[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Page 71538-71539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0374]

Nonprescription Drugs Advisory Committee and Pulmonary-Allergy 
Drugs Advisory Committee; Notice of Meeting and Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committees: Nonprescription Drugs Advisory Committee and 
the Pulmonary-Allergy Drugs Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 24, 2006, from 8 
a.m. to 5 p.m. Interested persons and organizations may submit written 
or electronic comments until January 6, 2006, to the Division of 
Dockets Management (see Addresses).
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2005N-0374 Use of Ozone-

Depleting Substance: Essential-Use Determination of Over-the-Counter 
(OTC) Epinephrine Metered Dose Inhalers'' and follow the prompts to 
submit your statement. Written comments should be submitted to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Location: Holiday Inn Select Bethesda, The Ballrooms, 8120 
Wisconsin Ave., Bethesda, MD. The hotel telephone number is 301-652-
    Contact Person: Darrell Lyons, Center for Drug Evaluation and 
Research (HFD 21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 
(301-827-7001, FAX: 301-827-6776, e-mail: lyonsd@cder.fda.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area) codes 3014512541 or 3014512545. Please call 
the Information Line for up to date information on this meeting.
    Agenda: The committee will discuss the continued need for the 
designation of OTC epinephrine-metered dose inhalers for the treatment 
of asthma as an essential use of ozone-depleting substances (ODSs) 
under Sec.  2.125 (21 CFR 2.125). ODSs are substances that deplete the 
stratospheric ozone, which include chlorofluorocarbons (CFCs). Once 
released, CFCs rise to the stratosphere. In the stratosphere, CFCs are 
gradually broken down by strong ultraviolet light, and they release 
chlorine atoms that then deplete stratospheric ozone. Depletion of 
stratospheric ozone by CFCs and other ODSs leads to higher ultraviolet 
B radiation levels, which in turn increase skin cancers and cataracts, 
as well as cause other significant environmental damage.
    FDA is soliciting comments and data to support or refute an 
essential-use designation for OTC epinephrine metered-dose inhaler 
(MDI) drug products. These products include the only OTC drug available 
in an MDI dosage form for the treatment of asthma. The OTC epinephrine 
MDIs use CFCs as propellants. The OTC indication is ``for temporary 
relief of shortness of breath, tightness of chest, and wheezing due to 
bronchial asthma.'' In some instances, use of this product early during 
an asthma attack could avert a serious or life-threatening worsening of 
the attack. There are currently a limited number of marketed OTC drug 
products containing epinephrine in a MDI dosage form.
    According to Sec.  2.125(f)(1), the following are criteria for 
continued ODS essential-use designation:
    (1) Substantial technical barriers exist to formulating the product 
without ODSs;
    (2) The product will provide an otherwise unavailable important 
public health benefit; and
    (3) Use of the product does not release cumulative significant 
amounts of ODSs into the atmosphere or the release is warranted in view 
of the high

[[Page 71539]]

probability of an unavailable important public health benefit.
    Under section 610 of the Clean Air Act (42 U.S.C. 7671(i)), MDIs 
that are not the subject of an essential-use designation cannot be 
legally distributed in interstate commerce.
    We particularly encourage comments on the second criterion in Sec.  
2.125(f)(i) regarding the public health benefit derived from the 
availability of these products in the OTC setting. Information that may 
aid in the Committee's discussion of essential use includes:
     Who currently uses OTC epinephrine MDIs?
     How many of these MDIs are used annually?
     What are the alternatives if these products are no longer 
     From literature sources, what is the value of use of the 
product to the users, and why do they use it?
     What established treatment guidelines recommend the use of 
OTC epinephrine?
     How many people with asthma do not have ready access to 
prescription medication through healthcare professionals?
    The background material will become available no later than the day 
before the meeting and will be posted under the Nonprescription Drugs 
Advisory Committee (NDAC) and the Pulmonary Drugs Advisory Committee 
(PADAC) on FDA's website at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
 (Click on the year 2006 and scroll down to NDAC or PADAC).

    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committees. 
Written comments should be submitted by close of business January 6, 
2006, to the Division of Dockets Management (see Addresses). Oral 
presentations from the public will be scheduled between approximately 1 
p.m. and 2 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person by close of business January 6, 2006, and submit a brief 
statement of the general nature of the information they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Darrell Lyons (see 
Contact Person) at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 17, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-23372 Filed 11-28-05; 8:45 am]