Tribal Self-Governance Program Planning Cooperative Agreement; New Funding Cycle for Fiscal Year 2006, 74020-74024 [E5-7280]
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Federal Register / Vol. 70, No. 239 / Wednesday, December 14, 2005 / Notices
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0483]
Guidance for Industry and Food and
Drug Administration; Requesting an
Extension to Use Existing Label Stock
After the Trans Fat Labeling Effective
Date of January 1, 2006; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled, ‘‘Requesting an Extension to
Use Existing Label Stock after the Trans
Fat Labeling Effective Date of January 1,
2006.’’ The trans fat final rule published
in the Federal Register on July 11, 2003.
This guidance document provides
guidance to FDA and the food industry
about when and how businesses may
request the agency to consider
enforcement discretion for the use, on
products introduced into interstate
commerce on or after the January 1,
2006, effective date, of some or all
existing label stock that does not declare
trans fat labeling in compliance with the
final rule.
DATES: This guidance is final upon the
date of publication. Submit written or
electronic comments on the guidance at
any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Nutritional Products, Labeling
and Dietary Supplements (HFS–800),
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
one self-addressed 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.
Julie
Moss, Center for Food Safety and
Applied Nutrition (HFS–830), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
301–436–2373, FAX: 301–436–2636.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
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FDA is announcing the availability of
a guidance document entitled
‘‘Requesting an Extension to Use
Existing Label Stock after the Trans Fat
Labeling Effective Date of January 1,
2006.’’ FDA issued a final rule on July
11, 2003 (68 FR 41434), to require food
labels to bear the gram amount of trans
fat without a percent Daily Value in the
Nutrition Facts panel (https://
www.cfsan.fda.gov/~acrobat/
fr03711a.pdf). The trans fat final rule
becomes effective on January 1, 2006.
This guidance document provides
guidance to FDA staff and the food
industry about when and how
businesses may request the agency to
consider enforcement discretion for the
use, on products introduced into
interstate commerce on or after the
January 1, 2006 effective date, of some
or all existing label stock that does not
declare trans fat labeling in compliance
with the final rule.
In compliance with section 212 of the
Small Business Regulatory Enforcement
Fairness Act (Public Law 104–121), we
are making available this guidance that
states in plain language the factors the
agency intends to consider concerning
requests for enforcement discretion by
small and other businesses regarding
compliance with this regulation.
FDA is issuing this guidance as a level
1 guidance consistent with FDA’s good
guidance practices regulation § 10.115
(21 CFR 10.115). Consistent with FDA’s
good guidance practices regulation, the
agency will accept comment, but is
implementing the guidance document
immediately in accordance with
§ 10.115(g)(2), because the agency has
determined that prior public
participation is not feasible or
appropriate. This document affects the
trans fat labeling effective date of
January 1, 2006, so it is urgent that FDA
explains its new enforcement policy
before that date. This guidance
represents the agency’s current thinking
on the subject. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. You may use an alternative
approach if such approach satisfies the
requirements of the applicable statutes
and regulations. If you want to discuss
an alternative approach, contact the
FDA staff responsible for implementing
this guidance (see FOR FURTHER
INFORMATION CONTACT).
II. Paperwork Reduction Act of 1995
This final guidance contains
information collection provisions that
are subject to review by the Office of
Management and Budget (OMB) under
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the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information in this guidance was
approved under OMB control number
0910–0571.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document 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 may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance document at
https://www.cfsan.fda.gov/
guidance.html.
Dated: December 5, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–23987 Filed 12–13–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
[Funding Opportunity Number: HHS–2006–
IHS–TSGP–0001; CFDA Number: 93.210]
Tribal Self-Governance Program
Planning Cooperative Agreement; New
Funding Cycle for Fiscal Year 2006
Key Dates: Applications Due—January
20, 2006; Objective Review Committee
to Evaluate Applications—March 8–9,
2006; Anticipated Project Start Date—
April 1 , 2006.
I. Funding Opportunity Description
The purpose of the program is to
award cooperative agreements that
provide planning resources to Tribes
interested in participating in the Tribal
Self-Governance Program (TSGP) as
authorized by Title V, Tribal SelfGovernance Amendments of 2000 of the
Indian Self-Determination and
Education Assistance Act of Public Law
(Pub. L.) 93–638, as amended. The
TSGP is designed to promote selfdetermination by allowing Tribes to
assume more control of Indian Health
Service (IHS) programs and services
through compacts negotiated with the
IHS. The Planning Cooperative
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Alaska Native Village Corporations, who
are located within the area served by an
Alaska Native regional health entity
already participating in compact status,
are not eligible (Pub. L. 106–260, Title
V, section 12(a)(2)).
Agreement allows a Tribe to gather
information to determine the current
types and amounts of Programs,
Services, Functions, and Activities
(PSFAs), and funding available at the
Service Unit, Area, and Headquarters
levels and identify programmatic
alternatives that will better meet the
needs of Tribal members.
II. Award Information
Type of Award: Cooperative
Agreement.
Estimated Funds Available: The total
amount identified for Fiscal Year (FY)
2006 is $600,000 for approximately
twelve (12) Tribes to enter the TSGP
planning process for compacts
beginning in Fiscal Year (FY) 2007 or
Calendar Year (CY) 2007. Awards under
this announcement are subject to the
availability of funds.
Anticipated Number of Awards: The
estimated number of awards to be
funded is approximately 12.
Project Period: 12 months.
Award Amount: $50,000 per year.
