Small Dispensers Assessment Under the Drug Supply Chain Security Act

Forms and Documents

Document Name	Status
SmallDispensersAssessment_SSB_11.2025.docx Supporting Statement B	2025-11-21
SmallDispensersAssessment_SSA_11.2025.docx Supporting Statement A	2025-11-21

IC Document Collections

IC ID	Document Title	Status
278173	Coordination with third-party entities related to assessment quiestions response Other-Questionnaire	New
278172	Coordination with third-party entities related to screener response Other-Screener	New
278148	Assessment Questionnaire Other-Questionnaire	New
278147	Screener Other-Screener	New
278143	Invitation email Other-Invitation email	New

ICR Details

OMB Control No:	ICR Reference No: 202511-0910-004
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Small Dispensers Assessment Under the Drug Supply Chain Security Act
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/03/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	30,873	0
Time Burden (Hours)	7,052	0
Cost Burden (Dollars)	375,956	0

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Abstract: The purpose of this statutorily required study is to assess the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level. Research questions include the accessibility of the necessary software and hardware to such dispensers; whether the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such dispensers; and if the necessary hardware and software can be integrated into business practices. Small dispensers of prescription drug products will be recruited to access and respond to the assessment questions on FDA's web site. Evaluation methods and analyses include qualitative analyses (for example, content analysis for responses), and quantitative analyses using descriptive statistics.

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Authorizing Statute(s): PL: Pub.L. 113 - 54 Title II Name of Law: Drug Supply Chain Security Act
   US Code: 21 USC 360eee and 360eee-1 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: PL: Pub.L. 113 - 54 Title II Name of Law: Drug Supply Chain Security Act

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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 18415	03/13/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52678	11/21/2025
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
Assessment Questionnaire
Coordination with third-party entities related to assessment quiestions response
Coordination with third-party entities related to screener response
Invitation email
Screener

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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	30,873	0	30,873	0	0	0
Annual Time Burden (Hours)	7,052	0	7,052	0	0	0
Annual Cost Burden (Dollars)	375,956	0	375,956	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: This is a new information collection required by the Drug Supply Chain Security Act.

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Annual Cost to Federal Government: $612,720

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 12/03/2025

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