[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Rules and Regulations]
[Pages 64044-64046]
[FR Doc No: 2020-20810]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0197; FRL-10014-80-Region 3]

Air Plan Approval; West Virginia; 1997 8-Hour Ozone Standard
Second Maintenance Plan for the West Virginia Portion of the
Parkersburg-Marietta, WV-OH Area Comprising Wood County

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a state
implementation plan (SIP) revision submitted by the West Virginia
Department of Environmental Protection (WVDEP) of the State of West
Virginia. This revision pertains to West Virginia's plan for
maintaining the 1997 8-hour ozone national ambient air quality
standards (NAAQS) through June 7, 2027 for the West Virginia portion of
the Parkersburg-Marietta, WV-OH Area comprising Wood County. EPA is
approving these revisions to the West Virginia SIP in accordance with
the requirements of the Clean Air Act (CAA).

DATES: This final rule is effective on November 9, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2020-0197. All documents in the docket are listed on
the https://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., confidential business
information (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 through
https://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.

FOR FURTHER INFORMATION CONTACT: Keila M. Pag[aacute]n-Incle, Planning
& Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2926. Ms. Pag[aacute]n-Incle can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 6, 2020 (85 FR 40160), EPA published a notice of proposed
rulemaking (NPRM) for the State of West Virginia. In the NPRM, EPA
proposed approval of West Virginia's plan for maintaining the 1997 8-
hour ozone NAAQS through June 7, 2027, in accordance with CAA section
175A. The formal SIP revision was submitted by WVDEP on December 10,
2019.

II. Summary of SIP Revision and EPA Analysis

    On May 8, 2007 (72 FR 25967, effective June 7, 2007), EPA approved
a redesignation request (and maintenance plan) from WVDEP for the
Parkersburg-Marietta Area. Section 175A(b) of the CAA requires that at
the end of the eighth year after the effective date of the
redesignation, the state must also submit a second maintenance plan to
ensure ongoing maintenance of the standard for an additional 10 years,
and in South Coast Air Quality Management District v. EPA,\1\ the D.C.
Circuit held that this requirement cannot be waived for areas, like
Parkersburg, that had been redesignated to maintenance for the 1997 8-
hour ozone NAAQS prior to revocation and that were designated
attainment for the 2008 ozone NAAQS. CAA section 175A sets forth the
criteria for adequate maintenance plans. In addition, EPA has published
longstanding guidance that provides further insight on the content of
an approvable maintenance plan, explaining that a maintenance plan
should address five elements: (1) An attainment emissions inventory;
(2) a maintenance demonstration; (3) a commitment for continued air
quality monitoring; (4) a process for verification of continued
attainment; and (5) a contingency plan.\2\ WVDEP's December 10, 2019
SIP submittal fulfills West Virginia's obligation to submit a second
maintenance plan and adequately addresses each of the five necessary
elements.
---------------------------------------------------------------------------

    \1\ 882 F.3d 1138 (D.C. Cir. 2018).
    \2\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
---------------------------------------------------------------------------

    As discussed in the July 6, 2020 NPRM, consistent with longstanding
EPA guidance,\3\ areas that meet certain criteria may be eligible to
submit a limited maintenance plan (LMP) to meet the requirements of CAA
section 175A. Specifically, states may meet CAA section 175A's
requirement to ``provide for maintenance'' by demonstrating that an
area's design values \4\ are well below the NAAQS and that it has had
historical stability attaining the NAAQS. EPA evaluated WVDEP's
December 10, 2019 submittal for consistency with all applicable EPA
guidance and CAA requirements. EPA found that the submittal met CAA
section 175A and all CAA requirements, and proposed approval of the LMP
for the Parkersburg-Marietta, WV-OH Area comprising Wood County as a
revision to the West Virginia SIP. The effect of this action makes
certain commitments related to the maintenance of the 1997 8-hour ozone
NAAQS Federally enforceable as part of the West Virginia SIP.
---------------------------------------------------------------------------

    \3\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas'' from Sally L. Shaver, Office of Air
Quality Planning and Standards (OAQPS), dated November 16, 1994;
``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas'' from Joseph Paisie, OAQPS, dated October 6,
1995; and ``Limited Maintenance Plan Option for Moderate
PM10 Nonattainment Areas'' from Lydia Wegman, OAQPS,
dated August 9, 2001.
    \4\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone nonattainment
area is the highest design value of any monitoring site in the area.
---------------------------------------------------------------------------

    Other specific requirements of WVDEP's December 10, 2019 submittal
and the rationale for EPA's proposed action are explained in the NPRM
and will not be restated here.

