[Federal Register: December 7, 2006 (Volume 71, Number 235)]
[Proposed Rules]
[Page 70912-70914]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07de06-24]
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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://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/[fxsp0
]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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/[fxsp0]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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/[fxsp0]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