CDC-RFA-DP16-001AMENDPUBL.pdf

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

Pregnancy Risk Assessment Monitoring System (PRAMS)

RFA-DP-16-001

Application Due Date: 11/20/2015

Pregnancy Risk Assessment Monitoring System (PRAMS)

RFA-DP-16-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Office

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Pregnancy Risk Assessment Monitoring System (PRAMS) Activity Code Amendment I. made November 6, 2015

Section I.2 Approach - For Components C and D, information is added about the anticipated length of the surveys.

Section III.3 Special Eligibility Requirements - For Components A, B, D, information is added about sampling.

Section VIII. Other Information - Added Appendix A. Questions from Potential Applicants and CDC Responses

Cooperative Agreement U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-16-001

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.946 Category of Funding Activity:

Health FOA Purpose The Purpose of this FOA is to assist state public health agencies in collecting population-based data on maternal and child health indicators of high scientific quality that can be used to monitor and evaluate the impact of programs and policies that influence maternal and infant health. This will be accomplished by funding 4 separate components of activities:

1) Component A: Core Surveillance to implement the Pregnancy Risk Assessment Monitoring System (PRAMS) surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy in 50 states, and to use PRAMS survey methods and supplements to monitor emerging issues that may arise during the data collection cycle, including the response to post-disaster or pandemic surveillance needs.

2) Component B: Point-in-time Surveillance to establish a point-in-time (e.g. one time, one birth year) surveillance on selected maternal behaviors and experiences that occur prior to, during, and after pregnancy and early infancy for entities with a small birth population (<20,000 annually), a lack of electronic birth records, or inadequate resources to maintain ongoing surveillance.

3) Component C: Stillbirth Surveillance Pilot to expand Core PRAMS methods and sampling to conduct a pilot survey among women who experienced a stillbirth and provide essential data for monitoring stillbirth and related factors such as prenatal, obstetric and postpartum health care. The information collected can fill data gaps and inform efforts to prevent the occurrence of stillbirth and improve care and support to those who experience pregnancy loss.

4) Component D: Family history of breast and ovarian cancer survey to expand Core PRAMS methods and sampling to collect data on family history of breast and ovarian cancer in women who recently delivered a live birth, adding valuable information to the current surveillance, medical evaluation, and cancer prevention efforts focused on identifying populations at risk, including women of reproductive age.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-16-001, 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.

Letter of Intent Due Date: 10/26/2015 Is a LOI: Recommended but not Required

Application Due Date: 11/20/2015

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).

Scientific Merit Review: 01/20/2016

Secondary Review: 03/01/2016

Estimated Start Date: 05/01/2016

Expiration Date: 11/21/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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. This FOA solicits applications to support state public health agencies to: 1) establish or http://www.grants.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Purpose. This FOA solicits applications to support state public health agencies to: 1) establish or maintain surveillance of selected maternal behaviors and experiences that occur prior to, during, and after pregnancy in 50 states; 2) provide a high quality data source for ongoing monitoring of risk factors for maternal and infant health; 3) use PRAMS methods and survey supplements to address emerging issues that may arise during the data collection cycle, including the response to post-disaster or pandemic surveillance needs; and 4) ensure data collection results are available to inform state and national program and policies, facilitate partnerships, and demonstrate the utility of PRAMS as a data source for state and national surveillance for women who have recently had a live birth.

The activities in the FOA will be conducted under 4 separate funding components:

1) Component A: Core Surveillance to implement the Pregnancy Risk Assessment Monitoring System (PRAMS) surveillance on selected maternal behaviors and experiences that occur prior to, during, and shortly after pregnancy in 50 states by establishing new sites and maintaining existing sites, and to use PRAMS survey methods and supplements to monitor emerging issues that may arise during the data collection cycle including the response to post-disaster or pandemic surveillance needs.

2) Component B: Point-in-time Surveillance to establish a point-in-time (e.g. one time, one birth year) surveillance on selected maternal behaviors and experiences that occur prior to, during, and after pregnancy and early infancy for entities with a small birth population (<20,000 annually), a lack of electronic birth records, or inadequate resources to maintain ongoing surveillance.

3) Component C: Stillbirth Surveillance Pilot to expand Core PRAMS methods and sampling to conduct a pilot survey among women who experienced a stillbirth and provide essential data for monitoring stillbirth and related factors such as prenatal, obstetric and postpartum health care. The information collected can fill data gaps and inform efforts to prevent the occurrence of stillbirth and improve care and support to those who experience pregnancy loss.

4) Component D: Family history of breast and ovarian cancer survey to expand Core PRAMS methods and sampling to collect data on family history of breast and ovarian cancer in women who recently delivered a live birth, adding valuable information to the current surveillance, medical evaluation, and cancer prevention efforts focused on identifying populations at risk, including women of reproductive age.

