DP15003AMENDPUBLICATION.pdf

Centers for Disease Control and Prevention

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

Comparison and Validation of Screening Tools For Substance Use Among Pregnant Women

RFA-DP-15-003

Application Due Date: 02/24/2015

Comparison and Validation of Screening Tools For Substance Use Among Pregnant Women

RFA-DP-15-003

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 Comparison and Validation of Screening Tools For Substance Use Among Pregnant Women Activity Code

AMENDMENT I. QUESTIONS FROM POTENTIAL APPLICANTS AND CDC RESPONSES

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

Activity Code: CDC-R21

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-DP-15-003

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

Health FOA Purpose The purpose of this FOA is to solicit proposals for a study to compare and validate substance use screening tools for pregnant women in the U.S. Such tools are to be used by providers caring for pregnant women to identify substance use during pregnancy with a focus on illicit and prescription drugs, and to inform the clinical management for substance-using pregnant women.

Key Dates Publication Date: To receive notification of any changes to RFA-DP-15-003, 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: 01/23/2015

Application Due Date: 02/24/2015

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

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

Scientific Merit Review: 04/20/2015 http://www.grants.gov

Secondary Review: 06/05/2015

Estimated Start Date: 09/01/2015

Expiration Date: 02/25/2015 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 solicit proposals for a study to compare and validate substance use screening tools for pregnant women in the U.S. Such tools are to be used by providers caring for pregnant women to identify substance use during pregnancy with a focus on illicit and prescription drugs, and to inform the clinical management for substance-using pregnant women.

Mechanism of Support. Grant Funds Available and Anticipated Number of Awards. NCCDPHP intends to fund one (1) award and to commit approximately $1,200,000 in total (including both direct and indirect costs) over the two-year 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 the award may also vary. The total amount awarded will depend upon the number, quality, duration, and cost of the applications received.

Budget and Project Period. An applicant may request a project period of up to two (2) years. The estimated total funding (including both direct and indirect costs) is $600,000 for the first year (12-month budget period). The estimated total funding (direct and indirect costs) for the entire project period is $1,200,000. The project period will run from 9/1/2015 to 8/31/2017.

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

Number of Applications. Eligible applicant institutions may submit more than one application, provided that each application is scientifically distinct.

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

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

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 317(k)(2) of the Public Health Service Act, 42 U.S.C.

247b(k)(2) and Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a).

1. Background and Purpose

The nature of this research opportunity is to conduct a study to compare and validate substance use screening tools for pregnant women in the U.S. with a focus on illicit and prescription drugs. The results of this study will help health providers caring for pregnant women to identify substance use during pregnancy and will inform clinical management for substance-using pregnant women.

Background

The 2012 National Survey on Drug Use and Health showed that among pregnant women approximately 5.9% had used illicit substances, 8.5% had consumed alcohol in the month before the survey, and nearly 16% smoked cigarettes. A five-fold increase in antepartum maternal opiate use, coincident with an “epidemic” of opiate prescription abuse between 2000 and 2009, has also been reported, with women being as likely as men to abuse opiate medications. Many pregnant women will continue to smoke cigarettes, drink alcohol, or use other substances throughout pregnancy and after delivery, unless these practices are recognized and addressed.

Prenatal cigarette use has deleterious effects on fetal development and long-term adverse consequences on postnatal development. Alcohol is a known teratogen with physical and behavioral effects gathered under the non-diagnostic umbrella term, Fetal Alcohol Spectrum Disorders (FASD). Moreover, prenatal alcohol exposure has been associated with lifelong consequences for the individual, family, and society. No safe threshold for prenatal alcohol exposure has been established. Although additional research is needed to confirm causal connections, exposure to illicit substances and non-prescription use of psychotropic medications is generally associated with adverse birth outcomes (e.g. preterm birth, low birth weight, and small for gestational age infants). While opioids have no demonstrated teratogenic or cytotoxic effects during pregnancy, fluctuating opioid concentrations in the maternal blood may lead to fetal withdrawal or overdose. In addition, illicit drug-dependent pregnant women are at increased risk of medical complications such as infectious diseases, malnourishment, and psychosocial problems such as inadequate obstetric care.

