ER INSTITUTE PRESENTS

ing you 

 to know 

he NCI

s

s...

...but were

afraid to ask

EPARTMENT OF HEALTH AND HUMAN SERVICES

nstitutes of Health • National Cancer Institute
NATIONAL CANCER INSTITUTE

GRANTS ADMINISTRATION BRANCH

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

NIH Publication No. 02-1222

Revised April 2002

LEO F. BUSCHER JR.

CHIEF GRANTS MANAGEMENT OFFICER

NATIONAL CANCER INSTITUTE

Grants Process 

and 

Administration
• Part I, An Overview, provides an introduction to how we in the Grants

Administration Branch view our role in this very important collaborative venture, a snapshot of the NCI as an organization, and a briefperspective of the legal underpinnings for grants.

• Part II, Process and Administration, charts the path of a grant application

from development, receipt, and assignment, through the peer reviewprocess, NCI funding determinations, award negotiation and issuance,and, finally, postaward administration.

• Part III, Funding Allocation, provides a brief budget overview and a

funding allocation example to help illustrate various nuances of theNCI grants process.

• Part IV, Application Types and Budget Mechanisms, provides descriptions of

the application types and budget mechanisms prevalent within the NCI.

• Part V, 

References and Resources, lists contacts and materials that are

helpful with regard to the general approach taken in the NCI grantsprocess.

• Part VI, Cross-Cutting Public Policies, summarizes some of the requirements that apply to grants management.

• Part VII, Glossary, lists definitions of terms and phrases most commonly

used in the award and administration of NIH grants.

It is a pleasure to acknowledge the staff of the NCI and the NIH whosecontributions made this publication possible. Specifically, I would like tothank the staff of NCI’s Office of Communications for their excellent logistical support.For additional information concerning the subject matter in this publication, the staff of the NCI Grants Administration Branch is pleased to answerany inquiries. Please let us know what you think of this publication by contacting us via the Feedback section of our web site. We welcome your suggestions on improving this publication.

Leo F. Buscher Jr.Leo F. Buscher Jr.Chief Grants Management OfficerNational Cancer Institute(301) 496-7753

o describe, in a general way, how a grant

hough the discussion relates to the

e grants process is similar in the other

) awarding components. We hope that 

ting point to understanding the overall

s. This publication can also be found 

n Branch World Wide Web site 

b/index.htm). 

n represents a concise progression of the

tion. 

iii

C

A

N

CER

INSTITUTE

h

T

h

rough

Administrative Excellence

APPLICANT

BUSINESS

STAFF

REVIEW

STAFF

NCIPAL

STIGATOR
Order of Precedence...................................................................................19

Part II – Process and Administration .........................................21Development, Receipt, and Assignment of Applications..........................23

Grantee Eligibility ......................................................................................23Development of Grant Application ..........................................................23Receipt and Assignment of Applications ..................................................25

Return of Incomplete and Late Grant Applications..........................25Grant Application Identification Number.........................................25Grant Application Referral..................................................................26

Principal Investigator .................................................................................26Grantee Institution Responsibility ............................................................26

Standards of Conduct .........................................................................27

Allowable Costs ..........................................................................................27Direct Costs.................................................................................................28Facilities and Administrative Costs (Indirect Costs)................................28

Rate Agreement...........................................................................................29

Peer Review ................................................................................................30

Initial Review Group and National Cancer Advisory Board Review.......30Initial Review Groups and Scientific Review Administrators ..................30Project Site Visits ........................................................................................32Scientific Review Group (SRG) Meetings .................................................33

Priority Scores......................................................................................35Percentile Rank ....................................................................................35Summary Statements...........................................................................36Early Notification of Applicant ..........................................................36

National Cancer Advisory Board...............................................................36

Responsibilities....................................................................................37Legislative Authority............................................................................37Composition........................................................................................37Pre-NCAB Meeting ..............................................................................38NCAB Meetings ...................................................................................38Expedited NCAB Review .....................................................................39Recommendations...............................................................................39Post-NCAB Meeting.............................................................................40

Appeals to Referral and Review of Applications ......................................40

NCI Funding Determinations ....................................................................41

Funding Decisions......................................................................................41Funding Selections......................................................................................41

...........................................................ii

.....................................................1

...........................................................3

................................................................3

tration....................................................3

................................................................4

ilosophy.................................................5

................................................................5

...........................................................7

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n...............................................................8

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................................................................9

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..............................................................13

..............................................................14

ements..................................................14

ve...........................................................14

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..............................................................16

..............................................................16

ts.......................................................17

.........................................................17

.........................................................17

..............................................................18

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v
Cancer Biology.....................................................................................72

Resource Development ..............................................................................72

Cancer Centers Support ......................................................................72Research Manpower Development.....................................................73Construction ........................................................................................74

Cancer Prevention and Control ................................................................74

Budget Mechanisms...................................................................................75

Research Project Grants..............................................................................75Cancer Centers and Specialized Program of Research Excellence...........79Other Research Grants ...............................................................................80Training.......................................................................................................84R&D Contracts............................................................................................84Intramural Research ...................................................................................85Research Management and Support..........................................................85Cancer Prevention and Control ................................................................85Construction...............................................................................................85

Comprehensive Minority Biomedical Program.........................................86

Research Supplements for Underrepresented Minorities in Biomedical Research..............................................................................86Supplements to Promote Reentry into Biomedical and Behavioral Research Careers ......................................................................87Research Supplements to Promote the Recruitment of Individuals with Disabilities into Biomedical Research Careers.............87Travel Award for Young Investigators........................................................87Historically Black Colleges and Universities Faculty in the Field of Cancer Award .........................................................................87Predoctoral Fellowship Awards for Minority Students ............................88The Minority Health Professional Training Initiative..............................88Continuing Umbrella of Research Experiences (CURE)..........................88Minority Institution/Cancer Center Program...........................................88

Part V – References and Resources............................................91Additional Sources of Information ...........................................................92

Grant Process and Administration Information ......................................92Grant Application Receipt Dates and Review and Award Schedule Information ................................................................................92Pre-submission Advice ...............................................................................92Program Announcements and Requests for Applications .......................92Additional Information Resources ............................................................93

..........................................................45

 Program Directors ..............................45 Grants Management Officer ..............45

..............................................................47

..............................................................48

..............................................................48

..............................................................49

..............................................................50

Obligation of Funds ..............................50

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al Status Reports...................................57

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cess ...................................................64

..........................................................65

..........................................................66

mple..................................................67

d Budget Mechanisms .............69

..........................................................70

..........................................................71

..............................................................71

..............................................................71

earch .....................................................71

..............................................................71

vii
PART I

An Overview

..............................................................94

Policies ......................................97

.................................................107

.................................................117

........................................................118

........................................................119

........................................................121

........................................................122

........................................................125

........................................................126

H/NCI Grants Process .............................2

tration Branch Electronic

................................................................4

nd Advisory Structure ...........................11

 Activities..............................................12

ancer Research to Applications............13

 Institute Grants Process.....................22

d by CSR for One Round....................24

pt and Assignment of Applications.....27

eviewing Grant Applications ...............31

uation for Scientific Merit ..................35

CI Funding Determinations ...............40

ural Funds............................................42

 by Mechanism ....................................43

titute Grants Program ..........................46

nd Issuance..........................................48

agement System: Electronic 

SHLINE and SMARTLINK II ...............54

omponents of the NCI Budget 

..............................................................64

mponents of the NCI Budget 

..............................................................64

ment Cycle...........................................65

Chart....................................................96

1

PART I – AN OVERVIEW

Aerial view of the NIH Campus in Bethesda, Maryland
Introduction

NIH Reinvention ActivitiesReinvention initiatives and other streamlining efforts under way at theNational Institutes of Health (NIH) have impacted the manner in which grantawards are processed at the National Cancer Institute (NCI). NIH hasachieved a number of milestones in the reinvention of its extramural researchadministration practices. Examples of such achievements include:• the implementation of a streamlined non-competing award process

(SNAP);

• the implementation of a streamlined process for the review of grant

applications;

• the simplification of summary statements;• the implementation of modular grant applications;• the implementation of the Edison system (http://www.iedison.gov/),

which streamlines the invention reporting process;

• the implementation of web-based CRISP (http://crisp.cit.nih.gov/), 

the Computer Retrieval of Information on Scientific Projects;

• the development of eSNAP (electronic SNAP); and • the progress toward a fully electronic grant life cycle.Despite these and future reinvention initiatives, the core concepts representedin this publication are expected to remain essentially the same.NIH Electronic Research AdministrationIn response to a Congressional mandate requiring Federal agencies to migratefrom paper-based to electronic systems, the NIH has undertaken the ElectronicResearch Administration (eRA) initiative to lower costs and administrativeeffort, expedite extramural grants processing, and provide better quality information to the NIH and the external grantee community. ERA integrates twoparallel systems: the NIH Commons (https://www-commons.cit.nih.gov/) andIMPAC II (http://era.nih.gov/impacii/). NIH staff communicate via theIMPAC II system. NIH is working toward integrating the NIH Commons withthe Federal Commons (http://www.fedcommons.gov/). The primary objectives of the eRA project are (1) to convert over two million pieces of paper inthe NIH application, initial peer review and secondary National Advisory

3

PART I – AN OVERVIEW

Initiates

research idea

and prepares

application

Submits

application

e

National Cancer

Advisory Board

recommends

action

Initial Review

Group (NCI or

CSR) evaluates for

scientific merit

NIH Center

for Scientific Review

assigns to NCI and

to study section

rants Process

GRANTEE

PRINCIPAL

VESTIGATOR
modules, NCI continues to develop and refine its current versions while partnering with NIH to improve others. By the end of 2002, all of the modules

will be developed and interconnected with one another, allowing for a singleentry point for grant data. Once it is fully implemented, NCI’s eGrantssystem will fulfill the goal of a paperless grants process. Grants Administration Branch PhilosophyNCI’s Grants Administration Branch (GAB) is the focal point for all businessrelated activities associated with the negotiation, award, and administration ofgrants and cooperative agreements within the NCI (see Figure 1, page 2).GAB’s web site can be found at http://www3.cancer.gov/admin/gab/index.htm. In GAB, we approach our work with grantee business officials, principal investigators (PIs), NIH and NCI review staff, and NCI program staff with acommon goal – the accomplishment of the project for which the grant isawarded.In our grants management role, we continually seek new and better ways topromote an environment in which PIs can pursue their research in the mostproductive and cost-effective manner possible. We place emphasis onproblem prevention. We accomplish this by working with grantee officials toensure that they have adequate business management systems and internalcontrols to properly safeguard Federal resources. We work with review andprogram staff to ensure the effective stewardship of Federal funds anduniform administration of various grant programs in accordance with Federalgrant requirements. Our goal is to support biomedical research throughadministrative excellence.Statement of PurposeThe Department of Health and Human Services (DHHS) touches the lives ofevery American. The American public expects grants awarded by DHHS’soperating divisions to help the DHHS achieve its health and human servicegoals. Additionally, the public expects DHHS’s grants to be well managed.The general goal of grants management is to provide quality stewardship ofgrants. Open, fair, and objective selection of projects with the highest potential for success is one key component of quality stewardship.The GAB is responsible for monitoring NCI’s grants process to ensure thatgrantees and the Federal Government perform all required business management actions in a timely manner, both prior to and after award. In carryingout this responsibility, the GAB evaluates and monitors (1) the businessmanagement capability and performance of applicant organizations andgrantees and (2) the internal operating procedures associated with the 

 post-award administrative process to an

grants administration, and (2) to inte

other systems within the Federal

 of NIH’s eRA project, NCI’s Grants

e process of implementing a system of

e, and monitor grants information

ts. This system, known as NCI’s eGrants

nts staff to work with and manage grants

ord processing files, spreadsheet files,

nd written documents. To prevent redun

esources, NCI is using some of the elec

 NIH, such as the Grant Award Notice

several years. For other electronic

5

PART I – AN OVERVIEW

anch Electronic Grants Process

Referral

Summary

Statements

Expedited

Review and

Early Awards

Council/

Board

Books 

aylists

NCI

rants

stem

Grant

ications

Grant

Files

Grant

Tracking

Developed by NCI
General Information

Abbreviations and Acronyms

CFR = Code of Federal RegulationsCSR = NIH’s Center for Scientific Review (formerly Division of

Research Grants)

DCB = NCI’s Division of Cancer Biology

DCCPS = NCI’s Division of Cancer Control and Population Science

DCP = NCI’s Division of Cancer Prevention

DCTD = NCI’s Division of Cancer Treatment and Diagnosis

DEA = NCI’s Division of Extramural Activities

DHHS = Department of Health and Human Services

EAB = NCI’s Extramural Advisory Board

F&A = Facilities and Administrative Costs

FSR = Financial Status Report

FY = Fiscal Year

GAB = NCI’s Grants Administration Branch

GMO = Grants Management Officer

GMS = Grants Management Specialist

IC = Institute and/or Center within NIH

IRG = Initial Review Group

MIS = Minority Investigator Supplement

NCAB = National Cancer Advisory Board

NCI = National Cancer Institute

NIH = National Institutes of Health

ODDES = NCI’s Office of the Deputy Director for Extramural Science

PA = Program Announcement

PHS = Public Health Service

R&D = Research and Development

RFA = Request for Applications

RPG = Research Project Grant

SBIR = Small Business Innovative Research

SNAP = Streamlined Non-Competing Award Process

SRA = Scientific Review Administrator

STTR = Small Business Technology Transfer

USC = United States Code

grants process. Due to the interrelation

d program matters, close coordination

ost important.

ent of purpose to the grantee commu

H as a pledge to:

grant awards within the appropriate

r research through administrative excel

for providing timely and accurate grant

ffice with whom the grantee, program

l elements can interact to obtain guid

garding the review and interpretation of

rements as they apply to research grants

ement aspects of grants to ensure the

nds.

ng a partnership with the grantee and

ff to ensure the issuance of award docu

grant requirements and protect the NIH

ud, and costly disputes.

 both within the NIH and to the grantee

ng commitment to improve grants 

he grantee to perform its research 

search environment free of unnecessary

equirements.

o F. Buscher Jr.

F. Buscher Jr.

ef Grants Management Officer

onal Cancer Institute

) 496-7753

7

PART I – AN OVERVIEW
Director, 19 Institutes, seven Centers, and the National Library of Medicine

and has 75 buildings located on more than 300 acres in Bethesda, Maryland.The NCI is one of the 19 Institutes within the NIH. An organizational chartfor the NIH is provided in Part V of this publication (see Figure 17, page 96).NCI MissionSimply stated, the mission of the NCI is to eliminate cancer and prevent thedevastation that cancer imposes on individuals, families, and society as awhole. NCI's goal is to stimulate and support scientific discovery and itsapplication to achieve a future where all cancers are uncommon and easilytreated. NCI works toward this goal in two major ways: 1) NCI provides

vision to the Nation and leadership for NCI-funded researchers across theUnited States and around the world and 2) NCI works to ensure that theresults of research are used in clinical practice and public health programs toreduce the burden of cancer for all people.

NCI BackgroundThe NCI, established under the National Cancer Act of 1937, is the FederalGovernment's principal agency for cancer research and training. TheNational Cancer Act of 1971 broadened the scope and responsibilities of theNCI and created the National Cancer Program. Under the National CancerAct of 1971, the Director of the NCI is authorized to submit a professionaljudgment budget reflecting the full funding needs of the National CancerProgram directly to the President. This budget is referred to as the BypassBudget. An overview of the budget process is presented in Part III of thispublication.NCI FunctionOver the years, legislative amendments have maintained the NCI’s authoritiesand responsibilities and have added new information disseminationmandates as well as a requirement to assess the incorporation of state-of-theart cancer treatments into clinical practice. The NCI coordinates the NationalCancer Program, which conducts and supports research, training, healthinformation dissemination, and other programs with respect to the cause,diagnosis, prevention, and treatment of cancer, rehabilitation from cancer,and the continuing care of cancer patients and the families of cancer patients.Specifically, NCI:• Supports and coordinates research projects conducted by universities,

hospitals, research foundations, and businesses throughout this countryand abroad through research grants and cooperative agreements.

• Conducts research in its laboratories and clinics.

on

e health and well being of Americans by

man services and by fostering strong,

derlying medicine, public health, and

of the Office of the Secretary, which

port Center, which provides centralized

ting divisions, which manage over 300

ating divisions are:

Families (ACF).

nd Quality (AHRQ).

Disease Registry (ATSDR).

Prevention (CDC).

id Services (CMS) [formerly the Health

HCFA)].

FDA).

ministration (HRSA).

IH).

lth Services Administration (SAMHSA).

 assistance to needy families, children’s

 programs, and other services. The AoA

s health insurance programs. The NIH,

S, and SAMHSA are all devoted to

c Health Service (PHS).

knowledge that will lead to better health

d that mission by conducting research in

esearch of non-Federal scientists in

ls, and research institutions throughout

he training of research investigators; and

information. NIH’s budget has grown

 one-room Laboratory of Hygiene, to

e NIH is composed of the Office of the

9

PART I – AN OVERVIEW
NCI Research Settings

NCI-sponsored research takes place in three settings: the laboratory, the clinic,and the community. In the laboratory, research is pursued on the biology ofcancer, the fundamental properties of cancer-causing agents and processes, andthe body’s defense against and response to cancer. In the clinic, patientoriented research is carried out in prevention, detection, diagnosis, treatment,and rehabilitation. In the community, research is carried out on the causes,risks, predispositions, incidence, and behavioral aspects of cancer. As thediagram in Figure 5 (page 13) indicates, the components of this research triadinterface.Figure 5 shows a progression from the results of research through dissemination to application. Research results must be communicated to those whoultimately apply these results in health care and disease prevention settings.NCI Executive CommitteeThe NCI Executive Committee (EC), which consists of high-level institutemanagers, makes all major organizational and operating decisions affectingthe NCI, including:• Formulating scientific and management policy decisions.• Establishing grant pay lines and funding plans for those grant programs

not administered solely by one division.

in fundamental sciences and clinical

sic and clinical research programs and

ncer through career awards, training

cer control.

ancer centers.

nizations and other national and foreign

earch and training activities. 

er research by industrial concerns where

ar capability for programmatic research. 

ation on cancer. 

ories, clinics, and related facilities neces

he award of construction grants. 

cture can be seen in Figure 3 (page 11).

the focal point for the National Cancer

ent’s Cancer Panel, the National Cancer

f Scientific Counselors (BSC), and the

he BSA gives final concept approval for

(RFAs) while the BSC gives final concept

extramural research divisions, one intra

amural research center monitor and

vities through extramural and intramural

e Deputy Director for Extramural Science

 of the Director, coordinates initiatives

 divisions: the Division of Cancer

er Control and Population Science

vention (DCP); and the Division of

CTD). The ODDES also monitors and

d Resources Program, as well as the grant

ves. The Division of Extramural

w of grants and contracts, and manages

SA.

4 (page 12), is composed of three major

ment, and cancer prevention and control.

dget activity areas may be found in the

of this publication. 

11

PART I – AN OVERVIEW President's

Cancer Panel

National Cancer

Advisory Board

Center for

Cancer

Research

Division

of Cancer

Epidemiology

and

Genetics

Division

of Cancer

Treatment

and

Diagnosis

Division

of Cancer

Biology

Division

of Cancer

Prevention

Division

of Cancer

Control and

Population

Sciences

Board of

Scientific Advisors

Board of

Scientific Counselors

Division of

Extramural Activities

Office of the

DIRECTOR

National

Cancer

Institute

Figure 3. NCI Organization and Advisory Structure
• Approving certain exceptions to grant funding plans.

