[Federal Register: December 12, 2005 (Volume 70, Number 237)]
[Notices]
[Page 73465]
[DOCID:fr12de05-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-117-000]

Gas Transmission Northwest Corporation; Notice of Proposed
Changes in FERC Gas Tariff

December 6, 2005.
    Take notice that on November 30, 2005, Gas Transmission Northwest
Corporation (GTN) tendered for filing as part of its FERC Gas Tariff,
Third Revised Volume No. 1-A, Sixth Revised Sheet No. 6, to become
effective January 1, 2006.
    GTN further states that a copy of this filing has been served on
GTN's jurisdictional customers and interested state regulatory
agencies.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7217 Filed 12-9-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 82 (Monday, May 1, 2017)]
[Proposed Rules]
[Pages 20310-20311]
[FR Doc No: 2017-08772]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 751

[EPA-HQ-OPPT-2016-0387; EPA-HQ-OPPT-2016-0231; FRL-9961-66]
RIN 2070-AK11 and RIN 2070-AK07

Trichloroethylene; Regulation of Vapor Degreasing Under TSCA
Section 6(a); Methylene Chloride and N-Methylpyrrolidone; Regulation of
Certain Uses Under TSCA Section 6(a); Reopening of Comment Periods

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; Reopening of comment periods.

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SUMMARY: In the Federal Register of January 19, 2017, EPA issued two
proposed rules under section 6 of the Toxic Substances Control Act
(TSCA). The first action proposed to prohibit the manufacture
(including import), processing, and distribution in commerce of
trichloroethylene (TCE) for use in vapor degreasing; to prohibit the
use of TCE in vapor degreasing; to require manufacturers (including
importers), processors, and distributors, except for retailers, of TCE
for any use to provide downstream notification of these prohibitions
throughout the supply chain; and to require limited recordkeeping. The
second action proposed to prohibit the manufacture (including import),
processing, and distribution in commerce of methylene chloride and N-
methylpyrrolidone (NMP) for consumer and most types of commercial paint
and coating removal; to prohibit the use of methylene chloride and NMP
in these commercial uses; to require manufacturers (including
importers), processors, and distributors, except for retailers, of
methylene chloride and NMP for any use to provide downstream
notification of these prohibitions throughout the supply chain; and to
require

recordkeeping. This document reopens and extends the comment periods
for each proposed rule for an additional 30 days. Commenters requested
additional time to submit written comments for the proposed rules.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPPT-2016-0387 and by docket identification (ID) number EPA-HQ-OPPT-
2016-0231 must be received on or before May 19, 2017.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register documents of January 19, 2017, (82 FR 7432) (FRL-
9950-08) or (82 FR 7464) (FRL-9958-57).

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Cindy Wheeler, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>or Ana Corado, Chemical Control Division
(7405M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document reopens public comment periods
established in the two proposed rules issued in the Federal Register of
January 19, 2017 (82 FR 7432) (FRL-9950-08) and (82 FR 7464) (FRL-9958-
57). In the first action, EPA proposed a rule under section 6 of the
Toxic Substances Control Act (TSCA) to prohibit the manufacture
(including import), processing, and distribution in commerce of
trichloroethylene (TCE) for use in vapor degreasing; to prohibit the
use of TCE in vapor degreasing; to require manufacturers (including
importers), processors, and distributors, except for retailers, of TCE
for any use to provide downstream notification of these prohibitions
throughout the supply chain; and to require limited recordkeeping. In
the second notice, EPA proposed a rule under section 6 of TSCA to
prohibit the manufacture (including import), processing, and
distribution in commerce of methylene chloride and N-methylpyrrolidone
(NMP) for consumer and most types of commercial paint and coating
removal; to prohibit the use of methylene chloride and NMP in these
commercial uses; to require manufacturers (including importers),
processors, and distributors, except for retailers, of methylene
chloride and NMP for any use to provide downstream notification of
these prohibitions throughout the supply chain; and to require
recordkeeping. EPA is hereby reopening the comment periods for 30 days,
to May 19, 2017.
    Even though EPA received requests for a lengthier extension of the
comment periods, the Agency has concluded that a 30-day reopening of
the comment period is sufficient. EPA has already provided for a
substantial comment period, now totaling 90 days, for each of the two
proposals. EPA has already extended the original 60-day comment period
for the proposed rule in TCE in vapor degreasing for 30 days, from
March 20, 2017, to April 19, 2017 (82 FR 10732, February 15, 2017).
This notice provides the second extension of the comment period for
that proposed rule. EPA proposed the rule on methylene chloride and NMP
in paint and coating removal with a 90-day comment period, ending on
April 19, 2017. Additionally, much of the technical bases for the
proposals has been available to the public since the risk assessments
for methylene chloride and TCE were published in 2014 and the risk
assessment for NMP was published in 2015, and the commenters' expressed
need for further extension was general in nature (e.g., the complexity
and importance of the subject matter, and prospective commenters'
desire to continue conferring and reviewing the technical basis for
EPA's proposal). The Agency, therefore, is extending the comment period
at its own discretion, in the interest of receiving comprehensive
public comment for the benefit of the current rules.
    To submit comments, or access a docket, please follow the detailed
instructions provided under ADDRESSES in the Federal Register documents
of January 19, 2017, (82 FR 7432) (FRL-9950-08) or (82 FR 7464) (FRL-
9958-57). If you have questions, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

