Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 51355-51356 [05-17181]
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Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Notices
comments to Dr. Armitage by mail or
courier. Commenters planning to attend
the meeting in person are asked to bring
35 copies of their comments for public
distribution. Oral Comments: Requests
to provide oral comments must be in
writing (e-mail or fax) and received by
Dr. Armitage no later than September
14, 2005 to reserve time on the meeting
agenda. Presentation time for oral
comment will typically be about five
minutes per speaker, but may be
reduced depending on time availability
and the number of requests.
Meeting Accommodations:
Individuals requiring special
accommodation to access the public
meeting listed above should contact the
DFO at least five business days prior to
the meeting so that appropriate
arrangements can be made.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 23, 2005.
Anthony Maciorowski,
Acting Director, EPA Science Advisory Board
Staff Office.
[FR Doc. 05–17198 Filed 8–29–05; 8:45 am]
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 via teleconference on September
22, 2005 from 1:30 p.m. to 5 p.m.
Location: NIH campus, Food and Drug
Administration Bldg. 29B, Conference
Room C, 8800 Rockville Pike, Bethesda,
MD. This meeting will be held by
teleconference. The public is welcome
to attend the meeting at the above
location. A speaker phone will be
provided at the specified location for
public participation in this meeting.
Important information about
transportation and directions to the NIH
campus, parking, and security
procedures is available on the internet
at https://www.nih.gov/about/visitor/
index.htm. Visitors must show two
forms of identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. If you are
planning to drive to and park on the
NIH campus, you must enter at the
South Drive entrance of the campus,
which is located on Wisconsin Ave. (the
medical center metro entrance), and
allow extra time for vehicle inspection.
Detailed information about security
procedures is located at https://
www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking,
visitors are encouraged to use public
transportation.
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[RFA AA169]
Building for Local Organizations in the
Republic of South Africa and the
Kingdoms of Lesotho and Swaziland;
Notice of Availability of Funds—
Amendment
A notice announcing the availability
of Fiscal Year (FY) 2005 funds for a
cooperative agreement for Building for
Local Organizations in the Republic of
South Africa and the Kingdoms of
Lesotho and Swaziland, was published
in the Federal Register, August 12,
2005, Volume 70, Number 155, pages
47209–47214.
This notice is amended as follows:
Page 47210, Approximate Total
Funding: delete $500,000, and replace
with $5,000,000. Page 47210,
Approximate Average Award, delete
$100,000, and replace with $500,000–
$1,000,000. Page 47210, Ceiling of
Award Range, delete $100,000, and
replace with $1,000,000.
Dated: August 23, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention,
U.S. Department of Health and Human
Services.
[FR Doc. 05–17177 Filed 8–29–05; 8:45 am]
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Food and Drug Administration
Vaccines and Related Biological
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: Vaccines and
Related Biological Products Advisory
Committee.
Contact Person: Christine Walsh or
Denise Royster, 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
PO 00000
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51355
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will hear an
overview of the research of the
Laboratory of Retroviruses and the
Laboratory of Immunoregulation,
Division of Viral Products, and the
Laboratory of Respiratory and Special
Pathogens and the Laboratory of
Methods Development and Quality
Control, Division of Bacterial Parasitic
and Allergenic Products, Office of
Vaccines Research and Review, Center
for Biologics Evaluation and Research
(CBER), and in closed session will
discuss the reports from the Laboratory
Site Visits of April 18 and 19, 2005, and
June 16, 2005.
Procedure: On September 22, 2005,
from 1:30 p.m. to 4 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 15, 2005. Oral
presentations from the public will be
scheduled between approximately 3
p.m. to 4 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before September 15, 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 22, 2005, from 4 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 Office of Vaccines Research and
Review, Division of Viral Products and
Division of Bacterial Parasitic and
Allergenic Products, CBER.
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 Christine
Walsh or Denise Royster (see CONTACT
PERSON) 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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51356
Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Notices
Dated: August 23, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05–17181 Filed 8–29–05; 8:45 am]
BILLING CODE4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Recruitment of Sites for Assignment of
Corps Personnel
Health Resources and Services
Administration (HRSA), HHS.