Mechanism of Support. Cooperative agreement (U01) Funds Available and Anticipated Number of Awards. Total funding is expected to be $37,190,000 (direct and indirect) over the five-year project period to support up to 61 anticipated awards.

Component A (Core Surveillance):

Estimated Funding (per year): $7,000,000 Estimated Number of Awards: 50 Average amount of each award: $140,000

Component B (Point–in–Time Surveillance):

Estimated Funding (per year): $400,000 Estimated Number of Awards: 4 Average amount of each award: $100,000

Component C (Stillbirth Surveillance Pilot):

Estimated Funding (per year): $80,000 Estimated Number of Awards: 2 Average amount of each award: $40,000

Component D (Family History of Breast and Ovarian Cancer Survey):

Estimated Funding (per year): $150,000

Estimated Number of Awards: 5 Average amount of each award: $30,000

Budget and Project Period. The estimated total funding for the first year (12 month budget period) is $7,630,000.00 and the estimated total funding (direct and indirect) for the entire project period is $37,190,000. The project period for each Component of funding is as follows:

Component A (Core Surveillance): 5 years – 05/01/2016 to 04/30/2021 Component B (Point–in–Time Surveillance): 3 years – 05/01/2016 to 04/30/2019 Component C (Stillbirth Surveillance Pilot): 3 years – 05/01/2016 to 04/30/2019 Component D (Family History of Breast and Ovarian Cancer Survey): 5 years – 05/01/2016 to 04/30/2021

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 include more than one PI; however, the first PI listed on the application will be the “contact PI” for all correspondence.

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

Application Type. New Special Date(s). CDC will conduct one teleconference for prospective applicants. This session will provide information about the FOA and will answer questions pertinent to preparing applications in response to this FOA.

Teleconference Date: October 14, 2:00 – 4:30 pm EST Web link: https://webconf.cdc.gov/lfl0/13HSD4H9 Call-in Number: (855) 644-0229 Toll Free Participant Code: 997938

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

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

Information about the Pregnancy Risk Assessment Monitoring System (PRAMS) is available at http://www .cdc.gov/prams/

This funding opportunity announcement will be posted at http://www.cdc.gov/chronicdisease/about/foa.htm

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority This program is authorized under Section 317K of the Public Health Service Act, [42 U.S.C. 247b-12], as amended.

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV https://era.nih.gov/commons/index.cfm https://webconf.cdc.gov/lfl0/13HSD4H9 http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm http://www.cdc.gov/prams/ http://www.cdc.gov/prams/ http://www.cdc.gov/chronicdisease/about/foa.htm

1. Background and Purpose The Pregnancy Risk Assessment Monitoring System (PRAMS) is a surveillance project of the Centers for Disease Control and Prevention (CDC) conducted in collaboration with numerous state and local health departments that was initiated in 1987 because infant mortality rates were no longer declining as rapidly as they had in prior years (1). PRAMS allows states to collect data on maternal attitudes, behaviors and experiences before, during and after pregnancy. The states use PRAMS data to inform maternal and child health programs by monitoring health behaviors, access to care, and receipt of services. For example, PRAMS data have been used to monitor various targets in Healthy People 2020, preconception health and health care indicators, and selected performance measures for various public health programs and initiatives.There is legislative support for PRAMS as follows:

The Prematurity Research Expansion and Education for Mothers who Deliver Infants Early (PREEMIE) Act supports the use of PRAMS to track pregnancy outcomes and help prevent preterm birth. Language in other bills have also supported the use of PRAMS to collect data on health and morbidity during pregnancy (2,4).

The purpose of PRAMS is to collect state-specific, population-based data on maternal and child health indicators of high scientific quality that can inform programs and policies related to maternal and infant health. The overall goal of PRAMS is to reduce maternal and infant morbidity and mortality by collecting information that can be used to inform:

Maternal and infant health programs Health policies Maternal behaviors

This new funding cycle aims to: 1) establish or continue surveillance of selected maternal attitudes, behaviors and experiences that occur prior to, during, and after pregnancy in 50 states by establishing new PRAMS sites and maintaining existing PRAMS sites; 2) provide a high quality data source for ongoing monitoring of risk factors for maternal and infant health; 3) use PRAMS survey supplements (questions added to the end of the PRAMS survey in the middle of a data collection cycle) to explore and monitor issues that may arise during the data collection cycle, including the response to post-disaster or pandemic surveillance needs; and 4) ensure data collection results are available to inform state and national programs and policies, facilitate partnerships, and demonstrate the utility of PRAMS as a data source for state and national surveillance.

