[Federal Register Volume 64, Number 105 (Wednesday, June 2, 1999)]
[Notices]
[Page 29657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13921]
[[Page 29657]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1454]
Draft Guidance for Industry on Nasal Spray and Inhalation
Solution, Suspension, and Spray Drug Products; Chemistry,
Manufacturing, and Controls Documentation; 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availability of a draft guidance for industry entitled ``Nasal Spray
and Inhalation Solution, Suspension, and Spray Drug Products;
Chemistry, Manufacturing, and Controls Documentation.'' This draft
document is intended to provide guidance for industry on the chemistry,
manufacturing, and controls (CMC) documentation to be submitted in new
drug applications (NDA's) and abbreviated new drug applications
(ANDA's) for nasal spray and inhalation solution, suspension, and spray
drug products. This draft guidance also covers CMC information
recommended for inclusion in the NDA's and ANDA's regarding the
components, manufacturing process, and associated controls with each of
these areas.
DATES: Written comments on the draft guidance may be submitted by
August 31, 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ADDRESSES: Copies of this draft guidance are available on the Internet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requests for single copies of the draft guidance for industry to the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. Send one self-addressed adhesive label to assist that office
in processing your requests. Submit written comments on the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug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.
Comments are to be identified with the docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Guiragos K. Poochikian, Center for
Drug Evaluation and Research (HFD-570), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-1050.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Nasal Spray and Inhalation
Solution, Suspension, and Spray Drug Products; Chemistry,
Manufacturing, and Controls Documentation.'' This draft guidance sets
forth information that should be provided to ensure continuing quality
and performance characteristics for these drug products.
This draft level 1 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 CMC documentation
to be submitted in NDA's and ANDA's for nasal spray and inhalation
solution, suspension, and spray drug products. 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 statute, regulations, or
both.
Interested persons may, on or before August 31, 1999, submit to the
Dockets Management Branch (address above) written comments on the draft
guidance. 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: May 25, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-13921 Filed 6-1-99; 8:45 am]
BILLING CODE 4160-01-F