This generic
clearance for FDA/CBER 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, and estimated burden); (b) participant
screeners, and (c) instruments/moderator guides. (2) OMB will
respond with clearance or questions within 10 working days. (3) OMB
and FDA will jointly evaluate the generic clearance in 18-months;
FDA will provide a summary of each collection approved under the
generic clearance (e.g., use of information) and an overview of the
studies likely to be submitted in the next 18-months.
Inventory as of this Action
Requested
Previously Approved
06/30/2014
6 Months From Approved
9,280
0
0
2,724
0
0
0
0
0
The Food and Drug Administration (FDA)
is seeking approval from the Office of Management and Budget (OMB)
for the generic clearance, Testing Communications on Biological
Products. FDA is the regulatory agency responsible for the safety
and effectiveness of medical products including biologics, drugs,
foods, cosmetics, medical products, radiological products, and
animal drugs. The purpose of the information collection is to
provide tools to assess the need for communications on specific
topics and to assist in the development and modification of
communication messages to promote public health and compliance with
regulations. FDA is requesting approval for collecting information
through a variety of research methods for developing and testing
communications involving biological, vaccine, and blood
products.
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.
FDA CBER Abbreviated SS.doc