[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Proposed Rules]
[Pages 11805-11808]
[FR Doc No: 2013-03841]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0814; FRL-9782-6]

Approval and Promulgation of Implementation Plans; Region 4
States; 110(a)(2)(D)(i)(II) Infrastructure Requirement for the 1997 and
2006 Fine Particulate Matter National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve submissions from Alabama, Georgia,
Kentucky, Mississippi, North Carolina, South Carolina and Tennessee for
inclusion into each state's implementation plan. This proposal pertains
to the infrastructure state implementation plans (SIPs) for these
States as they relate to certain Clean Air Act (CAA or Act)
requirements for the 1997 annual and 2006 24-hour fine particulate
matter (PM2.5) National Ambient Air Quality Standards
(NAAQS). The CAA requires that each state adopt and submit a SIP for
the implementation, maintenance, and enforcement of each NAAQS
promulgated by EPA. These plans are commonly referred to as an
``infrastructure'' SIPs. Specifically, EPA is proposing to approve the
submissions for Alabama, Georgia, Kentucky, Mississippi, North
Carolina, South Carolina and Tennessee that relate to the
infrastructure SIP requirement to protect visibility in another state.
All other applicable infrastructure requirements for the 1997 annual
and 2006 24-hour PM2.5 NAAQS associated with these States
are being addressed in separate rulemakings.

DATES: Written comments must be received on or before March 22, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2012-0814, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2012-0814,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2012-0814. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
Table of Contents

I. Background
II. What are States required to address under sections 110(a)(2)(D)?
III. What is EPA's analysis of how Region 4 States addressed element
(D)(i)(II) related to visibility?
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997 (62 FR 38652), EPA established an annual
PM2.5 NAAQS at 15.0 micrograms per cubic meter ([mu]g/

m\3\) based on a 3-year average of annual mean PM2.5
concentrations. At that time, EPA also established a 24-hour NAAQS of
65 [mu]g/m\3\. See 40 CFR 50.7. On October 17, 2006 (71 FR 61144), EPA
retained the 1997 annual PM2.5 NAAQS at 15.0 [mu]g/m\3\
based on a 3-year average of annual mean PM2.5
concentrations, and promulgated a new 24-hour NAAQS of 35 [mu]g/m\3\
based on a 3-year average of the 98th percentile of 24-hour
concentrations. By statute, SIPs meeting the requirements of sections
110(a)(1) and (2) are to be submitted by states within three years
after promulgation of a new or revised NAAQS. Sections 110(a)(1) and
(2) require states to address basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the NAAQS. States were required to submit such SIPs
to EPA no later than July 2000 for the 1997 annual PM2.5
NAAQS, and no later than October 2009 for the 2006 24-hour
PM2.5 NAAQS.
    Alabama, Georgia, Kentucky, Mississippi, North Carolina, South
Carolina and Tennessee's infrastructure submissions were received by
EPA on July 25, 2008, July 23, 2008, August 26, 2008, December 7, 2007,
April 1, 2008, March 14, 2008, and December 14, 2007, respectively, for
the 1997 annual PM2.5 NAAQS; and on September 23, 2009,
October 21, 2009, July 17, 2012,\1\ October 6, 2009, September 21,
2009, September 18, 2009, and October 19, 2009, respectively, for the
2006 24-hour PM2.5 NAAQS. Alabama, Georgia, Kentucky,
Mississippi, North Carolina, South Carolina and Tennessee were among
other states that did not receive findings of failure to submit because
they had provided a complete submission to EPA to address the
infrastructure elements for the 1997 PM2.5 NAAQS by October
3, 2008.
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    \1\ On July 17, 2012, Kentucky withdrew its September 8, 2009,
110(a)(1) and (2) infrastructure submission addressing the 2008 8-
hour ozone, 2006 PM2.5 and 2008 Lead NAAQS. Kentucky
replaced its September 8, 2009, section 110(a)(1) and (2)
infrastructure submission with a submission provided on July 17,
2012.
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    The rulemaking proposed through today's action only addresses
section 110(a)(2)(D)(i)(II) visibility requirements.

