NIH Publication No. 05-1222

NATIONAL CANCER INSTITUTE

Leo F. Buscher Jr.

Chief Grants Management Officer

National Cancer Institute

U.S. Department of Health and Human Services

National Institutes of Health

GRANTS PROCESS

AND

ADMINISTRATION

GRANTS ADMINISTRATION BRANCH

Revised August 2005

PROGRAM 

STAFF

REVIEW 

STAFF

APPLICANT BUSINESS 

STAFF

GRANTS MANAGEMENT 

STAFF

The purpose of this publication is to provide a general description of how a 

grant is awarded and administered. Although the discussion relates to the 

National Cancer Institute (NCI), the grants process is similar within the 

other National Institutes of Health (NIH) awarding components. We hope 

that this information will provide a starting point to understanding the 

overall grant application and award process.

Since its modest beginnings in a one-room lab in the late 1800s and its 

official establishment in 1930, through its current status including 27 

Institutes and Centers, the NIH has continuously worked as a partner with 

the research community in order to improve the health and quality of 

life for individuals around the world. In 1937, “Conquer Cancer” was the 

battle cry of the Public Health Service, which resulted in the establishment 

of the NIH’s first Institute, the NCI. Since then, advances gained through 

cancer initiatives have helped to prevent, diagnose, and treat cancer among 

millions of people. Today, the NCI Director’s challenge to the nation is “to 

eliminate the suffering and death due to cancer by 2015.” iPREFACE

PRINCIPAL

INVESTIGATOR

THE NATIONAL CANCER INSTITUTE

In Support of Biomedical Research Through Administrative Excellence
Advances in cancer research have translated through the years into progress 

for other serious diseases, as well. In honor of the advances in cancer 

research in the last 100 years, a special section follows the table of contents 

in this year’s publication of Everything You Wanted to Know About the NCI 

Grants Process but Were Afraid to Ask.

The organization of this publication represents a concise progression of the 

NCI grants process and administration.

CHAPTER 1 • Overview: the Grants Process

Provides an introduction to how we, in the Grants Administration 

Branch, view our role in this very important collaborative 

venture, including a snapshot of the NCI as an organization and 

a brief overview of the legal underpinnings of grants.

CHAPTER 2 • Allocation of Grant Funding

Provides a brief budget overview and a funding allocation 

example to help illustrate various nuances of the NCI grants 

process.

CHAPTER 3 • Review and Administration

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, 

post-award administration.

CHAPTER 4 • Funding Mechanisms

Provides descriptions of the application types and budget 

mechanisms prevalent within the NCI.

CHAPTER 5 • Cross-Cutting Public Policies

Summarizes some of the requirements that apply to grants 

management.

CHAPTER 6 • References and Resources

Lists contacts and materials that are helpful with regard to the 

general approach taken in the NCI grants process.

CHAPTER 7 • Glossary

Lists definitions of terms and phrases most commonly used in 

the award and administration of NIH grants.

CHAPTER 8 • Exhibits

Provides samples of significant documents used in the grants 

process.

ii
PREFACE

iii

It is a pleasure to acknowledge the staff of the NCI and the NIH whose 

contributions made this publication possible.

For additional information concerning the subject matter in this publication, 

the staff of the NCI Grants Administration Branch are pleased to answer any 

inquiries. This publication, along with other general information regarding 

the NCI’s Grants Administration Branch, can be found at:

http://www3.cancer.gov/admin/gab/index.htm.

In an effort to constantly improve the content and format of this publication, 

we welcome your comments via the Feedback section of this website.

Thank you,

Leo F. Buscher Jr.

Chief Grants Management Officer

National Cancer Institute

(301) 496-7753

1 • Overview: The Grants Process

2 • Allocation of Grant Funding

3 • Review and Administration

4 • Funding Mechanisms

5 • Cross-Cutting Public Policies

6 • References and Resources

7 • Glossary

8 • Exhibits

11

27

37

75

89

101

107

115

CONTENTS
PREFACE ...................................................................... i

ACRONYMS .............................................................. xi

100+ YEARS OF ADVANCES IN THE FIGHT 

AGAINST CANCER ............................................................ 1

CHAPTER 1 OVERVIEW: THE GRANTS PROCESS ........11

Introduction..............................................................................13

Statement of Purpose.................................................................13

General Information.................................................................14

The Department of Health and Human Services (HHS) ...........14

The National Institutes of Health (NIH) ...................................14

The National Cancer Institute...................................................16

Mission..................................................................................16

Background ...........................................................................16

Function................................................................................16

Organization .........................................................................17

Executive Committee............................................................17

Budget ...................................................................................18

Research Settings...................................................................18

Types of Funding Instruments..............................................19

Contracts ..........................................................................19

Grants and Cooperative Agreements ...............................19

NCI Grants Administration Branch ..........................................20

NCI Grants: Historical Perspective .......................................20

NIH/NCI Grants Process Electronic Suite .............................20

Grants Administration Branch .............................................21

Grants Authorities .....................................................................22

The Constitution...................................................................22

Statutes ..................................................................................22

Regulations............................................................................23

OMB Circulars.......................................................................23

Administrative Requirements ..........................................23

Cost Principles..................................................................24

Audits ...............................................................................24

Agency Implementations......................................................24

Cross-Cutting Public Policies................................................25 vi

TABLE OF CONTENTS
Notice of Grant Award..........................................................25

Order of Precedence..............................................................25

CHAPTER 2 ALLOCATION OF GRANT FUNDING....... 27

NCI Budget Development Cycle...............................................28

Funding Allocation Process: 1–2–3............................................28

Funding Allocation: A Practical Example..................................29

Budget Activities .......................................................................30

Research .....................................................................................30

Cancer Causation Research...................................................30

Detection and Diagnosis Research........................................30

Treatment Research...............................................................31

Cancer Biology......................................................................31

Resource Development..............................................................32

Cancer Centers Support........................................................32

Research Manpower Development.......................................33

Cancer Prevention and Control ................................................33

Program Management and Support ..........................................34

CHAPTER 3 REVIEW AND ADMINISTRATION............ 37

Development, Receipt, & Assignment of Applications ...........39

Grantee Eligibility......................................................................39

Principal Investigator Responsibility.........................................39

Grantee Institution Responsibility ............................................39

Standards of Conduct ...........................................................40

Development of Grant Application......................................40

Allowable Costs .........................................................................41

Direct Costs ...........................................................................41

Facilities and Administrative Costs ......................................42

Rate Agreement.....................................................................42

Receipt and Assignment of Applications...................................43

Return of Incomplete and Late Grant Applications..................43

Grant Application Identification Number ................................44

Grant Application Referral ........................................................44

Application Types .....................................................................45

Peer Review ...............................................................................46

TABLE OF CONTENTS

vii
Integrated Review Group (IRG).................................................46

Scientific Review Group (SRGs).................................................46

Scientific Review Administrators (SRAs) ...................................47

Project Site Visits .......................................................................48

Scientific Review Group Meetings (SRGs) .................................49

Priority Scores .......................................................................50

Percentile Rank .....................................................................51

Summary Statements ............................................................51

Early Notification to Applicant.............................................51

National Cancer Advisory Board...............................................52

Legislative Authority.............................................................52

Composition .........................................................................52

Pre-NCAB Meetings...............................................................53

NCAB Meetings .....................................................................53

Expedited NCAB Review.......................................................54

Recommendations ................................................................55

Post-NCAB Meetings .............................................................55

Appeals to Referral and Review of Applications........................55

NCI Funding Determinations ...................................................56

Funding Decisions .....................................................................56

Funding Selections.....................................................................57

Award Negotiation and Issuance..............................................60

Role and Responsibilities of NCI Program Directors.................60

Role and Responsibilities of the NCI Grants 

Management Officer..................................................................60

Pre-Award Activities...................................................................62

Grants Management Review.................................................63

Cost Analysis.........................................................................63

Administrative Review..........................................................64

Negotiation ...........................................................................65

Preparation of Awards and Obligation of Funds ..................65

Congressional Notification...................................................66

Acceptance of Award .................................................................66

