Research and Demonstration Projects for Indian Health, 49930-49931 [05-16912]
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Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices
section 513(f)(2) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360c(f)(2)). This guidance
document will serve as the special
control for RNA preanalytical systems.
Section 513(f)(2) of the act provides
that any person who submits a
premarket notification under section
510(k) of the act (21 U.S.C. 360(k)) for
a device that has not previously been
classified may, within 30 days after
receiving an order classifying the device
in class III under section 513(f)(1) of the
act, request FDA to classify the device
under the criteria set forth in section
513(a)(1) of the act. FDA shall, within
60 days of receiving such a request,
classify the device by written order.
This classification shall be the initial
classification of the device. Within 30
days after the issuance of an order
classifying the device, FDA must
publish a notice in the Federal Register
announcing such classification. Because
of the timeframes established by section
513(f)(2) of the act, FDA has
determined, under § 10.115(g)(2) (21
CFR 10.115(g)(2)), that it is not feasible
to allow for public participation before
issuing this guidance as a final guidance
document. Therefore, FDA is issuing
this guidance document as a level 1
guidance document that is immediately
in effect. FDA will consider any
comments that are received in response
to this notice to determine whether to
amend the guidance document.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s GGP regulation
(21 CFR 10.115). The guidance
represents the agency’s current thinking
on RNA preanalytical systems. 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 statute and regulations.
III. Electronic Access
To receive ‘‘Class II Special Controls
Guidance Document: RNA Preanalytical
Systems (RNA Collection, Stabilization
and Purification Systems for RT–PCR
used in Molecular Diagnostic Testing)’’
by fax call the Center for Devices and
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301–827–0111 from a touch-tone
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To receive ‘‘Class II Special Controls
Guidance Document: RNA Preanalytical
VerDate jul<14>2003
15:58 Aug 24, 2005
Jkt 205001
Systems (RNA Collection, Stabilization
and Purification Systems for RT–PCR
used in Molecular Diagnostic Testing),’’
you may either send a fax request to
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807, subpart E, OMB control number
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addressed in the guidance have been
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V. Comments
Interested persons may submit written
or electronic comments regarding this
document to the Division of Dockets
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submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: August 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–16913 Filed 8–24–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Research and Demonstration Projects
for Indian Health
AGENCY: Indian Health Service, HHS.
ACTION: Notice of single source
cooperative agreement with the National
Council of Urban Indian Health.
SUMMARY: The Indian Health Service
(IHS) announces the award of a
cooperative agreement to the National
Council of Urban Indian Health
(NCUIH) for demonstration project for
urban Indian health care education,
consultation, health care data
dissemination, training, and technical
assistance to determine the unmet
health care needs of urban Indians and
to assist the Secretary in assessing the
health status and health care of urban
Indians. The project is for a three year
project period effective September 1,
2005 to August 31, 2008. Annual
funding for the project is $417,000.
The award is issued under the
authority of the Public Health Service
Act, Section 301 and the Indian Health
Care Improvement Act, Public Law 94–
437, Sections 503, 504, and 511, and is
listed under Catalog of Federal Domestic
Assistance number 93–933.
The specific objectives of the project
are:
1. NCUIH will keep the Urban Indian
health programs and the IHS informed
of items of interest pertaining to the
health status and unmet needs of urban
Indians and the federal budget process
by reviewing activities that have taken
place in regard to Indian health care.
2. To disseminate information relative
to Title V, local Urban Indian health
issues, training opportunities, research
instruments, data, budget, NCUIH
activities and various forms of technical
assistance to the Urban Indian health
programs, keeping IHS informed of
activities taking place.
3. To disseminate information and
respond to all inquiries relative to Title
V, local Urban Indian health issues,
training opportunities, research
instruments, data, budget, NCUIH
E:\FR\FM\25AUN1.SGM
25AUN1
Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices
activities and will issue a quarterly
newsletter and develop a web page.
4. To coordinate meetings for the
Urban Indian health programs to
provide training, technical assistance,
and/or updated information addressing
the health care needs of Urban Indians.
Reporting Requirements:
1. Monthly Activity Report: The
organization will provide to the IHS
program office a monthly report
detailing activities performed for the
organization. These activity reports will
include:
• Trip reports for travel in connection
to the organization
• Information on meetings attended
by NCUIH regarding Indian health care
education activities, and any
documentation provided by NCUIH at
these meetings
• Information relative to health status
and health care needs of urban Indians
in urban centers
2. Program Progress Report: Program
progress reports are required semiannually. These reports will include
brief comparison of actual
accomplishments to the goals
established for the period, reasons for
slippage (if applicable), and other
pertinent information as required. A
final report is to be submitted within 90
days of expiration of the budget/project
period.
3. Financial Status Report: Financial
status reports are required semiannually. Standard Form 269 (long
form) will be used for financial
reporting. A final report must be
submitted within 90 days of expiration
of the budget/project period.
4. Financial Audit: A financial audit,
conducted by an independent auditor
will be completed annually for each
year within the project period (three).
