dp13-002 foa final amendment 1 02.21.13.docx

Amendment 1 made 2.21.13:

Section I. Funding Opportunity Announcement Description, and just immediately before 3. Reference List to add: OMB/PRA requirements are expected to apply.

Part 1. Overview Information, Key Dates, Expiration date – March 5, 2013

Attachment 1 - Questions from potential applicants with answers by CDC Table of Contents

Part 1. Overview Information

Key Dates Publication Date

To receive notification of any changes to RFA-DP-13-002, return to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notification Emails” link An email address is needed for this service.

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

· Purpose. The purpose of the FOA to assist applicants with the preparation of an application that aligns with this announcement. The intent of this FOA is to study the use of medical services and health outcomes among low-income women of reproductive age (15-44 years), before and after expansions in Medicaid eligibility. This research will require linkage of state Medicaid data with other key maternal and child health datasets including, but not limited to, birth certificates, death certificates, and hospital discharge data.

· Mechanism of Support. The funding mechanism is a cooperative agreement

· Funds Available and Anticipated Number of Awards. NCCDPHP intends to commit approximately $250,000 including both direct and indirect costs in FY2013 to fund one applicant for the first 12-month budget period. An award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the number, quality, duration, and cost of the applications received.

· Budget and Project Period. An applicant may request a project period of up to five years. The estimated total funding (direct and indirect) is $250,000 for the first year (12 month budget period). The estimated total funding (direct and indirect) for the entire project period is $1,250,000. The project period will run from 09/30/2013 to 09/29/2018.

· Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

· Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.

· Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

· Number of PDs/PIs. Applications may contain more than one PI, however, the first PI listed will be the “contact PI” for all correspondence.

· Number of Applications. Eligible applicant institutions may submit only one application.

· Application Type. New

· Special Date(s). None.

· Application Materials. See Section IV.1 for application materials.

· Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (770) 488-2783.

Part 2. Full Text

Section I. Funding Opportunity Announcement Description

Statutory Authority This program is authorized under Section 317K of the Public Health Service Act, 42 U.S.C. 247b-12. OMB/PRA requirements are expected to apply.

1. Background and Purpose In 2010, 49.1 million Americans, men and women, were uninsured, 53% of whom were 19 to 34 years of age. In addition, more than half of the insured adults had incomes below 138% of the federal poverty level. The Affordable Care Act (ACA) is expected to reduce the percentage of uninsured low-income women of reproductive age, in part, by expanding the Medicaid program to cover those with incomes at or below 138% of the federal poverty level. In states that choose to expand Medicaid, this expansion will begin in 2014. In addition, in October 2010, ACA required states to cover specific tobacco cessation services without a co-pay from beneficiaries for pregnant smokers enrolled in Medicaid. Providing health insurance will address some of the problems associated with being uninsured for this group, such as access to timely preventative care, including family planning, and access to ongoing medical care for those with chronic health problems such as hypertension or depression. Continuity of care for problems identified during pregnancy is expected to improve, especially for those women who, before implementation of ACA, were eligible for Medicaid due to pregnancy, but who lost their coverage shortly after delivery.

Many chronic diseases (e.g., depression, hypertension, and diabetes) and related risk factors (e.g., smoking, obesity, and physical inactivity) manifest during the reproductive years, presenting opportunities for early intervention. Chronic diseases and related risk factors not only impact women’s long-term health, but they are also associated with adverse pregnancy outcomes such as low birth weight, preterm deliveries, and birth defects. Chronic diseases, related risk factors, and adverse birth outcomes are known to disproportionately affect low-income women (Bombard et al., 2012). Thus, taking advantage of opportunities to identify and intervene with low-income women during the reproductive years could improve their long-term and reproductive health outcomes, and could reduce health care spending.

A recent evaluation of Medicaid expansions for men and women of all ages in 3 states compared with 3 neighboring states without expansions found a significant reduction in adjusted all-cause mortality, decreased rates of uninsured residents, decreased rates of delayed care due to costs, and increased rates of “excellent” or “very good” self-reported health status (Sommers et al, NEJM, 2012). Expanding insurance coverage among women of reproductive age may have significant health benefits. Medicaid expansions resulting from implementation of ACA may improve pregnancy outcomes and also increase the use of preconception health visits, contraceptives, smoking cessation services, behavioral counseling for obesity, and treatment for depression. Data are needed to examine changes in Medicaid enrollment and use of these services to evaluate the effect of Medicaid expansion on women’s health and maternal and infant health.

