Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 70653-70654 [E8-27714]
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Federal Register / Vol. 73, No. 226 / Friday, November 21, 2008 / Notices
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research, quality
improvement and information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: November 6, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8–27523 Filed 11–20–08; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–416]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
dwashington3 on PRODPC61 with NOTICES
AGENCY:
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be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual Early
and Periodic Screening, Diagnostic and
Treatment (EPSDT) Report; Use: States
are required to submit an annual report
on the provision of EPSDT services
pursuant to section 1902(a)(43)(D) of the
Social Security Act. These reports
provide CMS with data necessary to
assess the effectiveness of State EPSDT
programs, to determine a State’s results
in achieving its participation goal and to
respond to inquiries. This collection is
being submitted as a revision based on
minor changes made to the form and
instructions. CMS has added three
additional lines of data to the form
(lines 12d, 12e and 12f). This
information is currently being collected;
however, CMS expanded the lines to
obtain a better understanding for the
utilization of dental services. CMS
believes there will be no additional
burden for the changes made to the
form. The changes were necessary to
accommodate a need for more specific
dental data and to preliminary notify
States of a change in CPT codes. A
clarification was also made to line 14 of
the instructions. Form Number: CMS–
416 (OMB# 0938–0354); Frequency:
Yearly; Affected Public: State, Local or
Tribal Governments; Number of
Respondents: 56; Total Annual
Responses: 56; Total Annual Hours:
1,568.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by January 20, 2009:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
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70653
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: November 14, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–27711 Filed 11–20–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0029]
Determination That NUBAIN
(Nalbuphine Hydrochloride) Injection,
10 and 20 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) is announcing its
determination that NUBAIN
(nalbuphine hydrochloride) injection,
10 and 20 milligrams/milliliter (mg/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 nalbuphine
hydrochloride injection, 10 and 20 mg/
ml, 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 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
E:\FR\FM\21NON1.SGM
21NON1
dwashington3 on PRODPC61 with NOTICES
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/
VerDate Aug<31>2005
14:24 Nov 20, 2008
Jkt 217001
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
Frm 00043
Fmt 4703
Sfmt 4703
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
21NON1
]]>Agencies
[Federal Register Volume 73, Number 226 (Friday, November 21, 2008)]
[Notices]
[Pages 70653-70654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27714]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-P-0029]
Determination That NUBAIN (Nalbuphine Hydrochloride) Injection,
10 and 20 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) is announcing its
determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and
20 milligrams/milliliter (mg/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 nalbuphine
hydrochloride injection, 10 and 20 mg/ml, 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 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
[[Page 70654]]
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 (Sec.
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
Hikma Farmac[ecirc]utica 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 Sec. 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/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
