CDC-RFA-DD16-1605AMENDMENT2PUBLICATION.pdf

Centers for Disease Control

National Center on Birth Defects and Developmental Disabilities

Surveillance, intervention, and referral to services activities for infants with microcephaly or other adverse outcomes linked with the Zika virus

CDC-RFA-DD16-1605

Application Due Date: 01/05/2017

Surveillance, intervention, and referral to services activities for infants with microcephaly or other adverse outcomes linked with the Zika virus

CDC-RFA-DD16-1605

TABLE OF CONTENTS

Part I. Overview Information Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Application and Submission Information D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DD16-1605. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry

(ATSDR)

B. Funding Opportunity Title:

Surveillance, intervention, and referral to services activities for infants with microcephaly or other adverse outcomes linked with the Zika virus C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg /CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity /docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

Amendment Number (2)

Applications are not being solicited. Amendment is to add reporting language for timeliness and completeness of data in accordance with CDC case definitions. Please refer to Part II. Full Text, F. Award Administration Information Number 3. Reporting and Reporting 3(c). Performance Measure Reporting.

Amendment to change application due date to 7/1/2016 for applicants to submit two separate amounts and budget justification based on a higher estimated award amount. Please refer to the respective funding amounts in both tables in Section 2.a.iv.

D. Agency Funding Opportunity Number:

CDC-RFA-DD16-1605

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.073 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 01/05/2017, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

Applications are not being solicited and this announcement will be published for informational purposes only.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2016 https://foa.grantsolutions.gov/www.grants.gov https://foa.grantsolutions.gov/www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2016 funds to establish, enhance, and maintain rapid population-based surveillance of microcephaly and other adverse outcomes (especially central nervous system (CNS) defects) possibly linked to Zika virus infection during pregnancy using an active case-finding methodology; participate in centralized pooled clinical and surveillance data projects; ensure affected infants and families are referred to services; and assess health and developmental outcomes of these children. This aligns with the National Center on Birth Defects and Developmental Disabilities (NCBDDD) performance goal to “enhance birth defects surveillance, research, and prevention.”

This announcement is for non-research activities supported by CDC, i.e., conduct rapid active population-based ascertainment of select major birth defects possibly linked to maternal Zika virus and to use the data for public health action through monitoring, intervention, and referral to services.

Eligibility is limited to the states, DC, and territories with observed distribution of Aedes mosquitoes. FY 16 funds are estimated up to $20,000,000. Please refer to the Funding Strategy under Section 2.a.iv for a complete list of states, DC, and territories with respective funding amounts.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 50

d. Total Project Period Funding: $0 Although there is no project period ceiling, ceiling amounts may be solicited annually.

e. Average One Year Award Amount: $200,000

f. Total Project Period Length: 5

g. Estimated Award Date: 08/01/2016

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing effort to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Birth defects are a leading cause of infant mortality in the United States and contribute substantially to health care costs and life-long disabilities. The Birth Defects Prevention Act of 1998 directed CDC to carry out programs to collect data on birth defects and provide information to the public about the prevention of birth defects. The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito, as well as through sexual transmission. The illness is usually mild with symptoms lasting for several days to a week after being bitten by an infected mosquito. However, many infected individuals are asymptomatic.

The Zika virus can also be spread from a pregnant woman to her fetus. Zika virus infection has been linked to microcephaly and potentially other central nervous system (CNS) defects in babies of mothers who had Zika virus while pregnant. The full spectrum of outcomes of children exposed or potentially exposed to the Zika virus is not yet known.

In late 2015, there were reported cases of birth defects associated with the Zika virus occurring in South America with the potential for increased numbers of birth defects cases with the spread of virus to Central http://www.cdc.gov/ncbddd/birthdefects/microcephaly.html and North America and travelers coming from Zika endemic countries. In January 2016, CDC activated the Emergency Operations Center to address national and international public health concerns regarding the spread of the Zika virus and related adverse health outcomes in pregnant women. On February 1, 2016, the World Health Organization declared Zika virus infection a public health emergency of international concern.

