Part I Overview Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

AGENCY: Office of Secretary, Office of Public Health and Science, 
Office of Population Affairs 

FUNDING OPPORTUNITY TITLE: Family Planning Service 
Delivery Improvement Research (R01) 

Note: The policies, guidelines, terms, and conditions stated in this 
announcement may differ from those used by the NIH. 


ANNOUNCEMENT TYPE: Initial Competitive Grants 

ANNOUNCEMENT NUMBER: PAR-08-999 

NOTICE: Applications submitted in response to this Funding Opportunity 
Announcement (FOA) for Federal assistance must be submitted 

 electronically through Grants.gov (http://www.grants.gov) using the SF424 
Research and Related (R&R) forms and the SF424 (R&R) Application 
Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. 
 
This FOA must be read in conjunction with the application guidelines 
included with this announcement in Grants.gov/Apply for Grants (hereafter 
called Grants.gov/Apply). 

A registration process is necessary before submission and applicants are 
highly encouraged to start the process at least four (4) weeks prior to the 
grant submission date. See Section IV. 

CFDA NUMBER: 93.974 

DATES: 

Opening Date: April 15, 2008 
Letters of Intent Receipt Date(s): May 1 in 2008; January 2 in 2009 and 
2010 


NOTE: On-time submission requires that applications be successfully 
submitted to Grants.gov no later than 5:00 p.m. local time (of the 
applicant institution/organization). 

Application Due Date(s): May 15 in 2008; January 15 in 2009 and 2010 
 
Peer Review Date(s): July in 2008; May/June in 2009 and 2010 

Council Review Date(s): August in 2008, 2009 and 2010 

Earliest Anticipated Start Date(s): September 15 in 2008, 2009 and 2010 

Expiration Date: January 16, 2010 


ADDITIONAL OVERVIEW CONTENT 
EXECUTIVE SUMMARY 

Purpose. This FOA issued by the Office of the Secretary/Office of Public 
Health and Science/Office of Population Affairs encourages Research 
Project Grant (R01) applications from institutions/organizations that 
propose to conduct relevant studies which will promote improvements in 
the delivery of services in the Title X family planning program 
administered by the Office of Family Planning in the Office of Population 
Affairs. The purpose of this grant announcement is to encourage applied 
research attention to the following areas: 1) Clinic Efficiency Models; 2) 
Service Integration; and 3) Targeted Populations. Descriptions of 
previously-funded Service Delivery Improvement Research projects in 
other focused areas of study and improvement can be found at the 
following web address: 

http://www.hhs.gov/opa/familyplanning/grantees/research/index.html 

- Mechanism of Support. This FOA will utilize the R01 grant 
mechanism 

- Funds Available and Anticipated Number of Awards. Subject to the 
availability of funds, OPA intends to award $750,000 in Fiscal Year 
2008 to support an estimated three to four new research projects.

- Budget and Project Period. Budgets for total costs of up to 
$200,000 per year and a project duration of up to three years may be 
requested for a maximum of $600,000 total costs over a three-year 
project period. 

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

- Number of Applications. Applicants may submit more than one 
application, provided each application is scientifically distinct. 
 
- Resubmissions. Resubmission applications are allowed in response 
to this FOA. 
 
- Renewals. Renewal applications are not permitted in response to 
this FOA. 
 
- Special Date(s). This FOA uses non-standard due dates. See Receipt, 
Review and Anticipated Start Dates. 

- Application Materials. See Section IV.1 for application materials. 

- General Information. For general information on SF424 (R&R) 
Application and Electronic Submission, see these Web sites: 

    -- SF424 (R&R) Application and Electronic Submission Information: 
http://grants.nih.gov/grants/funding/424/index.htm 

    -- General information on Electronic Submission of Grant 
Applications: http://era.nih.gov/ElectronicReceipt/ 

- Hearing Impaired. Telecommunications for the hearing impaired are 
available at: TTY 301-451-0088. 



