[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 The draft guidance document is intended to provide 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INFORMATION section for electronic access to the draft guidance.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