As the health system and patient centered health care services continue evolving in states under the Affordable Care Act, surveys with state-based sampling like PRAMS become increasingly valuable resources for self-reported information from patients on access to care and receipt of services. To increase PRAMS flexibility and meet emerging needs, PRAMS has transformed key aspects of its structure and function (5), including:

Revision of the questionnaire to enhance PRAMS ability to be used to monitor the impact of the health system changes on maternal and infant health and behaviors and assist in efforts to translate science into public health practice.

Implementation of the web-based centralized PRAMS Integrated Data collection System (PIDS), with the capacity to support web-based survey administration, supplemental questions on emerging issues, and future linkages to other electronic data sources.

Improvement of data accessibility through the launch of an upgraded web-based data query system (PRAMStat) with the capacity to support sharing of surveillance data to broader audiences.

Together, these changes enhance the PRAMS infrastructure and add the flexibility necessary to support an expansion of PRAMS to become a national surveillance system. Importantly, the changes create the capacity for expansion beyond traditional surveillance methodology to increase sampling of high-risk populations and to increase responsiveness to emerging issues. These changes also create the opportunity to expand the use of PRAMS data beyond public health professionals and researchers to health care providers.

Healthy People 2020 and other National Strategic Priorities Healthy People 2020: PRAMS data are used to monitor progress towards 10 objectives related to Maternal, Infant, and Child Health (3 of which are developmental) (6):

MICH-16.2 – Increase the proportion of women delivering a live birth who took multivitamins/folic acid prior to pregnancy MICH-16.3 – Increase the proportion of women delivering a live birth who did not smoke prior to pregnancy MICH-16.4 – Increase the proportion of women delivering a live birth who did not drink alcohol prior to pregnancy MICH-16.5 – Increase the proportion of women delivering a live birth who had a healthy weight prior to pregnancy MICH-16.6 – Increase the proportion of women delivering a live birth who used contraception postpartum to plan their next pregnancy MICH-18 – Reduce postpartum relapse of smoking among women who quit smoking during pregnancy MICH-20 – Increase the proportion of infants who are put to sleep on their backs MICH-16.1 (Developmental) – Increase the proportion of women delivering a live birth who discussed preconception health with a health care worker prior to pregnancy MICH-19 (Developmental) – Increase the proportion of women giving birth who attend a postpartum care visit with a health worker MICH-34 (Developmental) – Decrease the proportion of women delivering a live birth who experience postpartum depressive symptoms.

Title V and CoIIN: The states use PRAMS data to inform maternal and child health programs by monitoring health behaviors, access to care, and receipt of services. For example, PRAMS data have been used to monitor preconception health and health care indicators, and selected performance measures for various programs and initiatives such as the Title V Maternal and Child Health (MCH) Program and The Collaborative Improvement and Innovation Network (CoIIN) to Reduce Infant Mortality (7,8).

CDC Winnable Battles: To keep pace with emerging public health challenges and to have an impact on the leading causes of death and disability, the CDC embarked on an initiative to achieve measurable impact in a short time for topics that are described as Winnable Battle areas. CDC’s Winnable Battles are areas with potential for large-scale public health effects and for which effective strategies exist to address them (9).

PRAMS data can be used in the assessment of a several Winnable Battles as they relate to maternal and child health:

HIV

Motor Vehicle Injuries Nutrition, Physical Activity, and Obesity Breastfeeding (part of the Nutrition, Physical Activity, and Obesity Winnable Battle) Teen Pregnancy Tobacco

Public Health Impact Data gathered by PRAMS will be used to: 1) document trends in adverse birth outcomes and other

Data gathered by PRAMS will be used to: 1) document trends in adverse birth outcomes and other reproductive health and MCH outcomes; 2) identify subpopulations at greatest risk for the adverse birth outcomes, and inform prevention strategies and program development; 3) inform the Title V needs assessment process to help states plan for and allocate MCH block grant funds and to provide background information for states that apply for other grant funds; 4) develop and evaluate programs and policies that support improvement of maternal and child health; 5) investigate merging issues in reproductive health; and

6) support health professionals to incorporate the latest research findings into their standards of practice.

Relevant Work Epidemiologic surveillance efforts that quantify disease and risk factors, and identify opportunities for prevention, are central to CDC’s planning and evaluation efforts. CDC expects that PRAMS will continue to reflect its essential character and purpose, which is to provide statistically representative, state-specific information on maternal attitudes, behaviors and experiences useful for state-level public health program planning and evaluation. Examples of numerous previous applications of PRAMS data to impact state-level programs and policies have been documented (10-13). Further, as mentioned above, enhancements to PRAMS to increase its flexibility will expand its potential uses (5).

2. Approach PRAMS is currently supported in 40 states and New York City. For some entities, this FOA will allow continuation of existing data collection efforts within the context of the new PRAMS infrastructure (see key transformations mentioned above). For others that do not have PRAMS, this FOA may mark the beginning of efforts to collect self-reported information on maternal and child health through this new infrastructure.

