[Federal Register Volume 66, Number 49 (Tuesday, March 13, 2001)]
[Notices]
[Pages 14590-14591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0079]


Acceptance of Foreign Clinical Studies; 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 final guidance entitled ``Acceptance of Foreign 
Clinical Studies.'' This final guidance is intended to clarify the 
ethical principles with which a sponsor must comply before FDA would 
accept a foreign clinical study not conducted under an investigational 
new drug application (IND) or investigational device exemption (IDE) in 
support of a marketing approval application.

DATES: Submit written comments on the final guidance at any time.

ADDRESSES: Submit written requests for single copies of the final 
guidance entitled ``Acceptance of Foreign Clinical Studies'' to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Send two self-addressed adhesive labels to assist that office 
in processing your requests. Submit written comments on the guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1601, Rockville, MD 20852. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the final guidance.

FOR FURTHER INFORMATION CONTACT: David A. Lepay, Office for Science 
Coordination and Communication (HF-34), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-4000.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA regulations allow for the acceptance of foreign clinical 
studies not performed under an IND or IDE in support of a marketing 
approval application for a drug, biological product, or device if 
certain conditions are met. Under these regulations, the study must 
conform to the ethical principles contained in the Declaration of 
Helsinki (the Declaration) or with the laws and regulations of the 
country in which the research was conducted, whichever provides greater 
protection of the human subjects. In October 2000, the World Medical 
Association approved a fifth revision of the Declaration. FDA is making 
this guidance available to clarify which version of the Declaration was 
incorporated into the drug regulations, and which version of the 
Declaration was incorporated into the device regulations, and, 
therefore, which version of the Declaration is applicable to foreign 
studies conducted without an IND or IDE. FDA will also review any other 
guidance documents on this subject, and modify them, if necessary, to 
conform to the clarification expressed in this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
The guidance represents the agency's current thinking on the ethical 
principles with which a sponsor must comply before FDA would accept a 
foreign clinical study not conducted under an IND or IDE in support of 
a marketing approval application. It does not create or confer

[[Page 14591]]

 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.
     Under FDA's good guidance practice regulations, this guidance is 
being issued as a Level 2 guidance because it sets forth the agency's 
existing practices (21 CFR 10.115(c)(2); 65 FR 56468, September 19, 
2000). Therefore, FDA is issuing this document as a final guidance 
prior to receiving public comment. However, as with all FDA guidance, 
the public is encouraged to submit written comments with new data or 
other new information pertinent to this guidance. The comments in the 
docket will be periodically reviewed, and, where appropriate, the 
guidance will be amended.

III. Comments

    Interested persons may, at any time, submit written comments on the 
final guidance to the Dockets Management Branch (address above). Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. The final guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain this guidance at 
http://www.fda.gov/cder.

    Dated: March 5, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-6135 Filed 3-12-01; 8:45 am]
BILLING CODE 4160-01-S