List of Subjects in 40 CFR Part 751

    Environmental protection, Chemicals, Export notification, Hazardous
substances, Import certification, Methylene Chloride, N-
Methylpyrrolidone, Trichloroethylene, Recordkeeping.

    Dated: April 18, 2017.
Wendy Cleland-Hamnett,
Acting Assistant Administrator for Chemical Safety and Pollution
Prevention.
[FR Doc. 2017-08772 Filed 4-28-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Page 44836]
[FR Doc No: 2017-20576]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4319-DR: Docket ID FEMA-2017-0001]

Kansas; Amendment No. 2 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Kansas (FEMA-4319-DR), dated June 16, 2017, and
related determinations.

DATES: The amendment was issued on September 8, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Michael R.
Scott, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of David G. Samaniego as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-20576 Filed 9-25-17; 8:45 am]
BILLING CODE 91110-123-P


Index Page
Docket No. FDA - 2022 - N - 1526
Fluorinated Polyethylene Containers for Food Contact Use; Request for Information

The following references marked with an asterisk (*) do not have a copyright.  Only REF. 1 9with no asterisk) has a copyright.

REF 1. Rand, A.A. and S.A. Mabury, ``Perfluorinated Carboxylic Acids in Directly Fluorinated High-Density Polyethylene Material,'' Environmental Science & Technology, 2011.
REF. 2. *Agency for Toxic Substances and Disease Registry, ``Toxicological Profile for Perfluoroalkyls,'' May 2021.
REF. 3. *The International Agency for Research on Cancer, Monogram for Perfluorooactanoic Acid, 2017.
REF 4. *Fact Sheet: Biden-Harris Administration Launches Plan to Combat PFAS Pollution, October 2021.


[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Rules and Regulations]
[Pages 12394-12396]
[FR Doc No: 2014-04779]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2013-0698; FRL-9907-32-Region 7]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a
revision to the State Implementation Plan (SIP) submitted by the State
of Missouri which revises the written reporting requirements for
maintenance, start-up, or shutdown activities; updates the information
a source operator must provide to the department when a notice of
excess emissions is received; and corrects references in the reporting
and record keeping section.

DATES: This final rule is effective on April 4, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R07-OAR-2013-0698. All documents in the docket are listed on
the www.regulations.gov Web site. 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 through
www.regulations.gov or in hard copy at the Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219. The Regional Office's official hours of business
are Monday through Friday, 8:00 a.m. to 4:30 p.m. excluding Federal
holidays. The interested persons wanting to examine these documents
should make an appointment with the office at least 24 hours in
advance.

FOR FURTHER INFORMATION CONTACT: Amy Bhesania, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What is EPA's response to comments?
IV. What action is EPA taking?