ACTION: General notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA)
announces that the listing of entities
and their Health Professional Shortage
Area (HPSA) scores that will receive
priority for the assignment of National
Health Service Corps (NHSC) personnel
(Corps Personnel, Corps members) for
the period July 1, 2005 through June 30,
2006, is posted on the NHSC Web site
at https://nhsc.bhpr.hrsa.gov/resources/
fedreg-hpol/. This list specifies which
entities are eligible to receive
assignment of Corps members who are
participating in the NHSC Scholarship
Program, the NHSC Loan Repayment
Program, and Corps members who have
become Corps members other than
pursuant to contractual obligations
under the Scholarship or Loan
Repayment Programs. Please note that
not all vacancies associated with sites
on this list will be for Corps members,
but could be for individuals serving an
obligation to the NHSC through the
Private Practice Option.
Eligible HPSAs and Entities
To be eligible to receive assignment of
Corps personnel, entities must: (1) Have
a current HPSA designation by the
Shortage Designation Branch in the
National Center for Health Workforce
Analysis, Bureau of Health Professions,
Health Resources and Services
Administration; (2) enter into an
agreement with the State agency that
administers Medicaid, accept payment
under Medicare and the State Children’s
Health Insurance Program, see all
patients regardless of their ability to
pay, and use and post a discounted fee
plan; and (3) be determined by the
Secretary to have (a) A need and
demand for health manpower in the
area; (b) appropriately and efficiently
used Corps members assigned to the
entity; (c) general community support
for the assignment of Corps members;
(d) made unsuccessful efforts to recruit;
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and (e) a reasonable prospect for sound
fiscal management by the entity with
respect to Corps members assigned
there. Priority in approving applications
for assignment of Corps members goes
to sites that (1) Provide primary, mental,
and/or oral health services to a HPSA of
greatest shortage; (2) are part of a system
of care that provides a continuum of
services, including comprehensive
primary health care and appropriate
referrals or arrangements for secondary
and tertiary care; (3) have a documented
record of sound fiscal management; and
(4) will experience a negative impact on
its capacity to provide primary health
services if a Corps member is not
assigned to the entity.
Entities that receive assignment of
Corps personnel must assure that (1)
The position will permit the full scope
of practice and that the clinician meets
the credentialing requirements of the
State and site; and (2) the Corps member
assigned to the entity is engaged in fulltime clinical practice at the approved
service location for a minimum of 40
hours per week with at least 32 hours
per week in the ambulatory care setting.
Obstetricians/gynecologists, certified
nurse midwives (CNMs), and family
practitioners who practice obstetrics on
a regular basis, are required to engage in
a minimum of 21 hours per week of
outpatient clinical practice. The
remaining hours, making up the
minimum 40-hour per week total,
include delivery and other clinical
hospital-based duties. For all Corps
personnel, time spent on-call does not
count toward the 40 hours per week. In
addition, sites receiving assignment of
Corps personnel are expected to (1)
Report to the NHSC all absences in
excess of the authorized number of days
(up to 35 work days or 280 hours per
contract year); (2) report to the NHSC
any change in the status of an NHSC
clinician at the site; (3) provide the time
and leave records, schedules, and any
related personnel documents for NHSC
assignees (including documentation, if
applicable, of the reason(s) for the
termination of an NHSC clinician’s
employment at the site prior to his or
her obligated service end date); and (4)
submit a Uniform Data System (UDS)
report. This system allows the site to
assess the age, sex, race/ethnicity of,
and provider encounter records for, its
user population. The UDS reports are
site specific. Providers fulfilling NHSC
commitments are assigned to a specific
site or, in some cases, more than one
site. The scope of activity to be reported
in UDS includes all activity at the site(s)
to which the Corps member is assigned.
