Data to Support Drug Product Communications

Forms and Documents

Document Name	Status
0695 Non sub change 2018.docx Justification for No Material/Nonsubstantive Change	2018-03-30
0695 GEN IC CDER SSA 2017 Ext.pdf Supporting Statement A	2017-12-28
0695 GEN IC CDER SSB 2017 Ext.pdf Supporting Statement B	2017-12-28

IC Document Collections

IC ID	Document Title	Status
230243	Identifying Messages to Promote Value and Education of Generic Prescribing Other-Script	Unchanged
230242	Educating Groups Influencing Generic Drug Use Other-Recruitment Email	Unchanged
230240	Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings Other-Screener	Unchanged

ICR Details

OMB Control No: 0910-0695	ICR Reference No: 201803-0910-011
Status: Historical Inactive	Previous ICR Reference No: 201712-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Data to Support Drug Product Communications
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OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 04/05/2018
	Date Received in OIRA: 04/03/2018
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	02/28/2021	02/28/2021	02/28/2021
Responses	43,875	0	43,875
Time Burden (Hours)	9,620	0	9,620
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 301 et seq. 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:
	82 FR 27840	06/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58621	12/13/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Identifying Messages to Promote Value and Education of Generic Prescribing
Educating Groups Influencing Generic Drug Use
Individual Interview Study of Healthcare Provider Perceptions of Boxed Warnings

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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: There are no program changes to the information collection. However, we have made adjustments to the burden hours and annual responses in keeping with the approval of a recent change request and previous burden approval. Thus the information collection reflects an increase to 43,875 in annual responses and a decrease to 9,620 total hours.

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

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

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: 04/03/2018

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