[Federal Register Volume 66, Number 238 (Tuesday, December 11, 2001)]
[Notices]
[Pages 64045-64046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30491]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0510]


Draft Guidance for Industry on Integration of Dose-Counting 
Mechanisms Into MDI 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availability of a draft guidance for industry entitled ``Integration of 
Dose-Counting Mechanisms into MDI Drug Products.'' This draft guidance 
makes recommendations to manufacturers to incorporate dose-counters 
into metered-dose inhalers (MDIs) being developed for the treatment of 
lung diseases. The recommendations made in this draft guidance are 
intended to enhance the use of MDIs, specifically to help patients 
identify when MDIs are no longer delivering reliable doses.

DATES:  Submit written or electronic comments on the draft guidance by 
February 11, 2002. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.

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

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Integration of Dose-Counting Mechanisms into MDI Drug 
Products.'' It is intended primarily for manufacturers of MDI drug 
products designed to deliver drugs to the lungs (e.g., an MDI for the 
treatment of asthma). Dose-counters are mechanisms designed to 
accurately track the number of actuations used by a patient over the 
life span of an individual MDI. The dose-counter would provide the 
patient with continuing, accurate data on the amount of medication left 
in the MDI. Currently, patients do not have an adequate way to track 
the number of metered-doses left in MDIs, and there is no way to detect 
when these devices have exceeded their dose limit. The incorporation of 
a reliable, accurate dose-counter into each MDI will enhance these drug 
products, which are relied on to deliver important and sometimes life-
saving drugs to patients with asthma and other obstructive lung 
diseases.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the 
integration of dose-counting

[[Page 64046]]

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 submit to the Dockets Management Branch 
(address above) written or electronic 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 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: December 3, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-30491 Filed 12-10-01; 8:45 am]
BILLING CODE 4160-01-S