Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov)

Title: Weight Loss in Obese Adults with Cardiovascular Risk Factors: Clinical Interventions (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-HL-06-007

Catalog of Federal Domestic Assistance Number(s)
93.837

Key Dates 
Release Date: December 2, 2005
Letters of Intent Receipt Date(s):  January 17, 2006
Application Receipt Dates(s):   February 15, 2006
Peer Review Date(s): June/July 2006
Council Review Date(s):  September 2006
Earliest Anticipated Start Date:  September 30, 2006
Expiration Date: February 16, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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(s) 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. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and 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
   
A.  Checklist of What Each Application Should Include
    B.  Budget and Related Issues
    C.  Plan for Sharing Data

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

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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

Purpose

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) invites applications for cooperative agreements to conduct Randomized Clinical Trials (RCTs) to test the effectiveness of interventions delivered in routine clinical practice on achieving weight loss in obese patients who have other CardioVascular Risk Factors (CVRFs).  Routine clinical practice, for the purpose of this RFA, is defined as outpatient clinical care-delivery and includes primary care settings as well as relevant specialty settings such as general internal medicine or cardiology practices.  Effectiveness studies focus on interventions that can be easily adapted and adopted in routine clinical practice settings.  Results of the studies are expected to be widely disseminated to improve the scientific basis of care for affected individuals.

Background

Sixty-five percent (129 million) of U.S. adults are overweight or obese.   Although weight loss in obese patients with other CVRFs is of high priority for clinical care settings, clinicians often pay inadequate attention to patients’ weight problems, hypothesized to be due to unproven models in clinical practice.  Yet, a wealth of information from academic clinical trials is now available showing efficacy of approaches to achieve and sustain clinically meaningful weight loss.  Adapting these interventions for use in routine clinical practice and testing their effectiveness would fulfill an urgent need for addressing the obesity epidemic.   Furthermore, the majority (40 million obese people and 46 million overweight people) have one or more treatable CVRFs, and losing weight has proven benefits on established CVRFs including diabetes, hypertension, and dyslipidemia.  Intervention data indicate that patient success with one risk factor enhances the likelihood of success with other risk factors.   Because risk factors have additive effects on cardiovascular disease, reducing more than one risk factor will have a larger effect than focusing only on obesity.   Public education campaigns by NHLBI and others will increase patients’ and practitioners’ willingness to try interventions, and the recent Centers for Medicaid and Medicare Services (CMS) decision accepting obesity as a disease opens the door to reimbursement for proven interventions.  These developments make this an opportune time to evaluate promising interventions delivered in clinical practice.

Trials in academic clinical settings have demonstrated that successful methods exist to reduce weight in obese persons:  in 1998 the NHLBI Obesity Education Initiative Evidence Report gave the highest level of evidence to the conclusion that low calorie diets can reduce body weight by 8 percent for 12 months (25 randomized controlled trials), and that the combination of low calorie diet and increased physical activity produces greater weight loss than diet or physical activity alone (15 randomized controlled trials).  Research also provides strong evidence that if intervention continues, then weight loss can be sustained.  Randomized trials employing behavioral interventions for diet and physical activity have succeeded in maintaining clinically meaningful weight loss for 18 months in PREMIER, 3 years in Trials of Hypertension Prevention II, and 4 years in the Diabetes Prevention Program (DPP), which had significant and clinically relevant effects on blood pressure, cholesterol, and diabetes.  Analyses suggest that these intervention strategies can be adapted to be feasible for routine care.  By using group rather than individual sessions, for example, the cost of the lifestyle component in DPP per case of diabetes prevented would have decreased by 70%.  Evidence from other trials shows that frequent group behavior counseling continued for longer than six months with adequately trained counselors can result in clinically meaningful weight loss in the majority of patients.  

While trial evidence suggests that interventions achieving and sustaining clinically significant weight loss are ready for modification to test in routine care, few trials have adequately addressed this research topic.  A 2003 review for the U.S. Preventive Services Task Force on obesity screening and intervention in routine clinical practice concluded that there is only one randomized controlled trial conducted in the primary care setting, which was of fair to good quality.  Generally, critical reviews of efficacy studies to improve patient and provider adherence to guidelines for reduction of cardiovascular risk factors for cholesterol, hypertension, or cigarette smoking indicate that the evidence on such strategies is incomplete and that the existing evidence is not sufficient to demonstrate that one strategy is superior to another.  

