Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Final Rule

Forms and Documents

Document	Type	Status	Availability
SUPPORTING STATEMENT FOR DRUG SHORTAGES FINAL 0759 7-13-2015.doc	Supporting Statement A	Uploaded 2015-07-14	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
209641	Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA)		Modified

ICR Details

OMB Control No: 0910-0759	ICR Reference No: 201507-0910-006
Status: Historical Active	Previous ICR Reference No: 201312-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: 20991
Title: Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Final Rule
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: 09/30/2015
	Date Received in OIRA: 07/15/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2018	36 Months From Approved
Responses	225	0	0
Time Burden (Hours)	450	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The final rule requires all applicants of covered approved drugs or biological products and all manufacturers of covered drugs marketed without an approved application to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply of the product in the United States. Covered drugs include those that are life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery; and that are not radiopharmaceutical products. The requirements in §§ 310.306, 314.81(b)(3)(iii), and 600.82 as added or amended by the final rule are designed to implement sections 506C and 506E of the Federal Food, Drug, and Cosmetic Act as required by Congress in the Food and Drug Administration Safety and Innovation Act.

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Authorizing Statute(s): PL: Pub.L. 112 - 144 506C&506E Name of Law: Food and Drug Administration Safety and Innovation Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG88	Final or interim final rulemaking	80 FR 38915	07/08/2015

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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: 1

IC Title	Form No.	Form Name
Notifications Required Under Sections 310.306 (unapproved drugs); 314.81(b)(3)(iii) (products approved under an NDA or ANDA); and 600.82 (products approved under a BLA)

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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	225	0	0	225	0	0
Annual Time Burden (Hours)	450	0	0	450	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: Changing Regulations

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

Burden Reduction Due to:

Short Statement: This is a new approval request. The total burden hours for the final rule is unchanged from the November 4, 2013, proposed rule.

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Annual Cost to Federal Government: $441,000

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: 07/15/2015

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