Release Date:  May 25, 2000

RFA:  HD-00-012

National Institute of Child Health and Human Development

Letter of Intent Receipt Date:  August 25, 2000
Application Receipt Date:       October 25, 2000



The Center for Population Research (CPR) of the National Institute of Child 
Health and Human Development (NICHD) seeks applications that address 
epidemiologic research on female pelvic floor disorders with the purpose of 
stimulating research that contributes to greater understanding of the 
development of pelvic floor disorders (such as pelvic organ prolapse, urinary 
incontinence, and fecal incontinence).  In response to recommendations made at 
the 1998 NIH-sponsored Workshop on Pelvic Floor Disorders, emphasis will be 
placed on research that describes the natural history of pelvic floor 
disorders, associated risk factors, and effectiveness of risk factor 
modification for primary or secondary prevention of pelvic floor disorders.  
It is anticipated that studies in these under-researched areas will provide 
much needed information that will substantially advance our understanding of 
the disease processes of pelvic floor disorders, and identify points at which 
intervention directed at modifiable risk factors can effectively prevent the 
development of pelvic floor disorders.


The Public Health Service (PHS) is committed to achieving the health promotion 
and disease prevention objectives of “Healthy People 2010,” a PHS-led national 
activity for setting priority areas.  This RFA is related to one or more of 
the priority areas.  Potential applicants may obtain “Healthy People 2010” at 


Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as Principal 


This RFA will use the National Institutes of Health (NIH) Research Project 
Grant (R01) and NICHD Small Grant (R03) award mechanisms.  Information and 
application instructions for the NICHD Small Grant are available in the NIH 
Guide for Grants and Contracts at: 
https://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html.   Responsibility 
for the planning, direction, and execution of the proposed project will be 
solely that of the applicant.  This RFA is a one-time solicitation.  Future 
unsolicited competing continuation applications will compete with all 
investigator-initiated applications and will be reviewed according to customary 
NIH peer-review procedures.  The anticipated date of award is July 1, 2001.

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts being examined by the NIH.  
Complete and detailed instructions and information on Modular Grant 
applications can be found at 


The NICHD intends to commit approximately $2 million in total costs [direct 
plus Facilities and Administrative (F&A) costs] in FY 2001 to fund six to 
eight new grants in response to this RFA.  For an R01 application, an 
applicant may request a project period of up to five years and a budget for 
direct costs of up to $250,000 per year.  For an R03 application, an applicant 
may request a project period of up to two years and a budget for direct costs 
of $50,000 per year; support may be requested for $50,000 (direct costs) for 
one year or $100,000 (direct costs) for two years.

Because the nature and scope of the research proposed may vary, it is 
anticipated that the size of each award also will vary.  Although the 
financial plans of the NICHD provide support for this program, awards pursuant 
to this RFA are contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 



The term pelvic floor disorders refers to a group of clinical conditions that 
includes pelvic organ prolapse, urinary incontinence, and fecal incontinence, 
and other sensory and emptying abnormalities of the lower urinary and 
gastrointestinal tracts.  It is estimated that one or more of these conditions 
affects up to one-third of adult women.  Almost 10 percent of women will 
undergo surgery for urinary incontinence or pelvic organ prolapse during their 
lifetime, and 30 percent of those having surgery will have at least two 
surgeries to try to correct the problem.  With the steady increase in the 
population of older women, the national cost burden related to pelvic floor 
disorders is large in terms of direct health care costs, lost productivity, 
and decreased quality of life.

Little epidemiologic information on the prevalence and incidence of pelvic 
organ prolapse exists, despite the fact that this disorder is one of the most 
common indications for gynecologic surgery.  Population-based epidemiologic 
research on pelvic organ prolapse has been hampered by the lack of validated 
survey instruments for assessing the prevalence or incidence of prolapse in 
different populations.  Tracking of surgical procedures related to prolapse at 
least provides an estimate of those women who have required surgery.  Prolapse 
has been reported to be the most common indication for hysterectomy in women 
older than 50 years and, in one report, accounted for 13 percent of 
hysterectomies in all age groups.  It is estimated that 500,000 surgical 
procedures for prolapse are performed annually in the United States.  This may 
be a consequence of the relative lack of acceptable and effective non-surgical 
treatments for prolapse and, thus, the lack of intervention until advanced 
prolapse has occurred.  There is no consensus as to a standardized threshold 
for intervention; it is not known if the effectiveness of surgery is improved 
if performed early in the course of disease, thus preventing further damage to 
pelvic function or support, or if intervention is best performed only when 
necessary to relieve symptoms.