An urgent public health response is needed to understand the impact of Zika virus during pregnancy on adverse birth outcomes. Establishing or enhancing existing population-based surveillance systems to rapidly identify cases of microcephaly and other defects potentially linked to Zika virus from all pregnancy outcomes is key to assessing the impact on communities. However, given the routine lag time in surveillance systems to capture timely case information (from several months up to 1-2 years), ‘real-time’ reporting and data collection are needed to monitor the impact of Zika virus on pregnancy and infant outcomes as events unfold. These include using a standard case definition across surveillance systems, expanding data sources to include non-traditional sources such as specialty clinics and State Laboratory reports of any pregnancy with positive or inconclusive Zika virus test results, employing innovative and timely approaches to data collection such as remote access to electronic medical records, and participating in CDC centralized pooled clinical and surveillance data projects including the U.S. Zika Pregnancy Registry. More information about the U.S. Zika Pregnancy Registry can be found at http://www.cdc.gov/zika/hc-providers/registry.html. This FOA will collaborate closely with the U.S. Zika Pregnancy Registry to ensure any cases of birth defects or Zika virus infection identified through the registry will be included in this project. Grantees are expected to participate in the State-coordinated Zika response, including prevention efforts and the sharing of critical information collected from the rapid ascertainment of microcephaly or other adverse outcomes with other health department programs to ensure affected infants and families are referred to health, early intervention, and other social services as well as perform data linkage and evaluation of their health and developmental outcomes. Under this FOA, grantees will submit anonymized, de-duplicated data to CDC.

b. Statutory Authorities This program is authorized under sections 311 and 317C of the Public Health Service Act [42 U.S.C. 243 and 247b-4], as amended.

c. Healthy People 2020 The National Center on Birth Defects and Developmental Disabilities (NCBDDD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2020” found at https://www.healthypeople.gov/. This FOA addresses “Healthy People 2020” priority area of Maternal, Infant, and Child Health, and specifically MICH-1.6, reduce the rate of infant deaths related to birth defects, and MICH-31, increase the proportion of children with special health care needs who receive their care in family-centered, comprehensive, and coordinated systems.

d. Other National Public Health Priorities and Strategies In January 2016, CDC activated the Emergency Operations Center (EOC) and formed the Pregnancy and Birth Defects Team (and later Task Force) to address national and international public health concerns regarding the spread of the Zika virus and adverse health outcomes in pregnant women. On February 8, 2016 the EOC was designated activation at Level 1 (the highest level). Additionally, on February 1, 2016, the World Health Organization declared the current Zika virus infection a public health emergency of international concern. Because the current Zika virus outbreak is expected to become endemic over the next 3-5 years in the North and South American continents and nearby islands, it is urgent to develop ‘real time’ reporting and monitoring of adverse pregnancy outcomes such as microcephaly and other CNS defects that might be associated with Zika virus infection.

CDC’s mission is to promote health and quality of life by preventing and controlling disease, injury, and disability. One of the many strategies that CDC employs to accomplish this goal includes monitoring health through the use of public health surveillance. Disease specific surveillance systems are critical for the http://www.cdc.gov/zika/hc-providers/registry.html https://www.healthypeople.gov/ through the use of public health surveillance. Disease specific surveillance systems are critical for the accomplishment of this and other objectives that support CDC’s mission. Refer to CDC’s website: www.cdc .gov.

e. Relevant Work For over four decades, CDC has been monitoring the prevalence of and investigating the risk factors for birth defects, as well as developing strategies to prevent these conditions. CDC continues to invest in state and local programs that gather data needed to understand how birth defects can be prevented and to improve the lives of people who have been affected by them.

NCBDDD has recently funded population-based birth defects surveillance cooperative agreements under FOAs #DD10-1001 and #DD16-1601 to develop and enhance birth defects surveillance, implement population-based programs to prevent birth defects, improve access of children with birth defects to health services and early intervention programs, and use the data for public health action.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

This FOA provides funding to establish a rapid active case ascertainment surveillance system for microcephaly and select CNS defects possibly linked to maternal Zika virus infection. The objective of this surveillance is to determine the impact of maternal Zika virus infection on adverse outcomes in U.S. states and territories with expected endemic transmission or potential cases associated with high volume of travel from endemic countries, i.e. areas with observed distribution of Aedes Aegypti and Aedes Albopictus mosquitoes. The grantees are expected to work collaboratively with CDC to rapidly monitor the occurrence of microcephaly and select CNS defects possibly linked to maternal Zika virus infection using rapid active case-finding methodologies and to translate the information collected for public health action to better understand the impact of these conditions on communities, drive population-level prevention strategies, improve referral to services for affected individuals and families, and link and evaluate health and developmental outcomes of these children.

