CDC-RFA-PS14-14020401SUPP17.pdf

Centers for Disease Control

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention

STD AAPPS Supplemental Funding for Enhanced Congenital Syphilis Response

CDC-RFA-PS14-14020401SUPP17

Application Due Date: 09/06/2017

STD AAPPS Supplemental Funding for Enhanced Congenital Syphilis Response

CDC-RFA-PS14-14020401SUPP17

TABLE OF CONTENTS

Part 1. Overview Information Part 2. Full Text of the Announcement

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 Federal Agency Name:

Federal Centers for Disease Control and Prevention (CDC) Notice of Funding Opportunity (NOFO) Title:

STD AAPPS Supplemental Funding for Enhanced Congenital Syphilis Response Announcement Type:

Revision – Type 3, Supplement Announcement to FOA CDC-RFA-PS14-1402

Agency Notice of Funding Opportunity Number:

CDC-RFA-PS14-14020401SUPP17

Catalog of Federal Domestic Assistance Number:

93.977 Key Dates:

Due Date for Application: 09/06/2017 Application must be successfully submitted to Grants.gov by 11:59pm Eastern Standard Time on the deadline date.

Additional Overview Content:

Executive Summary:

The CDC, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of STD Prevention (DSTDP) has developed this 15 month supplemental Funding Opportunity Announcement (FOA) titled, “STD AAPPS Supplemental Funding for Enhanced Congenital Syphilis Response," to strengthen capacity to address congenital syphilis in the United States and build upon activities supported under FOA CDC RFA-PS14- 1402, "Improving Sexually Transmitted Disease Programs through Assessment, Assurance, Policy Development, and Prevention Strategies" (STD AAPPS). Under CDC-RFA-PS14-1402 there are 59 State, local, and territorial project areas currently funded to conduct assessment, assurance, and policy strategies related to STD prevention and control. STD AAPPS began January 1, 2014, for a 5-year project period.

The purpose of this supplemental FOA is to fund a select set of project areas with high rates of congenital syphilis to go above and beyond the activities supported by STD AAPPS and bolster congenital syphilis control and prevention. The primary goal of this supplemental FOA is to strengthen the local response to congenital syphilis in the United States. The activities outlined in this FOA are expected to strengthen local and national capacity to address congenital syphilis. This supplemental FOA will support approximately 9 awardees currently funded under CDC-RFA-PS14-1402, STD AAPPS.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the NCHHSTP:

Reduce the incidence of primary and secondary (P&S) syphilis in women aged 15-44 Reduce the incidence of congenital syphilis

Increase the proportion of pregnant women that are screened for syphilis at least one month before delivery

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/integrity/docs /cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 318 (a) (b) (c) of the Public Health Service Act [42 U.S.C. Section 247c (a) (b) and (c)], as amended.

Background Syphilis is a sexually transmitted infection that is caused by the spirochete bacteria, Treponema pallidum. It remains an important and preventable cause of adverse pregnancy outcomes, including stillbirth, spontaneous abortion, preterm delivery, neonatal death and congenital syphilis of the neonate and infant [1-8]. Adverse birth outcomes attributable to syphilis are primarily due to in utero infection, with few transmissions occurring at time of delivery. Risk of adverse outcome varies by mother's stage of syphilis, with highest risk in primary and secondary syphilis. Natural history studies of early syphilis infection among pregnant women during the pre-penicillin era in the United States documented outcomes of 40% congenital infection, 25% stillbirth, and 14% neonatal death [5, 6]. Among pregnant women with syphilis infection, early treatment is important to reduce perinatal mortality and morbidity. In women treated in the first trimester of pregnancy, risks of adverse birth outcome are similar to women without syphilis; however risk increases significantly with each gestational week that treatment is delayed [9].

The national rate of congenital syphilis increased 48% between 2012 and 2015 (to 11.6 per 100,000 live births) and 487 cases of congenital syphilis were reported to CDC in 2015 [10, 11].

The increase in congenital syphilis mirrors a simultaneous increase in cases of primary and secondary syphilis reported in women (to 1.4 cases per 100,000 females during 2014–2015).

This represents a 27.3% increase compared to the previous year. In 2014–2015, the largest increases in syphilis rates among women were seen in the West (41.7%), followed by the Northeast (40.0%), South (20.0%), and Midwest (11.1%). In order to reduce rates of congenital syphilis, rates of primary and secondary syphilis among women of reproductive age must be reduced along with unintended pregnancies.

