Prescription Drug Advertisements

Forms and Documents

Document Name	Status
0686 SS 2017 Extension.pdf Supporting Statement A	2017-08-17

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	Removed
196331	Prescription Drug Advertisements 3rd Party Disclosure Requirements	Modified
196330	202.1(j)(4) - Voluntarily submitting the advertisement to FDA prior to publication for comment	Removed
196329	202.1(j)(1)(iii) - Providing a program to FDA for assuring that adverse information about the drug will be publicized	Removed
196328	202.1(j)(1) - Submission of advertisement to FDA for prior approval	Removed
196327	Prescription Drug Advertisements Reporting Requirements	Modified

ICR Details

OMB Control No: 0910-0686	ICR Reference No: 201706-0910-014
Status: Historical Active	Previous ICR Reference No: 201405-0910-012
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: 11/14/2017
	Date Received in OIRA: 08/17/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2020	36 Months From Approved	11/30/2017
Responses	21,804	0	25,839
Time Burden (Hours)	18,162,706	0	10,076,426
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA regulations regarding prescription drug advertising. Under authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that advertisements published in journals, magazines, newspapers, or other periodicals, as well as advertisements broadcast through media such as radio, television, and telephone communication systems comply with the public health protection provisions therein. Respondents to the information collection are sponsors of prescription drug product promotional material.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: FFDCA
  

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 23574	05/23/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 36799	08/07/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Prescription Drug Advertisements Reporting Requirements
Prescription Drug Advertisements 3rd Party Disclosure Requirements
202.1(j)(1)(iii) - Providing a program to FDA for assuring that adverse information about the drug will be publicized
202.1(j)(1) - Including information about the drug's fatalities or serious damage in the advertisement
202.1(j)(1) - Submission of advertisement to FDA for prior approval
202.1(j)(4) - Voluntarily submitting the advertisement to FDA prior to publication for comment

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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	21,804	25,839	0	0	-4,035	0
Annual Time Burden (Hours)	18,162,706	10,076,426	0	0	8,086,280	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 information collection reflects agency adjustments. While the number of annual burden hours increased from 10,076,426 hours to 18,162,706 hours (+8,086,280), the number of annual responses has decreased from 25,839 to 21,804 (-4,035). This is discussed more fully in the agency's supporting statement at Q15.

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

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: 08/17/2017

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