Programmatic Involvement: IHS TSGP
funds will be awarded as cooperative
agreements and will have substantial
programmatic involvement to establish
a basic understanding of IHS Programs,
Services, Functions and Activities
(PSFAs) as operations at the Service
Unit, Area, and Headquarters levels.
The IHS roles and responsibilities
will include:
• Identification of IHS staff that will
consult with applicants on methods
used by the IHS to manage and deliver
health care.
• Provide applicants with a list of
laws and regulations that provide
authority for the various IHS programs.
The Grantee roles and responsibilities
will include:
• Research and analysis of the
complex IHS budget, at the Service
Unit, Area, and Headquarters levels.
• Establishment of a process through
which Tribes can effectively approach
the IHS to identify programs and
associated funding which could be
incorporated into programs.
III. Eligibility Information
1. Eligible Applicants
To be eligible for a Planning
Cooperative Agreement under this
announcement, an applicant must meet
all of the following criteria:
A. Be a Federally-recognized Tribe as
defined in Title V, Public Law 106–260,
Tribal Self-Governance Amendments of
2000, of the Indian Self-Determination
and Education Assistance Act (the Act),
Public Law 93–638, as amended.
However, Alaska Native Villages or
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2. Cost Sharing or Matching Funds
The Self-Governance Planning
Cooperative Agreement Announcement
does not require matching funds or cost
sharing to participate in the competitive
grant process.
3. Other Requirements
The following documentation is
required (if applicable):
A. This program is described at
93.210 in the Catalog of Federal
Domestic Assistance. There is limited
competition under this announcement
because the authorizing legislation
restricts eligibility to Tribes that meet
specific criteria. (Refer to Section III,
ELIGIBLE APPLICANTS in this
announcement.)
B. Request participation in selfgovernance by resolution by the
governing body of the Indian Tribe. An
Indian Tribe that is proposing a
cooperative agreement affecting another
Indian Tribe must include resolutions
from all affected Tribes to be served.
C. Demonstrate, for three fiscal years,
financial stability and financial
management capability, which is
defined as no uncorrected significant
and material audit exceptions in the
required annual audit of the Indian
Tribe’s self-determination contracts or
self-governance funding agreements
with any Federal agency.
D. Grantees are required to submit a
current version of the organization’s
audit report. Audit reports can be
lengthy, therefore, the applicants may
submit them separately via regular mail
by the due date (January 20, 2006). If the
grantee determines that audit reports are
not lengthy, the applicants may scan the
documents and attach them to the
electronic application. Applicants must
submit two copies of the audits that
reflect three previous fiscal years under
separate cover directly to the Division of
Grants Operations, 801 Thompson
Avenue, TMP 360, Rockville, MD
20852, referencing the Funding
Opportunity Number, HHS–2006–IHS–
TSGP–0001, as prescribed by Public
Law 98–502, the Single Audit Act, as
amended (see OMB Circular A–133,
revised June 24, 1997, Audits of States,
Local Governments, and Non-Profit
Organizations), for the three previous
fiscal years. If this documentation is not
submitted by the due date, the
application will be considered as
unresponsive and will not be
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considered. Applicants must include
the grant tracking number assigned to
their electronic submission by
Grants.gov and the date submitted via
Grants.gov in their cover letter
transmitting the required audits for the
previous three fiscal years.
E. Tribal Resolution—A resolution of
the Indian Tribe served by the project
should accompany the application
submission. An Indian Tribe that is
proposing a project affecting another
Indian Tribe must include resolutions
from all affected Tribes to be served.
Tribal Consortia applying for a Planning
Cooperative Agreement, a minimum of
two individual Tribal Council
Resolutions must be submitted. Draft
resolutions are acceptable in lieu of an
official resolution. However, an official
signed Tribal resolution must be
received by the Division of Grants
Operations (DGO) by the end of the
Objective Review (March 9, 2006). If an
official signed resolution is not
submitted by March 9, 2006, the
application will be considered
incomplete and will be returned
without consideration.
*It is highly recommended that the
Tribal resolution be sent by Federal
Express for proof of receipt.
IV. Application and Submission
Information
1. Application package may be found on
https://Grants.gov
Information regarding the electronic
application process may be obtained
from either of the following persons:
Ms. Mary E. Trujillo, Office of Tribal
Self-Governance, Indian Health
Service, 801 Thompson Avenue, Suite
240, Rockville, Maryland 20852. (301)
443–7821.
Ms. Patricia Spotted Horse, Division of
Grants Operations, Indian Health
Service, 801 Thompson Avenue, TMP
360, Rockville, Maryland 20852. (301)
443–5204.
• Web address to obtain application
kit: https://www.ihs.gov/
NonMedicalPrograms/gogp/
gogp_submission.asp
2. Content and Form of Application
Submission
A. All applications should:
• Be single spaced.
• Be typewritten.
• Have consecutively numbered
pages.
• Use black type not smaller than 12
characters per one inch.
• Be printed on one side only of
standard size 81⁄2″ × 11″ paper.
• Contain a narrative that does not
exceed 7 typed pages that includes the
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sections listed below. (The 7 page
narrative does not include the work
plan, standard forms, Tribal
resolution(s), table of contents, budget,
budget justifications, narratives, and/or
other appendix items.)
Public Policy Requirements: All
Federal-wide public policies apply to
HHS grants with exception of Lobbying
and Discrimination.
