Participating Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov/
Components of Participating Organizations
National Immunization Program (NIP/CDC), at http://www.cdc.gov/nip/default.htm
Title: Costs to Private Provider Participation in Immunization Information Systems (IIS)
The CDC policies, guidelines, terms, and conditions may be found at http://www.cdc.gov/od/pgo/funding/pubcommt.pdf
Authority: This program is authorized under section 317 (k) (1) [42 U.S.C. 247b (k) (1)] of the Public Health Service Act, as amended.
Announcement Type: New
Request For Applications (RFA) Number: RFA-IP-06-009
Catalog of Federal Domestic Assistance Number(s):
93.185 Immunization Research, Demonstration, Public Information and Education-Training
and Clinical Skills Improvement Projects
Key Dates
Release Date: February 22, 2006
Letter of Intent Receipt Date: March 1, 2006
Application Receipt Date: April 10, 2006
Peer Review Date: TBD
Special Emphasis Panel Review Date: TBD
Earliest Anticipated Start Date: TBD September 15, 2006
Additional Information To Be Available Date (URL Activation Date): Add Information
Here
Expiration Date: TBD
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date
Additional Overview Content
Executive Summary
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
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. CDC Responsibilities
3. Collaborative
Responsibilities
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
4. General Questions Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The CDC and NIP are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses Healthy People 2010 priority area(s) of Immunization and Infectious Diseases and is in alignment with NIP performance goal(s) to reduce the number of indigenous vaccine-preventable diseases. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
Nature of research opportunity:
NIP is soliciting investigator-initiated
research that will help expand and advance our understanding of the cost and
barriers to private provider participation in Immunization Information Systems
(IIS).
Background information that
establishes the need for the research:
One of the Healthy People objectives for
2010 is to increase to at least 95% the proportion of children less than six
years of age participating in fully operational, population-based immunization
information systems (IISs).1 Widespread provider participation
is vital to achieving the national objective. However, recent data indicate
that in 2003 approximately 44% of children aged <6 years participated in
an IIS (CDC, unpublished data). In addition, 76% of public vaccination sites
and 36% of private provider vaccination sites participated in an IIS in 2003.2
In order to increase provider participation in IISs, it is necessary to understand
the barriers to participation, including costs. Therefore, the National Immunization
Program (NIP) is promoting evaluation projects that examine costs to providers
of participation in immunization information systems.
Numerous studies have been published advocating the importance and benefits of IISs.1 Several studies have documented the impact of IISs on reducing time spent on immunization related tasks in a clinic.3 Studies have also documented potential obstacles to IIS development. Some issues include data usefulness and confidentiality; liability for data entry errors; resources required for use; provider understanding of IIS benefits; and lack of confidence in the completeness and reliability of the data to make informed decisions.4 Resources required to operate an IIS have not been studied in detail and little data exist to quantify the cost of implementing an IIS in a private pediatric practice.
1. U.S. Department of Health and Human Services. Healthy People 2010, conference edn. Washington, DC: U.S Department of Health and Human Services, 2000 (also available at: http://www.healthypeople.gov.
2. CDC. Immunization Registry Progress United States, January-December 2003. MMWR 2005; 54(29): 722-724.
3. Glazner JE, Beaty BL, Pearson KA, Lowery NE, Berman S. (2004). Using an immunization registry: effect on practice costs and time. Ambulatory Pediatrics; 4(1):34-40.
4. Boyd TD, Linkins RW et al. Assessing immunization Registry Data completeness in Bexar County Texas. Am J Prev Med 2002; 22(3);184-187.
Scientific knowledge to be achieved:
Although population-based registries have been in
development for over a decade, private provider participation in these systems
is lacking. As of 2003, only 36% of private provider vaccination sites participated
in an IIS.2 Without improved provider participation in IIS, completeness
of vaccination records within these systems will continue to be a problem,
and constitute a major barrier in convincing other providers to participate.