Several opportunities exist to expand beyond core PRAMS surveillance by conducting surveillance of special populations, such as stillbirths, and conducting surveillance on special topics new to PRAMS such as cancer risk.

To meet the goals of the FOA, this announcement includes 4 separate funding components:

1) Component A: Core Surveillance

2) Component B: Point-in-time Surveillance

3) Component C: Stillbirth Surveillance pilot

4) Component D: Family History of Breast and Ovarian Cancer Survey

Component A: Core Surveillance 5-year project period

The Pregnancy Risk Assessment Monitoring System collects state- and population-based information on selected maternal behaviors and experiences that occur prior to, during, and after pregnancy. Component A is for both new and previously funded PRAMS projects that plan to conduct ongoing core PRAMS surveillance. These states may also use PRAMS methods and survey supplements to respond to emerging issues that arise during the data collection cycle including the response to post-disaster or pandemic surveillance needs.

Applicants may apply for Component A or B, but not both.

Component B: Point-in-time Surveillance 3-year project period

Component B is for eligible entities that plan to conduct point-in-time (e.g. one time, one birth year) PRAMS surveillance on selected maternal behaviors and experiences that occur prior to, during, and after pregnancy.

Component B is for entities with a small birth population (<20,000 annually), a lack of electronic birth records, or inadequate resources to maintain ongoing Core Surveillance, as specified in Component A above.

Applicants may apply for Component A or B, but not both.

Component C: Stillbirth Surveillance pilot 3-year project period

Stillbirth is defined as fetal deaths at 20 weeks of gestation or more. A number of factors associated with stillbirth include advanced maternal age, black race, smoking, pre-gestational diabetes, chronic hypertension, fetal growth impairment, and assisted reproductive technology. In the U.S., stillbirths occurs in 1 out of every 200 pregnancies (14).

Since its inception over 25 years ago, PRAMS has been instrumental in surveillance of maternal and neonatal health care, as well as risk factors for preterm birth and infant mortality. Women with stillbirth can be identified through vital records, utilizing similar methodologies currently in use to sample women with live births for PRAMS. Expanding PRAMS to include stillbirths could provide States with much-needed and timely data for surveillance of stillbirth factors related to prenatal and obstetric health care (e.g., for obesity, hypertension, and diabetes) and postpartum health care following pregnancy loss.

The expansion of PRAMS sampling to include women who experience a stillbirth has been a longstanding topic of interest for experts in the maternal and child health field. Thus CDC’s Division of Reproductive Health, in collaboration with researchers from Emory University, subject matter experts, and women who experienced stillbirths, has developed a PRAMS-like survey for mothers with stillbirths. Formative research was conducted, including interviews with experts, focus groups with women who experienced a stillbirth, and stakeholder meetings with experts in the field, and as a result, a final stillbirth surveillance questionnaire was developed that is now available for piloting in the field. Component C is for conducting a pilot of the stillbirth surveillance questionnaire which will allow CDC to collaborate with states to refine the survey methods. The list of questions will be provided at the start of the project period. It is anticipated that they will be similar in length to the core PRAMS survey located at http://www.cdc.gov/prams/questionnaire.htm .

Only applicants applying for Component A may apply for Component C. To be funded for Component C, applicants must have a responsive application for Component A and receive Component A funding.

Component D: Family History of Breast and Ovarian Cancer Survey 5-year project period

In 2011, 220,097 women in the United States were diagnosed with breast cancer and it is the most common cancer in women (excluding some kinds of skin cancer), regardless of race or ethnicity (15). Although ovarian cancer accounts for only about 3% of all cancers in women, it causes more deaths than any other cancer of the female reproductive system; each year in the United States, about 20,000 women get ovarian cancer and about 14,500 die from it (16). A positive family (medical) history of certain types of cancer can increase the risk of cancer. This increased risk may be due to genetic factors, shared lifestyle factors or other family traits. Therefore, taking a family history is considered an integral part of the medical evaluation, particularly important in genetic risk evaluation and risk management protocols that may ultimately help in the design of strategies to reduce cancer-associated mortality (17).

From 2003 to 2008, CDC's Office of Public Health Genomics awarded cooperative agreements to four state health departments to integrate genomics knowledge (e.g., genetic risk factors) and tools (e.g., family history assessments) into state chronic disease prevention programs and core public health functions. These genomics programs have focused on building infrastructure and partnerships, training the public health workforce, educating the general public, using surveillance surveys to assess integration of genomics with existing public health programs, and promoting genomics screening tools (18).