III. EPA's Response to Comments Received

    EPA received three comments on the July 6, 2020 NPRM, only two of
which related to air quality issues. All comments received are in the
docket for this rulemaking action. A summary of the two comments and
EPA's responses are provided herein.
    Comment 1: The commenter alleges that the plan should not be
approved due to ``a well-documented history of excessive emissions,
including particulates,'' in Parker County. The commenter asserts that
the concentration of PM10 \5\ in Parker County is one of the
highest in the nation and that ``if there were pollution control
measures in place for Parker County, Parker County would be able to
meet its air quality standards.'' In addition, the commenter raises a
number of issues related to road improvement plans, including a request
for EPA's position on the ``Parker County Road Improvement Plan.''
---------------------------------------------------------------------------

    \5\ PM10 is defined as particulate matter with an
aerodynamic diameter less than or equal to a nominal 10 micrometers.
---------------------------------------------------------------------------

    Response 1: As stated in the NPRM, the state's submission addresses
the Parkersburg-Marietta Area's

maintenance of the 1997 8-hour ozone NAAQS. Therefore, the commenter's
concerns about particulate matter pollution and emissions are beyond
the scope of this action. Particulate matter is regulated under a
separate NAAQS.\6\ Emissions of particulate matter and concentrations
of PM10 particulates are not relevant to whether the
Parkersburg-Marietta Area continues to attain and has a plan for
maintaining the 1997 8-hour ozone NAAQS for an additional 10 years.
Similarly, road projects in an unspecified Parker County Road
Improvement Plan are not relevant to whether the LMP for the 1997 8-
hour ozone NAAQS is approvable. EPA set forth in the NPRM the criteria
relevant to approvability of the LMP. EPA has determined that the
December 10, 2019 SIP revision includes adequate information to support
West Virginia's LMP. As set forth in the NPRM, EPA has determined that
the State provided sufficient assurances in the LMP for EPA to approve
West Virginia's 1997 8-hour ozone second maintenance plan for the
Parkersburg-Marietta Area. EPA's evaluation of the West Virginia's
December 10, 2019 SIP revision and the rationale for taking rulemaking
action on this submission was discussed in detail in the NPRM. EPA
continues to believe that it has considered the correct criteria and
that the LMP meets the criteria for approvability. Concerns about
particulate matter and road projects raised by the commenter are not
relevant with respect to EPA's decision to approve the LMP.
---------------------------------------------------------------------------

    \6\ See 40 CFR 50.6 and 50.7
---------------------------------------------------------------------------