There are several potential barriers to the successful prevention of congenital syphilis in the United States; addressing each provides an opportunity to reduce perinatal transmission and improve disease outcomes. Barriers include inadequate access to prenatal care, the lack of universal syphilis screening during pregnancy, delays in therapy and the use of inappropriate 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 antibiotics to treat syphilis detected in pregnancy. Lack of prenatal care has been associated with about one in four congenital syphilis cases reported in the United States. For example, of the 487 cases of congenital syphilis reported to CDC in 2015, 122 (25.1%) had no prenatal care and an additional 82 (16.8%) women had “unknown” prenatal care status listed. Universal screening for syphilis at the initial prenatal care visit is a longstanding CDC recommendation that is mandated by legislation in most states. Additional syphilis screening is recommended at 28 weeks gestational age and at delivery for women who are at high risk or live in areas of high syphilis morbidity although follow up testing is not universal, even in high morbidity areas. A single dose of benzathine penicillin (2.4 million units intramuscularly) is effective and safe and it remains the only recommended antimicrobial for the treatment of primary, secondary and early latent syphilis detected during pregnancy [12].

Public health programs in several US states and jurisdictions have devised novel strategies to reduce local congenital syphilis rates. Successful programs rely on a dedicated, multi-disciplinary staff including clinicians, epidemiologists and disease investigation specialists (DIS) and a close partnership established between public health officials and prenatal, obstetric and maternity care providers and facilities. This also requires community engagement with women and their communities. Some public health efforts have focused on improved disease reporting for women of childbearing age and for pregnant women, others have created programs to establish a statewide congenital syphilis morbidity and mortality case review board and others have worked on legislative efforts to mandate prenatal syphilis screening practices.

To address the increase in syphilis among women and their babies, and men, CDC released a Call to Action in April 2017 providing critical information on the role of public health departments in addressing congenital syphilis along with a range of other key partners [13].

This FOA builds on the CDC Call to Action to address the increase in congenital syphilis and effectively work to strengthen prevention efforts.

References

1. Dorfman, D.H. and J.H. Glaser, Congenital syphilis presenting in infants after the newborn period. N Engl J Med, 1990. 323(19): p. 1299-302.

2. Rac, M.W., Bryant, S. N., McIntire, D. D., Cantey, J. B., Twickler, D. M., Wendel, G.

D., Jr., Sheffield, J. S., Progression of ultrasound findings of fetal syphilis after maternal treatment. Am J Obstet Gynecol, 2014. 211(4): p. 426.e1-6.

3. Ricci, J.M., R.M. Fojaco, and M.J. O'Sullivan, Congenital syphilis: the University of Miami/Jackson Memorial Medical Center experience, 1986-1988. Obstet Gynecol, 1989. 74(5): p. 687-93.

4. Cole, H.N., F. Plotke, et al., Penicillin in the treatment of syphilis in pregnancy. J Vener Dis Inf, 1949. 30(4): p. 95-100.

5. Fiumara, N.J., Fleming, W. L., Downing, J. G. and Good, F. L. The incidence of prenatal syphilis at the Boston City Hospital. N Engl J Med, 1952. 247(2): p. 48-52.

6. Ingraham, N.R., Jr., The value of penicillin alone in the prevention and treatment of congenital syphilis. Acta Derm Venereol Suppl (Stockh), 1950. 31(Suppl. 24): p. 60-87.

7. Sheffield, J.S., Sanchez, P. J., Morris, G., Maberry, M., Zeray, F., McIntire, D. D., Wendel, G. D., Jr. Congenital syphilis after maternal treatment for syphilis during pregnancy. Am J Obstet Gynecol, 2002. 186(3): p. 569-73.

8. Michelow, I.C., Wendel, G. D., Jr., Norgard, M. V., Zeray, F., Leos, N. K., Alsaadi, R., Sanchez, P. J. Central nervous system infection in congenital syphilis. N Engl J Med, 2002. 346(23): p. 1792-8.

