Research on Aging and Cognitive Disorders

Research on Aging and Cognitive Disorders is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Supports research into the mechanisms, diagnosis, and treatment of cognitive disorders in aging populations.

Expired PA-06-105: Research On The Cognitive Sequelae Of Parkinson's Disease (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Part I Overview Information Department of Health and Human Services Participating Organizations Health (NIH), ( http://www.

nih. gov ) Components of Participating Organizations Neurological Disorders and Stroke (NINDS), ( http://www. ninds.

nih. gov ) Institute on Aging (NIA), ( http://www. nia.

nih. gov ) Institute of Nursing Research (NINR), ( http://www. ninr.

nih. gov/ ) Title: Research On The Cognitive Sequelae Of Parkinson's Disease (R01) PAS-02-107 which was previously released May 8, 2002. Update: The following update relating to this announcement has been issued: December 15, 2006 - This funding opportunity has been replaced by PA-07-198 , which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond.

Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants. gov and the use of the SF 424 Research and Related (R&R) forms.

Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants. gov.. For more information and an initial timeline, see http://era.

nih. gov/ElectronicReceipt/ . NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( http://grants.

nih. gov/grants/guide/index. html ).

Specific funding opportunity announcements will also clearly indicate if Grants. gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( http://grants.

nih. gov/grants/forms. htm ) for the most current information when preparing a grant application.

Program Announcement (PA) Number: PA-06-105 Catalog of Federal Domestic Assistance Number(s) Release Date: December 22, 2005 Letters of Intent Receipt Date(s): Not Applicable Submission Date(s): Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm for details dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm for details dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm for details Anticipated Start Date: Standard dates apply, please see http://grants. nih. gov/grants/funding/submissionschedule.

htm for details Information To Be Available Date (Url Activation Date): Not Applicable Expiration Date for Non-AIDS Applications : November 2, 2006 Expiration Date for AIDS and AIDS-Related Applications : January 3, 2007 this PA, the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Aging (NIA), and the National Institute of Nursing Research (NINR) invite research grant applications that address the underlying neurobiological mechanisms associated with the cognitive impairment in Parkinson's disease (PD), that address the development of clinical interventions and therapeutics for cognitive impairment in PD, or that promote improved clinical diagnosis or treatment of cognitive impairment in PD.

A goal of this PA is to begin a process where basic and clinical scientists from various disciplines can overcome barriers to cross-disciplinary and biobehavioral research and examine all aspects of cognition in the context of the diagnosis and treatment of the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications awards made under this solicitation will depend on the overall scientific merit of the applications and the availability of funds.

organizations include: for-profit or non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations, faith-based or community-based organizations, and units of state or local tribal government.

investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research. Applicants may submit more than one application, provided they are scientifically IV. 1 for application materials.

for the hearing impaired is available at: TTY 301-451-5936 coordinated programs being released by NINDS to promote research on the non-motor aspects of Parkinson’s disease, including Research On The Cognitive Sequelae Of Parkinson's Disease (R03) ( PA-06-106 ), and Research On The Cognitive Sequelae Of Parkinson's Disease (R21) ( PA-06-107 ). II Full Text of Announcement I. Funding Opportunity Description 1.

Mechanism(s) of Support III. Eligibility Information 2. Cost Sharing or Matching 3.

Other - Special Eligibility Criteria IV. Application and Submission Information 1. Address to Request Application Information 2.

Content and Form of Application 3. Submission Dates and Times A. Submission, Review and Anticipated Start Dates B.

Sending an Application to the NIH C. Application Processing 4. Intergovernmental Review 6.

Other Submission Requirements V. Application Review Information 2. Review and Selection Process A.

Additional Review Criteria D. Sharing Research Resources 3. Anticipated Announcement and Award VI.

Award Administration Information 2. Administrative and National Policy Requirements 1. Scientific/Research Contact(s) 2.

Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) VIII. Other Information - Required Federal Citations - Full Text of Announcement Section I.

Funding Opportunity Description Parkinson's disease (PD) is commonly viewed as an extrapyramidal motor disorder. Hence, a substantial body of research has focused on understanding the neural mechanisms underlying the most apparent symptoms (tremors, slowness, initiation of movements) and on treatment of these debilitating clinical manifestations.

