[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
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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
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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