[Federal Register Volume 61, Number 212 (Thursday, October 31, 1996)]
[Notices]
[Pages 56243-56244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27992]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0344]
Guidance for Industry for the Submission of Chemistry,
Manufacturing, and Controls Information for a Therapeutic Recombinant
DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use;
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 guidance document entitled ``Guidance for Industry
for the Submission of Chemistry, Manufacturing, and Controls
Information for a Therapeutic Recombinant DNA-Derived Product or a
Monoclonal Antibody Product for In Vivo Use.'' This guidance document
was prepared by the Center for Biologics Evaluation and Research (CBER)
and the Center for Drug Evaluation and Research (CDER). On May 14,
1996, FDA published a final rule that amended the biologics regulations
to eliminate the establishment license application (ELA) for
manufacturers of certain products. Instead, a sponsor may submit a
biologics license application that includes a chemistry, manufacturing,
and controls (CMC) section. This guidance document is intended to
assist applicants in the preparation of the CMC information for
marketing applications for certain specified products, including
therapeutic recombinant deoxyribonucleic acid (DNA)-derived products or
monoclonal antibody products for in vivo use, as well as those
recombinant DNA-derived products regulated using a new drug application
submitted to CDER.
DATES: Written comments may be submitted at any time, however, to
ensure comments are considered for the next revision they should be
submitted by January 29, 1997.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance for Industry for the Submission of
Chemistry, Manufacturing, and Controls Information for a Therapeutic
Recombinant DNA-Derived Product or Monoclonal Antibody Product for In
Vivo Use'' to the Manufacturers Assistance and Communications Staff
(HFM-42), Center for Biologics Evaluation and Research, 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 1-888-223-7329.
Persons with access to 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 (URL's):
http://www.fda.gov/cber/cberftp.html
ftp://ftp.fda.gov/CBER/
The document may also be obtained via File Transfer Protocol (FTP).
Requestors should connect to the FDA FTP Server, FTP.FDA.GOV
(192.73.61.21.). The 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 Word Perfect 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 guidance to the Dockets Managements
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. A copy of the guidance 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: Sharon A. Carayiannis, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: As outlined in the President's November,
1995, National Performance Review, ``Reinventing the Regulation of
Drugs Made from Biotechnology,'' FDA has announced that it will develop
a single harmonized application form for all licensed biological
products and all drug products. In the Federal Register of May 14, 1996
(61 FR 24227), FDA published a final rule entitled ``Elimination of the
Establishment License Application for Specified Biotechnology and
Specified Synthetic Biological Products.'' The final rule, also part of
FDA's continuing effort to achieve the objectives of the President's
``Reinventing Government'' initiatives, amended the biologics
regulations to eliminate ELA for specified biotechnology and specified
synthetic biological products, including: Therapeutic DNA plasmid
products, therapeutic synthetic peptide products of 40 or fewer amino
acids, monoclonal antibody products for in vivo use, and therapeutic
recombinant DNA-derived products.
Prior to the publication of the final rule, the manufacturers of
these biological products were required to submit both a product
license application and an ELA to FDA for marketing approval (21 CFR
601.2). Under the final rule, a company may submit information in a
single biologics license application for specified biotechnology and
specified synthetic biological products to harmonize the approval
requirements for specified biotechnology and specified synthetic
biological products with similar drug products approved under the new
drug provisions of the Federal Food, Drug, and Cosmetic Act (the act).
The guidance document announced in this notice is intended to
provide assistance to applicants in preparing the CMC section of the
harmonized application for a therapeutic
[[Page 56244]]
recombinant DNA-derived product or a monoclonal antibody product for in
vivo use (submission to CBER) or a recombinant DNA-derived product
subject to approval under section 505(b) of the act (21 U.S.C. 355(b))
(submission to CDER). The guidance document is divided into seven
sections as follows: (1) Introduction; (2) Drug Substance, including
discussions of description and characterization, manufacturer(s),
method(s) of manufacture, process controls, reference standard,
specifications/analytical methods, container/closure system, and drug
substance stability; (3) Drug Product, including discussions of
composition, specifications and methods for drug product ingredients,
manufacturer(s), methods of manufacturing and packaging, specifications
and test methods for drug product, container/closure system,
microbiology, drug product stability; (4) Investigational Product/
Formulation; (5) Environmental Assessment; (6) Method Validation; and
(7) References.
As with other procedural guidance documents, FDA does not intend
that this guidance document is all-inclusive. Alternative approaches
could be warranted in specific situations, and certain aspects might
not be applicable in all situations. If an applicant believed the
procedures described in this guidance document were inapplicable to a
specific situation for a particular product, the applicant could
provide, for FDA's consideration, information supporting an alternative
process. If an applicant chooses to use alternative processes, the
applicant may wish to discuss the matter further with the agency to
prevent expenditure of money and resources on activities that later
might be determined to be unacceptable by FDA. This document does not
bind FDA and does not create or confer any rights, privileges, or
benefits on or for any person, but is intended for guidance.
Interested persons may submit to Dockets Management Branch (address
above) written comments on the guidance document. Two copies of any
comments are to be submitted, except that individuals may submit one
copy. Comments and information are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
guidance document and received comments are available for public
examination in the office above between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 18, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-27992 Filed 10-30-96; 8:45 am]
BILLING CODE 4160-01-F