II. What are States required to address under sections 110(a)(2)(D)?

    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct
components, commonly referred to as ``prongs,'' that must be addressed
in SIP submissions. The first two prongs, which are codified in section
110(a)(2)(D)(i)(I), are provisions that prohibit any source or other
type of emissions activity in one state from contributing significantly
to nonattainment of the NAAQS in another state (prong 1), and
interfering with maintenance of the NAAQS in another state (prong 2).
The third and fourth prongs, which are codified in section
110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in
one state interfering with measures required to prevent significant
deterioration of air quality in another state (prong 3), or to protect
visibility in another state (prong 4). Section 110(a)(2)(D)(ii)
requires SIPs to include provisions insuring compliance with sections
115 and 126 of the Act, relating to interstate and international
pollution abatement.
    EPA has previously taken action to address Alabama, Georgia,
Kentucky, Mississippi, North Carolina, South Carolina and Tennessee's
SIP submissions related to prongs 1 through 3 of section
110(a)(2)(D)(i) and the requirements of section 110(a)(2)(D)(ii) for
the 1997 annual and 2006 24-hour PM2.5 NAAQS. Today's
proposed rulemaking relates only to requirements of section
110(a)(2)(D)(i)(II) (prong 4), which as previously described, requires
that the SIP contain adequate provisions to protect visibility in any
other State. More information on this requirement and EPA's rationale
for today's proposal that each state is meeting this requirement for
purposes of the 1997 annual and 2006 24-hour PM2.5 NAAQS is
provided below.

III. What is EPA's analysis of how Region 4 States addressed element
(D)(i)(II) related to visibility?

    Prong 4 of section 110(a)(2)(D)(i) requires that SIPs include
provisions prohibiting any source or other type of emissions activity
in one state from interfering with measures to protect visibility in
another state. In describing how its submission meets this requirement,
Alabama, Georgia, Kentucky, Mississippi, North Carolina, South Carolina
and Tennessee each referred to EPA-approved state provisions requiring
electric generating units (EGUs) to comply with the Clean Air
Interstate Rule (CAIR) and to the limited approval and limited
disapproval of Alabama, Georgia, Kentucky, Mississippi, North Carolina,
South Carolina and Tennessee's regional haze SIPs. Although Alabama,
Georgia, Kentucky, Mississippi, North Carolina, South Carolina and
Tennessee's regional haze SIPs have not been fully approved, EPA
believes that the infrastructure SIP submission together with
previously approved SIP provisions, specifically those provisions that
require EGUs to comply with CAIR and the additional measures in the
regional haze SIP addressing best available retrofit technology (BART)
and reasonable progress requirements for other sources or pollutants,
are adequate to demonstrate compliance with prong 4, thus, EPA is
proposing to fully approve this aspect of the submission.
    Alabama, Georgia, Kentucky, Mississippi, North Carolina, South
Carolina and Tennessee's regional haze SIPs relied on previous
incorporations of the CAIR into the EPA-approved SIPs as an alternative
to the requirement that the regional haze SIPs provide for source-
specific BART emission limits for sulfur dioxide (SO2) and
nitrogen oxides (NOX) emissions from EGUs. CAIR, as
originally promulgated, requires significant reductions in emissions of
SO2 and NOX to limit the interstate transport of
these pollutants, and EPA's determination that states could rely on
CAIR as an alternative to requiring BART for CAIR-subject EGUs had
specifically been upheld in Utility Air Regulatory Group v. EPA, 471
F.3d 1333 (D.C. Cir. 2006). Moreover, the states with Class I areas
affected by emissions from sources in Alabama, Georgia, Kentucky,
Mississippi, North Carolina, South Carolina and Tennessee had adopted
reasonable progress goals for visibility protection that were
consistent with the EGU emission limits resulting from CAIR.
    In 2008, however, the D.C. Circuit remanded CAIR back to EPA. See
North Carolina v. EPA, 550 F.3d 1176 (D.C. Cir. 2008). The court found
CAIR to be inconsistent with the requirements of the CAA, see North
Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008), but ultimately remanded
the rule to EPA without vacatur because it found that ``allowing CAIR
to remain in effect until it is replaced by a rule consistent with [the
court's] opinion would at least temporarily preserve the environmental
values covered by CAIR.'' North Carolina, 550 F.3d at 1178.
    After the remand of CAIR by the D.C. Circuit and the promulgation
by EPA of a new rule--the Cross State Air Pollution Rule (CSAPR) or
``Transport Rule''--to replace CAIR, EPA issued a limited disapproval
of Alabama, Georgia, Kentucky, Mississippi, North Carolina, South
Carolina and Tennessee's regional haze SIPs (and other states' regional
haze SIPs that relied similarly on CAIR) because EPA believed that full
approval of the SIP was not appropriate in light of the court's remand
of CAIR and the uncertain but limited remaining period of operation of
CAIR. EPA finalized a