CNS Defect Codes for Zika-Related Ascertainment Defect ICD-9-CM ICD-10-CM CDC/BPA Includes Cases With:

Microcephaly 742.1 Q02 742.1 Hydrocephaly 742.3 Q03 742.30, 742.38, 742.39 Arthrogryposis 754.89 Q74.3 755.8 Other CNS anomalies 742.2, 742.4 Q04 742.20-742.25 742.28x, 742.29x 742.31, 742.32x 742.41, 742.42 742.480-742.484, 742.486-742.489 742.49 742.88, 742.90, 742.99 But Exclude Cases That Also Have:

Holoprosencephaly No specific code

Q04.2 742.26 http://www.cdc.gov/ http://www.cdc.gov/

Arhinencephaly No specific code

Q04.1 742.27

Macrocephaly No specific code

Q04.5 742.40

Choroid plexus cysts No specific code

No specific code

742.485

Craniosynostosis 756.0* Q75.0 756.00-756.03 *This code may include conditions other than craniosynostosis. Exclude only those cases that truly have craniosynostosis.

The above list may be slightly modified based on published scientific guidance.

The logic model is a visual depiction of the programmatic approach and reflects how the activities, expected outputs, and outcomes are interrelated to achieve the program goals and objectives. Bolded text indicates outcomes the awardee is expected to achieve during the project period.

Strategies and Activities

Outcomes

Short-term Mid-term Long-term

Surveillance:

Implement strategies for rapid (real-time) population-based surveillance of microcephaly and select CNS defects

Capacity Development:

Build capacity through collaboration with partners and infrastructure improvements

Referral to Services:

Connect infants and families to health and social services

Data Reporting:

Participate in CDC centralized pooled surveillance and clinical case project

Health Outcomes:

Improved rapid and accurate ascertainment of microcephaly and select CNS defects possibly linked to maternal Zika virus approaches by state public health programs knowledge about birth defects and Zika virus by partnering organizations, agencies, and individuals

Increased awareness among at-risk

Improved use of surveillance data to inform policy among a broad range of stakeholders

Enhanced partnership collaborations to sustain public health response linkage and evaluation of health and developmental outcomes for children with microcephaly and select CNS conditions with possible link to maternal Zika virus

Improved birth and health outcomes overall, and improved outcomes among children with microcephaly and select CNS defects possibly linked to maternal Zika virus infection

Improved quality and duration of life for affected children and their families

Examine health and developmental outcomes of selected children born to women with positive or inconclusive Zika virus test populations about the identification and prevention of maternal Zika virus knowledge by public health professionals about pregnancy outcomes, both affected and unaffected as well as percent live born versus pregnancy loss.

knowledge by affected families about early identification and linkage of infants to health, early intervention, and other services.

i. Purpose To establish or enhance rapid "real time" active surveillance of microcephaly and select adverse outcomes (CNS defects) with possible association to Zika virus infection for all pregnancy outcomes (live births, stillbirth, and terminations) and to use the data for public health monitoring, prevention, and intervention. Demonstrate data utilization through collaboration with CDC on centralized pooled clinical and surveillance data projects, referral to services, and linkage and evaluation of outcomes of affected children and/or pregnancies with a positive or inconclusive Zika virus test.

ii. Outcomes As outlined in the logic model, the following are the outcomes the awardee is expected to achieve during the

As outlined in the logic model, the following are the outcomes the awardee is expected to achieve during the project period:

Short-term:

Improved rapid and accurate ascertainment of microcephaly and select CNS defects possibly linked to maternal Zika virus approaches by state public health programs.

Improved knowledge about birth defects and Zika virus by partnering organizations, agencies, and individuals.

Increased awareness among at-risk populations about the identification and prevention of the Zika virus.

Increased knowledge by public health professionals about pregnancy outcomes, both affected and unaffected, as well as percent live born versus pregnancy loss.

Increased knowledge by affected families about early identification and linkage of infants to health, early intervention, and other services.

Mid-term:

Improved use of surveillance data to inform policy among a broad range of stakeholders.

Enhanced partnership collaborations to sustain public health response.

Improved linkage and evaluation of health and developmental outcomes for children with microcephaly and select CNS conditions with possible link to maternal Zika virus.

iii. Strategies and Activities

1) Surveillance: Establish a rapid population-based surveillance of microcephaly and select CNS defects using an active case-finding methodology and standard case definition

Implement a rapid, active population-based surveillance system to ascertain any potential/possible cases of microcephaly and select CNS defects for all pregnancy outcomes, including live births, fetal deaths, and terminations. States and territories should:

Develop active case-finding methodologies for rapid notification and data collection of possible cases from a range of clinical sources including prenatal and hospital champions, and State laboratories that obtain positive or inconclusive maternal Zika virus tests.

