Questions & Answers – RFAs

Q&A from the 2018 Funding Cycle

On the RFAs – How to Apply page, under “How to Submit Applications,” the instructions say to “merge all documents in this order: PHS 398 Form pages 1 (signed), 2, 4, 5, checklist, PHS Inclusion Enrollment, Biographical sketches, Specific Aims, Research Strategy, References, Letters of Support, and any other REQUIRED Appendix into one PDF file.” What is the PHS Inclusion Enrollment. I cannot find a form with this title. Thanks for noticing this. We meant the PHS Human Subjects and Clinical Trials Information form. The name of the form was changed after the instructions for DRDC applicants were posted. If your project will enroll human subjects, then you would check “yes” to the first question on the PHS Human Subjects and Clinical Trials Information form. After that, a link becomes active on the form, about 2/3 of the way down the page, entitled “Click here to extract the human subject study record attachment.” This will open a new form entitled, “Study Record: PHS Human Subjects and Clinical Trials Information form.” Within this one, on the bottom of the first page, there is a button to “Add an Inclusion Enrollment Report.” You should add it, and fill out the first table for PLANNED enrollment.  The Study Record document, including the Inclusion Enrollment Report, should be included in your application. Don’t worry about the field that asks for a ClinicalTrials.gov identifier.  Please read further down on this Questions & Answers page to read more about this topic.

Regarding RFA-2018-03 Developmental Monitoring and Language, should the literature summary be placed in the appendices and is there a page limit? Also, would the references used for the literature summary be combined with the reference page for the research strategy or within the summary document?   The literature summary is a required element for this RFA, and should be included in the Research Strategy. It should be part of your “Project Description and Objectives” (part d of the Required Elements listed on the DRDC’s How to Apply page). The instructions say to “Include any pertinent background information that establishes the need for the research.” This includes the required “literature summary” that is listed on the RFA description page. References for your literature summary would therefore be included with all of the others for the Research Strategy.

Is a Table of Contents required for the DRDC applications? No.

I have more Personnel than will fit on Form Page 4  (Detailed Budget for Initial Budget Period).  How should I handle this?  Please save a copy of the Word version of the form and add rows as needed. If possible, you could also reduce the row heights, especially in sections where you do not have any funds requested. You can also reduce the row heights in the Personnel section to make more room.

Regarding RFA-2018-03 Developmental Monitoring and Language, is there a preference of WIC clinic setting versus the labor and delivery setting of a hospital? The limitation for the setting is only that which was stated in the RFA, namely, that it is limited to “home visiting, midwifery, labor and delivery, or WIC.” The peer reviewers who will judge the merit of the applications will only have access to the applications, and the RFA’s and relevant Q&A that have been posted on the DRDC website. Therefore, preference will not be given for one setting over another.

Are there any set requirements for font/size of included tables and figures in the proposal? No, there are no set requirements regarding tables and figures, except that they must fall within the page-limit for the research strategy. Although you are allowed to use a smaller font size for tables and figures than is required for the rest of the Research Strategy, you should ensure that they are readable. Some reviewers choose to print out the application rather than viewing them electronically.

Regarding  RFA-2018-02 Data Linkage to Study Rare Conditions, is the data required to be from the US or would data from a high-income European country be acceptable?  The data must be from the US.

Are the DRDC RFAs one-time opportunities or do you plan on re-issuing them next year? We do expect that the DRDC will have more grant opportunities available next year, but we do not what the content of future topics will be.  Every year, the NCBDDD decides on its research priorities and decides about the topics to fund through the DRDC.

Regarding RFA-2018-03 Developmental Monitoring and Language, within the list of “Successful Proposal” elements, there is this item: “Presentation of the study design with DRAFT protocol.” We are wondering if this draft protocol is referring to the Protection of Human Subjects portion of the proposal? Or is it meant to be a draft protocol for operations (such as a Manual of Operations for the research project activities)? If the latter, should this draft protocol be included as an Appendix? We should have been more clear about this, but that item really just refers to the Protection of Human Subjects section, as you guessed. Thus, you should will not need to add an appendix related to this item.

Regarding RFA-2018-03 Developmental Monitoring and Language, we plan to measure several of our variables through pre-post surveys. Will a description of the instrument and what variables it will measure suffice, or should we develop instruments for our application submission? Standard instruments should be included. If you are making new instruments, whenever possible, those should be included, and can be watermarked with DRAFT.