The identification of prenatal tobacco, alcohol, and other substance use is challenging. Healthcare professionals may be reticent to inquire about these practices and patients may be reluctant to disclose them because of stigma, denial, or change in behavior after pregnancy confirmation. Fears about legal and other sanctions may also contribute to non-disclosure. Finally, whereas the development and evaluation of screening measures for prenatal smoking and alcohol use are more advanced, the validity, reliability, and clinical utility of standardized questionnaires in screening for illicit drug use during pregnancy is not commensurate. The US Preventive Services Task Force (USPSTF) has issued several recommendations with regard to tobacco, alcohol, and illicit drug use by adult women, and concluded that there is currently insufficient evidence to evaluate the benefits and harms of screening for illicit drug use in clinical subpopulations including pregnant women because the validity, reliability, and clinical utility of standardized questionnaires in screening for illicit drug use during pregnancy have not been adequately http://www.cdc.gov/chronicdisease/about/foa.htm standardized questionnaires in screening for illicit drug use during pregnancy have not been adequately evaluated.

Purpose

The purpose of this FOA is to solicit proposals to conduct a research study to validate and compare the performance of substance use screening tools that are already available in the literature and can be used among pregnant women seeking medical services (e.g. antenatal or delivery care) in clinical settings in the United States. Examples of such screening tools include: 4Ps and related screening tool version (e.g. 5Ps screening tool adapted by the Massachusetts Institute for Health and Recovery in 1999 from 4Ps, in wide use in Massachusetts, California, Maine, Virginia, and South Carolina, and available at: http://www.mhqp.org /guidelines/perinatalPDF/IHRIntegratedScreeningTool.pdf); Substance Use Risk Profile – Pregnancy Scale (SURP-P); CRAFFT (Car, Relax, Alone, Forget, Friends, Trouble); National Institute for Drug Abuse (NIDA) Quick Screen.

Thus, the focus of this funding opportunity is not on development of new screening tools, but on the validation of already available screening tools for substance use in pregnant women and comparison of their performance on identifying illicit and prescription drugs. The performance of existing screening tools should be compared against each other for identification of each substance of interest (i.e. illicit and prescription drugs). Investigators will then be able to recommend the tool or tools best suited for screening for illicit and prescription drugs in pregnant women.

Healthy People 2020 and other National Strategic Priorities

This research will help meet national public health goals and objectives as it addresses the four “Healthy People 2020” priority areas listed below:

MICH-6 Reduce maternal illness and complications due to pregnancy;

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

MICH-11 Increase abstinence from alcohol, cigarettes, and illicit drugs among pregnant women;

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

The project specifically addresses the problem of substance use, an increasingly prevalent condition among the US population and a priority topic for CDC, NCCDPHP, and the Division of Reproductive Health.

Prescription drug abuse is an agency priority as recently highlighted in a CDC Vital Signs report (http://www.cdc.gov/vitalsigns/).

This research is aligned with NCCDPHP performance goals to define, conduct, and promote public health research in reproductive health.

This FOA addresses three (3) Division of Reproductive Health priorities:

1) to improve women’s reproductive health from menarche through menopause;

2) to improve pregnancy health and care, and one key strategic area of focus: science to practice (to identify and implement effective strategies for promoting science to practice and translation); and

3) to improve fetal, newborn and infant health.

Public Health Impact http://www.mhqp.org/guidelines/perinatalPDF/IHRIntegratedScreeningTool.pdf http://www.mhqp.org/guidelines/perinatalPDF/IHRIntegratedScreeningTool.pdf http://www.cdc.gov/vitalsigns/

Given the increasing use of substances during pregnancy, identification of women at risk is a critical need;

pregnancy may present a window of opportunity for intervention. However, identification of prenatal substance use is challenging. Many pregnant women will continue to smoke cigarettes, drink alcohol, or use other substances throughout pregnancy and after delivery unless these practices are recognized and addressed. This research will identify the substance use screening tools that best perform in clinical settings to identify illicit and prescription drug use by pregnant women. Wide implementation of substance use screening in pregnant women could result in better maternal and infant health outcomes and reduction in healthcare costs associated with pregnancy, delivery, and neonatal care.

