Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance

Forms and Documents

Document Name	Status
Emergency Clearance Memo - DrugShortages IFR.pdf Supplementary Document	2011-12-14
Supporting Statement for Drug Shortages IFR.doc Supporting Statement A	2011-12-19

IC Document Collections

IC ID	Document Title	Status
200543	Certification of Good Cause	New
200542	Notification of Discontinuance	New

ICR Details

OMB Control No: 0910-0699	ICR Reference No: 201112-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 01/18/2012
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/30/2012
	Date Received in OIRA: 12/21/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	6 Months From Approved
Responses	85	0	0
Time Burden (Hours)	240	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is requesting OMB approval of information collection activities resulting from regulations at 21 CFR 314.81(b)(3)(iii) and 314.91, as amended by the interim final rule, implementing section 506C of the Federal Food, Drug and Cosmetic Act. The regulations, as amended by the interim final rule, require applicants who are the sole manufacturers of certain drug or biologic products to notify FDA at least 6 months before discontinuing the manufacture of applicable products.

Emergency Justfication: FDA's Center for Drug Evaluation and Research (CDER) is requesting that a Paperwork Reduction Act (PRA) package for the Interim Final Rule regarding Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance be approved using the emergency clearance process under 5 C.F.R. ? 1320.13(a)(2)(i). Public harm is reasonably likely to ensue if the normal clearance procedures are followed. Public Harm is Reasonably Likely to Occur if Normal Clearance Procedures are Followed The interim final rule is essential to ensuring that the FDA receives timely reports from sole manufacturers of discontinuances of certain drug products. These discontinuances often lead to drug shortages. The number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010. Some shortages delay or deny needed care for patients, because they involve critical drugs used to treat cancer, to provide required parenteral nutrition, or to address other serious medical conditions. Cancer alone affects more than 11 million people in the United States annually. Other shortages force providers to prescribe second-line alternatives, which may be less effective and higher risk than first line therapies. If the FDA receives reports of discontinuances, it can work with the manufacturer and others to prevent the discontinuance from leading to a drug shortage, or, if a shortage does occur, to mitigate the impact of the shortage on patients. In the absence of immediate approval of the information collection in the interim final rule, the Agency will not receive all relevant information on discontinuances and drug shortages, putting the Agency at a serious disadvantage in addressing these shortages and putting many patients at risk. FDA believes that significant public harm will occur if normal Paperwork Reduction Act (PRA) clearance procedures are followed. In the six months or more it can take to obtain a full PRA clearance to authorize the information collection in the interim final rule, a significant number of patients could be exposed to drug shortage-related harm, including delay of treatment, denial of life saving therapies, or exposure to riskier alternatives. FDA believes that these circumstances can be mitigated or prevented through prompt FDA intervention based on the information provided by manufacturers. Accordingly, FDA is requesting that OMB use its emergency clearance process to immediately approve the PRA package for the interim final rule.

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Authorizing Statute(s): US Code: 21 USC 506C Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-ZA43	Final or interim final rulemaking	76 FR 78530	12/19/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Certification of Good Cause
Notification of Discontinuance

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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	85	0	0	85	0	0
Annual Time Burden (Hours)	240	0	0	240	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 approval request - Drug Shortages Interm Final Rule - for OMB approval under the emergency approval process of the Paperwork Reduction Act.

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Annual Cost to Federal Government: $0

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: 12/21/2011

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