Through collaboration with CDC’s Division of Reproductive Health and Division of Cancer Prevention and Control, an additional set of survey questions to assess family history of cancer risk and genetic screening has been developed. Including questions on the family history of breast and ovarian cancer in PRAMS provides http://www.cdc.gov/prams/questionnaire.htm an opportunity to identify women of reproductive age that might be high-risk or genetically predisposed to these cancers, and provide valuable information on cancer screening referrals and provision of genetic counseling to improve maternal health. Component D is for collecting data on the family history of breast and ovarian cancer with the new set of survey questions, using core surveillance methods. The questions are under development and will be provided at the start of the project period. It is anticipated that the list of questions in the survey supplement will not exceed 15.

Only applicants for Component A may apply for Component D. To be funded for Component D, applicants must have a responsive application for Component A and receive Component A funding.

Over the course of the project period there may be other opportunities to support enhanced PRAMS activities. CDC may fund these based on program priorities and availability of funding. Examples of such activities include but are not limited to:

Enhancements which may require oversampling of specific populations, for the evaluation of intervention programs targeting maternal and child health such as state or community programs for which the activities could be supported or evaluated by PRAMS data.

1.

Enhancements to data collection methodology to be responsive to special circumstances such as natural or man-made disasters that occur in geographic areas that may adversely affect pregnant women or reproductive health services.

2.

Questionnaire supplements in response to infectious disease epidemics that may adversely affect pregnant women such as influenza, Ebola, anthrax, or others that may arise

3.

Questionnaire supplements on topics related to non-infectious diseases that can inform programs and policies related to CDC or State priorities:

4.

Family history of chronic diseases (e.g., diabetes, hypothyroidism) in women of reproductive age who deliver a live infant Maternal PKU (Phenylketonuria) or Sickle-cell disease Infertility and the use of new ovarian stimulation protocols and technologies Availability and use of new family planning and contraception methods Environmental exposure to toxins Emerging tobacco products (e.g. e-cigarettes and vaping) to support states prevention efforts Marijuana use to support State monitoring and surveillance needs Assessment of the referral patterns to delivery hospitals to inform perinatal regionalization efforts

4. Enhancements for special analytic studies or data linkages to assess data quality or validity.

5. Expansion of PRAMS sampling methodology:

PRAMS stillbirth surveillance in additional states PRAMS follow-back survey for toddlers Use of PRAMS methods to collect information about the experiences, health, and behaviors of fathers of recently delivered live-born infants.

To participate in PRAMS, grantees must agree to share a pre-determined, pre-approved list of variables with CDC for release via a proposal process to researchers for anlaytic purposes, without additional state approval requirements. CDC will provide a PRAMS Data Sharing Agreement at time of award that outlines the details of the agreement. Compliance with this data sharing agreement is required.

Objectives/Outcomes Component A: Core Surveillance:

Component A: Core Surveillance:

Objectives

To implement state-specific population-based surveillance on selected maternal attitudes, behaviors and experiences that occur prior to, during, and after pregnancy.

1.

To collect population-based data of high scientific quality using the CDC PRAMS protocol and methods.

2.

To conduct comprehensive analyses of PRAMS data based on a written analysis plan designed to inform programmatic activities and public health practice.

3.

To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation in collaboration with a state-level steering committee.

4.

To have the capability to respond to post-disaster or pandemic surveillance needs that may arise during the data collection cycle by implementing a PRAMS survey supplement or oversample.

5.

Expected outcomes:

PRAMS sites will have statistically representative, high quality data to monitor risk factors for maternal and infant health. High quality data is based on an achievable response rate target set for all participating states.

1.

PRAMS sites will have access to data on a variety of topics for analysis and providing feedback to public health and health system leaders as they establish priorities for the states.

2.

Sites (with at least one year of weighted data) will have used PRAMS data to inform public health programs and policies, and health care system changes.

3.

PRAMS data will be available to CDC, state public health agencies, providers and external researchers for complex studies surrounding maternal and infant health.

4.

Component B: Point-in-time Surveillance

Objectives

To establish a point-in-time (e.g. one time, one birth year) surveillance on selected maternal attitudes, behaviors and experiences that occur prior to, during, and after pregnancy for entities with a small birth population (<20,000 annually), a lack of electronic birth records, or inadequate resources to maintain ongoing surveillance.

1.

To collect population-based data of high scientific quality using the CDC PRAMS Point-in-time protocol and methods.

2.

To conduct comprehensive analyses of PRAMS data based on a written analysis plan designed to inform programmatic activities and public health practice.

3.

To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation in collaboration with a state-level steering committee.

4.

Expected outcomes

PRAMS Sites will have statistically representative, high quality data to monitor risk factors for maternal and infant health. High quality data is based on an achievable response rate target set for all participating states.

1.

PRAMS Sites will have access to data on a variety of topics for analysis and providing feedback to health system leaders as they establish priorities for the states.

