Use of Ozone-Depleting Substances; Removal of Essential-Use Designations; Public Meeting, 37137-37139 [E7-13300]

Download as PDF Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Proposed Rules (equipment number M10055) with a modified fuel control assembly, install the secondary override pump control relays for the center tank fuel pumps in the P33 and P37 relays panels, and do all other specified actions as applicable, by accomplishing all of the applicable actions specified in the applicable service bulletin. The other specified actions must be accomplished before further flight after installing the secondary override pump control relays. Concurrent Modification of the M10055 Fuel Control Panel Assembly (l) For airplanes identified in paragraph 1.A.1. of Boeing Alert Service Bulletin 757– 28A0105, Revision 1, dated April 2, 2007, equipped with any fuel control panel assembly identified in paragraph 1.A. of BAE Systems Service Bulletin 233N3206–28–03, dated October 4, 2006: Before or concurrently with accomplishing the actions required by paragraph (k) of this AD, modify the fuel control panel assembly, in accordance with BAE Systems Service Bulletin 233N3206–28– 03, dated October 4, 2006. AWLs Revision for AWL No. 28–AWL–26 (m) Before or concurrently with accomplishing the actions required by paragraph (k) of this AD: Revise the AWLs section of the Instructions for Continued Airworthiness by incorporating AWL No. 28– AWL–26 of Boeing Temporary Revision (TR) 09–006, dated January 2007, into the MPD. Boeing TR 09–006 is published as Section 9 of the Boeing 757 MPD Document, D622N001–9, Revision January 2007. Accomplishing the revision in accordance with a later revision of the MPD is an acceptable method of compliance if the revision is approved by the Manager, Seattle ACO. pwalker on PROD1PC71 with NOTICES2 Terminating Action for AD 2002–24–51 (n) Accomplishing the actions required by paragraphs (g), (h), (i), and (j) of this AD terminates the AFM limitations required by paragraph (e) of AD 2002–24–51 for Model 757–200, –200CB, –200PF, and –300 series airplanes that have the automatic shutoff system installed, except for the following limitation: ‘‘Warning—Do not reset a tripped fuel pump circuit breaker.’’ Except for this limitation, all other AFM limitations required by paragraph (e) of AD 2002–24–51 for Model 757–200, –200CB, –200PF, and –300 series airplanes may be removed from the AFM after accomplishing the actions required by paragraphs (g), (h), (i), and (j) of this AD. Credit for Actions Done According to Previous Issue of Service Bulletin (o) Actions accomplished before the effective date of this AD in accordance with Boeing Alert Service Bulletin 757–28A0105, dated January 31, 2007, are considered acceptable for compliance with the corresponding actions specified in paragraph (k) of this AD. Alternative Methods of Compliance (AMOCs) (p)(1) The Manager, Seattle ACO, has the authority to approve AMOCs for this AD, if VerDate Aug<31>2005 16:43 Jul 06, 2007 Jkt 211001 requested in accordance with the procedures found in 14 CFR 39.19. (2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. (3) Installation of TDG Aerospace, Inc. Universal Fault Interrupter (UFI), installed and maintained in accordance with Supplemental Type Certificate (STC) ST01950LA, is approved as an AMOC with paragraphs (a) through (m) of this AD. Note 4: Information concerning the existence of approved AMOCs with this AD, if any, may be obtained from the Seattle ACO. Issued in Renton, Washington, on June 25, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7–13265 Filed 7–6–07; 8:45 am] BILLING CODE 4910–13–P 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. Proposed rule; notice of public meeting. ACTION: 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 ozonedepleting substances (ODSs) in selfpressurized 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. PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 37137 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: https:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: https:// 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 https:// 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 https://www.fda.gov/ohrms/dockets/ DATES: E:\FR\FM\09JYP1.SGM 09JYP1 37138 Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Proposed Rules 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: pwalker on PROD1PC71 with NOTICES2 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 https://www.gpoaccess.gov/fr/ index.html. If the applicable essentialuse 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 essentialuse designation for the seven drugs that are the subject of the proposed rule, we applied the criterion for removing an essential-use designation in § 2.125(g)(2) (21 CFR 2.125(g)(2)) to each drug. Under § 2.125(g)(2), an essential-use designation can be removed if it no longer meets the criteria specified in § 2.125(f) for adding a new essential use. The criteria in § 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. * * * VerDate Aug<31>2005 16:43 Jul 06, 2007 Jkt 211001 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 § 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 HFA1 MDIs be able to meet any increased demand caused by this rulemaking? (72 FR 32030 at 32035) • 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 1 ‘‘HFA’’ is used in the pharmaceutical industry, and is used here, to refer to the hydrofluoroalklane HFA–134a, a non-ozone-depleting propellant. PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 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 email to: theresa.martin@fda.hhs.gov. Please indicate ‘‘Speaker- Essential UseDesignation of Seven Drugs’’ in the SUBJECT line. When registering, speakers must provide the following information: (1) The drug product, E:\FR\FM\09JYP1.SGM 09JYP1 Federal Register / Vol. 72, No. 130 / Monday, July 9, 2007 / Proposed