[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Notices]
[Page 33154-33165]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn05-53]
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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/).
Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.
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
[[Page 33156]]
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
[[Page 33157]]
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: PGOTIM@cdc.gov.
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: OER@cdc.gov.
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 pgotim@cdc.gov.
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: PGOTIM@cdc.gov.
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:
BColleyGilbert@cdc.gov.
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: OER@cdc.gov.
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: SDawson@cdc.gov.
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,
http://www.whitehouse.gov/omb/query.html? col=omb&qt=Releasing+and+
Sharing+of+Data and Freedom of Information Act (FOIA),
http://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