DP15005AMENDPUBLICATION.pdf

Centers for Disease Control and Prevention

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

Evaluation of a Stepped Care Approach for Perinatal Depression Treatment in Obstetrics and Gynecology

Clinics

RFA-DP-15-005

Application Due Date: 02/25/2015

Evaluation of a Stepped Care Approach for Perinatal Depression Treatment in Obstetrics and Gynecology Clinics

RFA-DP-15-005

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

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

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

(NCCDPHP ERPO)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Funding Opportunity Announcement (FOA) Title Evaluation of a Stepped Care Approach for Perinatal Depression Treatment in Obstetrics and Gynecology Clinics Activity Code

AMENDMENT I. QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES

added to Section VIII. Other Information, February 9, 2015

Activity Code - U01

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-005

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.068 Category of Funding Activity:

Health FOA Purpose The purpose of this FOA is to: 1) determine the effectiveness of a stepped care approach to reducing depression symptomology and increasing treatment rates; 2) determine the feasibility of implementing a stepped care approach to depression treatment in obstetric clinics; and 3) develop recommendations for implementing best practice strategies for incorporating a stepped-care approach in obstetrics clinics. Results of this FOA may inform national guidelines regarding depression care for perinatal women.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-005, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/26/2015

Application Due Date: 02/25/2015

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

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

http://www.grants.gov

Scientific Merit Review: 04/20/2015

Secondary Review: 06/05/2015

Estimated Start Date: 09/30/2015

Expiration Date: 02/26/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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

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

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

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

Executive Summary

Purpose. The purpose of this FOA is to: 1) determine the effectiveness of a stepped care approach to reducing depression symptomology and increasing treatment rates among pregnant and postpartum women; 2) determine the feasibility of implementing a stepped care approach to depression treatment in obstetric clinics; and 3) develop recommendations for implementing best practice strategies for incorporating a stepped-care approach in obstetric clinics. Results of this FOA may inform national guidelines regarding depression care for pregnant and postpartum women.

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

Funds Available and Anticipated Number of Awards. NCCHDPHP intends to fund one (1) award and to commit approximately $2,500,000 in total (including both direct and indirect costs) over the project period. An award issued under this FOA is contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded will depend upon the quality, duration of project, and costs of the applications received.

Budget and Project Period. An applicant may request a project period up to five (5) years. The estimated funding (including both direct and indirect) for the first year (12 month budget period) is $500,000 and the estimated total funding (including both direct and indirect) for the entire project period is $2,500,000. The project period will run from 9/30/2015 to 09/29/2020.

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

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

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

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

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

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

DUNS number) is allowed.

Application Type. New Special Date(s). None Application Materials. SeeSection IV.1 for application materials.

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

(770) 488-2783.

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

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

This program is authorized under Section 317K of the Public Health Service Act 42 U.S.C. 247b-12 and Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a).

1. Background and Purpose

Among women of reproductive age, approximately 1 out of 10 women suffer from past-year depression (Ko et al., 2012). Depression is one of the most common causes of maternal morbidity and approximately 15% of women experience symptoms before, during, or after pregnancy (Dietz et al., 2007). Depression is associated with anxiety, increased rates of alcohol and drug abuse, and may also be associated with adverse reproductive outcomes, including decreased fertility, pre-term delivery, low birth weight infants, and impaired maternal functioning and infant development. Effective treatments for depression, such as counseling/behavioral therapy and prescription medication, are available. However, fewer than half of depressed women with diagnoses receive any treatment (Ko et al., 2012) and racial/ethnic disparities in receiving care have been documented (Kozhimannil et al., 2011).

Studies evaluating mandates for universal screening (e.g.., New Jersey legislation and federal Healthy Start programs) have not shown improvements in depressive symptomology or treatment rates (Kozhimanill et al., 2011; Yonkers et al., 2009). Only three intervention studies have documented high rates of screening, diagnosis and therapy initiation, as well as declines in maternal depressive symptoms (Leung et al., 2011;

Melville et al., 2014, Yawn et al., 2012). These studies incorporated multiple components such as:

implementation of screening procedures and care at a woman’s usual care site, care to begin immediately after a positive screen, provision of staff educational sessions and support tools for diagnosis, and other system changes to ensure women receive comprehensive care. However, two of these studies were among postpartum women only, one conducted in Hong Kong (Leung et al., 2011) and the other at a U.S. family medicine practice (Yawn et al 2012). In the third study, the authors applied many eligibility criteria that resulted in enrollment of only 32% of women who screened positive for depression and only 7% of the study population was pregnant (Melville et al., 2014). Therefore, it is unclear whether these components of care are feasible and pragmatic to incorporate in the majority of obstetric clinics serving prenatal and postpartum women.

