[Federal Register Volume 65, Number 38 (Friday, February 25, 2000)]
[Notices]
[Page 10097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4405]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-1267]


Guidance for Industry on NDAs: Impurities in Drug Substances; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``NDAs: Impurities in 
Drug Substances.'' This document recommends that applicants submitting 
new drug applications (NDA's) and holders of supporting Type II drug 
master files (DMF's) for drug substances not considered new drug 
substances refer to the guidance for industry on reporting drug 
substance impurities in the International Conference on Harmonisation 
(ICH) guidance document entitled ``Q3A Impurities in New Drug 
Substances.''

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written 
requests for single copies of this guidance to the Drug Information 
Branch (HFD-210), 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 Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Eric P. Duffy, Center for Drug 
Evaluation and Research (HFD-150), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5765.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``NDAs: Impurities in Drug Substances.'' 
Although ICH ``Q3A Impurities in New Drug Substances,'' which was 
published in the Federal Register on January 4, 1996 (61 FR 372), 
provided guidance to industry on the reporting, identification, and 
qualification of impurities in new drug substances produced by chemical 
syntheses, FDA believes that the guidance provided in ICH Q3A should 
also be considered when evaluating drug substances produced by chemical 
syntheses that are not considered new drug substances. FDA recommends 
that applicants preparing NDA's and holders preparing Type II DMF's 
refer to the information contained in that ICH document.
    In the Federal Register of January 21, 1999 (64 FR 3303), FDA 
announced the availability of a draft version of this guidance. The 
January 1999 document gave interested persons an opportunity to submit 
comments through April 21, 1999. All comments received during the 
comment period have been carefully reviewed and the guidance has been 
revised, where appropriate.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance 
represents the agency's current thinking on reporting impurities in 
drug substances for certain NDA's and DMF's. 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, regulations, or 
both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. 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.

    Dated: February 15, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-4405 Filed 2-24-00; 8:45 am]
BILLING CODE 4160-01-F