Vaginal delivery has been consistently identified to increase the risk of 
pelvic organ prolapse and other pelvic floor disorders, although clinical 
conditions may not become apparent until many years after childbirth.  There 
is not a clear relationship between the number of vaginal deliveries and the 
risk of pelvic floor disorders.  The first delivery may carry the highest risk 
for some types of pelvic floor damage, such as anal sphincter disruption; 
there also may be a cumulative risk of damage with subsequent births that 
contribute to the eventual development of a clinical pelvic floor disorder.

Damage at childbirth may directly or indirectly affect the pelvic muscles, 
nerves, connective tissue, or some combination.  Little is known about factors 
that minimize damage at vaginal birth and allow maximum recovery to reduce the 
risk of development of pelvic floor disorders in the future.  The majority of 
women who have delivered vaginally do not develop prolapse, even though 
changes related to vaginal birth can be identified in most parous women.  It 
is not known in which women these changes will ultimately progress to the 
development of a clinical disorder of pelvic function or support.  Little is 
known about different factors that influence the progression from asymptomatic 
compensated state to symptomatic clinical condition. 

Compared to the state of knowledge regarding pelvic organ prolapse, more 
research on prevalence and incidence of urinary incontinence already has been 
performed or is in progress.  The reported prevalence of urinary incontinence 
in adult women in the community varies from four percent to 41 percent, 
depending on the definition of incontinence used and the population under 
study.  Many risk factors have been studied, including age, race, reproductive 
history, obesity, medical illnesses, surgical history (particularly 
hysterectomy), smoking, hormone use, and physical exercise.  Little is known 
about the potential effectiveness of intervention directed at modifiable risk 
factors to prevent the subsequent development of urinary incontinence and 
other pelvic floor disorders.

Even less is known about the prevalence and incidence of other, less common, 
pelvic floor disorders such as fecal incontinence.  Fecal incontinence 
includes the involuntary and unwanted passage of gas, or of liquid or solid 
stool.  It is known that women who already have one pelvic floor disorder such 
as prolapse or urinary incontinence are much more likely to suffer from fecal 
incontinence as well, compared to women without other pelvic floor disorders.  
Vaginal birth is a strong risk factor for anal sphincter damage and subsequent 
fecal incontinence, particularly if midline episiotomy had been performed at 
childbirth.  However, many questions remain as to the prevalence of anal 
sphincter damage, both occult and clinically recognized, at the time of 
childbirth, with and without episiotomy use.  

In December 1999, NICHD and other NIH Institutes sponsored a Workshop on 
Terminology for Researchers in Female Pelvic Floor Disorders.  During this 
Workshop, recommendations were made for standardization of terminology 
regarding definitions of the conditions included under the general term of 
pelvic floor disorders, for definitions of outcomes after intervention, and 
for minimum data set collection for research studies.  All grant applications 
related to pelvic floor disorders are required to use these standard terms.  
Interested applicants should request a copy of the proceedings of the 
Terminology Workshop from the program contact listed under INQUIRIES, below.

Research Scope

On September 28-29, 1998, the NICHD, in collaboration with the Office of 
Research in Women's Health, the National Institute on Aging, the National 
Institute of Diabetes and Digestive and Kidney Diseases, and the Office of 
Rare Diseases, held a workshop to examine the state of basic, epidemiological, 
and clinical research addressing pelvic floor disorders.  A consensus emerged 
that underscored the lack of a substantive knowledge base that defined 
epidemiological parameters of pelvic floor disorders.  Such information was 
deemed critical to elucidating the multifactorial etiology of pelvic floor 
disorders, and guiding new strategies for prevention and treatment of pelvic 
floor disorders.  