The American College of Obstetricians and Gynecologists (ACOG) encourages women to visit their Ob/Gyn annually for well-woman visits (American College of Obstetricians and Gynecologists, 2012) and research shows that women are 4 times as likely to attend a behavioral health treatment visit if the provider is located at the same site as their obstetrical provider (Smith et al., 2009). However, ACOG does not currently recommend universal screening for perinatal depression due to lack of effective screening and referral/treatment approaches to improve women’s mental health. Additionally, the U.S. Preventive Services Task Force (USPSTF) recommends depression screening for adults only when staff-assisted depression care supports are in place to ensure accurate diagnosis, effective treatment, and follow-up; however, the USPSTF recommendations have not been rigorously examined among pregnant and postpartum women. Offering http://www.cdc.gov/chronicdisease/about/foa.htm treatment at the obstetric care visit may improve treatment uptake and outcomes. Stepped care is defined as initial treatment provided at the obstetric clinic, progress assessed routinely, and referral for more intensive treatment if a woman does not adequately respond to initial treatment. More research is needed to evaluate the effectiveness and feasibility of a stepped care approach to depression diagnosis and treatment among pregnant and postpartum women in obstetric clinics. Results of this FOA may inform national guidelines regarding depression care for perinatal women.

Healthy People 2020 and other National Strategic Priorities

This research addresses several Healthy People 2020 priority area(s):

a. Maternal, Infant, and Child Health (MICH) objectives:

i. MICH-10 Increase the proportion of pregnant women who receive early and adequate prenatal care.

ii. MICH-6 Reduce maternal illness and complications due to pregnancy (complications during hospitalized labor and delivery).

iii. MICH-34 (developmental) Decrease the proportion of women delivering a live birth who experience postpartum depressive symptoms.

b. Mental Health and Mental Disorders (MHMD) objectives:

i. MHMD-4 Reduce the proportion of persons who experience major depressive episodes (including postpartum depression).

ii. MHMD-9 Increase the proportion of adults with mental health disorders who receive treatment,and

iii. MHMD-11Increase depression screening by primary care providers.

The proposed research addresses one of CDC’s NCCDPHP core focus areas, or domains, “health system interventions to improve the effective delivery and use of clinical and other preventive services to prevent disease, detect diseases early, and reduce or eliminate risk factors and mitigate or manage complications.”

Additionally, the research addresses CDC’s Division of Reproductive Health’s priority to improve women’s reproductive health from menarche through menopause, and three key DRH strategic areas of focus: 1) Chronic Disease Prevention and Health Promotion in Women of Reproductive Age; 2) Maternal Mortality and Complications of Pregnancy; and 3) Infant Morbidity and Mortality.

Public Health Impact

Among women of reproductive age, approximately 1 out of 10 women suffer from past-year depression, or

1.2 million women annually (Ko et al., 2012). Depression is associated with adverse reproductive health outcomes. Maternal depression may be associated with adverse reproductive health outcomes. However, fewer than half of depressed women receive treatment. A successful intervention for a stepped care approach to treating pregnant and postpartum women with depression would provide a model for incorporation in obstetric practices nationally. Such evidence could also inform national recommendations aimed at reducing the public health burden of perinatal depression.

Relevant Work

Refer to Background and Purpose and Healthy People 2020 and other National Strategic Priorities sections.

2. Approach

The research goals of this FOA are: 1) to conduct a pragmatic randomized control trial that evaluates whether a stepped care approach to screening and provision of treatment for pregnant and/or postpartum women, conducted at her normal place of care, is effective and feasible compared to referral to treatment and

2) to develop recommendations for implementation of a stepped care approach at obstetric practices across the U.S. Stepped care is defined as initial treatment provided at the obstetric clinic, progress assessed routinely, and referral for more intensive treatment if a woman does not adequately respond to initial treatment.

Objectives/Outcomes

Objective 1: To design a randomized controlled trial among depressed pregnant and postpartum women that compares depressive symptomology and treatment rates between an intervention group that receives a stepped care approach to treatment and a control group receiving usual care. The study should also evaluate the effectiveness and feasibility of the stepped care approach.