Seventy-three percent of obese and overweight Americans have more than one treatable CVRF.  Since weight loss improves CVRFs, though often does not achieve optimal control, optimal clinical care requires pharmacotherapy for CVRFs, such as statins for Low-Density Lipoprotein (LDL)-cholesterol, plus weight loss approaches.  An integrated approach to cardiovascular risk reduction is scientifically as well as practically appealing.  The National Health and Nutrition Examination Surveys (NHANES) and other data indicate that the need for integration is substantial, because LDL-cholesterol levels and blood pressure are both often inadequately controlled.  In addition, an integrated approach may be efficient in clinical practice to control CVRFs, which involves helping a patient initiate or maintain healthful behaviors and appropriate pharmocotherapy.  Evidence guidelines for cigarette smoking [http://www.surgeongeneral.gov/tobacco/treating_tobacco_use.pdf], cholesterol or hypertension [http://www.nhlbi.nih.gov/guidelines/index.htm], and diabetes (http://care.diabetesjournals.org/cgi/content/full/28/suppl_1/s4)recommend integration of behavioral with pharmacotherapy and use of step care if initial approaches fail to achieve adequate reduction in the risk factor.  Whether starting a new drug, losing weight, or increasing physical activity -- the steps may be similar; these steps may include screening for the risk behavior, advising the patient of the need for change, referring for counseling, and conducting adequate follow-up. 

Objectives and Scope

The purpose of this RFA is to fund RCTs in routine clinical practice settings to test as the primary goal the effectiveness of  weight loss interventions in obese patients who have at least one other additional CVRF.  An important secondary focus of these effectiveness clinical trials is to incorporate the weight loss strategies with approaches to improve application of evidence-based guidelines to reduce the other cardiovascular risk factors commonly present in obese patients, such as elevated lipids, hypertension, metabolic syndrome, diabetes, or cigarette smoking.

Applications submitted must meet requirements in items 1-10 below or will be considered non-responsive to this RFA.

1. Studies should have three phases: (I) intervention refinement, (II) randomized clinical trial, and (III) dissemination.  Phase I, intervention refinement, could use several approaches, such as analyzing “best practices” and/or analyzing local needs, by, for example, employing focus groups, key informant interviews, surveys, or other formative assessment approaches.   Phase II should be a randomized trial to test the intervention program.  A dissemination plan should be proposed for Phase III, in which investigators will collaborate with the NHLBI in evaluating the interventions and in identifying and adapting intervention materials for potential dissemination.

2.  Eligibility.  The target population is obese adults who have at least one additional other CVRF such as elevated LDL-cholesterol, hypertension, metabolic syndrome, diabetes, or cigarette smoking. Applicants may select obese patients with only one specific additional other CVRF (e.g., focused on obese patients with hypertension) or obese patients with any one of the other, or with multiple other, additional CVRFs. Applicants should describe the characteristics of their populations, and identify objective eligibility criteria and justify their choices.

3. Design.  The design should include at least two randomized groups:  an intervention group and a comparison group.   Individual-level or cluster randomization could be used.  If cluster randomization is used, applicants should have a total of at least four clinical sites (two intervention and two comparison) allocated equally to intervention and comparison groups.  For example, studies could be designed so that clinics would be the unit of randomization and analysis.  If cluster randomization is proposed, proper attention should be paid to the hierarchical nature of the data. 

All studies should have a comparison group.  Individual study designs could compare one or more intervention programs with a comparison group.  The comparison group should be usual care or a minimal intervention, such as advice only or the current “standard of care.”  Factorial designs may be used, if well justified.  Participants in both the intervention group and the comparison group will continue to receive medical care from their usual source of care. 

Each application should identify the specific research question to be addressed, the intervention(s) to be delivered, the expected effects of the intervention (including magnitude of change), the secondary targets of the intervention (i.e., targeted CVRFs), and the statistical analyses to be conducted.   Proposed sample sizes with supporting power calculations should be described.  The clinical trials can be single or multi-site.