Employ innovative and timely approaches to data collection in electronic health records, such as remote access to clinical information.

Use a standard case definition as defined by CDC. Follow the National Birth Defects Prevention Network (NBDPN) case definition and surveillance notes, available at http://www.nbdpn.org/zikvbd.php.

Ensure clinical support for case review.

Collaborate and coordinate with U.S. Zika Pregnancy Registry effort.

Collaborate with other health department programs as part of the State coordinated Zika response to ensure that surveillance data are used for public health action.

Assess administrative datasets as supplemental data sources for the active reporting and notification.

Capacity Development:

2) Build capacity through collaboration with partners and infrastructure improvements

Ensure appropriate partnerships within the State health departments, including the State Laboratory, communicable disease program, state epidemiologist, birth defects surveillance program, State representatives for the U.S. Zika Pregnancy Registry, and the State’s organizations receiving Title V federal funds, to develop rapid data collection and reporting of both microcephaly and select CNS defects possibly linked to Zika virus, and any pregnancies with positive or inconclusive Zika virus tests. Also, establish linkages with other programs like Children with Special Health Care Needs

(TitleV) and early intervention to improve access for affected children to comprehensive, community-based, family-centered care.

Identify and engage appropriate clinical partners, especially with prenatal and hospital champions to rapidly report any potential cases. Provide guidance or training to obstetric, pediatric, and other providers as needed.

Engage the state hospital association, as appropriate.

Identify and engage appropriate State and local partners to disseminate prevention messages and materials.

Disseminate results with appropriate organizations within the State and with other States.

3) Referral to Services: Connect children and families to health and social services

Develop strategies and activities to ensure children with microcephaly and select CNS defects and their families are connected to health, early intervention, and social services in the community.

Include a discussion of eligible services the infant/family can apply for.

Create a plan outlining how the program is working to improve referral to services for affected individuals and families.

4) Data Analyses and Reporting

Provide support for data analyses to evaluate the data collected and set-up programs for ongoing monitoring of data.

Participate in centralized pooled clinical case and surveillance projects via secure transmission, meeting deadlines specified by CDC. This includes contribution of anonymized, de-duplicated data to CDC for projects, such as the Centralized Rapid Microcephaly and Select CNS Defect Outcomes Data System and Detailed Case Diagnosis Project with clinical verbatim diagnosis information. Collaborate with the U.S. Zika Pregnancy Registry.

5) Health and Developmental Outcomes of Children Identified from the Rapid Microcephaly and Select CNS Defect Surveillance System

Work with the U.S. Zika Pregnancy Registry to ascertain health and developmental outcomes of children with microcephaly and select CNS conditions and those with no apparent birth defects from women with positive or inconclusive Zika virus tests.

Evaluate the methodologies used and quality of data collected.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Work with CDC and other awardees to share strategies and lessons learned to improve rapid reporting and data collection strategies, analyses, utilization, and other activities.

Participate in a centralized rapid microcephaly and CNS defect surveillance and clinical case projects.

Participate on all cooperative agreement calls and meetings as identified by CDC program.

Participate in the State prevention efforts through collaboration with other health department programs, such as vector control and maternal and child health, as part of the State coordinated Zika response.

b. With organizations not funded by CDC:

Demonstrate effective relationships and cooperation with appropriate partners (e.g., state officials, Demonstrate effective relationships and cooperation with appropriate partners (e.g., state officials, state government departments, including informatics, state and local laboratories, state epidemiologist;

community based organizations; academic medical centers; physician groups; hospitals; prenatal clinics; and/or treatment centers). Letters of support/Memorandums of Understanding/Memorandums of Agreement stating agreed upon area of collaboration from state relevant officials and others should be included in the application.

Collaborate with other state population-based surveillance programs on collaborative projects. Provide evidence of access to the relevant data sources for identification of cases and evaluation of programmatic activities.

Collaborate and coordinate across state agencies and clinical settings to evaluate timeliness of reporting, quality of data collected, and the health outcomes identified.

Involve appropriate within-region partners, such as health care providers, community based organizations, academic medical centers and/or outpatient centers, and other organizations to assist with data collection and utilization.

Identify and engage appropriate partners within the region to develop, implement, and expand referral to services activities.

2. Target Populations The surveillance and data utilization activities should focus on a source population (women of child-bearing age, pregnant women, infants with possible microcephaly or other brain abnormalities) in a defined geographic area of the state and any special populations identified by the applicant.

a. Inclusion Awardees should consider underserved and high risk populations in their planned activities.

iv. Funding Strategy Awards will be made to all eligible applicants at the funding level indicated by the formula criteria in this published FOA.

