169th Meeting of the Advisory Council on Employee Welfare and Pension Benefit Plans; Notice of Meeting, 62708-62709 [2013-24626]
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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Notices
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the ALJ should not have allowed the
objectors to litigate the issue. However,
because Lannett may be entitled to the
issuance of a rule authorizing the
importation, I conclude that it is appropriate
to issue a declaratory order on the issue of
whether Lannett has established its
entitlement to be registered. See 5 U.S.C.
§ 554(e) (‘‘The agency, with like effect as in
the case of other orders, and in its sound
discretion, may issue a declaratory order to
terminate a controversy or remove
uncertainty.’’).
Pursuant to section 303(a) of the CSA,
‘‘[t]he Attorney General shall register an
applicant to manufacture controlled
substances in schedule I or II if he
determines that such registration is
consistent with the public interest and with
the United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971.’’ 21 U.S.C.
§ 823(a). ‘‘In determining the public interest,’’
section 303(a) directs the Attorney General to
consider the following factors:
(1) Maintenance of effective controls
against diversion of particular controlled
substances and any controlled substances in
schedule I or II compounded there from into
other than legitimate medical, scientific,
research, or industrial channels, by limiting
the importation and bulk manufacture of
such controlled substances to a number of
establishments which can produce an
adequate and uninterrupted supply of these
substances under adequately competitive
conditions for legitimate medical, scientific,
research, and industrial purposes;
(2) compliance with applicable State and
local law;
(3) promotion of technical advances in the
art of manufacturing these substances and the
development of new substances;
(4) prior conviction record of applicant
under Federal and State laws relating to the
manufacture, distribution, or dispensing of
such substances;
(5) past experience in the manufacture of
controlled substances, and the existence in
the establishment of effective controls against
diversion; and
(6) such other factors as may be relevant to
and consistent with public health and safety.
Id. It is well settled that the Agency need not
make findings as to all of the factors and that
it may give each factor the weight it deems
appropriate in determining the public
interest. See Novelty, Inc., v. DEA, 571 F.3d
1176, 1181 (D.C. Cir. 2009).
While there is insufficient evidence to
make findings with respect to factors two,
three, and six, the record establishes that
Lannett has experience in the manufacture
and development of pharmaceutical products
and that it maintains effective controls
against diversion (factor five). The record
also establishes that Lannett has not been
convicted of an offense related to the
manufacture or distribution of controlled
substances (factor four). Both of these
findings support the conclusion that granting
Lannett’s application for a registration would
be consistent with the public interest.
The ALJ found that Lannett had not shown
that competition among domestic
manufactures of dronabinol is inadequate
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and that the current manufacturers were
incapable of producing an adequate and
uninterrupted supply of this substance
(factor one). Relying on Lyle E. Craker, 74 FR
2101 (2009), the ALJ thus concluded this
factor ‘‘weighs strongly against a finding that
Lannett’s registration would be in the public
interest,’’ and concluded that the record does
not support granting its application.
I conclude, however, that Craker does not
require that Lannett’s application be denied.
As the D.C. Circuit has held, ‘‘section 823(a)’s
enumerated factors represent components of
the public interest rather than independent
requirements for registration and thus, the
[Agency] may find a registration consistent
with the public interest even if one (or
possibly more) of the public interest factors
is not satisfied.’’ Penick, 491 F.3d at 490. As
Penick recognized, the principal purpose of
factor one is to provide the Agency with
authority ‘‘to maintain control over diversion
‘by limiting the [number of firms engaged in
the] importation and bulk manufacture’ of
controlled substances.’’ Id. at 491.
Craker involved an application to
manufacture a schedule I controlled
substance on a continuing basis. By contrast,
the activity for which Lannett seeks an
importer’s registration (to perform stability
and bioequivalency testing) does not involve
an activity of a continuing nature, but rather,
three separate acts (at most) of importation.
As such, granting its application does not
raise the same concerns with respect to the
Agency’s ability to maintain effective
controls against diversion.
