) ........... 1,254 5,874 396 6,270 1 1 1 5,874 396 6,270 .08 (5 minutes) ............. .08 (5 minutes) ............. 0.75 (45 minutes) ......... 470 32 4,703 .................... ........................ 25,707 ...................................... 7,327 Activity General Population ......... Parent of Youth Baseline Survey. Participants ..................... Cohort 2 Youth Assent ... Cohort 2—Youth Aged 11 to 18. Totals ....................... 1 There khammond on DSKBBV9HB2PROD with NOTICES Number of respondents Type of respondent ................................................................................ Average burden per response Total hours are no capital costs or operating and maintenance costs associated with this collection of information. FDA has revised the burden since publication of the 60-day notice due to the decision to complete data collection for the Media Tracking Survey earlier than originally planned. Therefore, the estimated burden hours for the: (1) Screener and Consent Process, (2) Parent Baseline Questionnaire, (3) Media Tracking Screener, and (4) three waves of Media Tracking VerDate Sep<11>2014 18:38 Aug 30, 2019 Jkt 247001 Questionnaires are no longer needed or requested. In addition, we have completed the baseline and first wave of followup data collection for Cohort 2 of the General Market campaign evaluation. The new estimated burden for this collection is 25,707 responses and 7,327 hours. This is a decrease of 117,120 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 responses and 21,010 hours from the current approved information collection. Dated: August 26, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–18938 Filed 8–30–19; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\03SEN1.SGM 03SEN1

Agencies

[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Pages 46021-46022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18938]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0717]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Evaluation of the 
Food and Drug Administration's General Market Youth Tobacco Prevention 
Campaigns

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
3, 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 0910-0753. 
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, 10 a.m.-12 p.m., 
11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Evaluation of the Food and Drug Administration's General Market Youth 
Tobacco Prevention Campaigns

OMB Control Number 0910-0753--Extension

Overview of the Evaluation Studies
    The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the 
manufacture, marketing, and distribution of tobacco products to protect 
public health and to reduce tobacco use by minors. Section 
1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the 
development and implementation of FDA public education campaigns 
related to tobacco use. Accordingly, FDA is currently developing and 
implementing youth-targeted public education campaigns to help prevent 
tobacco use among youth and thereby reduce the public health burden of 
tobacco. The campaigns feature televised advertisements along with 
complementary ads on radio, on the internet, in print, and through 
other forms of media.
    Evaluation is an essential organizational practice in public health 
and a systematic way to account for and improve public health actions. 
Comprehensive evaluation of FDA's

[[Page 46022]]

public education campaigns will be used to document whether the 
intended audience is aware of and understands campaign messages; and 
whether campaign exposure influences beliefs about tobacco, 
susceptibility to tobacco use, and tobacco use behavior. All the 
information collected is integral to that evaluation.
    FDA conducted three studies to evaluate the effectiveness of its 
youth tobacco prevention campaigns: (1) An outcome evaluation study of 
its General Market Youth Tobacco Prevention Campaign, (2) an outcome 
evaluation of the Rural Male Youth Smokeless Tobacco Campaign, and (3) 
a media tracking survey. The timing of these studies follows the 
multiple, discrete waves of media advertising planned for the 
campaigns. The outcome evaluation of the smokeless tobacco campaign and 
the media tracking survey are now complete, while evaluation of the 
General Market Youth Tobacco Prevention campaign is ongoing.
The General Market Youth Tobacco Prevention Campaign
    The General Market Youth Tobacco Prevention Campaign targets youth 
who are at risk for smoking, or who have experimented with smoking but 
not progressed to regular smoking. The campaign evaluation consists of 
surveys conducted with two cohorts of youth and their parents or 
guardians. Each cohort consists of an initial baseline survey of youth 
aged 11 to 16, and followup surveys of the same youth at approximate 8-
month intervals. At baseline, surveys are also conducted with the 
parent or legal guardian of each youth to collect data on household 
characteristics and media use. Because youth age over the study period, 
the age range of youth and young adults among whom we collect data over 
the study period are aged 11 to 18.
    Data collection associated with the first cohort, including a 
baseline survey and four followup surveys, is complete. We have also 
completed baseline and first followup data collection for the second 
cohort. We are planning two additional followup surveys of youth in the 
second cohort.
Methods Used for the Evaluation Study
    All information for the General Market campaign evaluation is being 
collected through in-person and web-based questionnaires. Youth 
respondents were recruited from a probability sample drawn from 90 U.S. 
media markets gathered using an address-based postal mail sampling of 
U.S. households. Participation in the study is voluntary.
Purpose of the Evaluation Studies
    The studies are being conducted in support of the provisions of the 
Tobacco Control Act, which require FDA to protect the public health and 
reduce tobacco use by minors. The information being collected is 
necessary to inform FDA's efforts towards those goals and to measure 
the effectiveness and public health impact of the campaigns. Data from 
the outcome evaluation of the General Market and Rural Male Youth 
Smokeless campaigns are being used to examine statistical associations 
between exposure to the campaigns and subsequent changes in specific 
outcomes of interest, which include knowledge, attitudes, beliefs, and 
intentions related to tobacco use, as well as behavioral outcomes 
including tobacco use. Data from the media tracking survey are being 
used to estimate awareness of and exposure to the campaigns among youth 
nationally as well as among youth in geographic areas targeted by the 
campaign.
    In the Federal Register of May 17, 2019 (84 FR 22499), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Four comments were received that were not 
PRA related.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of       Total
         Type of respondent                    Activity            Number of    responses per     annual      Average burden per response    Total hours
                                                                  respondents    respondent     responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
General Population.................  Screener and Consent               6,270               1        6,270  .125 (7.5 minutes).............          784
                                      Process (Parent
                                      Permission).
Parent of Youth Baseline Survey....  Telephone Verification               627               1          627  .1333 (8 minutes)..............           84
                                      Survey.
 Participants......................  Recruitment Materials--            6,270               1        6,270  .20 (12 minutes)...............        1,254
                                      Panel Maintenance Letter,
                                      Lead Letter, Survey
                                      Invitation Email, Q&As;
                                      Study Description; Email
                                      Reminders, Reminder
                                      Letter, Notifications.
Cohort 2 Youth Assent..............  Youth Assent under 18......        5,874               1        5,874  .08 (5 minutes)................          470
Cohort 2--Youth Aged 11 to 18......  Youth Consent 18 and up....          396               1          396  .08 (5 minutes)................           32
                                     Cohort 2--Youth 1st, 2nd,          6,270               1        6,270  0.75 (45 minutes)..............        4,703
                                      3rd Followup Questionnaire.
                                    --------------------------------------------------------------------------------------------------------------------
    Totals.........................  ...........................  ...........  ..............       25,707  ...............................        7,327
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has revised the burden since publication of the 60-day notice 
due to the decision to complete data collection for the Media Tracking 
Survey earlier than originally planned. Therefore, the estimated burden 
hours for the: (1) Screener and Consent Process, (2) Parent Baseline 
Questionnaire, (3) Media Tracking Screener, and (4) three waves of 
Media Tracking Questionnaires are no longer needed or requested. In 
addition, we have completed the baseline and first wave of followup 
data collection for Cohort 2 of the General Market campaign evaluation.
    The new estimated burden for this collection is 25,707 responses 
and 7,327 hours. This is a decrease of 117,120 responses and 21,010 
hours from the current approved information collection.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18938 Filed 8-30-19; 8:45 am]
 BILLING CODE 4164-01-P


This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.