Priority Group 1: States and territories with observed distribution of Aedes Aegypti mosquito. All successful applicants will receive $200,000 per year. State and territories will receive an additional $80,000 or $160,000 per year based on:

Number of annual live births (benchmarked on 2014 live birth data):

States with annual livebirths of 100,000 or more will receive an additional $80,000.

States with annual livebirths of 200,000 or more will receive an additional $160,000.

Priority Group 2: States with observed distribution of Aedes Albopictus mosquito. All successful applicants will receive $100,000 per year. State and territories will receive an additional $80,000 or $160,000 per year based on:

Number of annual live births (benchmarked on 2014 live birth data):

States with annual livebirths of 100,000 or more will receive an additional $80,000.

States with annual livebirths of 200,000 or more will receive an additional $160,000.

Zika virus cases (3/30/2016)

State, Territory, District of Columbia

Priority:

Aedes mosquito range

Travel-associated Locally acquired

Total Live births

Base Funds

Additional Funds Per Total Livebirth $80K for 100,000 + Livebirths and $160K for 200,000 + Livebirths

TOTAL

Funding Level

Alabama 1 2 0 59,422 $200,000 $200,000

Arizona 1 0 0 86,887 $200,000 $200,000

Arkansas 1 1 0 38,511 $200,000 $200,000

California 1 17 0 502,879

$200,000 $160,000 $360,000

Connecticut 1 1 0 36,285 $200,000 $200,000

Delaware 1 3 0 10,972 $200,000 $200,000

District of Columbia

1 3 0 9,509 $200,000 $200,000

Florida 1 70 0 219,991

Georgia 1 7 0 130,946

$200,000 $80,000 $280,000

Hawaii 1 5 0 18,550 $200,000 $200,000

Indiana 1 4 0 84,080 $200,000 $200,000

Kansas 1 1 0 39,223 $200,000 $200,000

Kentucky 1 2 0 56,170 $200,000 $200,000

Louisiana 1 2 0 64,497 $200,000 $200,000

Maryland 1 5 0 73,921 $200,000 $200,000

Mississippi 1 0 0 38,736 $200,000 $200,000

Missouri 1 1 0 75,360 $200,000 $200,000

Nevada 1 0 0 35,861 $200,000 $200,000

New Jersey 1 2 0 103,305

New Mexico 1 0 0 26,052 $200,000 $200,000

New York 1 43 0 238,773

North Carolina

1 7 0 120,975

Ohio 1 8 0 139,467

Oklahoma 1 3 0 53,339 $200,000 $200,000

Pennsylvania 1 8 0 142,268

South Carolina

1 0 0 57,627 $200,000 $200,000

Tennessee 1 1 0 81,602 $200,000 $200,000

Texas 1 23 0 399,766

Virginia 1 7 0 103,300

West Virginia 1 5 0 20,301 $200,000 $200,000

American Samoa

1 0 14 1,077 $200,000 $200,000

Guam 1 No data No data 3,395 $200,000 $200,000

Northern Marianas

1 No data No data 517 $200,000 $200,000

Puerto Rico 1 3 258 34,434 $200,000 $200,000

Virgin Islands 1 1 10 1844 (2008)

$200,000 $200,000

Micronesia 1 No data No data 2485 (2003)

$200,000 $200,000

Marshall Islands

1 No data No data 1576 (2006)

$200,000 $200,000

Republic of Palau

1 No data No data 259 (2006)

$200,000 $200,000

Colorado 2 2 0 65,830 $100,000 $100,000

Illinois 2 9 0 158,556

$100,000 $80,000 $180,000

Iowa 2 4 0 39,687 $100,000 $100,000

Maine 2 0 0 12,698 $100,000 $100,000

Massachusetts 2 3 0 71,908 $100,000 $100,000

Minnesota 2 9 0 69,904 $100,000 $100,000

Nebraska 2 2 0 26,794 $100,000 $100,000

New Hampshire

2 2 0 12,302 $100,000 $100,000

Rhode Island 2 0 0 10,823 $100,000 $100,000

Utah 2 0 0 51,154 $100,000 $100,000

Vermont 2 0 0 6,130 $100,000 $100,000

Wisconsin 2 0 0 67,161 $100,000 $100,000

Funding Per Year - #1 $8,800,000

$1,200,000 $10,000,000

AMENDMENT:

If additional funds are available, awards will be made to all eligible applicants at the funding level indicated by the formula criteria in this published FOA.

