Guidelines for State Licensing of Wholesale Drug Distributors

Forms and Documents

Document Name	Status
0251 PRIA Feb 4 2022.PDF Supplementary Document	2022-02-19
0251 Stds for WDDs and 3PDs Part 205 SSA Reinstatement FEB 2022.docx Supporting Statement A	2022-02-19

IC Document Collections

IC ID	Document Title	Status
251693	FFDCA Sections 583 & 584 Recordkeeping	New
109945	FFDCA Sections 583 & 584 Reporting	Modified

ICR Details

OMB Control No: 0910-0251	ICR Reference No: 202202-0910-012
Status: Received in OIRA	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	Date Submitted to OIRA: 02/22/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	15,592	0
Time Burden (Hours)	28,036	0
Cost Burden (Dollars)	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH11	Proposed rulemaking	87 FR 6708	02/04/2022

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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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

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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	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

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.

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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

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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: 02/22/2022

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