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.
Inventory as of this Action
Requested
Previously Approved
08/31/2017
08/31/2017
08/31/2017
18,560
0
9,280
5,448
0
2,724
0
0
0
FDA plans to use the data collected
under this generic clearance to inform its biological product
communications campaigns. FDA expects data to guide the formulation
of its communication objectives on biological products. FDA also
plans to use the data to help tailor print, broadcast, and
electronic media communications in order for them to have powerful
and desired impacts on target audiences. The data will not be used
for the purposes of making policy or regulatory decisions. The
information collected will serve three major purposes. First, as
formative research it will provide critical knowledge needed about
target audiences to develop messages and campaigns about biological
product use. Second, as initial testing, it will allow FDA to
assess the potential effectiveness of messages and materials in
reaching and successfully communicating with their intended
audiences. Third, as evaluative research it will allow FDA to
ascertain the effectiveness of the message and the distribution of
method of these messages in achieving the objectives of the message
campaign. Data collected under this generic clearance will also
help inform the FDA's newly established Risk Communication Advisory
Committee and would constitute a further effort to respond to the
Institute of Medicine's recommendation in its September 2006 report
The Future of Drug Safety that FDA improve its communications with
the public.
The Food and Drug
Administration is submitting this nonmaterial/non-substantive
change request (83-C) to add 2,724 burden hours and 9,280 annual
responses. This generic clearance was originally thought to include
projects originating in only the Center for Biological Evaluation
and Research but because various programs within FDA deal with
biological 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.
0687 83-C increase in hours and responses request 12-15-14.docx
FDA CBER Abbreviated SS.doc
Focus Group Study of Healthcare Provider Knowledge of Biosimilar Biological Products - Phase 2