Priority Group 1: States and territories with observed distribution of Aedes Aegypti mosquito. All successful applicants will receive $400,000 per year. State and territories will receive an additional $160,000 or $320,000 per year based on:

Number of annual live births (benchmarked on 2014 live birth data):

States with annual livebirths of 100,000 or more will receive an additional $160,000.

States with annual livebirths of 200,000 or more will receive an additional $320,000.

Priority Group 2: States with observed distribution of Aedes Albopictus mosquito. All successful applicants will receive $200,000 per year. State and territories will receive an additional $80,000 or $160,000 per year based on:

Number of annual live births (benchmarked on 2014 live birth data):

States with annual livebirths of 100,000 or more will receive an additional $80,000.

States with annual livebirths of 200,000 or more will receive an additional $160,000.

Zika virus cases (3/30/2016)

State, Territory, District of Columbia

Priority:

Aedes mosquito range

Travel-associated Locally acquired

Total Live births

Base Funds Additional Funds Per Total Livebirths

TOTAL

Funding Level

Alabama 1 2 0 59,422 $400,000 $400,000

Arizona 1 0 0 86,887 $400,000 $400,000

Arkansas 1 1 0 38,511 $400,000 $400,000

California 1 17 0 502,879

$400,000 $320,000 $720,000

Connecticut 1 1 0 36,285 $400,000 $400,000

Delaware 1 3 0 10,972 $400,000 $400,000

District of Columbia

1 3 0 9,509 $400,000 $400,000

Florida 1 70 0 219,991

Georgia 1 7 0 130,946

$400,000 $160,000 $560,000

Hawaii 1 5 0 18,550 $400,000 $400,000

Indiana 1 4 0 84,080 $400,000 $400,000

Kansas 1 1 0 39,223 $400,000 $400,000

Kentucky 1 2 0 56,170 $400,000 $400,000

Louisiana 1 2 0 64,497 $400,000 $400,000

Maryland 1 5 0 73,921 $400,000 $400,000

Mississippi 1 0 0 38,736 $400,000 $400,000

Missouri 1 1 0 75,360 $400,000 $400,000

Nevada 1 0 0 35,861 $400,000 $400,000

New Jersey 1 2 0 103,305

New Mexico 1 0 0 26,052 $400,000 $400,000

New York 1 43 0 238,773

North Carolina

1 7 0 120,975

Ohio 1 8 0 139,467

Oklahoma 1 3 0 53,339 $400,000 $400,000

Pennsylvania 1 8 0 142,268

South Carolina

1 0 0 57,627 $400,000 $400,000

Tennessee 1 1 0 81,602 $400,000 $400,000

Texas 1 23 0 399,766

Virginia 1 7 0 103,300

West Virginia 1 5 0 20,301 $400,000 $400,000

American Samoa

1 0 14 1,077 $400,000 $400,000

Guam 1 No data No data 3,395 $400,000 $400,000

Northern Marianas

1 No data No data 517 $400,000 $400,000

Puerto Rico 1 3 258 34,434 $400,000 $400,000

Virgin Islands 1 1 10 1844 (2008)

$400,000 $400,000

Micronesia 1 No data No data 2485 (2003)

$400,000 $400,000

Marshall Islands

1 No data No data 1576 (2006)

$400,000 $400,000

Republic of Palau

1 No data No data 259 (2006)

$400,000 $400,000

Colorado 2 2 0 65,830 $200,000 $200,000

Illinois 2 9 0 158,556

Iowa 2 4 0 39,687 $200,000 $200,000

Maine 2 0 0 12,698 $200,000 $200,000

Massachusetts 2 3 0 71,908 $200,000 $200,000

Minnesota 2 9 0 69,904 $200,000 $200,000

Nebraska 2 2 0 26,794 $200,000 $200,000

New Hampshire

2 2 0 12,302 $200,000 $200,000

Rhode Island 2 0 0 10,823 $200,000 $200,000

Utah 2 0 0 51,154 $200,000 $200,000

Vermont 2 0 0 6,130 $200,000 $200,000

Wisconsin 2 0 0 67,161 $200,000 $200,000

Funding Per Year - #2 $17,600,000

$2,400,000 $20,000,000

Notes:

Live births (LB) 2014 data from NCHS, http://wonder.cdc.gov/ http://wonder.cdc.gov/

Live births (LB) 2014 data from NCHS, http://wonder.cdc.gov/

U.S. Virgin Islands LB http://healthvi.org/assets/documents/2011/2008-natality-and-mortality -indicators.pdf

Micronesia, Marshall Islands, Palau LB http://www.un.org/esa/population/publications/WFD2012 /MainFrame.html

ZIKV cases (3/30/2016) http://www.cdc.gov/zika/geo/united-states.html

Aedes distribution in US http://www.cdc.gov/zika/pdfs/zika-mosquito-maps.pdf

Aedes aegypti Priority 1 states/territories

Aedes albopictus Priority 2 states

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Evaluation and progress reports

Prepare a written assessment of the accomplishments, challenges and opportunities including a description of the problems encountered, lessons learned, potential improvements, etc.

