[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]
[Page 8884-8885]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe08-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0065 (formerly Docket No. 2005D-0203)]
Guidance for Industry on Safety Testing of Drug Metabolites;
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 ``Safety Testing of
Drug Metabolites.'' This guidance provides recommendations to industry
on when and how to identify and characterize drug metabolites whose
nonclinical toxicity needs to be evaluated. It also provides
recommendations on the timing and type of nonclinical studies that
should be conducted to investigate the potential for clinical toxicity
of drug metabolites. This guidance applies to small molecule
nonbiologic drug products under development. This guidance finalizes
the draft guidance published on June 6, 2005.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://www.regulations.gov. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Aisar Atrakchi, Center for Drug
Evaluation and Research (HFD-130), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, rm. 4384, Silver Spring, MD 20993-0002,
301-796-1036.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Safety Testing of Drug Metabolites.'' This guidance
addresses drug metabolites of small molecule nonbiologic drug products
and does not apply to some cancer products. It applies to drug
metabolites that are not adequately evaluated in standard toxicology
testing with the parent drug. This can happen if the metabolite is
present only in humans or if it is present at higher levels (referred
to in the guidance as ``disproportionate drug metabolite'') in humans
than in any of the animal toxicology test species. The guidance
provides recommendations on the timing and types of nonclinical safety
[[Page 8885]]
studies that should be conducted for drug metabolites that are present
at greater than 10 percent of the parent drug systemic exposure as
measured in plasma.
A draft version of this guidance was made available for public
comment in 2005 (70 FR 32839, June 6, 2005). All of the public comments
we received have been considered and the guidance was revised as
appropriate.
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 the safety testing of drug metabolites. 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 to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2827 Filed 2-14-08; 8:45 am]
BILLING CODE 4160-01-S