General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 42345-42346 [05-14455]
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Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices
Approved but Unfunded Applications
Applications that are approved but
unfunded may be held over for funding
in the next funding cycle, pending the
availability of funds, for a period not to
exceed one year.
VI. Award Administration Information
1. Award Notices
The successful applicants will be
notified through the issuance of a
Financial Assistance Award document
which sets forth the amount of funds
granted, the terms and conditions of the
grant, the effective date of the grant, the
budget period for which initial support
will be given, the non-Federal share to
be provided (if applicable), and the total
project period for which support is
contemplated. The Financial Assistance
Award will be signed by the Grants
Officer and transmitted via postal mail.
Organizations whose applications will
not be funded will be notified in
writing.
2. Administrative and National Policy
Requirements
Grantees are subject to the
requirements in 45 CFR Part 74 (nongovernmental) or 45 CFR Part 92
(governmental).
Direct Federal grants, sub-award
funds, or contracts under this ACF
program shall not be used to support
inherently religious activities such as
religious instruction, worship, or
proselytization. Therefore, organizations
must take steps to separate, in time or
location, their inherently religious
activities from the services funded
under this Program. Regulations
pertaining to the Equal Treatment For
Faith-Based Organizations, which
includes the prohibition against Federal
funding of inherently religious
activities, can be found at either 45 CFR
87.1 or the HHS Web site at: https://
www.os.dhhs.gov/fbci/waisgate21.pdf.
3. Reporting Requirements
Grantees will be required to submit
program progress and financial reports
(SF–269 found at https://
www.acf.hhs.gov/programs/ofs/
forms.htm) throughout the project
period. Program progress and financial
reports are due 30 days after the
reporting period. Final programmatic
and financial reports are due 90 days
after the close of the project period.
Program Progress Reports: SemiAnnually.
Financial Reports: Semi-Annually.
VII. Agency Contacts
Program Office Contact: William D.
Riley, Director, Family Violence
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19:28 Jul 21, 2005
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Division, 330 C Street, SW., Switzer
Building, Room 2117, Washington, DC
20447. Phone: 202–104–5529. E-mail:
wriley@acf.hhs.gov.
Grants Management Office Contact:
Peter Thompson, Grants Officer,
Administration on Children, Youth and
Families, 330 C Street, SW., Switzer
Building, SW., Washington, DC 20447.
Phone: 202–401–4608. E-mail:
pathompson@acf.hhs.gov.
VIII. Other Information
Notice: Beginning with FY 2006, the
Administration for Children and
Families (ACF) will no longer publish
grant announcements in the Federal
Register. Beginning October 1, 2005,
applicants will be able to find a
synopsis of all ACF grant opportunities
and apply electronically for
opportunities via: https://
www.Grants.gov. Applicants will also be
able to find the complete text of all ACF
grant announcements on the ACF Web
site located at: https://www.acf.hhs.gov/
grants/.
Please reference Section IV.3 for
details about acknowledgement of
received applications.
Dated: July 15, 2005.
Joan E. Ohl,
Commissioner, Administration on Children,
Youth & Families.
[FR Doc. 05–14459 Filed 7–21–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
General Hospital and Personal Use
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 the Committee: General
Hospital and Personal Use 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 August 9, 2005, from 8 a.m. to
4 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B and C,
620 Perry Pkwy., Gaithersburg, MD.
PO 00000
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42345
Contact Person: Scott A. Colburn,
Center for Devices and Radiological
Health (HFZ–480), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301–827–6892, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512520. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will hear a
presentation by the Office of
Surveillance and Biometrics in the
Center for Devices and Radiological
Health outlining their responsibility for
the review of postmarket study design.
The committee will discuss and make
recommendations on methods to assess
the potential of disease transmission by
multiple-use nozzle jet injectors (i.e., jet
injectors for which the fluid path for the
injection is used more than once). The
discussion will include premarket
testing recommendations to address this
issue.
Background information for the topic,
including the agenda and questions for
the committee, will be available to the
public 1 business day before the
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 August 3, 2005. Oral
presentations from the public will be
scheduled for approximately 30 minutes
at the beginning of deliberations and for
approximately 30 minutes near the end
of deliberations. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before August 3, 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 AnnMarie
Williams, Conference Management
Staff, at 240–276–0450, ext. 113, at least
7 days in advance of the meeting.