Currently, little is known about how providers use IIS, and the costs associated
with these activities. Findings will be used to develop strategies for reducing
IIS net costs to providers, thereby encouraging provider participation in
IISs, an important step in increasing the proportion of children less than
six years of age participating in fully operational, population-based IIS.
Objectives of this research
program:
NIP is soliciting investigator-initiated
research that will help expand and advance our understanding of the cost and
barriers to private provider participation in IIS. This study must include
both (1) examination of costs to provider participation in the IIS and (2)
strategies to reduce these costs. To promote provider participation in IIS,
the following research objectives are the focus of this solicitation:
1. Quantify the costs to health care providers of immunization related activities that are conducted through interaction with immunization information systems (IIS). These activities should include time for staff to perform duties associated with immunization assessment, administration, and documentation, particularly using the IIS for patient care and office management, tasks and time associated with transferring patient data to the IIS (via data entry or integrated data systems), and IIS ease of use.
2. Identify predictors of provider costs of participation in the IIS, including IIS and practice-level predictors.
3. Develop strategies to overcome cost barriers and enhance utilization of immunization information systems based on the predictors identified in objective two.
4. Evaluate the acceptability and feasibility of these strategies with state immunization and health department administrators responsible for improving provider participation in IIS, as well as with providers at the practice level.
Types of research and experimental
approaches that are being sought:
1. Select at least two states based on
IIS system in use.
2. Randomly select a sample of private pediatric providers from each state. The sample should be sufficient to detect the impact of IIS characteristics, available technology, practice size, staff experience with the IIS, and demographics on provider costs with 80 percent power at a five percent confidence level.
3. Develop a data collection instrument/methodology and collect data from sampled providers to assess staff productivity. Data should include: time for staff to perform duties associated with immunization assessment, administration, and documentation, time using the IIS for patient care and office management, tasks and time associated with transferring patient data to the IIS (via data entry or integrated data systems), and IIS ease of use. The awardee should also collect information on stage of adoption of the IIS at the practice level and assess staff readiness to use various IIS functions in order to capture the effects of experience with the IIS on time cost.
4. Analyze data, calculate provider cost per record, and identify factors related to provider cost of participating in an IIS.
5. Design interventions for addressing the factors related to provider costs of participation in an IIS. These interventions must address IIS and practice level factors related to enhancing utilization of immunization information systems. Interventions should involve a plan to promote collaboration between the state/ local health departments and practice-based activities as well as a plan for sustainability of these activities. Programs are expected to develop innovative strategies as well as evidence-based public health strategies based at least partially on the existing and emerging research base and careful scientific review of the literature. Effective public health strategies may include changes to the social and physical environments; health promotion, education, and information; technological advances; economic incentives and disincentives; system improvements; provider education and medical office-based improvement strategies.
6. Evaluate the feasibility and acceptability of these strategies through surveys of state immunization and health department administrators responsible for improving provider participation in IIS, as well as with providers at the practice level. Because sustainability is important, the strategy must include a plan for sustaining interventions.
7. Programs could optimize resources by coordinating and partnering with existing programs and resources in the community, surrounding areas, and the state. Collaborative partnerships with, for example, professional organizations; health care providers, employers/purchasers, and plans; Women, Infants, and Children (WIC) program; and many others are key to reaching affected populations and delivering and sustaining effective programs. Strong, cooperative linkages between clinical preventive care and community public health should be established and maintained.
8. Collaboratively disseminate research findings in peer-reviewed publications and for use in determining national policy.
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 UO1 award mechanism(s).
Specifically the assistance instrument will be a Research
Project--Cooperative Agreement.
The CDC U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC 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".
2. Funds Available
The participating CIO, the
National Immunization Program, intends to commit approximately $200,000 for both direct and indirect costs dollars
in FY 2006 to fund one awardee. The average award amount will be $200,000 for both direct and indirect costs
for the first 12-month budget period. An applicant may request a project
period of up to two years. An applicant may request up to $200,000 for the
first 12-month budget period. The approximate total project period funded
amount is approximately $400,000. The anticipated start date for new awards
is September 15, 2006.
