[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Rules and Regulations]
[Page 32479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15759]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312

[Docket No. 97N-0223]


Investigational New Drug Application; Exception from Informed 
Consent; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending its 
investigational new drug application (IND) regulations to clarify that, 
within 30 days after the receipt of an IND for any clinical 
investigation involving an exception from informed consent, FDA will 
provide a written determination as to whether the investigation may 
begin. This action is intended to clarify a recent amendment to the IND 
regulations for clinical investigations involving an exception from 
informed consent that states that FDA will provide a written 
authorization within 30 days of receipt of the IND.

EFFECTIVE DATE: June 23, 1997.

FOR FURTHER INFORMATION CONTACT: David LePay, Center for Drug 
Evaluation and Research (HFD-340), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-0020.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 2, 1996 
(61 FR 51498), FDA amended its regulations by adding Sec. 50.24 (21 CFR 
50.24) to provide a narrow exception from informed consent requirements 
for a limited class of emergency research. Under the amendments, 
certain research activities involving human subjects who are in need of 
emergency medical intervention, but who cannot give informed consent 
because of their life-threatening medical condition, and who do not 
have a legally authorized person to represent them, may be exempt from 
the informed consent requirements.
    The October 2, 1996, final rule also amended the IND regulations at 
Sec. 312.20(c) by adding paragraph (c) (21 CFR 312.20(c)), which 
requires a sponsor to submit a separate IND for any clinical 
investigation involving an exception from informed consent under 
Sec. 50.24. This requirement is to ensure that FDA has an opportunity 
to review the protocol and supporting information before the 
investigation begins. Section 312.20(c) also provides that the clinical 
investigation may not proceed without the prior written authorization 
from FDA. The requirement for written authorization is to document that 
the agency has reviewed the protocol and supporting information and has 
agreed that the investigation may proceed. To enable sponsors to begin 
these investigations as expeditiously as possible, current Sec. 312.20 
(c) also states that ``FDA shall provide such written authorization 30 
days after FDA receives the IND or earlier.''
     Current IND regulations at Sec. 312.40(b) (21 CFR 312.40(b)) state 
that an IND goes into effect 30 days after FDA receives the IND or upon 
earlier notification by FDA that the investigations may begin, unless 
FDA notifies the sponsor that the investigations are subject to a 
clinical hold. Thus, under current IND regulations, FDA may grant or 
deny permission for the investigations to begin, within 30 days after 
it receives an IND. The statement in Sec. 312.20(c) that ``FDA shall 
provide such written authorization 30 days after FDA receives the IND 
or earlier''suggests that the agency may only grant permission for the 
investigations to begin. To correct this unintended meaning, FDA is 
amending the last sentence in Sec. 312.20(c) to state that ``FDA shall 
provide a written determination 30 days after FDA receives the IND or 
earlier.''
    Because this amendment is nonsubstantive and is intended only to 
provide consistency with current IND regulations, FDA finds for good 
cause that notice and public procedure and delayed effective date are 
unnecessary (5 U.S.C. 553(b)(B) and (d)).

List of Subjects in 21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
312 is amended as follows:

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

    1. The authority citation for 21 CFR part 312 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C 321, 331, 351, 
352, 353, 355, 356, 357, 371); sec. 351 of the Public Health Service 
Act (42 U.S.C. 262).

    Section 312.20 is amended by revising the last sentence of 
paragraph (c) to read as follows:

Sec. 312.20  Requirement for an IND.

* * * * *
    (c) * * * FDA shall provide a written determination 30 days after 
FDA receives the IND or earlier.

    Dated: June 10, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-15759 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F