3. Submission Dates and Times
Applications must be submitted online by January 20, 2006. Late
applications not accepted for processing
will be returned to the applicant and
will not be considered for funding.
4. Intergovernmental Review
This funding opportunity is not
subject to Executive Order 12372,
‘‘Intergovernmental Review of Federal
Programs.’’ State approval is not
required.
5. Funding Restrictions
A. Only one planning cooperative
agreement will be awarded per
applicant.
A. Each planning cooperative
agreement shall not exceed $50,000. The
available funds are inclusive of direct
and indirect costs.
B. Planning awards shall not exceed
a maximum period of one year.
C. Pre-award costs are not allowable.
6. Other Submission Requirements
The application must comply with the
following:
A. Abstract (one page)—Summarizes
the project.
B. Application for Federal Assistance
(SF–424, Rev. 09/03).
C. Narrative (no more than 7 pages)
with time frame chart (one page); pages
numbered consecutively, including
appendices, and Table of Contents, and
should include the following:
(1) Background information on the
Tribe.
(1) Objectives and activities that
provide a description of what will be
accomplished.
(2) A line-item budget and narrative
justification.
(3) Appendix to include:
a. Resumes or position descriptions of
key staff.
b. Contractors/Consultants resumes or
qualifications.
c. Proposed Scope of Work.
Electronic Transmission—The
preferred method for receipt of
applications is electronic submission
through https://Grants.gov. However,
should any technical problems arise
regarding the submission, please contact
our Grants Policy Staff at (301) 443–
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6528 at least ten days prior to the
application deadline. To submit an
application electronically, please use
the https://www.Grants.gov apply site.
Download a copy of the application
package on the Grants.gov Web site,
complete it offline and then upload and
submit the application via the
Grants.gov site. You may not e-mail an
electronic copy of a grant application to
us.
Please note the following:
• Under the new IHS requirements,
paper applications are not the preferred
method. However, if you have technical
problems submitting your application
on-line, and you have contacted the
Grants Policy Staff and advised them of
the difficulties you are having in
submitting your application on-line, and
if it is determined by the Grants Policy
Staff that the technical difficulties
cannot be resolved, you may submit a
paper application after you have
downloaded the application package
from Grants.gov. The paper application
may be sent directly to the Division of
Grants Operations, 801 Thompson
Avenue, TMP 360, Rockville, MD 20852
by the due date, January 20, 2006.
• When you enter the Grants.gov site,
you will find information about
submitting an application electronically
through the site, as well as the hours of
operation. We strongly recommend that
you do not wait until the deadline date
to begin the application process through
Grants.gov.
• To use Grants.gov, you, as the
applicant, must have a DUNS Number
and register in the Central Contractor
Registry (CCR). You should allow a
minimum of 10–15 days to complete
CCR registration. See below on how to
apply.
• You must submit all documents
electronically, including all information
typically included on the SF–424 and
all necessary assurances and
certifications.
• Your application must comply with
any page limitation requirements
described in the program
announcement.
• After you electronically submit
your application, you will receive an
automatic acknowledgment from
Grants.gov that contains a Grants.gov
tracking number. The Indian Health
Service will retrieve your application
from Grants.gov.
• You may access the electronic
application for this program on https://
www.Grants.gov.
• You must search for the
downloadable application package by
CFDA number.
• To receive an application package,
the applicant must provide the Funding
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Opportunity Number: HHS–2006–IHS–
TSGP–0001.
E-mail applications will not be
accepted under this announcement.
DUNS Number: Beginning October 1,
2003, applicants were required to have
a Dun and Brandstreet (DUNS) Number.
The DUNS number is a nine-digit
identification number, which uniquely
identifies business entities. Obtaining a
DUNS number is easy and there is no
charge. To obtain a DUNS number,
access https://
www.dunandbradstreet.com or call 1–
866–705–5711. Interested parties may
wish to obtain their DUNS number by
phone to expedite the process.
Applications submitted electronically
must also be registered with the Central
Contractor Registry (CCR). A DUNS
number is required before CCR
registration can be completed. Many
organizations may already have a DUNS
number. Please use the number listed
above to investigate whether or not your
organization has a DUNS number.
Registration with the CCR is free of
charge.
Applicants may register by calling 1–
888–227–2423. Please review and
complete the CCR ‘‘Registration
Worksheet’’ located in the appendix of
the TSGP Planning Cooperative
Agreement application kit or on https://
www.Grants.gov/CCRRegister.
More detailed information regarding
these registration processes can be
found at https://www.Grants.gov.
V. Application Review Information
The instructions for preparing the
application narrative also constitute the
evaluation criteria for reviewing and
scoring the application. Weights
assigned to each section are noted in
parentheses.
1. Criteria
Goals And Objectives of the Project
(30 points). Are the goals and objectives
measurable; are they consistent with the
purpose of the program and terms of
this announcement; and, are they
achievable as demonstrated by an
implementation schedule?
Organizational Capabilities And
Qualifications (25 points). Describe the
organizational structure of the Tribe/
Tribal organization and the ability of the
organization to manage the proposed
project. Include resumes or position
descriptions of key staff showing
requisite experience and expertise and,
where applicable, include resumes of
consultants that demonstrate experience
and expertise relevant to the project.
Methodology (20 points). Describe
fully and clearly the methodology used
to reflect the needs of Tribal members
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and if the project can be accomplished
with expected available resources.
Budget Justification (15 points).
