View Information Collection Request (ICR) Package
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View ICR - Agency Submission
COMMENT
Time Remaining
Days
HR
Min
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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
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.
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
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 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
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
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.
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
Agency Contact:
Anne Taylor 240 402-5683 anne.taylor@fda.hhs.gov
Common Form ICR:
No
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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