Accordingly, I conclude that factor one
does not preclude the issuance of an import
registration to Lannett, subject to the
condition that its authority to import
dronabinol as a schedule I drug be limited to
the quantity which is necessary to support an
ANDA.30 I therefore conclude that upon
providing adequate justification for the
quantity of the importation, Lannett’s
registration would be consistent with the
public interest.31 21 U.S.C. § 823(a).
Order
Lannett is hereby directed to file with this
Office its testing protocol and an itemization
setting forth the various quantities it needs to
import for bioequivalency and stability
studies, as well as reserves. If FDA requires
that it import the entire batch that will be
used for bioequivalency and stability testing
and will not permit it to select its test
samples from the production batch and
import only those quantities, Lannett should
provide evidence supporting this. Finally, if
Lannett intends to pursue importation of the
additional batches, it must provide
additional justification for doing so. Lannett
must serve a copy of all filings on the
objectors. Lannett’s submission shall be due
no later than 90 days from date of the
30 DEA has long held that it has authority to
impose conditions on a registration. See Alfred
Khalily, 64 FR 31289 (1999); Gordon M. Acker,
D.M.D., 53 FR 50309 (1988).
31 Nor does the record establish any reason why
granting Lannett’s application would be
inconsistent with the United States’ obligations
under international treaties and the Single
Convention. See Penick Corp., 491 F.3d at 492–93.
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issuance of this Order; Lannett shall timely
inform this Office of any delays in obtaining
a response from FDA.32 It is further ordered
that Lannett’s application for a registration to
import dronabinol be held in abeyance.
Dated: November 15, 2012
Michele M. Leonhart
Administrator
[FR Doc. 2013–24621 Filed 10–21–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
169th Meeting of the Advisory Council
on Employee Welfare and Pension
Benefit Plans; Notice of Meeting
Pursuant to the authority contained in
Section 512 of the Employee Retirement
Income Security Act of 1974 (ERISA), 29
U.S.C. 1142, the 169th open meeting of
the Advisory Council on Employee
Welfare and Pension Benefit Plans (also
known as the ERISA Advisory Council)
will be held on November 4–5, 2013.
The meeting will take place in C5521
Room 4, U.S. Department of Labor, 200
Constitution Avenue NW., Washington,
DC 20210 on November 4, from 1 p.m.
to approximately 5:00 p.m. On
November 5, the meeting will start at
8:30 a.m. and conclude at
approximately 4:00 p.m., with a break
for lunch. The morning session on
November 5 will be in C5521 Room 1.
The afternoon session on November 5
will take place in Room S–2508 at the
same address. The purpose of the open
meeting on November 4 and the
morning of November 5 is for the
Advisory Council members to finalize
the recommendations they will present
to the Secretary. At the November 5
afternoon session, the Council members
will receive an update from the
Assistant Secretary of Labor for the
Employee Benefits Security
Administration (EBSA) and present
their recommendations.
The Council recommendations will be
on the following issues: (1) Successful
Retirement Plan Communications for
Various Population Segments, (2)
Locating Missing and Lost Participants,
and (3) Private Sector Pension Derisking and Participant Protections.
Descriptions of these topics are
available on the Advisory Council page
of the EBSA Web site at https://
www.dol.gov/ebsa/aboutebsa/erisa_
advisory_council.html.
32 The Objectors shall have thirty days from the
date of receipt of Lannett’s filing to submit a
response.
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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Notices
Organizations or members of the
public wishing to submit a written
statement may do so by submitting 30
copies on or before October 28, 2013 to
Larry Good, Executive Secretary, ERISA
Advisory Council, U.S. Department of
Labor, Suite N–5623, 200 Constitution
Avenue NW., Washington, DC 20210.
Statements also may be submitted as
email attachments in text or pdf format
transmitted to good.larry@dol.gov. It is
requested that statements not be
included in the body of an email.
Statements deemed relevant by the
Advisory Council and received on or
before October 28 will be included in
the record of the meeting and made
available in the EBSA Public Disclosure
Room. Do not include any personally
identifiable information (such as name,
address, or other contact information) or
confidential business information that
you do not want publicly disclosed.
