[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33154-33165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Incidence, Natural History, and Quality of Life of Diabetes in 
Youth

Part I--Overview Information

Department of Health and Human Services

Issuing Organization
    Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/ gov/).
Participating Organizations
    Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/ gov/).
    National Institutes of Health (NIH), (http://www.nih.gov/).
Components of Participating Organizations
    National Center for Chronic Disease Prevention and Health Promotion 
(NCCDPHP), (http://www.cdc.gov/nccdphp/), Division of Diabetes 
Translation (DDT), (http://www.cdc.gov/diabetes/).
    National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), (http://www.niddk.nih.gov/).
    Title: Incidence, Natural History, and Quality of Life of Diabetes 
in Youth.
    Announcement Type: New.
    Request For Applications (RFA) Number: RFA-DP-05-069.
    Catalog of Federal Domestic Assistance Number: 93.945.
    Key Dates: Release Date: May 11, 2005.
    Letters of Intent Receipt Date: May 25, 2005.
    Application Receipt Date: June 24, 2005.
    Earliest Anticipated Start Date: August 31, 2005.
    Expiration Date: June 25, 2005.
    Due Dates for E.O. 12372: Not Applicable.

Additional Overview Content

Executive Summary

     This RFA has two components, A and B:
    Component A solicits applications for conducting multi-center, 
population-based research studies aimed at: assessing the incidence and 
secular trends of diabetes in youth; enhancing our knowledge of the 
natural history of diabetes and its complications in children; 
conducting research on health care utilization, processes of care, and 
quality of life of youth with diabetes;

[[Page 33155]]

and developing and validating classification schemes of diabetes in 
youth suitable for public health surveillance.
    Component B solicits applications for a study Coordinating Center 
(CC) to provide the data management and analysis to support this multi-
center research study.
     The participating organizations plan on contributing $4.1 
million in FY 2005 to fund up to six new cooperative agreement awards 
for Component A and one cooperative agreement award for Component B.
     This funding opportunity will use the cooperative 
agreement funding mechanism (CDC U58).
     Applications may be submitted by: for-profit 
organizations, non-profit organizations; public or private institutions 
such as universities, colleges, hospitals, and laboratories; units of 
State government; domestic institutions; and faith- or community-based 
organizations, including Native American tribal organizations.
     Any individuals with the skills, knowledge, and resources 
necessary to carry out the proposed research are invited to work with 
their institution to develop an application for support. Individuals 
from underrepresented racial and ethnic groups, as well as individuals 
with disabilities, are always encouraged to apply for CDC funding 
announcements.
     An applicant may submit only one application for either 
Component A or B, but not both under this funding announcement.
     Applications must be prepared using the ``Application for 
a DHHS Public Health Service Grant'' (PHS 398, rev. 9/04). The PHS 398 
instructions and forms are available at http://grants.nih.gov/grants/forms.htm.
     Telecommunications for the hearing impaired is available 
at: TTY 301-451-0088.

Table of Contents

Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
    1. Research Objectives
Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available
Section III. Eligibility Information
    1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
    2. Cost Sharing or Matching
    3. Other--Special Eligibility Criteria
Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
    1. Letter of Intent
    B. Sending an Application to the CDC
    C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements
Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
    1. Principal Investigator Rights and Responsibilities
    2. NCCDPHP Responsibilities
    3. Collaborative Responsibilities
    4. Arbitration Process
    3. Reporting
Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/Grants Management Contact(s)
Section VIII. Other Information--Required Federal Citations

Part II--Full Text of Announcement

Section I. Funding Opportunity Description

    The purpose of this RFA is to support research that will expand the 
preliminary findings of a five year research project, SEARCH for 
Diabetes in Youth, and enhance our understanding of the natural 
history, complications, and risk factors of diabetes mellitus with 
onset in childhood and adolescence. This program addresses the 
``Healthy People 2010'' focus area of Diabetes.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Chronic Disease 
Prevention and Health Promotion (NCCDPHP): To increase the capacity of 
state diabetes control programs to address the prevention of diabetes 
and its complications at the community level.

1. Research Objectives

Nature of the Research Opportunity
    This RFA builds upon a five year research project, SEARCH for 
Diabetes in Youth, and solicits applications in the form of cooperative 
agreements to conduct research that will expand the preliminary 
findings from SEARCH and enhance our understanding of the natural 
history, complications, and risk factors of diabetes mellitus with 
onset in childhood and adolescence. A second component of this RFA is 
the funding of a data management, analysis, and study Coordinating 
Center (CC) that will collaborate with award recipients and the 
NCCDPHP.
Background
    Diabetes mellitus, a leading cause of end-stage renal disease, 
blindness, non-traumatic amputation, and cardiovascular disease, is one 
of the most prevalent severe chronic diseases of childhood in the 
United States. Until recently, diabetes diagnosed in children and 
adolescents was almost entirely considered to be type 1, which is 
usually attributed to the destruction of the beta cells of the pancreas 
leading to an absolute deficiency of insulin. However, in the last two 
decades diabetes in children and adolescents has emerged as a complex 
disorder with heterogeneity in its pathogenesis, clinical presentation, 
and outcomes.
    In adolescents, especially those from minority race/ethnic U.S. 
groups, type 2 diabetes appears to be increasing. Type 1 diabetes 
incidence is also increasing worldwide; however, type 1 diabetes 
registries in the U.S. have reported conflicting results. Knowledge of 
the magnitude of diabetes in adolescents and children, the rate of 
increase, and the clinical course and evolution of different forms of 
diabetes in children and youth is limited.
    In 2000, CDC in collaboration with the National Institute of 
Diabetes and Digestive and Kidney Diseases (NIDDK) of the National 
Institutes of Health (NIH) under Program Announcement 00097 
(Uniform Population-Based Approach to Case Ascertainment, Typology, 
Surveillance, and Research on Childhood Diabetes) established a 5-year 
research project to assess the burden of diabetes with onset in 
childhood and adolescence in the U.S. The goals of this project (now 
called SEARCH for Diabetes in Youth) were to: (1) Identify prevalent 
and incident cases of diabetes among individuals under age 20 years in 
order to estimate population prevalence and incidence rates; (2) 
develop gold standards for the classification of diabetes type in 
youth; and (3) describe and compare clinical presentation and 
characteristics of type 1, type 2, and other types of diabetes.
    Six SEARCH research centers, located across the U.S., were funded 
to conduct this study. Approximately 5.5 million children aged < 20 
years (6% of the <20 years U.S. population), with wide racial/ethnic, 
socioeconomic, and geographic representation, have been under 
surveillance at the SEARCH

