Guidelines for State Licensing of Wholesale Drug Distributors

ICR 202202-0910-012

OMB: 0910-0251

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2022-02-19
Supporting Statement A
2022-02-19
IC Document Collections
IC ID
Document
Title
Status
251693
New
109945
Modified
ICR Details
0910-0251 202202-0910-012
Received in OIRA 199105-0910-004
HHS/FDA CDER
Guidelines for State Licensing of Wholesale Drug Distributors
Reinstatement with change of a previously approved collection   No
Regular 02/22/2022
  Requested Previously Approved
36 Months From Approved
15,592 0
28,036 0
0 0

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.

PL: Pub.L. 113 - 54 Title II Name of Law: Drug Supply Chain Security Act
  
US Code: 21 USC 360eee-2 & 360eee-3 Name of Law: National Standards for Prescription Drug Wholesale and Third-Party Logistics Providers

0910-AH11 Proposed rulemaking 87 FR 6708 02/04/2022

No

2
IC Title Form No. Form Name
FFDCA Sections 583 & 584 Recordkeeping
FFDCA Sections 583 & 584 Reporting

  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 15,592 0 10,292 0 0 5,300
Annual Time Burden (Hours) 28,036 0 24,944 0 0 3,092
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We are revising regulations in 21 CFR part 205 and are revising the corresponding, inactive information collection 0910-0251 to implement these provisions.

$1,480,000
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/22/2022


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