Applicants who propose to include family members or significant others in the intervention, e.g., to increase structure and social support, should discuss how this approach may affect plans for informed consent, randomization procedures, data collection, and statistical analyses.

4. Interventions.  The primary intervention must be designed to be feasible for delivery in routine clinical practice, should be two years in duration, and should incorporate evidence-based behavioral approaches for weight loss such as individualized goal setting, self-monitoring, and identification of barriers and problem solving.  Evidence-based supplemental pharmacological interventions may be incorporated for weight loss, if justified.  Surgical procedures (e.g. gastric by-pass) are not acceptable interventions for this initiative. 

Weight loss strategies could be delivered solely within a clinical practice or by establishing joint health care system and community programs where the clinician plays a pivotal role in recommending weight loss, monitoring progress, and referring patients to quality community resources.  Joint programs may be more effective since they address weight reduction through multiple channels, so a community component is encouraged, which could include partnerships with the local Health Department, workplaces, faith-based organizations, existing weight loss and physical activity programs, or other community services.  Strategies to engage patients in their own home environments are also encouraged, such as telephone or internet clinic outreach and follow-up. 

Interventions should be conducted for a two-year period after randomization and, if the study design permits, should allow enrollment in the intervention program at multiple times to accommodate patients who are not initially motivated.  This may be most appropriate for a cluster randomized trial.  If the latter approach is proposed, proper attention to statistical issues is needed.

Intervention programs should be feasible for implementation beyond research settings (e.g., reasonable costs and potentially reimbursable), and approaches to maintain the intervention in the medical organization should be integrated (e.g., by engaging committed program advocates).

Some examples of weight loss interventions appropriate for this RFA include, but are not limited to, the following:

THESE ARE EXAMPLES ONLY.  APPLICANTS SHOULD NOT FEEL LIMITED TO THE TOPICS MENTIONED ABOVE AND ARE ENCOURAGED TO SUBMIT INTERVENTIONS PERTINENT TO THE OBJECTIVES OF THE RFA. 

The obesity intervention should be integrated with clinical practice guideline directed at the patient’s CVRF.  Most, if not all, CVRF guidelines integrate lifestyle (behavioral) interventions with pharmacotherapy; attention should be devoted to both aspects of the clinical practice guidelines.   The CVRF interventions should also be two years in duration

5.  Recruitment and Retention of Individuals.   Applicants should provide preliminary evidence of their ability to recruit participants in each clinical organization involved in the study, to provide appropriate oversight of participants, and to maintain high rates of participant follow-up throughout the intervention.

6.  Recruitment and Oversight of Organizations.  If applicants will be recruiting clinical organizations to participate in the study, applicants should provide evidence of their ability to recruit the organizations, and to provide appropriate oversight of compliance with study protocols in the organizations

7.  Collaboration.  The clinical trials supported by this RFA will not use a common study protocol.  However, after awards are made and whenever possible, investigators should collaborate and report in a standardized manner when they are measuring key common variables, such as height and weight, diet, blood pressure, physical activity, smoking status and rates, patient satisfaction, and quality of life, and when assessing population characteristics and program costs.  Investigators may also collaborate in the development of formative assessment measures, such as survey instruments and focus group guidelines, as well as on analyses to allow meta-analysis of the studies.  Collaboration on data archiving, such as selecting a single archive and archiving format, is encouraged.  

Investigators should indicate in their application their willingness to collaborate on the development and use of standardized measurement protocols, identification of eligibility criteria, formative assessment methods, data analysis, data archiving, and their willingness to collaborate with NHLBI scientists in all aspects of the study.  The cooperative agreement mechanism will be used and a Steering Committee formed to facilitate collaboration (see Section I.1,Study Components, and Section IV.2.A , Cooperative Agreement Terms and Condition of Award.)

