2010-24295. Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies.” This draft guidance is intended to help sponsors and investigators comply with the new requirements in the final rule entitled “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” published elsewhere in this issue of the Federal Register.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 28, 2010.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Janet Norden, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6324, Silver Spring, MD 20993-0002, 301-796-2500; or Laura Rich, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry and investigators entitled “Safety Reporting Requirements for INDs and BA/BE Studies.” This draft guidance is intended to help sponsors and investigators comply with the new requirements for investigational new drug applications (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies.

In the Federal Register of March 14, 2003 (68 FR 12406), FDA published a proposed rule to revise its regulations governing pre- and postmarket safety reporting for human drug and biological products. To make rulemaking more manageable, the Agency decided to issue revisions to the pre- and postmarket safety reporting regulations in two separate rulemakings. The final rule, entitled “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans,” published elsewhere in this issue of the Federal Register, revises the premarket regulations. The revisions in the final rule will improve the utility and quality of safety reports, expedite and strengthen FDA's ability to review critical safety information, improve safety monitoring of human drug and biological products, better protect human subjects enrolled in clinical trials, and harmonize safety reporting internationally. The new requirements revise the definitions used for IND safety reporting, make clear when to submit IND safety reports, and subject BA and BE studies to safety reporting requirements.

The draft guidance was developed to accompany the publication of the final rule. The draft guidance provides examples and explanations of the definitions used for IND safety reporting, makes recommendations for determining when and how to submit a safety report, and provides advice on other safety reporting issues that have generated questions from sponsors and investigators.

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on safety reporting requirements for INDs and BA/BE studies. 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. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

This draft guidance contains information collection provisions that 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 collection(s) of information in the draft guidance are estimated in section “VII. Paperwork Reduction Act of 1995” of the final rule entitled, “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans” published elsewhere in this issue of the Federal Register.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: September 23, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.