Submit a line-item budget with a brief
narrative justification for all
expenditures. Are costs identified
reasonable and allowable in accordance
with OMB Circulars A–87, ‘‘Cost
Principles for State and Local
Governments’’ and A–122, ‘‘Cost
Principles for Non-Profit
Organizations?’’
Management Of Health Program(s)
(10 points). Does the applicant propose
an improved approach to managing the
health program(s) and state/demonstrate
how the delivery of quality health
services will be maintained under selfgovernance?
Appendix Items:
• Work plan for proposed objectives.
• Position descriptions for key staff.
• Resumes of key staff that reflect
current duties.
• Consultant proposed scope of work
(if applicable).
• Indirect Cost Agreement.
• Organizational chart (optional).
2. Review and Selection Process
In addition to the above criteria/
requirements, applications are
considered according to the following:
A. Application Submission
(Application Deadline: January 20,
2006). Applications submitted in
advance of or by the deadline and
verified by the tracking number will
undergo a preliminary review to
determine that:
(1) The applicant and proposed
project type is eligible in accordance
with this grant announcement.
(2) The application is not a
duplication of a previously funded
project.
(3) The application narrative, forms,
and materials submitted meet the
requirements of the announcement
allowing the review panel to undertake
an in-depth evaluation; otherwise, it
may be returned.
B. Competitive Review of Eligible
Applications (Objective Review: March
8–9, 2006). Applications meeting
eligibility requirements that are
complete, responsive, and conform to
this program announcement will be
reviewed for merit by the Ad Hoc
Objective Review Committee (ORC)
appointed by the IHS to review and
make recommendations on these
applications. The review will be
conducted in accordance with the IHS
Objective Review Guidelines. The
technical review process ensures
selection of quality projects in a
national competition for limited
funding. Applications will be evaluated
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and rated on the basis of the evaluation
criteria listed in Section V.1. The
criteria are used to evaluate the quality
of a proposed project, determine the
likelihood of success, and assign a
numerical score to each application.
The scoring of approved applications
will assist the IHS in determining which
proposals will be funded if the amount
of TSGP funding is not sufficient to
support all approved applications.
Applications recommended for
approval, having a score of 60 or above
by the ORC and scored high enough to
be considered for funding, are
forwarded by the Division of Grants
Operations (DGO) for cost analysis and
further recommendation. The program
official forwards the final approval list
to the IHS Director for final review and
approval. Applications scoring below 60
points will be disapproved and returned
to the applicant.
74023
• 45 CFR part 92, ‘‘Department of
Health and Human Services, Uniform
Administrative Requirements for Grants
and Cooperative Agreements to State
and Local Governments Including
Indian Tribes.’’
• Public Health Service Grants Policy
Statement.
• Grants Policy Directives.
• Appropriate Cost Principles: OMB
Circular A–87, ‘‘State and Local
Governments.’’
• OMB Circular A–133, ‘‘Audits of
States, Local Governments, and NonProfit Organizations.’’
• Other Applicable OMB Circulars.
3. Reporting
A. Progress Report.
NOTE: In making the final selections, the
IHS Director will consider the ranking factor
and the status of the applicant’s single audit
reports. The comments from the ORC will be
advisory only. The IHS Director will make
the final decision on awards.
Program progress reports are required
semi-annually. These reports will
include a 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 must be submitted within 90
days of expiration of the budget/project
period.
3. Anticipated Award Date
B. Financial Status Report
Earliest Anticipated Award Date:
April 1, 2006.
Semi-annual financial status reports
must be submitted within 30 days of the
end of the half year. Final financial
status reports are due within 90 days of
expiration of the budget/project period.
Standard Form 269 (long form) will be
used for financial reporting.
Grantees are responsible and
accountable for accurate reporting of the
Progress Reports and Financial Status
Reports which are generally due semiannually. Financial Status Reports (SF–
269) are due 90 days after each budget
period and the final SF–269 must be
verified from the grantee records on
how the value was derived. Grantees are
allowed a reasonable period of time in
which to submit financial and
performance reports.
Failure to submit required reports
within the time allowed may result in
suspension or termination of an active
grant, withholding of additional awards
for the project, or other enforcement
actions such as withholding of
payments or converting to the
reimbursement method of payment.
Continued failure to submit required
reports may result in one or both of the
following: (1) The imposition of special
award provisions; and (2) the nonfunding or non-award of other eligible
projects or activities. This applies
whether the delinquency is attributable
to the failure of the grantee organization
or the individual responsible for
preparation of the reports.
VI. Award Administration Information
1. Award Notices
Division of Grants Operations (DGO)
will not award a grant without an
approved application in conformance
with regulatory and policy requirements
which describes the purpose and scope
of the project to be funded. When the
application is approved for funding, the
DGO will prepare a Notice of Award
(NoA) with special terms and conditions
binding upon the award and refer to all
general terms applicable to the award.
The NoA will serve as the official
notification of a grant award and will
state the amount of Federal funds
awarded, the purpose of the grant, the
terms and conditions of the grant award,
the effective date of the award, the
project period, and the budget period.
Any other correspondence announcing
to the Project Director that an
application was selected is not an
authorization to begin performance.
2. Administrative and National Policy
Requirements
Grants are administered in accordance
with the following documents:
• This grant announcement.
• Health and Human Services
regulations governing Public Law 93–
638 grants at 42 CFR 36.101 et seq.
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VII. Agency Contact(s)
1. Questions on the programmatic and
technical issues may be directed to:
Mary E. Trujillo, Program Specialist,
Telephone No.: 301–443–7821. Fax No.:
301–443–1050. E-mail:
metrujil@hqe.ihs.gov.