limited approval of Alabama, Georgia, Kentucky, Mississippi, North
Carolina, South Carolina and Tennessee regional haze SIPs, indicating
that except for its reliance on CAIR, the SIP met CAA requirements for
the first planning period of the regional haze program. See Alabama:
July 28, 2012 (77 FR 38515); Georgia: July 28, 2012 (77 FR 38501);
Kentucky: March 30, 2012 (77 FR 19098); Mississippi: July 27, 2012 (77
FR 38191); North Carolina: July 27, 2012 (77 FR 38185); South Carolina:
July 28, 2012 (77 FR 38509) Tennessee: April 24, 2012 (77 FR 243392),
and November 27, 2012 (77 FR 70689).\2\ EPA also finalized a limited
Federal Implementation Plan for Georgia, Kentucky, South Carolina and
Tennessee, which merely substituted reliance on EPA's more recent
CSAPR's NOX and SO2 trading programs for EGUs for
the SIP's reliance on CAIR. See 77 FR 33642, June 7, 2012.
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    \2\ Under CAA sections 301(a) and 110(k)(6) and EPA's long-
standing guidance, a limited approval results in approval of the
entire SIP submittal, even of those parts that are deficient and
prevent EPA from granting a full approval of the SIP revision.
Processing of State Implementation Plan (SIP) Revisions, EPA
Memorandum from John Calcagni, Director, Air Quality Management
Division, OAQPS, to Air Division Directors, EPA Regional Offices I-
X, September 7, 1992, (1992 Calcagni Memorandum) located at http://www.epa.gov/ttn/caaa/t1/memoranda/siproc.pdf.
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    Since the above-described developments with regard to Alabama,
Georgia, Kentucky, Mississippi, North Carolina, South Carolina and
Tennessee's regional haze SIPs, the situation has changed. In August
2012, the D.C. Circuit issued a decision to vacate CSAPR. EME Homer
City Generation, 696 F.3d7 (D.C. Cir. 2012). In this decision, the
court ordered EPA to ``continue administering CAIR pending the
promulgation of a valid replacement.'' Thus, EPA has been ordered by
the court to develop a new rule, and to continue implementing CAIR in
the meantime, and the opinion makes clear that after promulgating that
new rule EPA must provide states an opportunity to draft and submit
SIPs to implement that rule. Implementation of CAIR thus cannot be
replaced until EPA has promulgated a final rule through a notice-and-
comment rulemaking process; states have had an opportunity to draft and
submit SIPs; EPA has reviewed the SIPs to determine if they can be
approved; and EPA has taken action on the SIPs, including promulgating
a Federal Implementation Plan, if appropriate.
    At this time, the deadline for asking the Supreme Court to review
this decision has not passed, and the United States has made no
decision regarding whether to seek further appeal. Nonetheless, the EPA
intends to act in accordance with the holdings in the EME Homer City
Generation opinion. Based upon the direction provided in that opinion
for EPA to continue administering CAIR, the Agency believes that it is
appropriate to rely on CAIR emission reductions for now for purposes of
assessing the adequacy of Alabama, Georgia, Kentucky, Mississippi,
North Carolina, South Carolina and Tennessee's infrastructure SIPs with
respect to prong 4 while a valid replacement rule is developed and
until implementation plans complying with any new rule are submitted by
the states and acted upon by EPA or until the court case is resolved in
a way that provides different direction regarding CAIR and CSAPR. In
addition, EPA believes that based on the court's decision on CSAPR it
would be appropriate to propose to rescind its limited disapproval of
Alabama, Georgia, Kentucky, Mississippi, North Carolina, South Carolina
and Tennessee's regional haze SIPs and propose a full approval,
however, EPA is not at this time proposing to change the limited
approval and limited disapproval of these states' regional haze SIPs.
EPA expects to propose an appropriate action regarding Alabama,
Georgia, Kentucky, Mississippi, North Carolina, South Carolina and
Tennessee's regional haze SIPs in a separate rulemaking.
    As neither Alabama, Georgia, Kentucky, Mississippi, North Carolina,
South Carolina and Tennessee nor EPA has taken any action to remove
CAIR from the Alabama, Georgia, Kentucky, Mississippi, North Carolina,
South Carolina and Tennessee SIPs, CAIR remains part of the EPA-
approved SIP and can be considered in determining whether the SIP as a
whole meets the requirement of prong 4 of 110(a)(2)(D)(i). EPA is
proposing to approve the infrastructure SIP submission with respect to
prong 4 because Alabama, Georgia, Kentucky, Mississippi, North
Carolina, South Carolina and Tennessee's regional haze SIPs which EPA
has given a limited approval in combination with its SIP provisions to
implement CAIR adequately prevent sources in Alabama, Georgia,
Kentucky, Mississippi, North Carolina, South Carolina and Tennessee
from interfering with measures adopted by other states to protect
visibility during the first planning period. While EPA is not at this
time proposing to change the limited approval and limited disapproval
of Alabama, Georgia, Kentucky, Mississippi, North Carolina, South
Carolina and Tennessee's regional haze SIPs, EPA expects to propose an
appropriate action regarding Alabama, Georgia, Kentucky, Mississippi,
North Carolina, South Carolina and Tennessee's regional haze SIPs upon
final resolution of EME Homer City Generation v. EPA.