Failure to submit required reports
within the time allowed may result in
suspension or termination of the active
cooperative agreement, withholding of
payments or converting to the
reimbursement method of payment.
Continued failure to submit required
reports may result in the imposition of
special award provisions, or cause other
eligible projects or activities involving
the grantee organization not to be
funded.
Justification for Single Source: This
project has been awarded on a noncompetitive single source basis. NCUIH
is the only nationwide Indian
organization that is specifically
established to address the health needs
of American Indians and Alaska Natives
living in urban areas with membership
consisting of Urban Indian health
organizations funded under Title V of
the Indian Health Care Improvement
VerDate jul<14>2003
15:58 Aug 24, 2005
Jkt 205001
Act, Public Law 93–437, as amended,
and under authority 25 U.S.C. 1652.
Furthermore, it is the only nationwide
organization for urban American
Indians and Alaska Natives supporting
the growth of the Urban Indian health
care delivery system.
Use of Cooperative Agreement: A
cooperative agreement has been
awarded because of anticipated
substantial Programmatic involvement
by IHS staff in the project. Substantial
programmatic involvement is as follows:
1. IHS staff will participate in the
Board of Director meetings. Purposes
will be to present the IHS prospectus on
current health care issues affecting the
Urban Indian people and allow IHS the
opportunity to hear the continuing
unmet needs of Urban Indians.
2. IHS staff may, at the request of
NCUIH, participate on study groups and
may recommend topics for
consideration.
3. IHS will be involved in the
selection and approval process for
hiring key personnel. Key personnel are
the Executive Director, the Office
Administrator, and may include the
hiring of major consultants. NCUIH
must submit the Executive Director and
Office Administrator selection criteria to
IHS for approval when there becomes a
change in staffing.;
4. IHS will be involved in meetings
held by NCUIH.
Contacts: For program information,
contact Ms. Danielle Steward, Program
Specialist, Office of Urban Indian
Health Programs, Office of the Director,
Indian Health Service, Reyes Building,
801 Thompson Avenue, Rockville, MD,
20852, (301) 443–4680. For grants
management information, contact Lois
Hodge, Grants Management Officer,
Division of Grants Operations, Reyes
Building, 801 Thompson Avenue,
Rockville, MD, 20852, (301) 443–5204.
Dated: August 19, 2005.
Mary Lou Stanton,
Deputy Director for Indian Health Policy
Indian Health Service.
[FR Doc. 05–16912 Filed 8–24–05; 8:45 am]
BILLING CODE 4156–16–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Privacy Act of 1974; Report of Modified
or Altered System
AGENCY: Indian Health Service (IHS),
HHS.
ACTION: Notice of proposed modification
or Alteration to a System of Records
(SOR).
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
49931
SUMMARY: In accordance with the
requirements of the Privacy Act of 1974,
we are proposing to modify or alter an
SOR, ‘‘Health, Medical and Billing
Records (formerly known as the Health
and Medical Records Systems),’’ System
No. 09–17–0001. We propose to include
contract health service records, as an
additional category of individuals
covered by the system, which consists
of medical records to eligible American
Indians and Alaska Native (AI/AN)
people that supplements the health care
resources available with the purchase of
medical care and services that are not
available within the IHS direct care
system which may include, but not
limited to, basic and specialty health
care services from local and community
health care providers, including
hospital care, physician services,
outpatient care, laboratory, dental,
radiology, pharmacy, and transportation
services. Under the Purpose of the
system, we propose to include several
new purposes that are in line with the
Health Insurance Portability and
Accountability Act (HIPAA) Privacy
Rule provisions which were
incorporated into the published IHS
Notice of Privacy Practices (NPP) and to
include debt collection activities. We
are proposing to modify/alter/delete
several published routine uses, as
explained, to accommodate for program
and statutory changes as indicated:
Number 1 is modified/altered by
separating the medical treatment,
payment and health care operations into
two separate routine uses 1 and 2 to
include payment, billing, third-party
reimbursement and debt collection
activities; numbers 3, 4 and 11 are to
include business associate agreement
language to comply with HIPAA Privacy
standards and renumbered as 5, 6 and
12 respectively; number 5 is to include
a special requirement notice for
sensitive protected health information
(PHI) such as alcohol/drug abuse, HIV/
AIDS, STD or mental health patient
information and renumbered as 7;
number 6 is to reflect changes in
research disclosures to comply with
HIPAA Privacy standards and
renumbered as 8; number 7 is to include
various cases of abuses, neglect, sexual
assault and domestic violence and
emphasis on meeting the requirements
of 42 CFR part 2 and renumbered as 9;
number 8 is to clarify the disclosures
regarding suspected cases of child abuse
and renumbered as 10; number 9 is
modified to include legal proceedings
related to administrative claims and the
inclusive provision of the Department of
Health and Human Services (DHHS)/
Office of General Counsel (OGC)
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 70, Number 164 (Thursday, August 25, 2005)]
[Notices]
[Pages 49930-49931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
Research and Demonstration Projects for Indian Health
AGENCY: Indian Health Service, HHS.
