Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT DRUG SUPPLY CHAIN SECURITY FINAL.docx	Supporting Statement A	Uploaded 2015-09-17	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
218223	Notifications to Trading Partners of Termination - Dispensers	Other-Guidance	New
218222	Notifications to Trading Partners of Termination - Wholesale Distributors	Other-Guidance	New
218221	Notifications to Trading Partners of Termination - Manufacturers and Repackagers	Other-Guidance	New
218220	Consultation with FDA and Termination of Notification - Dispensers	Other-Guidance	New
218218	Consultation with FDA and Termination of Notification - Wholesale Distributors	Other-Guidance	New
218217	Consultation with FDA and Termination of Notification - Manufacturers and Repackagers	Other-Guidance	New
218216	Notifications to Trading Partners of an Illegitimate Product - Dispensers	Other-Guidance	New
218215	Notifications to Trading Partners of an Illegitimate Product - Wholesale Distributors	Other-Guidance	New
218214	Notifications to Trading Partners of an Illegitimate Products - Manufacturers and Repackagers	Other-Guidance	New
218213	Notifications to FDA - Dispensers	Other-Guidance	New
218212	Notifications to FDA - Wholesale Distributors	Other-Guidance	New
218211	Notifications to FDA - Manufacturers and Repackagers	Other-Guidance	New

ICR Details

OMB Control No: 0910-0806	ICR Reference No: 201509-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/09/2015
	Date Received in OIRA: 09/21/2015
Terms of Clearance:

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

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Abstract: 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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 33564	06/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 55364	09/15/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

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

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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	426,160	0	0	426,160	0	0
Annual Time Burden (Hours)	86,832	0	0	86,832	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $547,764

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 09/21/2015

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