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research centers to estimate diabetes prevalence and incidence by age, 
sex, race/ethnicity, and diabetes type.
Scientific Knowledge To Be Achieved Through this Funding Opportunity
    Data from SEARCH reveal important preliminary findings that warrant 
further scientific study:
     The incidence of diabetes in U.S. youth is higher at all 
the SEARCH sites and among all age groups than had been expected based 
on estimates from previous diabetes registries. However, this does not 
necessarily imply that the incidence has increased. Differences in case 
definition and in ascertainment methodology, or changes in screening 
patterns, may partly explain the higher incidence estimated by SEARCH. 
In order to assess temporal trends, it is necessary to monitor diabetes 
incidence in youth for a longer period of time using consistent 
methodology for case ascertainment and classification.
     Some subjects not only exhibit the clinical features of 
type 2 diabetes, but also have positive diabetes autoantibody status (a 
characteristic of type 1 autoimmune diabetes). This finding 
demonstrates the limits of the current diabetes classification scheme 
in youth and the need to better understand the natural history and 
long-term evolution of diabetes in youth, especially those with 
features of both type 1 and type 2 diabetes.
    This RFA will fund research that will expand our understanding of 
the natural history, complications, and risk factors of diabetes with 
onset in childhood and adolescence. Additional research will also 
provide consistency and ensure sustainable and simplified criteria for 
case ascertainment and classification for surveillance purposes, across 
centers, across populations, and over time. This approach will 
constitute an essential basis for assembling large numbers of incident 
cases for additional clinical, epidemiological, health care, or 
therapeutic research into childhood diabetes.
Experimental Approach and Research Objectives
    Using an established standardized multi-center, population-based 
approach in a diverse population, the objectives of this research 
program under Component A are to:
     Assess the incidence of diabetes with onset in childhood 
and adolescence by age, gender, and race/ethnicity.
     Describe the natural history of diabetes in youth, 
including the occurrence of diabetes micro- and macro-vascular 
complications and their risk factors.
     Assess the impact of quality of diabetes care in youth on 
short- and long-term diabetes outcomes, including quality of life.
     Develop and validate simple and low-cost case definition 
and classification of diabetes in youth that can be used for public 
health surveillance.
    Component B will establish a data management, analysis, and study 
Coordinating Center (CC) to collaborate with award recipients from 
Component A and with the NCCDPHP. The objectives of this research 
program under Component B are for the CC to:
     Create and maintain a central data repository and create 
protocols and mechanisms to secure transmission of data and relevant 
data management reports between the CC and the study sites.
     Ensure the training and certification of staff at the 
study sites on measurement and study procedures as outlined in the 
protocol and manual of operations.
     Provide statistical and other analytic support to the 
multi-center study.
     Act, directly or through a subcontractor, as a central 
laboratory for the analyses of specimens from the study sites and 
ensure rapid transmission of the results.
    See Section VIII, Other Information--Required Federal Citations, 
for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

    This funding opportunity will use the CDC (U58) cooperative 
agreement award mechanism for both Component A and B. The applicant 
will be solely responsible for planning, directing, and executing the 
proposed project. In the cooperative agreement mechanism, the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NCCDPHP 
staff being substantially involved, as a partner with the Principal 
Investigator, as described under the Section VI. 2. Administrative and 
National Policy Requirements, ``Cooperative Agreement Terms and 
Conditions of Award''.
    This funding opportunity uses the just-in-time budget concepts. It 
requires the summary budget information provided in the application 
package, including the budget justification and support, written in the 
form, format, and the level of detail as specified in the budget 
guidelines. You may access the latest version of the budget guidelines 
by accessing the following web site: http://www.cdc.gov/od/pgo/funding/budgetguide2004.htm.
    This RFA is a one-time solicitation. The total project period for 
an application submitted in response to this RFA may not exceed five 
years.

2. Funds Available

    The participating organizations, NCCDPHP and NIDDK, intend to 
commit approximately $4.4 million in FY 2005 to fund up to six 
competitive cooperative agreements under Component A and one 
competitive cooperative agreement under Component B in response to this 
RFA. An applicant under Component A may request a project period of up 
to five years and a budget for total costs between $450,000 and 
$650,000 per year. An applicant under Component B may request a project 
period of up to five years and a budget for total costs up to $1.1 
million per year.
    The earliest anticipated start date is August 31, 2005 with 
performance periods between September 2005 and September 2010.
    Although the financial plans of the NCCDPHP and NIDDK provide 
support for this program, awards pursuant to this funding opportunity 
are contingent upon the availability of funds, evidence of satisfactory 
progress by the recipient (as documented in required reports), and the 
determination that continued funding is in the best interest of the 
Federal Government.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions
    You may submit an application if your organization has any of the 
following characteristics:

 Public nonprofit organizations
 Private nonprofit organizations
 For profit organizations
 Universities
 Colleges
 Research institutions
 Hospitals
 Community-based organizations
 Faith-based organizations
 Federally recognized Indian tribal governments
 Indian tribes
 Indian tribal organizations
 State and local governments or their Bona Fide Agents (this 
includes the District of Columbia, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Mariana Islands, 
American Samoa, Guam, the

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Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau)

    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.
    Institution eligibility is limited to those with broad research 
capacity and access to the data sources that are representative of the 
overall U.S. population, including the specific populations targeted in 
this announcement.

1.B. Eligible Individuals

    Any individual with the skills, knowledge, and resources necessary 
to carry out the proposed research is invited to work with their 
institution to develop an application for support. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for CDC programs.

2. Cost Sharing or Matching

    Cost sharing is not required.