• Reviewing contract, cooperative agreement, and grant concepts.• Formulating the long-range strategic plan for the Institute.In addition to weekly meetings, the EC meets with other NCI staff twice ayear in the summer and winter, for one or two days, to establish budget priorities and policies for the forthcoming year.Types of Funding InstrumentsUsing a variety of funding instruments, including contracts, grants, and cooperative agreements, the DHHS accomplishes much of its mission through services provided by non-Federal entities. Each instrument has a specificpurpose and application, thus creating different relationships between theparties.The Federal Grant and Cooperative Agreement Act of 1977 requires Federalagencies to distinguish procurement relationships from assistance relationships. Although the Act does not dictate any specific terms and conditionsthat should be placed on contracts, grants, and cooperative agreements, itdoes require that the choice and use of these legal instruments reflect the typeof relationship expected between the Federal and non-Federal parties.

13

PART I – AN OVERVIEW 

s (dollars in thousands) 

ment and 

pport 

6,734 

% 

gram 

Research

$2,655,266

71%

$880,612 23.5

search 260,542 6.9

916,312 24.4

597,800 15.9

2,655,266 70.7

280,860 7.5

pment 131,469 3.5

3,000 0.1

nt 415,149 11.1

426,572 11.4

port 256,734 6.8

3,753,721 100.0

Figure 5. Progression From Cancer Research to Applications

RESEARCH SETTINGS RESEARCH AREAS Lab Clinic

Population

Disseminate

and Communicate

Research Results • BIOLOGY

• RISK • INTERVENTION

PreventionDetection

DiagnosisTreatmentSurvivorship

• CANCER CONTROL

Cancer PatientsGeneral PublicHealth CareProviders

Academicand PrivateOrganizationsGovernment

Amount Percent 

of Total

(%)
Since passage of the National Cancer Act and the creation of the National

Cancer Program in 1971, the NCI’s annual appropriation has increased nearly21-fold from $180 million in fiscal year (FY) 1971 to $3.75 billion in FY2001. Nearly $2.49 billion (over 66 percent) of the NCI’s FY 2001 appropriation was awarded in grants and cooperative agreements.Grant AuthoritiesThe ConstitutionThe requirements to which research grants are subject have their roots in anumber of specific sources or authorities, the broadest of which is the U.S.Constitution. Congress has the authority to impose conditions upon thereceipt of Federal assistance funds. The cornerstone of Congress’ authority inthe grants area is Article I, Section 8 of the United States Constitution,referred to as the Spending Power Clause, which provides that "...Congressshall have power to lay and collect taxes, duties, imposts and excises, to paythe debts and to provide for the...general welfare of the United States...."Thus, Congress can enact statutes authorizing Federal agencies to award grantsand impose reasonable conditions on the receipt of Federal assistance funds.Laws that authorize the formulation of regulations for grant programs areultimately based on constitutional provisions. For example, the DHHS andthe NIH grant appeals procedures can be traced to the due process principlesoutlined in the Constitution under the Fifth Amendment. Another exampleis the Public Health Service (PHS) grant application form, which containsprovisions relating to civil rights, handicapped individuals, and age and sexdiscrimination. These are all extensions of constitutional requirements forequal protection under the law covered in the 14th Amendment to the U.S.Constitution.StatutesThe next broad level of Federal grant lawmaking is the enactment of specificlaws by Congress. Two of the most general, but nonetheless most important,are authorizing legislation and appropriation legislation.The authority to award grants is contained in the basic substantive legislationestablishing a Federal program. Such legislation may authorize programexpenditures for a specific or indefinite number of years. In the NCI’s case,the Public Health Service Act, Section 301 (42 United States Code [USC] 241),contains the general authority, as indicated by Congress, under which researchgrants are awarded.Subsequent to the enactment of authorizing legislation, Congress generallyenacts appropriation laws permitting funds to be obligated for a specificprogram. Appropriation bills begin in the House of Representatives and then

 to procure cancer research services and

l Government. Contracts are used when

on is to acquire a specific service or end

se by, the NCI. The remainder of this

d cooperative agreements.

s

operative agreements are Federal finan

upport and stimulate research.

ed when the principal purpose of the

erty, services, or anything of value to a

ose or to stimulate a particular area of

 assistance mechanisms range from

iduals to reimbursements to States for

er beneficiaries for whom the Federal

ity. These assistance mechanisms also

ough financial institutions and various

 The two types of assistance mecha

and the cooperative agreement:

bstantial programmatic involvement is

 the recipient during performance of the

s allowing the recipient significant

 the research project; and (2) there is no

CI of a specified service or end product

 (1) when the applicant is responding to

 cooperative agreements and must tailor

nt’s requirements; and (2) when substan

 anticipated between the NCI and the

 of the activities.

tion, the word "grant" is used to indicate

 be construed to include cooperative

tive

 by NCI was awarded to Louis F. Fieser,

27, 1937. It was funded for $27,550 to

cinogenic activity. The grant identifica

ding of grant IC3, the NCI has funded

nting for $33 billion in expenditures.

15

PART I – AN OVERVIEW
Administrative Requirements

• A-102 (rev.) Uniform Administrative Requirements for Grants to State and

Local Governments (also known as the Common Rule). Establishesconsistency and uniformity among Federal agencies in the managementof grants and cooperative agreements with State, local, and federallyrecognized Indian tribal governments.

• A-110 (rev.) Uniform Administrative Requirements for Grants With

Institutions of Higher Education, Hospitals, and Other Non-ProfitOrganizations. Establishes consistent and uniform grants administrationrequirements placed by Federal agencies on non-profit organizationsother than State and local governments. 45 CFR Part 74 extends theprovisions of A-110 to commercial (for-profit) organizations.

Cost Principles• A-21 (rev.) Cost Principles for Educational Institutions. Establishes principles for determining costs applicable to grants, contracts, and other

agreements with educational institutions. 

• A-87 (rev.) Cost Principles for State, Local, and Indian Tribal

Governments. Establishes standards for determining costs for Federalawards carried out through grants, cost reimbursement contracts, andother agreements with State and local governments and federally recognized Indian tribal governments.

• A-122 (rev.) Cost Principles for Non-Profit Organizations. Establishes

principles for determining costs applicable to non-profit organizations.

• 45 CFR Part 74 Appendix E establishes principles for determining costs

applicable to hospitals. 

• 48 CFR Part 31.2 (Federal Acquisition Regulations) establishes cost principles for commercial (for-profit) organizations.Audits• A-133 Audits of States, Local Governments, and Other Non-Profit

Organizations (rev.). Establishes consistent and uniform audit requirements and defines Federal responsibilities for implementing and monitoring such requirements for States, local governments, and other nonprofit organizations receiving Federal awards. Audit requirements forcommercial (for-profit) organizations are contained in 45 CFR Part 74.

gh the appropriation process, Congress

grants administration decisions by

orized annually, and by setting condi

 vague, Federal agencies often need to

ils. A "rule" or "regulation" is a formal

 that has general or particular applica

with Federal regulations and statutes

ized, regulations have the full force and

ttp://www.gpo.gov/nara/cfr/index.html),

blished in the Federal Register

aces/aces140.html), contains the regula

g NCI grants. Program regulations

vide additional guidance regarding

rogram will be managed. (Some

or in addition to, regulations.) Three of

ng to NCI grants are:

rch Projects) for broad grant program

istrative Requirements for Awards and

her Education, Hospitals, Other Non

ercial Organizations; and Certain Grants

l Governments and Indian Tribal

istrative Requirements for Grants and

and Local Governments) for administra

orizing legislation and implementing

nt and Budget (OMB) issues

ging grants that apply to all Federal exec

are required to apply the directives, the

s regulation. Among the circulars rele

se that have to do with administrative

dits.

17

PART I – AN OVERVIEW
Order of Precedence

As a general rule, requirements imposed by statute (42 USC 241 et seq.) andrequirements imposed by program or general regulations (42 CFR Part 52 and45 CFR Parts 74 and 92) are supplemented by program policies and termsand conditions of individual grants. When grant requirements are inconsistent, the following order of precedence usually applies: Constitutionalmandates govern statutory provisions, and statutory mandates govern regulatory provisions. Regulations published in the Federal Register generallygovern unpublished requirements, including grant terms and conditions.Questions concerning any apparent conflict in requirements or precedence ofrequirements governing grants should be addressed to the GrantsManagement Officer, who may consult with the Office of the GeneralCounsel.

specify details of the enabling statutes,

sh handbooks, guidelines, or manuals.

ons by following the policies contained

which is a condensation of the NIH and

 and the laws and regulations pertaining

idelines for certain kinds of grants.

r Cancer Center Support Grants (Core

Construction Grants (C06), Clinical

ooperative Agreements (U10), Cancer

ds (K), and National Research Service

e requirements cut across Federal

ion of grants. These "cross-cutting"

t every grant program, are intended to

nd other protections in activities

A summary of some of these cross

at apply to grants management is

n. NIH grantees also are subject to

ual appropriations act that apply to the

ese requirements are included in Part VI

 been included in NIH’s annual appro

 change. However, these requirements

ts may be added in the future.

the official notification to the applicant

h grant award is authorized by statute.

ice of Grant Award (Exhibit D, page

2 USC 241. Each award also cites 

ts issuance.

posed on projects supported by Federal

ditions that are attached to an individual

al NGA. These terms and conditions

 award, policy statements, and OMB

 be incorporated by reference. By

funds from the grant payment system),

y with everything incorporated by refer

19

PART I – AN OVERVIEW
21

PA R T II – PROCESS AND ADMINISTRATION

Building 1, National Institutes of Health

(Building 1 houses the Office of the NIH Director and key NIH staff)

PART II

Process and

Administration
Development, Receipt, and

Assignment of ApplicationsThis section charts the path of a grant application from development, receipt,and assignment, through the peer review process, NCI funding determinations, award negotiation and issuance, and – finally – postaward administration (see Figure 6, page 22). As mentioned previously in this publication,elements of several major reinvention initiatives, along with other streamlining efforts under way at NIH, will impact the manner in which grantawards are processed at NCI. However, the core concepts discussed in thissection are expected to remain essentially the same.Grantee EligibilityGrants are awarded to nonprofit and for-profit organizations, institutions ofhigher education, hospitals, research foundations, state and local governments, Federal institutions, and, occasionally, individuals. Foreign institutions and international organizations are eligible to receive research grantsonly. Some programs, such as the Small Business Innovation Research(SBIR) grants, Small Business Technology Transfer (STTR) grants, andminority program grants, are established for certain categories of applicants.Development of Grant ApplicationThe principal investigator (PI) usually initiates an application for a grant.Both the PI and an authorized official of the applicant institution must signthe application prior to submission to the NIH (See Exhibit A for an example of a grant application "face page"). As grant applications arereceived (see Illustration 1, page 24) by the Center for Scientific Review(CSR), NIH, they are channeled through the peer review process described in the following pages. The NCI web sites on "Preparing Grant Applications"(http://deainfo.nci.nih.gov/extra/extdocs/apprep.htm) and "Grant Applicationand Review Process" (http://www.cancer.gov/research_funding/grants/)provide access to several resources available from NCI and the NIH thatcontain important considerations and suggestions to assist the PI and theapplicant institution in preparing a research grant application. Two or threeweeks may be needed for preparation of a small project application, whereascomplex proposals may require as much as a year. CSR's referral divisionprocesses approximately 45,000 grant applications per fiscal year.For new, expanded, and/or high-priority programs, the NCI may encouragethe submission of grant applications through the use of the following types ofsolicitations:

23

e Grants Process 

ewals) 

D ASSIGNMENT OF APPLICATIONS 

2nd Month 3rd Month

AND EVALUATION FOR SCIENTIFIC MERIT

5th Month 6th Month 

7th Month

ND NEED AND NCI FUNDING DETERMINATIONS

9th Month

TION AND ISSUANCE

10th Month

NCI assigns to

appropriate

NCI Program

Director

Summary

statements

and letters

forwarded to

investigators

Summary

statements

forwarded to

NCAB

CSR-IRG

CSR assigns

application to

NIH Institute

CSR assigns

application to

Initial Review

Group

NCI-IRG

ns

or

ded

"

Summary

statements

prepared

Investigator

begins

work

Award

issued

Award

received by

institution

Applications

selected

for funding

"Paylists"

forwarded to

GMO

PA R T II – PROCESS AND ADMINISTRATION
With the exception of applications submitted in response to RFAs or other

announcements that include specific budgetary limits, applicants anticipatingsubmission of an application exceeding $500,000 direct costs in any year ofthe project must seek approval from the NCI program director prior tosubmission. Applicants should contact NCI staff at least six weeks prior tosubmission of the application. If an amount significantly greater than$500,000 is requested, approval should be sought even earlier.Receipt and Assignment of ApplicationsThe referral section of the CSR serves as the central receipt point for allcompeting applications. Figure 7 (page 27) provides a typical timeframefrom the date of receipt of applications through assignment of applications.Within the CSR, all new and competing continuation applications are given abrief evaluation to determine what area of research each represents. CSRreferral officers then assign each application to (1) a specific NIH Instituteand (2) an IRG for scientific merit review. Applicants are notified by mail ofthese assignments, usually within six to eight weeks of submission.Return of Incomplete and Late Grant ApplicationsA grant application is considered incomplete and will be returned to thesubmitting institution if it is illegible, if it fails to follow the instructionsprovided on the appropriate application form, if it fails to follow specificinstructions provided in an RFA or PA, or if the material presented is insufficient to permit an adequate review. A grant application also will be returnedif the grant application is late.Grant Application Identification Number Each new application received is assigned an identification number, checkedfor completeness, and duplicated. There are nine application types that maybe used to identify a specific grant application. A description of these nineapplication types is provided in the "Application Types" section of Part IV ofthis publication. Copies of the application are forwarded to the appropriateInstitute and IRG. The following is an example of a grant application identification number: 

describe continuing, new, or expanded

t or cooperative agreement applications

onse to PAs are reviewed in the same

ications (i.e., by chartered peer review

 Initial Review Groups [IRGs]). Funds

ide.

wed in an Institute(PARs) are program

cial referral guidelines and are reviewed

) are issued to invite grant applications

o stimulate activity in NCI programmatic

on receipt date is specified, and the

ount of funds earmarked for the initia

kely to be funded. Applications are

he RFA before review. Applications

ar RFA are reviewed by an appropriate

oup. 

e NIH Guide for Grants and Contracts

dex.html) and, when appropriate, in

25

by CSR for One Round

Application Activity Administering Serial Suffix Suffix

Type Code Organization Number Grant Year Other

1 R01 CA 100228 01 A1 or S1

PA R T II – PROCESS AND ADMINISTRATION
Standards of Conduct

The NIH utilizes and depends upon a system of self-regulation on the part ofthe funded research community coupled with appropriate oversight by theNIH. Ethical concerns, such as human subjects protection (45 CFR Part 46),promotion of animal welfare (P.L. 99-158 Section 495), removal of financialconflict of interest (42 CFR Part 50, Subpart F), and prevention of scientificmisconduct (42 CFR Part 50, Subpart A), all follow the self-regulatory pattern. The principle of self-regulation requires (1) a high level of trust in the fundamental integrity of the research community, a community that is both awareof its responsibilities and motivated to meet those responsibilities, and (2)sufficient oversight to enable the NIH to assure the public that self-regulationis providing adequate safeguards for the ethical integrity of science.Allowable CostsResearch grant funds are awarded to supplement the support of research at aninstitution. Grant funds may be used for allowable direct costs specificallyincurred in the conduct of the research project and for "facilities and administrative" (F&A) costs (formerly known as indirect costs [overhead]) incurred byan institution in providing support services. These funds are not intended toreplace support already being furnished by the institution or for expensespreviously incurred.

Type 1) application for a traditional

CI (CA). The serial number, which is

icates that it is the 100,228th application

shows that this is the first year of

he next part of the suffix is used to iden

a supplement (S1).

cers. These individuals examine and

propriate NCI program director. The

ogress of his/her assigned application(s)

cess. The NCI establishes an official file

and scientific information into the

ndividual designated by the grantee

 The PI is responsible and accountable

 the proper conduct of the project. By

accepts responsibility for the scientific

ssion of progress and any other required

legally responsible and accountable to

ancial aspects of the grant-supported

lity

ntee institution agrees to administer any

 regulations and current policies that

f the NIH. Acceptance of an award

 and the PI responsibility for conducting

udently and in accordance with cost

n the approved application. The

e fiscal and administrative management

special terms or conditions of award that

 research.

on "Notice of Grant Award," the grantee

nd special provisions of an award by

nt system. The grantee institution is not

he project, nor are penalties generally

ng scientific goals. However, in certain

solve problems or weaknesses that arise

Monitoring Projects" section for further

27

Figure 7. Development, Receipt, and Assignment of Applications

1st Month 2nd Month 3rd Month

CSR assigns

application

to NIH

Institute

CSR assigns

application

to initial

Review Group

NCI assigns to

appropriate

NCI Program

Director

CSR-IRG

Applicant

investigator

develops

and submits

grant

application

to

NIH/CSR

NCI-IRG

CSR

Assignment

Office

PA R T II – PROCESS AND ADMINISTRATION
for F&A costs is determined by multiplying the rate times the total amount of

the allowable costs in the direct cost base for the project. Rate AgreementTo be reimbursed for F&A costs, the grantee institution must prepare an F&Acost rate proposal annually and submit it to the cognizant Federal agency.The cognizant agency is generally the agency that provides the largest amountof funds to a grantee over a representative period. The cognizant agency actsas a representative for all Federal agencies dealing with a grantee's commoncosts (e.g., F&A costs and fringe benefits). After review and negotiation ofthe F&A cost rate proposal, the cognizant agency establishes an accepted rate,formalized as the F&A cost rate agreement for that institution, and makes itavailable to all other interested Federal grantor agencies. The negotiated F&Acost rate is used to calculate the applicable amount of F&A costs for eachaward to the grantee institution. The NIH Notice of Grant Award includes both direct costs and applicable F&Acosts calculated by the grants management specialist. These funds are themaximum amount awarded during the budget period even if a higher F&Arate is subsequently negotiated. If the amount of funds required for F&Acosts decreases because of a new negotiated rate or because of postawardbudgetary changes in the direct costs of the grant, the excess F&A cost fundsgenerally may be rebudgeted to support allowable direct costs for the project,subject to specific requirements set forth in the applicable cost principles. 

 principal investigator, other key

quipment and supplies;

sultant services;

he research;

r research subjects;

eous expenses;

.

osts

 supports a policy of full reimbursement

 costs (formerly known as indirect costs

 with a few exceptions (e.g., reimburse

lowships, and career programs; cancer

s limited to eight percent of direct

an institution that are not readily identi

vity but are necessary to the general

onduct of its research activities.

ance;

ral expense;

n; and

gned to an F&A cost pool from which

 an organization on the basis of a rate.

a direct cost base. The amount awarded

29

PA R T II – PROCESS AND ADMINISTRATION
Each study section is organized and managed by a scientific review administrator (SRA), an NIH staff scientist who is the designated Federal official

responsible for ensuring that the grant applications are reviewed in an impartial environment. SRAs are responsible for overseeing the scientific peerreview of applications. Their major responsibilities include managing studysection meetings, nominating study section members, selecting ad hocreviewers and site visitors, providing orientation for members of reviewgroups, explaining and interpreting NIH review policies and procedures,managing project site visits and study section meetings, and preparingsummary statements. They are also responsible for attending advisory boardor council meetings to provide requested information in support of the peerreview committee recommendations, communicating with program staff onreview issues, and discussing review issues and policies with applicants.SRAs do not have continuing programmatic, scientific, or fiscal responsibilities for the applications after the scientific peer review is completed.The NCI Division of Extramural Activities also has SRAs who organize andmanage the peer review of grant and cooperative agreement applications thatare highly mission specific to the NCI. These include applications forprogram projects, cancer center support grants, multi-site clinical trials, NCI’sclinical trials cooperative groups, National Research Service Award (NRSA)grants, and cancer education grants.For program project grant (P01), cancer center support grant (P30), and clinical trial cooperative group cooperative agreement (U10) applications, NCIuses a two-tiered peer review process. For these applications, the first tier of

onal Cancer Advisory Board

onsists of two sequential levels of review

eview of research grant applications was

n 475 of the Public Health Service Act,

 in effect for several years. This level of

ew Groups (SRGs), whose primary func

ntific merit of research grant applications.