All estimated funding amounts are subject to availability of funds.
If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
For profit organizations are not eligible under section 317 (k) (1) [42 U.S.C. 247b (k) (1)] of the Public Health Service Act, as amended.)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.
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.
To be eligible for this RFA, the Principal Investigator must have conducted economic research and published the findings in a peer-reviewed journal, and have specific authority and responsibility to carry out the proposed project. Applications from Principal Investigators who do not meet these requirements will be considered non-responsive and will not be reviewed.
2. Cost Sharing or Matching
Cost sharing, matching, and cost participation are not required.
The most current Grants Policy Statement can be found at:
http://www.cdc.gov/od/pgo/funding/pubcommt.pdf
3. Other-Special Eligibility Criteria
Applications must demonstrate effective and well-defined working relationships within the performing organization and with outside entities which will ensure implementation of the proposed activities, as evidenced by letters of support from all relevant participating organizations. Place these letters in the appendix of your application. Applications must demonstrate an overall match between the applicant's proposed theme and research objectives and the program priorities as described under the heading, Research Objectives.
Principal Investigators are encouraged
to submit only one grant application in response to this RFA. However, applicants
may submit more than one application, provided they are scientifically distinct.
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.
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. For further assistance contact GrantsInfo, Telephone (301)
710-0267, Email: GrantsInfo@nih.gov.
CDC Telecommunications for the
hearing impaired: TTY 770-488-2783.
2. Content and Form of Application Submission
Applications must be prepared using the most current PHS 398 research grant
application instructions and forms. Failure to comply with PHS 398 requirements
may result in a non-responsive determination. Applications must have a Dun
& Bradstreet (D&B) Data Universal Numbering System 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
All requested information must be received in the CDC Procurement and Grants
Office by 4:00 p.m. Eastern Time on the deadline date. If you submit your
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 letter of intent and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.
Otherwise, CDC will not notify
you upon receipt of your submission. If you have a question about the receipt
of your application, first contact your courier. If you still have a question,
contact the PGO-TIMS 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. Receipt, Review and Anticipated
Start Dates
Letter of Intent Receipt Date: TBD
Application Receipt Date(s): TBD
Peer Review Date: TBD
Special Emphasis Panel Review Date:
TBD
Earliest Anticipated Start Date: September
15, 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes
the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.
The letter of intent should be sent to:
J. Felix Rogers,
PHD, MPH
Scientific Program Administrator
Office of Science, NIP
Centers for Disease
Control and Prevention
1600 Clifton Road, MS E-05
Atlanta, GA 30333
Telephone: (404) 639-6101
Fax: (404) 639-0801
Email: fxr3@cdc.gov
3.B. Sending an Application
Applications follow the PHS 398 application
instructions for content and formatting of your applications. If the instructions
in this announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement.
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and one signed photocopy in one package to:
Technical Information Management Section IP06-009
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
At the time of submission, two additional copies of the application, including the appendix
material, must be sent to:
J. Felix Rogers, PHD, MPH
Scientific Program Administrator
Office of Science, NIP
Centers for Disease
Control and Prevention
1600 Clifton Road, MS E-05
Atlanta, GA 30333
Telephone: (404) 639-6101
Fax: (404) 639-0801
Email: fxr3@cdc.gov
Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application Processing
Applications must be received on or before the
application receipt date(s) 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 and
responsiveness by NIP and PGO. Incomplete and
non-responsive applications will not be reviewed.
4. Intergovernmental Review
Your application is subject to Intergovernmental Review
of Federal Programs, as governed by Executive Order (EO) 12372. This order
sets up a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of contact
(SPOC) as early as possible to alert the SPOC to prospective applications,
and to receive instructions on your state’s process. Click on the following
link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html
5. Funding Restrictions
All CDC awards are subject to the terms and conditions,
cost principles, and other considerations described in the PHS Grants Policy
Statement.