8. Outcome Measures.  Because the primary research objective is to test approaches to achieving weight loss, the primary outcome should be reduction in BMI, from baseline to two years post-randomization.  Conceptually, there are secondary measures related to weight loss, secondary measures related to CVRF guidelines, and measures that may be related to both.   Applicants must select at least one measure related to CVRF clinical practice guidelines and must describe when they would be measured following randomization.  Some examples of potential secondary outcome measures include, but are not limited to, the following:

Information should be collected on patient satisfaction with, and economic costs of, the interventions so that at the end of the trial, it will be possible to estimate the cost of the interventions if they were more widely implemented.  Quality of life measures and cost-effectiveness analyses are encouraged.  Other measures may also be included, such as putative CVRFs, for example sleep issues (e.g. sleep duration, sleep disordered breathing, and excessive daytime sleepiness), C - reactive protein, or other inflammatory measures.

9.  Quality Control and Data Management.  Studies should incorporate quality control procedures for measurements, data collection, and data management, as well as for assuring fidelity to intervention delivery.

10.  Dissemination.   A critical feature of this project is the development of interventions with the potential to be incorporated into medical care systems, if the results demonstrate clinical effectiveness.  The application must include a dissemination plan that includes dissemination of study results, as well as dissemination of intervention approaches and materials if proven effective.  The plan should identify a target audience, describe methods to be used, and discuss how the intervention will be made translatable.  The plan should be updated at the end of the study when the results are known.  Intervention materials and programs must be delivered to the NHLBI at the completion of the research.

C. Study Components

Each awardee is responsible for refining and finalizing their protocols and for conducting the research.   Awardees should oversee implementation of their interventions and adherence to their protocols, and assure appropriate quality control procedures are in place.  Each awardee will be responsible for training and certification of their personnel.

The NHLBI will be substantially involved with the awardees in a partnership.  The NHLBI Program Scientist will monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and assure adherence to NHLBI policies.  NHLBI will appoint a Data and Safety Monitoring Board (DSMB) and appoint a chairperson of the Steering Committee among Principal Investigators.

A Steering Committee will be an important body for this project.  The Steering Committee is composed of the Principal Investigators of the RCTs and the NHLBI Program Scientist, each of whom will have one vote.  The Steering Committee will meet in-person three times a year for the first year and twice per year thereafter.  The Committee will meet by teleconference on at least a monthly basis.

One DSMB will be established to monitor data and oversee participant safety in all of the studies supported by this initiative.  At the first meeting, the DSMB will review the awardees’ protocols.  Subsequently, the DSMB will monitor and review recruitment, adverse events, data quality, outcome data, and overall awardee performance.  It has the responsibility to review interim data and final data, and recommend whether the protocol should be modified, and whether the study should be continued or should be terminated early.  Thus, its ethical responsibilities to the participants, as well as to the integrity of the study, are of paramount importance to the NHLBI.  The DSMB will meet twice each year.  At least one of the meetings each year will be in person.

A single DSMB will be responsible for monitoring all of the funded projects and will report to the Director of the NHLBI.  Therefore, applicants should not appoint DSMB members in advance of the peer review, or even inquire about the interest of possible DSMB members, because anyone so contacted would not be eligible to serve as a member of the peer review committee that will evaluate the applications for scientific merit. 

To facilitate coordination and serve as a resource for various clinical trial activities, this RFA will also support the costs of performing Resource and Coordination Functions (RCF) by one of the RCT awardees.  In consultation with the Steering Committee and NIH, the RCF will be responsible for conducting a number of tasks, including the following:

Applicants should propose to perform the resource and coordination functions in addition to conducting the RCT.  Applicants should submit a separate budget for the RCF, including the cost of meeting rooms and equipment for in-person meetings (see Section II.2).  The evaluation of the RCF will be separate from the overall review of the scientific merit of the RCT application (see Section IV. 6.B). 

D.  In-Person Meetings

In addition to the DSMB meetings, each awardee will be required to attend meetings in which study plans, findings, and issues of common interests and concerns will be shared and discussed.   Each applicant should include in their budgets funds for attending these meetings.  For budgeting purposes, the applicants should assume that in addition to DSMB meetings, in-person meetings will be convened three times during the first funding year and twice a year for each funding year thereafter.   Applicants should assume for budgeting purposes that the meetings will be for two days in the Washington, DC,, metro area and will require the attendance of the Principal Investigator and one other person. 

E. Time Line of the Project

The timeline for this initiative does not allow time for initial protocol approval or approval of facilities after each study has begun.  All such approvals must be submitted with the application.  IRB approvals of the initial protocol must be submitted prior to the award.  The duration of the grants resulting from this RFA will be five years.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use NIH’s cooperative agreement (U01) award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award."   Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

This RFA is a one-time solicitation.   After the initial five-year award period, future funding opportunities are unknown.