ACTION: Notice of single source cooperative agreement with the National
Council of Urban Indian Health.
-----------------------------------------------------------------------
SUMMARY: The Indian Health Service (IHS) announces the award of a
cooperative agreement to the National Council of Urban Indian Health
(NCUIH) for demonstration project for urban Indian health care
education, consultation, health care data dissemination, training, and
technical assistance to determine the unmet health care needs of urban
Indians and to assist the Secretary in assessing the health status and
health care of urban Indians. The project is for a three year project
period effective September 1, 2005 to August 31, 2008. Annual funding
for the project is $417,000.
The award is issued under the authority of the Public Health
Service Act, Section 301 and the Indian Health Care Improvement Act,
Public Law 94-437, Sections 503, 504, and 511, and is listed under
Catalog of Federal Domestic Assistance number 93-933.
The specific objectives of the project are:
1. NCUIH will keep the Urban Indian health programs and the IHS
informed of items of interest pertaining to the health status and unmet
needs of urban Indians and the federal budget process by reviewing
activities that have taken place in regard to Indian health care.
2. To disseminate information relative to Title V, local Urban
Indian health issues, training opportunities, research instruments,
data, budget, NCUIH activities and various forms of technical
assistance to the Urban Indian health programs, keeping IHS informed of
activities taking place.
3. To disseminate information and respond to all inquiries relative
to Title V, local Urban Indian health issues, training opportunities,
research instruments, data, budget, NCUIH
[[Page 49931]]
activities and will issue a quarterly newsletter and develop a web
page.
4. To coordinate meetings for the Urban Indian health programs to
provide training, technical assistance, and/or updated information
addressing the health care needs of Urban Indians.
Reporting Requirements:
1. Monthly Activity Report: The organization will provide to the
IHS program office a monthly report detailing activities performed for
the organization. These activity reports will include:
Trip reports for travel in connection to the organization
Information on meetings attended by NCUIH regarding Indian
health care education activities, and any documentation provided by
NCUIH at these meetings
Information relative to health status and health care
needs of urban Indians in urban centers
2. Program Progress Report: Program progress reports are required
semi-annually. These reports will include brief comparison of actual
accomplishments to the goals established for the period, reasons for
slippage (if applicable), and other pertinent information as required.
A final report is to be submitted within 90 days of expiration of the
budget/project period.
3. Financial Status Report: Financial status reports are required
semi-annually. Standard Form 269 (long form) will be used for financial
reporting. A final report must be submitted within 90 days of
expiration of the budget/project period.
4. Financial Audit: A financial audit, conducted by an independent
auditor will be completed annually for each year within the project
period (three).
Failure to submit required reports within the time allowed may
result in suspension or termination of the active cooperative
agreement, withholding of payments or converting to the reimbursement
method of payment. Continued failure to submit required reports may
result in the imposition of special award provisions, or cause other
eligible projects or activities involving the grantee organization not
to be funded.
Justification for Single Source: This project has been awarded on a
non-competitive single source basis. NCUIH is the only nationwide
Indian organization that is specifically established to address the
health needs of American Indians and Alaska Natives living in urban
areas with membership consisting of Urban Indian health organizations
funded under Title V of the Indian Health Care Improvement Act, Public
Law 93-437, as amended, and under authority 25 U.S.C. 1652.
Furthermore, it is the only nationwide organization for urban American
Indians and Alaska Natives supporting the growth of the Urban Indian
health care delivery system.
Use of Cooperative Agreement: A cooperative agreement has been
awarded because of anticipated substantial Programmatic involvement by
IHS staff in the project. Substantial programmatic involvement is as
follows:
1. IHS staff will participate in the Board of Director meetings.
Purposes will be to present the IHS prospectus on current health care
issues affecting the Urban Indian people and allow IHS the opportunity
to hear the continuing unmet needs of Urban Indians.
2. IHS staff may, at the request of NCUIH, participate on study
groups and may recommend topics for consideration.
3. IHS will be involved in the selection and approval process for
hiring key personnel. Key personnel are the Executive Director, the
Office Administrator, and may include the hiring of major consultants.
NCUIH must submit the Executive Director and Office Administrator
selection criteria to IHS for approval when there becomes a change in
staffing.;
4. IHS will be involved in meetings held by NCUIH.
Contacts: For program information, contact Ms. Danielle Steward,
Program Specialist, Office of Urban Indian Health Programs, Office of
the Director, Indian Health Service, Reyes Building, 801 Thompson
Avenue, Rockville, MD, 20852, (301) 443-4680. For grants management
information, contact Lois Hodge, Grants Management Officer, Division of
Grants Operations, Reyes Building, 801 Thompson Avenue, Rockville, MD,
20852, (301) 443-5204.
Dated: August 19, 2005.
Mary Lou Stanton,
Deputy Director for Indian Health Policy Indian Health Service.
[FR Doc. 05-16912 Filed 8-24-05; 8:45 am]
BILLING CODE 4156-16-M