(NCAB) performs the second level of

y the National Cancer Act of 1937 and

ervice Act in 1944. NCAB members

wledge in each of the relevant program

rities and procedures, and an awareness

es in biomedical research and of the

entative timeline for the IRG review of

cycles or "rounds" annually. The review

ions involving Acquired Immune

h and for applications in the Small

m (SBIR) and the Small Business

ntific Review Administrators

 Initial Review Groups (IRGs) distrib

s within the CSR. Each IRG has 5 to 10

study sections," that review applications

linical oncology, pathology, biochem

ding NIH Institute assignment.

20 study sections in the 20 IRGs. A

ns may be found at the following web

irgdesc.htm). 

d of 12 to 18 mostly non-Federal scien

their recognized competence in their

 the three review cycles per year, a CSR

 and 100 grant applications (see

31

Illustration 2. IRG Study Section Reviewing Grant Applications

PA R T II – PROCESS AND ADMINISTRATION
By contrast, as described in the previous section, many of the applications

reviewed by NCI review committees must be site visited because of thespecialized and complex nature of the applications. Large, complex applications such as those for cancer center support, program projects, and clinicaltrials cooperative groups routinely require a project site visit by a team of 10to 30 expert consultants, depending on the number of individual programcomponents and disciplines involved. Several members from the appropriate NCI chartered "parent" committee, as well as ad hoc consultants, formthe site visit team.Scientific Review Group (SRG) MeetingsScientific Review Groups (SRGs) (CSR study sections and NCI review committees) and Special Emphasis Panels (SEPs) meet from one to three monthsbefore each meeting of the National Cancer Advisory Board (NCAB). NCIprogram directors and grants management specialists may be present asobservers at the meetings but do not participate in the discussion or vote.Before every meeting, each reviewer is assigned several applications that fallinto his/her field of special competence to examine, evaluate, and summarize.The reviewer makes an initial recommendation to the review group about themerit of each application. For applications that have been site visited, two ormore members of the site visit team, usually IRG members, will summarizetheir findings and recommendations, including a budget and project period,for the full parent committee.Applications are evaluated for:1. Significance: Does this study address an important problem? If the aims

of the application are achieved, how will scientific knowledge beadvanced? What will be the effect of these studies on the concepts ormethods that drive this field?

2. Approach: Are the conceptual framework, design, methods, and analyses

adequately developed, well-integrated, and appropriate to the aims of theproject? Does the applicant acknowledge potential problem areas andconsider alternative tactics?

3. Innovation: Does the project employ novel concepts, approaches, or

methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

4. Investigator: Is the investigator appropriately trained and well-suited to

carry out this work? Is the work proposed appropriate to the experiencelevel of the principal investigator and other researchers (if any)?

5. Environment: Does the scientific environment in which the work will be

done contribute to the probability of success? Do the proposed experi

other means of interaction between the 

cants. The site visit provides an in-depth 

lication. The SRA prepares a site visit 

dations of the site visitors. A chartered 

iders site visit reports for several applica- 

mittees for P01s, one for P30s, and one 

pplications. The parent review 

n reviews the application and the site 

re to each application. The SRA 

fter the meeting of the parent review 

wed by a study section or chartered NCI

nterest or lack of expertise, the SRA

SEP) (formerly Special Review

NCI RFAs and PARs are usually reviewed

e committee is determined by the

tted grant applications.

on assigned to their committees from the

ines if the application contains suffi

tion necessary for the review committee

o allow the reviewers to gather informa

ication in order to make a final evalua

The CSR SRA usually assembles a

reviewers. Site visits enable the

nvestigator and other researchers, view

iscuss objectives. The NCI program

to provide program information, if

nding of the project and the reviewers’

ther at the request of the SRA, program

cer, a grants management specialist will

ss and administrative expertise.

 on the site visit team's observations and

n at the IRG meeting.

earch grant applications reviewed by 

the study section can complete its

deferral of the review to the next review

.

33

PA R T II – PROCESS AND ADMINISTRATION
Priority Scores

To determine the priority score, each IRG member assigns a numerical ratingthat reflects the reviewer's assessment of the scientific merit of the applicationrelative to the state of the art in the particular field. The numerical ratingsrange from 1.0 (best) to 5.0 (worst) with increments of 0.1.After the review meeting, the SRA averages the individual reviewers' ratings foreach scored application and multiplies by 100 to provide a three-digit numberthat is the priority score. At this point in the grant application reviewprocess, four to five months have elapsed since the principal investigatorsubmitted the application (see Figure 8 above).Percentile RankIn addition to a priority score, most applications reviewed by the CSR receivea percentile rank. The percentile rank represents the relative position of eachpriority score (along a 100.0 percentile band) among the scores assigned bythe IRG during the current plus the previous two rounds of the study section.Applications reviewed by NCI review groups receive priority scores only, andpercentile ranks are not calculated for these applications.The overall intent of percentile ranking (or "percentiling") is to improve thecomparability of scored applications across study sections and IRGs, and tominimize the impact of round-to-round quality variation. The percentile/priority score is the primary indicator of relative scientific merit when applications are being considered for funding within an Institute.

features of the scientific environment or

ngements? Is there evidence of institu

ccordance with NIH policy, all applica

ct to the following:

 gender, children, minorities, and their

scientific goals of the research. Plans

 of subjects are also evaluated.

 of the proposed budget in relation to

otection for humans, animals, or the

may be adversely affected by the project

ich are published in the NIH Guide to

ih.gov/grants/guide/index.html), list the

ew of applications submitted in response

tions by the review committee are:

ed for further consideration (NR), or

 require a majority vote; in the event of a

G members disagree with the majority),

majority vote, but the minority opinion

t. An application may be deferred if

make a definitive recommendation.

ubstantial scientific merit, it is given a

-reviewed applications, a percentile

on. An action for scoring is equivalent

awarded provided sufficient funds are

tandards, it is "not recommended for

of streamlined review, simply not

ocess implemented at NIH (particularly

eviewers identify but do not discuss or

upper half of the applications being

ound. For reviews of applications

viewers may be asked to identify the

 half of the group of applications under

red applications are provided as feed

35

PA R T II – PROCESS AND ADMINISTRATION

Figure 8. IRG Review and Evaluation for Scientific Merit

3rd Month 5th Month 6th Month 7th Month 4th Month

Summary

statements

and letters

forwarded to

investigators

IRG

members

review and

evaluate

IRG reviews,

votes, and assigns

priority scores or

"not recommended

for further

consideration"

Summary

statements

prepared

Site visit

made

Site visit

report

Summary

statements

forwarded to

NCAB
Responsibilities

The NCAB is responsible for the final external review of all grant applicationsreferred to the NCI, except those domestic applications requesting $50,000(or less) in direct costs per year (without human subject, animal welfare,minority/gender/children, or biohazard concerns), individual fellowshipapplications, applications with percentiles in the bottom one-half of thosereviewed by CSR, and applications not recommended for further consideration. The NCAB's responsibility is to evaluate all grant applications in relation to the needs of the NCI and the priorities of the National CancerProgram. It recommends support of meritorious projects to the NCIDirector. In addition, the NCAB advises the Director with regard to theNational Cancer Program as a whole.Legislative AuthorityIn accordance with P.L. 92-463, the Federal Advisory Committee Act, theSecretary of the Department of Health, Education, and Welfare chartered theNCAB on January 4, 1973. The NCAB's mandate is continuous, and theBoard is rechartered every two years.The National Cancer Act of 1971 (P.L. 92-218) and the Health ResearchExtension Act of 1985 (P.L. 99-158) specify that two-thirds of the membersshall be appointed from among the leading representatives of the health andscientific disciplines relevant to cancer and that one-third of the membersshall be appointed from the public and include leaders in the fields of publicpolicy, law, health policy, economics, and management.CompositionThe NCAB is composed of 18 members who are appointed by the Presidentfrom among persons who by virtue of their training, experience, and background are especially qualified to evaluate the programs of the NCI.Members serve overlapping terms of six years. The President designates oneof the appointed members to serve as Chair for a term of two years.Ex officio members of the Board include the Secretary of DHHS, the Directorof the Office of Science and Technology Policy, the Director of the NIH, theChief Medical Director of the Department of Veterans Affairs, the Director ofthe National Institute of Environmental Health Sciences, the Secretary ofLabor, the Commissioner of the Food and Drug Administration, theAdministrator of the Environmental Protection Agency, the Chair of theConsumer Product Safety Commission, the Assistant Secretary of Defense forHealth Affairs, the Director of the National Institute for Occupational Safetyand Health, and the Associate Director for Health and EnvironmentalResearch of the Office of Energy Research. Members of the President'sCancer Panel also attend as non-voting members.

ch IRG meeting, the SRA prepares the

red to as "pink sheets" because they used

g the judgment of the reviewers (see

consists of a concise statement of the

of its merit. Summary statements of

 score and, where applicable, a

scored applications include Committee

y indicate budget items that the

r elimination and a recommendation

 may be recommended for support for

ance with NIH cost containment princi

s four years. Summary statements are

hey are available. NCI staff also provide

embers for their review before the NCAB

he NIH Electronic Council Book (a

les are calculated by the IRG SRA, a

tter accompanied by the summary state

he IRG review is sent to the principal

ctor. The grantee business official is sent

notification letter. However, the grantee

the summary statement because it

rtaining to the PI. Currently, CSR sends

wing applications that are unscored or

eration: R01s that are non-RFAs, R15s,U43s, U44s. For fellowships, CSR sends

d RFAs and non-RFAs. CSR also sends

eviewed R01 applications that are within

m directors send out all other summary

ating that no assumptions should be

ng.

d

National Cancer Advisory Board (NCAB),

e President. Scientific experts and advo

ctor on issues related to all aspects of the

e a second level of review for NCI grant

37

PA R T II – PROCESS AND ADMINISTRATION
representation/justification of gender and/or minorities and/or children for

review by the NCAB. In addition to these special reports, NCAB membersalso receive MERIT (Method To Extend Research in Time) award nominationsand extensions and appeal letters from PIs who disagree with the IRG recommendation.If an NCAB member has a question about an application or thinks that additional information would be helpful, he/she is encouraged to contact the NCIprogram director responsible for that application. Most of the NCABmembers' concerns are resolved during telephone conversations with theprogram director. If not, they are discussed during the closed session of theNCAB meeting.During the closed session, the NCAB acts on all applications brought beforeit. Some applications are reviewed and discussed on an individual basis.For example, applications may be brought to the NCAB's attention by NCIprogram staff concerned with some aspect of the IRG review, such as therecommended level, period of support, or the percentile/priority scoreassigned. NCAB members themselves may bring up other applications fordiscussion. The NCAB's options are discussed in the following paragraphs. Expedited NCAB ReviewAn expedited NCAB approval process is used for pencentiled R01s reviewed byCSR and for all R21s, except for those applications submitted in response to aset-aside (RFA or PA with a set-aside). In addition, applications do notundergo expedited review if they involve foreign institutions or if the summarystatement expresses concerns with regards to human subjects, animal welfare,biohazards, or inadequate representation/justification of gender and/orminorities and/or children. The NCAB members approve grant applicationsusing the NIH Electronic Council Book and a notification letter is sent to thePI by the Grants Administration Branch notifying the PI of the NCAB approvaland plans for expedited funding.RecommendationsIn most cases, the NCAB concurs with the IRG’s recommendations.However, the NCAB may vote to change the IRG recommendations in thefollowing ways:• If the NCAB disagrees with an initial review based on scientific or technical merit, action is deferred. The application is returned for a re-review

by the same or a different IRG. If, after deferral and a second review, theNCAB still wishes to change the recommendation, it may do so.

• The NCAB may recommend that an application be considered for exception funding, in which case the application need not be returned to the

IRG for an additional review.

meeting of the NCAB, the Executive

Director, DEA, NCI) calls a meeting with

iew the materials that are to be

ion. The closed session materials are

let prepared by DEA staff from the mate

The Special Action Booklet identifies

h respect to human subjects, animal

 biohazards; foreign applications; all

T (Method To Extend Research in Time)

ther staff recommendations; and any

e brought to the attention of the NCAB.

he pending NCAB meeting are brought

CI Director or the Chair, no fewer than

ast two days. Meetings of the NCAB that

May/June, and September/October

ember/December NCAB meeting is

ic when general program activities and

ation, scheduled NCAB meeting dates

he Federal Register

aces/aces140.html). Attendance at the

ns is limited to NCAB members, IRG

NCI staff, and designated representatives

ppropriate NCI staff members attend

essary, specific details or additional

sion by the NCAB.

ore the NCAB meeting, summary state

or applications to be reviewed at the

e to all NCAB members via the NIH

lectronic Council Book is a restricted

mbers to view all the summary state

ns assigned to them for review based on

AB members are not given access to

institutions, however. By the time the

mmary statements, as well as other

e reviewed, will have been made avail

f Extramural Activities prepares and

il grant applications involving human

sks, foreign grants, and inadequate

39

PA R T II – PROCESS AND ADMINISTRATION
NCI Funding Determinations

Funding DecisionsAround October 1, the beginning of a new Federal fiscal year, the NCIExecutive Committee discusses program priorities and preliminary fundingallocations for the coming fiscal year. Considerations used in determiningprogram allocations include Congressional mandates, new scientific opportunities, new initiatives, program priorities, previous commitments such as noncompeting continuations, other projected needs, and the anticipated availability of funds. Final allocations and funding decisions cannot be madeuntil the actual amount of the appropriation is known.Generally, the NCI Executive Committee meets in October/November toestablish funding policy for grant applications submitted for the year’s firstfunding cycle, which begins with the September/October meeting of theNCAB. If Congress has passed an appropriation bill by this time, the fundingpolicy for the entire year may be established. When establishing pay lines forthe year, the NCI allocates funds available for competing grants among thethree funding cycles. Thus, applicants with the same priority score orpercentile ranking are normally paid regardless of the cycle in which theycompeted. The funding policy is reconsidered at least two more times duringthe year to coincide with the NCAB’s schedule of grant review cycles.Grant applications are grouped by mechanism for funding through one oftwo processes. A mechanism that is used solely by one Division (traininggrants, for example) will have a separate budget within the Division. TheDivision Director is responsible for establishing an annual funding plan forDivision-controlled programs. Those grant mechanisms that are common tomore than one Division (traditional research grants [R01], program projectgrants [P01], etc.) compete for funds from a common budget "pool." Theselection of applications to be funded from pool funds is discussed in thenext section. An example of the distribution of NCI fiscal resources is foundin Figures 10 and 10a (pages 42 and 43), which display budget spending byfunding mechanism for FY 2001.Funding SelectionsImmediately following a meeting of the NCAB, NCI program directors areprovided with an electronic "ranking list" of competing applications in theirprogram areas to review for payment and to verify the program assignment.The approved grant applications are ranked in percentile or priority scoreorder from most to least meritorious.

an application receiving a favorable 

w not be considered for support for

fic or technical merit.

e IRG, the NCAB may accept the 

ng the application for further review.

he IRG recommendation, the NCAB must

ning or disagreeing with the IRG decision

ing days after the NCAB meeting.

pplications given special attention, the

c concurrence with the IRGs' recommen

statements. NCAB members are

atements. They do not attend discus

eir own institutions or affiliated institu

e in the en bloc concurrence without

evel of review is completed using the

y statements are forwarded to the NCAB

ir concurrence or nonconcurrence.

intained during this process.

oard (NCAB) meeting, NCI staff

he NCAB's recommendations.

bsequently notified at the time of the

roximately eight to nine months have

r submitted the application (see Figure 9).

w of Applications

to the June 1997 NCAB, NIH abolished

nstitute level. Once an appeal has been

administrative mechanism of redress

py with the outcome of their review,

plication.

41

ng Determinations 

 Month 

CI funding policy 

tablished Applications selected

for funding

PA R T II – PROCESS AND ADMINISTRATION
PERCENT

AMOUNT OF TOTAL

(%)

RESEARCH GRANTS:

Research Project Grants

Traditional Research Project Grants (R01) $1,008,033 26.9Program Projects (P01) 301,115 8.0FIRST Awards (R29) 23,738 0.6Outstanding Investigator Awards (R35) 2,186 0.1MERIT Awards (R37) 26,682 0.7RFAs 149,448 4.0Cooperative Agreements (U01/U13/U19) 15,985 0.4Exploratory Grants - Phase I (R21) 42,605 1.1Exploratory Grants - Phase II (R33) 23,604 0.6Small Grants (R03) 9,024 0.2AREA Grants (R15) 358 0.0Shannon Awards (R55) 300 0.0Program Evaluation 17,692 0.5

Subtotal, RPGs 1,620,770 43.2

SBIR/STTR Grants (R43/R44 & R41/R42) 75,833 2.0Subtotal, Research Project Grants (RPGs) 1,696,603 45.2

Centers

Cancer Center Grants (P30/P20) 192,116 5.1SPORES (P50) 76,844 2.0Center Cooperative Agreements (U54) 10,771 0.3Subtotal, Centers 279,731 7.5

Other Research Grants:

Career Program:

Temin & Minority Mentored Career Development 

Awards (K01) 10,398 0.3

Senior Research Scientist Awards (K05) 550 0.0Academic Career (Preventive Oncology) Awards (K07) 6,309 0.2Mentored Clinical Scientist Development Awards (K08) 14,500 0.4Mentored Clinical Oncology Awards (K12) 8,409 0.2Career Transition Awards (K22) 1,191 0.0Mentored POR Career Development Awards (K23) 4,291 0.1Mid-Career Investigator in POR Awards (K24) 3,796 0.1Mentored Quantitative Research Career Dev.

Awards (R25) 133 0.0

Institutional Curriculum Awards (K30) 1,600 0.0Subtotal, Career Program 51,177 1.4

Cancer Education Program (R25) 21,740 0.6Clinical Cooperative Groups (U10) 154,261 4.1Minority Biomedical Support (S06) 3,479 0.1Scientific Evaluation (U09) 5,850 0.2Continuing Education (T15) 202 0.0Research Resource Grants (R24/U24) 29,339 0.8Exploratory Cooperative Agreements (U56) 1,042 0.0Conference Grants (R13) 2,111 0.1Subtotal, Other Research Grants 269,201 7.2

Subtotal, Research Grants 2,245,535 59.8

NRSA Training (F31, F32, F33, T32 & T36) 57,927 1.5Cancer Control Grants 183,665 4.9Construction Grants (C06) 1,500 0.0

Subtotal, Grants 2,488,627 66.3

Contracts (includes R&D, Interagency Agreements, Cancer 

Control, Construction contracts) 411,588 11.0

Intramural Research 567,297 15.1Research Management & Support 136,509 3.6Cancer Prevention and Control (excluding Cancer Control 

Grants and Contracts) 149,700 4.0

TOTAL NCI 3,753,721 100.0

43

nds (dollars in thousands)

Amount Percent 

of Total

(%)

$1,696,603 58.5

279,731 9.6269,201 9.3

183,665 6.3

57,927 2.0

1,500 0.1

2,488,627 85.8

411,588 14.2

2,900,215 100.0

Grants

$2,488,627

86%

PA R T II – PROCESS AND ADMINISTRATION

Figure 10a. NCI FY 2001 Budget by Mechanism (dollars in thousands)
Award Negotiation and Issuance

Role and Responsibilities of NCI Program DirectorsThe NCI currently has more than 120 extramural program directors, each ofwhom is assigned responsibility for a certain programmatic and scientificapproach to the cancer problem (see Figure 11, page 46). For example, thereare program directors for chemical carcinogenesis, tumor biology, biochemistry and pharmacology, immunology, radiation, clinical oncology, cancerprevention, and others.The program director is responsible for the programmatic and scientificaspects of his/her portfolio. In addition to the activities cited previously, the program director is responsible for:• Providing leadership and coordination in the medical and scientific

communities for research groups carrying out investigations in a particular program area.