2. Questions on grants management
and fiscal matters may be directed to:
Patricia Spotted Horse, Grants
Management Specialist, Telephone No.:
301–443–5204. Fax No.: 301–443–9602.
E-mail: pspotted@hqe.ihs.gov.
VIII. Other Information
The Public Health Service (PHS)
strongly encourages all grant and
contract recipients to provide a smokefree workplace and promote the non-use
of all tobacco products. In addition,
Public Law 103–227, the Pro-Children
Act of 1994, prohibits smoking in
certain facilities (or in some cases, any
portion of the facility) in which regular
or routine education, library, day care,
health care or early childhood
development services are provided to
children. This is consistent with the
PHS mission to protect and advance the
physical and mental health of the
American people.
Dated: December 7, 2005.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. E5–7280 Filed 12–13–05; 8:45 am]
Name of Committee: NIH Advisory Board
for Clinical Research.
Date: January 30, 2006.
Open: 10 a.m. to 1:30 p.m.
To review the Clinical Center operating
plan, ABCR workgroups and Budgetary
issues.
National Institutes of Health, Building 10,
10 Center Drive, 4–2551, CRC Medical Board
Room, Bethesda, MD 20892.
Closed: 1:30 p.m. to 2 p.m.
Agenda: To review and evaluate for
discussion of personal qualifications and
performance the disclosure of which
constitute a clearly unwarranted invasion of
privacy.
Place: National Institutes of Health,
Building 10, 10 Center Drive, 4–2551, CRC
Medical Board Room, Bethesda, MD 20892.
Contact Person: Maureen E. Gormley,
Executive Secretary, Mark O. Hatfield
Clinical Research Center, National Institutes
of Health, Building 10, Room 6–15610,
Bethesda MD 20892, 301/496–2897.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Dated: December 7, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–24015 Filed 12–13–05; 8:45am]
BILLING CODE 4140–01–M
BILLING CODE 4160–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set froth in section
552b(c)(6), Title 5 U.S.C., as amended
for discussion of personal qualifications
and performance, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
VerDate Aug<31>2005
15:29 Dec 13, 2005
Jkt 208001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Genomics of
Transplantation Cooperative Research
Program.
Date: December 19–21, 2005.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Time: 6 p.m. to 4 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: Double Tree Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Quirijn Vos, PhD,
Scientific Review Administrator, Scientific
Review Program, Division of Extramural
Activities, NIAID/NIH/DHHS, 6700B
Rockledge Drive, MSC 7616, Bethesda, MD
20892–7616, (301) 496–2550,
qvos@niaid.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 6, 2005.
Anna Snouffer,
Acting Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–24009 Filed 12–13–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel, SBIR
Phase 1 Contracts Topics 053 and 056.
Date: January 5, 2006.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Tracy Waldeck, PhD,
Scientific Review Administrator, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6132, MSC 9608,
Bethesda, MD 20852–9609, 301/435–0322,
waldeckt@mail.nih.gov.
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 70, Number 239 (Wednesday, December 14, 2005)]
[Notices]
[Pages 74020-74024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-7280]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service
[Funding Opportunity Number: HHS-2006-IHS-TSGP-0001; CFDA Number:
93.210]
Tribal Self-Governance Program Planning Cooperative Agreement;
New Funding Cycle for Fiscal Year 2006
Key Dates: Applications Due--January 20, 2006; Objective Review
Committee to Evaluate Applications--March 8-9, 2006; Anticipated
Project Start Date--April 1 , 2006.
I. Funding Opportunity Description
The purpose of the program is to award cooperative agreements that
provide planning resources to Tribes interested in participating in the
Tribal Self-Governance Program (TSGP) as authorized by Title V, Tribal
Self-Governance Amendments of 2000 of the Indian Self-Determination and
Education Assistance Act of Public Law (Pub. L.) 93-638, as amended.
The TSGP is designed to promote self-determination by allowing Tribes
to assume more control of Indian Health Service (IHS) programs and
services through compacts negotiated with the IHS. The Planning
Cooperative
[[Page 74021]]
Agreement allows a Tribe to gather information to determine the current
types and amounts of Programs, Services, Functions, and Activities
(PSFAs), and funding available at the Service Unit, Area, and
Headquarters levels and identify programmatic alternatives that will
better meet the needs of Tribal members.
II. Award Information
Type of Award: Cooperative Agreement.
Estimated Funds Available: The total amount identified for Fiscal
Year (FY) 2006 is $600,000 for approximately twelve (12) Tribes to
enter the TSGP planning process for compacts beginning in Fiscal Year
(FY) 2007 or Calendar Year (CY) 2007. Awards under this announcement
are subject to the availability of funds.
Anticipated Number of Awards: The estimated number of awards to be
funded is approximately 12.
Project Period: 12 months.
Award Amount: $50,000 per year.
Programmatic Involvement: IHS TSGP funds will be awarded as
cooperative agreements and will have substantial programmatic
involvement to establish a basic understanding of IHS Programs,
Services, Functions and Activities (PSFAs) as operations at the Service
Unit, Area, and Headquarters levels.
The IHS roles and responsibilities will include:
Identification of IHS staff that will consult with
applicants on methods used by the IHS to manage and deliver health
care.
Provide applicants with a list of laws and regulations
that provide authority for the various IHS programs.