Individuals or representatives of
organizations wishing to address the
Advisory Council should forward their
requests to the Executive Secretary or
telephone (202) 693–8668. Oral
presentations will be limited to ten
minutes, time permitting, but an
extended statement may be submitted
for the record. Individuals with
disabilities who need special
accommodations should contact the
Executive Secretary by October 28, 2013
at the address indicated.
Signed at Washington, DC, this 17th day of
October, 2013.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits
Security Administration.
[FR Doc. 2013–24626 Filed 10–21–13; 8:45 am]
OFFICE OF MANAGEMENT AND
BUDGET
Calendar Year 2013 Cost of Outpatient
Medical, Dental, and Cosmetic Surgery
Services Furnished by Department of
Defense Medical Treatment Facilities;
Certain Rates Regarding Recovery
From Tortiously Liable Third Persons
Office of Management and
Budget, Executive Office of the
President.
ACTION: Notice.
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AGENCY:
By virtue of the authority
vested in the President by section 2(a)
of Public Law 87–603 (76 Stat. 593; 42
U.S.C. 2652), and delegated to the
Director of the Office of Management
and Budget (OMB) by the President
through Executive Order No. 11541 of
July 1, 1970, the rates referenced below
are hereby established. These rates are
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Sylvia M. Burwell,
Director.
[FR Doc. 2013–24330 Filed 10–21–13; 8:45 am]
(ADAMS): You may access publicly
available documents online in the NRC
Library at https://www.nrc.gov/readingrm/adams.html. To begin the search,
select ‘‘ADAMS Public Documents’’ and
then select ‘‘Begin Web-based ADAMS
Search.’’ For problems with ADAMS,
please contact the NRC’s Public
Document Room (PDR) reference staff at
1–800–397–4209, 301–415–4737, or by
email to pdr.resource@nrc.gov. The
ADAMS accession number for each
document referenced in this notice (if
that document is available in ADAMS)
is provided the first time that a
document is referenced. The request to
extend the construction permit
expiration date, dated May 17, 2012, is
available electronically in ADAMS
under Accession No. ML12143A346.
• NRC’s PDR: You may examine and
purchase copies of public documents at
the NRC’s PDR, Room O1–F21, One
White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852.
SUPPLEMENTARY INFORMATION:
BILLING CODE 3110–01–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 50–391; NRC–2008–0369]
Tennessee Valley Authority; Watts Bar
Nuclear Plant, Unit 2
Nuclear Regulatory
Commission.
ACTION: Environmental assessment and
finding of no significant impact;
issuance.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is considering
extending the latest construction
completion date specified in
Construction Permit No. CPPR–92
issued to Tennessee Valley Authority
(permittee, TVA) for the Watts Bar
Nuclear Plant (WBN), Unit 2.
ADDRESSES: Please refer to Docket ID
NRC–2008–0369 when contacting the
NRC about the availability of
information regarding this document.
You may access publicly-available
information related to this action by the
following methods:
• Federal Rulemaking Web site: Go to
https://www.regulations.gov and search
for Docket ID NRC–2008–0369. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–287–3422;
email: Carol.Gallagher@nrc.gov. For
technical questions, contact the
individual(s) listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• NRC’s Agencywide Documents
Access and Management System
SUMMARY:
BILLING CODE 4510–29–P
SUMMARY:
for use in connection with the recovery
from tortiously liable third persons for
the cost of outpatient medical, dental
and cosmetic surgery services furnished
by military treatment facilities through
the Department of Defense (DoD). The
rates were established in accordance
with the requirements of OMB Circular
A–25, requiring reimbursement of the
full cost of all services provided. The
CY13 Outpatient Medical, Dental, and
Cosmetic Surgery rates referenced are
effective upon publication of this notice
in the Federal Register and will remain
in effect until further notice. Previously
published inpatient rates remain in
effect until further notice. Pharmacy
rates are updated periodically. A full
disclosure of the rates is posted at the
DoD’s Uniform Business Office Web
site: https://www.tricare.mil/ocfo/mcfs/
ubo/mhs_rates.cfm.
62709
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I. Introduction
The NRC is considering extending the
latest construction completion date
specified in Construction Permit No.
