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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT for Drug Shortages PR FINAL 11-26-13.doc Supporting Statement A	2013-11-26

IC Document Collections

IC ID	Document Title	Status
209641	Notifications required under proposed section 310.306, 314.81(b)(3)(iii) and 600.82	New

ICR Details

OMB Control No: 0910-0759	ICR Reference No: 201312-0910-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 20991
Title: Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Proposed 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: Comment filed on proposed rule	Conclusion Date: 01/27/2014
	Date Received in OIRA: 12/10/2013
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration is requesting OMB approval of information collection activities resulting from regulations at 21 CFR section 310.306, 314.81(b)(3)(iii), 314.92, and 600.82 as amended by the attached proposed rule, implementing section 506C and 506E of the Federal Food, Drug and Cosmetic Act. The proposed rule would require all applicants of covered, approved prescription drug or biological products, certain applicants of blood or blood compoents for transfusion, and all manufacturers of covered prescription 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 (significant disruption in supply for blood or blood components) of the product in the United States. The proposed rule would also require applicants and unapproved drug manufacturers to respond to any non-compliance letters issued for failure to comply with the proposed rule.

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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	Proposed rulemaking	78 FR 65904	11/04/2013

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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 proposed section 310.306, 314.81(b)(3)(iii) and 600.82

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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 approval request.

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Annual Cost to Federal Government: $6,600,000

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: 12/10/2013

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