The Grantee roles and responsibilities will include:
Research and analysis of the complex IHS budget, at the
Service Unit, Area, and Headquarters levels.
Establishment of a process through which Tribes can
effectively approach the IHS to identify programs and associated
funding which could be incorporated into programs.
III. Eligibility Information
1. Eligible Applicants
To be eligible for a Planning Cooperative Agreement under this
announcement, an applicant must meet all of the following criteria:
A. Be a Federally-recognized Tribe as defined in Title V, Public
Law 106-260, Tribal Self-Governance Amendments of 2000, of the Indian
Self-Determination and Education Assistance Act (the Act), Public Law
93-638, as amended. However, Alaska Native Villages or Alaska Native
Village Corporations, who are located within the area served by an
Alaska Native regional health entity already participating in compact
status, are not eligible (Pub. L. 106-260, Title V, section 12(a)(2)).
2. Cost Sharing or Matching Funds
The Self-Governance Planning Cooperative Agreement Announcement
does not require matching funds or cost sharing to participate in the
competitive grant process.
3. Other Requirements
The following documentation is required (if applicable):
A. This program is described at 93.210 in the Catalog of Federal
Domestic Assistance. There is limited competition under this
announcement because the authorizing legislation restricts eligibility
to Tribes that meet specific criteria. (Refer to Section III, ELIGIBLE
APPLICANTS in this announcement.)
B. Request participation in self-governance by resolution by the
governing body of the Indian Tribe. An Indian Tribe that is proposing a
cooperative agreement affecting another Indian Tribe must include
resolutions from all affected Tribes to be served.
C. Demonstrate, for three fiscal years, financial stability and
financial management capability, which is defined as no uncorrected
significant and material audit exceptions in the required annual audit
of the Indian Tribe's self-determination contracts or self-governance
funding agreements with any Federal agency.
D. Grantees are required to submit a current version of the
organization's audit report. Audit reports can be lengthy, therefore,
the applicants may submit them separately via regular mail by the due
date (January 20, 2006). If the grantee determines that audit reports
are not lengthy, the applicants may scan the documents and attach them
to the electronic application. Applicants must submit two copies of the
audits that reflect three previous fiscal years under separate cover
directly to the Division of Grants Operations, 801 Thompson Avenue, TMP
360, Rockville, MD 20852, referencing the Funding Opportunity Number,
HHS-2006-IHS-TSGP-0001, as prescribed by Public Law 98-502, the Single
Audit Act, as amended (see OMB Circular A-133, revised June 24, 1997,
Audits of States, Local Governments, and Non-Profit Organizations), for
the three previous fiscal years. If this documentation is not submitted
by the due date, the application will be considered as unresponsive and
will not be considered. Applicants must include the grant tracking
number assigned to their electronic submission by Grants.gov and the
date submitted via Grants.gov in their cover letter transmitting the
required audits for the previous three fiscal years.
E. Tribal Resolution--A resolution of the Indian Tribe served by
the project should accompany the application submission. An Indian
Tribe that is proposing a project affecting another Indian Tribe must
include resolutions from all affected Tribes to be served. Tribal
Consortia applying for a Planning Cooperative Agreement, a minimum of
two individual Tribal Council Resolutions must be submitted. Draft
resolutions are acceptable in lieu of an official resolution. However,
an official signed Tribal resolution must be received by the Division
of Grants Operations (DGO) by the end of the Objective Review (March 9,
2006). If an official signed resolution is not submitted by March 9,
2006, the application will be considered incomplete and will be
returned without consideration.
*It is highly recommended that the Tribal resolution be sent by
Federal Express for proof of receipt.
IV. Application and Submission Information
1. Application package may be found on https://Grants.gov
Information regarding the electronic application process may be
obtained from either of the following persons:
Ms. Mary E. Trujillo, Office of Tribal Self-Governance, Indian Health
Service, 801 Thompson Avenue, Suite 240, Rockville, Maryland 20852.
(301) 443-7821.
Ms. Patricia Spotted Horse, Division of Grants Operations, Indian
Health Service, 801 Thompson Avenue, TMP 360, Rockville, Maryland
20852. (301) 443-5204.
Web address to obtain application kit: https://www.ihs.gov/
NonMedicalPrograms/gogp/gogp_submission.asp
2. Content and Form of Application Submission
A. All applications should:
Be single spaced.
Be typewritten.
Have consecutively numbered pages.
Use black type not smaller than 12 characters per one
inch.
Be printed on one side only of standard size 8\1/2\'' x
11'' paper.
Contain a narrative that does not exceed 7 typed pages
that includes the
[[Page 74022]]
sections listed below. (The 7 page narrative does not include the work
plan, standard forms, Tribal resolution(s), table of contents, budget,
budget justifications, narratives, and/or other appendix items.)
Public Policy Requirements: All Federal-wide public policies apply
to HHS grants with exception of Lobbying and Discrimination.
3. Submission Dates and Times
Applications must be submitted on-line by January 20, 2006. Late
applications not accepted for processing will be returned to the
applicant and will not be considered for funding.
4. Intergovernmental Review
This funding opportunity is not subject to Executive Order 12372,
``Intergovernmental Review of Federal Programs.'' State approval is not
required.
5. Funding Restrictions
A. Only one planning cooperative agreement will be awarded per
applicant.
A. Each planning cooperative agreement shall not exceed $50,000.
The available funds are inclusive of direct and indirect costs.