However, PD is more than a motor disease; it also affects thinking, reasoning, learning, processing speed, and other cognitive abilities. Consequently, Parkinson's patients exhibiting motor and cognitive symptoms present unique challenges for the assessment and treatment of psychopathology in their disease process. In such patients, both quality of life and treatment outcome are severely compromised.

The cognitive changes seen in PD patients are less understood and studied than parkinsonian motor In June 2005, NINDS organized the second Parkinson’s Disease Research Summit, focused on the advancement of therapeutics in PD. For reasons listed above, a special breakout session on the non-motor complications of PD was convened.

The group discussed a wide range of non-motor aspects of PD, identifying behavioral and cognitive impairment as particularly important for future research studies; the participants made a number of high priority recommendations in this area.

The first of these priority recommendations involves expanding our understanding of the non-motor manifestations such as cognitive impairment in PD - an improved base of scientific knowledge would be a substantial contribution to therapeutics and intervention development. A second priority recommendation was the development of animal models that reproduce non-motor features of PD for research, drug discovery, and testing.

A third priority recommendation was the incorporation of the non-motor manifestations of PD, such as cognitive impairment, into clinical trials, which the group agreed would aid in the testing of both pharmacological and non-pharmacological interventions for these complications.

The last priority recommendation involves the development of improved methods for characterizing the non-motor complications, including standardized methods for clinical assessment.

In addition to these priority recommendations, the group also suggested a number of other strategies to move this field forward, including studies of how the cellular changes in PD lead to non-motor symptoms; the incorporation of studies of non-motor manifestations into the development of risk factor criteria; and further studies of the impact of these aspects of the In order to address these recommendations, this PA encourages research on all aspects of cognition in the context of the diagnosis and treatment of PD, the progression of the disease, and its co-morbidity with dementia or other non-motor or neuropsychiatric complications.

The purpose of this initiative is to: 1) focus the attention of neuroscientists on the underlying neurodegenerative processes that affect cognition in Parkinson's disease; 2) promote research on potential therapeutics for cognitive impairment in PD; this includes the development of relevant animal models which can provide greater understanding of cognitive changes in PD, or the development of screens in such models which could test the potential use of therapeutics for cognitive impairments in PD; 3) promote studies of improving diagnostic assessment of cognitive 4) promote the interaction of cognitive neuroscientists and clinical scientists conducting research in Parkinson's disease patients; 5) develop integrative research programs that advance our understanding of the substrates of cognitive function in health and in Applications that demonstrate the establishment of collaborative research programs with researchers at existing Udall Centers of Excellence for Parkinson's disease research are particularly encouraged.

Objectives of this research program include, but are not limited, to the following: Basic molecular or cellular studies of potential drugs or other treatments which could address cognitive impairments in PD. Behavioral and physiological characterization of models based on the new molecular understanding of synuclein, parkin and other proteins involved in the pathogenic processes of neurodegenerative disorders.

Studies on the neurobiological basis of cognitive impairments in Studies of genetic, environmental, behavioral, or other risk factors which may predispose to cognitive impairment in PD, including studies that examine the correlation between the precipitating causes of PD or risk factors for PD, with the disease progression and development of cognitive symptoms.

Development of relevant animal models for studying cognitive deficits in PD, for example, development of transgenic animals that would model the late-life onset of PD as seen in humans (e.g. conditional expression of Pre-clinical studies of cognitive tests and paradigms in animal Studies of neuroprotective or other agents in animal models of PD with induced cognitive deficits.

Studies that examine the association between clinical disease onset, neuropathology in PD and the development and severity of cognitive Studies of best outcome measures in PD patients with cognitive impairments, or co-morbid with dementia, depression, or other non-motor manifestations, including development and validation of specific assessment tools for PD patients with cognitive impairment.

Investigations of the relationship between age of onset of PD and PD-related cognitive changes. Development of pathological markers in the basal ganglia that better define PD with motor changes alone as compared to PD with motor and Studies that utilize novel experimental techniques for the study of human neuroanatomy to examine the neural systems damaged in PD.

