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

Forms and Documents

Document Name	Status
0677 SS Part B for 2017 Extension.pdf Supporting Statement B	2017-03-15
0677 SS Part A for 2017 Extension.pdf Supporting Statement A	2017-03-15

IC Document Collections

IC ID	Document Title	Status
235530	Focus Groups on Oncology Indications Other-Survey Instrument	New
235303	Focus Groups on Oncology Indications Other-Survey Instrument	New
228740	Educating Groups Influencing Generic Drug Use Other-Recruitment emails	New
227471	Generic Drug Substitution in Special Populations Other-Survey Instrument	New

ICR Details

OMB Control No: 0910-0677	ICR Reference No: 201703-0910-009
Status: Historical Active	Previous ICR Reference No: 201604-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Focus Groups About Drug Products As Used by The Food and Drug Administration
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/18/2017
	Date Received in OIRA: 03/15/2017
Terms of Clearance: 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
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	1,440	0	1,440
Time Burden (Hours)	2,520	0	2,520
Cost Burden (Dollars)	0	0	0

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Abstract: The information collection supports agency research through focus groups. This is a generic collection regarding drug products regulated by FDA and information collection is limited to this topic.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2)(D) Name of Law: FFDCA; Commissioner may conduct research
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 78161	11/07/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 13816	03/15/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Focus Groups on Oncology Indications
Educating Groups Influencing Generic Drug Use
Generic Drug Substitution in Special Populations
Focus Groups on Oncology Indications

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $200,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/15/2017

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