Continuation Support ...............................................................66

viii
Post-Award Administration ......................................................68

Award Payment..........................................................................68

Reporting Requirements ............................................................68

Electronic Transmittal of Financial Status Reports (FSRs).........69

Monitoring Projects ...................................................................70

Rebudgeting...............................................................................71

Audits.........................................................................................71

Grant Appeals ............................................................................72

Grant Closeout ..........................................................................72

Additional Post-Award Activities...............................................73

Record Retention .......................................................................73

By the Grantee ......................................................................73

By the NCI.............................................................................73

CHAPTER 4 FUNDING MECHANISMS...................... 75

Research Project Grants ............................................................76

Cancer Centers and Specialized Programs of Research 

Excellence..................................................................................80

Other Research Grants ..............................................................81

Training .....................................................................................84

R&D Contracts...........................................................................85

Intramural Research..................................................................86

Research Management and Support ........................................86

Cancer Prevention and Control ...............................................86

Construction..............................................................................86

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

CHAPTER 5 CROSS-CUTTING PUBLIC POLICIES ......... 89

CHAPTER 6 REFERENCES AND RESOURCES.............101

Publications.............................................................................102

Websites ...................................................................................102

TABLE OF CONTENTS

ix
CHAPTER 7 GLOSSARY ........................................... 107

CHAPTER 8 EXHIBITS ...............................................115

A. Grant Application Face Page ........................................... 116

B. Summary Statement ........................................................ 117

C. Ranking List ..................................................................... 120

D. Notice of Grant Award (NGA).......................................... 121

E. Progress Report Summary................................................ 124

F. Financial Status Report (FSR) .......................................... 125

FIGURES

1. Overview of the NIH/NCI Grants Process...........................12

2 NIH Organizational Chart...................................................15

3. NCI Organization and Advisory Structure..........................18

4. Progression From Cancer Research to Application.............19

5. NCI Grants Administration Branch

Electronic Grants Process....................................................21

6. NCI Budget Development Cycle .........................................28

7. NCI FY2004 Budget Activities .............................................35

8. NCI Grants Process..............................................................38

9. Development, Receipt, & Assignment of Applications.......43

10. SRG Review and Evaluation for Scientific Merit.................47

11 NCAB Review and NCI Funding Determinations ...............56

12. NCI FY2004 Extramural Funds............................................58

12a. NCI Obligations by Mechanism FY2004.............................59

13. NCI Extramural Grants Program.........................................61

14. Award Negotiation and Issuance.........................................63

15. Grant Payment Management System: SMARTLINK II........68

x
xi

Acronyms

Code of Federal Regulations

Center for Scientific Review, NIH

Division of Cancer Biology, NCI

Division of Cancer Control and Population Sciences, 

NCI

Division of Cancer Prevention, NCI

Division of Cancer Treatment and Diagnosis, NCI

Division of Extramural Activities, NCI

Extramural Advisory Board, NCI

Facilities and Administrative Costs

Financial Status Report

Fiscal Year

Grants Administration Branch, NCI

Grants Management Officer

Grants Management Specialist

Department of Health and Human Services

Institute and/or Center Within NIH

Integrated Review Group

Minority Investigator Supplement

National Cancer Advisory Board

National Cancer Institute

National Institutes of Health

Program Announcement

Program Announcements Reviewed in an Institute

Program Director

Public Health Service

Payment Management System

Research and Development

Request for Applications

Research Project Grant

Small Business Innovation Research

Streamlined Noncompeting Award Process

Scientific Review Administrator

Scientific Review Group

Small Business Technology Transfer

United States Code

CFR ...............

CSR ...............

DCB ..............

DCCPS ...........

DCP ..............

DCTD ............

DEA ..............

EAB ...............

F&A ...............

FSR ...............

FY..................

GAB ..............

GMO ..............

GMS ...............

HHS ...............

IC ..................

IRG ...............

MIS ...............

NCAB ............

NCI ...............

NIH ...............

PA .................

PAR ...............

PD .................

PHS ...............

PMS ..............

R&D ..............

RFA ...............

RPG ...............

SBIR ..............

SNAP .............

SRA ...............

SRG ...............

STTR .............

USC ...............

1

100+ YEARS OF ADVANCES 

IN THE FIGHT AGAINST CANCER

Washington Post, August 6, 1937–Article printed shortly after 

President Roosevelt authorized the building of the National

Cancer Institute.
The first cancer research laboratory was established, 

Gratwick Laboratories (Roswell Park Memorial Institute).

Radium found effective in treatment of tumors.

P. Rous discovered a virus that causes cancer in chickens.

Cancer cells were grown in the laboratory and considered 

the first long-term “tissue culture.”

The Ladies’ Home Journal published the first known article 

on cancer’s warning signs.

Coal tar gave rabbits cancer in experimental proof of 

carcinogenesis.

The National Institutes of Health was established by the 

Ransdell Act.

The National Cancer Institute Act was established on July 23, 

1937, providing funding for the NIH’s first Institute, the NCI.

♦	On November 27, the first NCI grant was awarded for 

$27,550 to Louis F. Fieser to investigate chemical structure 

and carcinogenic activity.

First issue of the Journal of the National Cancer Institute was 

published.

100+ YEARS OF ADVANCES IN THE FIGHT AGAINST CANCER

2

1898

1903

1911

1912

1913

1915

1930

1937

Left: June 6, 1938–

Members of the first 

National Advisory 

Cancer Council at 

the groundbreaking 

ceremonies for the

NCI building.

Right: 1939–The

National Cancer

Instituteʼs first home, 

“Building 6.”

1940

1938 NCI BUDGET: $400,000

1940–1949 NCI APPROPRIATIONS: $42 MILLION
The Pap smear was introduced into medical practice.

DNA found by O. Avery, C. MacLeod, and M. McCarty 

determined to be basic cell material.

S. Farber found that a folic acid derivative inhibits acute 

leukemia.

G. Hitchings synthesized 6-Mercaptopurine (6-MP) to 

combat childhood leukemia.

The FDA approved Nitrogen Mustard (Methclorethanine), a 

drug that interacts with DNA chemically to kill cancer cells.

E. Wynder, E. Graham, and Sir R. Doll confirmed cigarette 

smoking-cancer link.

DNA found to be genetic material in some viruses.

FDA approved Methotrexate as an anticancer drug.

♦	J. Watson and F. Crick discovered the structure of DNA.

The National Chemotherapy Program began.

Chromosome abnormality was first associated with 

leukemias.

M. Nirenberg and others proved triplet code governs DNA 

action.

1943

1944

1947

1948

1949

1950

1952

1953

1955

1960

1961

100+ YEARS OF ADVANCES IN THE FIGHT AGAINST CANCER

3

1960–1969 NCI APPROPRIATIONS: $1.8 BILLION

1950–1959 NCI APPROPRIATIONS: $330 MILLION

Left: October 31, 

1940–President 

Franklin Roosevelt 

dedicated the first

six buildings of the 

NIH.

Right: Life magazine, 

June 17, 1940–NCIʼs 

first Scientific Staff 

review.
The Royal College of Physicians issued a report on smoking 

and health.

The U.S. Surgeon General issued the Report on Smoking and 

Health.

♦	A virus (Epstein-Barr Virus) was linked to human cancer for 

the first time.

♦	The American Society of Clinical Oncology was established.

♦	FDA approved:

• 5-FU.

• Vinblastine, a drug that binds to tubulin and is 

derived from the ornamental shrub Vinca rosea.

• Vincristine, a sister drug to Vinblastine.

• Melphalan (L-PAM).

The NCI standardized testing of cancer-causing chemicals.

R. Heubner and G. Todano proposed the oncogene hypothesis.

H. Temin and D. Baltimore 

discovered reverse transcriptase 

enzymes, a key to gene engineering.

President Richard M. Nixon 

converted the Army’s former 

biological warfare facilities at 

Ft. Detrick, Maryland, to house 

research activities on the causes, 

treatment, and prevention of cancer.

Computed tomography (CT) was 

introduced in the United States.

♦	Recombinant DNA techniques 

were developed for cloning genes.

