PRESCRIPTION DRUG ADVERTISEMENTS

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0686 FINAL 6-11-14.doc Supporting Statement A	2014-06-11

IC Document Collections

IC ID	Document Title	Status
196332	202.1(j)(1) - Including information about the drug's fatalities or serious damage in the advertisement	Modified
196331	202.1 - Advertisements prepared in accordance with 202.1	Modified
196330	202.1(j)(4) - Voluntarily submitting the advertisement to FDA prior to publication for comment	Modified
196329	202.1(j)(1)(iii) - Providing a program to FDA for assuring that adverse information about the drug will be publicized	Modified
196328	202.1(j)(1) - Submission of advertisement to FDA for prior approval	Modified
196327	202.1(e)(6) - Waiver request to FDA	Modified

ICR Details

OMB Control No: 0910-0686	ICR Reference No: 201405-0910-012
Status: Historical Active	Previous ICR Reference No: 201105-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: PRESCRIPTION DRUG ADVERTISEMENTS
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: 08/21/2014
	Date Received in OIRA: 06/12/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	25,839	0	18,094
Time Burden (Hours)	10,076,426	0	6,702,166
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration's prescription drug advertising regulations in Section 202.1 describe requirements and standards for print and broadcast advertisements. Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: FD&CAct
  

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 11112	02/27/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 32554	06/05/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
202.1(e)(6) - Waiver request to FDA
202.1(j)(1) - Submission of advertisement to FDA for prior approval
202.1(j)(1)(iii) - Providing a program to FDA for assuring that adverse information about the drug will be publicized
202.1(j)(4) - Voluntarily submitting the advertisement to FDA prior to publication for comment
202.1 - Advertisements prepared in accordance with 202.1
202.1(j)(1) - Including information about the drug's fatalities or serious damage in the advertisement

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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	25,839	18,094	0	0	7,745	0
Annual Time Burden (Hours)	10,076,426	6,702,166	0	0	3,374,260	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 total burden hours has increased from 6,702,166 hours to 10,076,426. This is a result of an increase in submission over the last 3 years under these advertising regulations.

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Annual Cost to Federal Government: $5,700,000

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: 06/12/2014

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