In order to assess and improve health care services received by low-income women of reproductive age, integrated data systems are needed. Linking Medicaid administrative data (captures health care utilization and morbidities) to birth certificates (captures pregnancy outcomes), and to infant and fetal death certificates (captures cause of death) provides a comprehensive database for evaluation. The addition of linked hospital discharge data provides morbidity data on women and children/infants enrolled and not enrolled in Medicaid; those not enrolled in Medicaid could provide a comparison group for evaluations involving pregnancy and infant outcomes.

Healthy People 2020 and other National strategic priorities - This research addresses several “Healthy People 2020” priority area(s):

a. Tobacco use Objectives

i. TU-1 to reduce tobacco use by adults, and

ii. TU-6 to increase smoking cessation during pregnancy

b. Maternal, Infant, and Child Health Objectives

i. MICH- 1 to reduce the rate of fetal and infant deaths,

ii. MICH-8 to reduce low birth weight (LBW) and very low birth weight (VLBW),

iii. MICH-9 to reduce preterm births,

iv. MICH-10 to increase the proportion of pregnant women who receive early and adequate prenatal care, and

v. MICH-11 to increase abstinence from alcohol, cigarettes and illicit drugs among pregnant women.

vi. MICH-16 to increase the proportion of women delivering a live birth who received preconception care services and practiced key recommended preconception health behaviors

This research addresses the CDC Winnable Battle on Tobacco. In addition, this program is aligned with NCCDPHP performance goal(s) to define, conduct, and promote public health research in reproductive and infant health, and with the strategic priority, “Focus on Well-Being: Increase emphasis on promoting health and preventing risk factors, thereby reducing the onset of chronic health conditions.” This program is aligned with all three of the CDC's DRH goals: 1) improve women's reproductive health from menarche through menopause; 2) improve pregnancy health and care, and 3) improve fetal, newborn, and infant health.

Public Health Impact - Through this announcement, the CDC intends to fund one project that has the potential to yield high impact research aimed at reducing public health burden and improving population health of women of reproductive age, including pregnancy and infant health outcomes. This work will result in an improve understanding of the effect of increasing access to health care through Medicaid coverage on health care utilization and health outcomes among women of reproductive health.

2. Approach The goal of the study is to describe changes in receipt of medical services among all women of reproductive age, prevalence of pregnancy complications, pregnancy outcomes, and postpartum continuity of care before and after implementation of expansions in Medicaid eligibility. Disparities by racial/ethnic groups and socioeconomic status will also be evaluated. In addition to examining the total number and demographics of pregnant and non-pregnant women of reproductive age enrolled in Medicaid each year, the proposed study should be designed to examine changes in the prevalence of maternal health conditions and infant outcomes, and health care utilization among women of reproductive age since implementation of ACA. The prevalence of maternal health conditions and infant outcomes, and health care utilization to be examined include but are not limited to the following:

Prevalence

· Hypertension

· Obesity

· Smoking

· Pre-gestational and gestational diabetes

· Anxiety and depression

· Preterm, and small- and large-for-gestational age infants

· Fetal death

· Infant death

Health care utilization among women of reproductive age and infants

· Maternal hospitalization during pregnancy and re-hospitalization after delivery

· Trimester of enrollment in prenatal care

· Immunizations received during pregnancy

· Infant re-hospitalization after delivery

· Receipt of smoking cessation services

· Nutrition and behavioral counseling

· Substance abuse treatment

· Postpartum diabetes screening among women with a GDM-affected pregnancy

· Screening and treatment for chronic conditions (e.g. dyslipidemia, diabetes, and hypertension)

· Treatment for depression and anxiety

· Contraceptive use by method type

Objectives/Outcomes – The research objectives include the following:

Objective 1: Develop a research agenda, in collaboration with key state stakeholders (identified with the applicant’s proposal), such as state perinatal collaborative groups, and CDC collaborators, that evaluates the expansion of Medicaid on the health of Medicaid-eligible women of reproductive age, mothers, and infants in the state.

