Agency Information Collection Activities: Proposed Collection; Comment Request, 9658-9659 [05-3712]
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9658
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–3741 Filed 2–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Circulatory System Devices Panel of
the Medical Devices 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: Circulatory
System Devices Panel of the Medical
Devices 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 March 17, 2005, from 8 a.m. to
4 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Crystals Ballroom,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Geretta Wood, Center
for Devices and Radiological Health
(HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–443–8320,
ext. 143, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512625. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss
and make recommendations regarding a
premarket notification submission for
use in the induction, maintenance, and
reversal of mild hypothermia in the
treatment of unconscious adult patients
with spontaneous circulation after outof-hospital cardiac arrest when the
initial rhythm was ventricular
fibrillation.
Background information for the topic,
including the agenda and questions for
the committee, will be available to the
public one business day before the
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meeting on the Internet at https://
www.fda.gov/cdrh/panelmtg.html.
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 by March 5, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of committee
deliberations and for approximately 30
minutes near the end of the
deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before March 5, 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.
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 Shirley
Meeks at 240–276–0450, ext. 105, 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).
Dated: February 17, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–3742 Filed 2–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
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proposed projects being developed for
submission to OMB under the
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer at (301) 443–1891.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: Evaluation of the
Implementation and Outcomes of the
Maternal and Child Health Bureau’s
National Healthy Start Program—Phase
II (NEW)
The Health Resources and Service
Administration’s Maternal and Child
Health Bureau (MCHB) initiated the
Healthy Start Program in 1991 in
response to concerns about high infant
mortality rates. The Phase II evaluation
includes a survey of Healthy Start
Program participants designed to collect
information that is important to
understanding the implementation of
Healthy Start and the program effects
from a client perspective. Specifically,
the goals of the survey are to: describe
the participant population, assess the
services they received during the
prenatal and early postpartum periods,
describe their experiences and
satisfaction with the health system and
services, and examine their health
behaviors.
The survey will be administered to
participants at eight grantee sites. The
survey will use a mixed-mode approach:
it will be conducted primarily by
telephone using computer-assisted
telephone interviewing (CATI) with inperson field follow up if the telephone
attempts are unsuccessful.
Data gathered from the survey will be
used to provide HRSA the information
necessary to assess the grantees’
achievement of MCHB’s goal to improve
perinatal outcomes among racial and
ethnic minorities.
The estimated burden on respondents
is as follows:
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9659
Federal Register / Vol. 70, No. 38 / Monday, February 28, 2005 / Notices
Respondents
Number of
respondents
Responses
per
respondent
Total
responses
Minutes per
response
Total burden
(hours)
Participants ..........................................................................
1000
1
1000
30
500
Send comments to Susan G. Queen,
Ph.D., HRSA Reports Clearance Officer,
Room 11A–33, Parklawn Building, 5600
Fishers Lane, Rockville, MD 20857.
Written comments should be received
within 60 days of notice.
Dated: February 17, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–3712 Filed 2–25–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, DHHS.
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 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.
Compositions and Methods for the
Treatment of Immune-Related Disease
F. Xavier Valencia and Peter E. Lipsky
(NIAMS), U.S. Provisional Application
filed 07 Jan 2005 (DHHS Reference No.
E–355–2004/0–US–01).
Licensing Contact: Fatima Sayyid;
301/435–4521; sayyidf@mail.nih.gov.
The ability of the immune system to
discriminate between self and non-self
is controlled by central and peripheral
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tolerance mechanisms. One of the most
important ways the immune system
controls the outcome of such a response
is through naturally occurring
CD4+CD25+ regulatory T cells.
The present invention relates to
compositions and methods for treating
immune related disease, a method for
determining the presence of or
predisposition to an immune related
disease, and a pharmaceutical
composition for treating an immune
related disease in a mammal.
In addition to licensing, the
technology is available for further
development through collaborative
research opportunities with the
inventors.
Expression Tags for High Yield Soluble
Expression of Recombinant Proteins
Deb K. Chatterjee and Dominic
Esposito (NCI), U.S. Provisional
Application No. 60/564,982 filed 26 Apr
2004 (DHHS Reference No. E–103–2004/
0–US–01).
Licensing Contact: Susan Carson,
301–435–5020; carsonsu@mail.nih.gov.
Production of large quantities of
soluble and correctly folded proteins is
essential for a variety of applications
ranging from functional analysis and
structure determination to clinical trials.
E. coli is a widely used expression
system that offers the advantages of ease
of handling, cost-effectiveness and the
ability to produce proteins in high yield.