9. Qin J, Yang T, Xiao S et al. (2014) Reported estimates of adverse pregnancy outcomes among women with and without syphilis: a systematic review and meta-analysis. PLoS One 9(7):e102203

10. Centers for Disease Control and Prevention, Division of STD Prevention. STD Surveillance Report, 2015. 2016.

11. Bowen, V., Su, J., Torrone, E., Kidd, S., Weinstock, H. Increase in incidence of congenital syphilis - United States, 2012-2014. Morb Mortal Wkly Rep, 2015. 64(44): p.

1241-5.

12. Centers for Disease Control and Prevention. STD Treatment Guidelines 2015.

13. CDC Call to Action: Let’s work together to stem the tide of rising syphlis in the United

States, April 2017.

Purpose The purpose of this supplemental FOA, entitled STD AAPPS Supplemental Funding for Enhanced Congenital Syphilis Response is to strengthen local capacity to address congenital syphilis and support the priorities of the Division of STD Prevention. The activities in this FOA are expected to result in stronger local and national capacity to address congenital syphilis.

This supplemental FOA will support 7 related activities as described below.

Healthy People 2020 This supplement addresses the Healthy People 2020 focus area of Sexually Transmitted Diseases and the goal of reducing congenital syphilis (STD-8) and the focus on reducing disparities by race and ethnicity. This supplement also addresses the Healthy People 2020 focus area of Maternal, Infant, and Child Health, Pregnancy Health and Behaviors to increase the proportion of pregnant women who receive early and adequate prenatal care (MICH-10.2).

Other National Public Health Priorities and Strategies This supplemental award addresses the CDC Health Protection Goals of healthy people in every stage of life, and healthy people in healthy places. This supplement supports CDC’s strategic priorities of: (1) excellence in surveillance, epidemiology, and laboratory services and (2) strengthening support for state, tribal, local, and territorial public health. This supplement aligns with the priorities of the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP) to reduce the rate of non-HIV STDs. This supplement addresses the strategic goals of the Division of STD Prevention (DSTDP), which includes addressing STDs among pregnant women. It also supports the recent CDC Call to Action: Let’s Work Together to Stem the Tide of Rising Syphilis in the United States supporting a multi-sector response to congenital syphilis.

Key Outcomes By the end of the project period, the following outcomes will be achieved to better understand causes of and potential solutions to preventing congenital syphilis:

Improved congenital syphilis case data collection, including maternal and fetal epidemiologic and clinical risk factor data.

https://www.healthypeople.gov/

Improved pregnancy status ascertainment among cases of female syphilis and collection of prospective data on pregnant woman.

Strengthened congenital syphilis morbidity and mortality case review boards at the local and/or State level to improve the ability to identify causes of congenital syphilis and develop related interventions to address causes.

Improved methods to match vital statistics birth and mortality data with syphilis surveillance data to review syphilis testing practices among stillbirths, identify missed cases of syphilitic stillbirth, and strengthen congenital syphilis case report data.

Stronger partnerships to enable more timely response to congenital syphilis cases and congenital syphilis prevention.

Program Implementation

Recipient Activities Supported by this supplemental FOA, awardees will implement the following activities:

1. Identify and implement strategies to collect enhanced data to better understand causes of, and potential solutions to, preventing congenital syphilis including prospective collection of maternal and fetal epidemiologic and clinical risk factor information, and additional data needed to track pregnant women with syphilis.

Comprehensive information on maternal syphilis, fetal syphilis and congenital syphilis cases is critical for identifying factors associated with congenital syphilis and opportunities for intervention. Often, congenital syphilis case reports are sent to CDC with missing data, especially as relates to maternal data such as prenatal care, stage of maternal syphilis, gestational age at the time of maternal screening, treatment and delivery. Also, information on fetal syphilis, stillbirths due to syphilis and infants with a fourfold higher nontreponemal titer compared to the mother is not routinely collected. Efforts are needed to improve maternal syphilis, fetal syphilis and congenital syphilis epidemiologic and clinical case data as a key strategy to identify opportunities for interventions. Data collection, monitoring and case management can be improved through the prospective follow-up of pregnant women with syphilis and their fetus and infant, linking vital statistics birth and mortality data with STD surveillance records (see #4 below) and the retrospective ascertainment of congenital syphilis data through various means, such as enhanced post-partum interviewing and partnership-building, or electronic medical record linkages at prenatal and delivery facilities. These efforts may provide useful information to inform congenital syphilis prevention interventions and future data collection efforts.

