Advancing the Development of Medical Products Used In the Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases; Public Hearing; Change of Hearing Date and Location, 48356-48357 [2010-19637]
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48356
Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices
December 1, 2005, entitled ‘‘Antiviral
Activity Of Griffithsin Against SARS
And HCV’’, converted to PCT/US2006/
045930, filed December 1, 2006, and
entered national stage in U.S. (patent
application serial number 12/095,697),
and Europe (patent application serial
number 06838737.2) (HHS reference E–
025–2006/0) from Dr. Barry O’Keefe et
al. (NCI).
To Rodos Biotarget GmbH (Rodos here
after) having a place of business in
Germany. The patent rights in these
inventions have been assigned to the
United States of America.
DATES: Only written comments and/or
application for a license, which are
received by the NIH Office of
Technology Transfer on or before
September 9, 2010 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Sally Hu, PhD, M.B.A., Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
E-mail: hus@od.nih.gov; Telephone:
(301) 435–5606; Facsimile: (301) 402–
0220.
SUPPLEMENTARY INFORMATION:
The first invention, E–106–2003,
provides for isolated and purified
Griffithsin protein and antibodies, plus
related purified nucleic acids.
Griffithsin is a novel, potent anti-HIV
protein isolated from an aqueous extract
of the red algae Griffithsia and
Griffithsin inhibits viral binding, fusion
and entry into the host cells by binding
to viral envelope gp120. In addition, E–
106–2003 also provides the methods of
producing Griffithsin and methods of
inhibiting a viral infection (incl. HIV),
as well as vaccine development, and
screening assays.
The second invention, E–025–2006,
follows its predecessor patent
application (E–106–2003) and claims
new indications in particular for severe
acute respiratory syndrome (SARS) and
Hepatitis C. More specifically, the
subject invention provides for a
composition of an anti-viral
polypeptide, Griffithsin, glycosylationresistant Griffithsin, and related
conjugates, compositions, nucleic acids,
vectors, host cells, antibodies and
methods of production and use.
Based on the above two inventions,
Griffithsin can be developed as an HIV
entry inhibitor therapeutically or
prophylactically against retroviral
infections and also can be developed as
an inhibitor against non-retroviruses
infectious such as influenza virus,
including H5N1, SARS, Hepatitis C, and
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Ebola, measles, varicella, human herpes
viruses and others. In addition,
Griffithsin can be used in combination
with other anti-viral agents to treat
patients who have drug-resistant virus.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR 404.7. The prospective
exclusive license may be granted unless,
within 30 days from the date of this
published Notice, NIH receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR 404.7.
The prospective exclusive license will
enter an agreement with University of
Canterbury in Christchurch of New
Zealand complying with the U.S.
Government’s policy of the U.N. CBD
for sharing in a fair and equitable way
the results of research and development
and the benefits arising from the
commercial and other utilization of
genetic researches with the ‘‘Source
Country’’ providing such resources (U.N.
CBD; Article 15.7: https://www.cbd.int/
convention/convention.shtml).
The field of use may be limited to the
development of non-encapsulated and
encapsulated Griffithsin for use in
treating human viral infections where
those viral infections are human
immunodeficiency virus (HIV) or
hepatitis C virus (HCV).
Properly filed competing applications
for a license filed in response to this
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: August 3, 2010 .
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–19680 Filed 8–9–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0364]
Advancing the Development of Medical
Products Used In the Prevention,
Diagnosis, and Treatment of Neglected
Tropical Diseases; Public Hearing;
Change of Hearing Date and Location
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
change in date and location for the
upcoming public hearing entitled
‘‘Advancing the Development of Medical
Products Used in the Prevention,
Diagnosis, and Treatment of Neglected
Tropical Diseases.’’ A new date and
address are given for those attending the
public hearing.
DATES: The public hearing will be held
on September 23, 2010, from 9 a.m. to
5 p.m. However, depending on the level
of public participation, the meeting may
be extended or it may end early.
ADDRESSES: The public hearing will be
held at the National Labor College,
10000 New Hampshire Ave., Silver
Spring, MD 20903. Persons attending
the public hearing are advised that FDA
is not responsible for providing access
to electrical outlets.
