Testing Communications on Biological Products

ICR 201405-0910-019

OMB: 0910-0687

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2011-05-31
Supporting Statement B
2014-05-22
Supporting Statement A
2014-06-13
ICR Details
0910-0687 201405-0910-019
Historical Active 201102-0910-004
HHS/FDA CBER
Testing Communications on Biological Products
Extension without change of a currently approved collection   No
Regular
Approved without change 08/21/2014
Retrieve Notice of Action (NOA) 06/18/2014
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.
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2014
9,280 0 9,280
2,724 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.

US Code: 21 USC 1003(d)(2)(D) Name of Law: FFDCA
   US Code: 21 USC 393(d)(2)(D) Name of Law: FFDCA
   US Code: 21 USC 702 Name of Law: FFDCA
   US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  78 FR 60287 10/01/2013
79 FR 32963 06/09/2014
No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 9,280 9,280 0 0 0 0
Annual Time Burden (Hours) 2,724 2,724 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,674,708
Yes Part B of Supporting Statement
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.
06/18/2014


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