No material or nonsubstantive change to a currently approved collection
No
Regular
Approved without change
12/22/2014
12/04/2014
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.
table that charts list comparision
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