Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

The NIA has supported the development of major data collection efforts in areas such as cognition, genetics, long term care, retirement and economic status, caregiving, behavioral medicine, and the dynamics of health and functional change in the very old. This funding opportunity announcement (FOA) encourages secondary analysis and archiving of these data sources.

In February 2003 NIH reaffirmed its support for the concept of data sharing and stated that data should be made as widely and freely available as possible while safeguarding the privacy of participants, and protecting confidential and proprietary data (http://grants2.nih.gov/grants/policy/data_sharing/index.htm). Many datasets have been assembled prior to the implementation of this policy and have not been made available to the research community. This funding opportunity provides the opportunity to archive such data to make the data available to the research community.

Applications which are innovative and high risk with the likelihood for high impact are especially encouraged. See also NIH Small Research Grant Program which permits original data collection on several of the topics below (PA-06-180 also available at http://grants.nih.gov/grants/guide/pa-files/pa-06-180.html).

Examples of Areas of Investigation:

A. Archiving

The NIH requires that all data collected be made publicly available to the research community. Research teams can request funds under this FOA for data archiving to make previously un-archived studies available. Additionally, many powerful analyses can be conducted on sensitive datasets which cannot be made publicly available in their original form, because they include geographic information or data linked to administrative records. Such data can be made available as a synthetic dataset which can be useful for data exploration by researchers. Work on creating synthetic datasets can also be supported.

B. Biodemography of Aging

Biodemography of aging: including the demographic aspects of heritability and familial aggregation of disease and longevity and genetic variants; incorporation of genetic, biological, and disease variables into demographic models and age-specific mortality rates; the social roles of the elderly in nature; and biological mediators of the relationship between socio-economic status and health. Of particular interest are analyses of biological measures which have been included in social and behavioral data collections as recommended by Cells and Surveys: Should Biological Measures Be Included in Social Science Research? (Washington, DC: National Academy Press, 2001. Also available at http://www.nap.edu ) Analyses should target the correlates of these biomarkers with social and behavioral outcomes.

C. Ethical, Legal and Social Implications (ELSI) of Human Genetics Study on Aging

How would attrition rates be affected in longitudinal projects, how does collection of DNA influence willingness to participate in aging studies in general, and what are the larger factors (i.e., health insurance and privacy issues) that pose concern to study participants? Research assessing the role of demographic factors (e.g., age, sex, race/ethnicity) is also needed to understand cultural differences in perceptions of genetic research.

D. Dementia

Studies examining the impact of social relationships (e.g., social network structures, types, levels and quality of social support) on cognitive decline and dementia. Also, demography and economics of dementia and Alzheimer's Disease in older populations.

E. Trends in Chronic Disease and Disability

Investigation of the factors underlying the recent trend in declining disability in the older population. Determination and quantification of the causal factors underlying the trend (e.g. medical technological interventions, healthcare access and use, early life experiences, education, biomedical and social research advances, healthy lifestyle behaviors and public health measures). International comparative analyses of declining disability in countries with different institutional and family structures are encouraged.

F. Living Arrangements

Analysis of the factors that trigger movement of the elderly through various living arrangements, from independent living through the various forms of long- term care, and the functional and health-related outcomes associated with residential options available to older persons.

G. Healthcare and Policy Stimulations

Economic analyses of the impact of aging-related biomedical and social research and resulting new technologies and interventions. Estimation of the impact of medical interventions on future lifetime health care costs. Estimation of the impact of health (including links with geography and demography) on economic development, especially in developing countries. (See The World Health Report 1999: Making a Difference. World Health Organization. Also available at http://www.who.int/whr.). Estimation of the impact of changes in the functional status of the older population on Medicare and other health care costs. Evaluations and simulations of the impact of changes in DHHS and SSA policies (e.g. changing the age of eligibility for Medicare and Social Security benefits, and expanding coverage to include prescription drugs) on the health and functioning of the older population.

H. Burden of Illness

Measurement of the magnitude and socio-economic consequences of burden of illness in the older population. Improved analysis and methodology to allocate and impute burden of illness, given the importance of comorbidity in the older population. This may also include modeling risk factor trajectories and trends in non-communicable disease, disability and mortality in developed and developing countries, with emphasis on aging populations. Analyses and projections of the epidemiological transition in developing countries and research examining the demographic and economic impact of HIV/AIDS on population structure and the elderly, particularly in Africa and other developing countries.

I. Health, Work and Retirement

Health, work and retirement, including: implications of population aging for public and private retirement programs and for income security of future retirees; implications of women's life history (e.g., temporary exits from the labor force for child rearing and caregiving of older parents) on retirement income and savings adequacy; implications for late-life health and financial security of the timing of demographic events such as marriage, child-rearing, widowhood, etc.; determinants of retirement, family labor supply, and saving; consequences of retirement for health and functioning; comparative studies of labor force activity; effects of psychological factors (e.g. expectations, risk taking, personality, altruism, time preferences, etc.) and mental health characteristics (e.g. depression) on economic behaviors (e.g. savings and transfers); and economic and demographic analyses of employer- and organizational- level determinants of labor force participation at older ages.

