[Federal Register Volume 61, Number 19 (Monday, January 29, 1996)]
[Proposed Rules]
[Pages 2748-2749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1581]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 600 and 601
[Docket No. 95D-0415]
Draft Guidance; Changes To An Approved Application for Well-
Characterized Therapeutic Recombinant DNA-Derived and Monoclonal
Antibody Biotechnology Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Draft Guidance;
Changes to An Approved Application for Well-Characterized Therapeutic
Recombinant DNA-Derived and Monoclonal Antibody Biotechnology
Products.'' This draft guidance is intended to assist applicants in
determining how they should report changes to an approved license
application for well-characterized therapeutic recombinant DNA-derived
and monoclonal antibody biotechnology products under the proposed
revision to the biologics regulations issued elsewhere in this issue of
the Federal Register. In a separate document also published in this
issue of the Federal Register, FDA is announcing the availability of a
guidance document to assist applicants in determining how they should
report changes to an approved license application for biologic products
other than well-characterized therapeutic recombinant DNA-derived and
monoclonal antibody biotechnology products under the proposed rule. FDA
does not intend for these draft guidance documents to be used at this
time. The agency is providing these guidance documents for public
comment only.
DATES: Written comments by April 29, 1996.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Draft Guidance; Changes to An Approved Application
for Well-Characterized Recombinant DNA-Derived and Monoclonal Antibody
Biotechnology Products'' to the Congressional and Consumer Affairs
Branch (HFM-12), Center for Biologics Evaluation and Research, Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448,
301-594-1800 or call FDA's automated information system at 800-835-
4709. Send two self-addressed adhesive labels to assist that office in
processing your requests. Submit written comments on the draft guidance
to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., 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 guidance and received comments are available for public
examination in
[[Page 2749]]
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Persons with access to INTERNET may request that the draft guidance
document be sent by return E-mail by sending a message to
``[email protected]''. The draft guidance document may also be
obtained through INTERNET via File Transfer Protocol (FTP). Requestors
should connect to the Center for Drug Evaluation and Research (CDER)
using the FTP. The Center for Biologics Evaluation and Research (CBER)
documents are maintained in a subdirectory called CBER on the server,
``CDVS2.CDER.FDA.GOV'' (150.148.24.202). The ``READ.ME'' file in that
subdirectory describes the available documents that may be available as
an ASCII text file (*.TXT), or a WordPerfect 5.1 document (*.w51), or
both. A sample dialogue for obtaining the READ.ME file with a text-
based FTP program would be:
FTP CDVS2.CDER.FDA.GOV
LOGIN: CHARACTER
<``your e-mail="" address''="">
BINARY
CD CBER
GET READ.ME
EXIT
The draft guidance document may also be obtained by calling the CBER
FAX Information System (FAX-ON-DEMAND) at 301-594-1939 from a touch
tone telephone.
FOR FURTHER INFORMATION CONTACT:
Tracey H. Forfa or 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
Yuan Yuan Chiu, Center for Drug Evaluation and Research (HFD-510),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-3510.
Dated: January 16, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-1581 Filed 1-25-96; 10:42 am]
BILLING CODE 4160-01-F