These studies should also investigate whether this information can be correlated with the cognitive impairments seen in PD patients. Studies of neuroanatomical circuits and neurochemical processes mediating cognitive states and cognition-based individual differences in PD. of the specific consequences of deep brain stimulation (DBS) or other surgical interventions, on the cognitive aspects of Parkinson's disease.

addition to the above objectives, the NINR places a high priority on promoting research on potential biobehavioral interventions to maintain, support, or enhance the cognitive function of persons with PD. Such research may include: Development of models that integrate PD neuropathologies with cognitive function and provide the substrate for intervention development.

Assessment of new and existing interventions and their impact on functional capacity, disease management, disease course, and quality of life in Development of innovative theory-based cognitive and/or behavioral interventions that improve cognitive function and thereby support IADL function, enhance disease management, and improve quality of life in PD Development of assessment tools for detection of early cognitive change in patients with PD.

specifically interested in these additional research topics are encouraged to speak with the NINR contact (see Section VII.) prior to submitting an VIII, Other Information - Required Federal Citations , for policies related 1.

Mechanism(s) of Support This PA is one of three coordinated programs being released by NINDS to promote research on the non-motor aspects of Parkinson’s disease, including Research On The Cognitive Sequelae Of Parkinson's Disease (R03) ( PA-06-106 ), and Research On The Cognitive Sequelae Of Parkinson's Disease (R21) ( PA-06-107 ).

will be solely responsible for planning, directing, and executing the proposed uses just-in-time concepts. It also uses the modular as well as the non-modular budget 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 budget format described in the PHS 398 application instructions.

Otherwise follow the instructions for non-modular research grant applications. seeking to carry out pilot studies of therapies in preparation for a clinical trial that are specifically relevant to the mission of the NINDS should apply under the auspices of the Preliminary Investigations Leading To Optimal Trials In Neurology program announcement PAR-03-174. This announcement can be found at http://grants.

nih. gov/grants/guide/pa-files/PAR-03-174. html .

seeking to develop milestone-driven translational therapeutics programs for Cognitive Impairment in PD that are specifically relevant to the mission of the NINDS should apply under the auspices of either 1) the NINDS Exploratory/Developmental Projects in Translational Research Program Announcement (for translational R21 applications); or 2) NINDS Cooperative Program in Translational Research Program Announcement (for U01 or U54 applications).

These announcements can be found at http://grants. nih. gov/grants/guide/pa-files/PAR-05-157.

html or http://grants. nih. gov/grants/guide/pa-files/PAR-05-158.

html , respectively. the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

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 and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004 . III. Eligibility Information 1.

A.

Eligible Institutions application(s) if your organization has any of the following characteristics: or private institutions, such as universities, colleges, hospitals, and agencies of the Federal government or community-based organizations of State Tribal government of Local Tribal government 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. 2. Cost Sharing or Matching Policy Statement can be found at: http://grants.

nih. gov/grants/policy/nihgps_2003/nihgps_Part2. htm#matching_or_cost_sharing .

3. Other-Special Eligibility Criteria IV. Application and Submission Information 1.

Address to Request Application Information instructions are available at http://grants. nih. gov/grants/funding/phs398/phs398.

html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] .

the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application Submission prepared using the most current PHS 398 research grant application instructions and forms.

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www. dnb.

com/us/ . The D&B number should be entered on line 11 of the face page of the PHS 398 The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box Several special provisions apply to applications submitted by foreign organizations: back of customs and import fees is not allowed.

every effort should be made to comply with the format specifications, which are based upon a standard US paper size of 8. 5" x 11." for up to 8% administrative costs (excluding equipment) can now be requested ( http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-01-028. html ) must comply with federal/NIH policies on human subjects, animals, and must comply with federal/NIH biosafety and biosecurity regulations.

See Section VI. 2 . Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

research should provide a unique research opportunity not available in the U.S. 3. Submission Dates and Times Submission, Review and Anticipated Start Dates of Intent Submission Date: Not applicable Application Submission Date(s): Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm for details Peer Review Date: Application Receipt Dates(s): Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm for details Council Review Date(s): Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm for details Earliest Anticipated Start Date: Standard dates apply, please see http://grants. nih.

gov/grants/funding/submissionschedule. htm for details not required for the funding opportunity. prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application.

Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express Bethesda, MD 20817 (for express/courier service; applications are no longer permitted (see http://grants. nih. gov/grants/guide/notice-files/NOT-OD-03-040.

html ). must be submitted on or before the application receipt/submission dates described above ( Section IV. 3.