Research on the nature of work from the worker’s perspective is also encouraged. NIA cosponsored a report by the National Academy of Sciences titled the Health and Safety Needs of Older Workers. This report suggested areas that merit investigation in this field and research on work and on older workers can consult this report. Copies can be obtained at http://books.nap.edu/catalog/10884.html.

J. Race, Ethnicity and Socioeconomic Status

Interactions between health and socio-economic status (and their cumulative relationship) over time and across generations. Relationship among health, wealth and education; role of social cohesion as a mediating factor. Improved measures of socioeconomic position for aging populations; improved understanding of the mechanisms underlying associations between socio-economic status and health including the economic determinants of health promotion and disease prevention behaviors. Research to disentangle the effects of socio-economic status, social and environmental factors, health behaviors, and race and ethnicity on health.

Studies of the health of diverse racial and ethnic older populations and the health of small geographic areas. Variables of interest include the effects of lifelong poverty, birth weight, access to and utilization of employer-provided health insurance, recency and circumstances of immigration; the strain of physically demanding work; occupation; wealth, income and early-life health status; and experiences of discrimination.

Studies of the changing composition and conceptualization of race and ethnicity in the US and the effects on population health and health disparities; issues related to the development of racial and ethnic identity and to interactions among racial/ethnic identification and demographic, health, and other outcomes; and issues related to the measurement of race and ethnicity, including racial and ethnic self-identification.

The National Academies of Science recently concluded a panel on Racial and Ethnic Differences in Health in Later Life in the United States. Applicants are encouraged to consult the findings of the report (see http://books.nap.edu/catalog/11036.html )

K. General Demography

General demographic analyses of population aging, including: cohort analyses of aging, including the baby boom cohort; implications of changing family structures on caregiving needs; historical demographic and epidemiological research on the aging process and on the determinants of health and mortality in older populations; forecasting life and active life expectancy, health, medical services and long term care usage; migration and immigration; the impact of state and small area characteristics on health; improved descriptive analyses of centenarian populations; macro and micro dynamics of intergenerational exchanges; use of public and private resources in the period before death; and comparative international analyses of population aging using Census and other data.

L. Meta-analysis

Linking data sets for the purpose of conducting analyses (i.e. meta- analyses, mega-analyses). Applications are encouraged that combine raw data from different data collections to be explored in new and innovative ways in order to achieve new research aims, and/or to permit more breadth, precision, and reliability than can be achieved by the analysis of data from an isolated research study.

M. Caregiving

Research on informal caregiving. Research is encouraged on the transitions between various phases of the caregiving role, especially research on changes as a consequence of acquiring the caregiving role (pre- and post-caregiving). Research is also encouraged on the dyadic relationship between caregiver and care recipient. Research is needed on the embedded nature of the caregiver in the community structure. Such multi-level analysis is especially important.

N. Elder Mistreatment

Research is encouraged using existing databases such as aggregated Adult Protective Service records or state-level data on incidence and prevalence of elder mistreatment. Where adequate and existing data permit, research on the social determinants or risk factors associated with differential types of elder mistreatment is also needed.

O. Behavioral Medicine and Interventions

Research is encouraged that examines the dynamic interrelationships among aging, health, and behavior processes and that emphasizes the influence of the socio-cultural environment on the development and maintenance of health and illness behaviors (e.g., healthy lifestyle practices, medical self management, and coping with chronic illnesses and disabilities). Preliminary analyses that could lead to social, behavioral and environmental interventions for health promotion, disease prevention, and disability postponement are especially encouraged.

P. Cognitive Aging

Research is encouraged that examines changes in cognitive functioning over the life course. Examples include studies that: examine the influence of contexts (behavioral, social, cultural, and technological) on the cognitive functioning and life performance of aging persons; investigate the effects of age-related changes in cognition on activities of daily living, social relationships, and health status; and develop strategies for improving everyday functioning through cognitive interventions. Research is also encouraged on higher-order cognitive processes (e.g., problem-solving, decision-making), social cognition, memory strategies, perceptual skills, and reading and speech comprehension. Research is also welcomed that explores the role of individual difference factors in cognitive functioning (e.g., motivation, self-efficacy, beliefs about aging, emotions, sensory limitations, experience and expertise).

Q. Psychological Development and Integrative Science

Research is encouraged that combines diverse levels of analysis and examines reciprocal interactions among these levels, such as the effects of sociocultural, psychological (social, personality), biological, and genetic processes on behavioral and functional aging.

R. Early Life Determinants of Late-Life Health

Research is encouraged that examines the influence of early life characteristics (e.g. childhood health, SES or exposure to infectious disease) on morbidity and mortality in later life. Comparative and historical work in this area is also encouraged.