• Visiting grantee institutions to promote and explain the objectives of the

program and to exchange information.

• Reviewing and evaluating the state of the art of research in a specific

program area and stimulating scientific investigations in that fieldthrough the issuance of RFAs and PAs and recommending exceptionfunding.

• Making recommendations to NCI, NIH, and DHHS policymakers on

subjects related to his/her individual expertise.

• Serving as a liaison member on reviewing panels and as a participant in

national and international symposia and other meetings called to discussresearch in a specific program field.

In addition to these general scientific activities, program directors, as noted inmore detail below, collaborate with grants management specialists inproviding oversight of the NCI grants program.Role and Responsibilities of the NCI Grants ManagementOfficerThe Chief Grants Management Officer (GMO) and his/her staff are responsible for all business management aspects associated with the negotiation,award, and administration of grants and cooperative agreements. In additionto the preaward responsibilities cited previously and discussed in greaterdetail below, the GMO is responsible for:

ed of the dollars available for each partic

y, program directors select grants for

ntile score order. However, they may

ready receive support from other sources

the "saved" monies to fund applications

res that may be important to the

nds, approximately 8 to 10 percent of

 each round to fund exceptions. Four

d a final time at the end of the year), the

onsider recommendations from NCI

 Grant (RPG) applications which are

ach Division Director has discretionary

as exceptions within a budget and

ecutive Committee.

NCI Division Director, the NCI program

those applications selected for funding.

program director, the Division Director,

 Data Branch or his designee, and the

mes an authorization (paylist) (see

 Officer and grants management staff

mplete the administrative review, negoti

the three-step funding allocation process

a practical example of a funding alloca

blication.

45

PA R T II – PROCESS AND ADMINISTRATION
• Advising and assisting management and program officials in developing,

implementing, and evaluating program plans, strategies, regulations,announcements, guidelines, and procedures.

• Serving as the focal point for receiving and responding to all correspondence from grantees related to business management activities, such as

requests for prior approval required by terms of award or by policy, orrequests that could result in a change in the awarded amount.

• Reviewing grant applications from a management point of view for

conformity to laws, regulations, and policies.

• Negotiating grant budgets and issuing awards.• Providing business management consultation and technical assistance on

grant matters to internal staff, applicants, and grantees.

• Resolving audit findings involving the NCI grants program and/or

commenting on findings before the agency’s official position is madeknown to the grantee.

• Providing continuing surveillance of the financial and management

aspects of grants through reviews of reports, correspondence, site visits, orother appropriate means.

Because most business and management decisions have an impact onprogrammatic and scientific matters and vice versa, a close working relationship between the program directors and the GMO, or his/her staff, is essentialto the effective administration of the grants program.The common goal of program and grants management staff is to free investigators from unnecessary administrative burden and to respond to their needsin a timely and prudent manner while exercising their responsibility as stewards of public funds. The program director reviews a grantee’s request withregard to its impact on the science of the research project and informs theassigned grants management specialist of any scientific problems. NCI grantsmanagement specialists maintain an annual portfolio assignment thatincludes an average of over 200 grants.Preaward ActivitiesAfter funding decisions are made and paylists are developed, NCI programdirectors complete their review of each application selected for funding. As a result of this review, program directors may contact applicants to requestadditional or updated information regarding the applicant’s other sources ofsupport or overlap with other projects or to resolve scientific concernsexpressed by the initial reviewers regarding the involvement of human 

47

PA R T II – PROCESS AND ADMINISTRATION

rants Program

NCI 

ce of the 

irector

National Cancer

Advisory Board

(NCAB)

NCI Executive Committee

Grants Review

Responsibility

Grants Administrative

Responsibility

Division of Extramural

Activities (DEA)

Office of Management

(OM)

Grants

Administration

Branch

(GAB)

PROGRAMSBasic Prevention ScienceBreast & Gynecologic  CancerCancer BiomarkersChemopreventive Agent DevelopmentCommunity Oncology &  Prevention TrialsEarly DetectionGastrointestinal & Other CancersLung & Upper Aerodigestive CancerNutritional ScienceProstate & Urologic Cancer

PROGRAMSAIDS CancersBiochem. & Pharmacology (including Drug Discovery)Biological Response ModifiersCancer & NutritionClinical OncologyClinical TrialsDiagnostic ImagingDiagnostics ResearchImaging Technology DevelopmentMolecular ImagingRadiotherapy DevelopmentResources DevelopmentSurgical OncologyTechnology Deveopment

cutive Secretary, NCAB

earch Analysis

nority Programs

r Review of Grants & Contracts

mmittee Management

nts Policy

Grants ManagementGrant Award IssuanceGrants PolicyGrant FilesGrants FinanceGrantee Performance Monitoring

Division of

Cancer Treatment

and Diagnosis

(DCTD)

Division of

Cancer Prevention

(DCP)
mals, minority and gender representa

s. Grants management staff may

nal information regarding assurances and

documentation.

view and resolution of problems by

to the grants management specialist an

 each application to be funded. The

ogram director work together during this

ter for Scientific Review (CSR) and

quests updated other support, certifica

rd) approval, and human subjects educa

 not a guarantee of funding.

trol form from the program director and

ants management specialist begins the

Figure 12). This involves a cost analysis

administrative compliance with DHHS

ations with the grantee business official

amples of these activities are outlined 

iews the application for:

osed project.

• The applicant institution’s financial management capabilities.• Similarity to, or duplication of, existing programs or projects being

supported by other sources, to the extent that this can be ascertained.

• Specific requirements established by a particular program (e.g., the NCI

Construction Program; conference or training grants).

The extent of this analysis is a matter of judgment, based on factors such as:• The applicant’s previous experience in managing grant funds.• NCI’s experience with the grantee.• The dollar amount of the grant.• The complexity of the grant.• The financial history of the project.• NCI program concerns.

Administrative ReviewIn addition to analyzing the budget, the grants management specialist determines that all necessary assurances and reporting requirements have been metand that the applicant is in compliance with NIH and DHHS requirementsand with other appropriate rules and policies. The following is a brief itemization of some of the issues that must be addressed, when appropriate,before an award can be issued:• Compliance with 45 CFR Part 46, "Protection of Human Subjects."• Certification of required education in the Protection of Human Research

Participants.

• Compliance with PHS Policy on Humane Care and Use of Laboratory

Animals by Awardee Institutions.

• Civil rights, handicapped individuals, and sex and age discrimination

assurances.

• Compliance with Data and Safety Monitoring requirements.• Debarment, suspension, and voluntary exclusion certification.• Drug-free workplace certification.• DHHS-approved entity identification number (EIN) for the applicant

institution.

49

PA R T II – PROCESS AND ADMINISTRATION

uance

10th Month

onal

n

d

Investigator

begins

work

Award

issued

Award

received by

institution
The Notice of Grant Award contains:

• The name and address of the grantee institution.• The title of the project.• The name of the principal investigator under whose direction the research

is to be carried out.

• The period of grant support.• The amount recommended for future years of support.• Any special grant terms and conditions of award.In addition, all competing award notices and all non-competing awardnotices, except those in the Streamlined Non-Competing Award Process(SNAP) population, show the authorized direct costs by budget category (e.g.,personnel, supplies), thereby constituting prior approval for the expenditureof funds for specific purposes and items described in the grant applicationand/or agreed upon during negotiations. F&A costs are also included on theNGA. For additional information on F&A costs, refer to the section entitled"Facilities and Administrative Costs."If the awarding office has determined that a prospective grantee is financiallyunstable, has a history of poor performance, or has a management systemthat does not meet the agency’s standards, the awarding office may imposespecial conditions more restrictive than those prescribed by standard grantpolicy, or may delay issuing the award until it is satisfied that the agency’sstandards have been met.The Grants Management Officer certifies in signing the grant award that:• The choice of the award mechanism is proper under applicable policy.• The application on which the award is based was properly peer reviewed.• The award amount is accurate and appropriate for the grant-supported

activity.

• The applicant institution is judged to have (or is expected to acquire) 

adequate business management capability to administer the grant andaccount for Federal funds.

• The award is being made under the terms and conditions specified for the

particular program and is consistent with appropriate review recommendations.

• The award is consistent with governing legislation, regulations, and policies.

s.

sure.

on’s management capability.

m (grant/contract/cooperative agree

 certification.

eviewers on the summary statement.

taff.

with other support.

t.

n award is to establish the appropriate

lems, and agree on specialized terms and

degree and form of the negotiation

s the dollar amount and complexity of

blems identified. The grants manage

negotiations and obtain needed infor

espondence. However, it may become

o address certain issues or problems in

articipate in the on-site visit.

tion of Funds

the official notification to the applicant

he NGA document is in a letter format

e Grants Management Officer. NGAs

ia e-mail or mailed, if the grantee is not

51

PA R T II – PROCESS AND ADMINISTRATION
staff and the grantee. In addition, the submission of incomplete applications

frequently delays issuance of an award.Non-competing continuation applications are reviewed by NCI grantsmanagement specialists, as outlined earlier in the section entitled "PreawardActivities." In addition, program directors carefully review the noncompetingcontinuation application and the applicant’s annual progress reportsubmitted with the non-competing continuation application to determine ifscientific progress is adequate to justify continued support. Exhibit E is anabbreviated example of a progress report. When all requirements are satisfied, an award for the next budget period is issued. This process is repeatedeach year of the project period.NCI grants management specialists also review non-competing continuationapplications that fall into the SNAP population. The basic principle of theSNAP award is that total costs for the entire competitive segment are negotiated at the time of the initial competing award, thus eliminating the need toengage in annual total cost negotiations. As part of that negotiation, NCIstaff assures that proposed costs are allowable, allocable, reasonable, andnecessary for the project. Requirements for financial documentation arestreamlined in that only an annual programmatic progress report from thegrantee and a quarterly Federal Cash Transaction Report are required to besubmitted by the grantee. These reports enable NCI staff to monitor thescientific and financial aspects of the project. In addition, a Financial StatusReport (FSR) is required within 90 days after the end of the competitivesegment. SNAP applications are screened by the NCI Grants AdministrationBranch staff to determine if the three streamlining questions have beenanswered. If responses to these questions are not readily apparent or areincomplete, the NCI sends a letter to the grantee business official requestingthat the required information be provided in writing.Although a specific dollar amount is indicated on the Notice of Grant Awardfor each future year of recommended support, the amount awarded is subjectto the availability of funds appropriated for the fiscal year, as well as otherconsiderations related to scientific progress. Grants may be negotiated andawarded for less than the recommended level. Conversely, in unusual situations where the grantee can justify the need for additional funds, the NCI hasthe authority to grant the increase as long as the peer-reviewed and approvedscope of the project is not being expanded.If the grantee wants to request additional funds to expand the scope of theproject, a competing supplemental application must be submitted according toestablished deadlines. These applications undergo dual review and competefor funds with all other investigator-initiated competing applications.

clearly documented in the official grant

e Office of Financial Management, NIH,

in the NIH official accounting records.

mitted to the grantee business office or is

d enabled. It is the grantee’s responsi

 In addition, copies of the NGA are

NCI offices.

ion awards, Congress must be alerted at

the award so the appropriate representa

heir constituents. If the award exceeds

o be informed. This requirement is

NGA to the Office of Congressional

he general and special provisions of an

 obtaining funds (see "Grant Payment"

em.

rograms, approval of a project may

p to five years. Awards, however, are

ubject to the appropriation of funds by

 funds for the first 12-month period and

for each budget period within the

iod within the project period must be

r in a progress report summary

ant Progress Report, Form PHS 2590, two

the next budget period. A fillable

e found on the PHS 2590 webpage at

/2590/2590.htm#forms under "Form

n the following pages of this publica

ress Report form is referred to as the

g non-competing applications (Type 5s)

ation, results in extra work for both NCI

53

PA R T II – PROCESS AND ADMINISTRATION
Postaward Administration

Grant PaymentTo minimize the impact of cash withdrawals on the public debt level and toreduce related financing costs, the U.S. Department of the Treasury hasissued regulations governing the flow of cash to recipient organizations.Specifically, grantees should not request funds until actually needed fordisbursement purposes. Grant payments are administered by the DHHSPayment Management System. Payment is primarily made by ElectronicFunds Transfer. The grantee can request DHHS grant funds by calling theDivision of Payment Management and requesting to use the CASHLINEprocess or by accessing SMARTLINK II through the Internet. Funds aredeposited directly into the recipient’s bank account on the next business day.Figure 13 (page 54) illustrates these processes in detail.Information on the Payment Management System is available from:

Division of Payment ManagementP.O. Box 6021Rockville, Maryland 20852(301) 443-1660http://www.dpm.psc.gov/

Reporting RequirementsReports by grantees are required at specific times, depending on the purposeof the reports and the needs of the programs. They are:• Immediate reporting:

– Financial Conflict of Interest.– Inventions.– Lobbying Disclosure.– Misconduct in Science.– Serious Adverse Events that occur in human gene transfer clinical

studies.

– Developments that have a significant impact on the award-supported

activities.

– Problems, delays, or adverse conditions, which materially impair the

ability to meet the objectives of the award.

55

PA R T II – PROCESS AND ADMINISTRATION

ent System: Electronic Funds Transfer —

CASHLINE

SMARTLINK II

DHHS, Division of

Payment Management

nk Federal Reserve Bank,

Richmond

NCI Computer

Center

DHHS, Division of

Payment Management

Federal Reserve Bank,

Richmond
– Termination Notice, for National Research Service Award (NRSA)

grants, which is the basis for validating the total period of NRSAsupport and the amount of payback obligation (if any) for eachNRSA trainee. A Termination Notice must be submitted for eachtrainee immediately upon the termination of his/her support.

Electronic Transmittal of Financial Status ReportsDHHS regulations under 45 CFR Part 74.73(d) and Part 92.41(b) dictate thatFinancial Status Report (FSRs), must be submitted to NIH within 90 calendardays after the last day of each budget period. For awards under SNAP,excluding those awards to Federal institutions and foreign organizations, FSRsare no longer required annually but, rather, are required 90 days after the endof the competitive segment. The submission of timely and accurate FSRs iscentral to ensuring prudent and efficient stewardship of public resources.To facilitate the submission of FSRs, the NIH developed an interactivecomputer-based communications system to enable grantee organizations toelectronically transmit FSRs to the NIH mainframe computer. The electronicprocess eliminates the manual preparation, mailing, and handling of thehard-copy FSR, as well as the manual processing once the FSR arrives at NIH.The current electronic system has several advantages: FSRs transmitted viathis system are processed within 72 hours; the system gives users immediatefeedback because it can detect errors; electronically submitted FSRs cannot belost in the mail or sent to the wrong address; and users of the system canaccess current listings of grants for which FSRs are past due or for which FSRswill become due as of a specified period of time (terminating grants).In an effort to further assist the grantee community, the NIH is developing anew electronic FSR process to replace the current system. Once NIH implements this new electronic process, grantees will be able to fill out, submit,and revise FSRs electronically, using a friendly, web-based system. The FSRswill be stored and accessed electronically by NIH staff. The NIH intends todeploy the electronic FSR module in late 2002.Additional information about the electronic transmittal of FSRs is availablefrom:

NIH Office of Financial ManagementGovernment Accounting BranchBuilding 31, Room B1B05A31 Center Drive MSC 2050Bethesda, Maryland 20892-2050(301) 402-9123

onal Research Service Award (NRSA)

signed by each postdoctoral individual

overs his/her initial 12 months of post

ayback Agreement is not required for

dy received 12 months of postdoctoral

t or award or for predoctoral or prebac

nce with the Food and Drug

the NIH funds all or part of a clinical

onal new drug (IND) or investigational

 (see Exhibit F). FSRs are required

ncluded in the streamlined non

NAP) population. However, annual FSRs

 Federal institutions and foreign organi

the SNAP population. For the SNAP

d no later than 90 days after the expira

segment or after the grant transfers to a

E).

This form must be submitted to the

ior to or at the start of each trainee’s

ent. A stipend (or other allowance) may

tment form has been submitted.

ties Certification (APAC). Individuals

 obligation must complete an APAC

obligation is fulfilled.

ys after the final budget period) 

tification.

 for Academic Research Enhancement

which is an addendum to the progress

57

PA R T II – PROCESS AND ADMINISTRATION
• Pay grantees on a reimbursement rather than an advance basis.

• Suspend or terminate the active grant.

RebudgetingThe grantee institution is permitted to rebudget between budget categorieswithin the total costs awarded to meet unanticipated requirements, providedthe expenditures (1) are within the scope of the approved project, (2)enhance and do not impede the successful continuation or completion of theproject, and (3) are allowable under governing regulations and policies.Some rebudgeting actions may require specific prior approval from the NCI.The NIH Grants Policy Statement and the terms of the award should beconsulted regarding current policies on rebudgeting and prior approvalauthority. The grants management specialist assigned to the project may alsobe contacted for advice. AuditsIn general, grantees who expend $300,000 or more in Federal awards arerequired by OMB Circular A-133 to have an annual audit performed by apublic accountant or a Federal, state, or local government audit organizationthat meets the standards specified in generally accepted government auditingstandards. This audit should include a review of the internal controls thatare maintained to provide reasonable assurance that financial operations areproperly conducted; financial reports are presented fairly and accurately;applicable laws, regulations, and other grant terms have been complied with;resources are managed and used in an economical and efficient manner; anddesired results and objectives are being achieved in an effective manner. TheFederal Government may, at its discretion, review the internal accounting andother control systems during or after NIH support of the grant activity.Grant AppealsThe regulations of the DHHS provide grantee institutions with the opportunity to appeal certain postaward administrative decisions made with regard todirect, discretionary project grants or cooperative agreements by DHHS agencies, which include the Institutes and Centers of the NIH (45 CFR Part16). While there are two levels of appeal—an informal NIH procedure and aformal Departmental procedure—the grantee must first exhaust the informalprocedure (and through it, have received a decision that upholds the agency’sadverse determination) before the Departmental Appeals Board will accept anappeal. The specific adverse determinations that may be appealed are:• A disallowance or other determination denying payment of an amount

claimed under an award.

mbers of the responsible grants manage

are printed on each NGA letter. These

ntinuous monitoring of the business

ormance of the particular project.

the review and assessment of informa

gress reports, financial reports, site visits,

so, before and/or after award, the Grants

ialist, and/or program director may visit

 institution with identified problems or

ress, management systems, and

 controls.

