[Federal Register Volume 72, Number 216 (Thursday, November 8, 2007)]
[Proposed Rules]
[Pages 63141-63143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. 2007N-0262]
RIN 0910-AF92


Use of Ozone-Depleting Substances; Removal of Essential-Use 
Designation (Epinephrine); Public Meeting; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notice of public meeting and extension of 
comment period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to solicit comments on a proposed rule that would amend FDA's 
regulation on the use of ozone-depleting substances (ODSs) in self-
pressurized containers to remove the essential-use designation for oral 
pressurized metered-dose inhalers (MDIs) containing epinephrine. The 
proposed rule was published in the Federal Register of September 20, 
2007 (72 FR 53711). Information from the public meeting, which is 
required by agency regulations, will be considered in finalizing the 
rulemaking. In addition, the comment period on the proposed rule is 
being extended to December 19, 2007, to accommodate the meeting and to 
provide a short period after the meeting to receive additional 
comments.

DATES: The comment period for the September 20, 2007 (72 FR 53711) 
proposed rule is being extended to December 19, 2007. The public 
meeting will be held on December 5, 2007, from 9 a.m. to 3:30 p.m. 
Submit written or electronic comments for consideration at the meeting 
and requests to speak at the meeting by November 23, 2007. Register to 
attend the meeting by November 23, 2007. Submit written or electronic 
comments on the proposed

[[Page 63142]]

rule and this document by December 19, 2007.

ADDRESSES: The public meeting will be held at FDA, Center for Drug 
Evaluation and Research, Advisory Committee Conference Room, 5630 
Fishers Lane, rm. 1066, Rockville, MD 20852.
    You may submit comments, identified by Docket No. 2007N-0262 and 
RIN number RIN 0910-AF92, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted directly to the agency by e-mail. FDA 
encourages you to continue to submit electronic comments by using the 
Federal eRulemaking Portal or the agency Web site, as described 
previously in the ADDRESSES portion of this document under Electronic 
Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read the proposed rule, 
background documents, or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number 2007N-0262, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rose Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5383, E-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Clean Air Act, 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. In the Federal Register of September 20, 2007 (72 FR 53711) (the 
proposed rule), we proposed to amend our regulation on the use of ODSs 
in self-pressurized containers to remove the essential-use designation 
of MDIs containing epinephrine. You may find copies of the proposed 
rule on the Division of Dockets Management Web site (see ADDRESSES) and 
the GPO Access Web site at http://www.gpoaccess.gov/fr/index.html. If 
the essential-use designation is removed, epinephrine MDIs containing 
an ODS could not be marketed after the effective date of the final rule 
removing the essential-use designation.
    In proposing to remove the essential-use designation for 
epinephrine, we applied the criterion 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 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; (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.''
    We proposed that the removal of the essential-use designation for 
epinephrine be made effective on December 31, 2010. Depending on the 
data presented to us in the course of the rulemaking, we may determine 
that it is appropriate to have a different effective date than the one 
we proposed.
    The provisions in Sec.  2.125(g)(2) that provide the procedures and 
criteria being used in this rulemaking require that a public meeting be 
held before an essential use may be removed. This document announces 
the meeting that will be held to fulfill that requirement, which will 
also better inform the decisions we will be making during the 
rulemaking.

II. Issues and Questions for Discussion and Comment

    If you are going to speak at the meeting or submit a written 
comment, you may address any issue raised in the proposed rule or on 
any other issue that is relevant to our decision on the proposed rule. 
You may wish to discuss how the criteria described in section I of this 
document apply to MDIs containing epinephrine. You may wish to discuss 
how the fact that epinephrine MDIs are the most widely used over-the-
counter (OTC) treatment for the symptoms of asthma should affect our 
decision. You may also wish to discuss whether a different effective 
date is appropriate. We invite discussion of issues on which we 
specifically asked for comments in the proposed rule, including the 
following.
     Will production of albuterol HFA\1\ MDIs (a primary 
therapeutic alternative to OTC epinephrine MDIs) be able to meet any 
increased demand caused by this rulemaking? (72 FR 53711 at 53716)
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    \1\``HFA'' is used in the pharmaceutical industry, and is used 
here, to refer to the hydrofluoralkane HFA-134a, a non-ozone-
depleting propellant.
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     Will inhaled epinephrine become available in a non-ODS 
formulation and when can a non-ODS inhaled-epinephrine product be 
reasonably expected to enter the market? (72 FR 53711 at 53716)
     Should the availability of an inhaled-epinephrine OTC drug 
product that does not contain ODSs affect whether we publish a final 
rule or the effective date of any such rule? (72 FR 53711 at 53716)
     What efforts are currently being made to develop non-ODS 
inhaled-epinephrine drug products that would be suitable for OTC sale? 
(72 FR 53711 at 53718)
     What are the impediments to developing non-ODS inhaled-
epinephrine drug products that would be suitable for OTC sale? (72 FR 
53711 at 53718)
     How many people who face barriers to health care purchase 
epinephrine MDIs because of those barriers to health care? (72 FR 53711 
at 53720)
     Will programs providing free or low-cost drugs reduce any 
adverse impact on the public health caused by the removal of OTC 
epinephrine MDIs from the market? (72 FR 53711 at 53722)
     Do risks of self-treatment of asthma outweigh the public 
health benefits that OTC epinephrine MDIs may provide? (72 FR 53711 at 
53722)
     What are the expected costs and public health effects to 
individuals with asthma if OTC epinephrine MDIs were removed from the 
market without a

