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

Forms and Documents

Document Name	Status
IMPROVE FG Script ADP Final.docx Supplementary Document	2016-04-26
IMPROVE FG Script OCP Final.docx Supplementary Document	2016-04-26
OMB Amendment Memo.doc Justification for No Material/Nonsubstantive Change	2016-04-26
0677 SUPPORTING STATEMENT PART B FINAL 12-18-13.doc Supporting Statement B	2014-01-07
TEMPLATE Focus Groups about Drug Products.doc Supplementary Document	2014-01-08
0677 SUPPORTING STATEMENT PART A FINAL 12-18-13.doc Supporting Statement A	2014-01-07

IC Document Collections

IC ID	Document Title	Status
221655	Focus Groups to assess the post-marketing safety of authorized generic drug products Other-Study recruitment mailer	New
220108	Educating Groups Influencing Generic Drug Use Other-Survey	Unchanged
212699	Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge about How FDA Communicates Risks and Benefits of Prescription Medicines Other-Screener	Unchanged
211655	Medical Countermeasures Message Testing Other-Questionnaire	Unchanged

ICR Details

OMB Control No: 0910-0677	ICR Reference No: 201604-0910-008
Status: Historical Active	Previous ICR Reference No: 201401-0910-003
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/04/2016
	Date Received in OIRA: 04/27/2016
Terms of Clearance: 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
Expiration Date	03/31/2017	03/31/2017	03/31/2017
Responses	1,440	0	1,440
Time Burden (Hours)	2,520	0	2,520
Cost Burden (Dollars)	0	0	0

---

Abstract: 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.

---

Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 38993	06/28/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 72092	12/02/2013
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Medical Countermeasures Message Testing
Educating Groups Influencing Generic Drug Use
Focus Groups to assess the post-marketing safety of authorized generic drug products
Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge about How FDA Communicates Risks and Benefits of Prescription Medicines

---

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:

---

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

---

Common Form ICR:  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:

(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: 04/27/2016

---