Regarding RFA-2018-01 Screening for Tics in Children, how is the MOVeIT screener scored? What is the cut-off to make a determination of “positive screen” that was used in the initial validation study?  REVISED REPLYThe MOVeIT screener is scored by summing each response (never = 0; sometimes = 1; often = 2). In the original 14 item MOVeIT, scores range from 0 – 28. In the initial validation, a cutoff of ≥10 was suggested for parent-report, and a cutoff of ≥8 for child-report.Data on the 10-item MOVeIT is currently being analyzed; it is expected the cut-point will be lower for the 10-item MOVeIT (scores range from 0-20).

Regarding RFA-2018-03 Developmental Monitoring and Language, I noticed on the Q&A page that early child care centers cannot be included in the research study. However, Early Head Start and Head Start provide home visiting services to children in our state. Would this setting be appropriate for inclusion in the grant? Yes, in the home visiting setting only, since that is one of the settings named in the RFA. We have another project already funded studying developmental monitoring using LTSAE in Early Head Start centers.

Within the Human Subjects and Clinical Trials form, there is another form that must be extracted and then uploaded back into the main form. This extracted form is where the pages having to do with enrollment and subject protection are attached. Do each of these documents need to have a page number in the bottom center of the page? We are concerned that when we put all of these documents together in one pdf that the attachments in this document won’t be view-able. Thanks for bringing this to our attention. This is a new form for everyone, and we just ask that you do your best to follow the instructions. This part is not scored, so if you make errors or if something is lost in the conversion to pdf, then it won’t count against you. My best advise is to put this section at the back of your application, and then don’t worry about page numbers. If you get the grant, and some additional details regarding human subjects are needed, we will ask for them at that time. Also, The Protection of Human Subjects document is listed separately in Required Elements for the application, but it is also one of the documents that is supposed to be attached in the Human Subjects and Clinical Trials form. Should we both attach it to the Human Subjects form and also include it as a separate element within the application pdf? It is not necessary to repeat the Protection of Human Subjects document and attach it to the “human subjects and clinical trials” form, but it is important to follow the instructions onthe DRDC’s “How to Apply Page,” which calls for a specific section on the Protection of Human Subjects. The DRDC instructions for that section also cover these: Data Safety Monitoring Plan, Inclusion of Women and Minorities, and the Inclusion of Children; so those do not need to be repeated and attached to the Human Subjects and Clinical Trials Form either. In asking applicants to fill out this new form, we were trying to make sure that we captured the Planned Enrollment, as that is often required for reporting. The other items, including Study Timeline, may be omitted as attachments to the new form. Note that a proposed timeline is required in the Research Strategy, which is stated in the instructions on our How to Apply page.

Would you please elaborate on whether there are any parameters regarding the indirect cost rates to be charged to the DRDC grants? You are allowed to use your institution’s negotiated F&A rate for your proposal; however, the funding limit is set to include both direct and indirect costs. For example, if you are applying for a $150,000 grant, and your institutional F&A rate for research is 50%, then you could put in a budget for $100,000 Direct Costs and $50,000 Indirect Costs.

Regarding  RFA-2018-02 Data Linkage to Study Rare Conditions, the description of the grant lists primary conditions (spina bifida, muscular dystrophy, and fragile X syndrome as examples). Are we required to include these and only these specific rare conditions, or would a proposal would for studying cerebral palsy be acceptable?  We can only consider the three mentioned conditions (SB, FXS, MD); however, if the investigator will be studying at least one of the three mentioned conditions, it is acceptable to add cerebral palsy.

Regarding  RFA-2018-02 Data Linkage to Study Rare Conditions, will registry clinic sites be identified? Yes, the registry clinic sites will be identified.Will the locations at which reported surgical procedures were performed be available? No, the locations at which reported surgical procedures were performed is not available. Will the date of birth would be provided in mm-yyyy format? Yes.

Does the budget for the RFAs need to begin on September 30th or can they begin on October 1 of each year with a stop date on September 30th? Our grant years have always begun on Sept 30 in one year and ended on Sept 29 in the next year. This is because the CDC uses funds that must be expended before the end of their fiscal year; thus, they obligate the funds on the last day possible. This means that our subcontracts have to follow the same calendar and cannot be changed. As a practical matter, you can propose a budget that uses calendar months, beginning with October 1, 2018; but please keep in mind that the subcontract dates will begin and end as described above.

Regarding eligibility for RFA-2018-02 Data Linkage to Study Rare Conditions, if we wish to use the National Spina Bifida Patient Registry (NSBPR), which is generally released to researchers only in de-identified form, what indirect patient identifiers (e.g. date of birth, gender, dates of surgical procedures) will be released to researchers at NSBPR participating sites to enable linkage to administrative databases such as the Pediatric Health Information System? The potential indirect patient identifiers include date of birth, birth state/county, gender (male/female), race (Non-Hispanic White, Non-Hispanic Black, Hispanic, other), dates of surgical procedures/visits in mm-yyyy format, spina bifida type (Myelomeningocele, other) and insurance type (any private, non-private). Local sites would be able to release local spina bifida registry data for linkage according to local IRB oversight. Exactly what identifiers could be released at the local level would need to be determined by the local site in conjunction with the IRB there.