♦	The Surveillance, Epidemiology, and End Results (SEER) 

program was established.

CANCERLINE, a national database of published cancer 

research, was established.

1962

1964

1966

1969

1970

1971

1973

1974 4

1970–1979 NCI APPROPRIATIONS: $6.1 BILLION

December 23, 1971–

President Nixon signed the 

National Cancer Act of 1971
FDA approved doxorubicin, an antitumor antibiotic from 

the streptomyces bacterium.

Methods were developed to identify and sequence DNA 

fragments.

The Cancer Information Service (1-800-4-CANCER) opened.

♦	Interleukin-2 was discovered.

♦	The first human proto-oncogenes were discovered.

The first national cancer patient education program was 

founded (I Can Cope).

First human testing of a biological 

therapy (alpha-interferon).

♦	Tamoxifen was approved by the 

FDA for marketing as a treatment 

drug.

♦	FDA approved Cisplatin, a 

powerful anticancer drug.

♦	Metastatic cells were shown to 

arise from preexisting subpopulations of primary tumors.

p53 was discovered, the most frequently mutated gene in 

human cancer.

♦	The modified radical mastectomy replaced radical 

mastectomy for breast cancer treatment.

♦	1970s additional advances:

• Studies in human populations linked cancer risk to 

infectious agents, such as human papillomavirus 

(cervical cancer) and hepatitis B (liver cancer).

• Statistical methods developed to simultaneously 

control several factors in the analysis of studies and 

to quantify cancer risks.

• Studies clarified the patterns of cancer risk following 

exposure to ionizing radiation.

• Studies linked cancer risks to hormonal drugs, such 

as diethylstilbestrol (DES) taken during pregnancy 

and hormone replacement therapy.

1974

1975

1976

1977

1978

1979

100+ YEARS OF ADVANCES IN THE FIGHT AGAINST CANCER

5
Introduction of the first human viral vaccine that can 

prevent cancer (hepatitis B virus vaccine for liver cancer).

Lumpectomy plus radiation was found equivalent to 

mastectomy for breast cancer.

The first tumor-suppressor gene was cloned (Rb).

Adjuvant chemotherapy was proven to increase disease-free 

survival in early-stage breast cancer patients.

Adjuvant chemotherapy was proven to increase survival in 

colon cancer patients.

1980s additional advances:

• The flexible sigmoidoscopy and colonoscopy were 

developed to help find and remove precancerous 

growths.

• Continuous pain medication infusion pumps were 

developed.

• The first highly effective antinausea drugs were 

developed to alleviate side effects of chemotherapy.

• Biochemical and genetic assays were integrated into 

epidemiologic studies (molecular epidemiology).

First chemoprevention trial to show efficacy—Vitamin A 

analogue against mouth and throat tumors.

Adjuvant radiation and chemotherapy found to improve 

survival in rectal cancer.

6

1981

1985

1986

1988

1989

1990

1991

1980–1989 NCI APPROPRIATIONS: $12 BILLION

1990–1999 NCI APPROPRIATIONS: $21.8 BILLION

Left: Radiation 

Treatment

Right: MRI (Magnetic 

Resonance Imaging) 

introduced.
First of the hereditary non-polyposis colon cancer genes 

was cloned.

BRCA1, the first inherited breast cancer gene, was cloned.

1993

1994

FDA approvals:

• Tretonoin, the first successful differentiating agent.

• Porfimer sodium, a drug that sensitizes tumors to light, 

permitting photodynamic therapy in the U.S.

• Topecan, first of a class of drugs that interferes with the 

enzyme topoisomerase.

• Rituximab, first biotechnology product approved by FDA to 

treat patients with cancer.

• Trastuzumab (Herceptin), targets 

cancer cells that produce a 

protein found in high numbers 

of women with metastatic breast 

cancer.

1990s studies and trials:

• Breast Cancer Prevention Trial 

began, testing tamoxifen as a 

preventive agent in women at 

increased risk for the disease. 

In 1998, results found that 

tamoxifen reduced the chances 

of women at risk of developing breast cancer by half.

• NCI-sponsored studies in China showed the importance of 

nutrition in preventing cancer.

• Prostate Cancer Prevention Trial began in 1993, testing 

finasteride, a drug used to reduce symptoms of prostate 

enlargement.

• The Prostate, Lung, Colorectal, and Ovarian Cancer 

Screening Trial began recruiting 148,000 volunteers (the 

largest early-detection study).

• The Cancer Genome Anatomy Project was launched—

a multiyear project to assemble the first index of genes 

involved in cancer.

100+ YEARS OF ADVANCES IN THE FIGHT AGAINST CANCER

7
1990s additional advances:

• Breast cancer death rates began to decline!

• The multistep nature of carcinogenesis was proven.

• The transition from film-based radiography to digital 

computer-assisted medical imaging began.

• Several common genetic variants were linked to the risk of 

lung and other cancers.

• Flourescence in situ hybridization (FISH) technique developed.

A New Century...

♦	The NIH announced the funding of four new Breast Cancer and 

the Environment Research Centers to study the prenatal-to-adult 

environmental exposures that may predispose women to breast 

cancer.

♦	The NCI and the National Institute on Aging (NIA) launched an 

initiative to accelerate research into the relationship between aging 

and cancer.

♦	International clinical trials concluded that women should consider 

taking letrozole after 5 years of tamoxifen treatment to continue to 

reduce risk of recurrence.

♦	 Death rates from the four most common cancers—lung, breast, 

prostate, and colorectal—continued to decline in the late 1990s 

according to new data from the Annual Report to the Nation on the 

Status of Cancer, 1975–2000.

In 2001, there were 9,600,000 cancer survivors in the U.S.

Together, we—the NIH, the NCI, clinicians, scientists, researchers, 

administrators, volunteers, patients, and the American public—are 

making a difference!

8

2000–2005 NCI APPROPRIATIONS: $25.5 BILLION

1938–2005 NCI APPROPRIATIONS: $67 BILLION!
100+ YEARS OF ADVANCES IN THE FIGHT AGAINST CANCER 9
Introduction • 13

General Information • 14
11

CHAPTER

OVERVIEW: THE GRANTS PROCESS

Aerial view of the NIH Campus
12

Conducts

research

NIH Center for 

Scientific Review 

assigns to NCI and 

to study section

Submits

application

Initiates research 

idea and prepares 

application

Manages

funds

NCI monitors 

programmatic and 

business management 

performance of the 

grant

Scientific Review 

Group (NCI or 

CSR) evaluates for 

scientific merit

NCI makes funding 

selections and issues 

Grant Awards

NCI 

evaluates 

program 

relevance 

and need

National 

Cancer 

Advisory 

Board 

recommends 

action

PRINCIPAL INVESTIGATOR

FIGURE 1 Overview of the NIH/NCI Grants Process

GRANTEE

INSTITUTION
Statement of Purpose

The Department of Health and Human Services (HHS) touches the lives 

of every American. The American public expects grants awarded by 

HHS’s operating divisions to help the HHS achieve its health and human 

services goals. The general goal of grants management is to provide quality 

stewardship of grants. As an operating division of HHS, the National 

Institutes of Health (NIH) and its Institutes and Centers provide open, fair, 

and objective selection of projects with the highest potential for success; 

this is one key component of quality stewardship.

Within the National Cancer Institute (NCI), the Grants Administration 

Branch (GAB) is responsible for monitoring the grants process to ensure 

that grantees and the Federal Government perform all required business 

management actions in a timely manner, both prior to and after award. 

In carrying out this responsibility, the GAB evaluates and monitors: 

(1) the business management capability and performance of applicant 

organizations and grantees; and (2) the internal operating procedures 

associated with the business management aspects of the grants process. Due 

to the interrelationships between grants management and program matters, 

close coordination between GAB and program staff is most important.

The GAB directs the following statement of purpose to the grantee 

community and our colleagues within the NIH as a pledge to:

• Negotiate and issue quality NCI grant awards within the appropriate 

timeframe, thus facilitating cancer research through administrative 

excellence.

• Serve as the NCI’s resource point for providing accurate and timely 

business-related grant information.

