[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Page 22693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09220]
[[Page 22693]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-0178]
Guidance for Industry on 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 guidance for industry entitled ``Interpreting
Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations.'' The purpose of this guidance is 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: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Marjorie Shapiro, Center for Drug
Evaluation and Research (HFD-123), Food and Drug Administration, 9000
Rockville Pike, Bethesda, MD 20892, 301-827-0710, or Henry Startzman,
Office of Orphan Products Development, Office of Special Medical
Programs, Food and Drug Administration, 10903 New Hampshire Ave, Silver
Spring, MD 20993, 301-796-8660.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Interpreting Sameness of Monoclonal Antibody Products Under
the Orphan Drug Regulations.''
On July 26, 1999 (64 FR 40381), FDA announced the availability of
the draft version of this guidance. The public comment period closed on
October 25, 1999. A number of comments were received from the public,
all of which the Agency considered carefully as it finalized the
guidance and made appropriate changes. Any changes to the guidance were
minor and made to clarify statements in the draft guidance.
In the Federal Register of December 29, 1992 (57 FR 62076), FDA
published the orphan drug regulations final rule, and on June 12, 2013
(78 FR 35117) the Agency finalized certain amendments to the final rule
in order to clarify regulatory provisions and make minor improvements
to address issues that have arisen since 1992. 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 live viral vaccines. The current definition of
sameness for protein drugs (Sec. 316.3(b)(13)(ii)(A)), however, does
not consider the unique nature of antibodies. This final 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 guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on Interpreting Sameness of Monoclonal
Antibody Products Under the Orphan Drug Regulations. 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 requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and
have been approved under OMB control numbers 0910-0167 (21 CFR part
316), 0910-0001 (21 CFR part 314), and 0910-0014 (21 CFR part 312).
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09220 Filed 4-22-14; 8:45 am]
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