2.

Sites (with at least one year of weighted data) will have used PRAMS data to inform public health programs and policies, and health care system changes.

3.

PRAMS data will be available to CDC, state public health agencies, providers and external researchers for complex studies surrounding maternal and infant health.

4.

Component C: Stillbirth Surveillance Pilot

Objectives

To establish state-specific population based stillbirth surveillance by expanding core PRAMS methods and sampling to collect data on selected maternal attitudes, behaviors and experiences among women who experienced a stillbirth (i.e. fetal death at 20 weeks gestation or more).

1.

To pilot test existing stillbirth survey questions and methods based on results of existing formative research; assess success and barriers to inform efforts to implement stillbirth surveillance in other states.

2.

To conduct comprehensive analyses of the stillbirth data based on a written analysis plan designed to inform programmatic activities and public health practice related to stillbirth.

3.

To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation in collaboration with a state-level steering committee.

4.

Expected outcomes

PRAMS Sites will have collected essential data for stillbirth surveillance including related factors such as preconception and prenatal behaviors and experiences, and health care access and content.

1.

PRAMS Sites will have enhanced their existing Core surveillance activities and complemented vital records data by adding information directly from women not available otherwise.

2.

PRAMS Sites will have access to data on stillbirths and a variety of topics for analysis and providing feedback to health system leaders as they establish priorities for the states.

3.

PRAMS data will be available to CDC, state public health agencies, providers and external researchers to increase knowledge about stillbirths, inform efforts to prevent stillbirths, and improve care and support to those who experiencing this adverse pregnancy outcome.

4.

The results of the project will inform future efforts to conduct surveillance of stillbirths on a broader scale.

5.

Component D: Family history of breast and ovarian cancer survey

Objectives

To implement a survey of CDC-developed questions to collect data on family history of breast and ovarian cancer, cancer screening referrals, and provision of genetic counseling.

1.

To collect population-based data of high scientific quality using the CDC PRAMS protocol and methods.

2.

To conduct comprehensive analyses of cancer risk data based on a written analysis plan designed to inform or change programmatic activities and public health practice specific to the topic of family history of breast and ovarian cancer.

3.

To translate and disseminate analytic results into useable information for public health action that can guide program development and evaluation in collaboration with a state-level steering committee.

4.

Expected outcomes

PRAMS Sites will have collected data to add to states’ existing surveillance efforts on genomics and cancer.

1.

PRAMS Sites will have access to data on cancer risk and a variety of topics for analysis and to provide feedback to health system leaders as they will set forth priorities for the states.

2.

PRAMS Sites will have increased knowledge on cancer risk among women who deliver a live born infant.

3.

PRAMS data will be available to CDC, state public health agencies, providers and external researchers for complex studies surrounding maternal cancer risk.

4.

Results from the supplemental data collection will be used to inform state and national program and policies, facilitate partnerships, and demonstrate the utility of PRAMS as a data source for state breast and ovarian cancer surveillance.

5.

Target Population Components A, B & D: This FOA addresses the potentially vulnerable population of women recently delivering a live birth and their infants.

Component C: This FOA addresses the vulnerable population of women with a recent stillbirth.

Collaboration/Partnerships The applicants are expected to develop substantial collaborations and partnerships with a variety of program partners and stakeholders that use and promote PRAMS data as follows:

Components A & B

Assure active cooperation and collaboration among participating organizational units such as MCH, Vital Records, and Data Processing units.

Form and support a state-level steering committee consisting of key internal and external stakeholders;

steering committee members provide feedback on the content of the questionnaire, connect the PRAMS project to organizations that can use PRAMS data, and may provide support to the analysis and dissemination of results from the PRAMS survey.

Collaborate with CDC and other participating states to revise the common survey questions at agreed-upon intervals to evaluate state MCH programs and priorities.

Develop and implement a written analysis plan, to be updated annually, reflecting the evaluation of programmatic activities, including potential partners and collaborators in and outside of the health departments.

Component C:

Assure active cooperation and collaboration among participating organizational units such as MCH, Vital Records, and Data Processing units.

Form and support a state-level steering committee consisting of key internal and external stakeholders.

The steering committee membership should include fetal death review panel members and birth defects program professionals.

Develop and implement a written analysis and dissemination plan specific to stillbirth surveillance, to be updated annually, reflecting the evaluation of programmatic activities, including potential partners and collaborators in and outside of the health departments.

Component D:

Assure active cooperation and collaboration among participating organizational units such as MCH, Vital Records, and Data Processing units.

Form and support a state-level steering committee consisting of key internal and external stakeholders.

The steering committee membership should include genetic counselors and oncologists, primary care and cancer-genomics public health professionals.