• Act as the NCI’s authorized Federal office with which the grantee, 

program staff, or other NIH organizational elements can interact to 

obtain guidance, direction, and assistance regarding the review and 

interpretation of policies and administrative requirements as they apply 

to research grants and grantee institutions.

• Monitor the financial and management aspects of grants to ensure the 

effective utilization of Federal funds.

• Focus on building and maintaining a partnership with the grantee and 

with the NCI program and review staff to ensure the issuance of award 

documents that clearly communicate grant requirements and protect 

the NIH from waste, mismanagement, fraud, and costly disputes.

• Provide quality service promptly, both within the NIH and to the 

grantee community, reflecting a continuing commitment to improve 

grants management, thereby enabling the grantee to perform its 

research in an open Federal research environment free of unnecessary 

record collection and reporting requirements.

OVERVIEW: THE GRANTS PROCESS

13

INTRODUCTION
14

The Department of Health and Human Services (HHS)

The HHS’s mission is to enhance the health and well-being of Americans 

by providing effective health and human services and by fostering strong, 

sustained advances in the sciences underlying medicine, public health, 

and social services. The HHS consists of the Office of the Secretary, which 

provides leadership; the Program Support Center, which provides centralized 

administrative support; and 11 operating divisions, which manage over 300 

health-related programs. These operating divisions are:

• Administration for Children and Families (ACF)

• Administration on Aging (AoA)

• Agency for Healthcare Research and Quality (AHRQ)

• Agency for Toxic Substances and Disease Registry (ATSDR)

• Centers for Disease Control and Prevention (CDC)

• Centers for Medicare and Medicaid Services (CMS) (formerly the Health 

Care Financing Administration [HCFA])

• Food and Drug Administration (FDA)

• Health Resources and Services Administration (HRSA)

• Indian Health Service (IHS)

• National Institutes of Health (NIH)

• Substance Abuse and Mental Health Services Administration (SAMHSA)

The ACF is responsible for temporary assistance to needy families; children’s 

welfare, care, and support; disabilities programs; and other services. The 

AoA serves the elderly. The CMS manages health insurance programs. The 

NIH, AHRQ, ATSDR, CDC, FDA, HRSA, IHS, and SAMHSA are all devoted to 

public health and comprise the Public Health Service (PHS).

The National Institutes of Health (NIH)

The NIH’s mission is to uncover new knowledge that will lead to better 

health for everyone. The NIH works toward that mission by conducting 

research in its own laboratories; supporting the research of non-Federal 

scientists in universities, medical schools, hospitals, and research institutions 

throughout the country and abroad; helping to train researchers; and 

fostering communication of medical information. The NIH’s budget has 

grown from $300 in 1887, when the NIH was a one-room Laboratory of 

Hygiene, to more than $28.8 billion in 2004. The NIH is composed of the 

Office of the Director, 19 Institutes, 7 Centers, and the National Library of 

Medicine. Located on more than 300 acres in Bethesda, Maryland, the NIH 

is composed of more than 75 buildings.

GENERAL INFORMATION
OVERVIEW: THE GRANTS PROCESS

15

FIGURE 2 NIH Organizational Chart

NATIONAL INSTITUTES OF HEALTH

Clinical

Center

Center for 

Information 

Technology

National 

Institute of 

Dental and 

Craniofacial 

Research

National

Institute of

Arthritis and 

Musculoskeletal 

and Skin

Diseases

National

Institute of

Diabetes and 

Digestive

and Kidney

Diseases

National

Institute on 

Deafness

and Other 

Communication 

Disorders

Center for 

Scientific 

Review

National 

Institute for 

Neurological 

Disorders

and Stroke

National

Center for

Complementary

and

Alternative 

Medicine

National

Center for

Minority

Health and 

Health

Disparities

National 

Institute of 

General 

Medical 

Sciences

National 

Institute of 

Biomedical 

Imaging and 

Bioengineering

National

Institute of

Nursing

Research

National

Library of 

Medicine

National 

Institute on 

Aging

NATIONAL 

CANCER 

INSTITUTE

National

Eye

Institute

National

Institute of

Mental Health

National

Institute on

Drug Abuse

National 

Heart, Lung, 

and Blood 

Institute

National 

Center for 

Research 

Resources

National 

Institute of 

Allergy and 

Infectious 

Diseases

National 

Institute of 

Child Health 

and Human 

Development

National 

Institute on 

Alcohol 

Abuse and 

Alcoholism

National 

Institute of 

Environmental 

Health 

Sciences

National

Human

Genome

Research

Institute

Fogarty

International

Center
The National Cancer Institute (NCI)

Mission

Simply stated, the mission of the NCI is to eliminate cancer and prevent 

the devastation that cancer imposes on individuals, families, and society as 

a whole. The NCI’s goal is to stimulate and support scientific discovery and 

its application to achieve a future where all cancers are uncommon and 

easily treated. The NCI works toward this goal in two major ways:

• The NCI provides vision to the nation and leadership for NCI-funded 

researchers across the United States and around the world.

• The NCI works to ensure that the results of research are used in clinical 

practice and public health programs to reduce the burden of cancer for 

all people.

Background

The NCI, established under the National Cancer Act of 1937, is the Federal 

Government’s principal agency for cancer research and training. The 

National Cancer Act of 1971 broadened the scope and responsibilities of 

the NCI and created the National Cancer Program. Under the National 

Cancer Act of 1971, the Director of the NCI is authorized to submit a 

professional judgment budget reflecting the full funding needs of the 

National Cancer Program directly to the President. This budget is referred 

to as the Bypass Budget. An overview of the 

budget process is presented in Chapter 2 of 

this publication.

Function

Over the years, legislative amendments 

have maintained the NCI’s authority 

and responsibilities and have added new 

information dissemination mandates, 

as well as a requirement to assess the 

incorporation of state-of-the-art cancer 

treatments into clinical practice. The NCI 

coordinates the National Cancer Program, 

which conducts and supports research, 

training, health information 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, the NCI:

• Supports and coordinates research projects conducted by universities, 

hospitals, research foundations, and businesses throughout this country 

and abroad through research grants and cooperative agreements.

• Conducts research in its laboratories and clinics.

• Supports education and training in fundamental sciences and clinical 

disciplines for participation in basic and clinical research programs and 

16

Original road sign that 

reflects NCI as the only 

Institute of the NIH
OVERVIEW: THE GRANTS PROCESS

17

treatment programs relating to cancer through career awards, training 

grants, and fellowships.

• Supports research projects in cancer control.

• Supports a national network of cancer centers.

• Collaborates with voluntary organizations and other national and 

foreign institutions engaged in cancer research and training activities.

• Encourages and coordinates cancer research by industrial concerns where 

such concerns evidence a particular capability for programmatic research.

• Collects and disseminates information on cancer.

Organization

The NCI’s Office of the Director serves as the focal point for the National 

Cancer Program, with advice from the President’s Cancer Panel, the 

National Cancer Advisory Board (NCAB), the Board of Scientific Counselors 

(BSC), and the Board of Scientific Advisors (BSA).

The Division of Extramural Activities (DEA) coordinates the review of 

grants and contracts and manages the functions of the NCAB and the 

BSA. One intramural research Center, one intramural research Division, 

and four extramural research Divisions monitor and administer the NCI’s 

cancer research activities through extramural and intramural research 

programs.

The Office of the Director coordinates initiatives across the NCI’s four 

extramural research divisions:

• Division of Cancer Biology (DCB)

• Division of Cancer Control and Population Sciences (DCCPS)

• Division of Cancer Prevention (DCP)

• Division of Cancer Treatment and Diagnosis (DCTD)

Executive Committee

The NCI Executive Committee (EC), which consists of high-level Institute 

managers, makes all major organizational and operating decisions affecting 

the NCI, including:

• Formulating scientific and management policy decisions.

• Establishing grant paylines and funding plans for those grant programs 

not administered solely by one Division.

• Approving certain exceptions to grant funding plans.

• Reviewing contract, cooperative agreement, and grant concepts.

• Formulating the long-range strategic plan for the Institute.