Part II. Full Text of Announcement 
 
1. FUNDING OPPORTUNITY DESCRIPTION 
 
This FOA issued by the Office of Population Affairs (OPA) encourages 
research grant (R01) applications from public or non-profit private 
organizations for research on selected topic areas for family planning 
service-delivery-improvement. The purpose is to support applied research 
which will promote improvements in the delivery of family planning 
services offered under Title X of the Public Health Service Act. Projects 
funded under this program will conduct research, which is intended to help 
family planning administrators to achieve the goals of the Title X program. 
These goals, briefly stated, are to provide family planning services in order 
to help families and individuals attain the number and spacing of children 
they desire. In addition, Title X providers often make available related 
preventive health services, which help preserve reproductive health. It is 
anticipated that other providers of family planning services beyond Title X 
including officials of local, State and Federal government, as well as private 
organizations, will benefit from this research. 

Research grants supported under this announcement are expected to be 
consistent with one or more of the following performance goals for the 

Family Planning Program in the Department of Health and Human Services: 
1) Improve health outcomes, 2) Increase utilization of preventive health 
care, particularly among vulnerable and special needs populations, or 3) 
Increase the proportion of pregnancies that are intended. 


Background 
 
The Family Planning Program, authorized by Title X of the Public Health 
Service Act (42 U.S.C. 300, et seq.) and administered by the Office of 
Family Planning located in OPA is the only federal program devoted solely 
to funding family planning and related preventive, health-care services. This 
program supports a nationwide network of more than 4,400 clinics and 
provides family planning services and supplies as well as related preventive 
health services to approximately 5 million persons per year. Family 
planning, like many health-care services, faces continuing and emerging 
challenges to delivering quality care. This announcement calling for 
service-delivery improvement research applications is intended to help 
family planning programs meet those challenges. Section 1004 of the Public 
Health Service Act authorizes the Secretary to "make grants to public or 
nonprofit private entities … for projects for, research in… program 
implementation fields related to family planning and population." 
 
The research emphases identified for attention in this announcement reflect 
the goals of the Title X family planning program whose purpose, according 
to Section 1001 of the statute, is to "assist in the establishment and operation 
of voluntary family planning projects which shall offer a broad range of 
acceptable and effective family planning methods and services (including 
natural family planning methods, infertility services, and services for 
adolescents)."  

Section 1008 of the statute provides that "none of the funds appropriated 
under this title shall be used in programs where abortion is a method of 
family planning." 

By law (Section 1006 (c) (1)), a priority of the Title X program is to 
provide services to persons from low-income families. The program 
regulations describe Title X projects as consisting of "… the educational, 
comprehensive medical, and social services necessary to aid individuals to 
determine freely the number and spacing of their children." (42 CFR 59.1) 

 The research emphases of this announcement also are consistent with the 
current Title X Family planning program priorities. Regulations pertaining 
to grants for research projects are set out at 42 CFR part 52. 

 
 
Purpose of the Grant Announcement 
 
The purpose of the Family Planning Service Delivery Improvement 
Research program is to increase the ability of grantees to provide the range 
of Title X services more effectively. Title X’s range of services includes: 
pre-conceptional counseling and care; contraceptive counseling and care; 
preventive health screening and counseling; screening, counseling, and 
treatment of STIs; pregnancy diagnosis and referral for continuing care. 
Within this framework, this announcement invites applications using one or 
more of the following approaches: 

1. Clinic Efficiency Models 

According to the recommendations in the report released in 2004, entitled 
Future Directions for Family Planning Research: A Framework for Title X 
Family Service Delivery Improvement Research there is a need for more 
research “about the actual services they [Title X clients] receive, the 
effectiveness of those services, and how those services might be improved.” 

 Therefore more rigorous studies that identify and test promising practices in 
delivering family planning services are urged. 

 In times of rising of health care costs and limited resources, it is critical for 
health care systems to maximize efficiency while maintaining quality care. 
Towards this end, investigations are needed that shed light on how 
maximum efficiency in family planning clinic settings can be attained while 
still providing quality care in these settings. The basic concern is to identify 
strategies at the clinic level that can be shown simultaneously to maximize 
all desired outcomes in the delivery of family planning services, including 
numbers served. 

