Part I Overview Information


Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Immunization Program (NIP/CDC), (http://www.cdc.gov/nip/default.htm)

Title: Using Immunization Information Systems to Increase Childhood Immunization Coverage

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-06-007

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 14, 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: September 15, 2006
Additional Information To Be Available Date (URL Activation Date): Add Information Here
Expiration Date: April 11, 2006

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 determine the cost-effectiveness of using centralized Immunization Information Systems (IIS) to generate reminder and recall notices for children due or overdue for vaccinations.

Background information that establishes the need for the research:

Reminder and recall systems are effective in increasing up-to-date immunization coverage among children, and are recommended by the American Academy of Pediatrics (AAP), the Advisory Committee on Immunization Practices (ACIP), and the American Academy of Family Physicians (AAFP)1-2. Since 1994, states have received 336 million CDC immunization grant dollars to develop state-based immunization information systems (IIS) or registries in the 50 states, District of Columbia, and U.S. territories. Types of IIS vary widely between states, but approximately 41 CDC immunization grantees have population-based IIS, and 53 of the grantees are equipped to generate reminder and recall notices through their IIS. However, a recent nationwide survey of Vaccines for Children (VFC) private providers enrolled in their state IIS indicated that only 14% (range of 0-26%) used the reminder-recall options available to them.3 In addition, even though most IIS have the capacity to generate automated reminder and recall notices, little is known about the cost-effectiveness of implementing these functions from a centralized registry. 

Several new vaccines have been recommended for routine administration in children in 2005, including the hepatitis A vaccine and measles-mumps-rubella–varicella vaccine (MMRV). New vaccines are anticipated including human papillomavirus vaccine [HPV] and rotavirus vaccine. As these new vaccines are added, the immunization schedule will become increasingly complex for parents and providers. Strategies to remind parents about vaccinations due or overdue are increasingly important to ensure success in implementation of new vaccines and maintain coverage for current vaccines.  Given the importance of providing parents with periodic reminders and recalls for vaccinations needed by their children, NIP is seeking to support projects that will evaluate cost-effectiveness of using registries for reminder and recall in increasing receipt of timely vaccinations and up-to-date immunization rates among children.

¹ Szilagyi, P, Vann, J et al. Interventions Aimed at Improving Immunization Rates. The Cochrane Library  2003; 4.

² Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 1998; 47:715-17.

³ Survey of private provider participation in statewide registries. Conducted by the University of Michigan’s Child Health Evaluation and Research Unit. Administered between August 2002 and June 2004.

Scientific knowledge to be achieved:

Reminder and recall is an evidence-based strategy to improve immunization coverage among preschool-aged children; however, the strategy is vastly underutilized. Many states have functioning population-based IISs that could be used to conduct reminder/recall but experience with using IISs to conduct reminder and recall of children in need of immunizations is limited.  An essential outcome of this program will be determining the costs associated with using the registry to implement the evidence-based strategy of reminder/recall. A key study outcome includes determining the cost to the state (or city) using the registry, an important detail for decision-makers and future economic analyses.    

Objectives of this research program:

NIP is soliciting investigator-initiated research that will help expand and advance our understanding of the feasibility and cost of using IIS-based reminder and recall to improve vaccination coverage of preschool-aged children that are seen by private and public providers. To assess the feasibility of using registries to conduct reminder/recall, the following objectives are the focus of this solicitation:

Research and experimental approaches that are being sought:

1. Identify an urban area (at least 20,000 annual birth cohort) with a functioning web-based public IIS that is equipped to generate reminder and recall notices. At least 25% of this urban area should be African American.  This proportion of African Americans is necessary to be able to make comparisons among racial/ethnic groups, and have enough power to find significant differences. It is currently unknown how well recall/reminder strategies work among minority populations. 

2. Develop multiple arm study (optimally at least three groups: two intervention and one control) for evaluating different reminder and recall strategies for children aged 0-36 months. Each intervention group should implement a different reminder and recall system in order to increase capacity to identify and evaluate cost-effective strategies for increasing the proportion of vaccination visits completed on-time as well as increasing up-to-date coverage rates. We suggest that at least one intervention arm should test a minimal recall strategy, such as conducting recall following six months of age and at one other age milestone during the 2nd year of life.