The intervention must include a stepped-care approach, where, for the majority of depressed pregnant and postpartum women, screening and initial treatment both occur at a woman’s usual (single) site of obstetric care. Women are monitored for progress, and more intensive treatment is provided, through referral, if necessary, for those who do not respond to initial treatment.

The research design must be a randomized control trial. The study inclusion and exclusion criteria should yield a sample that is reflective of pregnant and/or postpartum women at risk for perinatal depression, with the aim of producing results generalizable to the larger population of depressed pregnant and postpartum women. Thus, the study population should have racial/ethnic and socioeconomic diversity, including multiple racial and ethnic groups and levels of socioeconomic status. Inclusion criteria should be pregnant and postpartum women who screen positive for depression. Exclusion criteria should be minimal and the study population should reflect that of the obstetric practice(s); rather than excluding women with common comorbidities to depression (e.g.

inter-personal violence, substance use, and post-traumatic stress disorder) the intervention protocol should include contingencies for these women.

The standard of care for women who screen positive for depression should reflect what is currently being implemented at the clinic(s) where the women are receiving prenatal/postpartum care. However, in the study design, investigators should consider the need to modify the standard of care to meet study objectives; for example, may need to implement universal screening for depression to capture depression prevalence.

To determine effectiveness of the stepped care approach, outcomes of interest at a minimum should include reduction in depressive symptomology and/or remission of depression and treatment uptake and adherence. Secondary outcomes may include: complications to treatment engagement and retention, suicide ideation/attempts; functioning, quality of life, and health status.

To determine feasibility of the stepped care approach in an obstetric clinical setting, process measures (e.g., number of clinicians trained; cost of intervention per patient and/or per clinic, time spent per patient to provide intervention, and number of referrals) should be monitored.

The proposed sample size should be large enough to detect a difference in depressive symptomology and treatment rates within the intervention and standard care groups.

Objective 2: To implement the study and analyze data to assess all outcomes including depressive symptomology and treatment rates, feasibility and process measures.

Establish a protocol for training clinic staff to provide the stepped care approach intervention.

Evaluate depressive symptomology and treatment rates using stepped care approach compared to standard of care.

Evaluate process measures (e.g., number of staff trained, time spent per patient to provide intervention, and number of referrals) to inform implementation process and future recommendations.

Objective 3: To disseminate study findings and, based on those findings, make recommendations on

Objective 3: To disseminate study findings and, based on those findings, make recommendations on implementation and sustainability of a stepped-care approach in obstetric clinics.

Summarize results of the project and prepare manuscripts in collaboration with CDC consultants.

Develop recommendations on implementation and sustainability, addressing pre-implementation needs, successful best-practice components, and solutions to challenges that obstetric clinics may experience when implementing a stepped-care approach to enhance care for women with depression.

Develop and implement a plan to disseminate the recommendations to obstetric clinics and other stakeholders (e.g., ACOG, USPTF).

Timeline – The anticipated timeline for the project consist of 3 phases over 5 years.

Phase 1: Development (Months 1-12)

Determine primary and secondary research questions for analysis.

Design stepped care approach intervention with best practices for screening and treatment from the literature.

Design study and develop data collection instruments.

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

Register the trial with ClinicalTrials.gov, if necessary.

Prepare OMB package, if necessary.

Phase 2: Intervention implementation (Months 13-48)

Finalize intervention materials.

Recruit and train staff to provide stepped care approach intervention and to conduct study.

Pilot test intervention and revise design, if needed.

Enroll women into the study, conduct intervention, and follow participants through at least 12 months.

Conduct quality assurance of intervention implementation and data collection.

Phase 3: Study findings, publications, and dissemination (Months 49-60)

Complete study data collection (by 51 months).

Analyze data to assess depressive symptomology, treatment uptake and retention, feasibility of intervention, and cost per patient of intervention.

Prepare and submit results to peer-review journals.

Share de-identified data with CDC staff for secondary analyses.

Draft and disseminate recommendations for implementation at obstetric clinics.

Target Population

The target population of this study will be all pregnant and postpartum females who screen positive for depression.

Collaboration/Partnerships

In addition to CDC, the applicant is expected to collaborate/partner with selected obstetric clinics to reach the study population. In addition, applicants may identify mental health professionals for consultation and/or referral of study participants if further treatment is needed.