53, the NCI and other DHHS awarding

al, the U.S. Comptroller General, or any

he right of timely and unrestricted

ers, or other records of recipients that are

r to make audits, examinations, excerpts,

ents. This right also includes timely

 personnel for the purpose of interview

ments. The rights of access are not

od, but shall last as long as records are

und, NCI staff work with the applicant

r begin the resolution of the trouble

r a mutually agreeable course of action

rocess can proceed.

are found to be severe enough to

nvestigator or the grantee institution to

rch project for which the grant was

ion refuses to adopt required assurances

 social and economic policy, and/or if

ms of award, NCI staff may take any of

continuation award.

g continuation award.

ed.

onditions on the award.

59

PA R T II – PROCESS AND ADMINISTRATION
61

PART I – AN OVERVIEW Record Retention By the Grantee Generally, financial and programmatic records, supporting documents, and all other records that are required by the terms of a grant must be retained by the grantee for three years from the date the final annual expenditure report is submitted to the NIH. For awards under SNAP (except those to foreign organizations and Federal institutions), the retention period begins on the date the expenditure report for the entire competitive segment is submitted to

the NIH and applies to all records for the entire competitive segment.Foreign organizations and Federal institutions must submit annual expenditure reports for all awards including those under SNAP and must retainrecords for these awards including those under SNAP for three years from thedate of submission of the annual FSR to NIH. If an audit or other action isin process at the expiration of the three-year retention period, the records areto be retained until all issues arising from the audit have been resolved by theNCI.By the NCIIn general, official grant records are retained for a period of 6 years.Construction grant records are retained for 20 years. If a grant is involved inan appeal or litigation, the retention period begins when the case is closed.There is a three-year retention period for unfunded applications that beginsupon notification to the applicant that an award will not be made or uponwithdrawal of the grant application.

ply with the terms of an award.

tinuation award under the project period

ial is for failure to comply with the terms

 award is invalid because it was not

n or because it was fraudulently

NIH Appeals Office only after the grantee

rom the Institute or Center (IC). The

 Appeals Office within 30 days of receipt

oard composed of knowledgeable NIH

d IC will be convened and chaired by the

 review the case and make the final NIH

 uphold the original NIH decision, the

ermination within 30 days to the

d upon conclusion of grant support.

B staff after NCI staff determine that all

 all required work of the grantee have

ired to submit:

R).

submitted no later than 90 days after

r after the grant transfers to a new insti

ure that all necessary scientific and

n received, reviewed, and accepted.

s

es, but to describe all of them would be

 A few of the other more common

t limited to: approving a change of

pproving a change in the principal inves

ng administrative supplements, phaseout

g grant periods with or without addi

d financial reports.
63

PA R T III – FUNDING ALLOCATION

PART III

Funding Allocation 
NCI Budget Development Cycle

The budget development cycle for a fiscal year is about 30 months, with threephases of this process—formulation, presentation, and execution—overlapping. In the example below (Figure 16), FY 2002 is being executed while FY2003 is being presented and FY 2004 is being formulated during the 2002fiscal year.In the spring of each year, preliminary budgets are submitted; the NIH budgetis paralleled by a professional needs budget, referred to as the Bypass Budget,prepared by NCI. In September, revised versions of these budgets aresubmitted to the Office of Management and Budget. In January, thePresident’s Budget is submitted and Congressional justification hearings areheld in February, March, or April.Figure 16. NCI Budget Development Cycle

FY 2002FY 2003

FY 2004:

NCI Bypass

NIH Preliminary

OCTOBER

2001

OCTOBER

2002

OCTOBER

2003

OCTOBER

2004

ExecutionPresentationFormulation

Execution

Presentation Execution

ederal Budget

et process are components of the execu

S. Government. In the legislative

ommittees control funding for NCI

fices that are involved in the develop

igure 15.

65

nents of the NCI Budget Process

ents of the NCI Budget Process

PA R T III – FUNDING ALLOCATION 

SENATE

APPROPRIATIONS

Appropriations

Committee

Subcommittee

on Labor, HHS,

Education and

Related Agencies

AUTHORIZATIONS

Health,

Education, Labor,

and Pension

Committee

Subcommittee

on Public Health

stitute 

Bypass

Budget

Office of Management andBudgetOffice of Science Policy andTechnology

President’s Cancer PanelNational Cancer AdvisoryBoardBoards of Scientific Advisorsand Counselors
Funding Allocation:

A Practical ExampleThe following is an entirely imaginary distribution of a completely fictionalappropriation for Research Project Grants (RPGs) using the following theoretical assumptions:• Appropriation level of $1.696 billion.• Mandate to fund 1,180 competing RPGs.• Mandate that the average cost of the competing RPGs be no more than

$352,000 (an increase over the prior year equal to the biomedical inflation index).

AMOUNT NO. OF AWARDS

Step 1Appropriation $1,696,000,000Small Business Set-aside -76,000,000Non-competing commitments -1,205,000,000Competing availability 415,000,000Step 1aCompeting availability 415,000,000 1,180Set-aside for RFAs -29,000,000 -50Remaining for R01, P01, R21, etc. 386,000,000 1,130Step 2Remaining for R01, P01, R21, etc. 386,000,000 1,130The breakdown would be:

Allocation for R01, R37 255,000,000 760Allocation for P01 46,000,000 27Allocation for R21, R33 30,000,000 145Allocation for R03, etc. 7,000,000 93Reserve for exceptions 48,000,000 105

At this point, these amounts would be distributed to each of the three rounds.Step 3 would consist of setting pay lines for RPGs based on historical dataand current review results.

n Process: 1 - 2 – 3

al description of the three-step funding

t Grants (RPGs):

priated by Congress, take out:

ommitments, including the program

des (e.g., SBIR)

es (RFAs)

eting grants.

aining for competing grants:

ms (R01 and P01) and the smaller mech

.

ent in reserve for RPG exceptions

eview exceptions)

o Program Division Director for supple

annon Awards

review rounds.

ta and current review results, set

67

PA R T III – FUNDING ALLOCATION
69

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS

PART IV

Application Types and

Budget Mechanisms
Budget Activities

In fiscal year 2001, the National Cancer Institute’s budget totaled$3,753,721,000. Expenditures in the three major budget activities areoutlined in the following paragraphs.ResearchCancer Causation ResearchCancer causation research concentrates on the events involved in the initiation and promotion of cancer. It encompasses chemical and physicalcarcinogenesis, biological carcinogenesis, epidemiology, chemoprevention,and nutrition research. Studies in this area focus on external agents such aschemicals, radiation, fibers and other particles, viruses, parasitic infections,and host factors such as hormone levels, nutritional and immunologic status,and the genetic endowment of the individual, all of which contribute to theinitiation and promotion of cancer. Fiscal year 2001 cancer causationresearch expenditures totaled $880,612,000, accounting for 23.5 percent ofthe NCI budget.Detection and Diagnosis ResearchDetection and diagnosis research includes studies designed to improve diagnostic accuracy, provide better prognostic information to guide therapeuticdecisions, monitor the response to therapy more effectively, detect cancer atits earliest presentation, and identify populations and individuals at increasedrisk for the development of cancer. Areas of emphasis include improvementsin the detection and diagnosis of breast, cervical, and uterine cancers andprostate cancer; the transfer of molecular technologies from the laboratory toclinical practice; the identification of better prognostic markers; increasedavailability of human tumor samples with associated clinical information;and research to identify genetic alterations involved in tumor pathogenesisand behavior. Fiscal year 2001 detection and diagnosis research expenditurestotaled $260,542,000, accounting for 6.9 percent of the NCI budget.Treatment ResearchTreatment research is composed of preclinical and clinical research.Preclinical research focuses on the discovery of new antitumor agents andtheir development in preparation for testing in clinical trials. These agentsinclude both synthetic compounds and natural products. Clinical researchinvolves demonstrating the effectiveness of new anticancer treatmentsthrough their systematic testing in clinical trials. Phase I trials establish themaximum tolerated dose of a new agent; Phase II trials examine its efficacyagainst a variety of cancers; and Phase III trials compare the new treatment

s

s that may be used to identify the stages

 type defines the procedures and speci

ss the grant award.

port of a project that has not yet been

2) — Request for an additional period of

nded project. Competing continuation

competing continuation, competing

ons for funds.

for additional funds, either for the

future year previously recommended, to

eting) or to expand the scope of work

r additional time and/or funds beyond

to certain mechanisms, including MERIT

and Career (K) awards. These F and K

funds. R37s compete for funds, and

il review.

Type 5) — Request to pay next budget

es not compete for available funds.

Type 6) — Request for support of a

t has been transferred from one Institute

nstitution (Type 7) — Request for

has been transferred from one grantee or

Type 8) — Non-competing continuation

d from one IC to another.

Type 9) — Competing continuation (Type

 one IC to another.

71

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
SPOREs, which are funded under the P50 grant mechanism, focus on prevention, detection, diagnosis, and treatment research for a single cancer site.

They are awarded to institutions that demonstrate the ability to performsignificant translational research.In order to encourage the development of cancer research centers in regionsnot currently served by existing NCI-designated clinical or comprehensivecenters, the NCI awards planning and development grants, using the P20mechanism, to assist eligible institutions to develop the organizational capability that could lead to the formation and/or development of cancer researchcenters or SPOREs.NCI’s Comprehensive Minority Institution/Cancer Center Partnership (U54)awards are cooperative agreements designed to establish comprehensive partnerships between the Minority Serving Institution (MSI) and the NCI-designated Cancer Centers. The partnership focuses on cancer research and one ormore target areas in cancer research training and career development, education or outreach programs to minority communities. These awards improvethe effectiveness of Cancer Center research through education and outreachactivities specifically designed to benefit racial and /or ethnic minority populations in the region the Cancer Center serves. They also create a stable,long-term collaborative relationship between the MSI and NCI-designatedCancer Center in areas of cancer research, research training and career development, education and/or outreach that increase the emphasis on problemsand issued relevant to the disproportionate cancer incidence and mortality inminority populations. Fiscal year 2001 expenditures totaled $280,680,000 for Cancer CentersProgram support (including SPOREs and Comprehensive MinorityInstitution/Cancer Center Partnership awards), accounting for 7.5 percent ofthe NCI budget.Research Manpower DevelopmentThe NCI Research Manpower Development Program supports and maintainsa pool of adequately trained scientists qualified to perform cancer research.Grants under this program primarily provide stipend and salary support forbasic and clinical scientists to perform cancer research. The NationalResearch Service Award Program is the major mechanism for providing longterm, stable support for a wide range of promising scientists and clinicians.Individual awards are made directly to both pre- and postdoctoral fellows,while institutional awards are made to scientists who, together with a groupof faculty-preceptors, administer a comprehensive research training programfor pre- and postdoctoral trainees. The Research Career Program supports thetraining of both scientists and research physicians during the first three to fiveyears between receipt of a Ph.D., M.D., or other professional degree and

ms of improved survival and decreased

esearch expenditures totaled

rcent of the NCI budget.

ctrum of basic research on cancer and the

nclude investigations of cellular and

ls, interactions between cells within a

ost immune defense mechanisms.

e that accumulates in stages. It is the

 explain the stepwise progression

ll and final tumor development. Fiscal

s totaled $597,800,000, accounting for

 of a group of individual, nationally

institutions with outstanding scientific

 particular research talents and special

ear 2001, there were 60 centers that

upport and accounted for 5.1 percent of

port Grant (CCSG) mechanism (P30) to

esearch and outreach activities on several

 designated as one of three types: basic,

umber of different organizational settings.

ntities entirely dedicated to cancer

 have been formed as clearly identifiable

and promote interactive cancer research

 college structures (matrix centers); and

onsortium centers).

port to the peer-reviewed research base

institution. The CCSG supports the

e) of the center and partially pays for

ties. Research projects themselves are

nts and contracts from the NIH and

agencies and organizations.

 Excellence (SPOREs) are designed to

the laboratory to clinical practice.

73

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
Budget Mechanisms

The NCI’s budget is organized according to the following nine major fundingareas:• Research Project Grants.• Cancer Centers and Specialized Programs of Research Excellence.• Other Research Grants.• Training.• R&D Contracts.• Intramural Research.• Research Management and Support.• Cancer Prevention and Control.• Construction.The following section, organized in the order outlined above, details each ofthe funding mechanisms used by the NCI.Research Project GrantsResearch Project Grants are awards for investigator-initiated researchproposals. Several types of awards are made in this category, which vary inthe type of mechanism, type of applicant, total amount of support, andlength of time. Fiscal year 2001 research project grant expenditures totaled$1,696,603,000 accounting for 45.2 percent of the NCI budget.P01 Research Program Project GrantResearch Program Project Grants (P01s) support an integrated, multiprojectresearch approach involving a number of independent investigators whoshare knowledge and common resources. A P01 has a defined centralresearch focus involving several disciplines or several aspects of one discipline. Each individual project should contribute or be directly related to thecommon theme of the total research effort, thus forming a system of researchactivities and projects directed toward a well-defined research program goal.R01 Research Project GrantResearch Project Grants (R01s) support a discrete, specified research project tobe performed by the named investigator(s) in an area representing his/herspecific interest and competencies. This is generally referred to as a traditional research project grant.

nitiated award. Fiscal year 2001

ogram expenditures totaled

cent of the NCI budget.

orts cancer facility modernization and

of grant funds to nonprofit cancer

sities and medical centers throughout

stitutions to construct, expand, and

ories and clinical trial facilities. Funds

nts and standards as judged by a peer

. At a minimum, the NCI construction

 by non-Federal funds from the recipient

also used to maintain the Federal facili

 Research and Development Center

 nearly 70-acre Government-owned,

eriodic routine maintenance and repair

 modernization or creation of research

 Program expenditures totaled

0.1 percent of the NCI budget. Of this

ncer Research Facilities (extramural)

trol Program conducts basic and applied

d extramural mechanisms in all phases of

 as cancer surveillance. A key priority of

for the effective translation of knowledge

esearch into health promotion and

enefit of the public. An integrated

s, and applications research is in place

on and control activities across the

rogram includes four components and

relate to other program activities of the

ation, epidemiology, and cancer treat

ncer Prevention Research, Cancer Control

nity Oncology, and Cancer Surveillance.

nd Control Program expenditures totaled

rcent of the NCI budget.

75

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
ization. Generally, support for Phase I STTR awards may not exceed

$100,000 for direct and indirect costs and a fixed fee for a period normallynot to exceed one year. Note: Phase I award levels and project periods arestatutory guidelines. Therefore, applicants are encouraged to propose abudget and project that is appropriate for completion of the research project.Deviations from the guidelines must be well justified.R42 Small Business Technology Transfer (STTR) Grant—Phase IIPhase II STTR Grants (R42s) support in-depth development of cooperativeresearch and development projects between small domestic for-profit organizations and research institutions, limited in time and amount, for whichfeasibility has been established in Phase I (R41) and which have potential forcommercialization. Generally, support for Phase II awards may not exceed$500,000 for direct and indirect costs and a fixed fee for a period normallynot to exceed two years. Note: Phase II award levels and project periods arestatutory guidelines. Therefore, applicants are encouraged to propose abudget and project that is appropriate for completion of the research project.Deviations from the guidelines must be well justified.R43 Small Business Innovation Research (SBIR) Grant—Phase IPhase I SBIR Grants (R43s) support research efforts by for-profit domesticsmall businesses. The objective of this phase is to establish the technicalmerit and feasibility of proposed research or research and development(R&D) efforts and determine the quality of performance of the small businessawardee organization prior to providing further Federal support in Phase II(R44). Generally, support for Phase I awards may not exceed $100,000 fordirect and indirect costs and a fixed fee for a period normally not to exceedsix months. Note: Phase I award levels and project periods are statutoryguidelines. Therefore, applicants are encouraged to propose a budget andproject that is appropriate for completion of the research project. Deviationsfrom the guidelines must be well justified.R44 Small Business Innovation Research (SBIR) Grant—Phase IIPhase II SBIR Grants (R44s) continue those R&D efforts started in Phase I(R43). Awards will be based on the results of Phase I and the scientific andtechnical merit and commercial potential of the Phase II application. OnlyPhase I awardees are eligible for Phase II. Generally, support for Phase IImay not exceed $750,000 for direct and indirect costs and a fixed fee for aperiod normally not to exceed two years. Note: Phase II award levels andproject periods are statutory guidelines. Therefore, applicants are encouragedto propose a budget and project that is appropriate for completion of theresearch project. Deviations from the guidelines must be well justified.

e research support specifically limited in

orical program areas. Small research

g studies that are generally for prelimi

ts are non-renewable.

Grant

1s) support the development of new

am areas. Support generally is restricted

Support and Transition (FIRST) Award

ent initial period of research support for

tigators to develop their research capabil

eir research ideas. This award mecha

d out.

Grant—Phase II

ment Grants (R33s) provide a second

exploratory, and developmental research

hanism.

ant (OIG)

ort to encourage experienced investiga

search productivity to embark on long

a categorical program area. This award

 phased out.

in Time (MERIT) Award

erm grant support to investigators whose

y are distinctly superior and who are

n an outstanding manner. Investigators

After initial review, NCI staff and the

ew competing R01 applications to select

 MERIT Award is followed by an oppor

more years, based on an expedited

g the initial period.

ransfer (STTR) Grant—Phase I

ooperative research and development

profit organizations and research institu

amount and are used to establish the

s that have a potential for commercial

77

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
award levels and project periods are statutory guidelines. Therefore, applicants are encouraged to propose a budget that is appropriate for completion

of the research project. Deviations from the guidelines must be well justified.Cancer Centers and Specialized Programs of ResearchExcellenceThe Cancer Research Centers Program as a whole contains a great diversity ofresearch approaches to the problem of cancer, incorporating all applicabledisciplines. Fiscal year 2001 Cancer Research Centers Program expenditurestotaled $279,731,000, accounting for 7.5 percent of the NCI budget.P20 Planning GrantPlanning Grants (P20s) support planning for new programs, expansion ormodification of existing resources, and feasibility studies for new approaches.Such awards have been particularly useful in the development of cancercenters and SPORES.P30 Cancer Center Support GrantCancer Center Support Grants (P30s) provide support primarily for theresearch infrastructure of an active and unified cancer center for the purposeof consolidating and focusing cancer-related activities, increasing researchproductivity, promoting shared use of research resources and improvedquality control, stimulating and promoting interdisciplinary and collaborativeresearch, and increasing the rate at which research discoveries are translatedinto medical benefits.P50 Specialized Center GrantSpecialized Center Grants (P50s) support any part of the full range of researchand development from very basic to clinical activities and may involve ancillary supportive activities such as protracted patient care necessary to theprimary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on cancer. These grants differ from Program ProjectGrants in that they are usually developed in response to an announcement ofthe programmatic needs of the NCI and later receive continuous attentionfrom its staff. Centers may also serve as regional or national resources forspecial research purposes.U54 Specialized Center – Cooperative AgreementSpecialized Center Cooperative Agreements (U54s) support any part of thefull range of research and development from very basic to clinical; mayinvolve ancillary supportive activities such as protracted patient care necessaryto the primary research or R&D effort. The spectrum of activities comprises amultidisciplinary attack on a specific disease entity or biomedical problemarea. These differ from program project in that they are usually developed in

s Award

mited award to investigators to further

niques; perform secondary analysis of

of innovative and creative approaches;

hat can demonstrate their research capa

 their already meritorious applications.

e Agreement

ort discrete, specified, circumscribed

ed investigator(s) in an area representing

es. This mechanism is utilized when

nt is anticipated between the NCI and

he contemplated activity.

ve Agreement

ments (U19s) support research programs

oward a specific major objective, basic

broadly based multidisciplinary and

al Federal programmatic staff involve

rs during performance of research activi

ditions of award. This mechanism can

ed resources, including clinical compo

ch effort.