For the purposes of this announcement, research is encouraged in, but not 
limited to identifying innovative strategies or models which maximize clinic 
efficiency. Attention should be given to actual services received; patient 
satisfaction with these; health benefits received from specific kinds of 
services; and the organizational and logistical arrangements that best deliver 
these client outcomes within a limited budget for operation. Among 
possible approaches to investigate are improved clinic arrangements in such 
areas as staffing, scheduling, waiting times, and other aspects affecting 
patient flow. Mix of services and staffing relative to types of clients served 
may also be considered. Research that adapts approaches to the Title X 
 context or builds on findings from research in other health care sectors is 
encouraged. Previous research may have identified approaches which have 
proven successful in a particular area. Research replicating promising 
strategies in newly selected sites is also encouraged. 

 
2. Service Integration 
 
Studies are needed to analyze trends toward greater integration of family 
planning services with other health care provision, along with the causes of 
and implications of such trends. It is important to learn more about processes 
of integrating family planning services with other types of care, including 
primary health care services. Data from the National Survey of Family 
Growth (2002) reveal that Title X clients are more likely to engage in 
behaviors which place them at risk of HIV, which suggest the need to further 
integrate HIV and other STI screenings in the Title X clinics. Thus attention 
should be given to the integration of family planning services with care for 
women infected with, or at increased risk of, STI’s including HIV. At the 
same time, the family planning visit provides the much-needed window of 
opportunity for addressing other reproductive health issues, including infant 
mortality and low birthweight or involuntary sexual activity, particularly for 
female clients. 

 This announcement encourages research that demonstrates strategies which 
have been effective in the integration of family planning services with other 
health services. Research which investigates, under what conditions various 
approaches are likely to be successful and the consequences for family 
planning service delivery (i.e., the impact on staffing, cost, quality of care, 
patient recruitment, satisfaction, etc) is appropriate under this program. 
Other pertinent questions include: what role can integration of family 
planning services with other health services play in enhancing the overall 
well-being of family planning clients while still promoting family planning 
service delivery goals? How might any promising or evidence-based 
strategies arising in other programs be replicated or adapted for the Title X 
setting?
 

3. Targeted Populations 

There continues to be a need for research that would shed light on a number 
of unanswered questions related to special populations. Vulnerable clients 
who engage in high-risk behaviors and who may pose unusual challenges to 
Title X providers are among such groups who might be offered for research 
attention. For the purposes of this announcement, three populations are 
highlighted: adolescents; males; and recent immigrants. However, proposals 
presenting a compelling case for studying a population other than these three 
also will be considered. Extensive research has helped to inform the 
development of interventions that have targeted some segments of the 
population but there is a need for innovative approaches that impact 
previously underserved populations. For example, recent findings from CDC 
reveal a slight rise in the teen birth rate for the first time in 14 years, which 
underscores the need to identify successful strategies for reaching 
adolescents with a prevention message. 

 Males are among the hard-to-reach populations identified for attention in the 
current priorities of the Family Planning Program. While efforts have been 
successful in targeting males for reproductive health services as 
demonstrated by OPA-funded projects for only males, there continues to be 
a need to evaluate the effectiveness of programs designed to address their 
needs in the Title X clinic setting. Previously funded SDI research projects 
have brought forward the awareness that reproductive health needs of men in 
the U.S. are not generally well-understood, but have also given insights 
about further needed research. According to an OPA-funded study 
conducted by Kalmuss (2007), the reproductive health needs of men in the 
U.S. are not adequately being addressed. 

Research has shown that health disparities involving Hispanics or Latinos, 
who constitute the fastest-growing immigrant population in the U.S, are due
to access barriers, including cultural and language barriers. OPA has funded 
research that focuses on Mexican immigrants and Latino immigrants in rural 
areas, and there is interest in broadening this research to other immigrant 
populations. 

Successful proposals must demonstrate a well-developed understanding of 
the family planning and reproductive health needs of the target population 
chosen for study. Relevant areas of inquiry include, but are not limited to: 
how best to tailor services to targeted populations; physical or location 
barriers which may inhibit client access; the implications for client access, of 
the attitudes and behavior of clinic personnel; the development and testing of 
targeted outreach strategies which improve health outcomes; and the 
replication of strategies or interventions which are adapted for different 
subgroups. 

 

II. AWARD INFORMATION: 

1. Mechanism of Support. This FOA will use the RO1 award mechanism. 
The Project Director/Principal Investigator (PD/PI) will be solely 
responsible for planning, directing, and executing the proposed project. 

