Focus Groups About Drug Products As Used by The Food and Drug Administration

ICR 201604-0910-008

OMB: 0910-0677

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-04-26
Supplementary Document
2016-04-26
Justification for No Material/Nonsubstantive Change
2016-04-26
Supporting Statement B
2014-01-07
Supplementary Document
2014-01-08
Supporting Statement A
2014-01-07
ICR Details
0910-0677 201604-0910-008
Historical Active 201401-0910-003
HHS/FDA CDER
Focus Groups About Drug Products As Used by The Food and Drug Administration
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 05/04/2016
Retrieve Notice of Action (NOA) 04/27/2016
Prior terms remain in effect: This generic clearance for FDA/CDER focus groups is approved for 3-years under the following conditions: (1) For individual focus groups, 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, number of focus groups, justification for any proposed incentive, and estimated burden); (b) the participant screener, and (c) moderator guide. (2) OMB will respond with clearance or questions within 10 working days.
  Inventory as of this Action Requested Previously Approved
03/31/2017 03/31/2017 03/31/2017
1,440 0 1,440
2,520 0 2,520
0 0 0

The Federal Food, Drug, and Cosmetic Act authorizes FDA to conduct educational and public information programs (21 U.S.C. Section 393(d)(2)(D)). FDA is requesting OMB approval for collecting information through the use of focus groups for studies involving drug products that are regulated by FDA. FDA plans to conduct these studies annually on a variety of topics related to regulated drug products. Each study will include a variable number of groups, potentially representing different geographic and educational strata. Each focus group includes a certain number of participants and takes approximately 1.75 hours.

US Code: 21 USC 355 Name of Law: FFDCA
  
None

Not associated with rulemaking

  78 FR 38993 06/28/2013
78 FR 72092 12/02/2013
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 1,440 1,440 0 0 0 0
Annual Time Burden (Hours) 2,520 2,520 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$200,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
04/27/2016


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