IV. Proposed Action

    As described above, EPA is proposing to approve submissions from
Alabama, Georgia, Kentucky, Mississippi, North Carolina, South Carolina
and Tennessee to incorporate provisions into the States' implementation
plans to address prong 4 of section 110(a)(2)(D)(i) of the CAA for both
the 1997 and 2006 PM2.5 NAAQS. Specifically, EPA is
proposing to approve the States' prong 4 of section 110(a)(2)(D)(i)
submissions because they are consistent with section 110 of the CAA.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);

     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    EPA has preliminarily determined that this proposed rule does not
have tribal implications as specified by Executive Order 13175 (65 FR
67249, November 9, 2000), because the determination does not have
``substantial direct effects'' on an Indian Tribe as a result of this
action. With respect to today's proposed action as it relates to South
Carolina, EPA notes that the Catawba Indian Nation Reservation is
located within the South Carolina and pursuant to the Catawba Indian
Claims Settlement Act, S.C. Code Ann. 27-16-120, ``all state and local
environmental laws and regulations apply to the Catawba Indian Nation
and Reservation and are fully enforceable by all relevant state and
local agencies and authorities.'' Thus, the South Carolina SIP applies
to the Catawba Reservation, however, because today's proposed action is
not approving any specific rule into the South Carolina SIP, but rather
proposing that the State's already approved SIP meets certain CAA
requirements, EPA has preliminarily determined that there are no
substantial direct effects on the Catawba Indian Nation. EPA has also
preliminarily determined that these revisions will not impose any
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping requirements, Volatile organic
compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: February 7, 2013.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2013-03841 Filed 2-19-13; 8:45 am]
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[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56061-56062]
[FR Doc No: 2022-19740]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1999]

Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug
Applications for VIOXX (Rofecoxib) Tablets and Suspension

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug applications (NDAs) for VIOXX
(rofecoxib) Tablets, 12.5 milligrams (mg), 25 mg, and 50 mg, and VIOXX
(rofecoxib) Suspension, 12.5 mg/5 milliliter (mL) and 25 mg/5 mL, held
by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., P.O.
Box 100, 1 Merck Dr., Whitehouse Station, NJ 08889 (Merck). Merck has
voluntarily requested that FDA withdraw approval of these applications
and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of September 13, 2022.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and

Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: FDA approved VIOXX (rofecoxib) Tablets (NDA
21042 and NDA 21647) and VIOXX (rofecoxib) Suspension (NDA 21052) for
the following indications:
     For relief of the signs and symptoms of osteoarthritis.
     For relief of the signs and symptoms of rheumatoid
arthritis in adults.
     For relief of the signs and symptoms of pauciarticular or
polyarticular course juvenile rheumatoid arthritis in patients 2 years
and older and who weigh 10 kg (22 lbs) or more.
     For the management of acute pain in adults.
     For the treatment of primary dysmenorrhea.
     For the acute treatment of migraine attacks with or
without aura in adults.
    On September 27, 2004, Merck informed the Agency it had halted the
Adenomatous Polyp Prevention on VIOXX (APPROVe) trial due to an
increased relative risk for confirmed cardiovascular events, such as
heart attack and stroke, beginning after 18 months of treatment in
patients taking VIOXX (rofecoxib) compared to those taking placebo. On
September 30, 2004, Merck voluntarily withdrew VIOXX from the U.S.
market. In early 2005, FDA conducted a comprehensive review of the
approved cyclooxygenase-2 (COX-2) selective and non-selective non-
steroidal anti-inflammatory drugs (NSAIDs) and the risk of adverse
cardiovascular events. On April 6, 2005, after holding a joint meeting
of the Arthritis and Drug Safety and Risk Management Advisory
Committees, FDA issued a decisional memorandum summarizing the Agency's
analysis and recommendations regarding the NSAIDs that were the subject
of the review (https://www.fda.gov/media/74279/download). In that
report, FDA made various recommendations, including modifications to
the safety information in the labeling of approved COX-2 selective
NSAIDs, including VIOXX. On June 3, 2005, Merck subsequently requested
FDA's input on the content of potential supplemental NDAs to support
labeling changes, in the event that Merck decided to bring the drug
back to the U.S. market. On December 12, 2005, FDA identified certain
safety analyses and other information that would be required in support
of such supplemental NDAs.
    In Merck's letter requesting withdrawal of VIOXX, Merck summarized
its views of the reasons for withdrawal of approval as follows. Merck
ultimately made a business decision not to recommence distribution of
VIOXX in the United States and, therefore, did not conduct the
additional analyses or submit supplemental NDAs supporting the
reintroduction of VIOXX. In light of the company's commercial decision
not to reintroduce VIOXX to the U.S. market, Merck has requested that
FDA withdraw approval of NDA 21042, NDA 21052, and NDA 21647 for VIOXX
tablets and suspension.
    FDA has determined that withdrawal of these NDAs under Sec.
314.150(d) (21 CFR 314.150(d)) is appropriate, because Merck did not
provide the additional information necessary to reintroduce VIOXX
(rofecoxib) to the U.S. market that FDA requested in its December 12,
2005, correspondence. On October 7, 2021, Merck requested that FDA
withdraw approval of NDA 21042, NDA 21052, and NDA 21647 for VIOXX
(rofecoxib) under Sec.  314.150(d) and waived its opportunity for a
hearing.
    For the reasons discussed above, and in accordance with the
applicant's request, approval of NDA 21042 and NDA 21647 for VIOXX
(rofecoxib) Tablets, 12.5 mg, 25 mg, and 50 mg, and NDA 21052 for VIOXX
(rofecoxib) Suspension, 12.5 mg/5 mL and 25 mg/5 mL, and all amendments
and supplements thereto, are withdrawn under Sec.  314.150(d).
Distribution of VIOXX (rofecoxib) Tablets, 12.5 mg, 25 mg, and 50 mg,
and VIOXX (rofecoxib) Suspension, 12.5 mg/5 mL and 25 mg/5 mL, into
interstate commerce without an approved application is illegal and
subject to regulatory action (see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19740 Filed 9-12-22; 8:45 am]
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