WOMEN"S HEALTH IN SPORTS AND EXERCISE

PA NUMBER: PA-02-115

RELEASE DATE:  June 21, 2002

EXPIRATION DATE:  May 1, 2005, unless reissued. 

PARTICIPATING INSTITUTES AND CENTERS (ICs):  
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIAMS
 (http://www.niams.nih.gov/)
National Institute of Child Health and Human Development, NICHD
 (http://www.nichd.nih.gov/)
Office of Research on Women"s Health, ORWH
 (http://www4.od.nih.gov/orwh/)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS), National Institute of Child Health and Human Development (NICHD) and 
the Office of Research on Women"s Health (ORWH) encourage investigator-
initiated research grant applications to study women"s health in sports and 
exercise.  The purpose of this Program Announcement (PA) is to stimulate and 
foster a wide range of basic, translational and patient-oriented clinical 
studies.  Improvement in our basic knowledge of the pathophysiology of sports 
injuries in women will help to solve the puzzle of why female athletes are more 
susceptible to certain types of injury.  In addition, translational studies 
will be helpful in developing optimal prevention, rehabilitation and training 
strategies for injuries and overuse syndromes in the female athlete throughout 
the life spectrum.   This pathophysiology may also be applicable to women with 
disabilities, as compensation for disability often includes some athletic 
activity. 

RESEARCH OBJECTIVES

It is well known that enhanced physical activities have numerous beneficial 
health effects during adult years, such as a reduction in morbidity and 
mortality from diseases of several body systems (e.g., cardiovascular disease).  
An unfortunate consequence of physical fitness and sports participation is the 
development of injuries.  In the United States, organized athletic programs 
involve at least 20 million children and adolescents each year (Tofler I, et al, 
N Engl J Med 1996 Jul 25,335:281-283).  The possibility of a high school 
athlete being injured during a season ranges from a low of 21%, to a high of 
81%, in football (Women"s Health in Sports and Exercise, AAOS 2001).  Mueller 
estimates that a median injury rate of 50% would result in >3 million high 
school sports injuries per year.  Most athletic injuries are not accidents and 
are preventable. 

With increased participation of women in sports activities, there has been a 
concomitant increase in sports injuries and overuse syndromes in women.  Women 
participating in the same sports as men generally have the same type of 
injuries as their male counterparts (Arendt E, et al, Am J Sports Med 1995 Nov-
Dec, 23(6):694-701).  Anatomical and physiological considerations give female 
participants certain advantages, some disadvantages, and result in several 
unique injury risks and conditions, as compared to their male counterparts.  In 
particular, female athletes appear to be 2-8 times more likely to sustain a 
knee or ankle injury than their male counterparts.  This has been related to 
anatomical differences, neuromuscular differences, and to the possibility that 
estrogen receptors, normally present in ligaments, may serve as an intrinsic 
risk factor to ligamentous injury.  While preliminary studies have shown that 
the results of reconstruction of the knee"s anterior cruciate ligament, for 
example, may not be gender-dependent, little is known about optimal treatments 
and rehabilitation strategies for common female athletic injuries.

Other musculoskeletal problems also are more common in the female athlete.  
These include scoliosis in the spine, patellofemoral problems, bunions, and 
increased pronation in the foot.  Another potential issue related to the foot 
is the fact that most women"s athletic shoes are designed for men and have been 
scaled down, but not adapted to the shape of a woman"s foot.  

Following the work of Cann and associates, the phrase "the female athletic 
triad" was coined to describe the complex interplay of disordered eating, 
menstrual irregularity, and osteoporosis seen in the female athlete (Cann DE, 
et al, JAMA 1984 Feb 3,251(5):626-9).  It is not known whether the loss in bone 
mineral density at a young age will lead to premature fracture, but the 
incidence of stress fractures in amenorrheic athletes is increasing (The Female 
Athlete, AAOS 1997).

