Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0435 PDMA SSA Ext 2024.docx	Supporting Statement A	Uploaded 2024-06-06	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
43602	Prescription Drug Marketing: Reporting		Modified
190489	Prescription Drug Marketing: Recordkeeping		Modified

ICR Details

OMB Control No: 0910-0435	ICR Reference No: 202403-0910-010
Status: Historical Active	Previous ICR Reference No: 202105-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements
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 with change	Conclusion Date: 02/19/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/06/2024
Terms of Clearance: Terms continue: Approved consistent with the understanding that, upon finalization of any agency rulemaking amending 21 CFR Part 203 (see RIN 0910-AH56), FDA will submit a request to revise the information collection accordingly. Furthermore, within the next 2 years, FDA will seek comment specifically on the accuracy of the change in burden estimate in this collection as explained below: Because current implementation of requirements under the Drug Supply Chain Security Act (currently approved in OMB control no. 0910-0806) apply to manufacturers, wholesalers, and dispensers as well as distributers, we have considered that current recordkeeping requirements for drug samples under 21 CFR part 203 may apply to more respondents. To account for this activity, we increased the number of responses and hours per each of the 140 pharmaceutical companies identified in Row 3 of Table 2 in Q-12 above (“§§ 203.30 – 203.39; documentation regarding sample distribution”), and have included it with the other recordkeeping elements.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2028	36 Months From Approved	02/28/2025
Responses	6,865,417	0	373,063
Time Burden (Hours)	577,572	0	61,544
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports implementation of the Prescription Drug Marketing Act and FDA regulations. The regulations are intended to protect the public against the threat of subpotent, adulterated, counterfeit, and misbranded drugs posed by the existence of drug diversion schemes and a drug diversion submarket, and the absence of appropriate controls over and creation and maintenance of appropriate records regarding the distribution of prescription drugs.

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Authorizing Statute(s): None

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:
	89 FR 3928	01/22/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 48431	06/06/2024
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Prescription Drug Marketing: Recordkeeping
Prescription Drug Marketing: Reporting

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ICR Summary of Burden

table that charts list 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	6,865,417	373,063	0	0	6,492,354	0
Annual Time Burden (Hours)	577,572	61,544	0	0	516,028	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 adjustments. Since the last renewal, we have adjusted our estimate of the overall burden to reflect an increase of 6,512,054 responses and 520,956 hours annually. We attribute the increase to an increase in both reporting and recordkeeping associated with drug samples.

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Annual Cost to Federal Government: $1,008,807

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? No

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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: 06/06/2024

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