B. Planning awards shall not exceed a maximum period of one year.
C. Pre-award costs are not allowable.
6. Other Submission Requirements
The application must comply with the following:
A. Abstract (one page)--Summarizes the project.
B. Application for Federal Assistance (SF-424, Rev. 09/03).
C. Narrative (no more than 7 pages) with time frame chart (one
page); pages numbered consecutively, including appendices, and Table of
Contents, and should include the following:
(1) Background information on the Tribe.
(1) Objectives and activities that provide a description of what
will be accomplished.
(2) A line-item budget and narrative justification.
(3) Appendix to include:
a. Resumes or position descriptions of key staff.
b. Contractors/Consultants resumes or qualifications.
c. Proposed Scope of Work.
Electronic Transmission--The preferred method for receipt of
applications is electronic submission through https://Grants.gov.
However, should any technical problems arise regarding the submission,
please contact our Grants Policy Staff at (301) 443-6528 at least ten
days prior to the application deadline. To submit an application
electronically, please use the https://www.Grants.gov apply site.
Download a copy of the application package on the Grants.gov Web site,
complete it offline and then upload and submit the application via the
Grants.gov site. You may not e-mail an electronic copy of a grant
application to us.
Please note the following:
Under the new IHS requirements, paper applications are not
the preferred method. However, if you have technical problems
submitting your application on-line, and you have contacted the Grants
Policy Staff and advised them of the difficulties you are having in
submitting your application on-line, and if it is determined by the
Grants Policy Staff that the technical difficulties cannot be resolved,
you may submit a paper application after you have downloaded the
application package from Grants.gov. The paper application may be sent
directly to the Division of Grants Operations, 801 Thompson Avenue, TMP
360, Rockville, MD 20852 by the due date, January 20, 2006.
When you enter the Grants.gov site, you will find
information about submitting an application electronically through the
site, as well as the hours of operation. We strongly recommend that you
do not wait until the deadline date to begin the application process
through Grants.gov.
To use Grants.gov, you, as the applicant, must have a DUNS
Number and register in the Central Contractor Registry (CCR). You
should allow a minimum of 10-15 days to complete CCR registration. See
below on how to apply.
You must submit all documents electronically, including
all information typically included on the SF-424 and all necessary
assurances and certifications.
Your application must comply with any page limitation
requirements described in the program announcement.
After you electronically submit your application, you will
receive an automatic acknowledgment from Grants.gov that contains a
Grants.gov tracking number. The Indian Health Service will retrieve
your application from Grants.gov.
You may access the electronic application for this program
on https://www.Grants.gov.
You must search for the downloadable application package
by CFDA number.
To receive an application package, the applicant must
provide the Funding Opportunity Number: HHS-2006-IHS-TSGP-0001.
E-mail applications will not be accepted under this announcement.
DUNS Number: Beginning October 1, 2003, applicants were required to
have a Dun and Brandstreet (DUNS) Number. The DUNS number is a nine-
digit identification number, which uniquely identifies business
entities. Obtaining a DUNS number is easy and there is no charge. To
obtain a DUNS number, access https://www.dunandbradstreet.com or call 1-
866-705-5711. Interested parties may wish to obtain their DUNS number
by phone to expedite the process.
Applications submitted electronically must also be registered with
the Central Contractor Registry (CCR). A DUNS number is required before
CCR registration can be completed. Many organizations may already have
a DUNS number. Please use the number listed above to investigate
whether or not your organization has a DUNS number. Registration with
the CCR is free of charge.
Applicants may register by calling 1-888-227-2423. Please review
and complete the CCR ``Registration Worksheet'' located in the appendix
of the TSGP Planning Cooperative Agreement application kit or on http:/
/www.Grants.gov/CCRRegister.
More detailed information regarding these registration processes
can be found at https://www.Grants.gov.
V. Application Review Information
The instructions for preparing the application narrative also
constitute the evaluation criteria for reviewing and scoring the
application. Weights assigned to each section are noted in parentheses.
1. Criteria
Goals And Objectives of the Project (30 points). Are the goals and
objectives measurable; are they consistent with the purpose of the
program and terms of this announcement; and, are they achievable as
demonstrated by an implementation schedule?
Organizational Capabilities And Qualifications (25 points).
Describe the organizational structure of the Tribe/Tribal organization
and the ability of the organization to manage the proposed project.
Include resumes or position descriptions of key staff showing requisite
experience and expertise and, where applicable, include resumes of
consultants that demonstrate experience and expertise relevant to the
project.
Methodology (20 points). Describe fully and clearly the methodology
used to reflect the needs of Tribal members
[[Page 74023]]
and if the project can be accomplished with expected available
resources.
Budget Justification (15 points). Submit a line-item budget with a
brief narrative justification for all expenditures. Are costs
identified reasonable and allowable in accordance with OMB Circulars A-
87, ``Cost Principles for State and Local Governments'' and A-122,
``Cost Principles for Non-Profit Organizations?''
Management Of Health Program(s) (10 points). Does the applicant
propose an improved approach to managing the health program(s) and
state/demonstrate how the delivery of quality health services will be
maintained under self-governance?
Appendix Items:
Work plan for proposed objectives.
Position descriptions for key staff.
Resumes of key staff that reflect current duties.
Consultant proposed scope of work (if applicable).
Indirect Cost Agreement.
Organizational chart (optional).
2. Review and Selection Process
In addition to the above criteria/requirements, applications are
considered according to the following:
A. Application Submission (Application Deadline: January 20, 2006).
Applications submitted in advance of or by the deadline and verified by
the tracking number will undergo a preliminary review to determine
that:
(1) The applicant and proposed project type is eligible in
accordance with this grant announcement.