 This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) 
Application Guide). It also uses the non-modular budget formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm. Hence, modular 
budget formats do not apply in this case. 

 
2. Funds Available. The OPA, subject to the availability of funds, intends to 
make available approximately $750,000 each year (Fiscal Years 2008, 2009 
and 2010) to support an estimated three to four new research projects in each 
of the three years. Because the nature and scope of the proposed research 
will vary from application to application, it is anticipated that the size and 
duration of each award will also vary. Budgets for total costs of up to 
$200,000 per year and a project duration of up to three years may be 
requested for a maximum of $600,000 total costs over a three-year project 
period. The awards to be made are for applied research and do not cover 
costs of delivering services that the applied research project may propose to 
evaluate. 

Grants will be funded in annual increments (budget periods) and may be 
approved for a project period of up to three years. Funding for all budget 
periods beyond the first year of the grant is contingent upon the availability 
 of funds, satisfactory progress of the project, and adequate stewardship of 
Federal funds. 

 

 III. ELIGIBILITY INFORMATION 

 
1. Eligible Applicants 

 Any public or private nonprofit entity located in any State, the District of 
Columbia, or any United States territory, commonwealth, or possession is 
eligible to apply for an R01 grant under this announcement. Faith-based 
organizations are eligible to apply for these service delivery improvement 
research grants. 

2. Cost Sharing or Matching 
No cost sharing or matching of non-Federal funds is required 

3. Other-Special Eligibility Criteria 

- Resubmissions. Resubmission applications are permitted in 
response to this FOA. 

- Renewals. Renewal applications are not permitted in response to 
this FOA 


Section IV. Application and Submission Information 

To download a SF424 (R&R) Application Package and SF424 (R&R) 
Application Guide for completing the SF424 (R&R) forms for this FOA, use 
the “Apply for Grant Electronically” button in this FOA or link to 
http://www.grants.gov/Apply/ and follow the directions provided on that 
Web site. 
A one-time registration is required for institutions/organizations at both: 

- Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and 

- eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm) 

PDs/PIs should work with their institutions/organizations to make sure they 
are registered in the NIH eRA Commons. 

Several additional separate actions are required before an applicant can 
submit an electronic application, as follows: 

1) Organizational/Institutional Registration in Grants.gov/Get Registered 

- Your organization will need to obtain a Data Universal Number 
System (DUNS) number and register with the Central Contractor 
Registration (CCR) as part of the Grants.gov registration process. 

- If your organization does not have a Taxpayer Identification Number 
(TIN) or Employer Identification Number (EIN), allow for extra time. 
A valid TIN or EIN is necessary for CCR registration. 

-The CCR also validates the EIN against Internal Revenue Service 
records, a step that will take an additional one to two business days. 

- Direct questions regarding Grants.gov registration to: 
Grants.gov Customer Support 
Contact Center Phone: 800-518-4726 
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time 
Email support@grants.gov 


2) Organizational/Institutional Registration in the eRA Commons 

- To find out if an organization is already Commons-registered, see the 
"List of Grantee Organizations Registered in NIH eRA Commons.” 

- Direct questions regarding the Commons registration to: 
eRA Commons Help Desk 
Phone: 301-402-7469 or 866-504-9552 (Toll Free) 
TTY: 301-451-5939 
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time 
Email commons@od.nih.gov 


3) Project Director/Principal Investigator (PD/PI) Registration in the NIH 
eRA Commons: Refer to the NIH eRA Commons System (COM) Users 
Guide. 

- The individual(s) designated as PDs/PIs on the application must be 
registered also in the NIH eRA Commons. In the case of multiple 
PDs/PIs, all PDs/PIs must be registered and be assigned the PI role 
in the eRA Commons prior to the submission of the application. 

- Each PD/PI must hold a PD/PI account in the Commons. Applicants 
should not share a Commons account for both an Authorized 
Organization Representative/Signing Official (AOR/SO) role and a 
PD/PI role; however, if they have both a PD/PI role and an NIH 
Internet Assisted Review (IAR) role, both roles should exist under one 
Commons account. 