Develop and implement a written analysis and dissemination plan specific to the history of cancer among women of reproductive age who deliver a live birth, to be updated annually, reflecting the evaluation of programmatic activities, including potential partners and collaborators in and outside of the health departments.

Evaluation/Performance Measurement The applicants are expected to, in collaboration with CDC, effectively collect data, monitor the quality of

The applicants are expected to, in collaboration with CDC, effectively collect data, monitor the quality of their data, and make use of these data in informing policies and programs:

Components A & B

Ensuring stable surveillance operations by:

Following CDC’s surveillance protocol Cross training of staff in carrying out the routine data collection operations Documenting the operational details

1.

Ensuring data quality by:

Initial checking of data files generated by sampling program Examining data collection operations from PIDS-generated reports Monitoring response rates; CDC PRAMS has set the minimum acceptable response rate (i.e. 65% for 2007-2011 and 60% for 2012) for inclusion of PRAMS data in multi-state comparison reports.

2.

Analyzing data by:

Identifying an individual at the state level who is dedicated to performing data analysis using software designed for complex survey data Identifying analysis priorities and analysis plans.

3.

Using and disseminating data by:4.

Developing linkages within the state health department and other partners Promoting use of data with both public and private organizations.

Distributing PRAMS results to inform maternal and child health policies.

Documenting efforts to translate data into useable information for public health action. For this FOA, grantees are required to submit with their annual report, two (2) examples of how data were used to inform policies or programs that address maternal and infant health.

Documentation is required annually for grantees with a weighted data set and will be required for newly funded states 1 year after receipt of the first weighted dataset. Grantees will use a “Data to Action” template.

Component C:

Ensuring stable surveillance operations by:

Following CDC’s stillbirth surveillance protocol Cross training of staff in carrying out the routine data collection operations Documenting the operational details

1.

Ensuring data quality by:

Initial checking of data files generated by sampling program Examining data collection operations from PIDS-generated reports

2.

Analyzing data by:

Identifying an individual at the state level who is dedicated to performing data analysis using software designed for complex survey data Identifying analysis priorities and analysis plans related to stillbirth.

3.

Using and disseminating data by:

Developing linkages within the state health department and other partners with expertise in stillbirth and fetal deaths.

Promoting use of data with both public and private organizations.

Distributing PRAMS results to inform maternal and child health policies.

4.

Component D:

Ensuring stable surveillance operations by:

Following CDC’s surveillance protocol developed for Component D.

Cross training of staff in carrying out the routine data collection operations

1.

Cross training of staff in carrying out the routine data collection operations Documenting the operational details

Ensuring data quality by:

Initial checking of data files generated by sampling program Examining data collection operations from PIDS-generated reports

2.

Analyzing data by:

Identifying an individual at the state level who is dedicated to performing data analysis using software designed for complex survey data Identifying analysis priorities and analysis plans related to cancer risk.

3.

Using and disseminating data by:4.

Developing linkages within the state health department and other partners with expertise in genomics or cancer.

Promoting use of data with both public and private organizations.

Distributing PRAMS results to inform maternal and child health policies.

Translation Plan Applicants are expected to develop a research translation and dissemination plan to ensure surveillance findings are translated into policies or programs that address maternal and infant health. The plan should:

Components A & B

Describe the data needs and priority topics for PRAMS analysis.

Describe existing partnerships and any planned partnerships for dissemination and translation and how findings will be disseminated through various channels, including steering committee members, health policy makers, and health providers and translated into public health action.

Component C:

Describe the data needs and priority topics for PRAMS analysis related to stillbirth surveillance.

Describe existing partnerships and any planned partnerships for dissemination and translation of the stillbirth surveillance data and how findings will be disseminated through various channels, including steering committee members, health policy makers, and health providers and translated into public health action to reduce stillbirth occurrence.

Component D:

Describe the data needs and priority topics for PRAMS analysis related to breast and ovarian cancer.

Describe existing partnerships and any planned partnerships for dissemination and translation of the cancer surveillance data and how findings will be disseminated through various channels, including steering committee members, health policy makers, and health providers and translated into public health action to promote cancer prevention among women of reproductive age.

OMB/PRA is expected to apply.

References:

Centers for Disease Control and Prevention (CDC). PRAMS. Available at: www.cdc.gov/PRAMS . Accessed July 2, 2015.

1.

H.R. 4602 (107th): Safe Motherhood Act for Research and Treatment. Available at: https://www.govtr ack.us/congress/bills/107/hr4602/text. Accessed July 13, 2015.

2.

S. 252 (113th): Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Reauthorization Act. Available at: https://www.govtrack.us/congress/bills/113/s252/text.

3.

http://www.cdc.gov/PRAMS https://www.govtrack.us/congress/bills/107/hr4602/text https://www.govtrack.us/congress/bills/107/hr4602/text https://www.govtrack.us/congress/bills/113/s252/text

Accessed July 13, 2015.

