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]
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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