- When multiple PDs/PIs are proposed, all PDs/PIs at the applicant 
organization must be affiliated with that organization. PDs/PIs located 
at another institution need not be affiliated with the applicant 
organization, but must be affiliated with their own organization to be 
able to access the Commons. 

- This registration/affiliation must be done by the AOR/SO or his/her 
designee who is already registered in the Commons. 

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA 
Commons since both are authorized to view the application image. 
 
Note that if a PD/PI is also an NIH peer reviewer with an Individual DUNS 
and CCR registration, that particular DUNS number and CCR registration 
are for the individual reviewer only. These are different than any DUNS 
number and CCR registration used by an applicant organization. Individual 
DUNS and CCR registration should be used only for the purposes of 
personal reimbursement and should not be used on any grant applications 
submitted to the Federal Government. 

Several of the steps of the registration process could take four weeks or 
more. Therefore, applicants should immediately check with their business 
official to determine whether their organization/institution is already 
registered in both Grants.gov and the Commons. The NIH will accept 
electronic applications only from organizations that have completed all 
necessary registrations. 

1. Request Application Information 
Applicants must download the SF424 (R&R) application forms and the 
SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply. 

 Note: Only the forms package directly attached to a specific FOA can be 
used. You will not be able to use any other SF424 (R&R) forms (e.g., 
sample forms, forms from another FOA), although some of the 
"Attachment" files may be useable for more than one FOA. 
For further assistance, contact GrantsInfo -- Telephone 301-435-0714; 
Email: GrantsInfo@nih.gov. 
Telecommunications for the hearing impaired: TTY 301-451-0088. 

2. Content and Form of Application Submission 

Prepare all applications using the SF424 (R&R) application forms and in 
accordance with the SF424 (R&R) Application Guide for this FOA through 
Grants.gov/Apply. 

The SF424 (R&R) Application Guide is critical to submitting a complete 
and accurate application to NIH. Some fields within the SF424 (R&R) 
application components, although not marked as mandatory, are required by 
NIH (e.g., the “Credential” log-in field of the “Research & Related 
Senior/Key Person Profile” component must contain the PD/PI’s assigned 
eRA Commons User ID). Agency-specific instructions for such fields are 
clearly identified in the Application Guide. For additional information, see 

 “Frequently Asked Questions – Application Guide, Electronic Submission of 
Grant Applications.” 

The SF424 (R&R) application has several components. Some components 
are required, others are optional. The forms package associated with this 
FOA in Grants.gov/APPLY includes all applicable components, required 
and optional. A completed application in response to this FOA includes the 
data in the following components: 

Required Components: 

SF424 (R&R) (Cover component) 

Research & Related Project/Performance Site Locations 
Research & Related Other Project Information 
Research & Related Senior/Key Person 
PHS398 Cover Page Supplement 
PHS398 Research Plan 
PHS398 Checklist 

PHS398 Research & Related Budget 

Optional Components: 
PHS398 Cover Letter File 
Research & Related Subaward Budget Attachment(s) Form 

 
3. Submission Dates and Times 
See Section IV.3.A. for details. 
3.A. Submission, Review, and Anticipated Start Dates 
Opening Date: April 15 in 2008(Earliest date an application may be 
submitted to Grants.gov) 
Letters of Intent Receipt Date(s): May 1 in 2008; January 2 in 2009 and 
2010 
Application Due Date(s): May 15 in 2008; January 15 in 2009 and 2010 
Peer Review Date(s): July in 2008; May/June in 2009 and 2010 
Council Review Date(s): August in 2008, 2009 and 2010 

 Earliest Anticipated Start Date(s): September 15 in 2008, 2009 and 2010 

3.A.1. Letter of Intent 

Prospective applicants are asked to submit a letter of intent that includes the 
following information: 

- Descriptive title of proposed research. 

- Name, address, and telephone number of the Principal Investigator 

- Names of other key personnel. 

- Number and title of this funding opportunity. 

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 OPA staff to estimate the potential review workload and plan the 
review. 

The letter of intent is to be sent by the date listed in Section IV.3.A. 
The letter of intent should be sent to: 

Eugenia Eckard, Office of Population Affairs 

1101 Wootton Parkway, Suite 700 

Rockville, MD 20852, 

(240) 453-2800 

Eugenia.eckard@hhs.gov. 