Rules 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: https:// 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 https://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] pwalker on PROD1PC71 with NOTICES2 BILLING CODE 4160–01–S VerDate Aug<31>2005 16:43 Jul 06, 2007 Jkt 211001 AGENCY FOR INTERNATIONAL DEVELOPMENT 22 CFR Part 201 [USAID Regulation 1] RIN 0412–AA–51 Rules and Procedures Applicable to Commodity Transactions Financed by USAID: Miscellaneous Amendments U.S. Agency for International Development. ACTION: Notice of proposed rulemaking. AGENCY: SUMMARY: The U.S. Agency for International Development (USAID) proposes to amend its regulation governing commodity transactions that are financed by USAID to: 1. Revise the criteria for noncompetitive procurement for private-sector programs to more closely reflect private-sector practices; 2. revise the commodity and package marking requirements to address the use of the new USAID Identity; 3. revise and add definitions to better specify the terminology used; 4. revise agency organizational names and acronyms to specify the current USAID usage; 5. reinstate § 201.13 coverage on ocean transportation costs because it was inadvertently deleted from prior editions; 6. provide for advertising public-sector procurements over $25,000 in the USAID Procurement Bulletins as the primary means of advertising these procurements to U.S. suppliers (in lieu of advertising publicsector procurements over $100,000 in ‘‘FedBizOpps,’’ the successor to ‘‘Commerce Business Daily’’) to facilitate prompt public notification of procurement opportunities and minimize government expense in providing notice; 7. make numerous clarifications and editorial amendments to better specify the regulation; and 8. specify the current Paperwork Reduction Act approval expirations, as required by the Act. DATES: Submit comments on or before September 7, 2007. ADDRESSES: submit comments by any of the following means: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions there for submitting comments. • Fax: (202) 216–3395. • Mail: USAID, Office of Acquisition and Assistance, Policy Division, Room 7.9–18, 1300 Pennsylvania Avenue, NW., Washington, DC 20523–0001. Instructions: All submissions must include the title of the proposed action, and Regulatory Information Number PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 37139 (RIN) for this rulemaking. Please include your name, title, organization, postal address, telephone number, and e-mail address in the text of the message. FOR FURTHER INFORMATION CONTACT: Kenneth Monsess, Telephone: (202) 712–4913, E-mail: kmonsess@usaid.gov. SUPPLEMENTARY INFORMATION: Public Participation: Because security screening precautions have slowed the delivery and dependability of surface mail to USAID/Washington, USAID recommends sending all comments to the Federal eRulemaking Portal listed above (all comments must be in writing to be reviewed). All comments will be made available for public review without change, including any personal information provided, from three days after receipt to finalization of rule at https:// www.Regulations.gov. Order of Precedence: The procurement of commodities and commodity-related services by other parties that are financed by USAID pursuant to 22 CFR part 201, as opposed to those that are procured by USAID, are not normally subject to 48 CFR chapters 1 and 7 (the Federal Acquisition Regulation [FAR] and the USAID Acquisition Regulation [AIDAR]). In exceptional circumstances where this part 201 is made applicable, pursuant to § 201.02, to a transaction that is subject to 48 CFR chapters 1 and 7, the latter shall take precedence in areas of conflict except under authority of a FAR or AIDAR deviation pursuant to 48 CFR 1.4 or 48 CFR 701.4; and § 201.02 has been clarified to so state. Executive Order 12866 determination: This rule is significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget. The rule has been reviewed in accordance with the Regulatory Flexibility Act. USAID has determined that the rule will not have a significant economic impact on a substantial number of small entities, and therefore a Regulatory Flexibility Analysis is not required. Paperwork Reduction Act statement: OMB approvals for information collections under this regulation are addressed in § 201.03 and Appendices A and B to part 201. List of Subjects in 22 CFR Part 201 Administrative practice and procedure, Commodity procurement, Foreign relations. For the reasons set out in the preamble, USAID proposes to amend 22 CFR part 201 as follows: E:\FR\FM\09JYP1.SGM 09JYP1

Agencies

[Federal Register Volume 72, Number 130 (Monday, July 9, 2007)]
[Proposed Rules]
[Pages 37137-37139]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13300]


=======================================================================
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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.

-----------------------------------------------------------------------

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: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: https://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 https://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 https://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 https://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)
---------------------------------------------------------------------------

    \1\ ``HFA'' is used in the pharmaceutical industry, and is used 
here, to refer to the hydrofluoroalklane HFA-134a, a non-ozone-
depleting propellant.
---------------------------------------------------------------------------

     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: https://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 https://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

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