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11121
Federal Register/Vol. 73, No. 41 /Friday, February 29, 2008 /Notices
duration of oral presentations to the
time available. Your comments should
consider the list of topics that we have
proposed to the Committee and should
focus on issues specific to those topics.
The list of research topics to be
discussed at the meeting will be
available on the following Web site
prior to the meeting: http://
www.cms.hhs.gov/mcd/
index
_
list.asp?list
_
type=mcac. We
require that you declare at the meeting
whether you have any financial
involvement with manufacturers of any
items or services being discussed (or
with their competitors).
The Committee will deliberate openly
on the topics under consideration.
Interested persons may observe the
deliberations, but the Committee will
not hear further comments during this
time except at the request of the
chairperson. The Committee will also
allow a 15-minute unscheduled open
public session for any attendee to
address issues specific to the topics
under consideration. At the conclusion
of the day, the members will vote and
the Committee will make its
recommendation(s) to CMS.
III. Registration Instructions
The Coverage and Analysis Group is
coordinating meeting registration. While
there is no registration fee, individuals
must register to attend. You may register
by contacting the person listed in the
FOR FURTHER INFORMATION CONTACT
section of this notice by the deadline
listed in the
DATES
section of this notice.
Please provide your full name (as it
appears on your state issued driverís
license), address, organization,
telephone, fax number(s), and e-mail
address.
You will receive a registration
confirmation with instructions for your
arrival at the CMS complex. You will be
notified if the seating capacity has been
reached.
This meeting is located on Federal
property; therefore, for security reasons,
any individuals wishing to attend this
meeting must register by the date as
specified in the
DATES
section of this
notice.
IV. Security, Building, and Parking
Guidelines
This meeting will be held in a Federal
government building; therefore, Federal
security measures are applicable. In
planning your arrival time, we
recommend that you arrive reasonably
early to allow additional time to clear
security. Security measures include the
following:
•
Presentation of government-issued
photographic identification to the
Federal Protective Service or Guard
Service personnel.
•
Interior and exterior inspection of
vehicles (this includes engine and trunk
inspection) at the entrance to the
grounds. Parking permits and
instructions will be issued after the
vehicle inspection.
•
Passing through a metal detector
and inspection of items brought into the
building. We note that all items brought
to CMS, whether personal or for the
purpose of presentation or to support a
presentation, are subject to inspection.
We cannot assume responsibility for
coordinating the receipt, transfer,
transport, storage, set-up, safety, or
timely arrival of any personal
belongings or items used for
presentation or to support a
presentation.
Note: Individuals who are not registered in
advance will not be permitted to enter the
building and will be unable to attend the
meeting. The public may not enter the
building earlier than 30 to 45 minutes prior
to the convening of the meeting.
All visitors must be escorted in areas
other than the lower and first floor
levels in the Central Building.
Authority: 5 U.S.C. App. 2, section 10(a).
(Catalog of Federal Domestic Assistance
Program No. 93.773, MedicareóHospital
Insurance; and Program No. 93.774,
MedicareóSupplementary Medical
Insurance Program).
Dated: February 14, 2008.
Barry M. Straube,
Chief Medical Officer and Director, Office
of Clinical Standards and Quality, Centers
for Medicare and Medicaid Services.
[FR Doc. E8ñ3829 Filed 2ñ28ñ08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2008–P–0125] (formerly
Docket No. 2007P–0172)
Determination That MINOCIN
(Minocycline Hydrochloride) Capsules
Equivalent to 75 Milligrams Base 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) is announcing its
determination that MINOCIN
(minocycline hydrochloride) Capsules
equivalent to (EQ) 75 milligrams (mg)
base was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for minocycline
hydrochloride capsules if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Carol E. Drew, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306,
Silver Spring, MD 20993ñ0002, 301ñ
796
–3601.
SUPPLEMENTARY INFORMATION:
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98ñ
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 ëëlisted drug,íí 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,íí
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 drugís 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).
Regulations also provide that the agency
must make a determination as to
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
(ß314.161(a)(1) (21 CFR 314.161(a)(1))).
FDA may not approve an ANDA that
does not refer to a listed drug.
On May 1, 2007, Kendle International,
on behalf of Aurobindo
Pharmaceuticals, Ltd., submitted a
citizen petition (Docket No. 2007Pñ
0172/CP1) to FDA under 21 CFR 10.30.
The petition requests that the agency
determine whether MINOCIN
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11122
Federal Register/Vol. 73, No. 41 /Friday, February 29, 2008 /Notices
(minocycline hydrochloride) Capsules
EQ 75 mg base (NDA 050ñ649),
manufactured by Triax Pharmaceuticals,
Ltd. (Triax), was withdrawn from sale
for reasons of safety or effectiveness.
MINOCIN is a tetracycline-class
antibiotic medicine used to treat certain
infections caused by bacteria. MINOCIN
Capsules EQ 75 mg base was approved
on February 12, 2001. Our records show
that the 75 mg strength of this product
was marketed for a short period of time
in 2001. MINOCIN Capsules EQ 75 mg
base were discontinued in September
2001 and the drug product was moved
from the prescription drug product list
to the ëëDiscontinued Drug Product Listíí
section of the Orange Book.
FDA has reviewed its records and,
under ß314.161, has determined that
MINOCIN Capsules EQ 75 mg base was
not withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that MINOCIN Capsules EQ
75 mg base was withdrawn for reasons
of safety or effectiveness. FDA has
independently evaluated relevant
literature and data for possible
postmarketing adverse events and has
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 MINOCIN
(minocycline hydrochloride) Capsules
EQ 75 mg base in the ëëDiscontinued
Drug Product Listíí section of the Orange
Book. The ëëDiscontinued Drug Product
Listíí delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to minocycline
hydrochloride capsules EQ 75 mg base
may be approved by the agency if all
other legal and regulatory requirements
for the approval of ANDAs are met. 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: February 21, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8ñ3879 Filed 2ñ28ñ08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Cancer Care for
Uninsured Individuals: A Feasibility
Study (NCI)
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request to review and approve
the information collection listed below.
This proposed information collection
was previously published in the Federal
Register on December 21, 2007 (Vol. 72,
No. 245, p. 72741 and allowed 60-days
for public comment. One public
comment was received that questioned
why the study was not funded by
University of Alabama (UAB) funds. A
response was made on February 8, 2008,
that indicated that UAB was funding
this study. The National Institutes of
Health may not conduct or sponsor, and
the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Proposed Collection: Title: Cancer
Care For Uninsured Individuals: A
Feasibility Study. Type of Information
Collection Request: New. Need and Use
of Information Collection: The purpose
of this information collection is to
assess the feasibility of obtaining health
insurance information for participants
of the Prostate, Lung, Colon and Ovarian
(PLCO) Cancer Screening Trial
participants from health care providers
and self reports. The ultimate objective
is to compare the health care utilization
of insured and uninsured PLCO
participants. The PLCO data provides a
unique opportunity to study health care
seeking behavior after an abnormal
cancer screening test and the effect of
lack of health insurance. Participants
who had positive cancer screening tests
were referred to their doctors for follow-
up care. No additional care was
provided by the trial. The study
collected detailed information on tests
received for diagnosis, clinical
presentation of disease, and cancer
treatment. Since the PLCO original data
collection had not recorded the health
insurance of participants at the time of
their screening, it is necessary to collect
it retrospectively. This feasibility study
will request information from 50
physicians and 150 participants. The
aims are to determine the:
(1) Total number of physicians to be
contacted to obtain insurance
information on all PLCO participants
who had a positive cancer screening
test;
(2) Percentage of physicians willing
and able to provide insurance
information;
(3) Percentage of participants with
and without insurance;
(4) Number of participants for whom
insurance status can be only determined
by self report;
(5) Percentage of PLCO participants
who accept to respond to the survey;
(6) Percentage of individuals who are
willing to provide information on
insurance status; and,
(7) Potential proportion of PLCO
participants without health insurance.
These results will be used to design
a study to examine the health care
behavior of insured and uninsured
PLCO participants. This is relevant to
understand the results of the PLCO
Cancer Screening Trial and other
screening trials currently being
conducted in the U.S. The success of
these trials is conditional on
participantsí access to care following a
recommendation for follow-up.
Uninsured individuals may be more
likely to join these trials than insured
ones in order to get free preventive care.
They may also be more likely to not
seek, or delay seeking, care after an
abnormal screening test even though
they are encouraged to get care and they
may be highly motivated to receive the
best care possible. It is relevant for other
decision makers to understand whether
uninsured persons are receiving
appropriate care after abnormal
screening results. The efforts to control
cancer disease and the loss of life
associated with it are concentrated on
population wide screening. These
endeavors may be compromised if a
significant proportion of the population
does not get appropriate follow-up after
screening or does not get the care
known to be effective for their disease.
Frequency of Response: One time.
Affected Public: Individuals and
households; businesses or other for-
profit. Type of Respondents: Individuals
older than 55 who participated in the
PLCO Screening trial and physicians
who provided care for them. The annual
reporting burden is shown in the
following table.
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[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11346]
[DOCID:fr13mr07-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-169-001]

