Data to Support Drug Product Communications as Used by the Food and Drug Administration

Forms and Documents

Document Name	Status
OMB Non Sub Change for Educating Infuencers of Generic Drug Use.pdf Justification for No Material/Nonsubstantive Change	2016-07-26
OMB Justification Memo 122215.doc Justification for No Material/Nonsubstantive Change	2016-01-06
Abbreviated SS.doc Supplementary Document	2011-09-27
SUPPORTING STATEMENT PART B 10-15-14.doc Supporting Statement B	2014-10-15
SUPPORTING STATEMENT PART A 10-15-14.doc Supporting Statement A	2014-10-15

IC Document Collections

IC ID	Document Title	Status
224206	IMPROVE Study Phase 2 Other-IMPROVE Survey Instrument	New
223175	CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response Other-Study Screener	New
221657	Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications Other-Physician Screener	Unchanged
221063	Animation in DTC Promotion Other-Interview Screener	Unchanged
220613	Educating Groups Influencing Generic Drug Use Other-Revised Study Instruments	Modified
220363	Clinical Trial Data in Professional Prescription Drug Promotion Other-Survey	Unchanged
218520	Pretests for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements Other-Survey - Pretest 1	Unchanged
218426	Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines Other-Survey	Unchanged
216972	Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews) Other-Screener	Unchanged
214412	Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-To-Consumer Prescription Drug Ads (Cognitive Interviews) Other-Questionnaire	Unchanged
213287	Interviews/Surveys	Unchanged

ICR Details

OMB Control No: 0910-0695	ICR Reference No: 201607-0910-010
Status: Historical Active	Previous ICR Reference No: 201601-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Data to Support Drug Product Communications 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: 08/09/2016
	Date Received in OIRA: 07/28/2016
Terms of Clearance: Prior terms remain in effect. This generic clearance for FDA/CDER 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, etc.); (b) participant screeners, and (c) instruments/moderator guides. (2) OMB will respond with clearance or questions within 10 working days.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	12/31/2017	12/31/2017
Responses	20,500	0	20,500
Time Burden (Hours)	9,500	0	9,500
Cost Burden (Dollars)	0	0	0

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Abstract: Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews. FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.

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Authorizing Statute(s): US Code: 21 USC 355 Name of Law: FD&C 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:
	79 FR 19096	04/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 58786	09/30/2014
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in Direct-To-Consumer Prescription Drug Ads (Cognitive Interviews)
Clinical Trial Data in Professional Prescription Drug Promotion
CONFER Study; Comprehension of Over-the-Counter Naloxone for Emergency Response
Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements (Cognitive Interviews)
Testing FDA's Drug Safety Communications with Consumers to Improve Consumer Knowledge About How FDA Communicates Risks and Benefits of Prescription Medicines
Pretests for a Study on Quantitative Information in Direct-to-Consumer Television Advertisements
IMPROVE Study Phase 2
Educating Groups Influencing Generic Drug Use
Studies to Enhance FDA Communications Addressing Opioids and Other Potentially Addictive Pain Medications
Interviews/Surveys
Animation in DTC Promotion

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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	20,500	20,500	0	0	0	0
Annual Time Burden (Hours)	9,500	9,500	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: The Food and Drug Administration is submitting this nonmaterial/non-substantive change request (83-I) to add 9,500 burden hours and 20,500 annual responses. This generic clearance was originally thought to include projects originating in only the Center for Drug Evaluation and Research but because various programs within FDA deal with drug products we experienced more use of this generic approval then anticipated and, therefore, require an increase in hours until the expiration date in 2017.

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Annual Cost to Federal Government: $2,209,708

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 07/28/2016

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