[Federal Register Volume 64, Number 142 (Monday, July 26, 1999)]
[Notices]
[Pages 40381-40382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2096]
Draft ``Guidance for Industry: Interpreting Sameness of
Monoclonal Antibody Products Under the Orphan Drug Regulations;''
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 ``Guidance for Industry:
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan
Drug Regulations.'' The draft guidance document is intended to provide
sponsors and manufacturers FDA's current thinking on the criteria by
which two monoclonal antibody products would be considered the same
under the Orphan Drug Act and implementing regulations.
DATES: Written comments may be submitted at any time, however, comments
should be submitted by October 25, 1999, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of ``Guidance for
Industry: Interpreting Sameness of Monoclonal Antibody Products Under
the Orphan Drug Regulations'' to the Office of Communication, Training,
and Manufacturers Assistance (HFM-940), 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 the office in processing your requests. The document may also be
obtained by mail by calling the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800, or by fax by calling the FAX Information
System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance. Submit
written comments on the document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft document entitled
``Guidance for Industry: Interpreting Sameness of Monoclonal Antibody
Products Under the Orphan Drug Regulations.''
In the Federal Register of December 29, 1992 (57 FR 62076), FDA
published the orphan drug regulations final rule. The final rule
established in part 316 (21 CFR part 316) regulations that prescribe
certain incentives for the development of ``orphan drugs,'' drugs which
are intended for use in rare diseases or conditions. One of the
incentives for orphan drug development is to obtain exclusive approval
for the pioneer product for a period of 7 years during which no
approval will be given to a subsequent sponsor of the same drug product
for the same indication unless it proves to be clinically superior, as
defined in Sec. 316.3(b)(3). In determining whether or not two products
would be considered the same, FDA recognized that different criteria
were necessary for macromolecules versus small molecules
(Sec. 316.3(b)(13)). Macromolecules include a variety of structures
including proteins, nucleic acids, carbohydrates and closely related,
complex, partly definable drugs such as vaccines or surfactants. The
current definition of sameness for protein drugs
(Sec. 316.3(b)(13)(ii)(A)) however, does not consider the unique nature
of antibodies. The draft document is intended to describe FDA's
thinking on the criteria by which two monoclonal antibody products
would be considered the same under the Orphan Drug Act and its
implementing regulations.
This draft guidance document represents the agency's current
thinking on the interpretation of the orphan drug regulations as they
pertain to monoclonal antibodies. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirement of the applicable statute, regulations, or both. As
with other guidance documents, FDA does not intend this document to be
all-inclusive and cautions that not all information may be applicable
to all situations. The document is intended to provide information and
does not set forth requirements.
II. Comments
This draft document is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Dockets Management Branch (address above) written
[[Page 40382]]
comments regarding this draft guidance document. Written comments may
be submitted at any time, however, comments should be submitted by
October 25, 1999, to ensure adequate consideration in preparation of
the final document. Two copies of any comments are to be submitted,
except individuals may submit one copy. Comments should be identified
with the docket number found in brackets in the heading of this
document. A copy of the document and received comments are available
for public examination in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document using
the World Wide Web (WWW). For WWW access, connect to CBER at ``http://
www.fda.gov/cber/guidelines.htm''.
Dated: July 14, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-18928 Filed 7-23-99; 8:45 am]
BILLING CODE 4160-01-F