I. What is being addressed in this document?

    EPA is approving revisions to the Missouri SIP submitted to EPA on
July 8, 2010 which amends 10 CSR 10-6.050 Start-up, Shutdown, and
Malfunction Conditions. Specifically, Missouri amended subsection 3(B)
to remove the option for verbal notification and therefore only written
notification is allowed for any maintenance, start-up, or shutdown
activity which is expected to cause an excess release of emissions that
exceeds one hour. This change makes the written notification
requirements consistent for subsections (3)(B) which covers
maintenance, start-up and shutdown, and (3)(A) which covers
malfunctions. Subparagrah (3)(B)3. was removed because the requirement
was only applicable to malfunctions which is addressed in subsection
(3)(A).
    The remaining revisions to the rule are administrative changes
which revise the rule to be consistent with the state's standard rule
format or make other minor clarifying changes. Subparagraphs (3)(B)3
through (3)(B)9 were renumbered to adjust for the removal of item
(3)(B)3. Subparagraph (3)(C)2 includes minor administrative changes to
meet the state's standard rule

format. Subparagraphs (3)(C)2.A and (3)(C)2.B were removed because they
were redundant and replaced with references to the appropriate
applicable subsections of the rule. Subsection (4)(B) was revised to be
consistent with the state's standard rule format.
    In a separate action on February 22, 2013, EPA has proposed to
address a petition by Sierra Club related to SSM provisions, including
10 CSR 10-6.050(3)(C) (78 FR 12459). In this separate action, EPA
proposed to deny the petitioner's request that EPA take action under
Clean Air Act (CAA) section 110(k)(5) or (6) to direct the state to
revise this provision. The revisions in today's action do not address
the sections of the regulation challenged by the Sierra Club in its
petition. The revisions in today's action clarify and strengthen the
Missouri SIP. By removing the option for oral notification in 10 CSR
10-6.050(3)(B), and requiring written notification, the Missouri SIP is
more stringent. The revision in 10 CSR 10-6.050(3)(C)2.A clarifies the
notification requirements for malfunctions by referring to section 10
CSR 10-6.050(3)(A). The revision in 10 CSR 10-6.050 (3)(C)2.B clarifies
the general notification requirements for maintenance, startup, or
shutdown activities by referring to the general notification
requirements set forth in 10 CSR 10-6.050(3)(B).
    The revisions in today's action are consistent with CAA
requirements for SIP provisions and do not violate the anti-backsliding
provisions in section 110(l) or section 193 of the CAA because they are
SIP strengthening and do not interfere with any applicable requirements
concerning attainment or reasonable further progress nor do they affect
control measures in effect prior to the 1990 CAA Amendments related to
nonattainment areas. Further, these revisions are consistent with the
action proposed by EPA on February 22, 2013 as mentioned above (78 FR
12459).

II. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. In
addition, as explained above, the revision meets the substantive SIP
requirements of the CAA, including section 110 and implementing
regulations.

III. What is EPA's response to comments?

    The public comment period on EPA's proposed rule opened December 3,
2013, the date of its publication in the Federal Register, and closed
on January 2, 2014 (78 FR 72608). During this period, EPA received no
comments.

IV. What action is EPA taking?

    EPA is taking final action to amend the Missouri SIP by approving
the state's request to amend 10 CSR 10-6.050 Start-Up, Shutdown, and
Malfunction to update written reporting requirements, correct
references, and other minor clarifying changes. Approval of these
revisions ensures consistency between state and Federally-approved
rules. EPA has determined that these changes will not relax the SIP or
adversely impact air emissions.

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. 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
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 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).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 5, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: February 13, 2014.
Mike Brinks,
Acting Regional Administrator, Region 7.

    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart AA--Missouri

0
2. In Sec.  52.1320 the table in paragraph (c), under Chapter 6 is
amended by revising the entry for ``10-6.050'' to read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (c) * * *

                                        EPA-Approved Missouri Regulations
----------------------------------------------------------------------------------------------------------------
                                                      State
   Missouri  citation             Title          effective date    EPA approval date          Explanation
----------------------------------------------------------------------------------------------------------------
                                    Missouri Department of Natural Resources

                                                  * * * * * * *
    Chapter 6--Air Quality Standards, Definitions, Sampling and Reference Methods, and Air Pollution Control
                                      Regulations for the State of Missouri

                                                  * * * * * * *
10-6.050................  Start-up, Shutdown,          07/30/10  03/05/14 [insert      .........................
                           and Malfunction                        Federal Register
                           Conditions.                            page number where
                                                                  the document
                                                                  begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-04779 Filed 3-4-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3435-3436]
[FR Doc No: 2016-01096]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-3319]