2. Funds Available

The NHLBI intends to commit up to $3 million in Fiscal Year 2006 to fund three to five RCTs in response to this RFA.  The maximum amount for each RCT for five years will be $3,550,000 in direct costs.  Each applicant may request a project period of five years and a budget for direct costs of up to $500,000 for the first year, $850,000 for the second year, $850,000 for the third year, $850,000 for the fourth year, and $500,000 for the fifth year.  Because the nature and scope of the proposed research will vary from application to application, it is anticipated the size and duration of each award will also vary.  Although the financial plans of the NHLBI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.   A total of up to $20 million is available from NHLBI over the five-year period for the project.  It is anticipated that the maximum award for the RCF will be approximately $675,000 in direct costs, including direct costs of up to $150,000 for the first year, $125,000 for the second year, $125,000 for the third year, and $125,000 for the fourth year, and $150,000 for the fifth year.  The RCF costs are in addition to the RCT costs.

The anticipated start date for these awards is September 30, 2006. 

 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:

Practice based research networks are one example of a clinical setting suitable for the type of research described in this RFA, but other clinical settings may be equally capable of conducting this type of research. 

Applications that do not meet the eligibility criteria (i.e., are not responsive) will be returned without review.  This funding opportunity is for new applications. 

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 programs.  A minimum time commitment of 20% is expected from the Principal Investigator.

The Principal Investigator for each application is expected to possess certain essential qualifications:

(1) capability of leading a strong scientific research team;  (2) scientific leadership experience and a strong academic and scientific background, as exemplified by scientific publications and a record of peer-reviewed scientific support; and (3) knowledge of NIH grant and research policies, including those concerning human participants in research, human biological material, data management, and data privacy.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

Each applicant may submit only one application in response to this RFA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application 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 Grants Info, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

This application will not require electronic submission of the SF424 (R&R) Grant Application Form.

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

2. Content and Form of Application Submission

Applications must be 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 form.

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 must be checked.

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times are not applicable.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date:  January 17, 2006
Application Receipt Date(s): February 15, 2006
Peer Review Date: June/July 2006
Council Review Date:  September 2006
Earliest Anticipated Start Date:  September 30, 2006

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NHLBI staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD  20892-7924 (Express mail zip code: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application.  Submit a signed, typewritten original of the application, including the checklist, and three 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 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD  20892-7924 (Express mail zip code: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application.  Type the RFA number on the label.  Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review.  In addition, the RFA title and number must be typed on line 2 of the face page of the application form, and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.).  If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NHLBI.  Incomplete and non-responsive applications will not be reviewed.  If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no 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

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. The Grants Policy Statement can be found at 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 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

6.A. Checklist of What Each Application Should Include

Background

Population, Recruitment, and Retention

Study Design and Intervention

Measurement

Quality Control Methods

Statistics

Staff

Partnerships and Approvals

Collaboration

Resource and Coordinating Functions (RCF)

Dissemination

6.B. Budget and Related Issues 

Applications should contain five budget periods of 12 months each.  Applicants should provide adequate written budget justification and include all applicable direct and F&A costs.  Applications must include estimates of staffing needs, including the Principal Investigator and other professional and support staff.  Applications must include estimates of travel costs for in-person investigator meetings (three the first funding year, 2 thereafter) and semi-annual  DSMB meetings (at least one must be in person in the Washington DC metro area) to review the study progress, as detailed under the section on Special Requirements, along with statements indicating willingness to participate in these meetings.  Applications must include budget for staff to conduct data entry at their centers, for any equipment needed for data collection and intervention delivery, and for conference calls.  The budget for resource and coordinating functions (RCF) should be provided separately.

6.C. Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application.  The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.   The terms and conditions of the cooperative agreement mechanism being used for this RFA (Section VI.2.A.) require data to be delivered to NHLBI, which will fulfill the data sharing requirements.