esearch (SBIR) Cooperative

 (U43s) support projects, limited in

hnical merit and feasibility of research

may ultimately lead to commercial prod

utilized when an assistance relationship

pient and in which substantial program

ween the NCI and the recipient during

ivity. Cooperative agreement applica

topics specifically listed in the current

hase I award levels and project periods

pplicants are encouraged to propose a

e for completion of the research project.

be well justified.

esearch (SBIR) Cooperative

44)

s (U44s) support in-depth development

s been established in Phase I (U43) and

 products or services. Note: Phase II

79

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
K08 Mentored Clinical Scientist Development Award

Mentored Clinical Scientist Development Awards (K08s) support the development of outstanding clinical research scientists. These awards providespecialized study for clinically trained professionals who are committed to acareer in research and have the potential to develop into independent investigators. NCI provides support for the K08 through the Clinical InvestigatorAward and the Minorities in Clinical Oncology Award.K12 Mentored Clinical Scientist Development Program AwardMentored Clinical Scientist Development Program Awards (K12s) supportnewly trained clinicians appointed by an institution for development of independent research skills and experience in a fundamental science within theframework of an interdisciplinary research and development program.K22 Career Transition AwardCareer Transition Awards (K22s) support newly trained basic or clinical investigators to develop their independent research skills through a two-phaseprogram—an initial period involving an intramural appointment at NIH anda final period of support at an extramural institution. The award is intendedto facilitate the establishment of a record of independent research by theinvestigator in order to sustain or promote a successful research career. TheNCI supports two K22 awards: the Scholars Program and the TransitionCareer Development Award. The NCI Scholars Program provides an opportunity for outstanding new investigators to begin independent researchcareers first intramurally within the special environment of the NCI and thento continue their careers extramurally at an institution of their choice. TheNCI Transition Career Development Award is a fully portable mechanism thatfacilitates the transition of talented clinician cancer scientists, clinicians inpatient-oriented cancer research and researchers in cancer prevention, controland the population sciences from the mentored stage of their careers to juniorfaculty positions or equivalent.K23 Mentored Patient-Oriented Research Career Development AwardMentored Patient-Oriented Research Career Development Awards (K23s)provide support for the career development of investigators who focus theirresearch endeavors on patient-oriented research. The mechanism providessupport for a period of supervised study and research for clinically trainedprofessionals who have the potential to develop into productive clinicalinvestigators.K24 Mid-Career Investigator in Patient-Oriented Research AwardMid-Career Investigator in Patient-Oriented Research Awards (K24s) provideclinicians the opportunity to dedicate time for patient-oriented research andto mentor other clinical investigators.

programmatic needs of an Institute or

ntinuous attention from its staff.

national resources for special research

taff helping to identify appropriate

pport comprehensive partnerships

s (MSIs) and the NCI-designated Cancer

e partnerships focus on cancer research

er research training or cancer research

e partnerships may also focus on cancer

ucation for or cancer outreach to

Career Program and all other research

ct Grants, Research Centers, and/or

t for National Research Service Awards.

cludes all "K" awards. Fiscal year 2001

269,201,000, accounting for 7.2 percent

 Development Award

ment Awards (K01s) provide research

f sponsored research experience as a way

w to the applicant or in an area that

plicant’s scientific career. NCI supports

Award and the Mentored Career

rt outstanding established scientists who

level of productivity, research accom

er prevention, control and population

vide protected time to devote to research

tigators.

ort more junior candidates who are

d research expertise in a specific area or

ith acknowledged scientific expertise and

n improving the curricula and enhancing

demic institution.

81

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
S06 Minority Biomedical Research Support (MBRS)

Minority Biomedical Research Support (MBRS) grants provide funds tostrengthen the biomedical research and research training capability of ethnicminority institutions, thus creating a more favorable milieu for increasing theinvolvement of minority faculty and students in biomedical research.T09 Scientific EvaluationScientific Evaluation awards (T09s) provide the chairman of a trainingcommittee funds for operation of a review group.U09 Scientific Review and Evaluation (Cooperative Agreement)Scientific Review and Evaluation Cooperative Agreements (U09s) provide thechairman of an Initial Review Group (IRG) funds for operation of the IRG.U10 Clinical Research Cooperative AgreementClinical Research Cooperative Agreements (U10s) support clinical evaluationsof various methods of therapy and/or prevention in specific disease areas.These represent cooperative programs between sponsoring institutions andparticipating principal investigators, and are usually conducted under established protocols. U13 Conference Cooperative AgreementConference Cooperative Agreements (U13s) support international, national,or regional meetings, conferences, and workshops where substantial programmatic NCI staff involvement is planned to assist the recipients.U24 Resource-Related Research Project Cooperative AgreementResource-Related Research Project Cooperative Agreements (U24s) supportprojects contributing to the improvement of the capability of resources toserve biomedical research.U56 Exploratory Grant – Cooperative AgreementExploratory Grant Cooperative Agreements (U56s) support planning for newprograms, expansion or modification of existing resources, and feasibilitystudies to explore various approaches to the development of interdisciplinaryprograms that offer potential solutions to problems of special significance tothe mission of the NIH. These exploratory studies may lead to specialized orcomprehensive centers. Substantial Federal programmatic staff involvement isintended to assist investigators during performance of the research activities,as defined in the terms and conditions of award.

arch Career Development Award

er Development Awards (K25s) support

rs with quantitative scientific and engi

gy or medicine who have made a

ndeavors on behavioral and biomedical

ard

0s) support the development, conduct,

igned to improve the quality of the

investigators.

tional or international meetings, confer

ue in promoting the goals of the National

ment Award (AREA)

ale research projects conducted by

ree-granting domestic institutions.

t costs (plus applicable indirect costs)

Project

R24s) support research projects that will

o serve biomedical research.

port the development and implementa

, information provision, training, tech

uation. The NCI supports two distinct

cer Education and Career Development

rant Program (CEGP). The NCI Cancer

Program (R25T) is an institutional grant

ent and implementation of curriculum

oral and postdoctoral candidates in

y inter-disciplinary and collaborative.

gram (CEGP) is a flexible, curriculum

and sustaining innovative educational

e cancer incidence, mortality and

he quality of life of cancer patients. The

 that is not fulfilled adequately by any

NIH. These awards are dedicated to areas

83

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
Fiscal year 2001 R&D contract expenditures totaled $283,971,000, accounting

for 7.6 percent of the NCI budget.Intramural ResearchThe NCI intramural research program complements the extramural researchprogram and is housed on the NIH campus in Bethesda and at the FrederickCancer Research and Development Center in Frederick, Maryland. Fiscal year2001 intramural research program expenditures totaled $567,297,000,accounting for 15.1 percent of the NCI budget.Research Management and SupportThere are many activities that provide general management and support tothe NCI’s cancer research effort. Funding for research management andsupport (RMS) has remained relatively constant over the last several years.Fiscal year 2001 RMS expenditures totaled $136,509,000, accounting for 3.6percent of the NCI budget.Cancer Prevention and ControlThe NCI cancer prevention and control program supports research onmethods of cancer prevention and control conducted through grants,contracts, and in-house research. Fiscal year 2001 cancer prevention andcontrol program expenditures totaled $459,482,000, accounting for 12.2percent of the NCI budget.U10 Clinical Research Cooperative Agreement (See earlier discussionunder "Other Research Grants" section.)ConstructionThe NCI’s construction program supports the creation of additional state-ofthe-art cancer research laboratories and clinics for both basic and appliedcancer research. Fiscal year 2001 construction program expenditures totaled$3,000,000, accounting for less than 0.1 percent of the NCI budget.C06 Research Facilities Construction GrantResearch Facilities Construction Grants (C06s) provide matching Federalfunds for up to 75 percent of allowable costs for construction or majorremodeling to create new facilities for cancer research. In addition to basicresearch laboratories, construction grants may support the construction orrenovation of animal facilities, limited clinical facilities, and core facilitiesthat are an integral part of an overall cancer research effort. The request forNCI funding must be in excess of $150,000 and not more than $4 millionper application.

(NRSA) is the major mechanism for

or a wide range of promising scientists

001 NRSA expenditures totaled

ent of the NCI budget.

nal Research Service Award

arch Service Awards (F31s) provide

ed research training in specified health

rd the research degree (e.g., Ph.D.).

onal Research Service Award 

earch Service Awards (F32s) provide

viduals to broaden their scientific back

 research in specified health-related

ward for Senior Fellows

Senior Fellows (F33s) provide opportu

ke major changes in the direction of

ckground, acquire new research capabil

esearch field, or take time from regular

asing capabilities to engage in health

rch Service Award

ce Awards (T32s) support training oppor

toral level at qualified institutions.

cilities for the proposed program. After

aining program director is responsible

inistering the program. This program

ivities (Grant)

MARC) Ancillary Training Activities

f well-trained minority scientists in

hen the research and teaching capabili

CI cofunds these grants with the National

d or a project needs to be conducted

e contract mechanism is appropriate.

85

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
• Minority Undergraduate Student (MUS)—provides support to minority

undergraduate students who have demonstrated an interest in biomedicalor behavioral sciences and wish to pursue graduate-level training in theseareas.

• Minority High School Student (MHS)—provides support to minority

high school students who have an interest in the biomedical or behavioral sciences.

Supplements to Promote Reentry into Biomedical andBehavioral Research CareersThe NCI provides administrative supplements through a cofunding agreementwith the NIH Office of Research on Women’s Health to existing researchgrants for support of full- or part-time research by individuals with highpotential to re-enter an active research career after taking time off to attend tofamily responsibilities. These supplements provide a maximum of threeyears of support. The program is not intended to support graduate or postgraduate training and is not intended to support career changes from nonresearch to research careers for individuals without prior research training.Research Supplements to Promote the Recruitment ofIndividuals with Disabilities into Biomedical Research CareersThe NCI provides administrative supplements to active research grants for thesupport of full-time research by individuals with qualifying disabilities whoare capable of entering or resuming research careers.Travel Award for Young InvestigatorsThe NCI provides support through a travel fellowship for minority studentand faculty researchers and young minority clinicians. The intent of theprogram is to increase the attendance of minority scientists at national meetings and, in particular, to stimulate the participation of predoctoral and postdoctoral minority individuals as well as young minority clinicians in cancerresearch. The Minority Scholar in Cancer Research Award covers the costs ofregistration, transportation, meals, and lodging at the national AmericanAssociation for Cancer Research (AACR) and American Society for ClinicalOncology (ASCO) meetings.Historically Black Colleges and Universities Faculty in the Fieldof Cancer AwardThe NCI provides support for travel and subsistence to support the attendanceof meritorious faculty members from eligible institutions at annual meetingsor special conferences on more focused scientific topics of the AACR.

Minority 

am

dical Branch (CMBB) coordinates NCI’s

ncer-related research and training activi

sabilities, underserved segments of the

eeking reentry. Located within NCI’s

urces, the CMBB oversees the following

a of Research Experiences (CURE), career

patient oriented research, clinical

al oncology research, transition career

owship awards and the Cancer Center

within the CMBB. For questions

 new initiatives, contact the

 Branch at (301) 496-7344.

derrepresented Minorities in

y Biomedical Branch (CMBB), the NCI

minority individuals who are pursuing

at address the mission of the National

t (MIS)—provides short-term and long

nvestigators to participate in ongoing

veloping their own independent

oral Training (MIPT)—provides support

h to participate as postdoctoral

projects in preparation for independent

avioral sciences.

tants (MGRA)—provides support to

wish to develop research capabilities in

iences.

ers Degree Students (MPBM)—provides

ureate and post masters degree graduates

elated research while applying for grad

87

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
Centers in developing and sustaining activities focused on the disproportionate incidence, mortality, and morbidity in minority populations in the

region the cancer center serves.• Planning Grant for Minority Institution/Cancer Center Collaboration

(P20).

• Comprehensive Minority Institution/Cancer Center Partnership (U54).• Cooperative Planning Grant for Comprehensive Minority

Institution/Cancer Center Partnership (U56).

s for Minority Students

ips to minority students who are

arch degree. Included in this initiative

r Students with Disabilities who are

nal Training Initiative

esses the problem of low numbers of

rs, and other health professionals

 training in cancer-related subspecialties.

re intended for the career development

zing the K01, K07, or K08 mechanism.

Award (K01).

ward (K07).

(K08).

Award (K22).

rch (K23).

ment and Retention of Minority

search (R13).

rch Experiences (CURE)

ments to the R25T, K12, T32, and P30

periences at the high school level with

inority scientists who are capable of

rch.

nter Program

mplementation of pilot

rations between scientists and faculty at

 cancer center. NCI also supports the

ps between minority serving institutions

r groups of centers. The long range goal

ncer research capabilities of a minority

umber of minority scientists engaged in

fectiveness of NCI-designated Cancer

89

PA R T IV – APPLICATION T YPES AND BUDGET MECHANISMS
91

PA R T V – REFEREMCES AMD RESOURCES Map of NIH Main Campus, Bethesda, Maryland http://des.od.nih.gov/eWeb/parking/html/parking.htm

PART V

References and Resources
extramural research and research training programs, requesting publications, and

learning more about obtaining the NIH Guide for Grants and Contracts and otherinformation on the NIH system of web sites. Organizations may request application kits and forms from GrantsInfo if these materials cannot be accessed fromone of the following web sites (http://grants.nih.gov/grants/forms.htm) or(http://grants.nih.gov/grants/oer.htm).

GrantsInfoDivision of Extramural Outreach and Information ResourcesOffice of Extramural ResearchNational Institutes of Health6701 Rockledge Drive, Suite 3210Bethesda, MD 20892-7910Telephone: (301) 435-0714E-mail: GrantsInfo@nih.gov

Additional Information ResourcesAdditional grants information may be obtained by referring to the publications listed below.The following publications may be obtained from the Internet:• NIH Grants Policy Statement (Revised 3/1/01):

http://grants.nih.gov/grants/policy/nihgps_2001/

• NIH "Welcome Wagon" Letter -- Information for New Grantees 

(also helpful to established grantees) http://grants.nih.gov/grants/funding/welcomewagon.htm

• Catalog of Federal Domestic Assistance (CFDA):

http://aspe.os.dhhs.gov/cfda/index.htm orhttp://www.cfda.gov/default.htm

• NCI Fact Book: National Cancer Institute:

http://www.nci.nih.gov/admin/fmb/

Most NCI publications may be found on the web athttps://cissecure.nci.nih.gov/ncipubs/. Hard copies of most NCI publicationscan be obtained from:

Office of CommunicationsNational Cancer InstituteNational Institutes of HealthBuilding 31, Room 10A16Bethesda, Maryland 20892Toll-free number for the public: 1-800-4-CANCER TTY number for the deaf: 1-800-332-8615

es of Information

ion Information

ation provide a general description of a

 have served as an introduction to the

an overview of the various aspects of

es and Review and Award

plication receipt dates and review and

o the Division of Receipt and Referral,

IH, at (301) 435-0715. CSR’s homepage

sting $500,000 or more in direct costs

eement to accept assignment from

s prior to the anticipated submission of

ble to provide pre-submission advice on

ovide helpful comments and advice

 in preparing an application. 

the Office of Referral, Review, and

xtramural Activities (DEA), NCI, at 

Requests for Applications

ribe continuing, new, or expanded 

plications are invited and Requests 

invite grant applications in a well

a specific NCI programmatic 

uide for Grants and Contracts

dex.html). The NIH Guide for Grants

n of NIH program and policy notices. 

xtramural Research (OER) web site

).

 Guide for Grants and Contracts can be

ervice of the Division of Extramural

OER, Office of the Director, NIH.

btaining general information about NIH

93

PA R T V – REFEREMCES AMD RESOURCES
• NIH Grants and Contracts Page:

http://grants.nih.gov/grants/index.cfm

• NIH Office of Extramural Research (OER) Home Page:

http://grants.nih.gov/grants/oer.htm(Note: Electronic Research Administration (ERA), Edison, Peer ReviewPolicy and Issues, NIH Guide for Grants and Contracts, and CRISP can allbe accessed through this web site.)

• NIH Funding Opportunities: Grants:

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

• NIH Forms and Applications: 

http://grants.nih.gov/grants/forms.htm

• NIH Grants Policy and Guidance: 

http://grants.nih.gov/grants/policy/policy.htm

• NIH Guide for Grants and Contracts:

http://grants.nih.gov/grants/guide/index.html

The additional web sites listed below may also contain helpful information.• U.S. Federal Government Agency index:

http://www.lib.lsu.edu/gov/fedgov.html

• Code of Federal Regulations: 

http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

• Office of the Federal Register, National Archives and Records Administration:

http://www.access.gpo.gov/nara/index.html

• Office of Management and Budget (OMB) Circulars: 

http://www.whitehouse.gov/omb/circulars/

able from:

and Information Resources

g for Research and Research Training)

search Grant Application for the NIH"

ant Applications"

o the National Institutes of Health"

t Application to the National Institutes

nt Applications to the NIH: Views of an

strator"

tion to the National Institutes of Health:

elow may contain helpful information.

ab/index.htm

his publication, Everything You Wanted

rocess, can be accessed through this web

u think of this publication by contacting

ur web site.)

y, Maps, Almanac, Director’s Page:

95

PA R T V – REFEREMCES AMD RESOURCES
97

PA R T VI – CROSS-CUTTING PUBLIC POLICIES

PART VI

Cross-Cutting Public

Policies

ce of the 

rector

(OD)

National

Institute

on Aging

(NIA)

nter for

ormation

hnology

(CIT)

Center for

Scientific

Review

(CSR)

National

Institute of

Mental Health

(NIMH)

National

Institute of

Neurological

Disorders

and Stroke

(NINDS)

National

Center for

Complementary

and Alternative

Medicine

(NCCAM)

National

Center on

Minority Health

and Health

Disparities

(NCMHD)

National

Center for

Research

Resouces

(NCRR)

Office of the Director Staff Offices:Office of Extramural ResearchOffice of Intramural ResearchOffice of ManagementOffice of Science PolicyOffice of BudgetOffice of Communications and Public LiaisonOffice of Equal OpportunityOffice of Program CoordinationOffice of Legislative Policy and AnalysisOffice of Community LiaisonExecutive OfficeOffice of the Ombudsman/Center for

Cooperative Resolution

National

Heart, Lung,

and Blood

Institute

(NHLBI)

National

Institute on

Alcohol

Abuse and

Alcoholism

(NIAAA)

National

Institute of

Child Health

and Human

Development

(NICHD)

National

Institute of

Dental and

Craniofacial

Research

(NIDCR)

National

Institute on

Deafness and

Communications

Disorders

(NIDCD)

National

Institute of

General Medical

Sciences

(NIGMS)
cable state or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are

required to comply, as applicable, with the Animal Welfare Act asamended (7 USC 2131 et seq.) and other Federal statutes and regulationspertaining to animals.

• Architectural Barriers to the Handicapped (Elimination of)—

Architectural Barriers Act of 1968, as amended, the Federal PropertyManagement Regulations 101-19.6 (41 CFR 101-19.6), and the UniformFederal Accessibility Standards issued by the General ServicesAdministration (41 CFR 101-19.6, Appendix A) set forth requirements tomake facilities accessible to, and usable by, the physically handicapped,and include minimum design standards. All facilities constructed orrenovated with NCI grant support must comply with these requirements.These minimum standards must be included in the specifications for anyNCI-funded renovation or new construction. The grantee is responsiblefor conducting inspections to ensure compliance with these standards byany contractor performing construction services under the grant.