The current PA indicates the NIAMS"s, NICHD"s and ORWH"s continued interest in 
fitness, sports-related musculoskeletal injuries, and women"s health in sports 
and exercise.    The NICHD conducts and supports biomedical and behavioral 
research and research training in exercise for individuals with physical 
disabilities.  It is a direct outgrowth of a NIAMS and American Academy of 
Orthopaedic Surgeons (AAOS) sponsored workshop on the status and future research 
directions of Women"s Health in Sports and Exercise, held in June 1999.  The 
purpose of the workshop was to explore ways to encourage physical activity while 
trying to understand what can be done to prevent activity-related injuries.  To 
accomplish these aims, a multi-disciplinary panel of basic and clinical 
scientists was assembled to define current knowledge and to identify future 
cross-cutting research directions.  A more detailed description of the 
proceedings and suggested research topics can be found in Women"s Health in 
Sport and Exercise, which can be obtained from the American Academy of 
Orthopaedic Surgeons, 6300 North River Road, Rosemont, Illinois 60018 or at the 
following URL address: http://www4.aaos.org/product/prt_item.cfm?code=02516.

Through the use of this PA, the NIAMS, NICHD and ORWH anticipate the receipt 
of a broad range of applications targeted, but not limited, to the following 
areas related to women"s health in sports and fitness.

A.  Epidemiologic Issues

Collect epidemiologic data on women"s athletic injuries and overuse 
syndromes, including injury data, exposure data, demographic data, equipment 
information, injury history, playing experience, and data on women with 
disabilities who sustain common injuries that are normally sports-related.

Identify risk factors for common musculoskeletal injuries.

Clarify the anatomic, physiologic, and psychological effects of sports 
participation during the adolescent years.  Determine whether injuries are 
more likely at this time and if so, determine their long-term effects. 

Clarify the epidemiologic data on stress fractures, exploring the effects of 
(1) age, (2) gender, (3) skeletal status, (4) hormonal stress, (5) nutrition, 
(6) training techniques, and (7) sport specificity.

Examine the value of single sport versus multiple sports participation by 
young women, assessing the effect of such on (1) injury rates, (2) continued 
participation in fitness activities as an adult, (3) levels of fitness, and 
coping skills (psychological well-being).

Characterize the natural history of joint injury and subsequent degenerative 
joint disease, and determine if treatment strategies alter these results.  
Determine the effect of treatment and preventive strategies in women with 
disabilities.

Establish prospective epidemiologic studies to define risk factors for 
exercise-related musculoskeletal problems.

Determine the long-term effects of disability on the musculoskeletal system, 
particularly in women who participate in sports and recreational activities.

B. Neuromuscular Issues

Investigate neuromuscular control mechanisms used by the central nervous 
system to control joint musculature and stability in normal and injured 
states.

Study the patterns of movement for walking, running, and athletic maneuvers 
for important variables associated with respect to age and level of 
experience.  

Determine the optimal patterns of neural activation within a given sport 
activity.

Determine whether motor patterns in women are inherent or are driven by 
experience.

Determine whether motor activation patterns change with different stages of 
development, e.g., prepubescent, adolescent, early adult, elderly.

Further define at-risk injury positions for women"s sports and develop 
strategies to prevent these at-risk situations and to respond more 
appropriately when they occur.

Determine if there are gender-specific differences in movement patterns and 
if such differences affect injury risks.  If such patterns are discovered, 
are they alterable?

Identify differences in proprioception and neuromuscular control and how 
these relate to injuries and injury prevention techniques.

Identify and characterize motor control strategies/movement patterns and 
relate them to risks of acute and chronic injuries.

Identify possible differences in neuromuscular control in women with 
disabilities, as compared with able-bodied women.

C. Basic Science Issues

Identify specific neuromuscular proprioceptive and motor control factors 
associated with ACL injury.

Elucidate the appropriate dose-response relationship of physical activity to 
injury, across the life spectrum (pre-adolescent, adolescent, young adult, 
and aging adult).

Assess the relationship of body composition and performance in sports and 
physical activity.

Assess the relationship between performance and nutritional intake in the 
female athlete.

Clarify why females are more vulnerable to overuse syndromes.

Elucidate the effects of cyclical hormones on musculoskeletal soft tissues, 
especially ligaments, and their relationship to injury.

Clarify the role and effects of exercise and competition during pregnancy.

Evaluate the role of nutritional and hormonal status on responses to exercise 
training in women throughout the lifespan.

Elucidate the role of intense physical activities on normal bone metabolism 
throughout the life spectrum.  This should lead to the development of optimal 
training methods and adjuvant therapies to maximize bone mineral density.

Assess if women with disabilities, who are compensating in order to achieve 
or maintain previously acquired or potential functional levels, are also 
susceptible to certain sport or recreational injuries.

