SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.” Section 506B (“Reports of Postmarketing Studies”) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 356b) provides FDA with additional authority for monitoring the progress of postmarketing studies that drug and biological applicants have made a commitment to conduct. Postmarketing studies are those studies conducted after approval to gather additional information about the safety, efficacy, or optimal use of the approved drug or biological product.

Under section 506B(a) of the act, an applicant who has entered into an agreement with FDA to conduct a postmarketing study is required to provide the agency with an annual report on the status of the study until FDA notifies the applicant, in writing, that all postmarketing study commitments established under the application(s) have either been fulfilled or have been released. The annual report must address the progress of the study or the reasons for the failure of the applicant to conduct the study. Section 506B(c) of the act directs FDA to develop and publish annually in the Federal Register a report on the status of postmarketing studies that applicants have made a commitment to conduct and for which status reports have been submitted. In the Federal Register of October 30, 2000 (65 FR 64607), the agency published a final rule to implement section 506B of the act. The final rule makes several changes to the existing regulations for approved human drugs and licensed biological products.

In the Federal Register of April 4, 2001 (66 FR 17912), FDA published a notice announcing the availability of a draft guidance for industry entitled “Reports on the Status of Postmarketing Studies—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.” The notice gave interested persons an opportunity to submit comments by July 3, 2001. A number of comments were received in the docket for the 2001 draft guidance. After careful consideration of the comments, the draft guidance was revised. In addition to edits to improve clarity, the substantive changes made to the draft guidance included an update of the types of postmarketing studies currently required by FDA and an improved explanation of the procedures for establishing and revising study schedules.

This guidance is intended to provide information on the following: (1) Procedures concerning the submission of postmarketing study commitment status reports; (2) the content and format of a postmarketing study commitment status report; (3) timeframes for FDA's review of postmarketing study commitment final study reports; and (4) information about postmarketing study commitments that will be available to the public. This guidance applies to postmarketing study commitments for approved human drug products and licensed biological products that meet the definition of “drug” under the act. It does not apply to biological products that meet the definition of medical “device” under the act; or to veterinary drug products, which will be addressed separately.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the submission of postmarketing study commitment reports for approved human drug or licensed biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.81 and 601.70 have been approved under OMB control numbers 0910-0001 and 0910-0433.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​cder/​guidance/​index.htm, http://www.fda.gov/​cber/​guidelines.htm, or http://www.fda.gov/​ohrms/​dockets/​default.htm.