[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Draft Guidance for Industry on Nasal Spray and Inhalation 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availability of a draft guidance for industry entitled ``Nasal Spray 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 This draft guidance also covers CMC information 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DATES:  Written comments on the draft guidance may be submitted by 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ADDRESSES:  Copies of this draft guidance are available on the Internet 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requests for single copies of the draft guidance for industry to the 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 Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 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