Relevant Work

During a CDC-sponsored Expert Meeting on perinatal drug abuse organized in September 2012, the lack of validated screening tools for substance use in pregnant women was identified as a key gap in knowledge and practice. Given CDC’s interest in preventing substance use during pregnancy, addressing this knowledge gap represents a program priority.

2. Approach

The goal of this FOA is to conduct a study that compares and validates substance use screening tools for pregnant women in the US (for example, 4Ps and related screening tool version (e.g. 5Ps);

Substance Use Risk Profile – Pregnancy Scale (SURP-P); CRAFFT; National Institute for Drug Abuse (NIDA) Quick Screen). Applicants may propose comparison of any of the screening tools already available in the literature provided that an adequate sample size is available to compare psychometric properties between all proposed screening tools with respect to illicit and prescription drug use. It is expected that applicants will propose to conduct the study in one or more clinical settings offering services to pregnant women (e.g. antenatal or delivery care).

Objectives/Outcomes

Objective 1: Design a study that compares and validates substance use screening tools for pregnant women in the U.S. (for example, 4Ps and related version (e.g. 5Ps); Substance Use Risk Profile – Pregnancy Scale (SURP-P); CRAFFT; NIDA Quick Screen). The study population should be representative of the distribution of pregnant women in the U.S population in terms of age and race/ethnicity. The substances of interest that can be assessed include alcohol, tobacco, and illicit and prescription drugs, but the focus should be on screening for illicit and prescription drugs. The study design should include:

Development of the research protocol, a data analysis plan, and a process evaluation of key milestones of the project;

Identification and description of the study sites and study population including how the FOA eligibility criteria are met and how women will be recruited and enrolled by type of substance used;

Description of methods of identification of substance use; inclusion of a plan and justification for use of biological testing for illicit or prescription drugs for all or part of the sample is required;

Determination of sample size requirements to detect clinically-meaningful differences between all the screening tools selected for comparison.

Objective 2: Implement the study and analyze data to compare and validate the use of selected substance use screening tools:

Determine data collection methods;

Implement data collection;

Ensure that all women testing positive for any substance receive referral to appropriate care and treatment;

Develop a data analysis plan that includes:

determination of psychometric properties for all screening tools selected for assessment and comparison;

comparison of psychometric properties between the selected screening tools;

identification of best performing screening tool for use of illicit and prescription drugs during pregnancy.

Objective 3: Develop a dissemination plan for the results and study findings, including publishing results in peer-reviewed journals. The plan should include an assessment of the tools tested and a set of recommendations to inform the use, adoption, and potential for scaling-up use of any tested tools in primary care and obstetric settings.

Target Population

The target population is pregnant women ages 15-49 years. The study population must include women in all trimesters of pregnancy.

Collaboration/Partnerships

The applicant may consider developing partnerships in the community(ies) where the study will take place.

As such, the applicant may propose a multi-site study, in which case a description of all study sites as well as collaboration letters/agreements should be included with the application.

Evaluation/Performance Measurement

The applicant is expected to develop: 1) an evaluation plan that includes process evaluation of key milestones of the project, and 2) a plan to validate screening tools, including the comparison of psychometric properties between all selected tools with a focus on identification of illicit and prescription drugs.

Translation Plan

The application should address how research findings will be disseminated to key stakeholders together with a set of recommendations to inform the use, adoption, and potential for scaling-up use of any tested tools in primary care and obstetric settings.

References

Substance Abuse and Mental Health Services Administration, Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

Hayes MJ, Brown MS. Epidemic of prescription opiate abuse and neonatal abstinence. JAMA. 2012; 307:

1974-1975.

Hackshaw A, Rodeck C, Boniface S. Maternal smoking pregnancy and birth defects: a systematic review based on 173687 malformed cases and 11.7 million controls. Human Reproduction Update, 2011; 17:

589-604.

