[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33146-33154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11254]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Breast and Prostate Cancer Data Quality and Patterns of Care
Study
Announcement Type: New.
Funding Opportunity Number: CDC-RFA-DP05-071.
Catalog of Federal Domestic Assistance Number: 93.395.
Key Dates:
Release Date: May 11, 2005.
Letters of Intent Receipt Date: May 27, 2005.
Application Receipt Date: June 28, 2005.
Earliest Anticipated Start Date: August 31, 2005.
Expiration Date: June 29, 2005.
Due Dates for E.O. 12372:
Not applicable.
I. Funding Opportunity Description
Executive Summary
This RFA will support up to six registries to conduct
enhanced surveillance and operations research utilizing population-
based data from the National Program of Cancer Registries (NPCR). The
research will focus on improving the completeness, timeliness, quality,
and use of first course of treatment and stage data, and on describing
patterns of care for female breast cancer and prostate cancer. A long
term goal is to strengthen the capacity of NPCR funded state cancer
registries to use their data to improve aspects of cancer care.
It is estimated that approximately $2 million will be
available each year to fund up to six registries. A total of
approximately $6 million will be available for the entire three year
project period.
This funding opportunity will use the cooperative
agreement funding mechanism (CDC U58).
Eligible organizations include NPCR funded cancer
registries, or their designated agent, meeting United States Cancer
Statistics (USCS) publication criteria for the diagnosis year 2000 or
2001. For-profit organizations, non-profit organizations, public and
private institutions, units of State government, and domestic
institutions that can provide evidence of an active collaboration with
their respective NPCR funded cancer registry are also eligible to
apply.
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 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
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
I. Funding Opportunity Description
The purpose of this RFA is to support research focused on two
priority cancers, female breast cancer and prostate cancer, which will
build on and expand the work of two Patterns of Care (PoC) projects
conducted collaboratively by CDC and selected state cancer registries.
This program addresses the ``Healthy People 2010'' focus areas of
Access to Quality Health Services and Cancer.
Measurable outcomes of the program will be in alignment with the
following performance goals for the National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP): (1) To improve the quality
of state-based cancer registries, (2) to increase early detection of
breast and cervical cancer by building nationwide programs in breast
and cervical prevention, especially among high-risk, underserved women,
and (3) to expand community-based breast and cervical cancer screening
and diagnostic services to low income, medically underserved women. For
women diagnosed with cancer or pre-cancer, ensure access to treatment
services.
1. Research Objectives
Nature of Research Opportunity
The research priorities of the Centers for Disease Control and
Prevention's (CDC) Cancer Surveillance Branch, within the Division of
Cancer Prevention and Control, are to describe the burden of priority
cancers and patterns of care among minority, rural, and other
populations and to assess the quality of these data in NPCR funded
cancer registries. This RFA builds on and extends the work of two
patterns of care (PoC) projects conducted collaboratively by CDC and
selected state cancer registries. It solicits applications in the form
of cooperative agreements to utilize data from NPCR
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funded cancer registries to perform enhanced surveillance and research
regarding patterns of care in female breast and prostate cancers.
Recently published statistics from United States Cancer Statistics:
2001 Incidence and Mortality, a joint publication of CDC and the
National Cancer Institute in collaboration with the North American
Association of Central Cancer Registries, revealed that prostate cancer
is the leading cancer diagnosed in men in the United States (U.S.) and
breast cancer is the most common form of cancer diagnosed in U.S.
women. Prostate and female breast cancers are the second leading cause
of cancer death among men and women.
Background
In 1992, Congress established the NPCR by enacting the Cancer
Registries Amendment Act (Public Law 102-515). This law, generally,
authorizes the Centers for Disease Control and Prevention to provide
funds to states and territories to: improve existing cancer registries;
plan and implement registries where they do not exist; develop model
legislation and regulations to enhance the viability of registry
operations; set data standards for data completeness, timeliness, and
quality; provide training for registry personnel; and help establish a
computerized reporting and data-processing system.
The Institute of Medicine (IOM) reported in 1999 that some
individuals with cancer were not receiving the care known to be the
most effective for their cancer diagnoses. Subsequently in 2000, the
IOM strongly recommended that information from existing data systems,
specifically NPCR, be used to assess the quality of cancer care and
variations in adherence to established standards of care in the United
States. In addition, the 2000 IOM report also documented the need to
assess the quality of data in NPCR funded registries for measuring
variations in the delivery of cancer care.