[[Page 63143]]

similar product being available OTC? (72 FR 53711 at 53722)
    We consulted with FDA's Nonprescription Drugs Advisory Committee 
and Pulmonary and Allergy Drugs Advisory Committee at a joint meeting 
held on January 24, 2006, to discuss the essential-use status of MDIs 
containing epinephrine. During the meeting, several committee members 
expressed opinions that MDIs containing epinephrine provide important 
public health benefits to individuals with asthma who face barriers to 
health care and cannot obtain prescription drugs. You may wish to read 
the transcript of the joint meeting (available on the Division of 
Dockets Management Web site (see ADDRESSES)) or the summaries of the 
discussions at the meeting in the proposed rule (72 FR 53711 at 53716 
to 53724).

III. Registration, Agenda, and Transcript

    There is no fee to register for the meeting, but registration is 
required and space is limited. Interested parties are therefore 
encouraged to register early. Limited visitor parking is available for 
a fee, and the Twinbrook Metro Stop is within walking distance of the 
meeting site. Early arrival is encouraged, as there will be security 
screening. You will be asked for government-issued picture 
identification by the security officers. If you need special 
accommodations due to a disability, please include this information 
when registering.
    Registration for General Attendees. Registration is required to 
attend the public meeting. If you wish to attend the meeting, you must 
register by November 23, 2007, via e-mail to: [email protected]. 
Please indicate ``Essential-Use Designation of Epinephrine'' in the 
SUBJECT line and provide complete contact information for each attendee 
(including name, title, affiliation, e-mail address, and phone 
number(s)). Upon receipt and review for adequacy of information, an e-
mail will be sent to confirm registration.
    Registration for Speaking Attendees. If you wish to speak at the 
meeting, you must register by November 23, 2007, via e-mail to: 
[email protected]. Please indicate ``Speaker--Essential Use-
Designation of Epinephrine'' in the SUBJECT line. When registering, 
speakers must provide the following information: (1) The topic or issue 
to be addressed; (2) the speaker's name, title, company or 
organization, address, phone number, and e-mail address; and (3) the 
approximate length of time requested to speak. We encourage 
consolidation of like-minded presentations to enable a broad range of 
views to be presented.
    Agenda and Transcript. The agenda for the public meeting will be 
available on FDA's Center for Drug Evaluation and Research (CDER) Web 
site at: http://www.fda.gov/cder/meeting/ozone2007.htm. After the 
meeting, the agenda, presentations, and transcript will be placed on 
file in the Division of Dockets Management under Docket No. 2007N-0262 
and on CDER's Web site identified previously.
    Copies of the transcript 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 20 
working days after the meeting at a cost of 10 cents per page, or on 
compact disc at a cost of $14.25 each. You may also examine the 
transcript at the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and on the Internet at http://www.fda.gov/ohrms/dockets/default.htm.

IV. Extension of the Comment Period for the Proposed Rule

    FDA is extending the comment period for the proposed rule to 
December 19, 2007. We believe that extending the comment period is 
reasonable to accommodate the public meeting and to provide a short 
period after the meeting to receive additional comments.

V. Request for Comments

    Regardless of your attendance at the meeting, you may submit to the 
Division of Dockets Management (see ADDRESSES) written or electronic 
comments related to the proposed rule (see DATES). All relevant data 
and information should be submitted with the written comments. Submit a 
single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one copy. Comments are to 
be identified with Docket No. 2007N-0262. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: November 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-5593 Filed 11-5-07; 4:01 pm]
BILLING CODE 4160-01-S