Strategies/Activities:

1) Surveillance: Implement strategies to improve population-based birth defects surveillance

Indicators for success: a completed surveillance plan outlining approaches for rapid reporting and data collection using active population-based case finding methodologies; documentation of state authority to review and abstract medical records; documentation assessment of the data sources used, their quality, and usefulness; evidence that national guidelines and data quality standards were followed, including use of standard case definitions and clinical support for case review.

2) Capacity Development: Build rapid active population-based surveillance capacity through infrastructure and partner collaborations and infrastructure improvements

Indicators for success: a completed matrix identifying capacity building objectives, strategies, and partners agreed upon by partners and approved by CDC; documentation of ongoing partners meetings, with a summary of the outcomes; documentation of annual review and revisions to plans.

3) Referral to Services: Connect infants and families to health, early intervention and social services

Indicators for success: a completed plan outlining how the program is working to improve referral to services for affected individuals and families; demonstrated availability of data for referral purposes;

identification of gaps in referrals using appropriate methods (e.g., surveys, qualitative research using focus groups, follow-up of infants identified).

4) Data Analyses and Reporting:

Indicators for success: documented support for data analyses to evaluate the data collected and set-up programs for ongoing monitoring of data; materials using surveillance data are produced and disseminated;

documented data sharing and participation in centralized rapid microcephaly and CNS defect surveillance and clinical case project.

5) Health and Developmental Outcomes of Children Identified from the Rapid Microcephaly and Select CNS Defect Surveillance System

Indicators for success: plan developed outlining approach to collecting health and developmental outcomes data on children with microcephaly and select CNS conditions, and those with no birth defects from women http://wonder.cdc.gov/ http://healthvi.org/assets/documents/2011/2008-natality-and-mortality-indicators.pdf http://healthvi.org/assets/documents/2011/2008-natality-and-mortality-indicators.pdf http://www.un.org/esa/population/publications/WFD2012/MainFrame.html http://www.un.org/esa/population/publications/WFD2012/MainFrame.html http://www.cdc.gov/zika/geo/united-states.html http://www.cdc.gov/zika/pdfs/zika-mosquito-maps.pdf with positive or inconclusive Zika virus tests; evaluation of data collection methodologies and data quality.

Outcomes:

1) Improved approaches to rapidly and accurately ascertaining microcephaly and select CNS defects possibly linked to maternal Zika virus infection.

Indicator for success: evidence of rapid case-finding and assessment of data quality, completeness and timeliness, e.g. products/activities are completed showing improvements in timeliness and accuracy of case ascertainment and data collected.

2) Improved dissemination of accurate and timely information to organizations, agencies and individuals.

Indicator for success: number of publications disseminated, including journal impact/reach; percentage of users/target audiences indicating usefulness of the materials disseminated.

3) Increased awareness about prevention of adverse outcomes with possible link to Zika virus infection.

Indicator for success: evidence of prevention strategies used in targeted communities.

4) Increased knowledge about early identification and linkage of infants to health, early intervention, and other services.

Indicator for success: a completed plan outlining how the program is working to improve referral to services for affected individuals and families.

5) Improved use of surveillance data to inform policy among stakeholders.

Indicator for success: number of instances where decision makers used surveillance data to inform policy.

6) Enhanced partner collaborations to improve rapid reporting and response to emerging issues.

Indicator for success: number of completed projects or joint activities showing collaboration among partners.

7) Improved linkage and evaluation of health outcomes for children with microcephaly and select CNS conditions.

Indicator for success: percentage of affected individuals and families with utilization of health and other services as a result of a programs referral to services activities.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this FOA. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant).