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42346
Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Notices
Notice of this meeting is given under
the Federal Advisory committee Act (5
U.S.C. app. 2).
Dated: July 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–14455 Filed 7–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D–0492] (formerly Docket
No. 02D–0492)
Guidance for Industry on Estimating
the Maximum Safe Starting Dose in
Initial Clinical Trials for Therapeutics in
Adult Healthy Volunteers; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Estimating the Maximum Safe
Starting Dose in Initial Clinical Trials
for Therapeutics in Adult Healthy
Volunteers.’’ This guidance provides a
description and basis for a process by
which to select a maximum
recommended starting dose (MRSD) for
a first-in-human clinical trial of a
therapeutic in adult healthy volunteers.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one selfaddressed adhesive label to assist that
office in processing your requests.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT: Lois
M. Freed, Center for Drug Evaluation
and Research (HFD–120), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2647.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Estimating the Maximum Safe Starting
Dose in Initial Clinical Trials for
Therapeutics in Adult Healthy
Volunteers.’’ This guidance provides a
description and basis for a process by
which to select an MRSD for a first-inhuman clinical trial of a new molecular
entity in adult healthy volunteers. In the
Federal Register of January 16, 2003 (68
FR 2340), FDA published a notice
making available a draft guidance
entitled ‘‘Estimating the Safe Starting
Dose in Clinical Trials for Therapeutics
in Adult Healthy Volunteers.’’ The
notice gave interested persons an
opportunity to submit comments. As a
result of the comments, certain sections
of this guidance were reworded to
improve clarity. The guidance outlines
a recommended standardized approach
(including common conversion factors
for calculating human equivalent doses)
and vocabulary for selecting an MRSD
based on animal data, and discusses
factors to be considered in determining
reasonable safety margins. This
approach is applicable to a first-inhuman trial of a new drug or biological
therapeutic, regardless of intended
clinical use. The guidance also
discusses alternative approaches and
provides some examples of
circumstances under which alternative
approaches for selection of an MRSD
should be considered. Dose escalation is
not addressed.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on estimating the
maximum safe starting dose in initial
clinical trials for therapeutics in adult
healthy volunteers. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. The guidance
and received comments are available for
public examination in the Division of
PO 00000
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Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: July 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14456 Filed 7–21–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301) 443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: The National Health
Service Corps Uniform Data System
(OMB No. 0915–0232): Revision
The National Health Service Corps
(NHSC) of the Bureau of Health
Professions (BHPr), Health Resources
and Services Administration (HRSA), is
committed to improving the health of
the Nation’s underserved by uniting
communities in need with caring health
professionals and by supporting
communities’ efforts to build better
systems of care.
The NHSC needs to collect data on its
programs to ensure compliance with
legislative mandates and to report to
Congress and policymakers on program
accomplishments. To meet these
objectives, the NHSC requires a core set
of information collected annually that is
appropriate for monitoring and
evaluating performance and reporting
on annual trends. The following
information will be collected from each
site: services offered and delivery
method; users by various characteristics;
staffing and utilization; charges and
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]]>Agencies
[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Notices]
[Pages 42345-42346]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14455]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
General Hospital and Personal Use 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 the Committee: General Hospital and Personal Use 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 August 9, 2005, from 8
a.m. to 4 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Scott A. Colburn, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-6892, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512520. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will hear a presentation by the Office of
Surveillance and Biometrics in the Center for Devices and Radiological
Health outlining their responsibility for the review of postmarket
study design. The committee will discuss and make recommendations on
methods to assess the potential of disease transmission by multiple-use
nozzle jet injectors (i.e., jet injectors for which the fluid path for
the injection is used more than once). The discussion will include
premarket testing recommendations to address this issue.
Background information for the topic, including the agenda and
questions for the committee, will be available to the public 1 business
day before the 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 August 3,
2005. Oral presentations from the public will be scheduled for
approximately 30 minutes at the beginning of deliberations and for
approximately 30 minutes near the end of deliberations. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before August 3,
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 AnnMarie Williams,
Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days
in advance of the meeting.
[[Page 42346]]
Notice of this meeting is given under the Federal Advisory
committee Act (5 U.S.C. app. 2).
Dated: July 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-14455 Filed 7-21-05; 8:45 am]
BILLING CODE 4160-01-S
