Pharmaceutical Distribution Supply Chain

Forms and Documents

Document Name	Status
Form 3911 Documenting transaction information Form	Modified
0806 Drug Supply Chain SSA 2025 REV.docx Supporting Statement A	2025-05-02

IC Document Collections

IC ID	Document Title	Status
248286	Verification - ID & investigate suspect products; coordinate w/trading partners Other-21 USC 360eee-1(a)(3)	Modified
218221	Product ID & info. exchange w/authorized trading partners Other-Agency Guidance	Modified
218217	Disclosing illegitimate products: notifications to trading partners Other-Agency Guidance	Modified
218214	Documenting transaction information Form	Modified
218211	Reporting: Notifications to FDA; including requests for waiver, exception, or exemption Other-21 USC 360eee-1	Modified

ICR Details

OMB Control No: 0910-0806	ICR Reference No: 202407-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202107-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Pharmaceutical Distribution Supply Chain
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/02/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	74,375,565,700	0
Time Burden (Hours)	2,550,820	0
Cost Burden (Dollars)	0	0

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Abstract: This information collection implements the Drug Supply Chain Security Act. Manufacturers, repackagers, wholesale distributors, and dispensers must: (1) Notify FDA when they have determined that a product in their possession or control is illegitimate or if a manufacturer when they determine that a product has a high risk of illegitimacy; (2) terminate such notifications after consultation with FDA; (3) notify certain immediate trading partners about an illegitimate product or if a manufacturer about a product with a high risk of illegitimacy; and (4) notify immediate trading partners when such notifications are terminated.

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Authorizing Statute(s): US Code: 21 USC 360eee Name of Law: Drug Supply Chain Security 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:
	89 FR 72848	09/06/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 18675	05/01/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Disclosing illegitimate products: notifications to trading partners
Documenting transaction information	3911	Drug Notification
Product ID & info. exchange w/authorized trading partners
Reporting: Notifications to FDA; including requests for waiver, exception, or exemption	3911	Drug Notification
Verification - ID & investigate suspect products; coordinate w/trading partners

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ICR Summary of Burden

	Total Request	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	74,375,565,700	0	0	0	74,375,241,078	324,622
Annual Time Burden (Hours)	2,550,820	0	0	0	575,888	1,974,932
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: Our estimated burden for the information collection reflects some significant increases; most notably burden we attribute to the task of documenting individual transaction information. We have also increased the number of respondents submitting WEE requests in response to public comment and as discussed at Q-12 of our SSA. We also note significant ongoing recordkeeping attributable to documenting activities along the supply chain that we regard as usual and customary in complying with the self-executing requirements of Drug Supply Chain Security Act set forth in sections 581 and 581 (Subchapter H – Pharmaceutical Distribution Supply Chain) of the FD&C Act.

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Annual Cost to Federal Government: $3,800

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.     Yes

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: 05/02/2025

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