• Addressing trans-NCI policy issues affecting personnel and resources.

In addition to weekly meetings, the EC meets with other NCI staff twice 

a year, in the summer and winter, for 1 or 2 days, to establish budget 

priorities and policies for the forthcoming year.
Budget

The NCI’s budget is composed of four major activities:

• Research

• Resource Development

• Cancer Prevention and Control

• Program Management and Support

For additional information on the NCI budget activities and funding 

allocation, see Chapter 2, page 27.

Research Settings

NCI-sponsored research takes place in the following three settings:

• Laboratory: In the laboratory, research is pursued on the biology of 

cancer, the fundamental properties of cancer-causing agents and 

processes, and the body’s defense against and response to cancer.

• Clinic: In the clinic, patient-oriented research is carried out in 

prevention, detection, diagnosis, treatment, and rehabilitation.

• Community: In the community, research is carried out on the causes, 

risks, predispositions, incidence, and behavioral aspects of cancer 

within the population.

As the diagram in Figure 4 indicates, the interaction of these three 

components reflects the progression from the results of research through 

dissemination to application. Research results must be communicated 

to those who ultimately apply these results in health care and disease 

prevention settings.

18

FIGURE 3 NCI Organization and Advisory Structure

OFFICE OF THE 

DIRECTOR

National Cancer

Institute

Presidentʼs 

Cancer Panel

National Cancer

Advisory Board

Board of Scientific 

Counselors

Board of Scientific 

Advisors

Division of Extramural 

Activities Executive Committee

Division 

of Cancer 

Control and 

Population 

Sciences

Center for 

Cancer

Research

Division 

of Cancer 

Prevention

Division 

of Cancer 

Biology

Division 

of Cancer 

Treatment 

and 

Diagnosis

Division

of Cancer

Epidemiology 

and Genetics

Center to 

Reduce 

Cancer 

Health 

Disparities

Office of 

Centers, 

Training, and 

Resources
Types of Funding Instruments

Using a variety of funding instruments, including contracts, grants, and 

cooperative agreements, the HHS accomplishes much of its mission 

through services provided by non-Federal entities. Each instrument has 

a specific purpose and application, thus creating different relationships 

between the parties.

The Federal Grant and Cooperative Agreement Act of 1977 requires 

Federal agencies to distinguish procurement relationships from assistance 

relationships. Although the Act does not dictate any specific terms and 

conditions that should be placed on contracts, grants, and cooperative 

agreements, it does require that the choice and use of these legal 

instruments reflect the type of relationship expected between the Federal 

and non-Federal parties.

Contracts

The NCI uses the contract instrument to procure cancer research services 

and other resources needed by the Federal Government. Contracts are 

used when the principal purpose of the transaction is to acquire a specific 

service or end-product for the direct benefit of, or use by, the NCI. The 

remainder of this publication deals only with grants and cooperative 

agreements.

Grants and Cooperative Agreements

In contrast to contracts, grants and cooperative agreements are Federal 

financial assistance mechanisms used to support and stimulate research. 

Assistance relationships are established when the principal purpose of the 

transaction is to transfer money, property, services, or anything of value 

OVERVIEW: THE GRANTS PROCESS

19

FIGURE 4 Progression From Cancer Research to Application

Lab Clinic

Population

CANCER PATIENTS GENERAL PUBLIC

HEALTH CARE PROVIDERS

GOVERNMENT

ACADEMIC AND PRIVATE ORGANIZATIONS

Biology

Risk

Intervention

Prevention

Detection

Diagnosis

Treatment

Survivorship

Cancer Control

RESEARCH SETTINGS

Communicate 

and 

Disseminate 

Research

Results

RESEARCH AREAS
to a recipient to accomplish a public purpose or to stimulate a particular 

area of research authorized by law. HHS’s assistance mechanisms range 

from providing individuals with Federal cash assistance to reimbursing 

states for assistance provided to refugees or other beneficiaries for whom 

the Federal Government has accepted responsibility. These assistance 

mechanisms also include loan guarantees provided through financial 

institutions and various types of price supports and subsidies. The two 

types of assistance mechanisms used by the NCI are the grant and the 

cooperative agreement:

♦	 Grants are used when: (1) no substantial programmatic involvement is 

anticipated between the NCI and the recipient during performance of the 

financially assisted activities, thus allowing the recipient significant freedom of 

action in carrying out the research project; and (2) there is no expectation on 

the part of the NCI of a specified service or end-product for use by the NCI.

♦	Cooperative agreements are used when substantial programmatic involvement 

is anticipated between the NCI and the recipient during the performance 

of the activities. (Note: The NIH does not accept unsolicited cooperative 

agreement applications.)

In the following pages of this publication, the word grant is used to 

indicate an assistance mechanism and should be construed to include 

cooperative agreements as well.

Legal instruments reflect the type of relationship expected between the 

Federal and non-Federal parties.

NCI Grants Administration Branch

NCI Grants: Historical Perspective

The first cancer research grant funded by the NCI was awarded to Louis 

F. Fieser, of Harvard University, on November 27, 1937. It was funded for 

$27,550 to investigate chemical structure and carcinogenic activity. The 

grant identification number was IC3. Since the funding of grant IC3, the 

NCI has funded approximately 188,000 grants, accounting for $41 billion 

in expenditures.

Since passage of the National Cancer Act and the creation of the National 

Cancer Program in 1971, the NCI’s annual appropriation has increased 

nearly 26-fold, from $180 million in fiscal year (FY) 1971 to $4.72 billion 

in FY2004. Nearly $3.1 billion (over 67 percent) of the NCI’s FY2004 

appropriation was awarded in grants and cooperative agreements.

NIH/NCI Grants Process Electronic Suite

The NIH/NCI Grants Process Electronic Suite (GPES) is defined as the 

electronic process, from application receipt to record retention and 

disposal, that encompasses the 15 elements of the grant award process as 

displayed in Figure 5. The GPES is made up of an interconnected set of 

modules that provides for a single entry of grant data. The NCI Enterprise 

is composed of an Oracle database and NCI-developed applications that 

support the business needs of the NCI Extramural Staff.

20
Working in unison with the NIH Enterprise, the NCI Enterprise supports 

the grants process from pre-referral to award and crosses the business 

areas of NCI Referral, Program, Grants Administration, and Financial 

Management. The goals of the GPES are eliminating paper grant files and 

facilitating the ability to work the entire grants process electronically. 

Currently, NCI grants management staff are working 100 percent of their 

grant portfolio electronically.

Grants Administration Branch 

The NCI’s Grants Administration Branch (GAB) is the focal point for all 

business-related activities associated with the negotiation, award, and 

administration of grants and cooperative agreements within the NCI. The 

GAB’s website can be found at http://www3.cancer.gov/admin/gab/.

In the GAB, we approach our work with grantee business officials, Principal 

Investigators (PIs), NIH and NCI review staff, and NCI program staff with 

a common goal: the accomplishment of the project for which the grant is 

awarded.

In our grants management role, we continually seek new and better ways 

to promote an environment in which PIs can pursue their research in the 

OVERVIEW: THE GRANTS PROCESS

21

Developed by NIH Developed by NCI

NIH/NCI 

GRANTS 

PROCESS 

ELECTRONIC 

SUITE

Grant Files

Grant

Tracking

Referral

Expedited

Review and

Early Awards

Specialist

Work

Assignments

Checklists

Record

Retention

Grant

Applications

Paylists

Summary

Statement

Council/

Board

Books

Grant 

Award

Notices

Financial

Status 

Reports

Closeout

Program

FIGURE 5 NCI Grants Administration Branch Electronic Grants Process
most productive and cost-effective manner possible. We place emphasis on 

problem prevention. We accomplish this by working with grantee officials 

to ensure that they have adequate business management systems and 

internal controls to properly safeguard Federal resources. We work with 

review and program staff to ensure the effective stewardship of Federal 

funds and uniform administration of various grant programs in accordance 

with Federal grant requirements. Our goal is to support biomedical research 

through administrative excellence.