2. Develop and implement new strategies for actively ascertaining pregnancy status among cases of female syphilis, including strategies to link women to family planning (FP) services, high risk pregnancy case management programs, incorporating pregnancy ascertainment in DIS trainings and skills, and enhancing the ascertainment of pregnancy intentions.

Some STD programs currently offer pregnancy testing to women diagnosed with early syphilis in an attempt to increase the ascertainment of pregnancy status in this high-risk population. The timely identification of pregnancy in a woman with syphilis provides opportunities for higher-level case management, which may include basic treatment verification or linkage to care for women not currently seeking prenatal care or those with co-occurring substance use and mental health conditions. By expanding pregnancy testing, the ascertainment of pregnancy status from providers or electronic medical records, and pregnancy status collection during DIS assessments, pregnant women with syphilis will be identified earlier and may benefit from intervention opportunities otherwise not available if pregnancy status is unknown. Enhancing investigations may also provide more complete epidemiologic and clinical information on maternal, fetal and congenital syphilis cases such as more details about risk factors for congenital syphilis, including health care-seeking behaviors, health care access, co-occurring substance use and mental health conditions and other social determinants of health that might lead to better understanding and more informed public health and health care action and intervention.

3. Develop or strengthen Congenital Syphilis Morbidity and Mortality Case Review Boards with the purpose of identifying root causes of Congenital Syphilis and strengthening systems identified in need of improvement.

Congenital Syphilis Morbidity and Mortality Case Review Boards are defined here as regular, systematic reviews of all congenital syphilis cases in a jurisdiction, regardless of vital status, by a multidisciplinary group that includes—at a minimum— clinical, epidemiologic, surveillance, and DIS personnel. Medical records from mother and infant should be reviewed along with case data collected from syphilis case report forms and pre- or post-partum interviews with the case-mother. The primary purpose of the Case Review Board is to identify causes of congenital syphilis case status for each case and to identify opportunities for individual- or systems-level strengthening. After-action plans can be used to strengthen follow-through and build political will for systems-level changes.

4. Implement strategies to routinely match vital statistics birth and mortality data with syphilis surveillance data in order to review syphilis testing practices among mothers, to identify missed cases of syphilitic stillbirth, and to strengthen congenital syphilis case report data including stillbirth data.

CDC recommends routine syphilis testing of all mothers who give birth to stillborn infants; it is widely believed, however, that this practice is not universal. Using vital records to regularly review stillbirth data in a jurisdiction may provide a sense of how many infants/mothers were not evaluated appropriately for syphilis to inform provider interventions. More importantly, stillbirth records allow for matching to reported cases of female syphilis within a specified time-period, a method that has been used to identify missed/unreported cases of syphilitic stillbirth.

Vital records can also be used to glean additional data about reported congenital syphilis cases, including prenatal care and vital status of the infant.

5. Strengthen partnerships with local health care providers and community organizations and state and local Title V maternal and child health programs, Medicaid programs and health care organizations.

Awardees should identify and implement a coordinated strategy with a range of local and state partners to strengthen relationships with state and local Title V maternal and child health, Medicaid programs, health care providers and organizations, and community groups. These partnerships should focus on improving the following: screening, diagnosis, and treatment of syphilis for pregnant women and women of reproductive age; support for case management of pregnant women with syphilis, as needed, and timely reporting of cases to the public health department. This may include state and local chapters of ACOG and AAP; OBGyn and pediatric departments in university medical centers, health plans and other partners engaged with the target populations including women at risk for congenital syphilis, providers and health care systems who serve them and other stakeholders.

6. Engage with one or two local counties to work on the strategies described above, if applicable.

Awardees should select one or two local counties with high rates of congenital syphilis to involve in all appropriate project activities including the SIG (see #7). This may include an initial needs assessment of the current congenital syphilis prevention procedures and protocols at the local level, current staffing models and communication between local and State health departments to identify opportunities to strengthen the congenital syphilis prevention response.

7. Participate in a congenital syphilis special interest group (SIG) to work collectively on program activities and best practices to inform the revision of the CDC program guidance on congenital syphilis prevention and control.

Awardees will participate in a learning collaborative with all awardees and CDC to address project activities. This will include participation in webinars, conference calls, and possible in-person meetings. Awardees will ensure that local county partners also participate in the SIG.

