Prior terms remain in effect. This generic clearance for FDA/CDER is approved for 3 years under the following conditions: (1) For individual "tests," FDA shall submit a generic IC in ROCIS along with: (a) an abbreviated supporting statement in the template agreed to by OMB and FDA (including a statement of need, intended use of information, description of respondents, date(s) and location(s), collection procedures, justification for any proposed incentive, etc.); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
12/31/2017
12/31/2017
12/31/2017
20,500
0
20,500
9,500
0
9,500
0
0
0
Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.
The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-I) to add 9,500 burden hours and
20,500 annual responses.
This generic clearance was originally thought to include projects originating in only the Center for Drug Evaluation and Research but because various programs within FDA deal with drug products we experienced more use of this generic approval then anticipated and, therefore, require an increase in hours until the expiration date in 2017.
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.
OMB Non Sub Change for Educating Infuencers of Generic Drug Use.pdf
OMB Justification Memo 122215.doc
IMPROVE Study Phase 2