
[Federal Register: August 20, 2009 (Volume 74, Number 160)]
[Notices]
[Page 42080-42081]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au09-43]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0374]


Educating the Public About Removal of Essential-Use Designation
for Epinephrine; Public Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Educating the Public About Removal of Essential-Use
Designation for Epinephrine.'' The currently approved over-the-counter
(OTC) epinephrine metered-dose inhalers (MDIs) contain
chlorofluorocarbons (CFCs) and cannot be marketed after December 31,
2011. This 1-day public workshop is intended to seek input from key
stakeholders in the asthma community, the pharmaceutical industry,
experts in health care communication, and the public on strategies to
educate consumers about the decision to remove epinephrine MDIs from
the market and transition consumers to therapeutic alternatives that do
not contain CFCs or other ozone-depleting substances (ODSs). The agency
encourages individuals, patient advocates, industry, consumer groups,
health care professionals, researchers, and other interested persons to
attend this public workshop.

DATES:  The public workshop will be held on September 25, 2009, from
8:30 a.m. to 3 p.m. However, depending on public participation, the
meeting may be extended or may end early. See section III of this
document for information on how to register for the workshop. Written
or electronic comments must be submitted by November 24, 2009.

ADDRESSES:  The public workshop will be held at FDA's, Center for Drug
Evaluation and Research Advisory Committee Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD 20852.
    Submit written or electronic requests to make a presentation to
Faith Dugan (see FOR FURTHER INFORMATION CONTACT). Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://www.regulations.gov. All comments
should be identified with the docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT:  Faith Dugan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6182, Silver Spring, MD 20993-0002, 301-
796-3446, FAX: 301-847-8752, e-mail: Faith.Dugan@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Montreal Protocol on Substances that Deplete the Ozone
Layer (Montreal Protocol) and the Clean Air Act,\1\ FDA, in
consultation with the Environmental Protection Agency, is required to
determine whether an FDA-regulated product that releases an ODS is an
essential use of the ODS. Products containing an ODS, such as CFCs,
that are not designated as essential uses cannot be sold or distributed
in the United States. In the Federal Register of November 19, 2008 (73
FR 69532) (the final rule), we amended our regulation on the use of
ODSs in self-pressurized containers to remove the essential-use
designation for MDIs containing epinephrine. Epinephrine MDIs
containing an ODS cannot be marketed after December 31, 2011. You may
find copies of the final rule on the Internet at http://
www.regulations.gov.
---------------------------------------------------------------------------

    \1\ Montreal Protocol on Substances that Deplete the Ozone
Layer, September 16, 1987, 26 I.L.M. 1541 (1987); 1990 Amendments to
the Clean Air Act, Public Law No. 101-549 (November 15, 1990).
---------------------------------------------------------------------------

    Epinephrine is a short-acting adrenergic bronchodilator used in the
treatment of asthma. A new drug application (NDA) for OTC epinephrine
MDIs was approved in 1956. Epinephrine was designated as an essential
use in 1978 (43 FR 11301, March 17, 1978). Epinephrine MDIs are
marketed OTC as PRIMATENE MIST and as generic brands for certain retail
pharmacies. Epinephrine MDIs are the only MDIs for treatment of asthma
(or any other disease) that are approved for OTC use. Consumers do not
need a prescription from a health care provider to purchase OTC
epinephrine MDIs.
    In removing the essential-use designation for epinephrine, we
applied the criteria for removing an essential-use designation in Sec.
2.125(g)(2) (21 CFR 2.125(g)(2)). Under Sec.  2.125(g)(2), an
essential-use designation can be removed even though the active moiety
is not available in a non-CFC product if it no longer meets the
criteria specified in Sec.  2.125(f) for adding a new essential use.
The criteria in Sec.  2.125(f)(1) are: ``(i) Substantial technical
barriers exist to formulating the product without ODSs;

[[Page 42081]]