3. Other--Special Eligibility Criteria

    For Component A, the following criteria will be used to determine 
an applicant's eligibility:
     Access to a research infrastructure and an established 
population-based childhood diabetes registry. Evidence should be 
provided in the form of summaries of existing data collected in the 
last five years which shows incidence and prevalence of diabetes in 
youth by age, sex, race/ethnicity, and diabetes type. In addition, a 
description of an already established cohort of youth with diabetes 
including age, race/ethnicity, socio-economic status, and diabetes type 
distribution should be included.
     Experience in the recruitment and retention of youth with 
diabetes, especially those from older adolescent populations, racial/
ethnic minorities, and socio-economic disadvantaged populations.
     A minimum of five years experience collaborating with 
other partners in a multi-center study that included a common protocol, 
development of methods and procedures, design of instruments, the 
collection, analysis and interpretation of data, and dissemination of 
results. Evidence of previous collaborations with other institutional 
partners should be provided in the form of letters of support, 
publications, reports, and abstracts.
    For Component B (Coordinating Center), the following criteria will 
be used to determine an applicant's eligibility:
     A minimum of five years experience in directing and 
operating a coordinating center for collaborative, population-based, 
large-scale epidemiological research projects that included 
coordination of multi-site studies, development of training/
certification programs, monitoring site performance and progress of 
studies, and providing governance support.
     Experience in providing data management, analysis, and 
statistical support to multi-site research studies that included 
development and management of a multi-site database, the design, 
analysis, and interpretation of data, and the development/production of 
data summaries and statistical reports.
     Experience with working with centralized laboratories and 
tracking of specimens.
    Investigators may submit one application for either Component A or 
B, but not both under this funding announcement.
    If your application is incomplete or non-responsive to the special 
requirements listed in this section, it will not be entered into the 
review process and you will be notified that your application did not 
meet submission requirements. Applicants that request a funding amount 
greater than the ceiling of the award range will be considered non-
responsive.

    Note: Title 2 of the United States Code Section 1611 states that 
an organization described in Section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information

1. Address To Request Application Information

    The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format. Applicants must use the currently approved version of the PHS 
398. If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770/488-2700, E-mail: [email protected].

2. Content and Form of Application Submission

    Applications must be prepared using the most current PHS 398 
research grant application instructions and forms. Applications must 
have a D&B Data Universal Numbering System (DUNS) number as the 
universal identifier when applying for Federal grants or cooperative 
agreements. The D&B number can be obtained by calling 866/705-5711 or 
through the web site at http://www.dnb.com/us/. The D&B number should 
be entered on line 11 of the face page of the PHS 398 form.
    The title and number of this funding opportunity must be typed on 
line 2 of the face page of the application form and the YES box must be 
checked.

3. Submission Dates and Times

    Applications must be received on or before the receipt date 
described below (Section IV.3.A).
3.A. Receipt, Review and Anticipated Start Dates
    Letter of Intent Receipt Date: Add Information Here.
    Application Receipt Date: Month XX, 2005.
    Peer Review Date: Add Information Here.
    Earliest Anticipated Start Date: August 31, 2005.
    Explanation of Deadlines: All requested information must be 
received in the CDC Procurement and Grants Office by 4 p.m. Eastern 
Time on the deadline date.
    If you submit your LOI or application by the United States Postal 
Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives your submission after closing due to: (1) Carrier 
error, when the carrier accepted the package with a guarantee for 
delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the submission as having 
been received by the deadline.
    This announcement is the definitive guide on LOI and application 
content, submission address, and deadline. It supersedes information 
provided in the application instructions. If your application does not 
meet the deadline above, it will not be eligible for review, and will 
be discarded. You will be notified that you did not meet the submission 
requirements.

[[Page 33158]]

    CDC will not notify you upon receipt of your submission. If you 
have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770/488-2700. Before calling, please wait two to three days 
after the submission deadline. This will allow time for submissions to 
be processed and logged.
3.A.1. Letter of Intent
    CDC requests that you send a Letter of Intent (LOI) if you intend 
to apply for this funding announcement. Although an LOI is not 
required, is not binding, and does not enter into the review of a 
subsequent application, the information that it contains allows NCCDPHP 
staff to estimate the potential reviewer workload and plan the review.
LOI Format
     Two page maximum, one side only
     One-inch margins, 12 point font, single spaced
LOI Contents
     Number and title of this funding opportunity (RFA)
     Descriptive title of proposed research
     Name, address, e-mail, and telephone number of the 
Principal Investigator
     Names of other key personnel
     Participating Institutions
The LOI should be mailed, faxed, or emailed by Month XX, 2005 to
    Office of Extramural Research, NCCDPHP, Centers for Disease Control 
and Prevention, 4770 Buford Highway NE, Mailstop K-92, Atlanta, GA 
30341. Phone: 770/488-8390. Fax: 770/488-8046. E-mail: [email protected].
3.B. Sending an Application to the CDC
    Applications must be prepared using the PHS 398 research grant 
application instructions and forms as described above. Submit a signed, 
typewritten original of the application, including the checklist, and 
two signed photocopies in one package to: Technical Information 
Management--RFA DP-05-069, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341.
    At the time of submission, three additional copies of the complete 
application, including the appendix material, must be sent to: Brenda 
Colley Gilbert, Ph.D., M.S.P.H., Office of Extramural Research, 
NCCDPHP, Centers for Disease Control and Prevention, 4770 Buford 
Highway NE, Mailstop K-92, Atlanta, GA 30341. FedEx Address: Brenda 
Colley Gilbert, Ph.D., M.S.P.H., Office of Extramural Research, 
NCCDPHP, Koger Center/Williams Building, 2877 Brandywine Road, Room 
5516, Atlanta, GA 30341.
    For further assistance contact the CDC Procurement and Grants 
Office, Technical Information Management Section: Telephone 770/488-
2700, E-mail [email protected].
3.C. Application Processing Applications must be received on or before 
the application receipt date described above (Section IV.3.A.). If an 
application is received after that date, it will be returned to the 
applicant without review.
    Upon receipt, applications will be evaluated for completeness by 
the Procurement and Grants Office (PGO) and responsiveness by the 
NCCDPHP. Incomplete and non-responsive applications will not be 
reviewed.

4. Intergovernmental Review

    Executive Order 12372 does not apply to this program.

5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
     Reimbursement of pre-award costs is not allowed.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.

