[Federal Register: July 9, 2007 (Volume 72, Number 130)]
[Proposed Rules]               
[Page 37137-37139]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy07-13]                         

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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; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notice of public meeting.

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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 essential-use designations for certain 
oral pressurized metered-dose inhalers (MDIs). In the Federal Register 
of June 11, 2007 (72 FR 32030), the agency proposed to remove the 
essential use designation for MDIs containing flunisolide, 
triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in 
combination, cromolyn, and nedocromil. Information from the public 
meeting, which is required by agency regulations, will be considered in 
finalizing the rulemaking.

DATES: The public meeting will be held on August 2, 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 July 25, 2007. 
Register to attend the meeting by July 25, 2007. Submit written or 
electronic comments on the proposed rule and this notice by August 10, 
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. 2006N-0454 and RIN number 0910-AF93, by any of 
the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 the proposed rule, 
background documents, or comments received, go to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/



[[Page 37138]]

default.htm and insert the docket number(s) 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: Terry Martin, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5376, e-mail: 
theresa.martin@fda.hhs.gov.


SUPPLEMENTARY INFORMATION:

I. Background

    Under the Clean Air Act, FDA, in consultation with the EPA, 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 June 11, 
2007 (72 FR 32030) (the proposed rule), we proposed to amend our 
regulation on the use of ODSs in self-pressurized containers to remove 
the essential-use designations of MDIs containing flunisolide, 
triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in 
combination, cromolyn, and nedocromil. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.gpoaccess.gov/fr/index.html.
 If the applicable essential-use designations are all 

removed, flunisolide, triamcinolone, metaproterenol, pirbuterol, 
albuterol and ipratropium in combination, cromolyn, and nedocromil MDIs 
containing an ODS could not be marketed after the effective date of the 
final rule removing the essential-use designations.
    In proposing to remove the essential-use designation for the seven 
drugs that are the subject of the proposed rule, we applied the 
criterion for removing an essential-use designation in Sec.  
2.125(g)(2) (21 CFR 2.125(g)(2)) to each drug. 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) provides that * * * Substantial 
technical barriers exist to formulating the product without ODSs; the 
product will provide an unavailable important public health benefit; 
and 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 designations be 
made effective on December 31, 2009. In the proposed rule we said that 
depending on the data presented to us in the course of the rulemaking, 
we may determine that it is appropriate to have different effective 
dates for removing the essential-use designation for different drugs 
(72 FR 32030 at 32034).
    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 notice 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 flunisolide, triamcinolone, 
metaproterenol, pirbuterol, albuterol and ipratropium in combination, 
cromolyn, and nedocromil. You may also wish to discuss whether 
different effective dates are appropriate for different drugs (72 FR 
32030 at 32034). We invite discussion of issues on which we 
specifically asked for comments in the proposed rule, including the 
following:
     Do the other available therapies provide adequate 
alternatives for each of the seven drugs from a public health 
perspective? (72 FR 32030 at 32034)
     Will production of albuterol HFA\1\ MDIs be able to meet 
any increased demand caused by this rulemaking? (72 FR 32030 at 32035)
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    \1\ ``HFA'' is used in the pharmaceutical industry, and is used 
here, to refer to the hydrofluoroalklane HFA-134a, a non-ozone-
depleting propellant.
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     Are portable nebulizers suitable therapeutic alternatives 
for cromolyn MDIs and nedocromil MDIs, and will use of portable 
nebulizers be important in meeting the needs of patients who are 
currently using cromolyn MDIs and nedocromil MDIs? (72 FR 32030 at 
32037 and 32038)
     Does use of a single MDI containing albuterol and 
ipratropium in combination provide for better patient outcomes (e.g., 
fewer exacerbations or increased quality of life) compared to 
concomitant use of separate albuterol and ipratropium MDIs, and, if 
these improvements are shown to exist, should they be considered 
important public health benefits? (72 FR 32030 at 32039)
    We consulted with FDA's Pulmonary and Allergy Drugs Advisory 
Committee (PADAC) at their July 14, 2005, meeting on the essential-use 
status of MDIs containing flunisolide, triamcinolone, metaproterenol, 
pirbuterol, albuterol and ipratropium in combination, cromolyn, and 
nedocromil. During the meeting, several PADAC members expressed 
opinions that MDIs containing cromolyn and MDIs containing albuterol 
and ipratropium in combination provide important public health 
benefits. You may wish to read the transcript of the PADAC meeting 
(available on the Division of Dockets Management Web site (see 
ADDRESSES)) or the summaries of the discussions at the PADAC meeting in 
the proposed rule and comment on our tentative findings that MDIs 
containing cromolyn and MDIs containing albuterol and ipratropium in 
combination do not provide important public health benefits (72 FR 
32030 at 32037 to 32039).

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 July 25, 2007, via e-mail to: theresa.martin@fda.hhs.gov. 
Please indicate ``Essential-Use Designation of Seven Drugs'' 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 July 25, 2007, via e-mail to: 
theresa.martin@fda.hhs.gov. Please indicate ``Speaker- Essential Use-

Designation of Seven Drugs'' in the SUBJECT line. When registering, 
speakers must provide the following information: (1) The drug product,

[[Page 37139]]

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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. 2006N-0454 
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. 12A-16, 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
.


IV. 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 by August 10, 2007. 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. 2006N-0454. Received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: July 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13300 Filed 7-6-07; 8:45 am]

BILLING CODE 4160-01-S