Priority will be given to applications undertaking secondary analysis of publicly available datasets that NIA has supported. Such datasets include: the Alameda County Health and Ways of Living Study 1965, 1974, 1994, 1995 Panel; Early Indicators of Later Work Levels, Disease, and Death; Health and Retirement Study; Hispanic EPESE; Human Mortality Database; Longitudinal Employer Household Dynamics; Mexican Health and Aging Study; National Longitudinal Mortality Study; National Long-Term Care Survey;; Panel Study of Income Dynamics; 1990 Public-Use Microdata Sample for the Older Population and the Comparable Samples from ECE Countries (collected by the UN/ECE/PAU); Resources for Enhancing Alzheimer’s Caregiver Health (REACH); Social Environment and Biomarkers of Aging Study (SEBAS); Swedish Adoption/Twin Study of Aging (SATSA) and the Wisconsin Longitudinal Study (WLS). Information about these and other datasets that have been supported entirely or in part by the NIA, and instructions on how the data can be accessed, can be found in the Publicly Available Databases for Aging-Related Secondary Analyses in the Behavioral and Social Sciences, available in hard copy or on the web at http://www.nia.nih.gov/NR/rdonlyres/7AE4D0D9-9DF7-4DF4-B8B9-468F19106E23/0/PubliclyAvailDatasetsJul_2006B.pdf. A number of NIA supported datasets are currently being developed and archived; research on these new data sources is encouraged. Information about new data sources can be found in the above-referenced document which is updated to include newly available data sources.

Applicants are especially encouraged to refer to the Minority Aging and Health CD-Rom from the National Archive of Computerized Data on Aging (NACDA) offered to the research community through funding provided by NIA. A number of the datasets mentioned above are made available through NACDA at http://www.icpsr.umich.edu/NACDA/.

Information on other initiatives supported by NIA may be found at the following Internet address: http://www.nia.nih.gov/GrantsAndTraining/FundingOpportunities/CurrentFundingOpportunities.htm

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Small Research Grant (R03) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the Modular Applications and Awards section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically the Section 5.4, Modular Budget Component, of the Application Guide).

Competing renewal (formerly competing continuation ) applications will not be accepted. Small grant support may not be used for thesis or dissertation research. Two resubmissions (formerly revisions") of a previously reviewed R03 grant application may be submitted as defined in NIH Policy. See NOT-OD-05-046 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-046.html

Submission of an application under this funding opportunity precludes concurrent submission of any other Public Health Service application containing substantially the same research proposal. In addition, these R03 awards may not be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the Public Health Service.

For specific information about the R03 programs, see:

http://grants.nih.gov/grants/funding/r03.htm.

2. Funds Available

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

A project period of up to two years and a budget for direct costs of up to two $25,000 modules or $50,000 per year may be requested. Some preference may be given to one year projects. It is expected that most of the analyses proposed in response to this announcement can be completed within a year. However, a few analyses, especially those that propose to link multiple datasets, involve restricted confidential data, or involve collaborations among several sites may take more than one year. For these reasons, up to two years of research may be supported. The particular reason or reasons for requesting the second year of support must be stated in the budget justification.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

• For-profit organizations
• Non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Units of State government
• Units of local government
• Eligible agencies of the Federal government
• Foreign Institutions
• Domestic Institutions
• Faith-based or community-based organizations
• Units of State Tribal government
• Units of Local Tribal government

1.B. Eligible Individuals

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 support. However, NIA limits eligibility under the R03 mechanism to new investigators or established investigators working in a new area. More information regarding NIA’s use of the R03 mechanism can be found at the following address:

http://www.nia.nih.gov/GrantsAndTraining/FundingOpportunities/ResearchProjects.htm#r03.

A number of important datasets and archives are based in European and other countries (e.g., British birth cohorts, country-specific population registers). Many of these data sets offer unique insights into aging and are important aids in interpreting patterns of aging in the U.S. Domestic investigators are encouraged to collaborate with researchers at these foreign sites in order to access these datasets. Foreign-based investigators are also encouraged to apply for funding directly where it is clear that both the expertise and the data are at the foreign institution and of value to understanding aging in the U.S.

2. Cost Sharing or Matching
This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided they are scientifically distinct.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, 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/GetStarted) and
• eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

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

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

• 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 [email protected]

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 [email protected]

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 designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
• The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
• This registration/affiliation must be done by the Signing Official (SO) or their designee who is already registered in the Commons.
• Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify the application.

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 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 instructions for this FOA through the Grants.gov Apply http://www.grants.gov/Apply Web site.

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, Phone (301) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

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 (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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 Modular Budget

Optional Components:

PHS398 Cover Letter File
R&R Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

• Charge back of customs and import fees is not allowed.
• Format: Every effort should be made to comply with the format specifications which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
• Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI. 2., Administrative and National Security Requirements.

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Opening Date: May 2, 2006 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date: Not Applicable
Application Submission Date(s): Standard dates apply. See http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
AIDS Application Receipt Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date: Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.

3.A.1. Letter of Intent
A letter of intent is not required for this funding opportunity.

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply 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 to Grants.gov on or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the submission date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within 2 business days of notification of the NIH validation.

There will be immediate acknowledgement of receipt of applications via both Grants.gov and the Commons. Information related to the assignment of an application to the Scientific Review Group is also in the Commons.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

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. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

The NIH requires the PD/PI 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. 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 Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications: