[Federal Register Volume 72, Number 151 (Tuesday, August 7, 2007)]
[Proposed Rules]
[Pages 44037-44038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15372]


 ========================================================================
 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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 

  Federal Register / Vol. 72, No. 151 / Tuesday, August 7, 2007 / 
Proposed Rules  

[[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