6. Other Submission Requirements

    For Component A of this RFA the general instructions in the PHS 398 
should be followed; however, the applicant should include:
     Copies of publications, reports, and abstracts on the 
epidemiology of diabetes with onset in childhood and adolescence 
authored by the Principal Investigator or co-principal investigator and 
published within the last five years.
     Plans for recruiting children and adolescents with 
diabetes and retaining them for long-term follow-up, especially those 
from racial/ethnic minorities and socio-economically disadvantaged 
populations.
     Strategies for the follow-up of the incident cases and 
prevalent cases of childhood diabetes for studying the natural history 
of the disease and the long-term impact of quality of diabetes care.
     Letters of support from collaborating partners specifying 
the commitment of the parties involved including the terms of access to 
data and populations and any specified limits to collaboration.
    For Component B (Coordinating Center) of this RFA the general 
instructions in the PHS 398 should be followed; however, the applicant 
should include:
     Evidence that the applicant has the staffing and 
facilities to implement the program at the time of the award. The cost 
of coordinating at least four annual meetings with the Principal 
Investigators of the study sites and the Steering Committee must be 
included in the budget.
     A proposed organizational structure for facilitating and 
supporting, scientifically and administratively, a collaborative, 
multi-center research study.
     Examples of materials and methods used to recruit and 
retain children and adolescents in health care research.
     A description of the research infrastructure and physical 
facilities for developing a central database.
     Examples of innovative analytic approaches to evaluating 
research data from multi-site studies.
     Examples of detailed data management and quality control 
procedures, including methods for assuring privacy and maintaining 
confidentiality, methods for sending and receiving data, descriptions 
and examples of data forms and questionnaires, and descriptions of 
software/computer programs.
     A description of the approach that will be used for 
soliciting and evaluating proposals for centralized laboratories and/or 
reading centers.
    Principal Investigators must include a research plan of the 
activities to be conducted over the entire project period and a Data 
Release Plan that addresses the dissemination of any and all data 
collected in their application. This announcement also requires summary 
budget information provided in the application package, including the 
budget justification and support, written in the form, format, and the 
level of detail as specified in the budget guidelines. You may access 
the latest version of the budget guidelines by accessing the following 
Web site: http://www.cdc.gov/od/pgo/funding/budgetguide2004.htm.
    Projects that involve the collection of information from ten or 
more individuals and funded by cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

[[Page 33159]]

Section V. Application Review Information

1. Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals stated in Section I. Funding 
Opportunity Description of this announcement. Measures must be 
objective and quantitative, and must measure the intended outcome. 
These measures of effectiveness must be submitted with the application 
and will be an element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    The following will be considered in making funding decisions:
     Scientific merit of the proposed project as determined by 
peer review.
     Availability of funds.
     Relevance of program priorities.
    Preference may be given to applications based on evidence of 
accessibility to populations with racial/ethnic and socio-economic 
diversity necessary to achieve socio-economic and racial/ethnic 
representation of the U.S. population.

2. Review and Selection Process

    Upon receipt, applications will be reviewed for completeness by PGO 
and responsiveness by the NCCDPHP. Incomplete and/or non-responsive 
applications will not be reviewed. Applicants will be notified that 
their application did not meet submission requirements.
    Applications that are complete and responsive to the announcement 
will be evaluated for scientific and technical merit by an external 
peer review group in accordance with the review criteria stated below.
    As part of the initial merit review, all applications will:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score.
     Receive a written critique within 30 days after the 
review.
    Scored applications will receive a second level review by the 
NCCDPHP Secondary Review Committee. The review process will follow the 
policy requirements as stated in the GPD 2.04 [http://198.102.218.46/doc/gpd204.doc].
    The following review criteria will be addressed and considered in 
assigning the overall score, weighting them as appropriate for each 
application. Note that an application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score. For example, an investigator may propose 
to carry out important work that by its nature is not innovative but is 
essential to move a field forward.
    1. Significance. Does this study address an important problem? If 
the aims of the application are achieved, how will scientific knowledge 
or clinical practice be advanced? What will be the effect of these 
studies on the concepts, methods, technologies, treatments, services, 
or preventative interventions that drive this field?
    2. Approach. Are the conceptual or clinical framework, design, 
methods, and analyses adequately developed, well integrated, well 
reasoned, and appropriate to the aims of the project? Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?
    For Component A: Does the application adequately describe: (a) The 
population source (including size, age, ethnicity, medical insurance 
status, socio-economic status, and geographic distribution); (b) the 
partnership/network(s) which will provide access to information on the 
cases of diabetes within this population source; (c) access to racial 
and ethnic minority and socio-economically disadvantaged populations; 
(d) data sources (hospital and non-hospital) that will be used; (e) how 
the population size (denominator) will be ascertained for estimation of 
incidence and secular trends over the five years of study; and (f) 
strategies for the follow-up of the incident cases and prevalent cases 
of childhood diabetes for studying the natural history of the disease 
and the long-term impact of quality of diabetes care?
    For Component B: Does the applicant describe the approach that 
would be used for soliciting and evaluating proposals for centralized 
laboratories and/or reading centers?
    3. Innovation. Is the project original and innovative? For example: 
Does the project challenge existing paradigms or clinical practice; 
address an innovative hypothesis or critical barrier to progress in the 
field? Does the project develop or employ novel concepts, approaches, 
methodologies, tools, or technologies for this area?
    4. Investigators. Are the investigators appropriately trained and 
well suited to carry out this work? Is the work proposed appropriate to 
the experience level of the principal investigator and other 
researchers? Does the investigative team bring complementary and 
integrated expertise to the project (if applicable)?
    For Component A: Does the Principal Investigator or the co-
principal investigator have a history of conducting competitively 
funded peer reviewed research on the epidemiology of diabetes with 
onset in childhood and adolescence within the last five years? Is there 
evidence of prior experience in working collaboratively to carry out a 
population-based, multi-center study or standard protocol? Does the 
applicant's project team include significant expertise in pediatric 
endocrinology, epidemiology of diabetes and its micro- and macro-
vascular complications, and/or health care research?
    For Component B: Is the Principal Investigator an experienced 
biostatistician, epidemiologist, physician, or other professional with 
experience in directing a coordinating center for a collaborative, 
population-based, large-scale epidemiological research project? Does 
the applicant's project team include senior statistical staff that will 
devote substantial time to developing data analysis methods for use in 
the study? Does the applicant demonstrate experience in developing 
materials and methods for the recruitment and retention of children and 
adolescents?
    5. Environment. Does the scientific environment in which the work 
will be done contribute to the probability of success? Do the proposed 
studies benefit from unique features of the scientific environment, or 
subject populations, or employ useful collaborative arrangements? Is 
there evidence of institutional support?
    For Component A: Is there an institutional research infrastructure 
to carry out large, complex, population-based projects, as well as 
facilities to perform in-person visits, and handle and process 
biological samples?
    For Component B: Is there a description of the applicant's physical 
facilities, data management and computer resources, and facilities for 
data retrieval and storage?
2.A. Additional Review Criteria
    In addition to the above criteria, the following items will 
continue to be considered in the determination of scientific merit and 
the priority score:
    Protection of Human Subjects from Research Risk: Federal 
regulations (45