3.B. Submitting an Application Electronically to the NIH 
To submit an application in response to this FOA, applicants should access 
this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and 
follow Steps 1-4. Note: Applications must only be submitted electronically. 
PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

 3.C. Application Processing 
Applications may be submitted on or after the opening date and must be 
successfully received by Grants.gov no later than 5:00 p.m. local 
time (of the applicant institution/organization) on the application due 
date(s). (See Section IV.3.A. for all dates.) If an application is not submitted 
by the due date(s) and time, the application may be delayed in the review 
process or not reviewed. 

Once an application package has been successfully submitted through 
Grants.gov, any errors have been addressed, and the assembled application 
has been created in the eRA Commons, the PD/PI and the Authorized 
Organization Representative/Signing Official (AOR/SO) have two weekdays 
(Monday – Friday, excluding Federal holidays) to view the application 
image to determine if any further action is necessary. 

- If everything is acceptable, no further action is necessary. The 
application will automatically move forward to the Division of 
Receipt and Referral in the Center for Scientific Review for 
processing after two weekdays, excluding Federal holidays. 

- Prior to the submission deadline, the AOR/SO can “Reject” the 
assembled application and submit a changed/corrected application
 within the two-day viewing window. This option should be used if it 
is determined that some part of the application was lost or did not 
transfer correctly during the submission process, the AOR/SO will 
have the option to “Reject” the application and submit a 
Changed/Corrected application. In these cases, please contact the 
eRA Help Desk to ensure that the issues are addressed and 
corrected. Once rejected, applicants should follow the instructions 
for correcting errors in Section 2.12, including the requirement for 
cover letters on late applications. The “Reject” feature should also 
be used if you determine that warnings are applicable to your 
application and need to be addressed now. Remember, warnings do 
not stop further application processing. If an application submission 
results in warnings (but no errors), it will automatically move 
forward after two weekdays if no action is taken. Some warnings 
may need to be addressed later in the process. 

- If the two-day window falls after the submission deadline, the 
AOR/SO will have the option to “Reject” the application if, due to an 
eRA Commons or Grants.gov system issue, the application does not 
correctly reflect the submitted application package (e.g., some part of 
the application was lost or didn’t transfer correctly during the 
submission process). The AOR/SO should first contact the eRA 
Commons Helpdesk to confirm the system error, document the issue, 
and determine the best course of action. NIH will not penalize the 
applicant for an eRA Commons or Grants.gov system issue. 

- If the AOR/SO chooses to “Reject” the image after the submission 
deadline for a reason other than an eRA Commons or Grants.gov 
system failure, a changed/corrected application still can be submitted, 
but it will be subject to the NIH late policy guidelines and may not be 
accepted. The reason for this delay should be explained in the cover 
letter attachment. 

- Both the AOR/SO and PD/PI will receive e-mail notifications when 
the application is rejected or the application automatically moves 
forward in the process after two weekdays. 

Upon receipt, applications will be evaluated for completeness by the CSR. 
Incomplete applications will not be reviewed. 

There will be an acknowledgement of receipt of applications from 
Grants.gov and the Commons. The submitting AOR/SO receives the 
Grants.gov acknowledgments. The AOR/SO and the PI receive Commons 
 acknowledgments. Information related to the assignment of an application to 
a Scientific Review Group is also in the Commons. 
 
Note: Since email can be unreliable, it is the responsibility of the applicant 
to check periodically on the application status in the Commons. 

 The NIH will not accept any application in response to this FOA that is 
essentially the same as one currently pending initial merit review unless the 
applicant withdraws the pending application. The NIH will not accept any 
application that is essentially the same as one already reviewed. However, 
the NIH will accept a resubmission application, but such application must 
include an Introduction addressing the critique from the previous review. 
 
4. Intergovernmental Review 
Applicants under this announcement are exempt from the review 
requirements of Executive Order 12372, “Intergovernmental Review of 
Federal Programs,” as implemented by 45 CFR Part 100. 

