Proposed Collection; Comment Request; Pretesting of NIAID's HIV Vaccine Research Communications Messages, 49282-49283 [E7-17012]
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Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0324]
Withdrawal of Approval of a New
Animal Drug Application; Bacitracin
Zinc
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) for a bacitracin zinc
Type A medicated article. In a final rule
published elsewhere in this issue of the
Federal Register, FDA is amending the
animal drug regulations to remove
portions reflecting approval of this
NADA.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 301–827–
7818; e-mail:
pamela.esposito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pennfield
Oil Co., 14040 Industrial Rd., Omaha,
NE 68144, has requested that FDA
withdraw approval of NADA 128–550
for ANCHOR Zinc Bacitracin Type A
medicated article because the product is
not manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.115 Withdrawal of approval
of applications (21 CFR 514.115), notice
is given that approval of NADA 128–
550, and all supplements and
amendments thereto, are hereby
withdrawn, effective August 28, 2007.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
this NADA.
Dated: August 20, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7–16985 Filed 8–27–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Pretesting of NIAID’s HIV
Vaccine Research Communications
Messages
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Allergy and
Infectious Diseases (NIAID), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Pretesting
of NIAID’s HIV Vaccine Research
Estimated
number of
respondents
Type of respondents
Communications Messages. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This is a request for clearance to pretest
messages, materials and program
activities produced for the NIAID HIV
Vaccine Research Education Initiative
(NHVREI). The primary objectives of the
pretests are to (1) Assess audience
knowledge, attitudes, behaviors and
other characteristics for the planning/
development of health messages,
education products, communication
strategies, and public information
programs; and (2) pretest these health
messages, products, strategies, and
program components while they are in
developmental form to assess audience
comprehension, reactions, and
perceptions. The information obtained
from audience research and pretesting
results in more effective messages,
materials, and programmatic strategies.
By maximizing the effectiveness of these
messages and strategies for reaching
targeted audiences, the frequency with
which publications, products, and
programs need to be modified is
reduced. Frequency of Response: On
occasion. Affected Public: Individuals.
Type of Respondents: Adults at risk for
HIV/AIDS, particularly those who are
Black/African-American, Hispanic/
Latino, or men who have sex with men;
healthcare providers; representatives of
organizations disseminating HIV-related
messages or materials. The annual
reporting burden is shown in the table
below. There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Estimated
number of
responses per
respondent
Average
burden hours
per response
3,374
50
75
1
1
1
.3422
.75
.50
Total ......................................................................................................
pwalker on PROD1PC71 with NOTICES
At-risk Adults ................................................................................................
Healthcare providers ....................................................................................
Organization Gatekeepers ...........................................................................
3,499
........................
..........................
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
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19:52 Aug 27, 2007
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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.
To request
more information on the proposed
project or to obtain a copy of the data
collection plans and instruments,
contact Katharine Kripke, Assistant
FOR FURTHER INFORMATION:
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Estimated total
annual burden
hours requested
1155
37.5
37.5
1230
Director, Vaccine Research Program,
Division of AIDS, NIAID, NIH, 6700B
Rockledge Dr., Bethesda, MD 20892–
7628, or call non-toll-free number 301–
402–0846, or e-mail your request,
including your address to
kripkek@niaid.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
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Federal Register / Vol. 72, No. 166 / Tuesday, August 28, 2007 / Notices
Dated: August 21, 2007.
John J. McGowan,
Deputy Director for Science Management,
NIAID, National Institutes of Health.
[FR Doc. E7–17012 Filed 8–27–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Establishment
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the Scientific
Management Review Board (SMRB).
The NIH Reform Act of 2006 (Pub. L.
109–482) provides organizational
authorities to HHS and NIH officials to:
(1) Establish or abolish national research
institutes; (2) reorganize the offices
within the Office of the Director, NIH
including adding, removing, or
transferring the functions of such offices
or establishing or terminating such
offices; and (3) reorganize, divisions,
centers, or other administrative units
within an NIH national research
institute or national center including
adding, removing, or transferring the
functions of such units, or establishing
or terminating such units. The purpose
of the Scientific Management Review
Board (also referred to as SMRB or
Board) is to advise appropriate HHS and
NIH officials on the use of these
organizational authorities and identify
the reasons underlying the
recommendations.
Duration of this committee is tow
years from the date of Charter is filed.
Dated: August 20, 2007.
Elias A. Zerhouni,
Director, National Institutes of Health.
[FR Doc. 07–4221 Filed 8–27–07; 8:45 am]
BILLING CODE 4140–01–M
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.
pwalker on PROD1PC71 with NOTICES
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
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19:52 Aug 27, 2007
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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.
Development of Antigenic Chimeric St.
Louis Encephalitis Virus/Dengue Virus
Type Four Recombinant Viruses (SLEV/
DEN4) as Vaccine Candidates for the
Prevention of Disease Caused by SLEV
Description of Invention: St. Louis
Encephalitis Virus (SLEV) is a
mosquito-borne flavivirus that is
endemic in the Americas and causes
sporadic outbreaks of disease in
humans. SLEV is a member of the
Japanese encephalitis virus serocomplex
and is closely related to West Nile Virus
(WNV). St. Louis encephalitis is found
throughout North, Central, and South
America, and the Caribbean, but is a
major public health problem mainly in
the United States. Prior to the outbreak
of West Nile virus in 1999, St. Louis
encephalitis was the most common
human disease caused by mosquitoes in
the United States. Since 1964, there
have been about 4,440 confirmed cases
of St. Louis encephalitis, with an
average of 130 cases per year. Up to
3,000 cases have been reported during
epidemics in some years. Many more
infections occur without symptoms and
go undiagnosed. At present, a vaccine or
FDA approved antiviral therapy is not
available.