Additional guidance can be found at CDC Grants Policy Statement at http://www.cdc.gov/od/pgo/funding/pubcommt.pdf
Restrictions, which must be taken into account while writing your budget, are as follows:
6. Other Submission Requirements
Awardees must agree to the "Cooperative Agreement
Terms and Conditions of Award" in Section VI. "Award Administration
Information".
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.
Your research plan should address activities to be conducted over the entire project period.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan
for sharing research data in their application. The data sharing policy is
available at http://www.cdc.gov/od/pgo/funding/ARs.htm
under Additional Requirements 25 Release and Sharing of Data. All investigators
responding to this funding opportunity should include a description of how
final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
PHS policy requires that grant award recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (PHS Grants
Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)
Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources will
be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each non-competing Grant Progress Report (PHS 2590, http://www.cdc.gov/od/pgo/forminfo.htm
). See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described
below will be considered in the review process.
The following will be considered in making funding
decisions:
2. Review and Selection Process
Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit by an appropriate
peer review group convened by NIP in
accordance with the review criteria stated below.
As part of the initial
merit review, all applications will:
The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness. 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.
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?
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 project include plans to measure progress toward achieving the stated
objectives? Is there an appropriate work plan included?
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?
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)?
Is there a prior history by the Principal Investigator of conducting
economic research and publishing the
findings in peer-reviewed journals?
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? Is there an appropriate degree of
commitment and cooperation of other interested parties as evidenced by letters
of support detailing the nature and extent of the involvement?
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: 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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and
Minorities 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.
2.C. Sharing Research Data
Data Sharing Plan:
The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy.
Program staff will be responsible
for the administrative review of the plan for sharing research data.
2.D. Sharing Research Resources
PHS policy requires that grant award recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication. http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be responsible for the administrative
review of the plan for sharing research resources.
The adequacy of the resources sharing
plan will be considered by Program staff of the funding organization when
making recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award
of the grant. The effectiveness of the resource sharing will be evaluated
as part of the administrative review of each non-competing Grant Progress
Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm).
See Section VI.3. Reporting .
3. Anticipated Announcement and Award Dates
TBD
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed,
the Principal Investigator will also receive a written critique called a Summary
Statement.
Those applicants under consideration for funding will
be contacted by CDC 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 recipient 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. These costs may be reimbursed only to the extent considered allowable pre-award costs. 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.
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 NoA by reference.
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 U01 an "assistance"
mechanism (rather than an "acquisition" mechanism), in which substantial
CDC programmatic involvement with the awardees is anticipated during the performance
of the activities. Under the cooperative agreement, the CDC 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 CDC as defined above.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility
for:
Planning, directing, and executing
the proposed project with CDC staff being substantially involved as a partner.
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.
2.A.2. CDC Responsibilities
A CDC Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards,
as described below.
NIP activities for this program are as follows:
1. Monitor the cooperative agreement.
2. Participate in the development, implementation and evaluation of the research project.
3. Provide technical assistance on the selection and evaluation of data collection and data collection instruments.
4. Assist in the development of research protocols for Institutional Review Boards (IRB) review. The CDC IRB will review and approve the project protocol or will defer to outside IRB, and will do so on at least an annual basis until the research project is completed.
5. Contribute subject matter expertise in the areas of epidemiological methods, statistical analysis, and economic analysis.
6. Participate in the analysis and dissemination of information, data and findings from the project, facilitating dissemination of results.
7. Facilitate an annual meeting between awardee and CDC to coordinate planned efforts and review progress.
Additionally, an agency program official or CIO 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
Not Applicable
3. Reporting
You must provide CDC with an original, plus two hard
copies of the following reports:
These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the NoA.
Although the financial plans of the CIO(s) 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.
