[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Draft Guidance for Industry on NDA's: Impurities in Drug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availability of a draft guidance for industry entitled ``NDA's: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DATES: Written comments on the draft guidance document may be submitted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ADDRESSES: Copies of this draft guidance are available on the Internet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requests for single copies of the draft guidance for industry to the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 Submit written comments on the draft guidance to the Dockets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draft guidance for industry entitled ``NDA's: Impurities in Drug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]
BILLING CODE 4160-01-F