Determination That MEVACOR (Lovastatin) Tablets, 20 Milligrams
and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that MEVACOR (lovastatin) tablets, 20 milligrams (mg) and 40
mg, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to these drug products, and it will allow FDA to
continue to approve ANDAs that refer to the products as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Kate Greenwood, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire

Ave., Bldg. 51, Rm. 6286, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    MEVACOR (lovastatin) tablets, 20 mg and 40 mg, are the subject of
NDA 19-643, held by Merck & Co. Inc., and initially approved on August
31, 1987. MEVACOR is indicated: (1) To reduce the risk of myocardial
infarction, unstable angina, and coronary revascularization procedures
in individuals without symptomatic cardiovascular disease, average to
moderately elevated total cholesterol (total-C) and low-density
lipoprotein cholesterol (LDL-C), and below average high-density
lipoprotein cholesterol; (2) to slow the progression of coronary
atherosclerosis in patients with coronary heart disease as part of a
treatment strategy to lower total-C and LDL-C to target levels; and (3)
as an adjunct to diet for the reduction of elevated total-C and LDL-C
levels in patients with primary hypercholesterolemia (Types IIa and
IIb), when the response to diet restricted in saturated fat and
cholesterol and to other nonpharmacological measures alone has been
inadequate. MEVACOR is also indicated as an adjunct to diet to reduce
total-C, LDL-C, and apolipoprotein B levels in adolescent boys and
girls who are at least 1 year post-menarche, 10-17 years of age, with
heterozygous familial hypercholesterolemia if, after an adequate trial
of diet therapy, the following findings are present: (1) LDL-C remains
>189 mg/deciliter (dL) or (2) LDL-C remains >160 mg/dL and there is a
positive family history of premature cardiovascular disease (CVD) or
two or more other CVD risk factors are present in the adolescent
patient.
    MEVACOR (lovastatin) tablets, 20 mg and 40 mg, are currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
    Winifred M. Begley submitted a citizen petition dated September 10,
2015 (Docket No. FDA-2015-P-3319), under 21 CFR 10.30, requesting that
the Agency determine whether MEVACOR (lovastatin) tablets, 20 mg and 40
mg, were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that MEVACOR (lovastatin) tablets, 20 mg and 40 mg,
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
MEVACOR (lovastatin) tablets, 20 mg and 40 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of MEVACOR (lovastatin)
tablets, 20 mg and 40 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list MEVACOR (lovastatin)
tablets, 20 mg and 40 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to MEVACOR (lovastatin) tablets, 20 mg and 40
mg. Additional ANDAs that refer to these products may also be approved
by the Agency as long as they meet all other legal and regulatory
requirements for the approval of ANDAs. If FDA determines that labeling
for these drug products should be revised to meet current standards,
the Agency will advise ANDA applicants to submit such labeling.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01096 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P


CLEAN AIR INTERSTATE RULE DOCKETING FORM NAME OF GROUP: American Forestry & Paper Association, and other companies MEETING___ XX__ SPEECH_____ PHONE CALL_____

DATE: August 30, 2004 LOCATION OF MEETING/ SPEECH/ PHONE CALL: EPA, Washington DC, Ariel Rios North Building PURPOSE OF MEETING/ SPEECH/ PHONE CALL:

The purpose of the meeting was to discuss the concerns of AF & PA and other industry representatives with regard to the proposed Clean Air Interstate Rule ( CAIR). Discussion topics included opt in provisions for manufacturers, definitions of combined heat and power, the Nox SIP Call, and other issues.

Agenda: Introductions Overview ( Hunt)  5 minutes NOx SIP Call ( deRuyter; Bessette)  10 minutes Manufacturer's Opt in ( Hunt, deRuyter, Carter)  20 minutes Combined Heat and Power definition ( deRuyter)  5 minutes Next Steps/ Wrap up  5 minutes ATTENDEES:

From EPA: Jeff Holmstead, Sarah Dunham, Ben Hengst, Bob Meyers, Bill Wehrum, John Robbins Non EPA: Amy Schaffer, Weyerhaeuser Bob Bessette, CIBO John deRuyter, DuPont Ted Cromwell, ACC Leslie Hulse, ACC Tom Carter, PCA ( Cement) Tim Hunt, AF& PA David Harrison ( phone); NERA