5. Funding Restrictions 
The allowability, allocability, reasonableness and necessity of direct and 
indirect costs that may be charged to grants are outlined in the following 
 documents: OMB Circular A-21 (Institutions of Higher Education); OMB 
Circular A-87 (State and Local Governments); OMB Circular A-122 
(Nonprofit Organizations); and 45 CFR part 74, Appendix E (Hospitals). 
Copies of the Office of Management and Budget (OMB) Circulars are 
available on the Internet at 
http://www.whitehouse.gov/omb/grants/grants_circulars.html 

6. Other Submission Requirements and Information PD/PI Credential 
(e.g., Agency Login) 

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the 
“PROFILE – Project Director/Principal Investigator” section, “Credential” 
log-in field of the “Research & Related Senior/Key Person Profile” 
component. 

Organizational DUNS 

The applicant organization must include its DUNS number in its 
Organization Profile in the eRA Commons. This DUNS number must match 
the DUNS number provided at CCR registration with Grants.gov. For 
additional information, see “Frequently Asked Questions – Application 
Guide, Electronic Submission of Grant Applications.” 

 PHS398 Research Plan Component Sections 

 Page limitations of the PHS398 Research Plan component must be followed 
as outlined in the SF424 (R&R) Application Guide. While each section of 
the Research Plan component needs to be uploaded separately as a PDF 
attachment, applicants are encouraged to construct the Research Plan 
component as a single document, separating sections into distinct PDF 
attachments just before uploading the files. This approach will enable 
applicants to better monitor formatting requirements such as page limits. All 
attachments must be provided to NIH in PDF format, filenames must be 
included with no spaces or special characters, and a .pdf extension must be 
used. 

All application instructions outlined in the SF424 (R&R) Application Guide 
are to be followed, incorporating "Just-in-Time" information concepts, and 
with the following additional requirements: 

Appendix Materials 

Applicants must follow the specific instructions on Appendix materials as 
described in the SF424 (R&R) Application Guide (See 
http://grants.nih.gov/grants/funding/424/index.htm). 

Do not use the Appendix to circumvent the page limitations of the Research 
Plan component. An application that does not comply with the required page 
limitations may be delayed in the review process. 

 V. APPLICATION REVIEW INFORMATION 

1. Criteria 

 Only the review criteria described below will be considered in the review 
process. 

2. Review and Selection Process 

Applications that are complete will be evaluated for scientific and technical 
merit by an appropriate peer review group convened by the Center for 
Scientific Review using the review criteria stated below. 

Each of the technical review criteria will be addressed and considered by 
independent peer reviewers in assigning an overall or global priority score, 
using a score range from 1.0 to 5.0 (with 1.0 indicating highest priority and 
5.0, lowest priority). 

As part of the scientific peer review, all applications will: 

- Undergo a selection process in which only those applications deemed 
to have the highest scientific and technical merit, generally the top 
half of applications under review, will be discussed and assigned a 
priority score; 

- Receive a written critique; and 

- Receive a second level of review by OPA 

Final grant award decisions will be made by the Deputy Assistant Secretary 
for Population Affairs (DASPA) on the basis of priority score, program 
relevance, and the availability of funds. 

 Eligible family planning service delivery improvement research applications 
will be reviewed according to the following criteria: 

(1) Significance. If the aims of the project are achieved, how much will 
applied research knowledge be advanced? Does the project employ novel or 
creative concepts, approaches or methods that are insightful and likely to 
move forward the applied research area addressed in the application? 

(2) Scientific Merit. Are the conceptual framework, design, methods and 
analyses adequately developed, well-integrated and appropriate to the aims 
of the project? 

(3) Feasibility and Likelihood of Producing Meaningful Results. Are the 
plans for organizing and carrying out the project, including the 
responsibilities of key staff, the time line, and the proposed project period, 
adequately specified and appropriate? Does the application acknowledge 
potential problem areas and consider alternative tactics? For intervention 
evaluation studies, is adequate funding for the intervention already in place 
or assured for the intervention period to be evaluated, making the proposed 
evaluation feasible? 
 
(4) Competency of Staff. Are the principal investigator, and other key 
research staff, appropriately trained and well suited to carry out this project? 
 
(5) Adequacy of Facilities and Resources. Are the facilities and resources of 
the applicant institution and other study sites adequate? 