(2) The application is not a duplication of a previously funded
project.
(3) The application narrative, forms, and materials submitted meet
the requirements of the announcement allowing the review panel to
undertake an in-depth evaluation; otherwise, it may be returned.
B. Competitive Review of Eligible Applications (Objective Review:
March 8-9, 2006). Applications meeting eligibility requirements that
are complete, responsive, and conform to this program announcement will
be reviewed for merit by the Ad Hoc Objective Review Committee (ORC)
appointed by the IHS to review and make recommendations on these
applications. The review will be conducted in accordance with the IHS
Objective Review Guidelines. The technical review process ensures
selection of quality projects in a national competition for limited
funding. Applications will be evaluated and rated on the basis of the
evaluation criteria listed in Section V.1. The criteria are used to
evaluate the quality of a proposed project, determine the likelihood of
success, and assign a numerical score to each application. The scoring
of approved applications will assist the IHS in determining which
proposals will be funded if the amount of TSGP funding is not
sufficient to support all approved applications. Applications
recommended for approval, having a score of 60 or above by the ORC and
scored high enough to be considered for funding, are forwarded by the
Division of Grants Operations (DGO) for cost analysis and further
recommendation. The program official forwards the final approval list
to the IHS Director for final review and approval. Applications scoring
below 60 points will be disapproved and returned to the applicant.
NOTE: In making the final selections, the IHS Director will
consider the ranking factor and the status of the applicant's single
audit reports. The comments from the ORC will be advisory only. The
IHS Director will make the final decision on awards.
3. Anticipated Award Date
Earliest Anticipated Award Date: April 1, 2006.
VI. Award Administration Information
1. Award Notices
Division of Grants Operations (DGO) will not award a grant without
an approved application in conformance with regulatory and policy
requirements which describes the purpose and scope of the project to be
funded. When the application is approved for funding, the DGO will
prepare a Notice of Award (NoA) with special terms and conditions
binding upon the award and refer to all general terms applicable to the
award. The NoA will serve as the official notification of a grant award
and will state the amount of Federal funds awarded, the purpose of the
grant, the terms and conditions of the grant award, the effective date
of the award, the project period, and the budget period. Any other
correspondence announcing to the Project Director that an application
was selected is not an authorization to begin performance.
2. Administrative and National Policy Requirements
Grants are administered in accordance with the following documents:
This grant announcement.
Health and Human Services regulations governing Public Law
93-638 grants at 42 CFR 36.101 et seq.
45 CFR part 92, ``Department of Health and Human Services,
Uniform Administrative Requirements for Grants and Cooperative
Agreements to State and Local Governments Including Indian Tribes.''
Public Health Service Grants Policy Statement.
Grants Policy Directives.
Appropriate Cost Principles: OMB Circular A-87, ``State
and Local Governments.''
OMB Circular A-133, ``Audits of States, Local Governments,
and Non-Profit Organizations.''
Other Applicable OMB Circulars.
3. Reporting
A. Progress Report.
Program progress reports are required semi-annually. These reports
will include a 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 must be
submitted within 90 days of expiration of the budget/project period.
B. Financial Status Report
Semi-annual financial status reports must be submitted within 30
days of the end of the half year. Final financial status reports are
due within 90 days of expiration of the budget/project period. Standard
Form 269 (long form) will be used for financial reporting.
Grantees are responsible and accountable for accurate reporting of
the Progress Reports and Financial Status Reports which are generally
due semi-annually. Financial Status Reports (SF-269) are due 90 days
after each budget period and the final SF-269 must be verified from the
grantee records on how the value was derived. Grantees are allowed a
reasonable period of time in which to submit financial and performance
reports.
Failure to submit required reports within the time allowed may
result in suspension or termination of an active grant, withholding of
additional awards for the project, or other enforcement actions such as
withholding of payments or converting to the reimbursement method of
payment. Continued failure to submit required reports may result in one
or both of the following: (1) The imposition of special award
provisions; and (2) the non-funding or non-award of other eligible
projects or activities. This applies whether the delinquency is
attributable to the failure of the grantee organization or the
individual responsible for preparation of the reports.
[[Page 74024]]
VII. Agency Contact(s)
1. Questions on the programmatic and technical issues may be
directed to: Mary E. Trujillo, Program Specialist, Telephone No.: 301-
443-7821. Fax No.: 301-443-1050. E-mail: metrujil@hqe.ihs.gov.
2. Questions on grants management and fiscal matters may be
directed to: Patricia Spotted Horse, Grants Management Specialist,
Telephone No.: 301-443-5204. Fax No.: 301-443-9602. E-mail:
pspotted@hqe.ihs.gov.
VIII. Other Information
The Public Health Service (PHS) strongly encourages all grant and
contract recipients to provide a smoke-free workplace and promote the
non-use of all tobacco products. In addition, Public Law 103-227, the
Pro-Children Act of 1994, prohibits smoking in certain facilities (or
in some cases, any portion of the facility) in which regular or routine
education, library, day care, health care or early childhood
development services are provided to children. This is consistent with
the PHS mission to protect and advance the physical and mental health
of the American people.
Dated: December 7, 2005.
Robert G. McSwain,
Deputy Director, Indian Health Service.
[FR Doc. E5-7280 Filed 12-13-05; 8:45 am]
BILLING CODE 4160-16-P