[[Page 33160]]

CFR Part 46) require that applications and proposals involving human 
subjects be evaluated and that they reference the risk to the subjects, 
the adequacy of protection against these risks, the potential benefits 
of the research to the subjects and others, and the importance of the 
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). The involvement of human subjects 
and protections from research risk relating to their participation in 
the proposed research will be assessed (see the Research Plan, Section 
E on Human Subjects in the PHS Form 398).
    Inclusion of Women, Minorities and Children in Research: Does the 
application adequately address the CDC Policy requirements regarding 
the inclusion of women, ethnic, and racial groups in the proposed 
research? This includes: (1) The proposed plan for the inclusion of 
both sexes and racial and ethnic minority populations for appropriate 
representation; (2) The proposed justification when representation is 
limited or absent; (3) A statement as to whether the design of the 
study is adequate to measure differences when warranted; and (4) A 
statement as to whether the plans for recruitment and outreach for 
study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits. Plans for the 
recruitment and retention of subjects will also be evaluated (see the 
Research Plan, Section E on Human Subjects in the PHS Form 398).
2.B. Additional Review Considerations
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. The priority 
score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award Dates

    CDC expects to make awards on or about August 31, 2005.

Section VI. Award Administration Information

1. Award Notices

    After the peer review of applications is complete, Principal 
Investigators will receive a written critique called a Summary 
Statement. Those applications under consideration for funding will 
receive a call or e-mail from the Grants Management Specialist (GMS) of 
the Procurements and Grants Office (PGO) for additional information.
    A formal notification in the form of a Notice of Award (NoA) will 
be provided to the applicant organization. The NoA signed by the Grants 
Management Officer (GMO) is the authorizing document. This document 
will be mailed and/or emailed to the institutional fiscal official 
identified in the application.
    Selection of an application for award is not an authorization to 
begin performance. Any costs incurred before receipt of the NoA are at 
the recipient's risk. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

    The Code of Federal Regulations 45 CFR Part 74 and Part 92 have 
details about policy requirements. For more information on the Code of 
Federal Regulations, see the National Archives and Records 
Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. The following 
additional requirements can be found in Section VIII. Other Information 
of this document or on the CDC website at the following Internet 
address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be 
incorporated into the award statement and will be provided to the 
Principal Investigator, as well as to the appropriate institutional 
official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
    The following special terms of award are in addition to, and not in 
lieu of, otherwise applicable OMB administrative guidelines, HHS grant 
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is 
applicable when State and local Governments are eligible to apply), and 
other HHS, PHS, and CDC grant administration policies.
    The administrative and funding instrument used for this program 
will be the cooperative agreement (CDC U58), an ``assistance'' 
mechanism (rather than an ``acquisition'' mechanism), in which 
substantial NCCDPHP programmatic involvement with the awardees is 
anticipated during the performance of the activities. Under the 
cooperative agreement, the NCCDPHP's purpose is to support and 
stimulate the recipients' activities by involvement in and otherwise 
working jointly with the award recipients in a partnership role; it is 
not to assume direction, prime responsibility, or a dominant role in 
the activities. Consistent with this concept, the dominant role and 
prime responsibility resides with the awardees for the project as a 
whole, although specific tasks and activities may be shared among the 
awardees and the NCCDPHP as defined above.
2.A.1. Principal Investigator Rights and Responsibilities
    The Principal Investigator under Component A will have the primary 
responsibility for:
    1. Participating in the Steering Committee, the primary governing 
body of the study and comprised of the Principal Investigators from 
each study site (see section 2.A.3).
    2. Establishing and maintaining networks or partnerships with 
health care providers and health care systems that have access to 
information on cases of childhood diabetes.
    3. Participating in the methodology and protocol development of the 
study, on-going data collection and follow up, quality control, data 
analysis and interpretation, and the preparation of peer-reviewed 
publications for presentation of findings.
    4. Collaborating with other study investigators and following 
common protocol(s) and manuals of operations developed by the Steering 
Committee.
    5. Maintaining an effective and adequate management and staffing 
plan.
    6. Assuring and maintaining the confidentiality of all study data.
    7. Performing joint analysis with aggregate data and communicating 
scientifically via publications, abstracts, and presentations, the main 
and secondary findings pertaining to the goals of the study.
    Awardees of Component A will retain custody of and have primary 
rights to the data and software developed under these awards, subject 
to Government rights of access consistent with current HHS, PHS, and 
CDC policies.
    The Principal Investigator under Component B (Coordinating Center) 
will have the primary responsibility for:
    1. Promoting and facilitating a multi-center and collaborative 
environment among the award recipients.
    2. Facilitating the formation of a Steering Committee (SC) 
consisting of the Principal Investigators from each study site. The SC 
will have a minimum of four meetings each year and regular 
teleconferences throughout the year. The SC may create sub-committees 
as appropriate to accomplish its goals.
    3. Coordinating the statistical analyses and data management 
aspects of the study. The CC will have both scientific and 
administrative functions.
    4. Reviewing the study protocol and assisting in the development of 
the statistical design for the multi-center study, analyzing study 
results, and reviewing all manuscripts for statistical considerations. 
Based on input from the

[[Page 33161]]