· Build consensus on key research questions to be addressed related to the evaluation of the Medicaid expansion on enrollment in program, receipt of key preventative services, and morbidity among women of reproductive age and their infants.

· Develop with CDC collaborators a research protocol to link data (see required datasets below) and to analyze linked data, and submit protocol for human subjects review.

· Develop and formalize a data sharing agreement between CDC and the applicant.

· Develop a publication agreement between CDC and the applicant.

Objective 2: Link statewide Medicaid administrative data (eligibility, enrollment, encounter, and claims data), restricted to female enrollees ages 15-44 years, and their infants, to the following statewide data sets (at a minimum): 1) live birth certificate, 2) fetal death, 3) infant death, and 4) hospital discharge data (inpatient, emergency room, and outpatient) for consecutive years beginning with 2008 and continuing with current data as they become available.

· Obtain relevant data from respective state agencies each year.

· Document state outreach and promotion of Medicaid expansions and coverage of new services for each year.

· Link data and evaluate completeness of linkage.

· Share de-identified resulting data set with CDC collaborators.

Objective 3: Conduct analyses, prepare written manuscripts and oral presentations, and distribute key findings through peer reviewed journals, to state policy and program groups, and to other relevant stakeholders.

· Develop dissemination plan.

· Develop timeline for dissemination of oral and written products.

Timeline - The general timeline for the project will consist of 3 phases over 5 years.

Phase 1: Development (Months 1-12)

· Develop the research protocol for the evaluation study and submit the protocol for human subjects review.

· Develop data sharing and publication agreements.

· Develop and test data linkage and evaluate for 2008 Medicaid data of female enrollees ages 15-44 years, and their infants, to the following data sets (at a minimum):

· live birth,

· fetal death,

· infant death, and

· hospital discharge.

Phase 2: Ongoing linkage, analyses, publications, and dissemination (Months 13-24) Finalize linkage methodology with all datasets

· Complete linkage for years 2009-most current year available.

· Assess quality of linkage and data quality.

· Address data quality issues.

· Conduct initial analysis.

· Share preliminary de-identified data and results of analyses with CDC collaborators.

Phase 3: Complete study, ongoing publications and dissemination (Months 25-60)

· Complete linkage to year 2016 data.

· Share final de-identified data set with CDC collaborators.

· Conduct analyses, write manuscripts, prepare oral presentations, distribute findings to key state stakeholders and to other states in accordance with publication agreement.

Target population - The target population of this study will be females ages 15-44 years, and their infants who are residents of the state that is identified by the funded applicant.

Collaboration/Partnerships - In addition to collaborating with CDC, it is expected that the applicant will collaborate and develop partnerships with the state Medicaid office and the agency(ies) authorized to grant access to link birth certificate, fetal death, infant death, and the hospital discharge data to Medicaid data. In addition, key maternal and child health state programs, women’s health programs, and women’s health care providers could be potential collaborators on this study.

Evaluation/Performance measurement - The applicant is expected to develop a process evaluation of key milestones of the project.

Translation plan - The application should address how research findings will be disseminated to key stakeholders in the state as well as to other states that would benefit from the knowledge gained from the study.

OMB/PRA requirements are expected to apply.

3. Reference List

Bombard J., Dietz, P. M., Galavotti, C., England, L. J., Tong, V. T., Hayes, D. K., Morrow, B. Chronic diseases and related risk factors among low-income mothers. Matern Child Health J. 2012; 16(1):60-71.

Sommers BD, Baicker K, Epstein AM. Mortality and Access to Care among Adults after State Medicaid Expansions. N Engl J Med. 2012 [Epub ahead of print].

Section II. Award Information

Application Types Allowed

New - An application that is submitted for funding for the first time.

Funds Available and Anticipated Number of Awards

NCCDPHP intends to commit approximately $250,000 (including both direct and indirect costs) in FY2013 to fund one (1) applicant for the first 12-month budget period.

An applicant may request a project period of up to five (5) years. The funding amount may be up to $250,000 (including direct and indirect costs) each year for the 2nd, 3rd, 4th, and 5th years of the project.

