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