Affordable Care Act -- Title IV. Prevention of Chronic Disease and Improving Public Health.

Available at: http://www.hhs.gov/healthcare/rights/law/title/iv-prevention-of-chronic-disease.pdf .

Accessed July 13, 2014.

4.

Grigorescu VI, D'Angelo DV, Harrison LL, Taraporewalla AJ, Shulman H, Smith RA. Implementa tion science and the pregnancy risk assessment monitoring system. J Womens Health (Larchmt). 2014 Dec; 23(12):989-94.

5.

US Department of Health and Human Services. Maternal, Infant, and Child Health Objectives.

Healthy People 2020. Washington, DC: US Depart of Health and Human Services. Available at:

http://www.healthypeople.gov/2020/topics-objectives/topic/maternal-infant-and-child-health.

Accessed July 13, 2015.

6.

Health Resources and Services Administration (HRSA). Maternal and child health. Available at: http ://mchb.hrsa.gov/programs/titlevgrants/. Accessed July 13, 2015.

7.

HRSA. Maternal and Child Health Collaborative Improvement and Innovation Network to Reduce Infant Mortality. Available at: http://mchb.hrsa.gov/infantmortality/coiin. Accessed July 13, 2015.

8.

Centers for Disease Control and Prevention. Winnable Battles Report 2010-2014. Available at:

http://www.cdc.gov/winnablebattles/targets/pdf/winnablebattles2010-2015_progressreport2014_.pdf.

Accessed July 13, 2015.

9.

CDC. PRAMS data to action success stories. US Department of Health and Human Services, CDC;

2013. Available at http://www.cdc.gov/prams/dta-successstories.html.

10.

Patterns of Health Insurance Coverage Around the Time of Pregnancy Among Women with Live-Born Infants - Pregnancy Risk Assessment Monitoring System, 29 States, 2009. D'Angelo DV, Le B, O'Neil ME, Williams L, Ahluwalia IB, Harrison LL, Floyd RL, Grigorescu V. MMWR Surveill Summ. 2015 Jun 19;64 Suppl 4:1-19.

11.

Tetanus, Diphtheria, Pertussis Vaccination Coverage Before, during, and after Pregnancy - 16 States and New York City, 2011.Ahluwalia IB, Ding H, D'Angelo D, Shealy KH, Singleton JA, Liang J, Rosenberg KD. MMWR Morb Mortal Wkly Rep. 2015 May 22;64(19):522-6.

12.

Pregnancy Risk Assessment Monitoring System and the W.K. Kellogg Foundation Joint Project to Enhance Maternal and Child Health Surveillance: Focus on Collaboration. Ahluwalia IB, Harrison L, Simpson P, Wako E, Helms Shealy K, Kapaya M, Williams T, Williams L, D'Angelo D. J Womens Health (Larchmt). 2015 Apr;24(4):257-60.

13.

Prepregnancy risk factors for antepartum stillbirth in the United States. Reddy UM, Laughon SK, Sun L, Troendle J, Willinger M, Zhang J.Obstet Gynecol. 2010 Nov;116(5):1119-26.

14.

Centers for Disease Control and Prevention. Breast Cancer Statistics. Available at: http://www.cdc.gov /cancer/breast/statistics/index.htm. Accessed July 14, 2015.

15.

Centers for Disease Control and Prevention. Basic Information About Ovarian Cancer. Available at:

http://www.cdc.gov/cancer/ovarian/basic_info/index.htm. Accessed July 14, 2015.

16.

Allen HJ, Briceno CA, Piver MS: Assessment of family cancer history collection and utilization in patient care. Community Genet. 1998, 1:237-242.

17.

CDC's Office of Public Health Genomics. State Genomics Programs. Available at: http://www.cdc .gov/genomics/translation/states/. Accessed July 14, 2015.

18.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

https://www.govtrack.us/congress/bills/113/s252/text http://www.hhs.gov/healthcare/rights/law/title/iv-prevention-of-chronic-disease.pdf http://www.ncbi.nlm.nih.gov/pubmed/25405525 http://www.ncbi.nlm.nih.gov/pubmed/25405525 http://mchb.hrsa.gov/programs/titlevgrants/ http://mchb.hrsa.gov/programs/titlevgrants/ http://www.cdc.gov/prams/dta-successstories.html http://www.cdc.gov/cancer/breast/statistics/index.htm http://www.cdc.gov/cancer/breast/statistics/index.htm http://www.cdc.gov/cancer/ovarian/basic_info/index.htm http://www.cdc.gov/genomics/translation/states/ http://www.cdc.gov/genomics/translation/states/

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $37,190,000 The estimated total funding for the entire project period is…