Grants Authorities

The Constitution

The requirements to which research grants are subject have their roots in 

a number of specific sources or authorities, the broadest of which is the 

U.S. Constitution. Congress has the authority to impose conditions on the 

receipt of Federal assistance funds. The cornerstone of Congress’ authority 

in the grants area is Article I, Section 8, of the United States Constitution, 

referred to as the Spending Power Clause, which provides that “... Congress 

shall have power to lay and collect taxes, duties, imposts and excises, to 

pay the debts and to provide for the ... general welfare of the United 

States ....” Thus, Congress can enact statutes authorizing Federal agencies 

to award grants and impose reasonable conditions on the receipt of Federal 

assistance funds.

Laws that authorize the formulation of regulations for grant programs 

are ultimately based on constitutional provisions. For example, the HHS 

and the NIH grant appeals procedures can be traced to the due process 

principles outlined in the Constitution under the Fifth Amendment. 

Another example is the Public Health Service (PHS) grant application form, 

which contains provisions relating to civil rights, handicapped individuals, 

and age and sex discrimination. These are all extensions of constitutional 

requirements for equal protection under the law covered in the 14th 

Amendment to the U.S. Constitution.

Statutes

The next broad level of Federal grant lawmaking is the enactment of 

specific laws by Congress. Two of the most important are authorizing 

legislation and appropriation legislation.

The authority to award grants is contained in the basic substantive 

legislation establishing a Federal program. Such legislation may authorize 

program expenditures 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 research grants are awarded.

Subsequent to the enactment of authorizing legislation, Congress generally 

enacts appropriation laws permitting funds to be obligated for a specific 

program. Appropriation bills begin in the House of Representatives and 

then are acted upon by the Senate. Through the appropriation process, 

22
Congress greatly influences both program and grants administration 

decisions by controlling the amount of funds authorized annually and by 

setting conditions on the use of funds.

Regulations

Because the language of many laws is vague, Federal agencies often need 

to publish regulations to clarify the details. A “rule” or “regulation” is a 

formal document issued by a Federal agency that has general or particular 

applicability and legal effect. Compliance with Federal regulations and 

statutes must be taken seriously. When finalized, regulations have the full 

force and effect of law.

The Code of Federal Regulations (CFR) (http://www.gpoaccess.gov/cfr/

index.html), a codification of permanent rules published in the Federal 

Register (http://www.gpoaccess.gov/fr/index.html), contains the regulations 

for reviewing and administering NCI grants. These requirements provide 

additional guidance regarding program requirements and management. 

(Some programs have guidelines instead of or in addition to regulations.)

Three of the most important sections pertaining to NCI grants are:

• 42 CFR Part 52 (Grants for Research Projects) for broad grant program 

regulations.

• 45 CFR Part 74 (Uniform Administrative Requirements for Awards 

and Subawards to Institutions of Higher Education, Hospitals, Other 

Nonprofit Organizations, and Commercial Organizations; and Certain 

Grants and Agreements With States, Local Governments and Indian 

Tribal Governments).

• 45 CFR Part 92 (Uniform Administrative Requirements for Grants and 

Cooperative Agreements to State, Local, and Tribal Governments) for 

administrative regulations.

OMB Circulars

In addition to the provisions of authorizing legislation and implementing 

regulations, the Office of Management and Budget (OMB) issues 

government-wide circulars for managing grants that apply to all Federal 

Executive agencies. When these agencies are required to apply the 

directives, the effect on grantees is often the same as regulation. Among 

the circulars relevant to grants administration are those that have to do 

with administrative requirements, cost principles, and audits.

Administrative Requirements

♦ A-102 (rev.) Grants and Cooperative Agreements With State and Local 

Governments establishes consistency and uniformity among Federal agencies 

in the management of grants and cooperative agreements with state, local, 

and federally recognized Indian tribal governments.

♦ A-110 (rev.) Uniform Administrative Requirements for Grants and Agreements 

With Institutions of Higher Education, Hospitals, and Other Nonprofit 

Organizations sets forth standards for obtaining consistency and uniformity 

among Federal agencies in the administration of grants to and agreements with 

institutions of higher education, hospitals, and nonprofit organizations. 45 CFR 

Part 74 extends the provisions of A-110 to commercial (for-profit) organizations.

OVERVIEW: THE GRANTS PROCESS

23
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 Federal awards carried out 

through grants, cost reimbursement contracts, and other agreements with state 

and local governments and federally recognized Indian tribal governments.

♦ A-122 (rev.) Cost Principles for Nonprofit Organizations establishes principles 

for determining costs applicable to nonprofit 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 (rev.) Audits of States, Local Governments, and Other Nonprofit 

Organization 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 for commercial (for-profit) 

organizations are contained in 45 CFR Part 74. See page 73 for more 

information.

Agency Implementations

In addition to issuing regulations to specify details of the enabling 

statutes, agencies often find it helpful to publish handbooks, guidelines, 

or manuals. The NCI implements Federal regulations by following the 

policies contained in the NIH Grants Policy Statement and the NIH Guide to 

Grants and Contracts.

The NIH Grants Policy Statement is a condensation of the NIH and HHS 

grants administration policies, laws, and regulations. It provides both upto-date policy guidance that serves as NIH standard terms and conditions 

of awards for grants and cooperative agreements and extensive guidance to 

individuals who are interested in NIH grants.

The NIH Guide to Grants and Contracts is the official publication for NIH 

medical and behavioral research grant policies, guidelines, and funding 

opportunities. It is also used by the NIH Contracting offices and other 

HHS agencies to announce their funding opportunities. The NIH Guide 

serves in lieu of the Federal Register in compliance with the Administrative 

Procedures Act.

The NCI has developed individual guidelines for certain types of grants. 

There are now guidelines available for Cancer Center Support Grants (Core 

P30), Program Project Grants (P01), Specialized Programs of Research 

Excellence (P50, SPOREs), Construction Grants (C06), Clinical Trials 

Cooperative Group Program Grants (U10), and Cancer Education Grants 

(R25). 24
Cross-Cutting Public Policies

A variety of statutory or administrative requirements cut across Federal 

programs and impact the administration of grants. These “cross-cutting” 

public policies, which apply to almost every grant program, are intended 

to ensure fairness and equity, as well as physical and other protections in 

activities receiving Federal financial assistance. A summary of some of these 

cross-cutting public policy requirements that apply to grants management is 

provided in Chapter 5 of this publication. NIH grantees are also subject to 

requirements contained in the NIH’s Annual Appropriations Act that apply 

to the use of NIH grant funds. Some of these requirements are included in 

Chapter 5 of this publication because they have been included in the NIH’s 

Annual Appropriations Act for several years without change. However, these 

requirements may be changed, or other requirements may be added in the 

future.

Notice of Grant Award

The Notice of Grant Award (NGA) is the official notification to the 

applicant that a project has been funded. Each grant award is authorized 

by statute. For example, in the sample Notice of Grant Award letter 

(Exhibit D, p. 121), the authorizing legislation is 42 USC 241. Each award 

also cites particular regulations that authorize its issuance.

The final sources of requirements imposed on projects supported by 

Federal grants are the specific terms and conditions that are attached 

to an individual grant and incorporated into the formal NGA. These 

terms and conditions may include the basic purpose of the award, policy 

statements, and OMB Circulars. These latter materials may be incorporated 

by reference. By accepting the award (i.e., by drawing funds from the grant 

payment system), every grant recipient agrees to comply with everything 

incorporated by reference into the NGA.

Order of Precedence

As a general rule, requirements imposed by statute (42 USC 241 et seq.) 

and requirements imposed by program or general regulations (42 CFR Part 

52 and 45 CFR Parts 74 and 92) are supplemented by program policies 

and terms and conditions of individual grants. When grant requirements 

are inconsistent, the following order of precedence usually applies: 

Constitutional mandates govern statutory provisions, and statutory 

mandates govern regulatory provisions. Regulations published in the 

Federal Register generally govern unpublished requirements, including 

grant terms and conditions. Questions concerning any apparent conflict 

in requirements or precedence of requirements governing grants should be 

addressed to the Grants Management Officer, who may consult with the 

Office of the General Counsel.

