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.
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.
US Code:
21 USC 506C
Name of Law: Federal Food, Drug, and Cosmetic Act
This is a new approval request - Drug Shortages Interm Final Rule - for OMB approval under the emergency approval process of the Paperwork Reduction Act.
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:
(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;
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.
Emergency Clearance Memo - DrugShortages IFR.pdf
Supporting Statement for Drug Shortages IFR.doc
Certification of Good Cause