The estimated total funding (direct and indirect) for the entire five (5) year project period is $1,250,000.

One award will be issued under this FOA and the award is contingent upon availability of funds and a meritorious application.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($250,000), HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

There is no floor (minimum amount to be awarded) for this award.

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information Eligible Applicants

Eligible Organizations Higher Education Institutions:

· Public/State Controlled Institutions of Higher Education

· Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

· Hispanic-serving Institutions

· Historically Black Colleges and Universities (HBCUs)

· Tribally Controlled Colleges and Universities (TCCUs)

· Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education Nonprofits (Other than Institutions of Higher Education)

For- Profit Organizations Small Businesses For-Profit Organizations (Other than Small Businesses)

Governments State Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession

Other Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: 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 applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency’s existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements:

a. The proposed principal investigator or a member of the research team for this project must provide evidence that he/she has been the principal investigator or co- principal investigator on at least one study that involved data linkage of large population-based datasets. Applicant must include the abstract and reference of a report or publication in a peer-reviewed journal that demonstrates this experience.

b. Must provide evidence that the applicant will be linking Medicaid data among all female residents of a state that will expand Medicaid coverage to individuals with incomes at or below 138% of the federal poverty level by 2014. A letter from the state Medicaid office must be included stating that Medicaid will be expanding coverage to individuals at or below 138% of the federal poverty level by 2014.

c. Applicant must provide evidence that the state Medicaid office is willing to collaborate and able to share data in a timely fashion as part of this project. A letter from the state Medicaid office stating this agreement must be included.

d. The applicant must provide signed letters of support, a memorandum of agreement, or other documentation from the agency authorized to grant access to link birth certificate, fetal death, infant death, and the hospital discharge data to Medicaid data. The agreement must note all the years for which data are available and data access is granted. The applicant must also demonstrate that there are no state laws or policies that restrict the release of vital records data or hospital discharge data for the purposes of this research project, including that de-identified data can be shared with CDC collaborators.

Evidence for these criteria must be presented in Appendix A of the application.

4. Justification for Less than Maximum Competition: None

5. Responsiveness:

Evidence for these criteria must be presented in Appendix A of the application.

If your application is incomplete or non-responsive to the requirements listed in this section, it will not enter into the review process.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, http://www.grants.gov/applicants/org_step2.jsp.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and Central Contractor Registration All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM), the replacement system for the Central Contractor Registration (CCR) database. Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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 HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html).

10. Number of Applications Only one application per institution (normally identified by having a unique DUNS number) is allowed.

As defined in the HHS Grants Policy Statement, (http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded and uploaded as Attachment A from the following link: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm

Letter of Intent 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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity

The letter of intent should be sent to:

Michael A. Brown, M.P.H.

Scientific Program Official Extramural Research Program Office Centers for Disease Control and Prevention 4770 Buford Hwy, NE Mailstop F-46 Atlanta, GA 30342 Telephone: (770) 488-5118

FAX: (770) 488-7863

E-mail: mab5@cdc.gov

Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description). Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Adobe_VerB.pdf) must be followed along with any additional instructions provided in the FOA.

Introduction/Background

· Describe the total number, demographics (e.g., age, race/ethnicity, income level), and pregnancy status of Medicaid-enrolled females between the ages of 15 and 44 years in the last 4 years.

· Describe the current health status of reproductive age women who are residents of the state, including preterm rate, and rates of smoking, hypertension, diabetes and obesity among pregnant and non-pregnant women.

· Describe the current and future eligibility requirements for Medicaid enrollment.

· Describe briefly the current state Medicaid plan, including any waivers or amendments that apply to women of reproductive age.

· Describe what percent of Medicaid recipients are enrolled in a managed care organization and how that will affect availability of Medicaid encounter data.

· Describe the state’s planned approach to promote expansion of Medicaid to newly eligible women.

· Describe the research team’s experience linking Medicaid data to other large state-based databases.

· Describe the research team’s experience analyzing and disseminating health care utilization data.

· Describe past collaborations and/or demonstrated capacity to collaborate with key state agencies including but not limited to Medicaid, vital records, women’s health, and maternal and child health offices.

