Testing Communications on Biological Products

ICR 201102-0910-004

OMB: 0910-0687

Federal Form Document

Forms and Documents
IC Document Collections
IC ID
Document
Title
Status
ICR Details
0910-0687 201102-0910-004
Historical Active
HHS/FDA
Testing Communications on Biological Products
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 06/01/2011
Retrieve Notice of Action (NOA) 02/16/2011
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.

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

  75 FR 61492 10/05/2010
76 FR 5179 01/28/2011
No

0

  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 0 0 9,280 0 0
Annual Time Burden (Hours) 2,724 0 0 2,724 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new collection of information request to set up a new generic request.

$1,814,708
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@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.
02/16/2011


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