CPPR–92 issued to Tennessee Valley
Authority (permittee, TVA) for the
Watts Bar Nuclear Plant (WBN), Unit 2.
The facility is located at the permittee’s
site on the west branch of the Tennessee
River approximately 50 miles northeast
of Chattanooga, Tennessee. Therefore, as
required by section 51.21 of Title 10 of
the Code of Federal Regulations (10
CFR), the NRC performed an
environmental assessment. Based on the
results of the environmental assessment
that follows, the NRC has determined
not to prepare an environmental impact
statement for the action of extending the
completion date of the construction
permit, and is issuing a finding of no
significant impact.
II. Environmental Assessment
Identification of the Proposed Action
The proposed action would extend
the latest construction completion date
of Construction Permit No. CPPR–92
from March 31, 2013, to September 30,
2016. TVA submitted the construction
permit request by letter dated May 17,
2012 (ADAMS Accession No.
ML12143A346). TVA submitted the
request to extend the construction
permit at least 30 days before the
expiration of the existing permit,
therefore, in accordance with 10 CFR
2.109(a), the existing construction
permit will remain in effect until the
NRC staff has completed the review of
the request.
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]]>Agencies
[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62708-62709]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24626]
=======================================================================
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DEPARTMENT OF LABOR
Employee Benefits Security Administration
169th Meeting of the Advisory Council on Employee Welfare and
Pension Benefit Plans; Notice of Meeting
Pursuant to the authority contained in Section 512 of the Employee
Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. 1142, the
169th open meeting of the Advisory Council on Employee Welfare and
Pension Benefit Plans (also known as the ERISA Advisory Council) will
be held on November 4-5, 2013.
The meeting will take place in C5521 Room 4, U.S. Department of
Labor, 200 Constitution Avenue NW., Washington, DC 20210 on November 4,
from 1 p.m. to approximately 5:00 p.m. On November 5, the meeting will
start at 8:30 a.m. and conclude at approximately 4:00 p.m., with a
break for lunch. The morning session on November 5 will be in C5521
Room 1. The afternoon session on November 5 will take place in Room S-
2508 at the same address. The purpose of the open meeting on November 4
and the morning of November 5 is for the Advisory Council members to
finalize the recommendations they will present to the Secretary. At the
November 5 afternoon session, the Council members will receive an
update from the Assistant Secretary of Labor for the Employee Benefits
Security Administration (EBSA) and present their recommendations.
The Council recommendations will be on the following issues: (1)
Successful Retirement Plan Communications for Various Population
Segments, (2) Locating Missing and Lost Participants, and (3) Private
Sector Pension De-risking and Participant Protections. Descriptions of
these topics are available on the Advisory Council page of the EBSA Web
site at https://www.dol.gov/ebsa/aboutebsa/erisa_advisory_council.html.
[[Page 62709]]
Organizations or members of the public wishing to submit a written
statement may do so by submitting 30 copies on or before October 28,
2013 to Larry Good, Executive Secretary, ERISA Advisory Council, U.S.
Department of Labor, Suite N-5623, 200 Constitution Avenue NW.,
Washington, DC 20210. Statements also may be submitted as email
attachments in text or pdf format transmitted to good.larry@dol.gov. It
is requested that statements not be included in the body of an email.
Statements deemed relevant by the Advisory Council and received on or
before October 28 will be included in the record of the meeting and
made available in the EBSA Public Disclosure Room. Do not include any
personally identifiable information (such as name, address, or other
contact information) or confidential business information that you do
not want publicly disclosed.
Individuals or representatives of organizations wishing to address
the Advisory Council should forward their requests to the Executive
Secretary or telephone (202) 693-8668. Oral presentations will be
limited to ten minutes, time permitting, but an extended statement may
be submitted for the record. Individuals with disabilities who need
special accommodations should contact the Executive Secretary by
October 28, 2013 at the address indicated.
Signed at Washington, DC, this 17th day of October, 2013.
Phyllis C. Borzi,
Assistant Secretary, Employee Benefits Security Administration.
[FR Doc. 2013-24626 Filed 10-21-13; 8:45 am]
BILLING CODE 4510-29-P