The goals of this RFA are to stimulate research related to the natural history 
of pelvic floor disorders, associated risk factors, and effectiveness of risk 
factor modification for primary or secondary prevention of pelvic floor 
disorders.  Examples of research areas deemed important for developing this 
knowledge base and beyond include, but are not limited to, the following:

o The natural history of pelvic floor disorders, particularly pelvic organ 
prolapse and anal incontinence, including prevalence, incidence, and 
resolution of pelvic floor disorders over time.

o The promoting, intervening, and decompensating factors involved in the 
transition between normal pelvic floor structure and function, latent injury, 
and symptomatic condition.  Age-related changes in tissue integrity, muscle 
strength, and nerve function that may affect the development of pelvic floor 

o The role of specific events of the labor and delivery process in the 
development of pelvic floor disorders, which may include nerve damage, 
muscular damage, and/or direct tissue disruption.

o Risk factors (particularly potentially modifiable risk factors) associated 
with initial development of pelvic floor disorders, and with recurrence of 
pelvic floor disorders after non-surgical and surgical treatment.  These may 
include race; socioeconomic status; the impact of lifestyle, such as 
occupational and recreational activities; presence or absence of comorbid 
conditions, such as chronic lung disease; smoking; menopause, hormone use; 
obesity; constipation and the effect of chronic excessive straining; previous 
surgery such as hysterectomy; and other factors.

o The feasibility and effectiveness of risk factor modification for primary or 
secondary prevention of pelvic floor disorders.

Because this list is not meant to be all-inclusive, prospective applicants are 
encouraged to discuss their ideas for applications with the program staff 
listed under INQUIRIES.  In addition, prospective applicants are encouraged to 
review information related to studies currently funded by NIH to avoid 
unnecessary duplication.  Information on funded projects is available at 


It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH-supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are provided that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research.  This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the 
“NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research,” published in the Federal Register of March 28, 1994 (FR 59 14508-
14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 
18, 1994, and available on the Internet at: 


It is the policy of NIH that children (i.e., individuals under the age of 21) 
must be included in all human subjects research, conducted or supported by the 
NIH, unless there are scientific and ethical reasons not to include them.  
This policy applies to all initial (Type 1) applications submitted for receipt 
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
“NIH Policy and Guidelines on the Inclusion of Children as Participants in 
Research Involving Human Subjects,” published in the NIH Guide for Grants and 
Contracts, March 6, 1998, and available on the Internet at:  

Investigators also may obtain copies of these policies from the program staff 
listed under INQUIRIES.  Program staff may also provide additional relevant 
information concerning the policy.


All applications and proposals for NIH funding must be self-contained within 
specified page limitations.  Unless otherwise specified in an  NIH 
solicitation, internet addresses (URLs) should not be used to provide 
information necessary to the review because reviewers are under no obligation 
to view the Internet sites.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an  Internet site.


Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research, the name, address, and telephone 
number of the Principal Investigator, the identities of other key personnel 
and participating institutions, and the number and title of this RFA.  
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 NICHD staff to estimate the potential review workload and plan 
the review.  

The letter of intent is to be sent to the program staff listed under INQUIRIES 
by August 25, 2000.


The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research, on the Internet at 
https://grants.nih.gov/grants/funding/phs398/phs398.html, and from the Division 
of Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 
301-710-0267, E-mail:  grantsinfo@nih.gov.

As noted under RESEARCH OBJECTIVES, above, all grant applications related to 
pelvic floor disorders are required to use the standard terminology as 
recommended at the NIH Terminology Workshop for Researchers in Female Pelvic 
Floor Disorders held in December 1999.  All prospective applicants should 
request a copy of the proceedings of the Terminology Workshop by contacting 
Anne M. Weber, M.D., M.S. at the address listed under INQUIRIES, below.  
Applications not conforming to these guidelines will be considered 
unresponsive to this RFA and will be returned to the applicant without further 

Application Instructions for NICHD Small Grant (R03) Applications

The small grant (R03) research mechanism should be used for support of pilot 
studies and/or exploration of novel hypotheses and strategies that are sound 
and justifiable, but not sufficiently developed for the R01 mechanism.  A 
description of the NICHD Small Grants Program and complete application 
instructions are available from the program contact listed under INQUIRIES and 
on the Internet at 
https://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html.  These applications 
must be submitted according to the Modular Grant application instructions 
included in the NICHD Small Grant program announcement.