(ii) The product will provide an unavailable important public health
benefit; and (iii) Use of the product does not release cumulatively
significant amounts of ODSs into the atmosphere or the release is
warranted in view of the unavailable important public health benefit.''
    In a proposed rule published on September 20, 2007 (72 FR 53711),
we proposed an effective date for removal of the essential-use
designation for OTC epinephrine MDIs of December 31, 2010, and we
solicited comments on this proposed effective date. We received a
number of comments on the effective date and on the related issue of
ensuring adequate time to transition consumers who use OTC epinephrine
MDIs to non-CFC alternatives. After considering the comments, we were
persuaded that December 31, 2011, rather than December 31, 2010, as
proposed, is a more appropriate effective date for this rule. The
December 31, 2011, date provides additional time to disseminate
information about the transition to OTC epinephrine MDI users and
allows consumers more time to transition to appropriate non-CFC
alternatives. Although at least one manufacturer has stated its intent
to develop an OTC epinephrine MDI without CFCs,\2\ there is no
assurance that the product will be available by December 31, 2011.
Thus, we assume that OTC epinephrine MDI users will need to transition
to therapeutic alternatives that contain a different active moiety,
such as prescription albuterol MDIs.
---------------------------------------------------------------------------

    \2\ See Comment from Mr. Robert Sussman on behalf of Armstrong
Pharmaceuticals, Inc., submitted in response to the Proposed Rule on
Use of Ozone-Depleting Substances; Removal of Essential-Use
Designation (Epinephrine) at 1-2 (dated November 21, 2007) (Document
ID FDA-2007-N-0314-0032, available on the Internet at http://
www.regulations.gov).
---------------------------------------------------------------------------

II. Scope of Public Workshop

    FDA is holding this public workshop to obtain information about
usage of OTC epinephrine MDIs and to discuss the best methods for
disseminating information to consumers who use these MDIs about the
need to transition to alternative treatments for asthma. At the public
workshop, FDA will provide relevant background information, including a
brief summary of the Montreal Protocol, the Clean Air Act, and the
epinephrine final rule. FDA also will present an update on the current
transition from CFC MDIs to non-CFC alternatives and FDA's related
outreach efforts. Presentations by patient outreach experts and other
stakeholders will provide a framework for discussion about OTC use of
epinephrine and how best to educate epinephrine users about the phase-
out and therapeutic alternatives. The input from the public workshop
will help FDA in developing further outreach and education campaigns to
assist consumers in the transition away from OTC epinephrine MDIs.

A. Objectives of the Workshop

    The workshop objectives are as follows:
    1. Provide an overview of the regulatory framework for the
transition and FDA's current outreach activities.
    2. Discuss what is known about current OTC epinephrine MDI usage
and the demand for OTC epinephrine MDIs.
    3. Discuss the therapeutic alternatives to OTC epinephrine MDIs.
    4. Discuss how best to educate consumers who use OTC epinephrine
MDIs about the phase-out and therapeutic alternatives.

B. Issues for Comment

    FDA is interested in obtaining public comment on the following
issues relating to the transition from OTC epinephrine MDIs to
therapeutic alternatives that do not contain ozone-depleting
substances:
    1. What is known about current OTC epinephrine MDI usage? Who uses
them and under what circumstances?
    2. What sales data are available and what do they indicate about
use of OTC epinephrine MDIs?
    3. What treatment alternatives are available for consumers who must
switch from OTC epinephrine MDIs?
    4. What are effective outreach strategies for informing consumers
who use OTC epinephrine MDIs about the transition?
    5. What other education efforts should FDA undertake to effect an
orderly transition?

III. Registration

    Interested parties are encouraged to register early because space
is limited and seating will be on a first-come, first-served basis.
There is no fee to attend the public workshop. If you would like to
make an oral presentation during the open public session of the
workshop, you must register and provide an abstract of your
presentation by close of business on September 11, 2009. To register to
attend or speak at the public workshop, submit your name, title,
business affiliation (if applicable), address, telephone and fax
numbers, and e-mail address to Faith Dugan (see FOR FURTHER INFORMATION
CONTACT). FDA has included questions for comment in section II of this
document. You may identify by number each question you wish to address
in your presentation and the approximate time requested for your
presentation. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin. Persons registered to make an oral presentation
should check in at the registration table at 8 a.m.
    If you need special accommodations due to a disability, please
contact Faith Dugan (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.

IV. Comments

    Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

V. Transcripts

    Transcripts of the public workshop may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 45 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.regulations.gov.

    Dated: August 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19985 Filed 8-19-09; 8:45 am]

BILLING CODE 4160-01-S