In 2001, CDC responded to the IOM report by funding the Breast,
Prostate, and Colon Data Quality and Patterns of Care study (PoC Part
1) involving eight NPCR funded cancer registries. This study was
designed to assess the quality of data collected by population-based
registries and to determine the proportion of patients diagnosed within
a certain time period who received the established, stage-specific
standard of care. The eight NPCR funded cancer registries also
participated in Phase II of the international CONCORD study, which
sought to measure and explain differences in cancer survival between
Europe, Canada, and the United States. Additionally, CDC funded three
NPCR cancer registries for a second PoC study, Ovarian Cancer Treatment
Patterns and Outcomes (PoC Part 3), which was designed to describe the
first course of treatment for ovarian cancer and to assess the effects
of physician specialty on the quality of staging and treatment data.
Scientific Knowledge To Be Achieved Through This Funding Opportunity
The research to be supported by this RFA will focus on improving
the completeness, timeliness, quality, and use of recent first course
of treatment and stage data and on describing patterns of care for two
priority cancers, female breast cancer and prostate cancer. Additional
research on the patterns of care for patients diagnosed with these two
cancers, and continued assessment of the quality and completeness of
relevant data collected by population-based cancer registries, has the
potential to influence adherence to established standards of cancer
care. A long term goal of conducting such studies is to further develop
the capacity of NPCR funded registries to engage in advanced cancer
surveillance activities that will contribute to improving aspects of
cancer care.
Experimental Approach and Research Objectives
Using a standardized protocol for data collection by the
participating NPCR funded registries, enhanced surveillance and
research will be conducted targeting female breast cancer and prostate
cancer. The four broad research objectives of this RFA are to:
(1) Determine the proportion of patients who received the
recognized standard of care for stages I through III female breast
cancer.
(2) Describe the treatment patterns for all stages of prostate
cancer.
(3) Determine the tumor, patient, provider, and health system
characteristics that are associated with different cancer treatments
for female breast and prostate cancers.
(4) Assess the completeness and quality of the stage and first
course of treatment data that are collected by cancer registries for
female breast and prostate cancers.
These four research objectives will focus on the two most recent
diagnosis years available, as determined by the Steering Committee and
defined in the study protocol.
See Section VIII, Other Information--Required Federal Citations,
for policies related to this announcement.
II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the CDC (U58) cooperative
agreement award mechanism. The award recipient 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
Requirements, ``Cooperative Agreement Terms and Conditions of Award''.
This funding opportunity uses the just-in-time budget concepts. It
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.
This RFA is a one-time solicitation. The total project period for
an application submitted in response to this RFA may not exceed three
years
2. Funds Available
The NCCDPHP intends to commit approximately $2 million in FY 2005
to fund up to six new competitive cooperative agreements in response to
this RFA. An applicant may request a project period of up to three
years and a maximum budget for total costs of $333,000 per year.
Approximately $6 million will be available for the entire three years.
The earliest anticipated start date is August 31, 2005, with three
performance periods between September 2005 and September 2008.
Although the financial plans of the NCCDPHP provide support for
this program, awards pursuant to this funding opportunity are
contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications. Continuation of awards
will be conditioned on 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.
[[Page 33148]]
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
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 Marianna
Islands, American Samoa, Guam, the 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 and populations necessary to
conduct the research activities of the RFA.
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
The following criteria will be used to determine an applicant's
eligibility:
1.a. NPCR funded cancer registries, or their designated agent,
meeting United States Cancer Statistics (USCS) publication criteria for
either diagnosis year 2000 or 2001. Publication criteria are
demonstrated through case ascertainment of >=90% with <=5% of cases
being ascertained by death certificate only, <=5% of cases missing
race, <=3% of cases missing sex and age, and >=97% of cases passing a
set of single-field and inter-field computerized edits. Funding will be
contingent on registry data meeting USCS publication criteria for
diagnosis year 2002.
1.b. NPCR funded cancer registries that have a minimum of 2,000
female breast cancer cases (stages I through III) and 2,000 prostate
cancer cases (all stages) over the two year period, as demonstrated in
Appendix E of the 2000 and 2001 publications of USCS.
2. Public or private institutions that can demonstrate an effective
and well-defined working relationship between the institution and the
NPCR funded cancer registry in that state. Evidence must be provided in
the form of a Letter of Support from the NPCR funded registry
describing the strong working relationship and assuring access to data
for the period of the study.
