[Federal Register Volume 68, Number 49 (Thursday, March 13, 2003)]
[Notices]
[Page 12088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0043]


Guidance for Industry on Integration of Dose-Counting Mechanisms 
into Metered-Dose Inhaler Drug Products; 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 ``Integration of Dose-
Counting Mechanisms into MDI Drug Products.'' This guidance is intended 
to assist manufacturers who are developing or plan to develop drug 
products for oral inhalation using metered-dose inhalers (MDIs).

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:  Sandy Barnes, Center for Drug 
Evaluation and Research (HFD-570), Food and Drug Administration, 5600 
Fishers Lane, rm. 8B-45, Rockville, MD 20857, 301-827-1055.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Integration of Dose-Counting Mechanisms into MDI Drug 
Products.'' This guidance is intended to assist manufacturers who are 
developing or plan to develop drug products for oral inhalation using 
MDIs. The guidance reflects the agency's current recommendations 
regarding the integration of dose-counting mechanisms into MDI drug 
products for oral inhalation. Although the contents of the guidance 
should be considered by any manufacturer of any MDI drug product 
(including nasal MDI products), this guidance is neither specifically 
intended for manufacturers of already marketed MDI drug products for 
oral inhalation nor for manufacturers developing MDIs for other routes 
of administration (e.g., nasal MDIs). It is also not intended for 
manufacturers developing multidose dry powder inhalers (MDPIs), which 
already incorporate dose counters as an integral part of the delivery 
system. Manufacturers developing new MDPIs are encouraged to continue 
including dose counters in their delivery systems and may find the 
contents of this guidance useful in their planning.
    A draft guidance of the same name was made available for public 
comment in a notice published in the Federal Register of December 11, 
2001 (66 FR 64045). This guidance contains only clarifying editorial 
changes.
    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 integrating dose-counting mechanisms into 
MDI 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 mailed 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: March 5, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-5956 Filed 3-12-03; 8:45 am]
BILLING CODE 4160-01-S