2010-13420. Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of an information sheet guidance entitled, “Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572).” This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This information sheet guidance provides FDA's responses to the most frequently asked questions.

DATES:

Submit either written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), 10903 New Hampshire Ave., Silver Spring, MD 20993 or to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the information sheet guidance document.

FOR FURTHER INFORMATION CONTACT:

Joseph Salewski, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring MD 20993, 301-796-3395.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of an information sheet guidance entitled, “Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572).” This guidance is intended to assist sponsors, clinical investigators, and IRBs involved in clinical investigations of investigational drugs and biologics in complying with the requirement that each investigator complete and sign a Form FDA 1572 before participating in an investigation. This guidance describes how to complete the Statement of Investigator form (Form FDA 1572).

FDA developed this information sheet guidance in response to numerous questions from the research community regarding the Form FDA 1572. In this guidance, we provide answers to frequently asked questions concerning the purpose of this form, when this form needs to be completed and signed by the investigator, how to best complete the various blocks within the form, and when the form might need to be updated. In addition, we clarify questions related to the use of Form FDA 1572 by clinical investigators participating in studies conducted outside the United States that may or may not be under an investigational new drug application.

This information sheet guidance is part of the Information Sheet Guidance Initiative, announced on February 3, 2006, in the Federal Register (71 FR 5861), which describes FDA's intention to update the process for developing, issuing, and making available guidances intended for IRBs, clinical investigators, and sponsors. Known as “Information Sheets,” these guidances have provided recommendations to IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in research regulated by the FDA since the early 1980s. The Information Sheet Guidance Initiative is intended to ensure that the Information Sheets are consistent with the FDA's good guidance practices (GGPs). As part of the initiative, which will be ongoing, the agency plans to rescind Information Sheets that are obsolete, revise and reissue Information Sheet Guidances that address current issues, and develop new Information Sheet Guidances as needed.

In the Federal Register of July 29, 2008 (73 FR 43940), FDA announced the availability of a draft version of the guidance entitled, “Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572).” The July 2008 guidance gave interested persons an opportunity to submit comments through September 29, 2008. All comments received during the comment period have been carefully reviewed and, where appropriate, incorporated in the guidance. As a result of the public comments and editorial changes, the guidance is clearer than the draft version.

This information sheet guidance is being issued consistent with FDA's GGPs regulation (21 CFR 10.115). The information sheet guidance represents the agency's current thinking on completing the Form FDA 1572. 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. The 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 for Form FDA 1572 have been approved under OMB Control No. 0910-0014.

III. 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.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​Drugs/​Guidance7ComplianceRegulatoryInformation/​Guidances/​default.htm or http://www.regulations.gov.

Dated: May 27, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.