[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Notices]
[Pages 5786-5787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3322]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 91N-0428]


Briefing Document for Biological Response Modifiers Advisory 
Committee; 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 draft document entitled ``Addendum to the Points to 
Consider on Human Somatic Cell and Gene Therapy (1991).'' This draft 
addendum is being made available as briefing material for the February 
1996 Biological Response Modifiers Advisory Committee meeting. This 
action is being taken to ensure that all interested parties are aware 
of the information in the document that will be the subject of the 
committee's discussion.

DATES: Written comments by March 28, 1996.

ADDRESSES: Submit written requests for single copies of the draft 
Points to Consider (PTC) addendum to the Division of Congressional and 
Public Affairs (HFM-11), 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 Voice Information System at 1-800-
835-4709.
    Persons with access to the INTERNET may obtain the document in 
several ways. Users of ``Web Browser'' software, such as Mosaic, 
Netscape, or Microsoft Internet Explorer may obtain this document via 
the World Wide Web by using the following Uniform Resource Locators: -
http://www.fda.gov/cber/cberftp.html
ftp://ftp.fda.gov/CBER/
 The document may also be obtained via File Transfer Protocol (FTP). 
Requesters should connect to FDA's FTP Server, FTP.FDA.GOV 
(192.73.61.21). CBER documents are maintained in a subdirectory called 
``CBER'' on the server. Logins with the user name of anonymous are 
permitted, and the user's e-mail address should be sent as the 
password. The ``READ.ME'' file in that subdirectory describes the 
available documents which may be available as an ASCII text file 
(*.TXT), or a WordPerfect 5.1 or 6.x document (*.w51,wp6), or both. 
Finally, the document can be obtained by ``bounce-back e-mail''. A 
message should be sent to: ``[email protected]''.
    Submit written comments on the draft PTC addendum to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the draft PTC 
addendum and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: Suzanne L. Epstein, Center for 
Biologics Evaluation and Research (HFM-521), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
0450.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of 
briefing material being supplied to the advisory committee as 
background information for the meeting. The draft PTC addendum is being 
made available as briefing material prior to the advisory committee 
meeting to ensure that all interested parties have an opportunity to 
obtain and review the material in advance of the meeting. A notice 
announcing the February 1996 Biological Response Modifiers Advisory 
Committee meeting and agenda was published in the Federal Register of 
January 31, 1996 (61 FR 3427 at 3428).
    In the Federal Register of November 29, 1991 (56 FR 61022), FDA 
announced the availability of a draft PTC document entitled ``Points To 
Consider in Human Somatic Cell Therapy and Gene Therapy.'' At that 
time, most gene therapy proposals involved ex vivo use of retroviral 
vectors to transduce cultured cells, which were then administered to 
patients. Since that time, the range of proposals has expanded to 
include additional classes of vectors and also the in vivo use of 
vectors (direct vector administration to patients). Accordingly, FDA 
has drafted an addendum to the 1991 PTC in Human Somatic Cell and Gene 
Therapy that includes current information regarding the production, 
testing, and administration of recombinant vectors for gene therapy. 
Prior to making a draft PTC addendum available for industry use, FDA is 
presenting the issues discussed in the document at the next advisory 
committee meeting.
    As with other PTC documents, FDA does not intend the draft PTC 
addendum to be all-inclusive and cautions that not all information may 
be applicable to all situations. The draft PTC addendum is intended to 
provide information and does not set forth requirements. FDA 
anticipates that manufacturers and other interested parties may develop 
alternative methods and procedures, and discuss them with FDA. FDA 
recognizes that advances will continue in the area of somatic cell and 
gene therapy, and FDA intends to update and revise the document in 
order to improve its usefulness. The draft PTC addendum does not bind 
FDA and does not create or confer any rights, privileges, or benefits 
on or for any person, but is intended merely for guidance.
    Comments received from the meeting and comments submitted to the 
Dockets Management Branch will be considered in determining whether 
revision of the draft PTC addendum is warranted. At a later date after 
the meeting, a Federal Register notice will be published to announce 
the availability of the PTC addendum for industry use. The PTC addendum 
will provide CBER's current thinking regarding issues related to gene 
therapy.
    The briefing document and received comments may be seen in the 
Dockets Management Branch (address above) between 9 a.m. and 4 p.m., 
Monday through Friday.


[[Page 5787]]

    Dated: February 8, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-3322 Filed 2-9-96; 3:00 pm]
BILLING CODE 4160-01-F