A. ) and at http://grants. nih.

gov/grants/dates. htm . applications will be evaluated for completeness by CSR.

Incomplete applications any application in response to this funding opportunity 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks. 4.

Intergovernmental Review initiative is not subject to intergovernmental subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants. nih.

gov/grants/policy/policy. htm . 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 or competing continuation 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 or competing continuation 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 Instructions for Modular Grant applications. requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at http://grants. nih.

gov/grants/funding/phs398/phs398. html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398.

Additional information on modular budgets is available at http://grants. nih. gov/grants/funding/modular/modular.

htm .

Instructions for Applications Requesting $500,000 (direct costs) or More per requesting $500,000 or more in direct costs for any year must carry out the program staff at least 8 weeks before submitting the application, i.e., as you are developing plans for the study; from the IC staff that the IC will accept your application for consideration 3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the 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 . Plan for Sharing Research the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data.

Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave).

Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application. more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application.

The funding organization will be responsible for monitoring the data sharing policy ( http://grants. nih. gov/grants/policy/data_sharing ).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants. nih. gov/grants/policy/nihgps_2003/index.

htm and http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_Part7.

htm#_Toc54600131 ). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible. The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications.

The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants. nih. gov/grants/funding/2590/2590.

htm ). the review criteria described below will be considered in the review process. 2.

Review and Selection Process for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines. Appropriate scientific review groups 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.

merit review, all applications will: 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. level of review by an appropriate national advisory council or board.

considered in making funding decisions: of the proposed project as determined by peer review goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health.

In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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. Significance: Does this study address an important problem?

If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Is the project original and innovative?

For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success?

Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

criteria, the following items will continue to be considered in the determination of scientific merit and the priority score: of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form of Women, Minorities and Children in Research: 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 will be assessed.

Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the 2.

C. Sharing Research Data the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

The funding organization will be responsible for monitoring the data sharing policy. http://grants. nih.

gov/grants/policy/data_sharing . responsible for the administrative review of the plan for sharing research data. Sharing Research Resources grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.

nih. gov/grants/policy/nihgps/part_ii_5. htm#availofrr and http://www.

ott. nih. gov/policy/rt_guide_final.

html ). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. responsible for the administrative review of the plan for sharing research resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications.

Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590).

See Section 3. Anticipated Announcement and Award Dates VI. Award Administration Information under consideration for funding, NIH will request "just-in-time" information from the applicant.

For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_part4.

htm ). A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document.

Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the Selection of an application for award is not an authorization to begin performance.

Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.

5. Funding Restrictions . 2.

Administrative and National cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_Part4. htm ) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities ( http://grants. nih.

gov/grants/policy/nihgps_2003/NIHGPS_part9. htm ). required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( http://grants.

nih. gov/grants/funding/2590/2590. htm ) and financial statements as required in the NIH Grants Policy Statement.

your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management 1. Scientific/Research Contacts: Institute of Neurological Disorders and Stroke Executive Blvd.

, Room 2108, MSC 9521 Rockville , MD 20852 (for UPS, FedEx, etc.) National Institute of Neurological Disorders and Stroke Telephone: (301) 496-5680 Judith A. Finkelstein, Ph. D.

National Institute on Aging Gateway Building , Suite 350 National Institute of Nursing Research Democracy Blvd. , Suite 710 3.

Financial or Grants Management National Institute of Neurological Disorders and Stroke Executive Blvd, Suite 3254 Bethesda , Maryland 20892 Grants and Contract Management Office National Institute on Aging Grants and Contracts Management National Institute of Nursing Research, NIH Bethesda , MD 20892-4870 (courier use 20817) Required Federal Citations support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( http://grants.

nih. gov/grants/olaw/references/PHSPolicyLabAnimals. pdf ) as mandated by the Health Research Extension Act of 1985 ( http://grants.

nih. gov/grants/olaw/references/hrea1985. htm ), and the USDA Animal Welfare Regulations ( http://www.

nal. usda. gov/awic/legislat/usdaleg1.

htm ) (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained ( http://www. hhs. gov/ohrp/humansubjects/guidance/45cfr46.

htm ).