Regarding RFA-2018-07 Accelerated Timeline for EHDI Benchmarks could you please elaborate or provide an example of what is expected for the variable lists or data dictionaries?  To fulfill the requirements of the proposed project, applicants must have access to data or cohorts that allow for the comparison of the current 1-3-6 and the proposed 1-2-3 EHDI benchmarks. Applicants must be able to describe and document a data collection and management plan with detailed information at each benchmark. At minimum, the applicant should include: child characteristics (including date of birth if calculating age at each benchmark, sex, race, ethnicity, and co-morbid conditions); screening results (age at screen or date of screen for age calculation, method of screening); diagnostic results (age at diagnosis or date of diagnostic evaluation, method of diagnosis, type of hearing loss, severity, laterality); intervention information (enrollment in early intervention, date enrolled or age enrolled, type of intervention); and developmental and academic outcomes to be determined by the applicant. Additional information could be included in the variable lists, e.g., gestational age, birthweight, maternal/paternal characteristics, family history, and data on hearing aid, cochlear implant or assistive device.

Regarding RFA-2018-03 Developmental Monitoring and Language, are the permissible settings limited to home visiting, midwifery, labor and delivery, or WIC? Also, is it permissible to compare one of these settings to a different type of setting?  As long as the study is carried out in one of those listed settings, the requirement would be met, and it would be acceptable to include a different, additional setting as a comparison.

Is there a Facilities form/document required as part of the application packet? Not at this point. If you are successful in getting one of the grants, we may ask for that before we issue the sub-contract.

Regarding RFA-2018-03 Developmental Monitoring and Language, would we be responsive to this RFA if we proposed a project testing the integrated intervention in a hospital setting when implemented by nurses? Yes, having nurses in a hospital setting as implementers for the intervention would be appropriate for this RFA. FOLLOW-UP: Can we implement the intervention in well-child visits in a hospital setting? No.  This intervention is not appropriate for well-child visits in a hospital setting; because the CDC has already completed research in that area.

Regarding RFA-2018-03 Developmental Monitoring and Language, can the LTSAE integration and the proposed research be conducted in an early childhood center? No,  this RFA is not intended for an intervention in child care centers. CDC’s aim is to better understand developmental monitoring and developmental promotion in a wide variety of settings. However, since CDC recently funded a similar project in child care settings, this project is to focus on other settings of interest, and an early childhood center would not be appropriate.

I am interested in applying for an award, and I would like to speak with the program officer if possible to make sure I understand the requirements for the proposal, and to ensure that my proposal meets the intended purpose of the award. I could not find contact information on the website to identify an appropriate point of contact. Is there someone I could talk to? As part of our cooperative agreement with the CDC, we have been designated to be the contact point for all applicant questions. The DRDC will only answer written questions, and cannot take any telephone calls. We consult with CDC as needed to answer the queries personally and in a timely manner, and we also post all questions and answers on the DRDC website. This is done to assure a fair process for all applicants, and it mirrors the procedures most federal agencies use for their grants.

For RFA-2018-01 Screening for Tics in Children, are there preferences for the diagnostic “gold standard” tic disorders measures to be used in the study? In addition to the DOTS/DISC, would it be recommended that we use something like the Yale Global Tic Severity Scale? There is not a preference for the diagnostic “gold standard.” From the funding announcement: “Gold standards might include, but are not limited to, expert clinical assessment, or use of a validated tool for specific symptoms or diagnoses.” A clinician-rated scale, like the YGTSS, could be appropriate as the gold standard or part of the gold standard, but you should use your best judgement.

Are state governmental agencies eligible to apply for RFA-2018-05 Intensity of Interventions for Hearing Loss and RFA-2018-07 Accelerated Timeline for EHDI Benchmarks?  Yes, a state governmental agency is eligible to apply for any of the DRDC RFAs.

For RFA-2018-01 Screening for Tics in Children, was the tic screen to be used in this project developed for use in children with Autism Spectrum Disorder (ASD) or other developmental delays? That is, should our population include children with these conditions or just typically-developing children? Our concern is that the screener may pick up the stereotypical movements of children with ASD and create a lot of false positives for tic disorders. One of the goals of the RFA is to “determine the degree to which tics can serve as a marker for other mental, emotional, and behavioral disorders, including ADHD and at least one other disorder, in a general population (e.g. school, primary care) of children.”  The screener was developed to identify tics in children without previously diagnosed tic disorders. Initial work has been focused on maximizing its sensitivity to identify children with tics, with less concern about false positives. There is ongoing work that will begin to address the potential for false positive results among children with developmental delays. Focusing on a general population of children should allow for better understanding of whether the tic screen is specific for identifying tic disorders, or if it can also improve identification of other disorders.