Steering Committee, the CC will prepare and update the protocols and 
manuals of operation, provide materials to aid in patient recruitment 
and retention, and ensure the training and certification of staff at 
the study sites as outlined in the study protocol.
    5. Establishing a database to accommodate data generated by each 
study site, developing a data transmission system, and assessing data 
quality and completeness throughout the study. The CC will provide for 
central registration of all individuals enrolled in the study.
    6. Establishing, directly or through subcontracts, central 
laboratories and reading centers, as determined by the Steering 
Committee.
    7. Providing statistical reports on the progress of the study at 
Steering Committee meetings and facilitating communication among 
investigators, including scheduling meetings and conference calls, 
developing agendas and documenting minutes, and maintaining membership 
rosters and committee lists.
    The Principal Investigator of the CC will be a member of the 
Steering Committee. The Coordinating Center will not retain custody of 
or have primary rights to the data and software developed under this 
award. Primary rights to collected data will remain with the awardees 
under Component A.
2.A.2. NCCDPHP Responsibilities
    For both Component A and B, a NCCDPHP Project Scientist will have 
substantial programmatic involvement that is above and beyond the 
normal stewardship role in awards, as described below:
    1. Support the grantees' activities by collaborating and providing 
scientific and public health consultation and assistance in the 
development of activities related to the cooperative agreement.
    2. Assist in facilitating communication among grantees' for the 
development of common multi-center protocol(s), quality control, 
interim data monitoring, data analysis, interpretation, reporting, and 
coordination.
    3. Ensure adherence of human subjects requirements, and approval of 
study protocol by appropriate local IRBs, for all cooperating 
institutions participating in the research study.
    4. Serve as a consultant to the Steering Committee.
    5. Facilitate the process for obtaining Certificates of 
Confidentiality in the form of 301(d), as appropriate.
    6. Collaborate to produce technical reports or manuscripts for 
peer-reviewed publications, as appropriate. Provide assistance for 
joint analysis with aggregate data.
    An External Advisory Committee (EAC) will be appointed by the 
NCCDPHP. It will consist of a Chair and scientists with expertise in 
epidemiology, biostatistics, and diabetes. Clinical scientists 
knowledgeable about diabetes, but who are not participating at a 
designated Research Center, may be invited to assess the study 
protocol.
    The EAC will evaluate the protocol proposed by the Steering 
Committee based on the importance of the question to be addressed, 
scientific merit of the experimental design, feasibility, and 
consistency with NCCDPHP mission and policies. The EAC will provide a 
written critique of the protocol and a final recommendation to the 
Steering Committee and the NCCDPHP. During the implementation phase of 
the protocol, the EAC will monitor each research center for adherence 
to the study protocol and progress towards study goals. The EAC will 
have the authority to recommend protocol or procedural changes or early 
termination of any award for poor performance.
    The EAC is advisory to both the NCCDPHP and the Steering Committee. 
The Chairperson of the Steering Committee and the Principal 
Investigator of the CC will attend annual EAC meetings.
    The CDC reserves the right to terminate or curtail the study (or an 
individual award) in the event of substantial shortfall in participant 
recruitment, follow-up, data reporting, quality control, or other major 
breach of the protocol. The CDC can also terminate or curtail the study 
(or an individual award) if human subject safety or ethical issues 
dictate a premature termination. The CDC may also terminate the project 
if there is failure to develop or implement a mutually agreeable 
collaborative protocol.
    Additionally, an agency program official or NCCDPHP program 
director will be responsible for the normal scientific and programmatic 
stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
    The Steering Committee, the main governing board of the study, will 
be comprised of the Principal Investigator from each study site, the 
Principal Investigator of the CC, and a NCCDPHP Project Scientist 
serving as consultant. A chairperson will be selected from the non-
federal Steering Committee members. The chairperson must have proven 
evidence of leadership ability and be able to make an adequate time 
commitment to the cooperative agreement.
    The Steering Committee will meet initially to develop the protocol 
and throughout the year to discuss the progress of the study. It will 
have primary responsibility for developing common research designs, 
protocols and manuals of operations, facilitating the conduct and 
monitoring of studies, and reporting study results. The Steering 
Committee must approve the protocol, changes to protocols, and manuals 
of operation. The Principal Investigator of each study site will be 
responsible for the execution of the protocol and will provide progress 
reports to the Steering Committee. The Steering Committee will also 
develop policies relating to access to patient data and specimens and 
ancillary studies. It will establish guidelines for presentations at 
scientific meetings and for writing and publishing manuscripts on the 
findings of the study.
    Each full member of the Steering Committee will have one vote. 
Grantee members of the Steering Committee will be required to accept 
and implement policies approved by the Steering Committee. To promote 
the development of a collaborative program among awardees, Principal 
Investigators are expected to attend Steering Committee meetings and 
participate in conference calls on a regular basis.

3. Reporting

    Grantees must provide CDC with an original, plus two hard copies of 
the following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC website) no less than 90 days 
before the end of the budget period. The progress report will serve as 
your non-competing continuation application and must contain the 
following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Annual Progress Report, due 90 days after the end of the budget 
period.
    3. Financial status report, no more than 90 days after the end of 
the budget period.
    4. Final financial and performance reports, no more than 90 days 
after the end of the project period.

[[Page 33162]]

    5. Data collected must be released to the public no later than two 
years after the end of the budget period as specified in the 
application's Data Release Plan and in accordance with CDC policy on 
Releasing and Sharing Data.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

Section VII. Agency Contacts

    We encourage your inquiries concerning this funding opportunity and 
welcome the opportunity to answer questions from potential applicants. 
Inquiries may fall into three areas: scientific/research, peer review, 
and financial or grants management issues:
    1. General Questions: Technical Information Management Section, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. 
Telephone: 770/488-2700. E-mail: [email protected].
    2. Scientific/Research Contacts: Brenda Colley Gilbert, Ph.D., 
M.S.P.H., Office of Extramural Research, NCCDPHP, Centers for Disease 
Control and Prevention (CDC), 4770 Buford Highway NE, Mailstop K-92, 
Atlanta, GA 30341. Telephone: 770/488-8390. E-mail: 
[email protected].
    3. Peer Review Contacts: Scientific Review Administrator, Office of 
Extramural Research, NCCDPHP, Centers for Disease Control and 
Prevention (CDC), 4770 Buford Highway NE, Mailstop K-92, Atlanta, GA 
30341. Telephone: 770/488-8390. E-mail: [email protected].
    4. Financial or Grants Management Contacts: Sylvia Dawson, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), Koger Office Park, Colgate Building, Mail-Stop E-14, 
2920 Brandywine Road, Atlanta, GA 30341-5539. Telephone: 770/488-2771. 
E-mail: [email protected].

Section VIII. Other Information

Required Federal Citations

AR-1
Human Subjects Requirements
    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
(DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) 
regarding the protection of human research subjects. All awardees of 
CDC grants and cooperative agreements and their performance sites 
engaged in human subjects research must file an assurance of compliance 
with the Regulations and have continuing reviews of the research 
protocol by appropriate institutional review boards. In order to obtain 
a Federalwide Assurance (FWA) of Protection for Human Subjects, the 
applicant must complete an on-line application at the Office for Human 
Research Protections (OHRP) website or write to the OHRP for an 
application. OHRP will verify that the Signatory Official and the Human 
Subjects Protections Administrator have completed the OHRP Assurance 
Training/Education Module before approving the FWA. Existing Multiple 
Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and 
Single Project Assurances (SPAs) remain in full effect until they 
expire or until December 31, 2003, whichever comes first.
    To obtain a FWA contact the OHRP at: http://ohrp.osophs.dhhs.gov/irbasur.htm OR If your organization is not Internet-active, please 
obtain an application by writing to: Office for Human Research 
Protections (OHRP), Department of Health and Human Services, 6100 
Executive Boulevard, Suite 3B01, MSC 7501, Rockville, Maryland 20892-
7507. (For Express or Hand Delivered Mail, Use Zip Code 20852)

    Note: In addition to other applicable committees, Indian Health 
Service (IHS) institutional review committees must also review the 
project if any component of IHS will be involved with or will 
support the research. If any American Indian community is involved, 
its tribal government must also approve the applicable portion of 
that project.

