[Federal Register Volume 61, Number 233 (Tuesday, December 3, 1996)]
[Notices]
[Pages 64136-64137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30770]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0334]


Procedures for Issuance of and Review and Response to Materials 
Submitted in Response to Clinical Hold for Investigational New Drug 
(IND) Applications; 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 two documents entitled ``Centerwide Policy on Issuance 
of and Response to Clinical Hold Letters for Investigational New Drug 
Applications'' (OD-R-8-96, Center for Biologics Evaluation and Research 
(CBER)) and ``IND Process and Review Procedures'' (MAPP 6030.1, Center 
for Drug Evaluation and Research (CDER)). The documents specify the 
procedures for the issuance of and review and response to material 
submitted in response to a notice of clinical hold. It is intended that 
these documents will clarify the agency's policy in regard to responses 
to clinical holds. The documents are made available as part of the 
agency's commitment to review and respond to data submitted in response 
to a clinical hold within 30 days of receiving the submission, as 
stated in the November 1995, Presidential National Performance Review 
report entitled ``Reinventing the Regulation of Drugs Made from 
Biotechnology.''

ADDRESSES:
    CBER Information: For additional copies of the documents submit 
written requests to the Manufacturers Assistance and Communication 
Staff (HFM-42), Center for Biologics Evaluation and Research (CBER), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your requests. The document may also be obtained by mail or 
FAX by calling the CBER FAX Information System at 1-888-CBER FAX, or 
301-827-3844. Persons with access to the Internet may obtain the 
document using FTP, the World Wide Web (WWW), or bounce-back e-mail. 
For FTP access, connect to CBER at ``ftp://ftp.fda.gov/CBER/''. For WWW 
access, connect to CBER at ``http://www.fda.gov/cber/cberftp.html''. 
For bounce-back e-mail send a message to ``[email protected]''.
    CDER Information: For additional copies of the documents contact 
the Drug Information Branch (HFD-210), Division of Communications 
Management, Center for Drug Evaluation and Research (CDER), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-
1012. The form may also be obtained by calling the CDER FAX-ON-DEMAND 
System at 1-800-342-2722, or 1-301-827-0577. An electronic version of 
the documents is also available via Internet using FTP, Gopher, or the 
World Wide Web (WWW). For FTP, connect to the CDER anonymous FTP server 
at cdvs2.cder.fda.gov and change to the ``guidance'' directory. For 
Gopher, connect to the CDER Gopher server at

[[Page 64137]]

gopher.cder.fda.gov and select the ``Industry Guidance'' menu option. 
For WWW, connect to the FDA home page at http://www.fda.gov.
    Submit written comments on the documents to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857. Corporations should submit two copies of any 
comments and individuals may submit one copy. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. Copies of the documents and received comments 
are available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
     Timothy W. Beth, Center for Biologics Evaluation and Research 
(HFM-630), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-594-3074, or
     Murray M. Lumpkin, Center for Drug Evaluation and Research (HFD-
2), Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 
20852-1420, 301-594-5417.

SUPPLEMENTARY INFORMATION: The President's November 1995 report, 
``Reinventing the Regulation of Drugs Made from Biotechnology,'' 
outlined changes to the biologics regulations designed to reduce the 
burden of FDA regulations on industry without reducing public health 
protection. One of the recommended modifications was to have 
investigational new drug (IND) reviewers respond within 30 days whether 
newly submitted information supports the initiation or continuation of 
a human investigation that the agency has put on clinical hold.
    Companies or individuals that intend to study IND's or biologics in 
humans generally are required first to submit an IND application to the 
agency. They may proceed with the study 30 days after the agency 
receives the application unless FDA puts the study on clinical hold 
(Sec. 312.42 (21 CFR 312.42).) Section 312.42(a) describes a clinical 
hold as an ``order issued by FDA to the sponsor to delay a proposed 
clinical investigation or to suspend an ongoing investigation.'' 
Section 312.42(d) states that the hold may be relayed to the sponsor by 
telephone or other rapid means of communication and that FDA will 
provide a written explanation of the basis of the hold to the sponsor 
no more than 30 days following the hold. Though Sec. 312.42(d) allows 
for communication of the reasons for a hold within 30 days following 
the placement of the hold, both CBER and CDER provide this notification 
in even shorter timeframes, consistent with the procedures set forth in 
the CBER and CDER documents. Thus, a researcher or company that intends 
to begin testing a biologic or new drug in humans, may not begin or 
continue the study until FDA releases the clinical hold. Removal of the 
hold may be relayed by telephone or other rapid means of communication 
unless FDA notified the sponsor in writing that once a correction or 
modification was made they could proceed as outlined in Sec. 312.42(e).
    In the past, FDA had no internal operating procedures regarding how 
much time it may take to evaluate data submitted by the sponsor in 
response to the clinical hold. FDA is committed to promptly reviewing 
and responding to data submitted in response to a clinical hold and to 
do so within 30 days of receiving the submission. FDA believes that the 
30-day period meets the needs of sponsors, will prevent delays during 
review of data, and will prevent unnecessary delays in the start or 
continuation of clinical studies. These procedures are contained in 
CBER's Policy and Procedure Guide, OD-R-8-96, ``Centerwide Policy on 
Issuance of and Response to Clinical Hold Letters for Investigational 
New Drug Applications,'' dated August 20, 1996, and in CDER's Manual of 
Policies and Procedures, MAPP 6030.1, ``IND Process and Review 
Procedures,'' dated June 20, 1996.
    Although these documents do not create or confer any rights for or 
on any person and do not operate to bind FDA or the public, they do 
represent the agency's current thinking on time periods for the review 
and response to materials submitted in response to clinical hold for 
IND's.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the procedure documents. FDA will 
review the comments received and, if appropriate, consider preparing 
revised documents based upon that review. Corporations should submit 
two copies of any comments and individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Copies of the documents and received 
comments are available for public examination in the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: November 19, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-30770 Filed 12-2-96; 8:45 am]
BILLING CODE 4160-01-F