Modular Grant Application Instructions for Research Project Grant (R01) 

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The “JUST-IN-
TIME” concept allows applicants to submit certain information only when there 
is the possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers, and Institute 
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used 
in applying for these grants, with the modifications noted below.

o FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total 
Direct plus Facilities and Administrative (F&A) costs] for the initial budget 
period.  Items 8a and 8b should be completed indicating the Direct and Total 
Costs for the entire proposed period of support.

of the PHS 398.  It is not required and will not be accepted with the 

categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page.  (See https://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the total direct costs requested 
for each year.  This is not a Form Page.

o Under Personnel, list all project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing 
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus F&A costs) for each year, each rounded to the nearest $1,000.  List the 
individuals/organizations with whom consortium or contractual arrangements 
have been made, the percent effort of personnel, and the role on the project.  
Indicate whether the collaborating institution is foreign or domestic.  The 
total cost for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount.  Include the Letter of Intent to 
establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

BIOGRAPHICAL SKETCH:  The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific 
role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all personnel, following the instructions below.  No more than three pages may 
be used for each person.  A sample biographical sketch may be viewed at: 

- Complete the educational block at the top of the Form Page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

o CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied in 
the calculation of the F&A costs for the initial budget period and all future 
budget years.

o The applicant should provide the name and phone number of the individual to 
contact concerning fiscal and administrative issues if additional information 
is necessary following the initial review.

Submission Instructions

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
stapled to the bottom of the face page of the application and must display the 
RFA number HD-00-012.  A sample RFA label is available at 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf.  Please note this is 
in the pdf format.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form and the YES box must be 

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies, in one package to:

BETHESDA, MD  20892-7710
BETHESDA, MD 20817 (for express/courier service)

At the time of submission, two additional copies of the application should be 
sent to:

L.R. Stanford, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Bethesda, MD  20852 (for express/courier service)
Telephone:  (301) 496-9254
Applications must be received by October 25, 2000.  If an application is 
received after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed.  This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness to the RFA by NICHD staff.  Incomplete and/or non- responsive 
applications will be returned to the applicant without further consideration.  

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NICHD in accordance with the review criteria stated below.  As part of the 
initial merit review, all applications will receive a written critique and may 
undergo a process in which only those applications deemed to have the highest 
scientific merit will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Child Health and Human 
Development Council (NACHHD).

Review Criteria

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following aspects 
of the application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  Each of these 
criteria will be addressed and considered in assigning the overall score, 
weighting them as appropriate for each application.  Note that the application 
does not need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, an 
investigator may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims 
of the application are achieved, how will scientific knowledge be advanced?  
What will be the effect of these studies on the concepts or methods that drive 
this field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches, or 
methods?  Are the aims original and innovative?  Does the project challenge 
existing paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the experience 
level of the Principal Investigator and other researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 

In addition to the above criteria, in accordance with NIH policy, all 
applications also will be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects also will be 

o The reasonableness of the proposed budget and duration in relation to the 
proposed research.

o The adequacy of the proposed protection for humans, animals or the 
environment, to the extent they may be adversely affected by the project 
proposed in the application. 


Letter of Intent Receipt Date:    August 25, 2000
Application Receipt Date:         October 25, 2000
Peer Review Date:                 January-February 2001
Council Review:                   June 2001                  
Earliest Anticipated Start Date:  July 1, 2001


Award criteria that will be used to make award decisions include scientific 
merit (as determined by peer review); availability of funds; and programmatic 


Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Anne M. Weber, M.D., M.S.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13C, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6972
FAX:  (301) 480-1972
E-mail:  webera@mail.nih.gov 

Direct inquiries regarding fiscal matters to:

Mr. Michael J. Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17J, MSC 7510
Bethesda, MD  20892-7510 
Rockville, MD 20852 (Express Mail)
Telephone:  (301) 435-7008
FAX:  (301) 402-0915
E-mail:  ml70m@nih.gov 


This program is described in the Catalog of Federal Domestic Assistance No. 
93.864, Population Research.  Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and promote the non-use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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