The SIG will be used to facilitate and share best or promising practices among jurisdictions in a variety of areas, including data improvement, case-management, health communication, community engagement, and the other activities presented in this FOA.

Organization Capacity of Awardees to Execute the Approach Applicants must have the statutory authority to conduct communicable disease or infectious disease surveillance and the organizational structure and capacity to execute the program approach and strategies and meet the project period outcomes, in local jurisdictions with high numbers of congenital syphilis cases over the course of the project period. The anticipated level of specific organizational capacity needed to execute the approach successfully includes capacity in:

Organizational structure and management that supports the activities, including partnering with no more than two counties (if applicable)

Surveillance, information technology, data management, and epidemiology Human resource management and financial management to support the activities.

Evaluation and Performance Measurement To document progress towards achieving project outcomes, awardees are expected to monitor and report on process and impact performance measures. Through the special interest group (activity #7, described above), CDC and awardees will define these measures collaboratively.

CDC will also review these measures every 6 months and revise accordingly. At a minimum, awardees are expected to monitor and report annually on the following measures (providing number and percent):

Maternal syphilis cases with complete epidemiologic and clinical data Fetal syphilis cases with complete epidemiologic and clinical data Congenital syphilis cases with complete epidemiologic and clinical data Pregnant women with syphilis who meet the criteria for high risk pregnancy case management receiving case management Female syphilis cases with pregnancy status documented within 14 days of diagnostic test collected Congenital syphilis cases reviewed by a Congenital Syphilis Morbidity and

Mortality Case Review Board within two months of identification Female syphilis cases matched to vital statistics birth and mortality records; still births matched to a woman with syphilis Health care providers and community organizations engaged for local congenital syphilis prevention partnerships Maternal and child health programs, health care organizations, and Medicaid programs engaged for state and local congenital syphilis prevention partnerships

Collaborations Applicants are expected to collaborate with various organizations under this award.

Collaborations with other CDC programs and CDC-funded organizations may include NCHHSTP/DHAP HIV mother to child transmission programs, NCHHSTP/DVH perinatal hepatitis B programs, and NCCDPHP/DRH. Collaborations with organizations not funded by CDC may include State Title V programs, Medicaid programs, OBGyn and pediatric departments in local university medical centers, local ACOG and AAP chapters, and local health plans.

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

CDC Activities CDC activities may include:

Working collaboratively with grantees on activity protocols and data forms Ensuring Office of Management and Budget (OMB) approval for data sent to CDC Maintaining operation and security of data entry portal Receiving and managing national data Providing technical assistance to develop and implement the annual work, evaluation, and performance measurement plans Coordinating program activities across sites and offering leadership and communication structures needed to do so effectively Leading and collaborating on analyses and dissemination of findings, including best practices

Section II. Award Information Type of Award: Cooperative Agreement CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: H25 Venereal Disease

Fiscal Year Funds: 2017 Approximate Total Supplemental Funding: $6,000,000 This amount is subject to availability of funds. Includes indirect costs.

Approximate Number of Awards: 9 (subject to availability of funds)

Approximate Average Award: $600,000 This amount is for the budget period only and includes direct costs and indirect costs as applicable.

Floor of Individual Award Range: $0 Ceiling of Individual Award Range: $700,000 This ceiling is for a 12-month budget period.

Anticipated Award Date: 09/29/2017 Budget Period Length: 15 month(s) Project Period Length: 1.25 year(s)

Section III. Eligibility Information

Eligible Applicants The following recipients may submit an application:

Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

Eligibility for this expansion supplement is limited to current awardees of CDC-RFA-PS14- 1402 “Improving Sexually Transmitted Disease Programs through Assessment, Assurance, Policy, and Prevention Strategies” (STD AAPPS). Current awardees of STD AAPPS include 59 states, territories, and city health departments. Eligibility for STD AAPPS was limited to those 59 entities, based on existing public health infrastructure and STD epidemiology. The limited eligibility memo for STD AAPPS was approved on January 8, 2013. In order to accomplish the supplemental award project objectives, the funded entity must have had 14 or more babies born with congenital syphilis reported to CDC in 2015.

Required Registrations

System for Award Management and Universal Identifier Requirements 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. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov: The first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov. All applicant organizations must register with www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants must start the registration process as early as possible.

Cost Sharing or Matching Cost Sharing / Matching Requirement: No

Other

Special Requirements None.

