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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:
0910-0251
ICR Reference No:
202202-0910-012
Status:
Historical Inactive
Previous ICR Reference No:
199105-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Guidelines for State Licensing of Wholesale Drug Distributors
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Comment filed on proposed rule
Conclusion Date:
03/28/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/22/2022
Terms of Clearance:
In accordance with 5 CFR 1320, the revised information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports implementation of sections 583 and 584 of the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Supply Chain Security Act (DSCSA), requiring that FDA establish national standards for the licensure of wholesale drug distributors and third-party logistic providers. The regulations are intended to ensure that the supply chain remains secure and that those prescription drugs subject to the DSCSA that are moving through the supply chain are properly stored, handled, and transported. These measures are intended to help protect American consumers from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.
Authorizing Statute(s):
PL:
Pub.L. 113 - 54 Title II
Name of Law: Drug Supply Chain Security Act
Citations for New Statutory Requirements:
US Code: 21 USC 360eee-2 & 360eee-3 Name of Law: National Standards for Prescription Drug Wholesale and Third-Party Logistics Providers
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AH11
Proposed rulemaking
87 FR 6708
02/04/2022
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
FFDCA Sections 583 & 584 Recordkeeping
FFDCA Sections 583 & 584 Reporting
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:
We are revising regulations in 21 CFR part 205 and are revising the corresponding, inactive information collection 0910-0251 to implement these provisions.
Annual Cost to Federal Government:
$1,480,000
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
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:
02/22/2022
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