    Comment 2: The commenter claims that EPA must disapprove West
Virginia's LMP because ``the proposed rule will not ensure that the
communities in this area will be well served in terms of its electrical
needs and its water needs,'' and ``will not address the potential
problems with drinking water supplies nor the environmental damage from
increased air pollution this plan allows.'' The commenter alleges that
EPA ``will not allow'' the LMP go into effect without evaluating the
impact it could have on the state and communities, because Federal
agencies are required under the National Environmental Policy Act
(NEPA) to assess impacts from proposed Federal actions on the
environment, health and safety. Further the commenter contends that the
LMP proposal includes an increase of ``the amount of gas extraction
that would require pumping water deep underground,'' which will
potentially harm the drinking water supplies in communities, including
Parkersburg.
    Response 2: The commenter raised several issues with respect to
EPA's proposed approval of West Virginia's second 10-year maintenance
plan for the Parkersburg-Marietta Area for the 1997 8-hour ozone NAAQS,
but EPA disagrees that any of them provide a basis for disapproving the
state's submission. The commenter first raises concern about the plan's
``failure to ensure that the community will be well served in terms of
its electrical needs and its water needs.'' However, these issues are
beyond the scope of EPA's action, which address only CAA requirements
for the Parkersburg-Marietta Area with respect to the 1997 8-hour ozone
NAAQS. Second, the commenter's allegation that the EPA is required
under NEPA to assess the impacts of its maintenance plan approval is
incorrect; section 7(c) of the Energy Supply and Environmental
Coordination Act of 1974 (15 U.S.C. 793(c)(1)) exempts all EPA actions
under the CAA from the requirements of NEPA, and this action is an
approval of a SIP under the CAA. Third, the commenter's allegation that
``the plan proposes to increase the amount of gas extraction that would
require pumping water deep underground'' and her concern that the
``plan also lacks mitigation measures . . . related to the increased
use of water and gas to extract shale gas in the area'' appears to be
referring to a different action. The SIP submission at issue in this
action does not affect in any way gas extraction in West Virginia, much
less propose to increase the amount of extraction, and therefore it
appropriately does not address mitigation measures related to that
subject. Finally, EPA does not agree with the commenter's allegation
that the plan allows for increased air pollution. The state's
submission maintains the same controls and contingency measures that
were adopted into the SIP to attain and maintain the 1997 8-hour ozone
NAAQS and any potential future violations of that standard.
    As noted in the NPRM, CAA section 175A requires only that the State
of West Virginia make adequate demonstration that the Parkersburg-
Marietta Area will continue to maintain the 1997 8-hour ozone NAAQS
until 2027 (20 years after redesignation). EPA has considered the
appropriate statutory criteria and believes the record supports
approval of the LMP. Concerns regarding electricity supply and water
supply raised by the commenter are not relevant with respect to EPA's
decision to approve the LMP.

IV. Final Action

    EPA is approving the 1997 8-hour ozone NAAQS second 10-year
maintenance plan for the Parkersburg-Marietta, WV-OH Area comprising
Wood County as a revision to the West Virginia SIP.

V. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because it is not a significant regulatory
action under Executive Order 12866.
     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.

B. Submission to Congress and the Comptroller General

    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).

C. Petitions for Judicial Review

    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 December 8, 2020. 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 pertaining to West Virginia's limited maintenance
plan for the Parkersburg-Marietta, WV-OH Area comprising Wood County
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, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: September 15, 2020.
Cosmo Servidio,
Regional Administrator, Region III.
    For the reasons stated in the preamble the EPA amends 40 CFR part
52 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 XX--West Virginia

0
2. In Sec.  52.2520, the table in paragraph (e) is amended by adding
the entry ``1997 8-Hour Ozone Standard Second Maintenance Plan for the
West Virginia Portion of the Parkersburg-Marietta WV-OH Area Comprising
Wood County'' at the end of the table to read as follows:

Sec.  52.2520  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                                          State
   Name of non-regulatory SIP        Applicable         submittal       EPA  approval    Additional  explanation
            revision               geographic area        date              date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
1997 8-Hour Ozone Standard       Parkersburg-            12/10/2019  10/9/2020, [insert  .......................
 Second Maintenance Plan for      Marietta WV-OH                      Federal Register
 the West Virginia Portion of     Area Comprising                     citation].
 the Parkersburg-Marietta, WV-    Wood County.
 OH Area Comprising Wood County.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2020-20810 Filed 10-8-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 26, 2009 (Volume 74, Number 57)]
[Notices]
[Page 13215-13216]
[DOCID:fr26mr09-79]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0145]

Developing a Consolidated Pediatric Rheumatology Observational
Registry; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Developing a Consolidated Pediatric Rheumatology
Observational Registry.'' This 2-day public workshop is intended to
seek constructive input from key stakeholders in the pediatric
rheumatology community, the pharmaceutical industry and the public to
explore the value and feasibility of developing a consolidated
pediatric rheumatology observational registry.

DATES: The public workshop will be held on May 12, 2009, from 8:30 a.m.
to 5 p.m. and on May 13, 2009, from 8:30 a.m. to noon. Register by
April 21, 2009, to make a presentation at the workshop. See section III
of this document for information on how to attend or present at the
workshop. We are opening a docket to receive your written or electronic
comments. Written or electronic comments must be submitted to the
docket by July 14, 2009.

ADDRESSES: The public workshop will be held at the Hilton Washington
DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD
20910 (Metro: Silver Spring Station on the Red Line). Submit written or
electronic requests to make a presentation to Diane Ehrlich (see FOR
FURTHER INFORMATION CONTACT).
    Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061.
Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. All comments should be identified with the docket
number found in brackets in the heading of this document.
    Transcripts of the hearing will be available for review at the
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 30 days after the workshop.