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Evaluation and Selection Process
In approving applications for the
assignment of Corps members, the
Secretary shall give priority to any such
application that is made regarding the
provision of primary health services to
a HPSA with the greatest shortage. For
the program year July 1, 2005—June 30,
2006, HPSAs of greatest shortage for
determination of priority for assignment
of Corps personnel will be defined as
follows: (1) Primary care HPSAs with
scores of 14 and above are authorized
for the assignment of Corps members
who are primary care physicians
participating in the Scholarship
Program; (2) primary care HPSAs with
scores of 13 and above are authorized
for the assignment of Corps members
who are family nurse practitioners (NPs)
and physician assistants (PAs)
participating in the Scholarship
Program; (3) primary care HPSAs with
scores of 8 and above are authorized for
the assignment of Corps members who
are CNMs participating in the
Scholarship Program; (4) mental health
HPSAs with scores of 20 and above are
authorized for the assignment of Corps
members who are psychiatrists
participating in the Scholarship
Program; (5) dental HPSAs with scores
of 20 and above are authorized for the
assignment of Corps members who are
dentists participating in the Scholarship
Program; and (6) HPSAs (appropriate to
each discipline) with scores of 14 and
above are authorized for the assignment
of Corps members who are participating
in the Loan Repayment Program. HPSAs
with scores below 14 will be eligible to
receive assignment of Corps personnel
participating in the Loan Repayment
Program only after assignments are
made of those Corps members matching
to those HPSAs receiving priority for
placement of Corps members through
the Loan Repayment Program (i.e.,
HPSAs scoring 14 or above). Placements
made through the Loan Repayment
Program in HPSAs with scores 13 or
below will be made by decreasing HPSA
score, and only to the extent that
funding remains available. All sites on
the list are eligible sites for individuals
wishing to serve in an underserved area
but who are not contractually obligated
under the Scholarship or Loan
Repayment Program. A listing of HPSAs
and their scores is posted at https://
belize.hrsa.gov/newhpsa/newhpsa.cfm.
Sites qualifying for automatic primary
care HPSA designations have been
scored and may be authorized to receive
assignment of Corps members if they
meet the criteria outlined above and
their HPSA scores are above the stated
cutoffs. If there are any sites on the list
E:\FR\FM\30AUN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 167 (Tuesday, August 30, 2005)]
[Notices]
[Pages 51355-51356]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17181]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological 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: Vaccines and Related Biological 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 via teleconference on
September 22, 2005 from 1:30 p.m. to 5 p.m.
Location: NIH campus, Food and Drug Administration Bldg. 29B,
Conference Room C, 8800 Rockville Pike, Bethesda, MD. This meeting will
be held by teleconference. The public is welcome to attend the meeting
at the above location. A speaker phone will be provided at the
specified location for public participation in this meeting. Important
information about transportation and directions to the NIH campus,
parking, and security procedures is available on the internet at http:/
/www.nih.gov/about/visitor/index.htm. Visitors must show two forms of
identification such as a Federal employee badge, driver's license,
passport, green card, etc. If you are planning to drive to and park on
the NIH campus, you must enter at the South Drive entrance of the
campus, which is located on Wisconsin Ave. (the medical center metro
entrance), and allow extra time for vehicle inspection. Detailed
information about security procedures is located at https://www.nih.gov/
about/visitorsecurity.htm. Due to the limited available parking,
visitors are encouraged to use public transportation.
Contact Person: Christine Walsh or Denise Royster, 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 3014512391. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will hear an overview of the research of the
Laboratory of Retroviruses and the Laboratory of Immunoregulation,
Division of Viral Products, and the Laboratory of Respiratory and
Special Pathogens and the Laboratory of Methods Development and Quality
Control, Division of Bacterial Parasitic and Allergenic Products,
Office of Vaccines Research and Review, Center for Biologics Evaluation
and Research (CBER), and in closed session will discuss the reports
from the Laboratory Site Visits of April 18 and 19, 2005, and June 16,
2005.
Procedure: On September 22, 2005, from 1:30 p.m. to 4 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 15, 2005. Oral presentations from the public will be
scheduled between approximately 3 p.m. to 4 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 15,
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 22, 2005, from 4 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 Office of Vaccines Research and
Review, Division of Viral Products and Division of Bacterial Parasitic
and Allergenic Products, CBER.
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 Christine Walsh or
Denise Royster (see CONTACT PERSON) 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 51356]]
Dated: August 23, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17181 Filed 8-29-05; 8:45 am]
BILLING CODE4160-01-S