Limited access data will be released under the studies awarded through this RFA.  Limited access data refers to study data, with certain deletions and recoding, which are released to requesting institutions and investigators for specific purposes and with certain restrictions and conditions.  Limited access data will be made available to the public in accordance with the NHLBI Policy for Distribution of Data (http://www.nhlbi.nih.gov/resources/deca/policy_new.htm) as revised on June 27, 2005.

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

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

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI in accordance with the review criteria stated below.

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

The 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 RCT address an important problem?  Is the underlying rationale for the RCT strong?  If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced?  What will be the effect of the RCT on the concepts, methods, technologies, treatments, services, or preventive 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 study?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  Are the informed consent procedures, randomization procedures, intervention approaches, data collection, quality control, data management, and statistical analyses appropriate for the design and unit of randomization selected (individual, family, medical practice)?  Are the described weight loss interventions evidence-based and feasible for implementation and maintenance in clinical practice if found effective?  Are the sample size and statistical power adequate?  Does the primary outcome measure assess BMI reduction?  For the other CVRF(s) selected, is the intervention(s) based on one or more evidence-based clinical practice guidelines, such as the JNC-7?   Are all important aspects of the guidelines, such as the behavioral and pharmacological, addressed for the CVRF(s) selected?  Is there at least one secondary outcome measure related to the evidence-based clinical practice guidelines? 

Innovation:  Is the study original and innovative? For example: Does the research challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the RCT 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 study?

Environment:  Does the scientific environment in which the work will be done contribute to the probability of success?   Does the RCT take advantage of unique features of the scientific and cultural environment or employ useful collaborative arrangements?  Is there evidence of institutional support?

Collaboration:   Have the investigators stated their willingness to collaborate with staff from the NHLBI and from other RCTs supported by this initiative?  Is there evidence that the applicant is willing to collaborate on the development of key common measures and measurement protocols, such as height and weight, blood pressure, patient satisfaction, quality of life and assessing program costs?  Is there evidence that the applicant will collaborate on data archiving and data elements that will allow meta-analyses?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Inclusion of Women and Minorities in Research:  The adequacy of plans to include subjects from both genders, and all racial and ethnic groups (and subgroups) as appropriate for the scientific goals of the research will be assessed.  Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398). 

Protection of Human Subjects from Research Risk:  The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

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.

2.B. Additional Review Considerations

Dissemination Plans:  The plans for making successful intervention materials and results into useable, feasible, and implementable materials to appropriate audiences (e.g., health providers, patients, public) and collaborating with NHLBI.  The plans for dissemination of results to health care providers and scientific communities.

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 budget.

2.C. Resource and Coordination Functions

The adequacy of the plan for the Resource and Coordination Functions (RCF) will be assessed by the reviewers.  However, reviewers will not factor the proposed RCF plan into the determination of scientific merit or the priority score.   Each plan will receive a secondary priority score which is separate from the primary priority score of the parent application.   The following review criteria will be used:

Significance:  Does the applicant address the importance of performing resource and coordinating functions in order to enhance the value of the research program?

Approach:  Are the proposed approaches appropriate for facilitating coordination and serve as a resource among awardees?  Are state-of-the-art coordinating and resource strategies proposed?

Environment:  Is there evidence of institutional support?  Does the applicant have prior experience in performing coordinating functions?

2.D. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan will 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 presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. 

2.E. Sharing Research Resources

Not Applicable

3. Anticipated Announcement and Award Dates

Announcements about awards from this solicitation will be made by September 30, 2006.

Section VI. Award Administration Information

1. Award Notices

 If the application is 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 business official.

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 Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when state and local governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (U01),   an “assistance" mechanism (rather than "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients’ activities by involvement in and otherwise working jointly with the award recipients in a partnership role: it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The awardee(s) will have lead responsibilities in all aspects of the study, including any modification of study design; conduct of the study; quality control; data analysis and interpretation; preparation of publications; and collaboration with other investigators, unless otherwise provided for in these terms or by action of the Steering Committee. 

Study investigators are encouraged to publish and to release publicly and disseminate results and other products of the study in accordance with study protocols and governance.   Within two years of the end of the period of NHLBI support for the project, data not previously released and other study materials or products not previously distributed are to be made available to individuals who are not study investigators, provided such release is consistent with the study protocol and governance and the preceding paragraph.   In addition, study investigators must establish a plan for making data sets and materials available to the scientific community and to the NHLBI immediately upon completion of the two-year period following the end of the period of NHLBI support.

