[Federal Register Volume 64, Number 13 (Thursday, January 21, 1999)]
[Notices]
[Page 3303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-1267]


Draft Guidance for Industry on NDA's: Impurities in Drug 
Substances; 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availability of a draft guidance for industry entitled ``NDA's: 
Impurities in Drug Substances.'' This draft 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DATES: Written comments on the draft guidance document may be submitted 
by April 21, 1999. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm''. Submit written 
requests for single copies of the draft guidance for industry to the 
Drug Information Branch (HFD-210), Center for Drug Evaluation and 
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857. Submit written comments on the draft guidance to the Dockets 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, Office of New Drug 
Chemistry, Office of Pharmaceutical Science, Center for Drug Evaluation 
and Research (HFD-180), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-7310.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``NDA's: Impurities in Drug 
Substances.'' Although ICH guidance document entitled ``Q3A Impurities 
in New Drug Substances,'' which was published in the Federal Register 
on January 4, 1996 (61 FR 371), 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 also applies to 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 reporting information contained in that document.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
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 requirement of the applicable statute, 
regulations, or both.
    Interested persons may submit written comments on the draft 
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 draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: January 13, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-1364 Filed 1-20-99; 8:45 am]
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