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.
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.
$2,209,708
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726
ila.mizrachi@fda.hhs.gov
No
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 Justification Memo 122215.doc
Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications