Oncologic Drugs Advisory Committee; Notice of Meeting, 70654-70655 [E8-27713]
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70654
Federal Register / Vol. 73, No. 226 / Friday, November 21, 2008 / Notices
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withdrawn from sale for reasons of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).
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whether a listed drug was withdrawn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
(§ 314.161(a)(1) (21 CFR 314.161(a)(1))).
FDA may not approve an ANDA that
does not refer to a listed drug.
On January 11, 2008, West-Ward
Pharmaceutical Corp., on behalf of
ˆ
Hikma Farmaceutica of Portugal,
submitted a citizen petition (Docket No.
FDA–2008–P–0029) to FDA under 21
CFR 10.30. The petition requests that
the agency determine whether NUBAIN
(nalbuphine hydrochloride) injection,
10 and 20 mg/ml (NDA 18–024),
manufactured by Endo Pharmaceuticals
(Endo), was withdrawn from sale for
reasons of safety or effectiveness.
NUBAIN was approved on May 15,
1979. NUBAIN is an analgesic drug
product used for the relief of moderate
to severe pain. NUBAIN may be used as
a supplement to balanced anesthesia, for
preoperative and postoperative
analgesia, and for obstetrical analgesia
during labor and delivery. Manufacture
of NUBAIN was discontinued in 2003,
and the drug product was moved from
the prescription drug product list to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
FDA has reviewed its records and,
under § 314.161, has determined that
NUBAIN (nalbuphine hydrochloride)
injection, 10 and 20 mg/ml, was not
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
identified no data or other information
suggesting that NUBAIN (nalbuphine
hydrochloride) injection, 10 and 20 mg/
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14:24 Nov 20, 2008
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ml, 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 NUBAIN
(nalbuphine hydrochloride) injection,
10 and 20 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 NUBAIN (nalbuphine hydrochloride)
injection, 10 and 20 mg/ml, may be
approved by the agency if all other legal
and regulatory requirementsfor 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: November 14, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–27714 Filed 11–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
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 December 16, 2008, from 8 a.m.
to 4 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy, Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
PO 00000
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5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–6793, fax: 301–
827–6776, e-mail:
nicole.vesely@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
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
biologics license application (BLA)
125084, trade name ERBITUX
(cetuximab), ImClone Systems, Inc., and
BLA 125147, trade name VECTIBIX
(panitumumab), Amgen, Inc., in the
context of K-ras as a predictive and/or
prognostic biomarker in oncology drug
development.
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 2008 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 December 2, 2008.
Oral presentations from the public will
be scheduled between approximately
11:30 a.m. to 12:30 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 November 24, 2008. 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
E:\FR\FM\21NON1.SGM
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Federal Register / Vol. 73, No. 226 / Friday, November 21, 2008 / Notices
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
November 25, 2008.
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 Nicole
Vesely at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–27713 Filed 11–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Privacy Act of 1974; Report of
Amended or Altered System; Medical,
Health and Billing Records System
AGENCY:
Indian Health Service (IHS),
HHS.
Amendment of One Altered
Privacy Act System of Records.
ACTION:
SUMMARY: Pursuant to the provisions of
the Privacy Act of 1974, as amended, 5
U.S.C. 552a(e)(4), the IHS has amended
and is publishing the proposed
alteration of a system of records, System
No. 09–17–0001, ‘‘Medical, Health and
Billing Records.’’ The amended and
altered system of records makes only
administrative edits and revisions as
necessary.
The amended and altered
system, which incorporates the
comments received following the initial
publication, shall become effective
November 21, 2008.
FOR FURTHER INFORMATION CONTACT: Ms.
Patricia Gowan, IHS Lead Health
Information Management (HIM)
Consultant and Area HIM Consultant,
dwashington3 on PRODPC61 with NOTICES
DATES:
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14:24 Nov 20, 2008
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Office of Health Programs, Phoenix Area
Office, Two Renaissance Square, Suite
606, 40 North Central Avenue, Phoenix,
AZ 85004–4450, Telephone (602) 364–
5172 or via the Internet at
Patricia.Gowan@ihs.gov.
As
required by the Privacy Act of 1974, as
amended, 5 U.S.C. 552a(e)(4), this
document sets forth the amendment of
the proposed alteration of a system of
records maintained by the IHS, in
response to comments received
following the initial publication in the
Federal Register at 73 FR 50038 on
August 25, 2008. IHS is altering System
No. 09–17–0001, ‘‘Health, Medical and
Billing Records,’’ for a few reasons.
First, the changes will enable IHS to
disclose controlled substance
prescription data to a centralized
database administered by an authorized
State public health entity, such as State
prescription drug monitoring programs
(PMP). Second, the changes will enable
IHS to disclose data from the National
Patient Information Reporting System
(NPIRS)/National Data Warehouse
(NDW) to the various Epidemiology
Centers established and funded under
25 U.S.C. 1621m. During the comment
period, IHS received several responses
from the public. Only one comment
recommended any changes to the
proposed alteration.
Comment: One commenter suggested
adding a new routine use to allow the
disclosure of IHS records to
Epidemiology Centers under a Business
Associate Agreement (BAA).
Response: After a careful review of
this comment, IHS disagrees with the
suggested change therefore has not
revised the notice. The proposed
revision to Routine Use number 10 is
sufficient to enable IHS to share
information with Epidemiology Centers
established and funded under 25 U.S.C.
1621m. The BAA would only be
sufficient for sharing information with
Epidemiology Centers that perform
functions involving the use or
disclosure of individually identifiable
health information on behalf of IHS. The
Epidemiology Centers are funded
through cooperative agreements. They
engage in many authorized activities
that do not involve the use or disclosure
of individually identifiable health
information or are otherwise not carried
out on behalf of IHS.
This Notice meets the requirement to
notify the public that the IHS is
amending the proposed changes in the
IHS system of records by incorporating
the administrative changes following
the initial publication at 73 FR 50038,
August 25, 2008. With this notification,
SUPPLEMENTARY INFORMATION:
PO 00000
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70655
this system of records is effective
November 21, 2008.
Dated: November 14, 2008.
Robert G. McSwain,
Director, Indian Health Service.
09–17–0001
SYSTEM NAME:
Medical, Health, and Billing Records
Systems, Health and Human Services/
Indian Health Service/Office of Clinical
and Preventive Services (HHS/IHS/
OCPS).
SECURITY CLASSIFICATION:
None.
SYSTEM LOCATION:
IHS hospitals, health centers, school
health centers, health stations, field
clinics, Service Units, IHS Area Offices
(Appendix 1), and Federal Archives and
Records Centers (Appendix 2).
Automated, electronic and
computerized records, including Patient
Care Component (PCC) records, are
stored at the Information Technology
Support Center (ITSC), IHS, located in
Albuquerque, New Mexico (Appendix
1). Records may also be located at
contractor sites. A current list of
contractor sites is available by writing to
the appropriate System Manager (Area
or Service Unit Director/Chief Executive
Officer) at the address shown in
Appendix 1.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Individuals, including both IHS
beneficiaries and non-beneficiaries, who
are examined/treated on an inpatient
and/or outpatient basis by IHS staff and/
or contract health care providers
(including Tribal contractors).
CATEGORIES OF RECORDS IN THE SYSTEM:
Note: Records relating to claims by and
against the HHS are maintained in the
Administrative Claims System, 09–90–0062,
HHS/Office of the Secretary/Office of the
General Counsel (HHS/OS/OGC). Such
claims include those arising under the
Federal Torts Claims Act, Military Personnel
and Civilian Employees Claims Act, Federal
Claims Collection Act, Federal Medical Care
Recovery Act, and Act for Waiver of
Overpayment of Pay.
1. Health and medical records
containing examination, diagnostic and
treatment data, proof of IHS eligibility,
social data (such as name, address, date
of birth, Social Security Number (SSN),
Tribe), laboratory test results, and
dental, social service, domestic
violence, sexual abuse and/or assault,
mental health, and nursing information.
2. Follow-up registers of individuals
with a specific health condition or a
E:\FR\FM\21NON1.SGM
21NON1
]]>Agencies
[Federal Register Volume 73, Number 226 (Friday, November 21, 2008)]
[Notices]
[Pages 70654-70655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27713]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
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 December 16, 2008, from
8 a.m. to 4 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy, Gaithersburg, MD. The hotel phone number is 301-977-
8900.
Contact Person: Nicole Vesely, 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,
301-827-6793, fax: 301-827-6776, e-mail: nicole.vesely@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 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 biologics license application
(BLA) 125084, trade name ERBITUX (cetuximab), ImClone Systems, Inc.,
and BLA 125147, trade name VECTIBIX (panitumumab), Amgen, Inc., in the
context of K-ras as a predictive and/or prognostic biomarker in
oncology drug development.
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 2008 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
December 2, 2008. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. to 12:30 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 November 24, 2008. 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
[[Page 70655]]
the speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by November 25, 2008.
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 Nicole Vesely at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27713 Filed 11-20-08; 8:45 am]
BILLING CODE 4160-01-S