Investigators may submit only one application under this funding
announcement. If your application is incomplete or non-responsive to
the special eligibility 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 the submission requirements. Applicants
that request a funding amount greater than the award ceiling 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 PHS 398
Application Form 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: May 27, 2005.
Application Receipt Date: June 38, 2005.
Peer Review Date: Week of July 25, 2005.
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 deadlines. 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.
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.
[[Page 33149]]
3.A.1. Letter of Intent
CDC requests that prospective applicants send a Letter of Intent
(LOI). 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 or PA)
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 e-mailed by May 27, 2005, to:
Office of Extramural Research, NCCDPHP, Centers for Disease Control and
Prevention, 4770 Buford Highway, NE., Mailstop K-92, Atlanta, GA 30341.
Telephone: 770/488-8390. Fax: 770/488-8046. E-mail: [email protected].
3.B. Sending an Application
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-CDC-RFA DP-05-071, 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., Centers for Disease Control and
Prevention, Office of Extramural Research, NCCDPHP, 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
The general instructions in the PHS 398 should be followed;
however, applications must also include the following:
1. A work plan describing activities to meet the project goals and
objectives and demonstrating the capability to abstract the required
number of cases.
2. A personnel plan describing the team members' roles in carrying
out the objectives of the project, including the planned percent of
effort for team members.
3. A timeline that adequately demonstrates appropriate distribution
of project activities over the three year study period.
4. Letters of support from collaborating partners that provide
evidence of an active collaboration and commitment to work as full
partners.
This announcement 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.
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 United States 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 RFA will be
evaluated for scientific and technical merit by an external peer review
group convened by the NCCDPHP in accordance with the review criteria
stated below.
As part of the initial merit review, all applications will:
Undergo a selection process in which only those
applications deemed to have the highest scientific merit, generally the
top half of applications under review, will be discussed and assigned a
priority score.
[[Page 33150]]
Receive a written critique within 30 days after the
review.
Scored applications will receive a second level of 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?
Does the work plan describe activities that meet the project goals
and objectives and demonstrate the capability to abstract the required
number of cases? Does the personnel plan describe the team members'
roles in carrying out the objectives of the project? Are the PI's and
other team members' percent effort adequate for the conduct of the
study? Is a timeline provided that demonstrates appropriate
distribution of project activities over the three-year study period?
Does the applicant provide evidence of the capacity to engage in
advanced cancer surveillance activities that will ultimately contribute
to improving aspects of cancer care?
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?
Does the project have the potential to provide insights about
patterns of care in diverse racial, ethnic, geographic, socio-economic,
and other special populations?
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)?
Does the project team have expertise in cancer surveillance
research or provide evidence of recent preparation that would enhance
its successful involvement in such a project?
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?
2. A. Additional Review Criteria
Collaboration. Does the applicant provide evidence of an active
collaboration and commitment to work as full partners? Do current or
past cancer surveillance projects involve successful collaborations
between the researchers and the partnering public or private
institutions?
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 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.
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 the application is completed, the
Principal Investigator will receive a written critique called a Summary
Statement. Those applications under consideration for funding will
receive a call or email from the Grants Management Specialist (GMS) of
the Procurements and Grants Office (PGO) with 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 officer
identified in the application.
Selection of the application for award is not an authorization to
begin performance. Any cost incurred before receipt of the NoA is 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 Web site 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
[[Page 33151]]
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 at each research site will have the
primary responsibility to lead the efforts of the research team to:
1. Participate effectively within the research collaborative group,
composed of investigators from each of the research sites and CDC
investigators, to develop the specific research questions to be
addressed in the project (Section I Research Objectives, 1-4) and the
resulting standard research protocol, including the study design,
design of the instruments, development of study methods and procedures,
collection, analysis and interpretation of data, and methods for
dissemination of results.
2. Assist in the development of a research protocol for the
Institutional Review Board (IRB) review by all cooperating institutions
participating in the research project. The CDC IRB will review and
approve the protocol initially, and on at least an annual basis, until
the research project is completed.
3. Collaborate with other study investigators and follow common
protocols and manuals of operation developed by the Steering Committee.
4. Obtain an annual, updated local institutional IRB approval.
5. Assure and maintain the confidentiality of all study data.
6. Participate actively in CDC site visits designed to support and
enhance research progress and performance.
