View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0806
ICR Reference No:
202407-0910-009
Status:
Active
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/14/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/02/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2028
36 Months From Approved
Responses
74,375,565,700
0
0
Time Burden (Hours)
2,550,820
0
0
Cost Burden (Dollars)
0
0
0
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.
Authorizing Statute(s):
US Code:
21 USC 360eee
Name of Law: Drug Supply Chain Security Act
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 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
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
ICR Summary 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
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.
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
Agency Contact:
Domini Bean 301 796-5733 domini.bean@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:
05/02/2025
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