OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Request for Generic Clearance of FDA, Testing Communications On Drugs

ICR 201106-0910-004 · OMB 0910-0695 · Historical Active

Forms and Documents
Document
Name
Status
Supplementary Document
2011-09-27
Supporting Statement B
2011-08-31
Supporting Statement A
2011-06-07
IC Document Collections
IC ID
Document
Title
Status
213206 New
210814 New
205722 New
203522 New
201833 New
201601 New
ICR Details
0910-0695 201106-0910-004
Historical Active
HHS/FDA
Request for Generic Clearance of FDA, Testing Communications On Drugs
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 10/12/2011
Retrieve Notice of Action (NOA) 06/08/2011
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. (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
10/31/2014 36 Months From Approved
19,822 0 0
4,757 0 0
0 0 0
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 drug products that are regulated by FDA.
US Code: 21 USC 355 Name of Law: FFDCA
  
None
Not associated with rulemaking
  76 FR 6800 02/08/2011
76 FR 32217 06/03/2011
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 19,822 0 0 19,822 0 0
Annual Time Burden (Hours) 4,757 0 0 4,757 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new generic IC.
$2,209,708
No
No
No
No
No
Uncollected
Eliazabeth Berbakos 3018271482
  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.
06/08/2011