FOR FURTHER INFORMATION CONTACT: Ann
M. Staten, Office of Critical Path
Programs, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 32, rm. 4106, Silver Spring,
MD 20993–0002, 301–796–8504,
Ann.Staten@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 20,
2010 (75 FR 42103), FDA published a
notice announcing a public hearing that
is intended to solicit general views and
information from interested persons on
issues related to advancing the
development of medical products
(drugs, biological products, and medical
devices) used in the prevention,
diagnosis, and treatment of neglected
tropical diseases. The registration dates
from the July 20, 2010, notice have not
changed. Individuals interested in
making an oral presentation should
submit a notice of participation by
September 1, 2010. All others attending
the public hearing are requested to
register by September 17, 2010.
Because of a scheduling conflict with
the published date, FDA is announcing
in this notice a new date and location
for the public hearing.
II. New Date and Location for the Pubic
Hearing
The new date will be September 23,
2010 (see DATES). The new location will
be the National Labor College (see
ADDRESSES). Directions and information
on parking, accommodations, and
transportation options can be found at
https://www.nlc.edu/about/maps-anddirections.
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Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices
Dated: August 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–19637 Filed 8–9–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2010–0231]
Collection of Information Under
Review by Office of Management and
Budget; OMB Control Number: 1625–
0089
Coast Guard, DHS.
Thirty-day Notice requesting
comments; correction.
AGENCY:
ACTION:
The U.S. Coast Guard is
issuing a correction to a Federal
Register Notice published on July 9,
2010 to extend the comment period for
ten (10) additional days, and address
previous comments received on this
collection of information: 1625–0089,
National Recreational Boating Survey.
The Notice stated that no comments
were received from the public when in
fact we received four. The comment
period for the Notice, which closes
August 9, 2010, is now extended to
August 19, 2010. All comments and
related material must either be
submitted to our online docket via
https://www.regulations.gov on or before
August 19, 2010, or reach the Docket
Management Facility (DMF) by that
date.
SUMMARY:
Please submit comments on or
before August 19, 2010.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2010–0231] to the DMF
at the U.S. Department of
Transportation (DOT) or to the Office of
Information and Regulatory Affairs
(OIRA). To avoid duplicate submissions,
please use only one of the following
means:
(1) Online: (a) To Coast Guard docket
at https://www.regulation.gov. (b) To
OIRA by e-mail via:
oira_submission@omb.eop.gov.
(2) Mail or Hand delivery. (a) DMF
(M–30), DOT, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001. Hand deliver between the hours of
9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The
telephone number is 202–366–9329. (b)
To OIRA, 725 17th Street, NW.,
Washington, DC 20503, attention Desk
Officer for the Coast Guard.
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DATES:
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(3) Fax. (a) To DMF, 202–493–2251.
(b) To OIRA at 202–395–5806. To
ensure your comments are received in a
timely manner, mark the fax, attention
Desk Officer for the Coast Guard.
The DMF maintains the public docket
for this Notice. Comments and material
received from the public, as well as
documents mentioned in this Notice as
being available in the docket, will
become part of the docket and will be
available for inspection or copying at
room W12–140 on the West Building
Ground Floor, 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. You may also
find the docket on the Internet at https://
www.regulations.gov.
A copy of the ICR is available through
the docket on the Internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–611), ATTN Paperwork Reduction
Act Manager, U.S. Coast Guard, 2100
2nd St., SW., Stop 7101, Washington,
DC 20593–7101.
FOR FURTHER INFORMATION CONTACT: Mr.
Arthur Requina, Office of Information
Management, telephone 202–475–3523,
or fax 202–475–3929, for questions on
these documents. Contact Ms. Renee V.
Wright, Program Manager, Docket
Operations, 202–366–9826, for
questions on the docket.
SUPPLEMENTARY INFORMATION: The Coast
Guard is issuing this correction to an
earlier Notice published on July 9, 2010,
(75 FR 39552) in order to extend ten (10)
additional days to the comment period
and address previous comments
received on this collection of
information: 1625–0089, National
Recreational Boating Survey.
Comments to Coast Guard or OIRA
must contain the OMB Control Number
of the ICR. They must also contain the
docket number of this request, [USCG–
2010–0231]. For your comments to
OIRA to be considered, it is best if they
are received on or before August 19,
2010.
Public participation and request for
comments: We encourage you to
respond to this request by submitting
comments and related materials. We
will post all comments received,
without change, to https://
www.regulations.gov. They will include
any personal information you provide.
We have an agreement with DOT to use
their DMF. Please see the ‘‘Privacy Act’’
paragraph below.