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. Scientific/Research Contacts:
Felix Rogers, PhD, MPH
Scientific Program Administrator
Office of the Director, NIP
Centers for Disease Control and Prevention
1600 Clifton Road, MS E-05
Atlanta, GA 30333
Telephone: (404) 639-6101
Fax : (404) 639-0108
Email: fxr3@cdc.gov
2. Peer Review Contacts:
Dr. M. Chris Langub
Scientific Review Administrator
Office of the Director/Office of Public Health
Research
Centers for Disease Control and Prevention
1600 Clifton Road, MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4903
Fax: (404) 639-4903
Email: eeo6@cdc.gov
3. Financial or Grants Management
Contacts:
Ann Cole
Grants Management Specialist
Centers for Disease Control and Prevention
Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2686
Fax: (770) 488-2777
Email: jcole@cdc.gov
4. General Questions Contacts:
Sharron Orum
Grants Managements Specialist
Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
Email: PGOTIM@cdc.gov
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) require that applications
and proposals involving human subjects must be evaluated with reference to
the risks 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).
Additional CDC Requirements under AR-1 Human Subjects Requirements can be
found on http://www.cdc.gov/od/pgo/funding/ARs.htm.
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.
Executive Order 12372 Review
Applications are subject to Intergovernmental
Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The
order sets up a system for State and local governmental review of proposed
Federal assistance applications. Applicants should contact their State single
point of contact (SPOC) as early as possible to alert the SPOC to prospective
applications and to receive instructions on the State process. For proposed
projects serving more than one State, the applicant is advised to contact
the SPOC for each State affected.
Click on the following link to get the current SPOC list http://www.whitehouse.gov/omb/grants/spoc.html
Indian tribes must request tribal government review of their applications.
SPOCs or tribal governments that have recommendations about an application submitted to CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:
Sharron Orum, Grants Management Specialist
Procurement and Grants Office
Announcement Number IP06-009
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146
CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.
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:
1. A description of the population to be served.
2. A summary of the services to be provided.
3. 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.
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).
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.
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.
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.
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.
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.
Conference Support
The purpose of conference support funding is to provide PARTIAL support
for specific nonfederal conferences in the areas of health promotion and disease
prevention information/education programs. Because conference support by CDC
creates the appearance of CDC co-sponsorship, there will be active participation
by CDC in the development and approval of those portions of the agenda supported
by CDC funds. CDC funds will not be expended for non-approved portions of
meetings. In addition, CDC will reserve the right to approve or reject the
content of the full agenda, press events, promotional materials (including
press releases), speaker selection, and site selection. Contingency awards
will be made allowing usage of only 10% of the total amount to be awarded
until a final full agenda is approved by CDC. This 10% portion will provide
funds to support costs associated with preparation of the agenda. The remainder
of funds will be released only upon approval of the final full agenda. CDC
reserves the right to terminate co-sponsorship if it does not concur with
the final agenda.
Any conference sponsored by CDC or ATSDR shall be held in facilities that are fully accessible to the public as required by the Americans with Disabilities Act Accessibility Guidelines (ADAAG). Accessibility as per ADAAG also addresses accommodations for persons with sensory impairments.
The conference organizer(s) may use CDC's name only in factual publicity for the conference, and they should understand that CDC involvement in the conference does not necessarily indicate support for the organizer's general policies, activities, products, or service.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small,
minority and women-owned business firms. The Department of Health and Human
Services is strongly committed to the objective of this policy and encourages
all recipients of its grants and cooperative agreements to take affirmative
steps to ensure such fairness. In particular, recipients should:
1. Place small, minority, women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
Research Integrity
The signature of the institution official on the face page of the application
submitted under this Funding Opportunity Announcement is certifying compliance
with the Department of Health and Human Services (DHHS) regulations in Title
42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH
MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section 93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
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/
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.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination
of any and all data collected under the CDC data sharing agreement will be
released as follows:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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