• Civil Rights—(45 CFR Part 80) The Civil Rights Act of 1964, Title VI,

requires that no person in the United States shall, on the basis of race,color, or national origin, be excluded from participation in, be denied thebenefits of, or be subjected to discrimination under any program oractivity receiving Federal financial assistance. The DHHS implementingregulations are codified at 45 CFR Part 80.

• Data and Safety Monitoring—NCI requires oversight and monitoring of

all human intervention studies to ensure the safety of participants and thevalidity and integrity of the data. This policy is in addition to any monitoring requirements imposed by 45 CFR Part 46, FDA, and the NIHGuidelines for Research Involving Recombinant DNA Activities. Thelevel of monitoring should be commensurate with the risks and the sizeand complexity of the clinical trial. Oversight and monitoring underPhase III clinical trials must be in the form of Data Safety MonitoringBoards (DSMBs). A DSMB also may be appropriate for Phase I and IIclinical trials if the studies have multiple clinical sites, are blinded(masked), or employ particularly high-risk or vulnerable populations.The DSMB monitoring function is above and beyond that traditionallyprovided by Institutional Review Boards (IRBs). However, the IRB mustbe cognizant of the procedures used by DSMBs, and the DSMBs mustprovide periodic reports to investigators for transmittal to the local IRB. 

• Debarment—(45 CFR Part 76 and 45 CFR Part 92.43) This action is

taken by a debarring official in accordance with Federal agency regulations implementing Executive Order 12549 to exclude a person or organi99

blic Policies

requirements applicable to Federal

e NIH and the NCI. The term “public

t is based on social, ecomonic, or other

 be attached to the expenditure of

m participants, and contractors, in

ure of Federal funds or research or other

oss-cutting requirements that apply to

rams, NIH grantees are subject to

ual appropriations acts that apply to the

se requirements are included here

priations acts for several years without

be changed or other requirements may

nds to uphold high ethical, health, and

of the research it funds and the expendi

The public policy requirements specified

dards. The signature of the authorized

tion certifies that the organization is in

ly with, all applicable certifications and

cases, included) in the application

 as discussed in this section:

nding—All HHS grantees must acknowl

ng statements, press releases, requests for

her documents describing projects or

part with Federal money. Grantees are

ge and dollar amounts of the total

d with Federal money, and (2) the

 the total costs financed by nongovern

cy Statement, Part II, Subpart A: Terms

wards).

art 91) The Age Discrimination Act of

n the basis of age in any program or

l assistance. The DHHS implementing

R Part 91.

4) Animal welfare refers to special

 involving the use of live vertebrate

erimentation, testing, and related

mply with the PHS Policy on Humane

mals. This policy does not affect appli

PA R T VI – CROSS-CUTTING PUBLIC POLICIES
individual in the United States shall, solely by reason of the handicap, be

excluded from participation in, denied the benefits of, or subjected todiscrimination under any program or activity receiving Federal financialassistance. The DHHS implementing regulations are codified at 45 CFRParts 84 and 85.

• Human Embryo Research, Continued Ban on Funding—NCI appropriated funds may not be used to support human embryo research under

any extramural award instrument. NIH funds may not be used for thecreation of a human embryo(s) for research purposes or for research inwhich a human embryo(s) is destroyed, discarded, or knowinglysubjected to risk of injury or death greater than that allowed for researchon fetuses in utero under 45 CFR 46.208(a)(2) and subsection 498 (a)and (b) of the PHS Act. The term "human embryo(s)" includes anyorganism not protected as a human subject under 45 CFR 46, as of thedate of enactment of the governing appropriations act, that is derived byfertilization, parthenogenesis, cloning, or any other means from one ormore human gametes or human diploid cells. In addition to the statutory restrictions on human fetal research under subsections 498 (a) and(b) of the PHS Act, by Presidential memorandum of March 4, 1997, NCIis prohibited from using Federal funds for cloning of human beings.

• Human Embryonic Stem Cell Research—For the latest on human

embryonic stem cell research, please refer to the following website:http://www.nih.gov/news/stemcell/index.htm.

• Lobbying (Anti-Lobbying)—(45 CFR Part 93) Recipients of Federal

grants, cooperative agreements, contracts, and loans are prohibited by 31USC 1352, "Limitation on Use of Appropriated Funds to InfluenceCertain Federal Contracting and Financial Transactions," from usingFederal (appropriated) funds to pay any person for influencing orattempting to influence any officer or employee of an agency, a Memberof Congress, an officer or employee of Congress, or an employee of aMember of Congress with respect to the award, continuation, renewal,amendment, or modification of any of these instruments. These requirements are implemented for HHS in 45 CFR Part 93, which also describestypes of activities, such as legislative liaison activities and professionaland technical services, which are not subject to this prohibition.Applicants for NIH awards with total costs expected to exceed $100,000are required to certify that (1) they have not made, and will not make,such a prohibited payment, (2) they will be responsible for reporting theuse of non-appropriated funds for such purposes, and (3) they willinclude these requirements in consortium agreements and contractsunder grants that will exceed $100,000 and obtain necessary certifications

101

actions. Grantees may be debarred or

ave seriously and willfully not complied

d to have engaged in scientific miscon

 not receive Federal assistance funds and

ansactions for the period covered by the

Part 76, Subpart F) The Drug-Free

aw 100-690, Title V, Subtitle D, as

izations receiving grants from any

 a drug-free workplace. Under this law,

ited from engaging in the unlawful

nsing, possession, or use of a controlled

he application, the authorized organiza

ntee will provide a drug-free workplace

nts to notify NCI in the event that an

g a criminal drug statute. Failure 

ts may be cause for debarment. 

re set forth in 45 CFR Part 76,

nd Suspension (Non-procurement) and

for Drug-Free Workplace (Grants)."

uired to submit a final Financial Status

t and Certification, and final progress

he end of grant support unless an exten

lure to submit timely and accurate final

 to the organization or awards to the

ecords and other information can be

om the Government under the Freedom

66. However, there are certain rules and

in handling requests for records under

(45 CFR Parts 84 and 85) Before a grant

pplicant organization must certify that 

04 of the Rehabilitation Act of 1973, 

 Act provides that no handicapped 

PA R T VI – CROSS-CUTTING PUBLIC POLICIES
subject invention must be included in any patent application stemming from

a subject invention. The Federal Government must be granted a nontransferable, nonexclusive, royalty-free, paid-up license to practice the subject invention. For final closeout of a research grant application, the grantee mustprovide the awarding Institute a Final Invention Statement and Certification(Form HHS 568) within 90 days following the expiration or termination ofthe project period. Any issues involving extramural subject inventionreporting requirements should be directed to the Division of ExtramuralInvention Reports and Technology Resources, Office of Extramural Activities,NIH. Requests should be directed to:Division of Extramural Reports and Technology ResourcesOffice of Policy for Extramural Research AdministrationOffice of Extramural ResearchBuilding 31, Room 5B62Bethesda, Maryland 20892Telephone: (301) 435-1986.

• Privacy Act—(45 CFR Part 5b) The Privacy Act of 1974, 5 USC 552a,

provides certain safeguards for information about individuals maintainedin a system of records, as identified by the Act (i.e., information may beretrieved by the individual's name or other identifying information).These safeguards include the rights of individuals to determine whatinformation about them is maintained in Federal agencies' files (hardcopy or electronic) and how it is used, to have access to such records, andto correct, amend, or request deletion of information in their records thatis inaccurate, irrelevant, or outdated. Records maintained by NCI withrespect to grant applications, grant awards, and the administration ofgrants are subject to the provisions of the Privacy Act. Requests shouldbe directed to:NCI Privacy Act CoordinatorBuilding 31, Room 10A34Bethesda, MD 20892.

• Program Fraud Civil Remedies Act—(45 CFR Part 79) The Program

Fraud Civil Remedies Act of 1986, Public Law 99-509, imposes civilpenalties against persons who make false, fictitious, or fraudulent claimsto the Federal Government for money (including money representinggrants, loans, or other benefits).

• Protection of Children—The Pro-Children Act of 1994, Public Law 103-

227, Title X, Part C, imposes restrictions on smoking in facilities wherefederally funded children's services are provided. The Act specifies thatsmoking is prohibited in indoor facilities (or in some cases portions of

103

nts and contractors. The signature of the

 on the application serves as the

nce for the applicant organization. NIH

sed to pay the salary or expenses of an

m participant, or contractor or those of

esigned to influence legislation or appro

ss or any State legislature. 

R Part 50) Fabrication, falsification,

t seriously deviate from those commonly

mmunity for proposing, conducting or

misconduct in science. This does not

fferences in interpretations or judgments

ceives or applies for a research, research

 under the Public Health Service Act

e certifying that it is in compliance with

R Part 50.

R Part 30, Subpart B, and 4 CFR Parts

ction Act (31 USC 3711) and the Federal

CFR Parts 101-105) require NIH to collect

ment and, except where prohibited by

nquent debts owed to NIH by grantees

 regulations at 45 CFR Part 30). Debts

covery of funds, unobligated balances,

 goal of OMB Circular A-129 is the

t. Before a grant award can be made,

certify that it is not delinquent on the

 Part 401) Pursuant to the Bayh-Dole Act

10, 1987), all recipients of NIH research

contractors and consortium participants

unds under NIH grants and contracts,

sinesses, or non-profit organizations) are

rting requirements and regulations. These

ed by the Department of Commerce,

es (and, in some cases, employee inven

ceived or first actually reduced to practice

an NIH award. Grantee organizations

 under the "Inventions and Patents"

the NIH Grants Policy Statement

cy/nihgps_2001/part_iia_6.htm#Inventions

 Federal support in the development of a

PA R T VI – CROSS-CUTTING PUBLIC POLICIES
Executive Pay scale. For the latest concerning salary limitations, see the

NIH Guide for Grants and Contracts(http://www.nih.gov/grants/guide/index.html) and use the search feature.

• Sex Discrimination—(45 CFR Part 86) Section 901 of Title IX of the

Education Amendments of 1972 (20 USC 1681), as amended, providesthat no person in the United States shall, on the basis of sex, be excludedfrom participation in, be denied the benefits of, or be subjected todiscrimination under any educational program or activity receivingFederal financial assistance. The DHHS implementing regulations arecodified at 45 CFR Part 86.

• Smoke-Free Workplace—The NIH strongly encourages all recipients of its

grants to provide smoke-free workplaces and promote the nonuse oftobacco products. NIH defines the term "workplace" to mean officespace (including private offices and other work space), conference ormeeting rooms, corridors, stairways, lobbies, rest rooms, cafeterias, andother public spaces.

• Suspension—(45 CFR Part 76 and 45 CFR Part 92.43) Temporary withdrawal of a grantee’s authority to obligate grant funds, pending either

corrective action by the grantee, as specified by NCI, or a decision by NCIto terminate the award. NIH will generally suspend (rather than immediately terminate) a grant and allow the grantee an opportunity to takeappropriate corrective action prior to NIH's making a termination decision. NIH may decide to terminate the grant if the grantee does not takeappropriate corrective action during the period of suspension. However,NIH may terminate without first suspending the grant if the deficiency isso serious as to warrant immediate termination or public health orwelfare concerns require immediate action.

• Termination—(45 CFR Part 76 and 45 CFR Part 92.43) Permanent withdrawal by NCI of a grantee’s authority to obligate previously awarded

grant funds before that authority would otherwise expire, including thevoluntary relinquishment of that authority by the grantee. NIH mayterminate without first suspending the grant if the deficiency is so seriousas to warrant immediate termination or public health or welfare concernsrequire immediate action. A grant also may be terminated, partially ortotally, by the grantee or by NIH with the consent of the grantee.

• Withholding of Support—A decision not to make a non-competing

continuation award within the current competitive segment.Withholding may occur for one or more of the following reasons: 1) Agrantee is delinquent in submitting required reports; 2) Adequate Federalfunds are not available to support the project; 3) A grantee fails to show

105

arly for the provision of health care, day

nt, education, or library services to

are funded by applicable Federal funds,

r local governments. Applicable Federal

 agreements, loans, loan guarantees,

tion, maintenance, and operations

Health and Human Services, Education,

ing both discretionary and nondiscre

this Act.

—(45 CFR Part 46) Protection of human

FR Part 46, is required of all research

ts are involved. A human subject is

iving individual about whom an investi

udent) conducting research obtains (a)

raction with the individual, or (b) iden

e regulation also extends to the use of

 fluids from individually identifiable

nal protection for certain classes of

, pregnant women, human in-vitro fertil

lation exempts certain categories of

ts (listed in 45 CFR Part 46.101(b))

no risk.

uipment and Products—In accordance

propriations acts, all equipment and

ooperative agreement, or contract funds

 greatest extent possible.

ection of Human Subjects—Beginning

mented a policy requiring education on

h participants for all key personnel

grants or proposals for contracts or

awards for projects involving human

ds are awarded for applications or

man subjects, documentation must be

have received training in the protection

nformation on this requirement may be

ral Research (OER) web site, specifically

licy/hs_educ_faq.htm. 

ent of Health and Human Services

Y 2002, Public Law 107-116, restricts the

ividual under an NCI grant, cooperative

 to Executive Level I of the Federal

PA R T VI – CROSS-CUTTING PUBLIC POLICIES
107

PA R T VII – GLOSSARY

ng the objectives of the project; 4) A

s of a previous award; 5) A grantee's

rovide adequate stewardship of Federal

would indicate that continued funding

sts of the Federal Government.

PART VII

Glossary
• Budget—A categorical or non-categorical request for funds required to

support the proposed activity.

• Budget Period—The interval of time (usually 12 months) into which the

grant project period is divided for funding and reporting purposes.

• Catalog of Federal Domestic Assistance (CFDA)

—

(http://aspe.os.dhhs.gov/cfda/index.htm) or(http://www.cfda.gov/default.htm) The CFDA is a government-widecompendium of Federal programs and activities that provides assistanceor benefits to State and local governments; public, quasi-public, profit,and nonprofit institutions; and specialized groups and individuals. Thecatalog is compiled and published annually by the General ServicesAdministration.

• Competitive Segment—The initial project period recommended for

support (usually one to five years) or each extension of the prior projectresulting from the award of a competing continuation grant.

• Consortium Agreement—A collaborative arrangement in support of a

research project in which some portion of the programmatic activity iscarried out through a formalized agreement between the grantee and oneor more other organizations that are separate legal entities administratively independent of the grantee.

• Contract (R&D)—An instrument used by NCI to procure cancer research

services and other resources needed by the Federal Government.Contracts are legally binding documents and used when the principalpurpose of the transaction is to acquire a specific service or end productfor the direct benefit of, or use by, the NCI.

• Contract (under a grant)—A written agreement between a grantee and a

third party to acquire routine goods or services.

• Cooperative Agreement—An award instrument reflecting an assistance

relationship between the NCI and a recipient in which substantial NCIprogrammatic involvement is anticipated during performance of theactivity. 

• Direct Costs—Costs that can be specifically identified with a particular

activity or project.

• Expedited Board Concurrence and Early Award Initiative—This NCI

initiative focuses on that part of the grant review and award cycle inwhich NCI has the most influence, the award negotiation and issuance,which accounts for two months of the 10-12 month grant review andaward process.

109

es most commonly used in the award

or financial assistance for a

 on the appropriate application form:

wn in the table below, is used for all

(Type 1) or competing continuation

same form is used for a competing

ype 3) when requesting additional funds

nsion to meet the needs of a project.

cation forms have corresponding forms

r non-competing continuation support

ive segment. The form corresponding

0. Some of these forms may be

owing web sites

orms.htm) and

oer.htm).

y, property, services, or anything of value

late a public purpose authorized by

onships are expressed in less detail than

 responsibilities for ensuring perform

nt or are shared with the NCI.

y NCI, based on an approved applica

on or an individual to carry out an 

USE FORM NUMBER

rch Program—Phase I..........PHS 6246-1rch Program—Phase II ........PHS 6246-2

sfer Program—Phase I ..........PHS 6246-3sfer Program—Phase II.........PHS 6246-4

rvice Award

ip Award ..................................PHS 416-1

................................................PHS 5161-1

....................................................PHS 424

PA R T VII – GLOSSARY
• Indirect Costs—See Facilities and Administrative (F&A) Costs.

• Institute/Center (IC)—The NIH organizational component responsible

for a particular grant program(s) or set of activities. NCI is an IC.

• Initial Review Group (IRG)—A group of study sections or peer review

committees that are arrayed by scientific discipline. Study sections orpeer review committees of scientists advise on the scientific and technicalmerit of research applications submitted for support. 

• Institutional Animal Care and Use Committee (IACUC)—A committee

set up by an institution to review at least once every six months the institution’s program for humane care and use of animals. The IACUCreviews research protocols involving the care and use of animals at theinstitution and makes recommendations to the Institutional Officialregarding any aspect of the institution's animal program, facilities, orpersonnel training.

• Institutional Review Board (IRB)—A board or committee set up by a

research institution to ensure the protection of rights and welfare ofhuman research subjects participating in research conducted under itsauspices. The IRB makes an independent determination to approve,require modifications in, or disapprove research protocols based onwhether human subjects are adequately protected, as required by federalregulations and local institutional policy.

• Modular Grants—An initiative that expands the existing reinvention

initiatives that are designed to concentrate the focus of investigators, theirrespective institutions, peer reviewers, and NIH staff on the science NIHsupports rather than on the details of budgets. Under modular budgetproposals, applicants are instructed to prepare the budget request indirect cost modules of $25,000 up to a maximum direct cost level of$250,000. (Budget requests beyond this level follow traditional application instructions.) This process eliminates the need for much of thebudget detail, thereby relieving administrative burdens on both NIH staffand grantee organizations and simplifying cost management for NIHprogram staff.

• Monitoring—A process whereby the programmatic and business management performance aspects of a grant are reviewed by assessing information gathered from various required reports, audits, site visits, and other

sources.

• Notice of Grant Award—The legally binding document that notifies the

grantee and others that an award has been made. This document

111

&A) Costs—Costs (previously known as

y a grantee for common or joint objec

t be identified specifically with a partic

cess.gpo.gov/su_docs/aces/aces140.html)

provides a uniform system for commu

ations and legal notices issued by

uncements of the availability of funds for

he Code of Federal Regulations is an

he general and permanent rules

 financial report due no later than 90 days

d or, for grants in the SNAP population,

institutions or foreign organizations, no

each competitive segment. The FSR

 for the competitive segment as main

cords of the grantee institution. Grantees

ntinued funding of their grant(s).

chanism providing money, property, or

 out an approved project or activity.

primarily with the recipient and there is

or participation in the performance of

dividual awarded a grant or cooperative

egal, financial, and scientific responsi

 the awarded funds and for the perform

ity. A grantee organization can be

r-profit, educational institution, hospital,

agency, or other legally accountable

MO)—The individual designated by an

nsible for ensuring that both the

et all requirements of laws, regulations,

—An individual selected by the Grants

he focal point of the awarding compo

t activities associated with the negotia

of a grant or cooperative agreement.

nistration policy and provisions.

PA R T VII – GLOSSARY
• Program Announcement (PA)—A formal statement that describes and

gives notice to the grantee community of the existence of an NIH-wide or individual Institute/Center extramural research activity/interest orannounces the initiation of a new or modified activity/interest or mechanism of support and invites applications for grant or cooperativeagreement support. NCI uses RFAs to announce cooperative agreements.PAs are published in the NIH Guide for Grants and Contracts(http://www.nih.gov/grants/guide/index.html). Funds may or may notbe set-aside for PAs.

• Program Official—The NCI official responsible for the programmatic,

scientific and/or technical oversight and monitoring of a grant. Theprogram official works closely with grants management staff.