AR-2
Requirements for Inclusion of Women and Racial and Ethnic Minorities in 
Research
    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian or Alaska Native, Asian, Black or African American, 
Hispanic or Latino, Native Hawaiian or Other Pacific Islander. 
Applicants shall ensure that women, racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where clear and compelling rationale exist 
that inclusion is inappropriate or not feasible, this situation must be 
explained as part of the application. This policy does not apply to 
research studies when the investigator cannot control the race, 
ethnicity, and/or sex of subjects. Further guidance to this policy is 
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, 
and dated Friday, September 15, 1995.
AR-8
Public Health System Reporting Requirements
    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based non-
governmental organizations submitting health services applications must 
prepare and submit the items identified below to the head of the 
appropriate State and/or local health agency(s) in the program area(s) 
that may be impacted by the proposed project no later than the 
application deadline date of the Federal application. The appropriate 
State and/or local health agency is determined by the applicant. The 
following information must be provided:
    A. A copy of the face page of the application (SF 424).
    B. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not exceed one page, and include the 
following: A description of the population to be served. A summary of 
the services to be provided. A description of the coordination plans 
with the appropriate state and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the State Single Point 
of Contact (SPOC) or directly from the applicant.
AR-9

Paperwork Reduction Act Requirements

    Under the Paperwork Reduction Act, projects that involve the 
collection of information from 10 or more individuals and funded by a 
grant or a cooperative agreement will be subject to review and approval 
by the Office of Management and Budget (OMB).
AR-10
Smoke-Free Workplace Requirements
    CDC strongly encourages all recipients to provide a smoke-free 
workplace and to promote abstinence from all tobacco products. Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities that receive Federal funds in which education, library, day 
care, health care,

[[Page 33163]]

or early childhood development services are provided to children.
AR-11
Healthy People 2010
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. For 
the conference copy of ``Healthy People 2010,'' visit the internet 
site: http://www.health.gov/healthypeople.
AR-12
Lobbying Restrictions
    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier 
contractors) are prohibited from using appropriated Federal funds 
(other than profits from a Federal contract) for lobbying congress or 
any Federal agency in connection with the award of a particular 
contract, grant, cooperative agreement, or loan. This includes grants/
cooperative agreements that, in whole or in part, involve conferences 
for which Federal funds cannot be used directly or indirectly to 
encourage participants to lobby or to instruct participants on how to 
lobby.
    In addition, no part of CDC appropriated funds, shall be used, 
other than for normal and recognized executive-legislative 
relationships, for publicity or propaganda purposes, for the 
preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress or any State 
or local legislature, except in presentation to the Congress or any 
State or local legislature itself. No part of the appropriated funds 
shall be used to pay the salary or expenses of any grant or contract 
recipient, or agent acting for such recipient, related to any activity 
designed to influence legislation or appropriations pending before the 
Congress or any State or local legislature.
    Any activity designed to influence action in regard to a particular 
piece of pending legislation would be considered ``lobbying.'' That is 
lobbying for or against pending legislation, as well as indirect or 
``grass roots'' lobbying efforts by award recipients that are directed 
at inducing members of the public to contact their elected 
representatives at the Federal or State levels to urge support of, or 
opposition to, pending legislative proposals is prohibited. As a matter 
of policy, CDC extends the prohibitions to lobbying with respect to 
local legislation and local legislative bodies.
    The provisions are not intended to prohibit all interaction with 
the legislative branch, or to prohibit educational efforts pertaining 
to public health. Clearly there are circumstances when it is advisable 
and permissible to provide information to the legislative branch in 
order to foster implementation of prevention strategies to promote 
public health. However, it would not be permissible to influence, 
directly or indirectly, a specific piece of pending legislation. It 
remains permissible to use CDC funds to engage in activity to enhance 
prevention; collect and analyze data; publish and disseminate results 
of research and surveillance data; implement prevention strategies; 
conduct community outreach services; provide leadership and training, 
and foster safe and healthful environments.
    Recipients of CDC grants and cooperative agreements need to be 
careful to prevent CDC funds from being used to influence or promote 
pending legislation. With respect to conferences, public events, 
publications, and ``grassroots'' activities that relate to specific 
legislation, recipients of CDC funds should give close attention to 
isolating and separating the appropriate use of CDC funds from non-CDC 
funds. CDC also cautions recipients of CDC funds to be careful not to 
give the appearance that CDC funds are being used to carry out 
activities in a manner that is prohibited under Federal law.
AR-14
Accounting System Requirements
    The services of a certified public accountant licensed by the State 
Board of Accountancy or the equivalent must be retained throughout the 
project as a part of the recipient's staff or as a consultant to the 
recipient's accounting personnel. These services may include the 
design, implementation, and maintenance of an accounting system that 
will record receipts and expenditures of Federal funds in accordance 
with accounting principles, Federal regulations, and terms of the 
cooperative agreement or grant.
Capability Assessment
    It may be necessary to conduct an on-site evaluation of some 
applicant organization's financial management capabilities prior to or 
immediately following the award of the grant or cooperative agreement. 
Independent audit statements from a Certified Public Accountant (CPA) 
for the preceding two fiscal years may also be required.
AR-15
Proof of Non-profit Status
    Proof of nonprofit status must be submitted by private nonprofit 
organizations with the application. Any of the following is acceptable 
evidence of nonprofit status: (a) A reference to the applicant 
organization's listing in the Internal Revenue Service's (IRS) most 
recent list of tax-exempt organizations described in section 501(c)(3) 
of the IRS Code; (b) a copy of a currently valid IRS tax exemption 
certificate; (c) a statement from a State taxing body, State Attorney 
General, or other appropriate State Official certifying that the 
applicant organization has a nonprofit status and that none of the net 
earnings accrue to any private shareholders or individuals; (d) a 
certified copy of the organization's certificate of incorporation or 
similar document that clearly establishes nonprofit status; (e) any of 
the above proof for a State or national parent organization and a 
statement signed by the parent organization that the applicant 
organization is a local nonprofit affiliate.
AR-16
Security Clearance Requirement
    All individuals who will be performing work under a grant or 
cooperative agreement in a CDC-owned or leased facility (on-site 
facility) must receive a favorable security clearance, and meet all 
security requirements. This means that all awardee employees, fellows, 
visiting researchers, interns, etc., no matter the duration of their 
stay at CDC must undergo a security clearance process.
AR-22
Research Integrity
    The signature of the institution official on the face page of the 
application submitted under this Program Announcement is certifying 
compliance with the Department of Health and Human Services (DHHS) 
regulations in Title 42 Part 50, Subpart A, entitled ``Responsibility 
of PHS Awardee and Applicant Institutions for Dealing with and 
Reporting Possible Misconduct in Science.''
    The regulation places several requirements on institutions 
receiving or applying for funds under the PHS Act that are monitored by 
the DHHS Office of Research Integrity's (ORI) Assurance Program. For 
examples:
    Section 50.103(a) of the regulation states: ``Each institution that 
applies for or receives assistance under the Act for