Monshouer K, Huizink AC, Harakeh Z et al. Prenatal smoking exposure and the risk of behavioral problems and substance use in adolescence: the TRAILS study. Eur Addict Res, 2011; 17: 342-350.

Riley EP, Infante A, Warren KR. Fetal alcohol spectrum disorders: an overview. Neuropsychol Rev, 2011;

21: 73-80.

Winklbaur B, Kopf N, Ebner N et al. Treating pregnant women dependent on opioids is not the same as treating pregnancy and opioid dependence: a knowledge synthesis for better treatment for women and neonates. Addiction. 2008; 103: 1429-1440.

Gouin K, Murphy K, Shah PS, and the Knowledge Synthesis Group on Determinants of Low Birth Weight and Preterm Births. American Journal of Obstetrics and Gynecology. 2011; 204: 340.e1-12.

Roussote F, Soderberg L, Sowell E. Structural, metabolic, and functional brain abnormalities as a result of prenatal exposure to drugs of abuse: evidence from neuroimaging. Neuropsychol Rev. 2010; 20: 376-397.

Substance abuse reporting and pregnancy: the role of the obstetrician-gynecologist. Committee Opinion No.

473. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2011; 117: 200-1.

U.S. Preventive Services Task Force. Screening for Illicit Drug Use: U.S. Preventive Services Task Force Recommendation Statement. January 2008. http://www.uspreventiveservicestaskforce.org/uspstf08/druguse /drugrs.htm

U.S. Preventive Services Task Force. Counseling and interventions to prevent tobacco use and tobacco-caused disease in adults and pregnant women: US Preventive Services Task Force Reaffirmation Recommendation Statement. Ann Intern Med. 2009; 150: 551-555.

USPSTF A and B Recommendations. U.S. Preventive Services Task Force. http://www.uspreventiveservices taskforce.org/uspstf/uspsabrecs.htm.

Section II. Award Information

Funding Instrument Type: Grant A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

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: $1,200,000

NCCDPHP intends to commit approximately $600,000 (including both direct and indirect costs) in FY 2015 to fund one (1) applicant for the first 12-month budget period. The estimated total funding (direct and indirect) for the entire two (2) year project is $1,200,000.

Anticipated Number of Awards: 1

An applicant may request up to $600,000 for the first 12-month budget period, including both direct and indirect costs.

If an applicant requests a funding amount greater than the ceiling of the award range for the first year ($600,000), 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: $600,000 Per Budget Period Award Floor: $0 Per Budget Period Total Project Period Length: 2 year(s) Throughout the project period, CDC's commitment to continuation of awards will depend on the availability http://www.uspreventiveservicestaskforce.org/uspstf08/druguse/drugrs.htm http://www.uspreventiveservicestaskforce.org/uspstf08/druguse/drugrs.htm http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm

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 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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

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

Eligible applicants must meet the following criteria:

a. Have an established relationship with study site(s) allowing access to the study population;

b. Have the ability to enroll a sufficient number of pregnant women in order to detect differences between all the screening tools selected for validation and comparison over the 2-year project period;

c. The PI of the proposed study must have served as PI or co-PI on at least one other study assessing screening tools for substance use during pregnancy; the study may have involved primary data collection or be a secondary data analysis;

d. The research team must include at least one obstetrician and one psychiatrist.

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.

a. Applicants must provide evidence of an established relationship with the study site(s) granting access to the study population in the form of signed letters or written agreements with each study site;

b. Applicants should report, by substance type, the number and percentage of substance-using pregnant women receiving care at each proposed site where women will be recruited and enrolled into the study;

c. Applicants must provide evidence of the principal investigator’s previous research on at least one other study assessing screening tools for substance use during pregnancy that involved primary data collection or secondary data analysis as evidenced in the Research & Related Senior/Key Person section of the SF424 (R&R). To address this request, please include the abstract from the study publication;

d. The applicant must provide evidence that the project team will include an obstetrician and a psychiatrist, 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 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 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 https://www.sam.gov/index.html

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.

Multiple applications per institution are allowed, provided that each application is scientifically distinct.

