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

Forms and Documents

Document Name	Status
0677 OMB Memo Template.docx Supplementary Document	2020-01-10
Summary of Generic Drug Substitution in Special Populations.doc Supplementary Document	2020-01-09
Summary of Educating Groups Influencing Generic Drug Use.doc Supplementary Document	2020-01-09
0677 Summary of Oncology Indications Survey 2019.doc Supplementary Document	2020-01-09
0677 Supporting Statement Part B 2020.docx Supporting Statement B	2020-01-09
0677 Supporting Statement Part A 2020.docx Supporting Statement A	2020-01-09

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0910-0677	ICR Reference No: 202001-0910-002
Status: Active	Previous ICR Reference No: 201703-0910-009
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: 02/07/2020
	Date Received in OIRA: 01/10/2020
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 generally respond with clearance or questions within 10 working days.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	05/31/2020
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: This ICR supports the guidance for industry entitled “Focus Groups About Drug Products as Used by the Food and Drug Administration” on the information collection resulting from focus groups about drug products as used by FDA. Focus groups provide an important role in gathering information because they allow for a more in-depth understanding of individuals’ attitudes, beliefs, motivations, and feelings than do quantitative studies. Focus groups serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative research tool, have three major purposes: (1) to obtain information that is useful for developing variables and measures for quantitative studies; (2) to better understand people’s attitudes and emotions in response to topics and concepts; and (3) to further explore findings obtained from quantitative studies.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2)(D) Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	84 FR 34186	07/17/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 72369	12/31/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 01/10/2020

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