[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
