[Federal Register Volume 71, Number 235 (Thursday, December 7, 2006)]
[Proposed Rules]
[Pages 70912-70914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. 2006N-0416]
RIN 0910-AF93


Use of Ozone-Depleting Substances; Removal of Essential Use 
Designations; Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is publishing this 
companion proposed rule to the direct final rule, published elsewhere 
in this issue of the Federal Register, that is intended to amend our 
regulation on the use of ozone-depleting substances (ODSs) in 
pressurized containers to remove the essential use designations for 
beclomethasone, dexamethasone, fluticasone, bitolterol, salmeterol, 
ergotamine tartrate, and ipratropium bromide used in oral pressurized 
metered-dose inhalers (MDIs). Under the Clean Air Act, FDA, in 
consultation with the Environmental Protection Agency (EPA), is 
required to determine whether an FDA-regulated product that releases an 
ODS is essential. None of these products is currently being marketed, 
which provides grounds for removing their essential use designation.

DATES: Submit written or electronic comments by February 20, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2006N-0416 
and RIN Number 0910-AF93, 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 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 in the 
Electronic Submissions portion of this paragraph.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN) for this 
rulemaking. All comments received will 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 background documents or 
comments received, 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: Martha Nguyen or Wayne H. Mitchell, 
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

    As described more fully in the related direct final rule, the Clean 
Air Act prohibits most uses of chlorofluorocarbons (CFCs) (a class of 
ODSs). Medical products which FDA, in consultation with EPA, determines 
to be essential are exempt from the general ban. In 1978, we published 
a rule listing several essential uses of CFCs and providing criteria 
for adding new essential uses (43 FR 11301 at 11316, March 17, 1978). 
The rule was codified as Sec.  2.125 (21 CFR 2.125) and was 
subsequently amended various times to add or remove essential uses. In 
2002, we amended Sec.  2.125 to provide, among other things, criteria 
for the removal of additional essential use designations in the future. 
The rule provides that if any product that releases an ODS is no longer 
being marketed, the product may have its essential use designation 
revoked through notice-and-comment rulemaking.
    We are proposing to amend our regulations to remove oral 
pressurized metered-dose inhalers releasing beclomethasone, 
dexamethasone, fluticasone, bitolterol, salmeterol, ergotamine 
tartrate, and ipratropium bromide from the list of essential uses of 
ODSs found at Sec.  2.125(e) (21 CFR 2.125(e)). None of these products 
is currently being marketed in MDIs that release ODSs, which, under 
Sec.  2.125(g)(1) (21 CFR 2.125(g)(1)), is grounds for removing the 
essential use status. Because these products are no longer being 
marketed, this action will not result in any drugs being made 
unavailable to patients.

[[Page 70913]]

II. Additional Information

    This proposed rule is a companion to the direct final rule 
published in the final rules section in this issue of the Federal 
Register. This companion proposed rule and the direct final rule are 
identical in substance. This companion proposed rule will provide the 
procedural framework to proceed with standard notice-and-comment 
rulemaking in the event the direct final rule receives significant 
adverse comment and is withdrawn. The comment period for the companion 
proposed rule runs concurrently with the comment period of the direct 
final rule. Any comments received under the companion proposed rule 
will be treated as comments regarding the direct final rule and vice-
versa.
    A significant adverse comment is one that explains why the rule 
would be inappropriate, including challenges to the rule's underlying 
premise or approach, or would be ineffective or unacceptable without a 
change. A comment recommending a rule change in addition to this rule 
will not be considered a significant adverse comment, unless the 
comment states why this rule would be ineffective without the 
additional change.
    If no significant adverse comment is received in response to the 
direct final rule, no further action will be taken related to the 
companion proposed rule. Instead, we will publish a confirmation notice 
within 30 days after the comment period ends, and we intend the direct 
final rule to become effective 30 days after publication of the 
confirmation notice, except for Sec.  2.125(e)(4)(v) (21 CFR 
2.125(e)(4)(v)), which we intend to become effective August 1, 2007.
    If we receive significant adverse comments, we will withdraw the 
direct final rule. We will proceed to respond to all the comments 
received regarding the direct final rule, treating those comments as 
comments to this proposed rule. The agency will address the comments in 
the subsequent final rule. We will not provide additional opportunity 
for comment. If we receive a significant adverse comment which applies 
to part of the rule and that part may be severed from the remainder of 
the rule, we may adopt as final those parts of the rule that are not 
the subject of significant adverse comment.
    For additional background information, see the corresponding direct 
final rule published in the final rules section in this issue of the 
Federal Register. All persons who may wish to comment should review the 
complete rationale for this amendment set out in the preamble of the 
direct final rule.

III. Environmental Impact

    We have carefully considered, under 21 CFR part 25, the potential 
environmental effects of this action. We have concluded that the action 
will not have a significant impact on the human environment and that an 
environmental impact statement is not required. Our finding of no 
significant impact and the evidence supporting that finding, contained 
in an environmental assessment, may be seen in the Division of Dockets 
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through 
Friday.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is not a significant regulatory action as defined by 
the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because we are proposing to remove the essential use 
designations for certain drug products that are either no longer being 
marketed or are no longer being marketed in a formulation releasing 
ODSs, the agency certifies that the proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $118 million, using the most current (2004) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

V. The Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the rule does not contain policies that have substantial direct effects 
on the States, on the relationship between the National Government and 
the States, or on the distribution of power and responsibilities among 
the various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, we do 
not plan to prepare a federalism summary impact statement for this 
rulemaking procedure. We invite comments on the federalism implications 
of this proposed rule.

VII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
This comment period runs concurrently with the comment period for the 
direct final rule; any comments received will be considered as comments 
regarding the direct final rule. Submit a single copy of electronic 
comments or two copies of any mailed comments, except that individuals 
may submit one 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.

List of Subjects in 21 CFR Part 2

    Administrative practice and procedure, Cosmetics, Drugs, Foods.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Clean Air Act, and under authority delegated to the Commissioner of 
Food and Drugs, after consultation with the Administrator of the 
Environmental Protection Agency, it is proposed that 21 CFR part 2 be 
amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

    1. The authority citation for 21 CFR part 2 continues to read as 
follows:


[[Page 70914]]


    Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 
U.S.C. 7671 et seq.


Sec.  2.125  [Amended]

    2. Section 2.125 is amended by removing and reserving paragraphs 
(e)(1)(i), (e)(1)(ii), (e)(1)(iv), (e)(2)(ii), (e)(4)(i), (e)(4)(ii), 
and (e)(4)(v).

    Dated: October 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20796 Filed 12-6-06; 8:45 am]
BILLING CODE 4160-01-S