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

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

https://www.grants.gov http://fedgov.dnb.com/webform/displayHomePage.do http://www.sam.gov/ https://www.grants.gov

Section IV. Application and Submission Information

Address to Request Application Package Applicants must download the application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 for further instruction. CDC Telecommunications for the hearing impaired or disable is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it is needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by email, fax, CD’s or thumb drives of applications will not be accepted.

Content and Form of Application Submission Unless specifically indicated, this announcement requires submission of the following information:

This section describes what is expected of the applicant regarding each section of the supplemental FOA. Applicants are required to submit all of the components listed in the section.

A. Letter of intent (LOI): A LOI is optional, but is requested. The purpose of a LOI is to allow CDC program staff to estimate the number of submitted applications and plan for their review.

LOIs should be emailed directly to Dr. Jennifer Fuld, PhD, MA, Chief, Program Development and Quality Improvement Branch, DSTDP, (jfuld@cdc.gov) by August 15, 2017.

B. Table of Content (No page limit and not included in the Project Narrative limit): The applicant must provide a table of contents for the entire submission package. The file should be submitted to www.grants.gov as a separate attachment and entitled “Table of Contents.”

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be https://www.grants.gov mailto:support@grants.gov mailto:jfuld@cdc.gov http://www.grants.gov submitted in the following format:

Maximum number of pages: 10. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.

Font size: 12 point unreduced, Times New Roman Single spaced Page margin size: One inch Number all narrative pages; not to exceed the maximum number of pages.

Applicants should name the file “Project Narrative” and upload the project narrative to www .grants.gov in a PDF file format under “Project Narrative” in the mandatory documents section on www.grants.gov. The work plan, although a separate section, is counted within the 10-page limit. Applicants should number pages of the narrative. If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed. The Project Narrative must be succinct, self-explanatory, and in the order listed in this section. It must address outcomes and activities to be conducted over the project period as identified in the Program Implementation section.

The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed.

The narrative should include all the bolded headers outlined under this section.

1. Background (1/2 page) Applicants must provide a description of relevant background information that includes the context of the problem (see CDC Background).

2. Purpose (1/2 page) Applicants must describe specifically how their application will address the public health problem of congenital syphilis in their jurisdiction.

3. Program Strategy (4 pages) The applicant must clearly and concisely describe the program activities and methods the applicant intends to use to meet the project period outcomes. The applicant should outline their experience to date with each of the seven activities, as well as they planned approach to strengthening their work for each activity under this award.

Target Populations: Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities.

Collaborations: Applicants should describe plans to partner with local counties to fulfill the requirements of the supplement. State applicants must submit a letter of collaboration or MOU from the local county health officer(s) and this file should be named “County letter of collaboration or MOU” and uploaded as a PDF file under “Other Attachment Forms” on www .grants.gov. Applicants should also describe how they intend to collaborate with local health http://www.grants.gov http://www.grants.gov http://www.grants.gov care providers and health care organizations, training organizations such as the NNPTC and maternal-child health programs. Letter of collaborations with local health care organizations, training centers and maternal-child health programs are strongly encouraged.

4. Organizational Capacity of Applicants to Implement the Approach (1 page) Applicants must describe their organizational capacity to achieve the outcomes of the award.

The organizational capacity statement should describe how the applicant’s agency is organized, the nature and scope of its work, and the public health capabilities it possesses. Applicants should note the statutory authority to conduct communicable disease or infectious disease surveillance in their jurisdiction.

Applicants must describe the relationship to any local health departments (LHD) that they select for collaboration (if applicable) including an LHD organizational chart, key local staff, data transfer/sharing process, and case management, partner services or other collaborative activities relevant to the supplement.

Applicants must include an agency organizational chart, clearly identifying the organizational placement and management structure of the STD prevention and surveillance program, vital statistics program, Title V maternal-child programs, and Medicaid programs within the health department or State/local government. Applicants should name the file “Organizational Charts” and upload as a PDF file under “Other Attachment Forms” on www.grants.gov.

Applicants should specify who will have day-to-day responsibilities for state and local leadership of the project, monitoring the project’s on-going progress, preparation of reports, and communication with CDC and other partners.

5. Applicant Evaluation and Performance Measurement Plan (1 page) Applicants should outline their capacity to report on the proposed performance measures described above, as well as their approach to monitoring progress towards the project goals and any additional evaluation work proposed.

