[Federal Register Volume 74, Number 160 (Thursday, August 20, 2009)]
[Notices]
[Pages 42080-42081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19985]


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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.

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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: [email protected].

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.
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    \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).
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    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.
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    \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).
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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