D. Coaching/Training/Equipment Issues

Continue to investigate the multitude of physiological, biochemical, and 
psycho-social responses to training during pregnancy.

Determine the optimal resistance training programs for the most favorable 
adaptations and benefits across the life spectrum.

Establish guidelines for medical clearance and continued athletic 
participation. 

Better understand the roles of sports floor surfaces and foot-surface 
interfaces on injury rates.  Can gender-specific shoe wear or sports surfaces 
or a combination of both improve safety?

Better understand the role(s) of sport-specific equipment and protective 
devices in enhancing athletic safety and performance.  Is such equipment 
gender specific? 

Develop optimal training methods for young female athletes to improve 
fundamental motor skills.

E. Surveillance/Patient-Oriented Research Issues

Conduct randomized clinical trials and population-based investigations to 
more fully specify the types, modes, amounts, intensities, and patterns of 
physical activity that are necessary to promote health and specific 
physiologic and metabolic adaptations and to facilitate 
recovery/rehabilitation from disease and injury.

Improve surveillance systems to (1) monitor population levels and trends of 
physical activity and fitness, especially for the current consensus public 
health recommendations for physical activity, and (2) document exercise-
related health problems such as musculoskeletal injuries and sudden death 
associated with exercise.

Conduct long-term trials of physical activity interventions across the life 
spectrum, to evaluate their long-term effects on activity behavior and 
health.

Develop optimal prevention, intervention and treatment strategies for each 
dimension of the female athletic triad.  Develop clinical guidelines for 
screening, prevention, and treatment of the female athletic triad.

Design prospective studies that relate prevention strategies to modifiable 
risk factors or to modifiable injury mechanisms.

Develop prospective studies to identify females at risk for ACL injuries, and
to better understand the factors that predispose to this injury.

Develop optimal rehabilitation techniques for the treatment and prevention of 
musculoskeletal injuries and overuse syndromes in female athletes.

F.  Social/Psychological Issues

Identify factors that motivate girls" participation in sports and exercise, 
as well as factors that lead to attrition from or exercise participation.

Define and develop strategies to overcome socioeconomic, ethnic, and/or 
cultural barriers to girls participating in sports and physical activity.

Identify (1) psychological risk factors for injury, (2) short and long-term 
effects of injury, and (3) determine appropriate intervention in the 
management of emotional issues after injury, in the female athlete.

Investigate factors that facilitate involvement as well as barriers to 
participation in sports and physical activity for women throughout the life 
spectrum.

Investigate the biopsychosocial factors underlying the causes of the female 
athletic triad.

MECHANISM(S) OF SUPPORT 

This PA will use the NIH research project grant (R01) award mechanism(s).  As 
an applicant, you will be solely responsible for planning, directing, and 
executing the proposed project.  The total project period for an application 
submitted in response to this PA may not exceed 5 years.

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign
o Faith-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research, and financial or grants management issues:

o Direct your questions about scientific/research issues to:

James S. Panagis, MD, MPH
Director, Orthopaedics Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 45, Room 5AS-37K, MSC 6500
Bethesda, MD  20892
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  jp149d@nih.gov

Carol Sheredos, PT, MA
Program Support Specialist
National Center for Medical and Rehabilitation Research
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 2A03
Bethesda, MD 20892
Telephone:(301) 402-2242
FAX:(301) 402-0832
Email:  sheredc@mail.nih.gov

o Direct your questions about financial or grants management matters to:

Melinda Nelson
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-49F, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  mn23z@nih.gov

Christopher Myers
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A17H, MSC 7510
Bethesda, MD 20892-7510
Telephone:(301) 435-6996
FAX:(301) 402-0915
Email:  cm143g@nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:

1)Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board

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 your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your 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, you 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 your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
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?  Do you acknowledge potential problem areas and consider alternative 
tactics?

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

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your 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 
support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  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.

INCLUSION:  The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

DATA SHARING:  The adequacy of the proposed plan to share data, if 
applicable.

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  
Specific information about NIAMS support of clinical research can be found 
at: http://www.niams.nih.gov/rtac/clinical/index.htm.
 
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-
files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are 
available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy 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 that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on 
hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at  
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: 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.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: 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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.846 and 93.929, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  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 described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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