6. Work Plan (3 pages) Applicants are required to provide a concise work plan based on the required strategies described above. The work plan integrates and delineates more specifically how the awardee plans to carry out achieving the project period outcomes, strategies and activities, evaluation and performance measurement.

Applicants are required to provide a work plan based on the approach, which includes the plan and timeline for: collecting enhanced epidemiologic and clinical data on maternal, fetal and CS cases; actively ascertain pregnancy status among cases of female syphilis; strengthening CS Morbidity and Mortality Case Review Boards; matching birth and mortality vital statistics data with syphilis surveillance data; strengthening partnerships with providers and MCH community;

and engaging with highly affected counties. During the project period, additional data fields, as determined in several of the listed activities, will be collected and submitted to CDC. During the project period, participation in a CDC-led special interest group will also be required. Work plans will be reviewed and updated within the first month of the project period as well as revised as needed over the course of the project period.

Budget Narrative (no page limit) Applicants must provide an individual budget for the project period as a separate attachment at www.grants.gov. Funds provided to a county or local jurisdiction should be specified in this budget narrative.

Additional information may be included in the application appendices. The appendices must be uploaded to the "Other Attachments Form" of application package in Grants.gov. Note:

appendices will not be counted toward the narrative page limit. This additional information includes:

CVs or resumes of key staff (optional) Organizational charts of state and local health department structures (required) Letters of support stating commitment of collaboration or MOU from health officer of local health department(s) (required) Letters of support stating commitment of collaboration from health care organizations, training centers and maternal – child health programs (optional)

Additional information submitted via Grants.gov must be uploaded in a PDF file format, and should be named:

No more than 8 electronic attachments should be uploaded per application.

CDC Assurances and Certifications: All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.asp x

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective http://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

Submission Dates and Times This announcement is the definitive guide on application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the recipient will be notified the application did not meet the submission requirements.

This section provides applicants with submission dates and times. Applications that are submitted after the deadlines will not be processed.

If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Application Deadline Date Due Date for Applications: 09/06/2017

Explanation of Deadlines: Application must be successfully submitted to Grants.gov by 11:59pm Eastern Standard Time on the deadline date.

Intergovernmental Review

The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State's process. Visit the following Web address to get the current SPOC list:

http://www.whitehouse.gov/omb/grants_spoc/.

Pilot Program for Enhancement of Employee Whistleblower Protections All applicants will be subject to a term and condition that applies the terms of 48 CFR section

3.908 to the award and requires that grantees inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C 4712.

http://www.whitehouse.gov/omb/grants_spoc/

Copyright Interest Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

Federal Funding Accountability and Transparency Act of 2006 (FFATA), P.L. 109–282, as amended by section 6202 of P.L. 110–252 requires full disclosure of all entities and organizations receiving Federal funds including awards, contracts, loans, other assistance, and payments through a single publicly accessible Web site, www.USASpending.gov.

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by applicants: 1) information on executive compensation when not already reported through the SAM, and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the FFATA and HHS guidelines, go to:

http:// frwebgate.access.gpo.gov /cgi-bin/getdoc.cgi ?dbname= 109_cong_bills&docid= f:s2590enr.txt.pdf, https://www.fsrs.gov/documents/ffata_legislation_110_252.pdf

Funding Restrictions http://www.USASpending.gov http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf

Restrictions, which must be taken into account while writing the budget, are as follows:

Recipients may not use funds for research.

Recipients may not use funds for clinical care.

Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

Other than for normal and recognized executive-legislative relationships, no funds may be used for: publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body.

See Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC awardees

Reimbursement of pre-award costs is not allowed.

Awardees may not use funds for any kind of impermissible lobbying activity designed to influence proposed or pending legislation, appropriations, regulations, administrative actions, or Executive Orders.

Awardees may not use funds for food purchases.

The recipient can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html

Other Submission Requirements

Application Submission Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the recipient encounters difficulty in accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, recipients will receive a "submission receipt" email generated by Grants.gov. Grants.gov will then generate a second e-mail http://www.cdc.gov/grants/additionalrequirements/index.html http://www.cdc.gov/grants/additionalrequirements/index.html http://www.cdc.gov/grants/additionalrequirements/index.html http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html https://www.Grants.gov message to recipients which…