FOR FURTHER INFORMATION CONTACT: Diane Ehrlich, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6190, Silver Spring, MD 20993-0002, 301-
796-3452, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Currently, approved drug and therapeutic biological products for
patients with juvenile idiopathic arthritis (JIA) (or juvenile
rheumatoid arthritis (JRA)) are monitored for long-term safety beyond
the information available at the time of approval on a product-by-
product basis using registries mandated by FDA's postmarketing
requirements. FDA is addressing concerns raised by individuals in the
pediatric rheumatology community about the current approach of using
product-specific pediatric rheumatology observational safety
registries. Some of the concerns expressed include the following:
    1. It is difficult to capture important information from children
and adolescents whose medication is switched over time because long-
term data on these patients will not be available under the product
specific registries. Patients on ``real-life'' combinations of
medications and/or nonstandard doses are often not included in product-
specific registries.
    2. Current registries do not always provide an adequate control
group to assess background rates of important adverse events.
    3. The limited number of patients with JIA will make adequate
enrollment in product-specific observational registries more difficult
as the number of approved drug and biological products increases.
    4. A nonproprietary registry rather than a proprietary registry
would allow wider access to the safety data that is collected.
    5. A consolidated pediatric rheumatology observational registry may
allow more efficient identification of longer term safety issues in
this population.

II. Scope of Public Workshop

    At the public workshop, FDA will present its current thinking on
the use of product-specific postmarketing registries to capture long-
term safety data of drug and biological products administered to
patients with JIA. Product-specific registries will be compared with a
consolidated pediatric rheumatology observational registry that could
meet the regulatory postmarketing requirements of FDA and also collect
other safety information and support potential research initiatives.

A. Objectives of the Workshop

    The workshop objectives are as follows:
    1. Discuss potential registry models, taking into account existing
registries for other diseases and in other countries.
    2. Discuss the advantages and disadvantages of a common
consolidated registry for JIA, taking into account:
     The pediatric rheumatology perspective.
     The pharmaceutical company perspective.
    3. Discuss methods to capture information regarding safety signals
in rare diseases.
    4. Discuss the value of working through existing large pediatric

rheumatology collaborative networks, such as the Childhood Arthritis
and Rheumatology Research Alliance or the Pediatric Rheumatology
Collaborative Study Group.
    5. Define, for phase 4 studies in JIA patients, the database
standards and elements of data collection (e.g., data quality,
monitoring) that are necessary and sufficient to meet FDA regulatory
requirements.
    6. Discuss how pertinent research initiatives can be accomplished
in the framework of a consolidated JIA registry, including:
     Ethical considerations.
     Data sharing considerations.
    7. Discuss the options for funding a consolidated JIA registry.

B. Issues for Comment

    FDA is interested in obtaining public comment on the following
issues relating to development of a consolidated pediatric rheumatology
observational registry:
    1. Should we transition from product-specific registries to a
consolidated pediatric rheumatology observational registry?
    2. Currently, the product-specific registries are conducted by the
individual sponsors of the approved drugs and/or biological products
with the safety data submitted to FDA.
     How should a consolidated pediatric rheumatology
observational registry be structured to collect data and conduct
analyses to meet the standards for postmarketing requirements set by
FDA and provide information about long-term safety?
     What hurdles must be overcome to transition from product-
specific registries to a consolidated pediatric rheumatology
observational registry (e.g., industry concerns, pediatric rheumatology
community concerns, proprietary issues of longer term data and informed
consent, fulfilling FDA regulatory requirements, challenges of registry
funding, management and ownership or sharing of data)?
    3. What data should be collected in a consolidated pediatric
rheumatology observational registry? Consider the following topics:
    Database standards and terminology (e.g., compatibility with large
databases).
    Necessary and sufficient data elements (e.g., safety,
effectiveness, growth and development, comorbidities, tracking
medication switches over time, as well as concurrent medication).
    Length of individual patients' participation and overall duration
of the consolidated pediatric rheumatology observational registry
(e.g., managing pediatric data through and beyond the age of consent).
    4. What are the optimal methods to analyze data from a consolidated
pediatric rheumatology observational registry to identify safety
signals? For example, should the methods define risk windows for
attribution to a drug or biological product; internal controls; and/or
analyses of confounding by indication, switches in medication, and
multiple concurrent medications?
    5. What are the opportunities for research initiatives within a
consolidated observational rheumatology registry?

