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OMB Control No: 0910-0435	ICR Reference No: 202502-0910-009
Status: Active	Previous ICR Reference No: 202403-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements
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: 06/06/2025
	Date Received in OIRA: 03/31/2025
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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2028	02/29/2028	02/29/2028
Responses	6,865,417	0	6,865,417
Time Burden (Hours)	577,572	0	577,572
Cost Burden (Dollars)	0	0	0

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.

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

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

IC Title	Form No.	Form Name
Prescription Drug Marketing: Recordkeeping
Prescription Drug Marketing: Reporting	3911

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	6,865,417	6,865,417
Annual Time Burden (Hours)	577,572	577,572
Annual Cost Burden (Dollars)	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:

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

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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