Gastrointestinal Drugs Advisory Committee; Notice of Meeting, 75176-75177 [2010-30274]
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75176
Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices
animal drug user fees and fee waivers
and reductions.
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.regulations.
gov. Submit written comments on the
collection of information to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be
identified with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Johnny Vilela, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7651, Juanmanuel.Vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Animal Drug User Fees and Fee
Waivers and Reductions—(OMB
Control Number 0910–0540—Extension)
Enacted on November 18, 2003, the
Animal Drug User Fee Act (ADUFA)
(Pub. L. 108–130) amended the Federal
Food, Drug, and Cosmetic Act and
requires FDA to assess and collect user
fees for certain applications, products,
establishments, and sponsors. It also
requires the Agency to grant a waiver
from, or a reduction of those fees in
certain circumstances. Thus, to
implement this statutory provision of
ADUFA, FDA developed a guidance
entitled ‘‘Guidance for Industry: Animal
Drug User Fees and Fee Waivers and
Reductions.’’ It provides guidance on the
types of fees FDA is authorized to
collect under ADUFA, and on how to
request waivers and reductions from
FDA’s animal drug user fees. The
guidance also describes the types of fees
and fee waivers and reductions, the
information FDA recommends
respondents submit in support of a
request for a fee waiver or reduction,
how respondents may submit such a
request, and FDA’s process for
reviewing requests.
Respondents to this collection of
information are new animal drug
sponsors. Requests for waivers or
reductions may be submitted by a
person paying any of the animal drug
user fees assessed—application fees,
product fees, establishment fees, or
sponsor fees.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Annual
frequency
per response
Total annual
responses
Hours per
response
Total
hours
740(d)(1)(A) Significant barrier to innovation ......................
740(d)(1)(B) Fees exceed cost ...........................................
740(d)(1)(C) Free choice feeds ..........................................
740(d)(1)(D) Minor use or minor species ...........................
740(d)(1)(E) Small business ...............................................
Request for reconsideration of a decision ...........................
Request for review—(user fee appeal officer) .....................
22
0
2
52
0
5
2
1
1
1
1
1
1
1
22
0
2
52
0
5
2
2
2
2
2
0
2
2
44
0
4
104
0
10
4
Total ..............................................................................
........................
........................
........................
........................
166
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
1 There
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 2008.
Dated: November 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30264 Filed 12–1–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
BILLING CODE 4160–01–P
Gastrointestinal 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
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15:28 Dec 01, 2010
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WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 231 / Thursday, December 2, 2010 / Notices
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Gastrointestinal
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 January 12, 2011, from 8 a.m to
5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, Bldg. 31, the
Great Room, White Oak Conference
Center (rm. 1503). Information regarding
special accommodations due to a
disability, visitor parking and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘White Oak Conference Center
Parking and Transportation Information
for FDA Advisory Committee Meetings.’’
Please note that visitors to the White
Oak Campus must have a valid driver’s
license or other picture ID, and must
enter through Building 1.
Contact Person: Kristine T. Khuc,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, e-mail:
kristine.khuc@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512538. 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: On January 12, 2011, the
committee will discuss the safety and
efficacy of new drug application (NDA)
022–486, for Solpura (liprotamase)
Capsules, by Alnara Pharmaceuticals,
for the proposed indication (use) in the
treatment of exocrine pancreatic
insufficiency due to cystic fibrosis,
chronic pancreatitis, pancreatectomy
(surgical removal of all or part of the
pancreas), or other conditions that may
impair or limit function of the pancreas.
The pancreas is an organ involved, in
part, in the digestion of food through the
use of specialized proteins called
VerDate Mar<15>2010
15:28 Dec 01, 2010
Jkt 223001
enzymes. Exocrine pancreatic
insufficiency is a decreased ability to
digest food due to deficient enzyme
production by the pancreas.
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/
AdvisoryCommittees/Calendar/
default.htm. 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 28, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. to 2 p.m. Those individuals
interested in making 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
December 17, 2010. 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 December 20, 2010.
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 Kristine T.
Khuc 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/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
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75177
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 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30274 Filed 12–1–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Novel Compositions and Methods To
Treat Glioblastoma and Other Cancers
Description of Technology: There
remains a significant unmet need for
therapeutics to treating glioblastoma
multiforme, a very aggressive type of
brain tumor. Glioblastoma is difficult to
treat with conventional surgery,
chemical, and radiation therapies. With
approximately 18,000 new glioblastoma
cases in the U.S. each year, and a
comparable market in Europe, the global
market for such products forecast to be
over $300 million. In light of the high
unmet need in malignant astrocytoma
and little in the way of pipeline
competition, this indication represents a
potential easy route to market for new
drugs.
E:\FR\FM\02DEN1.SGM
02DEN1
]]>Agencies
[Federal Register Volume 75, Number 231 (Thursday, December 2, 2010)]
[Notices]
[Pages 75176-75177]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30274]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Gastrointestinal 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
[[Page 75177]]
of the Food and Drug Administration (FDA). The meeting will be open to
the public.
Name of Committee: Gastrointestinal 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 January 12, 2011, from 8
a.m to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, Bldg. 31, the Great Room, White Oak Conference
Center (rm. 1503). Information regarding special accommodations due to
a disability, visitor parking and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings.''
Please note that visitors to the White Oak Campus must have a valid
driver's license or other picture ID, and must enter through Building
1.
Contact Person: Kristine T. Khuc, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: kristine.khuc@fda.hhs.gov, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512538. 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: On January 12, 2011, the committee will discuss the safety
and efficacy of new drug application (NDA) 022-486, for Solpura
(liprotamase) Capsules, by Alnara Pharmaceuticals, for the proposed
indication (use) in the treatment of exocrine pancreatic insufficiency
due to cystic fibrosis, chronic pancreatitis, pancreatectomy (surgical
removal of all or part of the pancreas), or other conditions that may
impair or limit function of the pancreas. The pancreas is an organ
involved, in part, in the digestion of food through the use of
specialized proteins called enzymes. Exocrine pancreatic insufficiency
is a decreased ability to digest food due to deficient enzyme
production by the pancreas.
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/AdvisoryCommittees/Calendar/default.htm. 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 28, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. to 2 p.m. Those individuals interested in
making 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 December 17, 2010. 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 December 20, 2010.
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 Kristine T. Khuc 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30274 Filed 12-1-10; 8:45 am]
BILLING CODE 4160-01-P