However, the enhanced production
obtainable with E. coli expression
systems is frequently accompanied by
problems of protein insolubility,
production host non-viability and
aberrant protein folding. Many strategies
have been proposed to address these
problems, in particular the use of fusion
vectors that mediate the expression of a
target gene linked to a peptide signal
sequence or to a ‘‘chaperone’’ or
‘‘carrier’’ protein that is capable of
‘‘escorting’’ the fusion protein out of the
cytoplasm and into the periplasmic
space. However, there remains a need
for methods that provide soluble
proteins that are correctly folded and in
functional form without unacceptably
diminishing the yield of recovered
protein or requiring complex host
strains.
NIH researchers have developed a
fusion polynucleotide in which a
polynucleotide encoding a desired
target protein is linked to one or more
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chaperone protein domains (Skp and
DsbC) with or without the signal
sequence. This permits the expressed
proteins to be transported to the
periplasm or to be retained in the
cytoplasm respectively and these
vectors were used to successfully
express significant amounts of such
difficult to express proteins as Hif1a,
Folliculin (fol), a Folliculin domain
(FD), Wnt5a, Endostatin, YopD, IL13
and IFN-Hybrid3. These fusion vectors
are available for licensing and are useful
tools for the expression of commercially
viable amounts of functional proteins of
therapeutic and scientific interest.
In addition to licensing, the
technology is available for further
development through collaborative
research with the inventors via a
Cooperative Research and Development
Agreement (CRADA).
Novel Potent Monoamine Oxidase
Inhibitors
Kenneth L. Kirk et al. (NIDDK), U.S.
Provisional Application No. 60/484,710
filed 03 Jul 2003 (DHHS Reference No.
E–226–2003/0–US–01); PCT
Application No. PCT/US04/21505 filed
01 Jul 2004 (DHHS Reference No. E–
226–2003/0–PCT–02).
Licensing Contact: Norbert Pontzer;
301/435–5502; pontzern@mail.nih.gov.
Copper- (EC, 1.4.3.6) and flavincontaining amine oxidases (EC, 1.4.3.4)
make up two general classes of the
widely distributed monoamine
oxidases. Reversible and irreversible
inhibitors of the flavin monoamine
oxidases have been developed and
investigated for treatment of diseases of
the CNS such as depression, Parkinson’s
disease and Alzheimer’s disease. These
researchers have developed several new
arylethyl and benzyl amine derivatives
that incorporate both the key
cyclopropane ring and fluorine
substitution at strategic positions. The
combined effects of this substitution
pattern have led to new inhibitors of
greatly increased potency and
selectivity for all classes of monoamine
oxidases. Their potent copper amine
oxidase inhibitors are the best reversible
inhibitors known and could provide
vascular protection in advanced
diabetics. Further information on these
compounds can be found in Yoshida et
al., J. Med. Chem. (25 Mar 2004) 47 (7):
1796–1806, 2004, and Yoshida et al.,
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]]>Agencies
[Federal Register Volume 70, Number 38 (Monday, February 28, 2005)]
[Notices]
[Pages 9658-9659]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3712]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to OMB under the Paperwork Reduction Act
of 1995. To request more information on the proposed project or to
obtain a copy of the data collection plans and draft instruments, call
the HRSA Reports Clearance Officer at (301) 443-1891.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection 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 on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Evaluation of the Implementation and Outcomes of the
Maternal and Child Health Bureau's National Healthy Start Program--
Phase II (NEW)
The Health Resources and Service Administration's Maternal and
Child Health Bureau (MCHB) initiated the Healthy Start Program in 1991
in response to concerns about high infant mortality rates. The Phase II
evaluation includes a survey of Healthy Start Program participants
designed to collect information that is important to understanding the
implementation of Healthy Start and the program effects from a client
perspective. Specifically, the goals of the survey are to: describe the
participant population, assess the services they received during the
prenatal and early postpartum periods, describe their experiences and
satisfaction with the health system and services, and examine their
health behaviors.
The survey will be administered to participants at eight grantee
sites. The survey will use a mixed-mode approach: it will be conducted
primarily by telephone using computer-assisted telephone interviewing
(CATI) with in-person field follow up if the telephone attempts are
unsuccessful.
Data gathered from the survey will be used to provide HRSA the
information necessary to assess the grantees' achievement of MCHB's
goal to improve perinatal outcomes among racial and ethnic minorities.
The estimated burden on respondents is as follows:
[[Page 9659]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Total Minutes per Total burden
Respondents respondents respondent responses response (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants....................................................... 1000 1 1000 30 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance
Officer, Room 11A-33, Parklawn Building, 5600 Fishers Lane, Rockville,
MD 20857. Written comments should be received within 60 days of notice.
Dated: February 17, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-3712 Filed 2-25-05; 8:45 am]
BILLING CODE 4165-15-P
