[Federal Register Volume 72, Number 90 (Thursday, May 10, 2007)]
[Notices]
[Page 26639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0173]


Draft Guidance for Industry on Protecting the Rights, Safety, and 
Welfare of Study Subjects--Supervisory Responsibilities of 
Investigators; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Protecting the 
Rights, Safety, and Welfare of Study Subjects--Supervisory 
Responsibilities of Investigators.'' This draft guidance is intended to 
assist investigators in meeting their responsibilities with respect to 
protecting human subjects and ensuring the integrity of data in the 
conduct of clinical investigations. The draft guidance also clarifies 
FDA's expectations concerning the investigator's responsibility for 
supervising a clinical study in which some study tasks are delegated to 
employees of the investigator or to outside parties.

DATES:  Submit written or electronic comments on the draft guidance by 
July 9, 2007. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Critical Path Programs (HF-18), Office of the 
Commissioner, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit telephone requests to 
800-835-4709 or 301-827-1800. Submit written comments on the draft 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of 
Critical Path Programs (HF-18), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7864.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Protecting the Rights, Safety, and Welfare of Study 
Subjects--Supervisory Responsibilities of Investigators.'' Under the 
regulations in part 312 (21 CFR part 312) (Investigational New Drug 
Application) and part 812 (21 CFR part 812) (Investigational Device 
Exemptions), an investigator is responsible for ensuring that a 
clinical investigation is conducted according to the signed 
investigator statement, the investigational plan, and applicable 
regulations; for protecting the rights, safety, and welfare of subjects 
under the investigator's care; and for the control of drugs, biological 
products, and devices under investigation (Sec. Sec.  312.60 and 
812.100). This draft guidance clarifies the responsibilities of 
investigators in the conduct of clinical investigations conducted under 
parts 312 and 812, particularly the responsibilities to supervise the 
conduct of the clinical investigation, and to protect the rights, 
safety, and welfare of study participants in drug, biologic, and 
medical device clinical trials. The draft guidance also provides 
recommendations on how investigators should supervise the study-related 
actions of persons not in the direct employ of the investigator, 
including certain study staff and parties conducting associated testing 
and assessments.
    This 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 the 
supervisory responsibilities of investigators. 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 draft 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 part 312 have been approved under OMB 
Control No. 0910-0014; and the collections of information in part 812 
have been approved under OMB Control No. 0910-0078.

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 any 
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. 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 orhttp://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9055 Filed 5-9-07; 8:45 am]
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