Implementation of the Drug Supply Chain Security Act - Identification of Suspect Product and Notification

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
218223	Notifications to Trading Partners of Termination - Dispensers	Removed
218222	Notifications to Trading Partners of Termination - Wholesale Distributors	Removed
218221	Notifications to Trading Partners of Termination - Manufacturers and Repackagers	Modified
218220	Consultation with FDA and Termination of Notification - Dispensers	Removed
218218	Consultation with FDA and Termination of Notification - Wholesale Distributors	Removed
218217	Consultation with FDA and Termination of Notification - Manufacturers and Repackagers	Modified
218216	Notifications to Trading Partners of an Illegitimate Product - Dispensers	Removed
218215	Notifications to Trading Partners of an Illegitimate Product - Wholesale Distributors	Removed
218214	Notifications to Trading Partners	Modified
218213	Notifications to FDA - Dispensers	Removed
218212	Notifications to FDA - Wholesale Distributors	Removed
218211	Notifications to FDA	Modified

ICR Details

OMB Control No: 0910-0806	ICR Reference No: 201812-0910-001
Status: Active	Previous ICR Reference No: 201509-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Implementation of the Drug Supply Chain Security Act - Identification of Suspect Product and Notification
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/28/2019
	Date Received in OIRA: 12/06/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2022	36 Months From Approved	12/31/2018
Responses	59,232	0	426,160
Time Burden (Hours)	12,086	0	86,832
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 360eee-1(h)(2) Name of Law: FD&C Act
   PL: Pub.L. 113 - 54 582(h)(2) Name of Law: DSCSA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 45254	09/06/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 62585	12/04/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Notifications to FDA	3911
Notifications to Trading Partners	3911
Notifications to Trading Partners of Termination - Dispensers	3911
Notifications to FDA - Dispensers	3911
Notifications to Trading Partners of an Illegitimate Product - Wholesale Distributors	3911
Consultation with FDA and Termination of Notification - Dispensers	3911
Notifications to Trading Partners of an Illegitimate Product - Dispensers	3911
Consultation with FDA and Termination of Notification - Wholesale Distributors	3911
Consultation with FDA and Termination of Notification - Manufacturers and Repackagers	3911
Notifications to Trading Partners of Termination - Manufacturers and Repackagers	3911
Notifications to FDA - Wholesale Distributors	3911
Notifications to Trading Partners of Termination - Wholesale Distributors	3911

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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	59,232	426,160	0	0	-366,928	0
Annual Time Burden (Hours)	12,086	86,832	0	0	-74,746	0
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:

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Annual Cost to Federal Government: $484,500

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? Uncollected

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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: 12/06/2018

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