7. Participate in the analyses of aggregated study data and state-
specific data.
8. Develop and produce technical reports or manuscripts for peer-
reviewed publications.
9. Serve as a member of the Steering Committee that will provide
scientific oversight for the study.
10. Participate in national, regional, and local communication of
study development, implementation, and findings to public,
professional, and governmental organizations and agencies, through
written, oral, and electronic means.
11. Communicate state-specific findings to the public, cancer
registry, and medical and cancer control communities through
presentations and publications.
Awardees 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 and
applicable federal laws and regulations.
2. A.2. NCCDPHP Responsibilities
A NCCDPHP Project Scientist and PoC multidisciplinary team will
have substantial programmatic involvement that is above and beyond the
normal stewardship role in awards, as described below:
1. Participate in the development of the study by providing
scientific consultation and technical assistance in the development of
the research questions, study design and protocol, the development of
sampling procedures, the design of the instruments, development of
study methods and procedures, including collection, analysis, and
interpretation of data, resolution of data quality issues, and
dissemination of results.
2. Facilitate communication among recipients for the development of
a common protocol, quality control, interim data monitoring, data
analysis, interpretation of findings, reporting, and coordination of
activities, through written, oral, and electronic means.
3. Support the recipients' activities by collaborating and
providing ongoing scientific and public health consultation and
assistance in the development of activities related to the cooperative
agreement, including conducting site visits to recipient institutions.
4. Facilitate movement of the initial research protocol through the
CDC Institutional Review Board (IRB), including keeping the CDC IRB
abreast of protocol amendments, and facilitating annual reviews.
5. Participate in joint data analyses and interpretation and the
presentation and publication of findings.
6. Collaborate in producing technical reports and manuscripts for
peer-reviewed publications, as appropriate.
7. Facilitate distribution and dissemination of research findings.
8. Assure and maintain the confidentiality of all study data.
Additionally, an agency program official or the 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 following are areas of joint responsibility between the award
recipients and the NCCDPHP project team:
1. Participation in the development of a Steering Committee that
will provide scientific oversight for the study. The Steering
Committee, the main governing board of the study, will be composed of
the Principal Investigator from each research site and a NCCDPHP
Project Scientist serving as consultant. The role of chairperson will
be rotated among the Principal Investigators of the research sites. The
Principal Investigators must have proven evidence of leadership ability
and be able to make an adequate time commitment to the cooperative
agreement.
The Steering Committee, in collaboration with NCCDPHP project
scientists, 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 a common research design, protocols and
manuals of operations, facilitating the conduct and monitoring of
studies, developing policies relating to access to patient data, and
reporting study results. The Steering Committee must approve the
protocol, changes to protocols, and manuals of operation. The Principal
Investigator of each research site will be responsible for the
execution of the protocol and will provide progress reports to the
Steering Committee. The Steering Committee will establish guidelines
for presentations at scientific meetings and for writing and publishing
manuscripts on the findings of the study.
2. Identify ways to collaborate with cancer care providers and
others to use
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research findings to improve care to patients.
3. Establish agreements for sharing data.
Each full member will have one vote. Grantee members of the
Steering Committee will be required to accept and implement policies
approved by the Steering Committee.
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.
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, PhD, M.S.P.H., Centers for Disease Control
and Prevention, Office of Extramural Research, NCCDPHP, 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, Centers for Disease Control and
Prevention, Office of Extramural Research, NCCDPHP, 4770 Buford
Highway, NE., Mailstop K-92, Atlanta, GA 30341. Telephone: 770/488-
8390. E-mail: [email protected].
4. Financial or Grants Management Contacts
Lucy Picciolo, Procurements and Grants Office, Centers for Disease
Control and Prevention, Koger Office Park, Colgate Building, Mailstop
E-14, Atlanta, GA 30341-5539. Telephone: 770/488-2683. 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) Web site 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-9 Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the
collection of information from ten 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, or early childhood development services are provided
to children.
[[Page 33153]]
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. 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 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
[[Page 33154]]
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-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 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 399B of the Public Health Service Act (PHS Act), 42 U.S.C. 280e,
399C of the PHS Act, 42 U.S.C. 280e-1, 399D of the PHS Act, 42 U.S.C.
280e-2, 317(k)(2) of the 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.
Dated: May 31, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-11254 Filed 6-6-05; 8:45 am]
BILLING CODE 4163-18-P