Awardees will retain custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. The collaborative protocol and governance policies will call for the continued submission of information centrally to the RCF; procedures for data analysis, reporting and publication; and procedures to protect and ensure the privacy of medical and genetic data and records of individuals. The NHLBI Program Scientist, on behalf of the NHLBI, will have the same access, privileges and responsibilities regarding any collaborative data as the other members of the Steering Committee.

2.A.2. NIH Responsibilities

The NIH Program Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.  The NHLBI Program Official will monitor patient recruitment and study progress, ensure disclosure of conflicts of interest, and ensure adherence to NHLBI policies.  NHLBI will appoint all members of the Data and Safety Monitoring Board (DSMB).

The NHLBI Program Scientist will serve on the Steering Committee; he/she or other NHLBI scientists may serve on other study committees, when appropriate. The NHLBI Program Scientist (and other NHLBI scientists) may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees, e.g., recruitment, intervention, follow-up, quality control, assessment of problems affecting the trials and possible protocol changes, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, and development of solutions to major problems such as insufficient participant enrollment. 

The NHLBI reserves the right to terminate or curtail the study (or an individual award) in the event of (1) failure to develop or implement a mutually agreeable collaborative protocol; (2) substantial shortfall in participant recruitment, follow-up, data reporting, or quality control; (3) major breach of the protocol or substantive changes in the agreed-upon protocol with which NHLBI cannot concur; (4) attainment of a major study endpoint before schedule with persuasive statistical significance; or (5) human subject ethical issues that may dictate a premature termination.

Additionally, an agency program official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NHLBI Program Official may also serve as the NHLBI Project Scientist.

2.A.3. Collaborative Responsibilities

Awardee(s) agree to the governance of the study through a Steering Committee.  Steering Committee voting membership shall consist of the Principal Investigators (i.e.,, cooperative agreement awardees), the NHLBI Project Scientist, and the Chairperson.  Meetings of the Steering Committee will ordinarily be held by telephone conference call or in the metropolitan Washington, DC, area.

Support or other involvement of industry or any other third party in the study -- e.g., participation by the third party; involvement of study resources or citing the name of the study or NHLBI support; or special access to study results, data, findings or resources -- may be advantageous and appropriate.  However, except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by NHLBI. 

A Data and Safety Monitoring Board will be appointed by the Director, NHLBI to provide overall monitoring of interim data and safety issues; the Steering Committee will nominate members for this Board.   Meetings of the Data and Safety Monitoring Board will ordinarily be held in the Washington, DC, metro area.  An NHLBI scientist, other than the NHLBI Program Scientist, shall serve as Executive Secretary to the Board.  Because the Board serves as an independent group advisory to the NHLBI, study investigators will not communicate with Board members regarding study issues, except as authorized by the Board's Executive Secretary.

Upon completion of the project, awardees are expected to put their intervention materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NHLBI, for the conduct of research at no charge other than the costs of reproduction and distribution.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened.  It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee.  This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be 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.

Section VII. Agency Contacts

We encourage 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 issues:

1. Scientific/Research Contact:

Barbara Wells, Ph.D.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8106, MSC 7936
Bethesda, MD 20892-7936
Telephone: (301) 435-0417
FAX: (301) 480-1864
Email: WellsB@nhlbi.nih.gov

2. Peer Review Contacts:

Chief, Review Branch
Division of Extramural Affairs
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214, MSC 7924
Bethesda, MD  20892-7924 (Express mail zip code: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: nhlbichiefreviewbranch@nhlbi.nih.gov

3. Financial or Grants Management Contact:

James Huff
Grants Management Specialist
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7044, MSC 7159
Bethesda, MD  20892-7926
Telephone: (301) 435-0171
FAX:  (301) 451-5462
Email:  huffj@nhlbi.nih.gov

Section VIII. Other Information

Required Federal Citations

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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 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 funding opportunity 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.

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 "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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:   (1) 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 (2) 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

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 (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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://publicaccess.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from (1) currently funded NIH research projects or (2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information" the "Privacy Rule" on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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