[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Notices]
[Page 71538-71539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no05-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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-
2000.
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
available?
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
presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
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]
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