2.A. Additional Review Criteria 
In addition to the above criteria, the following items will continue to be 
considered in the determination of scientific merit and the rating: 

.Resubmission Applications (formerly “revised/amended” applications): 
Are the responses to comments from the previous scientific review group 
adequate? Are the improvements in the resubmission application 
appropriate? 

Protection of Human Subjects from Research Risk: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. See the “Human 
Subjects Sections” of the PHS398 Research Plan component of the SF424 
 (R&R). 

Inclusion of Women and Minorities in Research: The adequacy of plans 
to include subjects from both genders, and all racial and ethnic groups (and 
subgroups), as appropriate for the scientific goals of the research will be 
assessed. Plans for the recruitment and retention of subjects will also be 
evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan 
component of the SF424 (R&R) 


2.B. Additional Review Considerations 
Budget and Period of Support: The reasonableness of the proposed budget 
and the appropriateness of the requested period of support in relation to the 
proposed research may be assessed by the reviewers. The priority score 
should not be affected by the evaluation of the budget. 

New Investigator: New Investigator applications (whatever the funding 
level request) will be evaluated by the review criteria listed in this section, 
but the reviewers will be instructed to take into account the Principal 
Investigator’s stage of career development. 

3. Anticipated Announcement and Award Dates 
 
OPA anticipates awarding three to four Family Planning Service Delivery 
Improvement Research (R01) Grants by September 15, 2008, announcing 
the awards shortly thereafter. 


 VI. AWARD ADMINISTRATION INFORMATION 

 1. Notification of Award 

 The OPA does not release information about individual applications during 
the review process. When a final funding decision has been made, each 
applicant will be notified by OPA of the outcome. The official document 
notifying an applicant that a project application has been approved for 
funding is the Notice of Grant Award, which specifies the amount of money 
awarded, the purpose of the grant, the length of the project period, and the 
terms and conditions of the award. 

 2. Administrative and National Policy Requirements 

In accepting this award, the recipient stipulates that the award and any 
associated activities are subject to all provisions of 45 CFR parts 74 and 92, 
currently in effect or implemented during the period of the grant. 

When issuing statements, press releases, requests for proposals, bid 
solicitations and other documents describing projects or programs funded in 
 whole or in part with Federal money, all grantees shall clearly state the 
percentage and dollar amount of the total costs of the program or project 
which will be financed with Federal money and the percentage and dollar 
amount of the total costs of the project or program that will be financed by 
non-governmental sources. 
 

 3. Reporting Requirement 

 At the completion of the project, the grant recipient must submit a brief 
summary in 2,500 to 4,000 words, written in non-scientific (layman’s) terms 
and a Financial Status Report (SF-269). The narrative should highlight the 
findings and their implications for improving family planning service 
delivery. A plan for disseminating research findings should accompany the 
narrative. This plan should indicate how products of the research will be 
made accessible to the Office of Population Affairs, as well as to the Title X 
family planning administrators and practitioners, researchers, and State and 
local policy-makers. The summary, plan, and Financial Status Report must 
be submitted to the Grants Management Specialist identified on the Notice 
of Grant Award within 90 days of the project’s completion. 


 VII. AGENCY CONTACT(S): 

For information on specific research or program requirements, contact 
Eugenia Eckard, Office of Population Affairs 

 1101 Wootton Parkway, Suite 700 

 Rockville, MD 20852, 

 (240) 453-2800 

 Eugenia.eckard@hhs.gov. 

 
For inquiries on the peer review process, contact 

Dana Plude, Ph.D. 

Chief, Biobehavioral and Behavioral Processes Integrated Review Group 

Center for Scientific Review, National Institutes of Health 

6701 Rockledge Drive Room 3176 

Bethesda, MD 20892 

(301) 435-2309 

pluded@csr.nih.gov 


For assistance on administrative and budgetary requirements, contact 

OPHS Grants Management Office 

1101 Wootton Parkway, Suite 550 

 Rockville, MD 20852 
 
(240) 453-8822 

 Karen.campbell@hhs.gov. 


 
VIII. Other Information 

The authority for this funding program is Section 1004 of the Public Health 
Service (PHS) Act. 
 
Dated: [March 25, 2008] 

 

Susan Orr 

Deputy Assistant Secretary for Population Affairs