In order to conduct educational and
public information programs relating to tobacco use, as authorized
by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 393(d)(2)(D)), and to develop
stronger health warnings on tobacco packaging as authorized by the
Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act), it is beneficial for the Food and Drug Administration (FDA)
to conduct research and studies relating to the control and
prevention of disease as authorized by section 301 of the Public
Health Service Act (42 U.S.C 241(a)). In this generic collection of
information, FDA will use formative pretests to assess the likely
effectiveness of tobacco communications with specific target
audiences. The information collected will serve two major purposes:
(1) It will provide the critical knowledge needed about target
audiences and the decisionmaking process when choosing to use, not
use, or quit using tobacco products, including adolescents (ages 13
to 17) where communications will aim to discourage tobacco use
before it starts. (2) It will allow FDA to assess the potential
effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences.
Pretesting messages with a sample of the target audience will allow
FDA to refine messages while they are still in the developmental
stage.
The Food and Drug
Administration is submitting this nonmaterial/non-substantive
change request (83-C) to add 7,160 burden hours and 12,440 annual
responses. This will allow CTP to continue its media campaign
efforts and other upcoming projects. In the meantime CTP plans on
creating two new generics which will provide CTP a separate copy
testing and focus group/individual interview collection. CTP plans
on exhausting the additional burden hours and responses available
under 0910-0674, which will be available for use while these new
generic collections are submitted to OMB for review and approval.
After the hours in 0674 are depleted, and approval is granted on
the two new generic collections FDA will discontinue 0910-0674.
There are no other changes beyond the additional hours and
responses being requested.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
0910-0674 Additional Burden change request 83c 6.20.14.docx
Tobacco Pretesting Part B SS final 1_17_13.doc
LGBT Young Adult Tobacco Use Prevention Campaign: Copy Testing