III. Attendance and Registration to Speak

    There is no fee to attend the workshop, and attendees who do not
wish to make an oral presentation do not need to register. Seating will
be on a first-come, first-served basis.
    If you would like to make an oral presentation during the open
public session on day one of the workshop, you must register and
provide an abstract of your presentation by close of business on April
21, 2009. To speak, submit your name, title, business affiliation (if
applicable), address, telephone and fax numbers, and e-mail address to
Diane Ehrlich (see FOR FURTHER INFORMATION CONTACT). FDA has included
questions for comment in section II of this document. You should also
identify by number each question you wish to address in your
presentation, and the approximate time requested for your presentation.
FDA will do its best to accommodate requests to speak. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and to request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. Persons registered to make an oral presentation
should check in before the workshop.
    Ample time will be allowed during the scheduled agenda for
attendees to ask questions of panelists. In addition, we strongly
encourage written comments to the docket. Written or electronic
comments will be accepted until July 14, 2009.
    If you need special accommodations because of disability, please
contact Diane Ehrlich (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the workshop.

IV. Comments

    Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by July 14, 2009 (see DATES). Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.

V. Transcript

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
Division of Freedom of Information (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.

    Dated: March 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6709 Filed 3-25-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32366-32367]
[FR Doc No: 2011-13884]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2007-P-0347 formerly 2007P-0431/CP1 and FDA-2010-P-
0505]

Determination That ORLAAM (Levomethadyl Acetate Hydrochloride)
Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale
for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10
milligrams (mg)/milliliter (mL), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for levomethadyl
acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory
requirements are met.

FOR FURTHER INFORMATION CONTACT:  Sandra Park, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6221, Silver Spring, MD 20993-0002, 301-
796-3601.

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 approved 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 only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    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). Under Sec.  314.161(a)(1) (21 CFR 314.161(a)(1)), the
agency must determine whether a listed drug was withdrawn from sale for
reasons of safety or effectiveness before an ANDA that refers to that
listed drug may be approved. FDA may not approve an ANDA that does not
refer to a listed drug.
    ORLAAM (levomethadyl acetate HCl) oral solution, 10 mg/mL, is the
subject of NDA 20-315, held by Roxane Laboratories, Inc. (Roxane), and
approved on July 9, 1993. ORLAAM is indicated for the management of
opiate dependence, reserved for use in treatment of opiate-addicted
patients who fail to show an acceptable response to other adequate
treatments for opiate addiction, either because of insufficient
effectiveness or the inability to achieve effective dose due to
intolerable adverse effects from those drugs.
    In a letter dated April 10, 2003, Roxane notified FDA that ORLAAM
(levomethadyl acetate HCl) oral solution, 10 mg/mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the Orange Book. In the Federal Register of
November 7, 2007 (72 FR 62858), FDA

announced that it was withdrawing approval of NDA 20-315, effective
December 7, 2007.
    Charles O'Keeffe of the Virginia Commonwealth University School of
Medicine submitted two citizen petitions, one dated October 31, 2007
(Docket No. FDA-2007-P-0347), and the second dated September 22, 2010
(Docket No. FDA-2010-P-0505), under 21 CFR 10.30, requesting that the
agency determine whether ORLAAM (levomethadyl acetate HCl) oral
solution, 10 mg/mL, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing agency
records, FDA has determined under Sec.  314.161 that ORLAAM
(levomethadyl acetate HCl) oral solution, 10 mg/mL, was not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that ORLAAM (levomethadyl
acetate HCl) oral solution, 10 mg/mL, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, 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 ORLAAM (levomethadyl
acetate HCl) oral solution, 10 mg/mL, 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. ANDAs that refer to ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, may 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 this drug product should be
revised to meet current standards, the agency will advise ANDA
applicants to submit such labeling.

    Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13884 Filed 6-3-11; 8:45 am]
BILLING CODE 4160-01-P