The inventors have previously
developed a WNV/Dengue4Delta30
antigenic chimeric virus as a live
attenuated virus vaccine candidate that
contains the WNV premembrane and
envelope (prM and E) proteins on a
dengue virus type 4 (DEN4) genetic
background with a thirty nucleotide
deletion (Delta30) in the DEN4 3’-UTR.
Using a similar strategy, the inventors
have generated an antigenic chimeric
virus, SLE/DEN4Delta30. Preclinical
testing results indicate that
chimerization of SLE with DEN4Delta30
decreased neuroinvasiveness in mice,
did not affect neurovirulence in mice,
and appeared to overattenuate the virus
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49283
for non-human primates. Modifications
of the SLE/DEN4Delta30 vaccine
candidate are underway to improve its
immunogenicity.
This application claims live
attenuated chimeric SLE/DEN4Delta30
vaccine compositions and bivalent
WNV/SLE/DEN4Delta30 vaccine
compositions. Also claimed are methods
of treating or preventing SLEV infection
in a mammalian host, methods of
producing a subunit vaccine
composition, isolated polynucleotides
comprising a nucleotide sequence
encoding a SLEV immunogen, methods
for detecting SLEV infection in a
biological sample and infectious
chimeric SLEV.
Application: Immunization against
SLEV or SLEV and WNV.
Development Status: Live attenuated
vaccine candidates are currently being
developed and preclinical studies in
mice and monkeys are in progress.
Suitable vaccine candidates will then be
evaluated in clinical studies.
Inventors: Stephen S. Whitehead,
Joseph Blaney, Alexander Pletnev, Brian
R. Murphy (NIAID).
Patent Status: U.S. Provisional
Application No. 60/934,730 filed 14 Jun
2007 (HHS Reference No. E–240–2007/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Collaborative Research Opportunity:
The NIAID Laboratory of Infectious
Diseases is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize live attenuated virus
vaccine candidates for St. Louis
encephalitis virus. Please contact Dr.
Whitehead at 301–496–7692 for more
information.
Monoclonal Antibodies Against Dengue
and Other Viruses With Deletion in Fc
Region
Description of Invention: The four
dengue virus (DENV) serotypes (DENV–
1 to DENV–4) are the most important
arthropod-borne flaviviruses in terms of
morbidity and geographic distribution.
Up to 100 million DENV infections
occur every year, mostly in tropical and
subtropical areas where vector
mosquitoes are abundant. Infection with
any of the DENV serotypes may be
asymptomatic or may lead to classic
dengue fever or more severe dengue
hemorrhagic fever (DHF) and dengue
shock syndrome (DSS), which are
increasingly common in the dengue
endemic areas. Immunity to the same
virus serotype (homotypic immunity) is
life-long, whereas immunity to different
serotypes (heterotypic immunity) lasts
E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 72, Number 166 (Tuesday, August 28, 2007)]
[Notices]
[Pages 49282-49283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17012]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Pretesting of NIAID's HIV
Vaccine Research Communications Messages
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Allergy
and Infectious Diseases (NIAID), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine
Research Communications Messages. Type of Information Collection
Request: NEW. Need and Use of Information Collection: This is a request
for clearance to pretest messages, materials and program activities
produced for the NIAID HIV Vaccine Research Education Initiative
(NHVREI). The primary objectives of the pretests are to (1) Assess
audience knowledge, attitudes, behaviors and other characteristics for
the planning/development of health messages, education products,
communication strategies, and public information programs; and (2)
pretest these health messages, products, strategies, and program
components while they are in developmental form to assess audience
comprehension, reactions, and perceptions. The information obtained
from audience research and pretesting results in more effective
messages, materials, and programmatic strategies. By maximizing the
effectiveness of these messages and strategies for reaching targeted
audiences, the frequency with which publications, products, and
programs need to be modified is reduced. Frequency of Response: On
occasion. Affected Public: Individuals. Type of Respondents: Adults at
risk for HIV/AIDS, particularly those who are Black/African-American,
Hispanic/Latino, or men who have sex with men; healthcare providers;
representatives of organizations disseminating HIV-related messages or
materials. The annual reporting burden is shown in the table below.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average Estimated total
Type of respondents number of responses per burden hours annual burden
respondents respondent per response hours requested
----------------------------------------------------------------------------------------------------------------
At-risk Adults................................. 3,374 1 .3422 1155
Healthcare providers........................... 50 1 .75 37.5
Organization Gatekeepers....................... 75 1 .50 37.5
=================
Total...................................... 3,499 .............. .............. 1230
----------------------------------------------------------------------------------------------------------------
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.
FOR FURTHER INFORMATION: To request more information on the proposed
project or to obtain a copy of the data collection plans and
instruments, contact Katharine Kripke, Assistant Director, Vaccine
Research Program, Division of AIDS, NIAID, NIH, 6700B Rockledge Dr.,
Bethesda, MD 20892-7628, or call non-toll-free number 301-402-0846, or
e-mail your request, including your address to kripkek@niaid.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
[[Page 49283]]
Dated: August 21, 2007.
John J. McGowan,
Deputy Director for Science Management, NIAID, National Institutes of
Health.
[FR Doc. E7-17012 Filed 8-27-07; 8:45 am]
BILLING CODE 4140-01-P