Questar Overthrust Pipeline Company; Notice of Compliance Filing

March 7, 2007.
    Take notice that on February 27, 2007, Questar Overthrust Pipeline
Company (Overthrust) tendered for filing as part of its FERC Gas
Tariff, First Revised Volume No. 1-A, the following tariff sheets, to
be effective March 12, 2007:

Fourth Revised Sheet No. 31
Fifth Revised Sheet No. 32
Seventh Revised Sheet Nos. 33 and 34
Fifth Revised Sheet No. 34A
Fourth Revised Sheet No. 66
Original Sheet No. 66A

    Overthrust is proposing to modify its gas quality specifications to
control hydrocarbon liquid dropout by setting a maximum Cricondentherm
Hydrocarbon Dew Point (CHDP) with a ``safe harbor'' provision.
    Overthrust states that after consultation with its shippers,
Overthrust is requesting that the Commission make the proposed tariff
sheets effective January 1, 2008, in order to give Overthrust's
shipper's time to prepare for the changes in Overthrust's gas quality
specifications.
    Overthrust states that copies of the filing have been served upon
Overthrust's customers and the public service commissions of Utah and
Wyoming.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing a protest
must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests 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 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>.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4487 Filed 3-12-07; 8:45 am]

BILLING CODE 6717-01-P