[Federal Register: August 7, 2007 (Volume 72, Number 151)]
[Proposed Rules]
[Page 44037-44038]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au07-8]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 44037]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 2
[Docket No. 2006N-0454]
RIN 0910-AF93
Use of Ozone-Depleting Substances; Removal of Essential-Use
Designations; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule, extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to
September 10, 2007, the comment period for the proposed rule published
in the Federal Register of June 11, 2007 (72 FR 32030). The proposed
rule would amend FDA's regulation on the use of ozone-depleting
substances (ODSs) in self-pressurized containers to remove the
essential-use designations for oral pressurized metered-dose inhalers
(MDIs) containing flunisolide, triamcinolone, metaproterenol,
pirbuterol, albuterol and ipratropium in combination, cromolyn, and
nedocromil. FDA is taking this action in response to a request for an
extension.
DATES: Submit written or electronic comments by September 10, 2007.
ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0454, 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 number 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 ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents,
comments, a transcript of, and material submitted for, the Pulmonary-
Allergy Advisory Committee meeting held on June 10, 2005, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number,
found in brackets in the heading of this document, 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: Wayne H. Mitchell or Martha Nguyen,
Center for Drug Evaluation and Research (HFD-7), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2007 (72 FR 32030), we
published a proposed rule (the proposed rule) to amend FDA's regulation
on the use of ozone-depleting substances (ODSs) in self-pressurized
containers (21 CFR 2.125) to remove the essential-use designations for
MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol,
albuterol and ipratropium in combination, cromolyn, and nedocromil. In
the Federal Register of July 9, 2007 (72 FR 37137), we published a
notice of an open public meeting (meeting notice) to be held on August
2, 2007. In the proposed rule and meeting notice, we invited interested
persons to comment on the proposed rule by August 10, 2007.
The agency has received a request for a 90-day extension of the
comment period from Graceway Pharmaceuticals, LLC (Graceway) (Docket
No. 2006N-0454/EXT1). Graceway subsequently supplemented this request
with a request dated July 17, 2007, to reschedule the August 2, 2007,
public meeting on the proposed rule. Graceway holds the new drug
application (NDA) for MAXAIR AUTOHALER, a pirbuterol MDI that uses an
ODS as a propellant. The proposed rule would remove from the market
pirbuterol MDIs that contain an ODS.
Graceway requested that FDA extend the comment period by 90 days
because the proposal presents complex medical, scientific, and economic
issues and the existing comment period does not allow sufficient time
to develop a meaningful or thoughtful response to the request for
comments.
FDA has considered the request and is extending the comment period
on the proposed rule for 30 days, until September 10, 2007. The agency
believes this extension will allow adequate time for interested persons
to submit comments while still permitting FDA and the U.S. Government
to meet their obligations under the Clean Air Act (42 U.S.C. 7401 et
seq.) and the Montreal Protocol on Substances that Deplete the Ozone
Layer (Montreal Protocol) (September 16, 1987, 26 I.L.M. 1541 (1987)),
available at http://www.unep.org/ozone/pdfs/Montreal-Protocol2000.pdf.
\1\ This rulemaking necessarily relates to other
actions taken or to be taken by the U.S. Government, including
requesting essential-use exemptions from the Parties to the Montreal
Protocol for quantities of ODSs for use in MDIs and allocation of the
ODSs to U.S. manufacturers for use in MDIs under section 604(d) of the
Clean Air Act (42 U.S.C. 7671c). Delays in
[[Page 44038]]
finalizing this proposed rule potentially could delay or prevent the
U.S. Government from taking actions to ensure a smooth transition to
inhaled drug products for the treatment of asthma and chronic
obstructive pulmonary disease that do not contain ODSs. We note that
interested persons have had ample notice that FDA was considering
removing the essential-use designation for pirbuterol and the six other
drugs that are the subject of this rulemaking, including the following:
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\1\ FDA has verified all Web site addresses cited in this
document, but FDA is not responsible for any subsequent changes to
the Web sites after this document has published in the Federal
Register.
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This issue was first considered at the July 14, 2005,
meeting of the Pulmonary-Allergy Advisory Committee (see 70 FR 24605,
May 10, 2005). The trade press reported on this meeting; and minutes
and a transcript of the meeting were placed on the Internet.\2\
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\2\ ``CFC-Only Asthma Drugs Likely to Lose `Essential Use'
Designation,'' The Pink Sheet, July 18, 2005, p. 15; minutes of the
meeting and a transcript of the meeting are available at http://www.fda.gov/ohrms/dockets/
(select ``Advisory Committee Materials,''
then ``2005,'' then ``Pulmonary-Allergy Drugs Advisory Committee'').
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At the 17th Meeting of the Parties to Montreal Protocol
(Dakar, Senegal, December 12 through 16, 2005), the Parties decided
that developed countries should provide a date to the Ozone Secretariat
before the 18th meeting of the Parties (New Delhi, October 30 through
November 3, 2006), by which time a regulation or regulations will have
been proposed to determine whether MDIs, other than those that have
albuterol as the only active ingredient, are nonessential.\3\ The U.S.
Government provided information to the Ozone Secretariat that a
proposed rule that would eliminate the essential-use designation of
pirbuterol and the six other drugs that are the subject of the proposed
rule should publish by the end of May 2007.
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\3\ For more information, see the discussion in the proposed
rule (72 FR 32030 at 32031 and 32032).
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We also announced our intention to publish a proposed rule
by the end of May 2007 that would eliminate the essential-use
designation of pirbuterol and the six other drugs that are the subject
of the proposed rule in the Unified Agendas\4\ published in the Federal
Register on December 11, 2006 (71 FR 73195 at 73223), and April 30,
2007 (72 FR 22489 at 22156).
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\4\ The Unified Agenda (also known as the Semiannual Regulatory
Agenda), published twice a year in the Federal Register, summarizes
the rules and proposed rules that each Federal agency expects to
issue during the next 6 months.
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Because interested persons have had ample notice of this rulemaking
dating back at least to May 2005, we do not intend to grant further
requests for extension of the comment period on the proposed rule.
As discussed in the previous paragraphs, FDA believes this
extension will allow adequate time for interested persons to submit
comments on the proposed rule, and that rescheduling the public meeting
was unnecessary. The deadline for registration passed soon after the
request to reschedule the meeting was made and interested persons had
already made travel and other arrangements to participate on the
scheduled date. Anyone who was unable to participate in the meeting
still has the opportunity to submit written comments for an additional
30 days, as outlined in this notice.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the proposed
rule (see DATES). Submit a single copy of electronic comments or two
paper copies of any mailed comments, except that individuals may submit
one paper copy. Comments are to 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.
Dated: August 1, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15372 Filed 8-6-07; 8:45 am]
BILLING CODE 4160-01-S