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Awardees will be required to submit a more detailed Evaluation and Performance Measurement plan within the first 6 months of award, as described in the Reporting Section of this FOA.

c. Organizational Capacity of Awardees to Implement the Approach Applicants should possess the capacity and legal authority to collect population-based birth and birth defects data on microcephaly and select CNS defects and obtain State Laboratory reporting of pregnancies with positive or inconclusive Zika test results. There should be a coordinated effort with the U.S. Zika Pregnancy Registry. Applicant must describe the level of organizational capacity necessary to implement the FOA successfully. Organizational capacity includes skill sets to implement the required activities, such as: overall program and performance management, data analysis, data linkage, epidemiologic and clinical expertise, communication/material development, evaluation, performance monitoring, and financial reporting. If there are any vacant positions, the applicant should include a job description (including applicant qualifications) and address both the recruiting strategies and estimated timeline for filling the position.

Eligibility is limited to State/Territorial agencies or their Bona Fide agents because they have the public health authority and/or legislative mandate to conduct population-based birth defects surveillance. This authority allows them unique and specific access to datasets from multiple data sources that are required to implement the activities outlined in this FOA. They also have the experience, capacity, expertise, and resources to implement a population-based surveillance program.

d. Work Plan Applicants are required to provide a work plan consisting of a logic model (specific to their project plans and activities) and related narrative for the five-year program, and a detailed description of the first year of the award, consistent with the project’s logic model provided in this FOA.

Applicants are expected to use activities that are consistent with those indicated under the “Program Strategy” section. The work plan should provide outcomes and the related program strategies/activities and should be consistent with the narrative in the Approach and Performance Measurement and Evaluation sections.

Sample Work Plan Template

Project Period Outcome:

Outcome Objective:

Strategies / Activities

Performance Measures

Data Collection, Analysis, Plan

Responsible Person/ Organizational Unit

Status (Update/ Completion Date)

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

In a cooperative agreement, CDC staff is substantially involved in the program activities above and beyond routine grant monitoring.

Provide technical assistance to: establish a rapid active surveillance system to ascertain potential/possible cases of microcephaly and select CNS defects for all pregnancy outcomes; ensure data are used for prevention and intervention activities; and provide other guidance to state agencies and interested parties.

1.

Assist in designing, developing, and evaluating methodologies and approaches used for active, rapid population-based birth defects surveillance.

2.

Provide standard case definitions for conditions included in the rapid surveillance system. Provide technical assistance for clinical case reviews.

3.

Assist with database development and support. Provide database templates and abstraction forms.4.

Assist in analyzing surveillance data.5.

Assist in designing, developing, and evaluating plans.6.

Assist in designing, developing, and evaluating plans to improve the access of children with microcephaly and other birth defects to services.

7.

Provide a reference point for sharing grantee and non-grantee state, regional, and national data and contact information pertinent to the surveillance and prevention of birth defects.

8.

Assist with linkage strategies and evaluation of health outcomes for children identified with microcephaly and select CNS defects possibly linked to maternal Zika virus infection.

9.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program

Support to Awardees Section.

2. Award Mechanism: U50

3. Fiscal Year: 2016

4. Approximate Total Fiscal Year Funding:

$20,000,000

5. Approximate Project Period Funding:

$0

This amount is subject to the availability of funds.

Although there is no project period ceiling, ceiling amounts may be solicited annually.

Estimated Total Funding: $0

6. Total Project Period Length:

5 year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$200,000 Per Budget Period

9. Award Ceiling: $360,000 Per Budget Period

This amount is subject to the availability of funds.

Although there is no budget period ceiling, award ceiling amounts may be solicited annually. Please refer to the estimated FY 16 award amounts in Funding Strategy - Section 2.a.iv.

10. Award Floor: $100,000 Per Budget Period

11. Estimated Award Date: 08/01/2016

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

Additional Eligibility Category:

Government Organizations:

State governments or their bona fide agents (includes the District of Columbia) Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

2. Additional Information on Eligibility State, territory, and District of Columbia governments or their bona fide agent.

Eligible applicants that can apply for this funding opportunity are listed below:

State governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a letter from the state or local government delegating authority to the applicant to conduct the activities in this FOA is required. Attach with “Other Attachment Forms” when submitting via www.grant s.gov.

The estimated award ceiling for this FOA is $360,000. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs .gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition Eligibility is limited to State, District of Columbia, and Territorial agencies or their Bona Fide agents http://www.grants.gov/ http://www.grants.gov/ http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Eligibility is limited to State, District of Columbia, and Territorial agencies or their Bona Fide agents because they have the public health authority and/or legislative mandate to conduct population-based birth defects surveillance. This authority allows them unique and specific access to datasets from multiple data sources that are required to implement the activities outlined in this FOA.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing effort to promote sustainability is strongly encouraged.

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number.