Evaluation/Performance Measurement

The applicant is expected to develop an evaluation of key process milestones and outcomes such as the following:

Number of clinicians trained, cost of intervention per patient and/or per clinic, and time spent per patient to provide the intervention.

Depressive symptomology and treatment rates using stepped care approach compared to standard of care.

Translation Plan

The applicant should address how research findings and recommendations will be disseminated to key stakeholders (e.g. obstetric providers, ACOG, researchers) who would benefit from the knowledge gained from the study.

OMB/PRA may apply.

Reference list:

American College of Obstetricians and Gynecologists. Well-woman visit. Committee Opinion No. 534.

Obstet Gynecol 2012;120:421–4.

Dietz, P.M., et al., Clinically identified maternal depression before, during, and after pregnancies ending in live births. Am J Psychiatry, 2007. 164(10): p. 1515-20.

Ko, J.Y., et al., Depression and treatment among U.S. pregnant and nonpregnant women of reproductive age, 2005-2009. J Womens Health (Larchmt), 2012. 21(8): p. 830-6.

Kozhimannil K.B. et al., New Jersey's efforts to improve postpartum depression care did not change treatment patterns for women on Medicaid. Health Aff (Millwood). 2011;30(2):293-301.

Kozhimannil K.B. et al., Racial and Ethnic Disparities in Postpartum Depression Care Among Low-Income Women. Psychiatr Serv. 2011; 62(6): 619-625.

Leung, S.S., et al., Outcome of a postnatal depression screening programme using the Edinburgh Postnatal Depression Scale: a randomized controlled trial. J Public Health (Oxf), 2011.

Smith, M.V. et al. Success of mental health referral among pregnant and postpartum women with psychiatric distress. Gen Hosp Psychiatry. 2009;31(2):155-62.

Yawn, B.P., et al., TRIPPD: a practice-based network effectiveness study of postpartum depression screening and management. Ann Fam Med, 2012. 10(4): p. 320-9. 33(2): p. 292-301.

Yonkers K.A. et al., Depression screening of perinatal women: an evaluation of the healthy start depression initiative. Psychiatr Serv. 2009;60(3):322-8.

Section II. Award Information

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

Application Types Allowed:

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

Estimated Total Funding: $2,500,000

Anticipated Number of Awards: 1

NCCDPHP intends to commit approximately $500,000 (including both direct and indirect costs) in FY2015 to fund one (1) applicant for the first 12-month budget period. The estimated total funding (direct and indirect) for the entire five (5) year project is $2,500,000.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($500,000), HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $500,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 5 year(s) Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

The following types of Higher Education Institutions are always encouraged to apply for CDC support as http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

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

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

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

3. Special Eligibility Requirements

Applicants must have the support of one or more obstetric clinics in which the project will be implemented.

The principal investigator of the project must have experience as an investigator or co-investigator in conducting a randomized control trial among pregnant and/or postpartum women, experience conducting clinical research on mental health topics, and experience disseminating the findings in peer-reviewed publication(s).

The applicant must have, as part of the research team, an obstetrician and a mental health specialist (e.g. psychiatrist, psychologist, or counselor with appropriate credentials).

4. Justification for Less than Maximum Competition

None

5. Responsiveness

Evidence for the special eligibility criteria listed in number 3 above must be presented in Appendix A of the application.

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

Letter of support from obstetric clinic(s) affirming their participation in the study, and a description of their patient population.

The applicant must provide evidence of the principal investigator’s previous research conducting a randomized control trial among pregnant or postpartum women and experience in the mental health field, in the form of peer-reviewed publications on this subject matter, as evidenced in the Research & Related Senior/Key Person Section of the SF424 (R&R).

The applicant must provide evidence that the project team will include an obstetrician and mental health specialist (e.g. psychiatrist, psychologist, or counselor with appropriate credentials) as evidenced in the Research & Related Senior/Key Person Section of the SF424 (R&R).

