[Federal Register Volume 67, Number 129 (Friday, July 5, 2002)]
[Notices]
[Pages 44858-44859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16797]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-1454]


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 guidance for industry entitled ``Nasal Spray and 
Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, 
Manufacturing, and Controls Documentation.'' This document provides 
guidance for industry on the chemistry, manufacturing, and controls 
documentation that should be submitted in new drug applications (NDAs) 
and abbreviated new drug applications (ANDAs) for nasal spray and 
inhalation solution, suspension, and spray drug products intended for 
local and/or systemic effect. The guidance also provides 
recommendations on labeling.

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

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT:  Guirag Poochikian, Center for Drug 
Evaluation and Research (HFD-570), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1050.

SUPPLEMENTARY INFORMATION:

[[Page 44859]]

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Nasal Spray and Inhalation Solution, Suspension, and Spray 
Drug Products--Chemistry, Manufacturing, and Controls Documentation.'' 
This guidance provides recommendations on the information that should 
be submitted in NDAs and ANDAs for these products, including 
information on drug product components, manufacturing process, and the 
associated controls. However, it does not address the manufacture of 
drug substances. The guidance gives recommendations on information that 
should be provided to ensure continuing quality and performance 
characteristics for these drug products. This guidance also provides 
information on labeling.
    In the Federal Register of June 2, 1999 (64 FR 29657), FDA 
announced the availability of a draft version of this guidance. The 
June 1999 guidance gave interested persons an opportunity to submit 
comments through August 31, 1999. All comments received during the 
comment period have been carefully reviewed and incorporated in this 
revised guidance where appropriate. As a result of the public comment, 
the guidance is clearer and more concise than the draft version. FDA is 
participating in research relating to these types of drug products 
through the Product Quality Research Institute (Internet address at 
http://www.pqri.org) and will evaluate whether to update the guidance 
as information from this research becomes available.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on chemistry, manufacturing, and controls 
documentation 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 statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (see 
ADDRESSES). 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 24, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-16797 Filed 7-3-02; 8:45 am]
BILLING CODE 4160-01-S