Specific Aims

· Specify overall aims or objectives for the research project.

Research strategy

· Describe the proposed linkage methodology including variables used in the linkage, and measures of completeness of the linkage.

· Address the quality of data linkage and validation of key study outcomes

· Describe planning process for developing a research agenda for analyzing the linked data. Describe how key stakeholders, including women’s health and maternal and child health programs in the state, and CDC collaborators will participate in development of the research agenda.

· Provide letter(s) of support from proposed state agencies that will be collaborating on this project. In addition to a commitment to collaborate, the letter of support should identify proposed roles for the agencies.

· Describe 3-5 potential key research questions that will be addressed by the data linkage.

· Describe the analytical approach to address each potential key research question

· Describe plans to share de-identified data with CDC collaborators for analyses.

· Describe how research findings will be disseminated to key stakeholders in the state as well as to other states that would benefit from the knowledge gained from this study.

· Describe expected contributions to the field (e.g., evaluation of outreach to increase Medicaid enrollment).

· Develop a process evaluation of key milestones of the project.

Staffing and Milestones for Development and Implementation Phases

· Describe experience and expertise of key proposed staff, including substantial ability to work with large data sets, to implement data linkage in this project, and to collaborate effectively with key state agencies.

· If data linkage is already done by the applicant, describe linkage methodology including variables used in the linkage, and measures of completeness of the linkage.

· Identify tasks and develop a timeline for key milestones and protocol development activities to occur in the first 12 months of the project. Include milestones and/or measurable outputs that will be used to indicate progress toward having an Institutional Review Board (IRB)-approved protocol and access to all required datasets.

· Identify key milestones and staffing needs for implementation of the project (e.g., data linkage, linkage evaluation, data cleaning, data management, data analysis, report writing).

· Provide evidence of a clear management and staffing plan for the 5-year period. Include organizational charts with key personnel on the project.

· Include in the budget planned travel for 2 staff each year to attend an annual meeting in Atlanta, GA to discuss study progress and any issues related to accomplishing project objectives.

Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/grants/guide/url_redirect.htm?id=12000).

Submission Dates and Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov/), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov. Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS at 770-488-2700; www.pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. A third and final e-mail message is generated once the applicant’s application package has passed validation and the grantor has confirmed receipt of the application.

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

1. Track his/her submission and verify the submission status (tracking should be done initially regardless of rejection or success).

0. If the status states “rejected,” do #2a or #2b.

1. Check his/her emails from both Grants.gov and eRA Commons for rejection notices.

1. If the deadline has passed, he/she should email the Grant Management Specialist listed in the FOA (pgotim@cdc.gov) explaining why the submission failed.

1. If there is time before the deadline, he/she should correct the problem(s) and resubmit as soon as possible.

Intergovernmental Review (E.O. 12372) This initiative is not subject to intergovernmental review (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11142).

Funding Restrictions All HHS/CDC awards are subject to the terms and conditions, cost principles, and other requirements described in the HHS Grants Policy Statement. Pre-award costs may be allowable as an expanded authority, but only if authorized by CDC.

Other Submission Requirements and Information

Application Submission Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically (http://grants.nih.gov/grants/guide/url_redirect.htm?id=11144).

Important reminders:

All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to CDC.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

Applicants are reminded to enter the approved Federal Wide Assurance (FWA) that the applicant has on file with the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8-digit number. Do not enter the FWA before the number. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under and appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other CDC human subject related policies described in Part II of this Application Guide and in the HHS Grants Policy Statement.

See more resources to avoid common errors and submitting, tracking, and viewing applications: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm or http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm

Upon receipt, applications will be evaluated for completeness by the CDC Procurement and Grants Office (PGO) and responsiveness by PGO and the Center, Institute or Office of the CDC. Applications that are incomplete and/or nonresponsive will not be reviewed.

Section V. Application Review Information

1. Criteria Only the review criteria described below will be considered in the review process. As part of the CDC mission (http://www.cdc.gov/about/organization/mission.htm), all applications submitted to the CDC in support of public health research are evaluated for scientific and technical merit through the CDC peer review system.

Overall Impact Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or…