[[Page 33164]]

any project or program which involves the conduct of biomedical or 
behavioral research must have an assurance satisfactory to the 
Secretary (DHHS) that the applicant: (1) Has established an 
administrative process, that meets the requirements of this subpart, 
for reviewing, investigating, and reporting allegations of misconduct 
in science in connection with PHS-sponsored biomedical and behavioral 
research conducted at the applicant institution or sponsored by the 
applicant; and (2) Will comply with its own administrative process and 
the requirements of this Subpart.''
    Section 50.103(b) of the regulation states that: ``an applicant or 
recipient institution shall make an annual submission to the [ORI] as 
follows: (1) The institution's assurance shall be submitted to the 
[ORI], on a form prescribed by the Secretary, * * * and updated 
annually thereafter * * * (2) An institution shall submit, along with 
its annual assurance, such aggregate information on allegations, 
inquiries, and investigations as the Secretary may prescribe.''
    An additional policy is added in the year 2000 that ``requires 
research institutions to provide training in the responsible conduct of 
research to all staff engaged in research or research training with PHS 
funds.
AR-23
Compliance With Executive Order 13279
    Faith-based organization are eligible to receive federal financial 
assistance, and their applications are evaluated in the same manner and 
using the same criteria as those for non-faith-based organizations in 
accordance with Executive Order 13279, Equal Protection of the Laws for 
Faith-Based and Community Organizations. All applicants should, 
however, be aware of restrictions on the use of direct financial 
assistance from the Department of Health and Human Services (DHHS) for 
inherently religious activities. Under the provisions of Title 45, 
Parts 74, 87, 92 and 96, organizations that receive direct financial 
assistance from DHHS under any DHHS program may not engage in 
inherently religious activities, such as worship, religious 
instruction, or proselytization as a part of the programs or services 
funded with direct financial assistance from DHHS. If an organization 
engages in such activities, it must offer them separately, in time or 
location, from the programs or services funded with direct DHHS 
assistance, and participation must be voluntary for the beneficiaries 
of the programs or services funded with such assistance. A religious 
organization that participates in the DHHS funded programs or services 
will retain its independence from Federal, State, and local 
governments, and may continue to carry out its mission, including the 
definition, practice, and expression of its religious beliefs, provided 
that it does not use direct financial assistance from DHHS to support 
inherently religious activities such as those activities described 
above. A faith-based organization may, however, use space in its 
facilities to provide programs or services funded with financial 
assistance from DHHS without removing religious art, icons, scriptures, 
or other religious symbols. In addition, a religious organization that 
receives financial assistance from DHHS retains its authority over its 
internal governance, and it may retain religious terms in its 
organization's name, select its board members on a religious basis, and 
include religious references in its organization's mission statements 
and other governing documents in accordance with all program 
requirements, statutes, and other applicable requirements governing the 
conduct of DHHS funded activities. For further guidance on the use of 
DHHS direct financial assistance see Title 45, Code of Federal 
Regulations, Part 87, Equal Treatment for Faith-Based Organizations, 
and visit the Internet site: http://www.whitehouse.gov/government/fbci/.
AR-24
Health Insurance Portability and Accountability Act Requirements
    Recipients of this grant award should note that pursuant to the 
Standards for Privacy of Individually Identifiable Health Information 
promulgated under the Health Insurance Portability and Accountability 
Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose 
protected health information to public health authorities authorized by 
law to collect or receive such information for the purpose of 
preventing or controlling disease, injury, or disability, including, 
but not limited to, the reporting of disease, injury, vital events such 
as birth or death, and the conduct of public health surveillance, 
public health investigations, and public health interventions. The 
definition of a public health authority includes a person or entity 
acting under a grant of authority from or contract with such public 
agency. CDC considers this project a public health activity consistent 
with the Standards for Privacy of Individually Identifiable Health 
Information and CDC will provide successful recipients a specific grant 
of public health authority for the purposes of this project.
AR-25
Release and Sharing of Data
    The Data Release Plan is the Grantee's assurance that the 
dissemination of any and all data collected under the CDC data sharing 
agreement will be released as follows:
    a. In a timely manner.
    b. Completely, and as accurately as possible.
    c. To facilitate the broader community.
    d. Developed in accordance with CDC policy on Releasing and Sharing 
Data, April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, 
and in full compliance with the 1996 Health Insurance Portability and 
Accountability Act (HIPPA), (where applicable), The Office of 
Management and Budget Circular A110, (2000) revised 2003, 
www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data Sharing+of+Data and Freedom of Information Act (FOIA), 
www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan. 
Applicants should provide CDC with appropriate documentation on the 
reliability of the data. Applications submitted without the required 
Plan may be ineligible for award. Award will be made when reviewing 
officials have approved an acceptable Plan. The successful applicant 
and the Program Manager will determine the documentation format. CDC 
recommends data is released in the form closest to micro data and one 
that will preserve confidentiality.

Authority and Regulations

    This program is described in the Catalog of Federal Domestic 
Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review. Awards are made under the authorization 
of 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 
247b(k)(2) and 301(a) of the PHS Act, 42 U.S.C. 241(a). All awards are 
subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement. The NIH 
Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.


[[Page 33165]]


    Dated: June 1, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 05-11253 Filed 6-6-05; 8:45 am]
BILLING CODE 4163-18-P