The study methodology should be clearly defined and should specify: child enrollment criteria, method of assignment of children to study arms, method of assessing baseline coverage status, methods for generating and distributing reminders and recalls (i.e. telephone, mail, reminders and recalls vs. recalls-only), timing of distribution of reminder and recall notices, methods for assessing timeliness of vaccinations received, timing of post-intervention evaluations, and methodology for post-intervention comparison of up-to-date coverage rates and timely receipt of vaccinations. The control group should include only children who received their most recent vaccination at a provider site where a reminder and/or recall system is not routinely used, and where use of one is not initiated during the study period. Post-intervention coverage levels should also be assessed for the control group, using the same methodology as the intervention groups.

Programs must be culturally competent, and meet the health literacy and linguistic needs of target populations in the intervention groups. Therefore, development of reminder and recall notices must reflect cultural needs of the community. The key to success of this program will be full engagement of immunization providers in the target community, as well as local health department staff.

3. Randomly assign children from the registry to intervention and control arms to be able to make appropriate comparisons.  For optimal comparability, consider randomizing children within each practice to the three study arms.  Children assigned to each arm should be representative of the population in the urban area where the project is based and should use both private and public providers for routine immunization care.  As far as possible, no children should come from provider sites currently using any reminder or recall systems to notify patients of due or past-due vaccinations. Since disparities may exist between provider sites, it is important that clinics that serve patients of higher SES be represented as well as clinics serving patients of lower SES within each intervention group. Each group should include a sufficient sample for meaningful comparisons to be made.

4. Validate or document implementation of interventions, including number of age-eligible children assigned to each study arm (intervention and control). Track the accomplishment of activities and the achievement of short-term and intermediate outcomes; monitoring changes in health outcomes; and using program evaluation findings to complete an assessment of receipt of timely immunizations within each study arm, as well as an analysis of up-to-date status, across intervention and control groups. Evaluation will determine differences in increasing receipt of age-appropriate vaccines and rate of children returning for due and/or missed immunizations between each study arm. This evaluation will include identification and collection of appropriate process measures through multiple means and will also involve direct observation of practices. In order to verify evaluation outcomes, the awardee will develop a plan for a sample of children from each study arm to receive a chart audit to verify the estimate of immunization coverage as obtained from the IIS.

5. Use data collection forms and staff flow analysis to collect and verify cost data for using the IIS to generate reminder and recall notices in the various intervention algorithms. Data collection forms will be developed to record time spent on intervention-related activities and cost of training, travel, equipment and supplies. These forms must list all intervention-related activities. The cost per child in the study, and the incremental cost of the different interventions will be calculated. The awardee will also develop plans to calculate cost-effectiveness ratios for additional children vaccinated.

6. Develop methodology to compare cost-effectiveness of different registry-based reminder and recall initiatives, as employed by each of the intervention groups.

7. Determine cost-effectiveness of interventions by comparing timely receipt of vaccinations and overall coverage levels. Comparison should be done between differing intervention groups as well as between intervention and control groups.

8. Identify the most cost-effective, feasible and potentially sustainable intervention to increase timely receipt of vaccinations, and increase overall coverage levels among children up to 36 months of age.

9. Collaboratively disseminate research findings in peer-reviewed publications and for use in supporting utilization of IIS features like reminder and recall, 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 $220,000 for both direct and indirect costs dollars in FY 2006 to fund one awardee. The average award amount will be  $220,000 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 $220,000 for the first 12-month budget period. The approximate total project period funded amount is approximately $440,000. 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 immunization-related 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.

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) 435-0714, 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: March 1, 2006
Application Receipt Date(s): April 10, 2006
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 – IP06-007

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 immunization-related 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:

1. Quarterly /Grant Progress Report, should be received no less than 20 days following the end of each quarter.

2. Annual Progress Report, due 90 days after the end of the budget period. (use form PHS 2590, OMB Number 0925-0001, rev. 9/04 as posted on the CDC website)

3. Financial status report, no more than 90 days after the end of the budget period. The progress report will serve as your non-competing continuation application.

4. Final financial and performance reports, no more than 90 days after the end of the project period.

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.

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. 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 IP06-007
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.

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

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:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. 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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