OVERVIEW: THE GRANTS PROCESS

25
NCI Budget Development Cycle • 28

Funding Allocation Process: 1-2-3 • 28

Funding Allocation: A Practical Example • 29

Budget Activities • 30
27

ALLOCATION OF GRANT FUNDING

CHAPTER
28

The budget development cycle for a fiscal year is about 30 months, with 

three phases of this process—formulation, presentation, and execution—

overlapping. In the example below (Figure 6), FY2005 is being executed 

while FY2006 is being presented and FY2007 is being formulated.

In the spring of each year, preliminary budgets are submitted. The NIH 

budget is paralleled by a professional needs budget, referred to as the 

Bypass Budget, prepared by the NCI. In September, revised versions of these 

budgets are submitted to the Office of Management and Budget. In January, 

the President’s budget is submitted, and congressional justification hearings 

are held in February, March, or April.

Funding Allocation Process: 1–2–3

The following is a summarized general description of the three-step funding 

allocation process for Research Project Grants (RPGs):

Step 1: From the amount appropriated by Congress, deduct:

• The amount of noncompeting commitments, including the program 

evaluation budget.

• The amount for mandated set-asides (e.g., SBIR).

• The amount for program initiatives (RFAs).

This leaves the amount for competing grants.

NCI BUDGET DEVELOPMENT CYCLE

FIGURE 6 NCI Budget Development Cycle

2004

October October

2005 2006

October

2007

October

FY2006

FY2007

Formulation:

NCI Bypass Budget

Formulation:

HHS/NIH Budget

Execution:

Obligating Funds

Presentation:

Budget Hearings

Presidentʼs

Budget

Execution:

Obligating Funds

FY2005 Execution:

Obligating Funds

Presidentʼs

Budget

Presentation:

Budget Hearings
29ALLOCATION OF GRANT FUNDING

Step 2: From the amount remaining for competing grants:

• Distribute to the main mechanisms (R01 and P01) and the smaller 

mechanisms (R03, R21, R33, and R55).

• Hold approximately 5 to 10 percent in reserve for RPG exceptions 

(including accelerated executive review exceptions).

• Distribute the exception reserve to Program Division Director for 

supplements, RPGs, exceptions, and Shannon Awards.

• Allocate across each of the three review rounds.

Step 3: Based on historical data and current review results, set 

paylines for RPGs.

Funding Allocation: A Practical Example

The following example provides a sample appropriation and distribution for 

Research Project Grants (RPGs), using the following assumptions:

• Appropriation level of $2.161 billion

• Mandate to fund 1,492 competing RPGs

• Mandate that the average cost of the competing RPGs be no more than 

$332,000

Amount No. of Awards

Step 1

Appropriation $2,161,000,000

Small Business Set-Aside 100,000,000

Noncompeting Commitments 1,567,000,000

Competing Availability 494,000,000

Step 1a

Competing Availability 494,000,000 1,492

Set-Aside for RFAs 42,000,000 67

Remaining for R01, P01, R21, etc. 452,000,000 1,425

Step 2

Remaining for R01, P01, R21, etc. 452,000,000 1,425

The breakdown would be:

Allocation for R01, R37 302,000,000 906

Allocation for P01 52,000,000 33

Allocation for R21, R33 39,000,000 216

Allocation for R03, etc. 14,000,000 152

Reserve for exceptions 45,000,000 118

At this point, these amounts would be distributed to each of the three 

rounds.

Step 3 would consist of setting paylines for RPGs based on historical data 

and current review results.

In fiscal year 2004, the National Cancer Institute’s budget totaled 

$4,723,893,000. Expenditures in the four major budget activities are 

outlined in the following paragraphs.
30

Research

Cancer Causation Research

• FY2004 Obligations: $1,112,937,000

• 23.6% of the NCI Budget

Cancer causation research concentrates on the events involved in the 

initiation and promotion of cancer. It encompasses:

• Chemical and physical carcinogenesis

• Biological carcinogenesis

• Epidemiology

• Chemoprevention

• Nutrition research

Studies in this area focus on the following external agents that contribute to 

the initiation and promotion of cancer:

• Chemicals

• Radiation

• Fibers and other particles

• Viruses

• Parasitic infections

• Host factors such as hormone levels and nutritional and immunologic 

status

• Genetic endowment of the individual

Detection and Diagnosis Research

• FY2004 Obligations: $335,701,000

• 7.1% of the NCI Budget

Detection and diagnosis research includes studies designed to:

• Improve diagnostic accuracy.

• Provide better prognostic information to guide therapeutic decisions.

• Monitor response to therapy more effectively.

• Detect cancer at its earliest presentation.

• Identify populations and individuals at increased risk for the 

development of cancer.

Areas of emphasis include:

• Improvements in the detection and diagnosis of breast, cervical, uterine, 

and prostate cancers.

• Transfer of molecular technologies from the laboratory to clinical practice.

BUDGET ACTIVITIES
31ALLOCATION OF GRANT FUNDING

• Identification of better prognostic markers.

• Increased availability of human tumor samples with associated clinical 

information.

• Research to identify genetic alterations involved in tumor pathogenesis 

and behavior.

Treatment Research

• FY2004 Obligations: $1,092,437,000

• 23.1% of the NCI Budget

Treatment research is composed of preclinical and clinical research. 

Preclinical research focuses on the discovery of new antitumor agents and 

their development in preparation for testing in clinical trials. These agents 

include both synthetic compounds and natural products. Clinical research 

involves demonstrating the effectiveness of new anticancer treatments 

through their systematic testing in clinical trials:

• Phase I trial–The first step in testing a new treatment in humans. These 

studies test the best way to give a new treatment (for example, by mouth, 

intravenous infusion, or injection) and the best dose. The dose is usually 

increased a little at a time in order to find the highest dose that does not 

cause harmful side effects. Since little is known about the possible risks 

and benefits of the treatments being tested, Phase I trials usually include 

only a small number of patients who have not been helped by other 

treatments.

• Phase II trial–A study to test whether a new treatment has an anticancer 

effect (for example, whether it shrinks a tumor or improves blood test 

results) and whether it works against a certain type of cancer.

• Phase III trial–A study to compare the results of people taking a new 

treatment with the results of people taking the standard treatment (for 

example, which group has better survival rates or fewer side effects). 

In most cases, studies move into Phase III only after a treatment seems 

to work in Phases I and II. Phase III trials may include hundreds of 

people.

Cancer Biology

• FY2004 Obligations: $758,762,000

• 16.1% of the NCI Budget

Cancer biology supports a broad spectrum of research, including the 

body’s response to cancer. Since cancer is the result of genetic damage that 

accumulates in stages, it is the goal of cancer biology to identify and explain 

the stepwise progression between the initiating event in the cell and final 

tumor development. Studies include:

• Investigations of cellular and molecular characteristics of tumor cells.

• Interactions between cells within a tumor.

• Components of host immune defense mechanisms.
32

Resource Development

Cancer Centers Support

• FY2004 Obligations: $410,176,000

• 8.7% of the NCI Budget

The Cancer Centers Program consists of a group of individual, nationally 

recognized, geographically dispersed institutions with outstanding scientific 

reputations. Each institution reflects particular research talents and special 

technological capabilities. Cancer Center support mechanisms include P20s, 

P30s, P50 Specialized Programs of Research Excellence (SPOREs), and U54s.

The NCI awards planning and development grants (P20s) to encourage 

the development of cancer research centers in regions not currently served 

by existing NCI-designated Clinical or Comprehensive Centers. These 

awards assist eligible institutions to develop the organizational capability 

that could lead to the formation and/or development of cancer research 

centers or SPOREs. This program is currently under review. Refer to http://

www3.cancer.gov/cancercenters/ccb_guidelines.html for more information.

The NCI uses the Cancer Center Support Grant (CCSG) mechanism (P30) 

to support Cancer Centers that conduct research and outreach activities 

on several different cancers. There are two types of designations: Cancer 

Centers have a scientific agenda that is primarily focused on basic, 

population sciences, or clinical research or any two of the three components; 

Comprehensive Cancer Centers integrate research activities across three 

major areas: laboratory, clinical, and population-based research.

