Blood Products Advisory Committee; Notice of Meeting, 52399-52400 [05-17470]
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Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices
52399
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
1There
Total Hours
1,082
are no capital costs or operating and maintenance costs associated with this collection of information.
The following burden estimates are
based on FDA’s experience with
voluntary recalls under 21 CFR part 7.
FDA expects no more than two
mandatory recalls per year, as most
recalls are done voluntarily.
Section 810.10(d)—FDA estimates
that it will take approximately 8 hours
for the person named in a cease
distribution and notification order to
gather and submit the information
required by this section. The total
estimated annual burden is 16 hours.
Section 810.11(a)—Based on
experience in similar situations, FDA
expects that there will be only one
request for a regulatory hearing per year
and that it will take approximately 8
hours to prepare this request.
Section 810.12(a) and (b)—Based on
experience in similar situations, FDA
expects that there will be only one
written request for a review of a cease
distribution and notification order per
year and that it will take approximately
8 hours to prepare this request.
Section 810.14—Based upon its
experience with voluntary recalls, FDA
estimates that it will take approximately
16 hours to develop a strategy for
complying with the order.
Section 810.15(a) through (d)—Based
upon its experience with voluntary
recalls, FDA estimates that it will take
approximately 16 hours to notify each
health professional, user facility, or
individual of the order.
Section 810.15(e)—Based upon its
experience with voluntary recalls, FDA
estimates that there will be
approximately 5 consignees per recall
(10 per year) who will be required to
notify their consignees of the order.
FDA estimates that it will take them
about 1 hour to do so.
Section 810.16—FDA estimates that it
would take no more than 40 hours to
assemble and prepare a written status
report required by a recall. The status
reports are prepared by manufacturers 6
to 12 times each year. Therefore, each
manufacturer would spend no more
than 480 hours each year preparing
status reports. If there were two FDA
invoked recalls each year, the total
burden hours estimated would be 960
hours each year.
Section 810.17—Based on experience
with similar procedures, FDA estimates
that it would take 8 hours to draft a
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written request for termination of a
cease distribution and notification or
mandatory recall order.
Dated: August 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17499 Filed 9–1–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Blood Products 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). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
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 September 29, 2005, from 8 a.m.
to 5 p.m.
Location: Food and Drug
Administration, conference room 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Donald W. Jehn or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research
(HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–0314, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On September 29, 2005, the
committee will discuss new drug
application (NDA) 21–882 proposed
trade name EXJADE (deferasirox)
Tablets for Oral Suspension, Novartis
Pharmaceutical Corp., proposed for the
indication of the treatment of chronic
iron overload due to blood transfusions
(transfusional hemosiderosis).
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Following this discussion, the
committee will hear an overview of the
research programs in the Laboratory of
Hemostasis and the Laboratory of
Plasma Derivatives, Division of
Hematology, Office of Blood Research
and Review, Center for Biologics
Evaluation and Research (CBER), and in
closed session will discuss the report
from the laboratory site visit of February
25, 2005.
Procedure: On September 29, 2005,
from 8 a.m. to 4:15 p.m., the meeting is
open to the public. 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 by September 22, 2005. Oral
presentations from the public will be
scheduled between approximately 11:15
a.m. and 12:15 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before September 22, 2005, 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.
Closed Committee Deliberations: On
September 29, 2005, from
approximately 4:15 p.m. to 5 p.m., the
meeting will be closed to permit
discussion where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss
a review of internal research programs
in the Division of Hematology, Office of
Blood Research and Review, Center for
Biologics Evaluation and Research.
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 Donald Jehn
or Pearline K. Muckelvene 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).
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52400
Federal Register / Vol. 70, No. 170 / Friday, September 2, 2005 / Notices
Dated: August 26, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05–17470 Filed 9–1–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection: Comment
Request; Extension of OMB No. 0925–
0417/exp. 08/31/05, Responsibility of
Applicants for Promoting Objectivity in
Research for Which Public Health
Service Funding Is Sought and
Responsible Prospective
Contractors—42 CFR Part 50,
Subpart F
Summary: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
the Office of the Director (OD), Office of
Extramural Research (OER), the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below. Proposed
information collection was previously
published in the Federal Register on
May 12, 2005, Volume 70, No. 91, page
25095 and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. 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:
Responsibility of Applicants for
Promoting Objectivity in Research for
Which Public Health Service Funding Is
Sought and Responsible Prospective
Contractors—42 CFR Part 50, Subpart F;
Type of Information Collection Request:
Extension, OMB 0925–0417, Expiration
Date 8/31/05. Need and Use of
Information Collection: This is a request
for OMB approval for the information
collection and recordkeeping
requirements contained in the final rule
42 CFR Part 50 Subpart F and
Responsible Contractors: 45 CFR Part
94. Frequency of response: On occasion.
Affected Public: Individuals or
households; business or other for-profit;
not-for-profit institutions; and State,
Local or Tribal Government. Type of
Respondents: Any public or private
entity or organization. The annual
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reporting burden is as follows:
Estimated Number of Respondents:
42,800; Estimated Number of Responses
per Respondent: 1.60; Average Burden
Hours Per Response: 3.40; and
Estimated Total Annual Burden Hours
Request: 232,000.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time should be directed to the Office of
Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIR. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Ms.
Diane Dean, Division of Grants Policy,
Office of Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 3525, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number 301–435–
0930, or E-mail your request, including
your address to: hahnm@od.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: August 25, 2005.
Charles Mackay,
Chief, Project Clearance Branch, OPERA,
OER, National Institutes of Health.
[FR Doc. 05–17458 Filed 9–1–05; 8:45 am]
BILLING CODE 4140–01–M
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing: Selected
Technologies From the NIH Cancer
Therapeutics Portfolio
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: 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
contacting George G. Pipia, Ph.D.,
Technology Licensing Specialist, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852; telephone: 301/435–
5560; fax: 301/402–0220; e-mail:
pipiag@mail.nih.gov. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Antitumor Macrocyclic Lactones
Michael R. Boyd (NCI).
U.S. Patent No. 6,353,019 issued 05 Mar
2002 (HHS Reference No. E–244–
1997/0–US–07) and related foreign
patent applications.
Vacuolar-Type (H+)-ATPase-Inhibiting
Compounds and Uses Thereof
Michael R. Boyd (NCI).
U.S. Patent Application No. 09/914,708
filed 31 Aug 2001 (HHS Reference No.
E–244–1997/3–US–06) and related
foreign patent applications.
This technology covers a broad
composition of matter which includes
the salicylihalamides, lobatamides, and
numerous other structurally related
small molecules which have been
shown to inhibit mammalian vacuolar
ATPase at low nanomolar
concentrations. The compounds are also
potent inhibitors of cancer cell growth,
with particular specificity for
melanoma, osteosarcoma and selected
lung, colon and CNS tumor cell lines.
Experimental tumor and
pharmacokinetic studies are underway
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]]>Agencies
[Federal Register Volume 70, Number 170 (Friday, September 2, 2005)]
[Notices]
[Pages 52399-52400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17470]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Products 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Blood Products 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 September 29, 2005, from
8 a.m. to 5 p.m.
Location: Food and Drug Administration, conference room 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014519516. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On September 29, 2005, the committee will discuss new drug
application (NDA) 21-882 proposed trade name EXJADE (deferasirox)
Tablets for Oral Suspension, Novartis Pharmaceutical Corp., proposed
for the indication of the treatment of chronic iron overload due to
blood transfusions (transfusional hemosiderosis). Following this
discussion, the committee will hear an overview of the research
programs in the Laboratory of Hemostasis and the Laboratory of Plasma
Derivatives, Division of Hematology, Office of Blood Research and
Review, Center for Biologics Evaluation and Research (CBER), and in
closed session will discuss the report from the laboratory site visit
of February 25, 2005.
Procedure: On September 29, 2005, from 8 a.m. to 4:15 p.m., the
meeting is open to the public. 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 by
September 22, 2005. Oral presentations from the public will be
scheduled between approximately 11:15 a.m. and 12:15 p.m. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before September
22, 2005, 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.
Closed Committee Deliberations: On September 29, 2005, from
approximately 4:15 p.m. to 5 p.m., the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will
discuss a review of internal research programs in the Division of
Hematology, Office of Blood Research and Review, Center for Biologics
Evaluation and Research.
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 Donald Jehn or
Pearline K. Muckelvene 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).
[[Page 52400]]
Dated: August 26, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17470 Filed 9-1-05; 8:45 am]
BILLING CODE 4160-01-S