Regarding eligibility for RFA-2018-01 Screening for Tics in Children, are applicants from institutions outside of the United States eligible to apply?  No, unfortunately, the eligibility is restricted to US institutions only. This has now been clarified on the web page with the project description, in the section titled, “Eligible Applicants.”

Regarding eligibility for RFA-2018-02 Data Linkage to Study Rare Conditions are applicants from institutions outside of the United States eligible to apply?  No, unfortunately, the eligibility is restricted to US institutions only. This has now been clarified on the web page with the project description, in the section titled, “Eligible Applicants.”

Regarding RFA-2018-03 Developmental Monitoring and Language, can the applicant be based in a university in the United Kingdom (UK)? No, unfortunately, the eligibility is restricted to US institutions only. This has now been clarified on the web page with the project description, in the section titled, “Eligible Applicants.”

Regarding RFA-2018-03 Developmental Monitoring and Language, can we propose training a parent professional to deliver the intervention, and want to make sure that falls within the acceptable definition of “others.” Yes, “parent professional” would fit in with others.

Regarding RFA-2018-03 Developmental Monitoring and Language, can the LTSAE integration and the proposed research be conducted in a well-child setting? CDC’s aim is to better understand developmental monitoring and developmental promotion in a wide variety of settings. Because CDC recently funded a similar project in primary care settings, this project is to focus on other settings of interest, not including primary pediatric care.

Are tables and figures to be included in the page count for the Research Strategy? Yes, we have changed the instructions from previous cycles. The tables and figures need to be included in your research strategy within the set page limit. They should NOT be included as appendices.

Are investigators allowed to submit applications for more than one RFA? Yes.

With regard to RFA-2018-05 Intensity of Interventions for Hearing Loss and RFA-2018-07 Accelerated Timeline for EHDI Benchmarks, would use of an existing cohort that includes only children who are hard of hearing (and thus not children who are deaf) be acceptable for these RFAs? Yes, an applicant may apply if s/he has access to a cohort as described; however, the applicant should provide a clear rationale of why their population was limited, define the objectives of the proposed study, and how it aims to meet the RFA requirements with the cohort limitations.

For RFA-2018-05 Intensity of Interventions for Hearing Loss, is an existing cohort for which all outcome measures have already been collected acceptable? An existing cohort may be used for the RFA. Although the outcomes data does not have to be captured during the project period, the applicant should have the ability to link different data sources to collect outcome measures and clearly define the measurement tools used.

For RFA-2018-01 Screening for Tics in Children, where can I get a copy of the Moveit tic screener that is supposed to be used? I don’t see a citation for it. You may request a copy of the MOVeIT screener by emailing the DRDC at info@disabilityresearchcenter.com.

For RFA-2018-05 Intensity of Interventions for Hearing Loss, it is not clear whether  “language acquisition” includes the acquisition of American Sign Language. Please clarify? American Sign Language is NOT excluded; and all types of language acquisition are included under this RFA.  Please note that the project description was amended on January 29, 2018 at around 11:15AM to reflect this clarification.

Relevant Q&A from Previous Funding Cycles

Is it necessary for all project personnel to have an ERA Commons username?  At a minimum, the Principal Investigator for your project should have one.  If it is not possible for the PI to obtain an ERA Commons username before you submit your application, please have him or her apply for one and indicate that it is in process.

Can you please clarify if this would be a grant from the Disability Research and Dissemination Center or if it is considered a Subgrant under another federal award that you have been awarded and if so could you please confirm the sponsor? Successful applicants will be funded via a sub-contract from the University of South Carolina, which is the administrative home of the DRDC. The DRDC is funded through Grant#1U19DD001218 from the CDC’s National Center on Birth Defects and Developmental Disabilities.

Are we required to complete a budget justification for our application? Yes. Please see the PHS 398 Instructions and Form Page 5.  This form page is required to be included in your application packet and contains the budget justification. You will likely need to use continuation pages to fully justify your budget.

Are biosketches are required for Other Significant Contributors? They are not required, but we recommend including them, if available.

May I include the timeline in the appendix or must it be included in the Research Strategy?  Since the timeline is a required element of the research strategy, it needs to be included within the page limits specified for your application.  

