Oncologic Drugs Advisory Committee; Notice of Meeting, 32852-32853 [E7-11496]
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32852
Federal Register / Vol. 72, No. 114 / Thursday, June 14, 2007 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Request for reconsideration of a
decision
5
1 time for each
application
5
2
10
Request for review—(user fee appeal officer)
2
1 time for each
application
2
2
4
Total
60
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA’s database system,
there are an estimated 250 sponsors of
products subject to ADUFA. However,
not all sponsors will have any
submissions in a given year and some
may have multiple submissions. The
total number of waiver requests is based
on the number of submission types
received by FDA in fiscal year 2003.
FDA’s Center for Veterinary Medicine
estimates 30 waiver requests that
include the following: 5 significant
barriers to innovation, 1 fee exceed cost,
5 free choice feeds, 10 minor use or
minor species, 2 small business waiver
requests, 5 requests for reconsideration
of a decision, and 2 requests for user fee
appeal officer. The estimated hours per
response are based on past FDA
experience with the various waiver
requests in FDA’s Center for Drug
Evaluation and Research. The hours per
response are based on the average of
these estimates.
Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11425 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0221]
Otsuka Pharmaceutical Co., Ltd.;
Withdrawal of Approval of a New Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for RAXAR (grepafloxacin
hydrochloride (HCl)) Tablets held by
Otsuka Pharmaceutical Co., Ltd.
(Otsuka), c/o Otsuka Pharmaceutical
Development & Commercialization, Inc.,
VerDate Aug<31>2005
17:22 Jun 13, 2007
Jkt 211001
2440 Research Blvd., Rockville, MD
20850. Otsuka has voluntarily requested
that approval of this application be
withdrawn because the product is no
longer marketed, thereby waiving its
opportunity for a hearing.
DATES: Effective June 14, 2007.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In a letter
dated March 5, 2003, Otsuka requested
that FDA withdraw approval of NDA
20–695 for RAXAR (grepafloxacin HC1)
Tablets, stating that the product was no
longer being marketed. In FDA’s
acknowledgment letter of June 20, 2003,
the agency informed Otsuka that
RAXAR (grepafloxacin HCl) Tablets,
indicated for the treatment of a variety
of infections, had been removed from
the market because of safety concerns;
in its follow-up letter of January 12,
2007, the agency also informed Otsuka
that it had determined that the RAXAR
NDA should be withdrawn under
§ 314.150(d) (21 CFR 314.150(d))
because of its effect on cardiac
repolarization, manifested as QTc
interval prolongation on the
electrocardiogram, which could put
patients at risk of Torsade de Pointes. In
its letter of March 20, 2007, Otsuka
concurred in the agency’s determination
to initiate withdrawal of the RAXAR
NDA and waived its opportunity for a
hearing, provided under 21 CFR
314.150(a) and (b).
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 355(e)), § 314.150(d),
and under authority delegated to the
Director, Center for Drug Evaluation and
Research (21 CFR 5.105(a)), approval of
the NDA 20–695, and all amendments
and supplements thereto, is withdrawn,
effective (see DATES). Distribution of this
product in interstate commerce without
an approved application is illegal and
PO 00000
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Fmt 4703
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subject to regulatory action (see sections
505(a) and 301(d) of the act (21 U.S.C.
331(d)).
Dated: May 31, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–11427 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on July 24, 2007, from 8 a.m. to 5
p.m.
Location: Advisors and Consultants
Staff Conference Room, 5630 Fishers
Lane, rm. 1066, Rockville, MD 20857.
Contact Person: Johanna Clifford,
Center for Drug Evaluation and Research
(HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
6761, FAX: 301–827–6776, e-mail:
Johanna.Clifford@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
E:\FR\FM\14JNN1.SGM
14JNN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 114 / Thursday, June 14, 2007 / Notices
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss
the following new drug applications
(NDAs): (1) NDA 022–042, EVISTA
(raloxifene hydrochloride) Tablets, Eli
Lilly and Co., proposed indications for
the reduction in risk of invasive breast
cancer in postmenopausal women with
osteoporosis, and for the reduction in
risk of invasive breast cancer in
postmenopausal women at high risk of
breast cancer; and (2) NDA 021–801,
proposed trade name ORPLATNA
(satraplatin capsules), GPC Biotech Inc.,
proposed indication for the treatment of
patients with androgen independent
(hormone refractory) prostate cancer
(HRPC) that has failed prior
chemotherapy.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before July 10, 2007. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m., and 3:30 p.m. to 4 p.m.
Those desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before July 2,
2007. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
VerDate Aug<31>2005
17:22 Jun 13, 2007
Jkt 211001
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 3, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Johanna
Clifford at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 6, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E7–11496 Filed 6–13–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Recruitment of Sites for Assignment of
Corps Personnel
Health Resources and Services
Administration (HRSA), HHS.
AGENCY:
ACTION:
General notice.
SUMMARY: The Health Resources and
Services Administration (HRSA)
announces that the listing of entities,
and their Health Professional Shortage
Area (HPSA) scores, that will receive
priority for the assignment of National
Health Service Corps (NHSC) personnel
(Corps Personnel, Corps members) for
the period July 1, 2007 through June 30,
2008 is posted on the NHSC Web site at
https://nhsc.bhpr.hrsa.gov/resources/
fedreg-hpol/. This list specifies which
entities are eligible to receive
assignment of Corps members who are
participating in the NHSC Scholarship
Program, the NHSC Loan Repayment
Program, and Corps members who have
become Corps members other than
pursuant to contractual obligations
under the Scholarship or Loan
Repayment Programs. Please note that
not all vacancies associated with sites
on this list will be for Corps members,
but could be for individuals serving an
obligation to the NHSC through the
Private Practice Option.
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32853
Eligible HPSAs and Entities
To be eligible to receive assignment of
Corps personnel, entities must: (1) Have
a current HPSA designation by the
Shortage Designation Branch in the
Office of Workforce Evaluation and
Quality Assurance, Bureau of Health
Professions, Health Resources and
Services Administration; (2) enter into
an agreement with the State agency that
administers Medicaid, accept payment
under Medicare and the State Children’s
Health Insurance Program, see all
patients regardless of their ability to
pay, and use and post a discounted fee
plan; and (3) be determined by the
Secretary to have (a) a need and demand
for health manpower in the area; (b)
appropriately and efficiently used Corps
members assigned to the entity in the
past; (c) general community support for
the assignment of Corps members; (d)
made unsuccessful efforts to recruit; and
(e) a reasonable prospect for sound
fiscal management by the entity with
respect to Corps members assigned
there. Priority in approving applications
for assignment of Corps members goes
to sites that (1) provide primary, mental,
and/or oral health services to a HPSA of
greatest shortage; (2) are part of a system
of care that provides a continuum of
services, including comprehensive
primary health care and appropriate
referrals or arrangements for secondary
and tertiary care; (3) have a documented
record of sound fiscal management; and
(4) will experience a negative impact on
its capacity to provide primary health
services if a Corps member is not
assigned to the entity.
Entities that receive assignment of
Corps personnel must assure that (1) the
position will permit the full scope of
practice and that the clinician meets the
credentialing requirements of the State
and site; and (2) the Corps member
assigned to the entity is engaged in fulltime clinical practice at the approved
service location for a minimum of 40
hours per week with at least 32 hours
per week in the ambulatory care setting.
Obstetricians/gynecologists, certified
nurse midwives (CNMs), and family
practitioners who practice obstetrics on
a regular basis, are required to engage in
a minimum of 21 hours per week of
outpatient clinical practice. The
remaining hours, making up the
minimum 40-hour per week total,
include delivery and other clinical
hospital-based duties. For all Corps
personnel, time spent on-call does not
count toward the 40 hours per week. In
addition, sites receiving assignment of
Corps personnel are expected to (1)
report to the NHSC all absences in
excess of the authorized number of days
E:\FR\FM\14JNN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 114 (Thursday, June 14, 2007)]
[Notices]
[Pages 32852-32853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11496]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Oncologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on July 24, 2007, from 8
a.m. to 5 p.m.
Location: Advisors and Consultants Staff Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD 20857.
Contact Person: Johanna Clifford, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-6761, FAX: 301-827-6776, e-mail: Johanna.Clifford@fda.hhs.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512542. Please call the
Information Line for up-to-date information on this
[[Page 32853]]
meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: The committee will discuss the following new drug
applications (NDAs): (1) NDA 022-042, EVISTA (raloxifene hydrochloride)
Tablets, Eli Lilly and Co., proposed indications for the reduction in
risk of invasive breast cancer in postmenopausal women with
osteoporosis, and for the reduction in risk of invasive breast cancer
in postmenopausal women at high risk of breast cancer; and (2) NDA 021-
801, proposed trade name ORPLATNA (satraplatin capsules), GPC Biotech
Inc., proposed indication for the treatment of patients with androgen
independent (hormone refractory) prostate cancer (HRPC) that has failed
prior chemotherapy.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
10, 2007. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those
desiring to make formal oral presentations should notify the contact
person and submit a brief statement of the general nature of the
evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time
requested to make their presentation on or before July 2, 2007. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by July 3, 2007.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Johanna Clifford at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: June 6, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-11496 Filed 6-13-07; 8:45 am]
BILLING CODE 4160-01-S