• Project Period—The total time for which support of a discretionary

project has been programmatically approved. A project period mayconsist of one or more budget periods. The total project period iscomprised of the initial competitive segment and extensions.

• Recipient—The organizational entity or individual receiving a grant or

cooperative agreement. See Grantee.

• Recommended Levels of Future Support—The funding level recommended for each of the future years approved by the IRG and the NCAB.

These amounts are subject to availability of funds each year and evaluationof the scientific progress of the project. In addition, the recommendedfunding level may be subject to correction of arithmetic errors and toadjustments made in accordance with applicable grant policies, as appropriate.

• Request for Application (RFA)—A formal announcement that invites

grant or cooperative agreement applications in a well-defined scientificarea to support specific program initiatives, indicating the amount offunds set aside for the competition and the estimated number of awardsto be made. RFAs are published in the NIH Guide for Grants andContracts (http://www.nih.gov/grants/guide/index.html).

• Research Project Grant (RPG)—Award for an investigator-initiated

research proposal.

• Scientific Review Administrator (SRA)—A Federal scientist who presides

over an Initial Review Group and is responsible for coordinating andreporting the review of each application assigned to his/her committee,thereby serving as an intermediary between the applicant institution andthe reviewers of the application. The SRA prepares a summary statementfor each application reviewed by his/her IRG.

113

nd conditions or the award, and docu

unds. The award notice may be in letter

nically.

 A system of review of research applica

are the professional peers of the prin

directing or conducting the proposed

presents the relative position or rank of

ores assigned by that particular study

The lower the numerical value of the

range is from .1 to 99.9.

summary form of the intent of the appli

ations are requested for all construction

ederal funding exists. It is used to deter

etermine how well the proposed project

pplications; and eliminate any proposals

nce for funding before applicants incur

aring an application.

individual designated by the recipient

 or activity being supported by the grant.

untable to recipient organization offi

e project or program. The organization

d accountable to NCI for the perform

grant-supported activity.

al from NCI’s Grants Management

taward changes in the approved project

be obtained prior to undertaking the

CI funds.

mined by averaging the individual ratings

the IRG. Each IRG member assigns to

g that ranges from 1.0 (outstanding) to

her opinion of the scientific merit of the

s then expressed on a scale of 100 to

y purchase, lease, or barter of property or

e of the NCI or other Government

ment most often used is a contract. A

 and obligations of each of the parties

PA R T VII – GLOSSARY
• Study Section—The component part of an Initial Review Group that

advises on the scientific and technical merit of research applications.

• Substantial Foreign Component—Under a grant to a domestic institution, the performance of any significant element or segment of the project

outside of the United States, either by the grantee or by a researcheremployed by a foreign institution, with or without grant funds.

• Success Rate—The number of funded applications divided by the

number of applications reviewed by Initial Review Groups.

• Technical Assistance Review—An evaluation by NCI grants management

staff to assess an institution’s business and financial management systemsto ensure that applicable regulations and policies are being followed.

• Terms and Conditions of Award—All legal requirements imposed on a

grant, whether based on statute, regulation, policy, other referenced document, or the grant award document itself. The Notice of Grant Awardmay include both standard and special provisions that are considerednecessary to attain the grant’s objectives, facilitate postaward administration of the grant, conserve grant funds, or otherwise protect the interestsof the Federal Government.

• Total Project Costs—The total allowable costs (both direct costs and

facilities and administrative costs) incurred by the grantee to carry out agrant-supported project or activity. Total project costs include costscharged to the NCI grant and costs borne by the grantee to satisfy amatching or cost-sharing requirement.

115

uding its affiliates, that is independently

minant in its field of operation; has its

 United States and is organized for

d, or in the case of a publicly owned

 voting stock is owned by U.S. citizens

resident aliens; has no more than 500

latory requirements established by the

 13 CFR Part 121.

 individual under a fellowship or

 pre-established levels to provide for the

ng the period of training. A stipend is

 the services expected of an employee.

ward Process (SNAP)—A streamlined

e financial documents that were part of

a categorical budget for the next budget

f expenditures for the current budget

negotiates the direct costs for the entire

of the competing award or, in the case of

applicable number of modules for each

itive segment. This eliminates the need

nd negotiations, if applicable, and

uires to review and approve non

ions and to monitor these awards. 

AP, grantees are required to submit only

0, including an annual progress report.

ntees must answer questions pertaining

ances, and change in the level of effort

ange in performance site and/or if there

rantees also must submit the PHS-2590

 is anticipated, must include the esti

 income. Grantees (other than foreign

 also are required to submit a quarterly

 (FCTR) (SF-272) to the Payment

r awards under SNAP (other than awards

al institutions), a Financial Status Report

of a competitive segment rather than

mitted within 90 days after the end of

st report on the cumulative support

An FSR must be submitted at this time

inuation award is made. If no further

rve as the final FSR

PA R T VII – GLOSSARY
117

EXHIBITIS

Exhibits
Exhibit B. Summary Statement

119

ge

Form Approved Through 05/2004 OMB No. 0925-0001 

LEAVE BLANK — FOR PHS USE ONLY. 

Type 1 Activity R01 Number CA-100228-01 

Review Group BEM Formerly Council/Board (Month, Year) Sept 2001 Date Received 01/28/2001 

dolescent Tobacco Use 

NS OR PROGRAM ANNOUNCEMENT OR SOLICITATION 

New Investigator No Yes

3b. DEGREE(S) Ph.D.

on)

3d. MAILING ADDRESS (Street, city, state, zip code)

MASSACHUSETTS RESEARCH INSTITUTE500 Aspen LaneConcord, MA 02134E-MAIL ADDRESS: AMARTIN@MRI.EDU

5. VERTEBRATE ANIMALS No Yes

ase

s

5a. lf "Yes," lACUCapproval date

5b. Animal welfare assurance no.

QUIRED FOR INITIAL

ERIOD

8. COSTS OF REQUESTED FOR

PROPOSED PERIOD OF SUPPORT

 ($)

7b. Total Costs ($) 337,500

8a. Direct Costs ($) 900,000

8b. Total Costs ($) 1,350,000

10. TYPE OF ORGANIZATION

Public: Federal State Local

Private: Private Nonprofit

For-profit: General Small Business

 Woman-owned Socially and Economically Disadvantaged

11. ENTITY IDENTIFICATION NUMBER

1093465660A1DUNS No. (if available)Congressional District 24

RD

13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATIONName: Evan ThomasTitle: Administrative CoordinatorAddress: MASSACHUSETTS RESEARCH INSTITUTE

500 Aspen LaneConcord, MA 02134

Telephone: 617-444-0001FAX: 617-444-0000E-Mail: THOMASE@MRI.EDU

CE:

est of

s or

 to

he

.

SIGNATURE OF PI/PD NAMED IN 3a.

/S/

DATE

01/20/2001

CE:

est of

ces

m

ect

SIGNATURE OF OFFICIAL NAMED IN 13.

/S/

DATE

01/21/2001

Face Page Form Page 1

DR. REBECCA SANDERS SUMMARY STATEMENT301 496-2331 (Privileged Communication)PROGOFFICIAL@NIH.GOV

Application Number: 1 R01 CA100228-0l

Review Group: BEHAVIORAL MEDICINE STUDY SECTION - BEMMeeting Dates: SRG: JUNE 2001 COUNCIL: SEPT/OCT 2001

Requested Start Date: 02/01/2002

Investigator: Martin, AndrewOrganization: MASSACHUSETTS RESEARCH INSTITUTECity, State: CONCORD, MAProject Title. Community Intervention to Reduce Adolescent Tobacco UseSRG Action: Priority Score: 135 Percentile 5.3Human Subjects: 30-HS INV-N0 SRG CONCERNSAnimal Subjects: 10-ANMLS INV-NO SRG CONCERNSGender: G2A-MEN and WOMEN, SCIENTIFICALLY ACCEPTABLEMinority: M4A-MINORITY MAKE-UP SCIENTIFICALLY ACCEPTABLEChildren: C3A-CHILDREN INCLUDED, SCIENTIFICALLY ACCEPTABLE

PROJECT DIRECT COSTS ESTIMATED YEAR REQUESTED TOTAL COST 01 225,000 337,500 02 225,000 337,500 03 225,000 337,500 04 225,000 337,500

TOTAL 900,000 1,350,000

RESUME: This is an application to compare the impact of school-based with

community-based interventions on adolescent tobacco use. This is anexcellent proposal that should provide insights into a most difficultproblem.DESCRIPTION: The project is designed to evaluate the effects of a community

intervention aimed at reducing the prevalence of adolescent tobacco use.Fourteen small communities will be randomly assigned to receive a communityintervention plus a school-based prevention program or to receive a schoolbased program alone. The community intervention is designed to mobilizecommunity leaders and organizations to modify environmental influences onadolescent tobacco use so that experimentation is reduced, experimenters areprevented from becoming more regular users, and regular users are encouragedto quit. Task forces will be created to (a) conduct media campaigns thatpromote nonuse of tobacco by adolescents, (b) increase parental skill andefforts to promote adolescent nonuse of tobacco, (c) increase screening andcounseling of adolescents to encourage quitting or remaining tobacco free,(d) reduce access to tobacco products and situations in which to consumethem, and (e) increase incentives for adolescent nonuse of tobacco. Thestudy will also examine the effects of the community intervention on effortsof community organizations and leaders to affect adolescent tobacco use.

Continued

Date Released: 07/09/2001 Date Printed: 07/09/2001

EXHIBITIS
Exhibit C. Ranking List

121

ued)

lationship between adolescents' 

se tobacco and their attitudes, 

panels of seventh and ninth grade 

3-year intervals will be used to 

of community intervention aimed at 

tobacco use is extremely important in 

elated efforts. 

d and is expected to provide importantnity intervention aimed at reducing theinnovative aspects.

nvestigator, is a 1973 Ph.D. from the

logy. He is currently a Research

h Institute, Concord, Massachusetts,

 manuscripts in submission, and 38

reas relevant to the grant application.

chusetts Research Institute is highly

 data on the outcome of a combined

nd the process by which community

-based efforts. The multiple

rograms are impressive. Parental

 but more intriguing still is the

ing information at the work site.

to reduce availability at schools, it

 work sites are not explored.

s also useful.

r a school program only or a program

e, experimental test of the effects of

ne. While it is true that a community

nal validity of the design, it appearsmunity program without a school

ted with respect to traditional norms;

t, as do the statements on the analysis

m score for the community activity inal strong test of program efficacy. It

alysis, particularly the ANOVA

 Clearly, ANOVA is better than a

. And with several cases, it will be

agnostic methods to fully understand

 picture.

budget is high for the tasks planned.

e module.

art of the summary statement]

Paylist Report

December 2001

Cancer Activity: PreventionCost Center: Research Project GrantsBudget Mechanism: Traditional Research GrantsPayline: 21.00Paylist Number: 1309

Grant

Number

Principal

Investigator

Board

Meeting

Date

StartDate

Program

Director

Pri1

Scr

Pctl2

Rank

Total3

Cost

Estimated

Program T.C.

Recommended

Pay

Sel

AIDS

%

100194-01 JAMES 2001/06 1/1/2002 ANTHONY 120 2.2 350,766 299,112 X4 N

100228-01 MARTIN 2001/09 2/1/2002 SANDERS 135 5.3 337,500 300,000 X N

100220-01 LIU 2001/09 2/1/2002 SANDERS 140 6.1 305,710 290,344 X N100210-01 JOHNSON 2001/09 1/1/2002 ANTHONY 176 20.5 412,212 380,451 X N100224-01 STONE 2001/06 1/1/2002 SING 180 21.0 390,003 375,510 X N100214-01 DANIELLE 2001/09 2/1/2002 SING 199 26.0 280,990 N100243-01 LUZAR 2001/09 2/1/2002 SANDERS 211 28.7 240,765 N100234-01 BAILEY 2001/09 2/1/2002 ANTHONY 220 29.1 190,945 N

Notes:1 Priority Score2 Percentile Rank3 Total Cost under current funding policy4 Funding SelectionRecommending Official (Signature/Date) /s/

/s//s/

/s/

(Branch Chief)Approving Official (Signature/Date)(Division Director)Certifying Availability of Funds (Signature/Date)(Chief-NCI OM EFDB)Grants Management Officer (Signature/Date)

EXHIBITIS
Exhibit D. Notice of Grant Award (continued)

123

 GRANT AWARD *************************** 

Issue Date: 01/24/2002 

s *************************************** w 

n to Reduce Adolescent Tobacco Use

0306by awards a grant in the amount of

 Section I) to MASSACHUSETTS RESEARCH

renced project. This award is pursuant

 52 and is subject to terms and

 Terms and Conditions is acknowledged

own or otherwise obtained from the grantreporting inventions derived or reducedk under this grant. Rights tonization provided certain requirementsof NIH support. In addition, recipientsctivities are consistent with theirh resources developed under this award

 in accordance with NIH policy. For

http://www.iedison.gov.award, please contact the individual(s)

NAL CANCER INSTITUTE

SECTION I - AWARD DATA - 1 R01 CA100228-01AWARD CALCULATION (U.S. Dollars):Federal Direct Costs $200,000Federal F&A Costs $100,000APPROVED BUDGET $300,000TOTAL FEDERAL AWARD AMOUNT $300,000Recommended future year total cost support, subject to the availability offunds and satisfactory progress of the project, is as follows.02 $300,00003 $300,00004 $300,000FISCAL INFORMATION:CFDA Number: 93.396EIN: 1566001393A1Document Number: RlCA100228AIC / CAN / FY2002 / FY2003 / FY2004 / FY2005CA / 8422842 / 300,000 / 300,000 / 300,000 / 300,000NIH ADMINISTRATIVE DATA:PCC: 5CCJ2842 / OC: Al.4A / Processed: EDWARDSJ 020117 0957SECTION II - PAYMENT/HOTLINE INFORMATION - 1 R01 CA100228-01For Payment and HHS Office of Inspector General Hotline Information, see theNIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htmSECTION III - TERMS AND CONDITIONS - 1 R01 CA100228-01This award is based on the application submitted to, and as approved by, theNIH on the above-titled project and is subject to the terms and conditionsincorporated either directly or by reference in the following:a. The grant program legislation and program regulation cited in this Noticeof Grant Award.b. The restrictions on the expenditure of federal funds in appropriationsacts, to the extent those restrictions are pertinent to the award.c. 45 CFR Part 74 or 45 CFR Part 92 as applicable.d. The NIH Grants Policy Statement, including addenda in effect as of thebeginning date of the budget period.e. This award notice, INCLUDING THE TERMS AND CONDITIONS CITED BELOW.(see NIH Home Page at http://grants.nih.gov/grants/policy/awardconditions.htmfor certain references cited above.)This grant is awarded under the terms and conditions of the FederalDemonstration Partnership Phase III.

EXHIBITIS
Exhibit E. Summary Progress Report

125

inued)

over into the next budget period 

r approval. oncompeting Award Procedures (SNAP). 

earing on the award notice under 

pport” have been calculated by applying 

rative cost rate(s) in effect at theitted total direct cost level for eachdirect cost categorical breakdown in

n the 12/15/98 NIH Guide for Grants and

nih.gov/grants/guide/noticerequired to allocate and account foregory within their institutional

pplicable cost principles. The

 not apply to Modular Grant Awards.

plications should indicate “N/A” forant rebudgeting.

ptional customer service, the NCI

p a Feedback address on its web site

x.htm). General concerns and issuesures, and practices can be sent to theSpecific questions or concerns related

he Grants Management Specialist listed

al@nih.govvNSTITUTE YEAR 03 YEAR 04 ======= =======

 200,000 200,000

 100,000 100,000

 300,000 300,000

 Principal Investigator/Program Director (Last, first, middle): Martin, Andrew

Grant Number

PROGRESS REPORT SUMMARY CA100228-02

PERIOD COVERED BY THIS REPORT

PRINCIPAL INVESTIGATOR OR PROGRAM DIRECTOR FROM THROUGH

Andrew Martin 02/01/2002 01/31/2003APPLICANT ORGANIZATIONMASSACHUSETTS RESEARCH INSTITUTETITLE OF PROJECT (Repeat title shown in Item 1 on first page)Community Intervention to Reduce Adolescent Tobacco UseA. Human Subjects (Complete Item 6 on the Face Page)

Involvement of Human Subjects No Change Since Previous Submission Change.

B. Vertebrate Animals (Complete Item 7 on the Face Page)

Use of Vertebrate Animals No Change Since Previous Submission Change

SEE PHS 2590 INSTRUCTIONS.WOMEN AND MINORITY INCLUSION: See PHS 398 Instructions. Use Inclusion Enrollment Report Format Page and, if necessary,Targeted/Planned Enrollment Format Page.1. Has there been a change in the other support of key personnel since the Iast reporting period? NO.2. Will there be, in the next budget period, a significant change in the level of effort for key personnel from what was approved forthis project? NO.

3. Is it anticipated that an estimated unobligated balance (including prior year carryover) will be greater than 25 percent of thecurrent yearês total budget? NO.a. Specific AimsThe aims have not been modified and they are the same as those listed in the original grantproposal.b. Studies and ResultsOur progress is described under each aim as follows:1. This project's aim is to assess whether a community intervention to reduce tobacco use has a

greater impact on adolescent smoking prevalence than does a school-based program alone. Sixpairs of communities have been randomly assigned to a community intervention plus a schoolbased intervention program or to a school-based program alone.

2. The work conducted in this year has gone about as planned. Two communities were identified

and recruited to participate in the project. A noteworthy feature of our work has been thedevelopment of an instrument and set of procedures for assessing the degree to whichcommunity organizations are doing things that would affect adolescent tobacco use and otherproblems of youth. Organizations in each sector of the community have been sampled, andrepresentatives of those organizations have been asked to participate in a 20-minute phoneinterview. Thus far, 130 representatives of organizations in the two communities have beeninterviewed. An additional 50 interviews will be conducted in the next month. Proceduresfor the creation of a community board and a set of task forces to work on issues ofadolescent tobacco use have been identified.

3. Although results are not yet available about the efficacy of this intervention, we have

developed numerous modules for a community intervention and have identified ways to mobilizecommunity members to reduce tobacco use. We have also identified ways to recruit communitiesto participate in such a study. If we find that the intervention programs have significanteffects on the attitudes of young people or their parents, we will have defined low-cost,effective methods of modifying two major influences on tobacco use - other young people andparents.

4. During the coming year, we will recruit three pairs of matched communities to participate in

the project. Adolescents and a sample of their parents will be assessed in those communitiesplus the two communities we are already working in. Teachers will be trained to implementtobacco prevention programs in grades 6-12 in both treatment and control communities.

_________________________________________________________________________________________________________PHS 2590 (Rev. 05/01) Page 2 Form Page 5

(Use continuation pages if necessary)

EXHIBITIS
nly at the end of each competitive segment or 

sfers to a new institution] 

STATUS REPORT SETTS RESEARCH INSTITUTE /20062006

0.00 (10A)

1,200,000.00 (10B)

ction alternative 0.00 (10C)

1,200,000.00 (10D)1,200,000.00 (10E)

s 0.00 (10F)

1,200,000.00 (10G)

0.00 (10H)

idated obligations 0.00 (10I)ed obligations 0.00 (10J)iquidated obligations 1,200,000.00 (10K)l funds authorized 1,200,000.00 (10L)nds 0.00 (10M)

0.00 (10X)

request 0.00 (10Z) Alternative 0.00 (10V)

0.00 (10W)0.00 (10Y)

otal Total Fed Share0 (f) 100,000.00 (d) 100,000.00 (e)IVE COORDINATOR1

T-925