[Federal Register Volume 69, Number 66 (Tuesday, April 6, 2004)]
[Rules and Regulations]
[Page 17927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 312


Emergency Use of an Investigational New Drug; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to reflect a change in address for the agency contacts for 
submitting an investigational new drug application (IND) in an 
emergency situation. This action is editorial in nature and is intended 
to improve the accuracy of the agency's regulations.

DATES: This rule is effective April 6, 2004.

FOR FURTHER INFORMATION CONTACT: Mark I. Fow, Office of Emergency 
Operations (HFA-615), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-1240.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in part 312 
(21 CFR part 312) to reflect a change in address for the agency 
contacts for submitting an IND in an emergency situation that does not 
allow time for submission of an IND in accordance with Sec.  312.23 or 
Sec.  312.34. The current address for submission of investigational 
biological drugs in an emergency situation is the ``Division of 
Biological Investigational New Drugs (HFB-230), Center for Biologics 
Evaluation and Research, 8800 Rockville Pike, Bethesda, MD 20892, 301-
443-4864.'' The new address for investigational biological drugs 
regulated by the Center for Biologics Evaluation and Research is 
``Office of Communication, Training and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research, 301-827-2000.'' The 
current contact for submission of all other investigational drugs in an 
emergency situation is the ``Document Management and Reporting Branch 
(HFD-53), Center for Drug Evaluation and Research, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-4320.'' The new contact is the ``Division 
of Drug Information (HFD-240), Center for Drug Evaluation and Research, 
301-827-4570.'' The current contact for submitting requests for the 
Center for Biologics Evaluation and Research or the Center for Drug 
Evaluation and Research regulated products after normal working hours, 
eastern standard time, in an emergency situation is ``FDA Division of 
Emergency and Epidemiological Operations, 202-857-8400.'' The new 
contact is ``FDA Office of Emergency Operations (HFA-615), 301-443-
1240.''
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedure are unnecessary because FDA is merely correcting 
nonsubstantive errors.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 312

    Drugs, Exports, Imports, Investigations, Labeling, Medical 
research, Reporting and recordkeeping requirements, Safety.

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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

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

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371; 42 
U.S.C. 262.

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2. Section 312.36 is revised to read as follows:


Sec.  312.36  Emergency use of an investigational new drug (IND).

    Need for an investigational drug may arise in an emergency 
situation that does not allow time for submission of an IND in 
accordance with Sec.  312.23 or Sec.  312.34. In such a case, FDA may 
authorize shipment of the drug for a specified use in advance of 
submission of an IND. A request for such authorization may be 
transmitted to FDA by telephone or other rapid communication means. For 
investigational biological drugs regulated by the Center for Biologics 
Evaluation and Research, the request should be directed to the Office 
of Communication, Training and Manufacturers Assistance (HFM-40), 
Center for Biologics Evaluation and Research, 301-827-2000. For all 
other investigational drugs, the request for authorization should be 
directed to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, 301-827-4570. After normal working hours, 
eastern standard time, the request should be directed to the FDA Office 
of Emergency Operations (HFA-615), 301-443-1240. Except in 
extraordinary circumstances, such authorization will be conditioned on 
the sponsor making an appropriate IND submission as soon as practicable 
after receiving the authorization.

    Dated: March 31, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7734 Filed 4-5-04; 8:45 am]
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