[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Draft Guidance; Changes To An Approved Application for Well-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availability of a draft guidance document entitled ``Draft Guidance; 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 This draft guidance is intended to assist applicants in 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does not intend for these draft guidance documents to be used at this 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Draft Guidance; Changes to An Approved Application 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