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

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

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

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

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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

Section IV. Application and Submission Information

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

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of https://www.sam.gov/index.html 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 http://www.Grants.gov mailto:pgotim@cdc.gov

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

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

3. Letter of Intent Due Date for Letter of Intent: 01/26/2015

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Sue Shaw, MPH National Center for Chronic Disease Prevention and Health Promotion Extramural Research Program Operations and Services Centers for Disease Control and Prevention 4770 Buford Highway, NE M/S F-80 Atlanta, GA 30341 Telephone: (770) 488-6142 Email: zgx7@cdc.gov

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address mailto:zgx7@cdc.gov specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

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

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

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

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

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

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

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

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

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

Research Plan The applicant’s research plan should address activities that will be conducted over the entire 5-year project period and should include the following items:

Introduction/ Background

Describe the demographics (e.g., number, age, race/ethnicity, income, insurance status) of the clients/patients served by the site(s) where the intervention will be implemented and evaluated to demonstrate a diverse racial/ethnic population with varying socioeconomic levels. Include prevalence of depression among patients at study site(s). Include other clinical and community demographic data that might be relevant.

Describe the current practice for depression screening and treatment at study site(s).

Demonstrate capacity to recruit the estimated number of women screening positive for depression required for an adequately powered randomized controlled trial to examine meaningful differences in depressive symptomatology and treatment uptake.

Specific Aims

Specify overall aims or objectives for intervention development, implementation, evaluation, and dissemination of findings and recommendations.

Specify primary and secondary outcomes, how they will be measured, and expected effect size.

Research Strategy Describe approach for randomization and specify the unit of randomization (e.g., clinic, individual). If randomization is at the individual level, describe how feasibility [at the clinic level will be assessed].

Describe inclusion/exclusion criteria of study participants.

Describe how the proposed intervention will be implemented at study site(s). Include a description of usual care at the unit of control (e.g., clinic, individual) and whether additional care components will be implemented to enable appropriate comparison of the stepped-care approach among women who screen positive for depression (e.g., implementing universal screening at control site or among all women).

Describe the components that will be incorporated into the stepped-care approach at the intervention site from best practices identified in the literature (e.g., established relationships between obstetric providers and mental health professionals; care provided immediately after a positive screen; system level support to promote stepped collaborative care [e.g., linked medical records between obstetric and mental health professionals]; case-management approach; reminders in the electronic medical record for screening and documentation; and staff initial and ongoing training [nurse, physician, etc.]).

Describe approach for recruitment and retention of the study participants.

Describe how primary outcomes (i.e., reduction in depressive symptomatology and/or remission of depression and treatment uptake and adherence) and any secondary outcomes (e.g., complications to treatment engagement and retention, suicide ideation/attempts;

functioning, quality of life, and health status) will be assessed.

Describe measures of feasibility, including process measures (e.g., number of clinicians trained; cost of intervention per patient and/or per clinic, time spent per patient to provide intervention, and number of referrals).

Describe method and measures for data collection, management, and quality assurance.

Include participant burden (e.g., time) for each data measurement. It is important that the intervention and its data components be sufficient to determine effectiveness of the intervention, as well as realistic and pragmatic for incorporation in other obstetric clinics.

Describe a timeline for conducting follow-up assessments, after a positive screening for depression.

Describe the protocol to address the needs of women with co-morbidities, such as inter-personal violence, substance use, and post-traumatic stress disorder, and the clinical protocol to address the most severe cases.

Describe how data will be analyzed to demonstrate effectiveness and feasibility of the intervention, using appropriate statistical methods.

Describe plans for working collaboratively with CDC staff on the design, analyses, and dissemination of the study.

Describe how de-identified data will be shared with CDC collaborators for analyses.

Describe how the RCT findings will be translated into recommendations for implementation and sustainability in other obstetric clinics and how these recommendations will be disseminated to stakeholders.

Staffing and Milestones for Development and Implementation Process

Describe experience and expertise of key proposed staff, including team’s experience in developing, evaluating and disseminating findings from RCTs examining effectiveness and feasibility of a clinical intervention and experience working with the target population (i.e., pregnant and postpartum women) and within the site(s) where the study will take place.

Identify tasks and provide a timeline for key milestones and protocol development activities to occur in the first 12-months of the project. Include milestones that will be used to demonstrate progress toward having an Institutional Review Board (IRB) - approved protocol and, if required, an OMB approved protocol.

Identify key milestones and staffing needs for implementation of the RCT and evaluation in subsequent years of funding (e.g., training of clinic staff to deliver the intervention, recruitment, enrollment, and follow-up of patients, intervention delivery, data collection, management, and analysis, and report writing).

Describe the staffing plan for the 5-year project period. Include project organizational charts with key personnel.

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

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 35 pages for all appendices.

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

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

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

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

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/guide/url_redirect.htm?id=11128 http://www.grants.gov/

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

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

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

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

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

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free.