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 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: 01/23/2015 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

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 and Health Promotion Extramural Research Program Operations and Services (ERPOS) 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 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 mailto:zgx7@cdc.gov

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 2-year project period, and should include the following items:

Introduction/Background

Describe the demographics (age, race/ethnicity, insurance status) of the pregnant subjects served by the site(s) where the study will be implemented; include rates of substance use during pregnancy by type of substance;

Describe the site(s) from which pregnant women will be recruited; if available, include any clinic protocol specific to screening for substance use during pregnancy. Provide signed letter(s) of support from proposed site(s).

Demonstrate capacity to recruit the estimated number of pregnant women required for an adequate comparison of all selected screening tools. Capacity to recruit can be demonstrated by providing numbers and percentages of substance-using pregnant women attending care at proposed study sites in previous years or for previous, similar research studies.

Specific Aims Specify overall aims or objectives for the study Specify selected screening tools and provide a justification for their selection Specify how substance use indicators will be measured

Research strategy Describe the proposed study to compare and validate substance use screening tools among pregnant women;

Identify and describe the substance use screening tools that will be validated and how they address the intent of the FOA;

Describe inclusion criteria for study participants;

Describe how the proposed study approaches and methodologies will be integrated into ongoing services at the proposed site(s);

Describe how the proposed study will appeal to the target population and be culturally appropriate, including justification for incentives that will be used during the study;

Provide information on sample size calculations;

Describe approach for recruitment;

Describe method of data collection, management and quality assurance;

Describe if/how self-reported information will be verified/validated; biological testing for illicit and prescription drug use is required for at least a sub-sample of all study participants;

Describe the information technology (equipment, software, expertise) to be used;

Describe how study data will be analyzed to compare psychometric properties of all selected screening tools; if more than one site is proposed, include plans for data sharing and data pooling;

Describe dissemination plan, including planned manuscript(s);

Describe expected contributions to the field.

Staffing and Milestones for Development and Implementation Phases Provide list of study tasks and a timeline for the study;

Describe key milestones and/or measurable outputs that will be used to indicate progress toward having an Institutional Board Review (IRB)-approved protocol and all study materials pilot-tested, revised, and study staff trained;

Identify key milestones and staffing needs for study implementation (e.g. recruitment and enrollment, data collection, data management, data analysis, manuscript preparation);

Describe the proposed management and staffing plan for the study;

Describe experience and expertise of key proposed staff, including ability to conduct the proposed study;

Describe the research team’s experience recruiting and collecting data from the target population;

Describe the research team’s experience assessing screening tools and their performance in pregnant women;

Demonstrate commitment to collaborate through letter(s) of support from proposed study site(s), and identify proposed roles for study staff;

Include any potential study limitations or challenges to accomplishing the study objectives.

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

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.

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

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

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

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

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

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

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process. Applicants are encouraged also to check the status of their application submission to determine if the application packages are complete and error-free. Applicants who encounter system errors when submitting their applications must attempt to resolve them by contacting the Grants.gov Contact Center (1-800-518-4726; support@grants.gov). If the system errors cannot be resolved, applicants must contact CDC PGO TIMS at 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/ http://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 mailto:support@grants.gov system errors cannot be resolved, applicants must contact CDC PGO TIMS at 770-488-2700; www.pgotim@cdc.gov for guidance at least 3 calendar days before the deadline date.

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

Unsuccessful Submissions:

If an application submission was unsuccessful, the applicant must:

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

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

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

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

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

Due Date for Applications: 02/24/2015

Electronically submitted applications must be submitted no later than 5:00 p.m., ET, on the listed application due date.

10. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review (http:// www. whitehouse.gov/ omb/ grants_spoc).

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

For more information on expanded authority and pre-award costs, go to: http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

Applicants are advised that any activities involving standard information collection (i.e., surveys, questionnaires, data requests, etc.) from 10 or more non-federal individuals/entities are subject to Paperwork Reduction Act (PRA) requirements and may require the CDC to coordinate an OMB/PRA approval request.

12. Other Submission Requirements and Information

Application Submission Applications…