Regarding the application instructions, would you please elaborate or provide an example of an ‘information system’ as mentioned in (g) data security? For information system, we are asking you to tell us what type of data will be collected and how it will be obtained, recorded, and secured. You should also explain how you will protect that data, especially with regard to any confidential information or identifiers. 

Does DRDC require a fully approved IRB protocol prior to application submission? No, you do not need to have the protocol approved in advance. Please be sure to address the expected involvement of human subjects in your research, as instructed in section (f) of the “how to apply” page. It is also helpful if you indicate whether you expect the IRB to classify your protocol application as being Exempt, or if you expect it to undergo an Expedited or Full review. 

Do we need to describe the expertise and roles of project staff in the Research Strategy or should that go in an appendix? No. The expertise and roles of staff should go in the Budget Justification (PHS 398, Form Page 5) .

On the “How to Apply” page, under “Research Plan and Project Activities,” does the term “evaluation measures” refer to program evaluation for the research project?  The term refers to either your analytic plan or your program evaluation, whichever seems appropriate for the methodology you are proposing.

Will progress reports be required, if funded?  Yes. The DRDC Project Manager will instruct grantees on the timing and required elements for progress reports.  They will be required at least annually for the duration of the grant.

Are there margin requirements for the Research Strategy?  There are no set margin requirements, so you should use your best judgement. Keep in mind, however, that if your application makes the first cut, it will be sent in printed form to CDC for their full review. Thus, you would not want your text to be outside of the printable area.

Are applicants allowed to propose to use subcontractors for some project activities?  Yes. You may propose to use a subcontractor in your application. F&A costs for the first $25,000 of each consortium agreement may be included in your modified total direct cost base, which is used to calculate your overall F&A rate, as long as your institution’s negotiated F&A rate agreement does not expressly prohibit it. If you intend to establish a consortium agreement with a foreign institution or international organization, then F&A for the consortium is limited to 8%.

Is it allowable for a for-profit bidder to include a fee or profit in their proposed budget? If an entity has a  federally-negotiated indirect cost rate, it would be normal to use that rate to cover overhead costs, and to show that cost and calculation in the project budget.  If your organization does not have such an agreement in place, you could still ask for indirect costs (facilities and administration), but you would have to explain what it covers.  For non-governmental agencies, it is often the case that  their federally-negotiated rates are calculated as a percentage of salaries and fringe only, but it varies quite a bit from organization to organization. Other than indirect costs, a line-item for “profit” would be looked upon unfavorably.

What entities are eligible to apply for this funding? On the Research Overview & Grant Opportunities page, you will find links to each of the individual RFAs.  Each one is different and you should click the links to find the individual descriptions and to learn who is eligible to apply.

Regarding the budget, are applicants required to use the HHS salary cap ($187,000 for Executive Level II as of January 8, 2017), if there are project personnel whose salaries exceed the cap?  Yes.

May I have a copy of a recently funded research application? We cannot provide you with past applications; however, you may find it helpful to view the abstracts of funded projects here.

May I speak with someone at the DRDC by telephone to ask a few questions about the application process and areas that I should address in my research application? To be fair to all potential applicants, the DRDC will only answer written questions. We usually post questions and answers within a day or two of obtaining the answer.

Who is the CDC project officer for each RFA, and may I contact them regarding this opportunity? We have negotiated with CDC to be the contact point for all applicants. Part of that agreement is that we will get all questions in writing, and that we will post all questions and answers on the DRDC website. This is done to assure a fair process for all applicants, and it mirrors the procedures most federal agencies use for their grants. The DRDC is issuing the grants and we will answer your questions, with consultation from the CDC, as needed, in a timely manner.

How do I apply for one of the research funding opportunities? Refer to this page for instructions and the application form.

When do the research projects start? The start date for all 2018 RFAs is September 30, 2018.

Will the budget be allowed to cover our negotiated F&A rate, and is there a cap or limit on the allowable indirect costs? There are no specific limits on indirect costs, rather there are maximum annual costs for each RFA.  These are posted on each RFA’s description page, and these amounts must cover the applicants direct and indirect costs for the project. Applicants should use their federally negotiated indirect (F&A) cost rates, if available.

Will the DRDC  take a percentage of the awards for administrative expenses? No, DRDC does not take any funds from the awards.  We are separately funded by the CDC for indirect costs related to the sub-awards.

Does the DRDC have its own federal ID or do we need the University of South Carolina’s federal ID? The DRDC does not have its own federal ID number. The University of South Carolina’s EIN is 57-6001153.

Please provide me with the CFDA number?  There are no CDFA numbers that are directly tied to the DRDC grant opportunities.