Submitting comments: If you submit a
comment, please include the docket
number [USCG–2010–0231], indicate
the specific section of the document to
which each comment applies, providing
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48357
a reason for each comment. You may
submit your comments and material
online (via https://www.regulations.gov)
or by fax, mail, or hand delivery, but
please use only one of these means. If
you submit a comment online via
www.regulations.gov, it will be
considered received when you
successfully transmit the comment. If
you fax, hand deliver, or mail your
comment, it will be considered received
by the Coast Guard when it is received
at the DMF. We recommend you include
your name, mailing address, an e-mail
address, or other contact information in
the body of your document so that we
can contact you if we have questions
regarding your submission.
To submit your comment online, go to
https://www.regulations.gov, click on the
‘‘submit a comment’’ box, which will
then become highlighted in blue. In the
‘‘Document Type’’ drop down menu,
select ‘‘Notices’’ and insert ‘‘USCG–
2010–0231’’ in the ‘‘Keyword’’ box. Click
‘‘Search’’ then click on the balloon shape
in the ‘‘Actions’’ column. If you submit
your comments by mail or hand
delivery, submit them in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying and electronic
filing. If you submit them by mail and
would like to know that they reached
the Facility, please enclose a stamped,
self-addressed postcard or envelope. We
will consider all comments and material
received during the comment period
and address them accordingly.
Viewing comments and documents:
Go to https://www.regulations.gov to
view documents mentioned in this
Notice as being available in the docket.
Click on the ‘‘read comments’’ box,
which will then become highlighted in
blue. In the ‘‘Keyword’’ box insert
‘‘USCG–2010–0231’’ and click ‘‘Search.’’
Click the ‘‘Open Docket Folder’’ in the
‘‘Actions’’ column. You may also visit
the DMF in room W12–140 on the West
Building Ground Floor, 1200 New Jersey
Avenue SE., Washington, DC, between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays. To find
out OIRA’s decision on this ICR, visit
https://www.reginfo.gov/public/do/
PRAMain after the comment period. An
OMB notice of action on this request
will become available on that Web site
through a hyperlink in the OMB Control
Number: 1625–0089. Privacy Act:
Anyone can search the electronic form
of all comments received in dockets by
the name of the individual submitting
the comment (or signing the comment,
if submitted on behalf of an association,
business, labor union, etc.). You may
review the Privacy Act statement
regarding our public dockets in the
E:\FR\FM\10AUN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48356-48357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19637]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0364]
Advancing the Development of Medical Products Used In the
Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases;
Public Hearing; Change of Hearing Date and Location
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a change
in date and location for the upcoming public hearing entitled
``Advancing the Development of Medical Products Used in the Prevention,
Diagnosis, and Treatment of Neglected Tropical Diseases.'' A new date
and address are given for those attending the public hearing.
DATES: The public hearing will be held on September 23, 2010, from 9
a.m. to 5 p.m. However, depending on the level of public participation,
the meeting may be extended or it may end early.
ADDRESSES: The public hearing will be held at the National Labor
College, 10000 New Hampshire Ave., Silver Spring, MD 20903. Persons
attending the public hearing are advised that FDA is not responsible
for providing access to electrical outlets.
FOR FURTHER INFORMATION CONTACT: Ann M. Staten, Office of Critical Path
Programs, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg., 32, rm. 4106, Silver Spring, MD 20993-0002, 301-796-8504,
Ann.Staten@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 20, 2010 (75 FR 42103), FDA
published a notice announcing a public hearing that is intended to
solicit general views and information from interested persons on issues
related to advancing the development of medical products (drugs,
biological products, and medical devices) used in the prevention,
diagnosis, and treatment of neglected tropical diseases. The
registration dates from the July 20, 2010, notice have not changed.
Individuals interested in making an oral presentation should submit a
notice of participation by September 1, 2010. All others attending the
public hearing are requested to register by September 17, 2010.
Because of a scheduling conflict with the published date, FDA is
announcing in this notice a new date and location for the public
hearing.
II. New Date and Location for the Pubic Hearing
The new date will be September 23, 2010 (see DATES). The new
location will be the National Labor College (see ADDRESSES). Directions
and information on parking, accommodations, and transportation options
can be found at https://www.nlc.edu/about/maps-and-directions.
[[Page 48357]]
Dated: August 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19637 Filed 8-9-10; 8:45 am]
BILLING CODE 4160-01-S