Of the $409 million allocated to Cancer Centers in fiscal year 2004, 

approximately $245 million was awarded to the 63 active Centers. This 

accounted for 5.2 percent of the NCI budget.

Cancer Centers have developed in a number of different organizational 

settings. Some are independent institutional entities dedicated entirely to 

cancer research (freestanding Centers); some have been formed as clearly 

identifiable entities within academic institutions and promote interactive 

cancer research programs across departmental and/or college structures 

(matrix Centers); and others involve multiple institutions (consortium 

Centers).

The CCSG is intended to provide support to the peer reviewed research 

base of the Cancer Center within the larger institution. The CCSG supports 

the operational framework (infrastructure) of the Center and partially pays 

for shared laboratory resources and facilities. Research projects themselves 

are supported through individual grants and contracts from the NIH and a 

variety of other grant-funding agencies and organizations.

Specialized Programs of Research Excellence (SPOREs) are designed to 

stimulate translational research from the laboratory to clinical practice. 

SPOREs, which are funded under the P50 grant mechanism, focus on 

prevention, detection, diagnosis, and treatment research for a single cancer 
33ALLOCATION OF GRANT FUNDING

site. They are awarded to institutions that demonstrate the ability to perform 

significant translational research.

The NCI’s Comprehensive Minority Institution/Cancer Center Partnership 

(U54) awards are cooperative agreements designed to establish 

comprehensive partnerships between Minority-Serving Institutions (MSIs) 

and NCI-designated Cancer Centers. The partnerships focus on cancer 

research and one or more target areas in cancer research training and career 

development, education, or outreach programs to minority communities. 

These awards improve the effectiveness of Cancer Center research through 

education and outreach activities 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-designated Cancer Center in areas of cancer research, research 

training and career development, education, and/or outreach that increases 

the emphasis on problems and issues relevant to the disproportionate 

cancer incidence and mortality in minority populations.

Research Manpower Development

• FY2004 Obligations: $173,691,000

• 3.7% of the NCI Budget

The NCI Research Manpower Development Program supports and 

maintains a pool of trained scientists qualified to perform cancer research. 

Grants under this program primarily provide support for basic and clinical 

scientists. The National Research Service Award Program is the major 

mechanism for providing long-term, 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 group of faculty preceptors, administer a 

comprehensive research training program for pre- and postdoctoral trainees. 

The Research Career Program supports the training of both scientists and 

research physicians during the first 3 to 5 years between receipt of a Ph.D., 

M.D., or other professional degree and receipt of an individual investigatorinitiated award.

Cancer Prevention and Control

• FY2004 Obligations: $511,111,000

• 10.8% of the NCI Budget

The NCI Cancer Prevention and Control Program conducts basic and applied 

research through both intramural and extramural mechanisms. A key 

priority of this program is to develop strategies for the effective translation 

of knowledge gained from prevention and control research into health 

promotion and disease prevention activities for the benefit of the public. An 

integrated system of basic research, clinical trials, and applications research 

is in place and seeks to promote cancer prevention and control activities 

across the country.
34

The Cancer Prevention and Control Program includes four components and 

several subprograms, many of which relate to other program activities of 

the NCI, including information dissemination, epidemiology, and cancer 

treatment. 

The four components are:

• Cancer Prevention Research.

• Cancer Control Science.

• Early Detection and Community Oncology.

• Cancer Surveillance.

Program Management and Support

• FY2004 Obligations: $329,078,000

• 7.0% of the NCI Budget

Program Management and Support budgets are used for the critical technical 

and administrative services required for NCI to carry out its extramural, 

intramural, and cancer prevention and control programs. They include 

central administrative functions, overall program direction, grant and 

contract review and administration, personnel, program coordination, and 

financial management.
35ALLOCATION OF GRANT FUNDING

FIGURE 7 NCI FY2004 Budget Activities

Research:

Cancer Causation

Detection and Diagnosis Research

Treatment Research

Cancer Biology

Subtotal, Research

Resource Development:

Cancer Centers Support

Research Manpower Development

Subtotal, Resource Development

Cancer Prevention and Control

Program Management and Support

*TOTAL NCI

$1,112,937

335,701

1,092,437

758,762

3,299,837

$410,176

173,691

583,867

511,111

329,078

$4,723,893

23.6%

7.1%

23.1%

16.1%

69.9%

8.7%

3.7%

12.4%

10.8%

7.0%

100%

BUDGET ACTIVITY AMOUNT % OF TOTAL

RESEARCH

70%

PROGRAM 

MGMT & SUPP

7%

RESOURCE DEV

12%

CANCER PREV 

& CONTROL

11%
Development, Receipt, & • xx

Assignment of Applications • 39

Application Types • 45

Peer Review • 46

NCI Funding Determinations • 56

Award Negotiation and Issuance • 60

Post-Award Administration • 68
37

REVIEW AND ADMINISTRATION

CHAPTER

Building 1–James A. Shannon Building
38

FIGURE 8 NCI Grants Process

Applications

selected

for funding

NCI

funding

policy

established

NCAB

reviews

and makes

suggestions

Summary 

statements 

forwarded to 

NCAB

Summary

statements and

letters forwarded 

to investigators

NCI assigns to 

appropriate NCI 

Program Director

9TH MONTH

4TH MONTH

8TH MONTH

1ST MONTH 2ND MONTH 3RD MONTH

9TH MONTH

Final

review and

negotiations

Congressional

liaison

notified

Award

received by

institution

“Paylists”

forwarded

to GMO

Award

issued

Investigator

begins

work

3RD MONTH 5TH MONTH 6TH MONTH 7TH MONTH

10TH MONTH

CSR assigns 

application to 

NIH Institute

CSR assigns 

application to

Scientific Review 

Group

CSR 

Assignment 

Office

SRG reviews,

votes, and assigns

priority scores or 

“not recommended 

for further 

consideration”

SRG members 

review and 

evaluate

Summary 

statements

prepared

Applicant 

investigator 

develops and 

submits grant 

application to 

NIH/CSR

AWARD NEGOTIATION & ISSUANCE

NCAB REVIEW FOR PROGRAM RELEVANCE, NEED, & NCI FUNDING DETERMINATIONS

SCIENTIFIC REVIEW GROUP (SRG) REVIEW & EVALUATION FOR SCIENTIFIC MERIT

DEVELOPMENT, RECEIPT, & ASSIGNMENT OF APPLICATIONS

Site visit made Site visit report

CSR-SRG

NCI-SRG
This 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—post-award 

administration (see Figure 8, p. 38). Ongoing efforts to streamline the grants 

process at the NIH will continue to impact the manner in which grant 

awards are processed at the NCI. However, the core concepts discussed in 

this section are expected to remain essentially the same.

Grantee Eligibility

Grants may be awarded to:

• Nonprofit organizations

• For-profit organizations

• Institutions of higher education

• Hospitals

• Research foundations

• State and local governments

• Federal institutions

• Individuals (fellowships only)

• Foreign institutions and international organizations (research grants only)

• Faith-based organizations

Principal Investigator Responsibility

The Principal Investigator (PI) is the individual designated by and accountable 

to the grantee institution for the proper conduct of the project. By signing 

the grant application, the PI accepts responsibility for the scientific conduct 

of the project and for submission of the progress and other required reports.

Grantee Institution Responsibility

By applying for grant support, the grantee institution agrees to administer 

awarded grant(s) in accordance with the regulations and current policies 

that govern the research grant programs of the NIH. Acceptance of an award 

and its associated special terms and conditions imposes upon the grantee 

institution and the PI the responsibility for conducting the research while 

using grant funds prudently and in accordance with cost principles for the 

purposes set forth in the approved application. The grantee organization 

is legally responsible and accountable to the NIH for the performance and 

financial aspects of the grant-supported activity.

As noted in the “Notice of Grant Award” section, (p. 25) the grantee 

indicates acceptance of the general and special provisions of an award by 

drawing funds from the grant payment system. The grantee institution is not 

required to guarantee the success of the project, nor are penalties generally 

39REVIEW AND ADMINISTRATION

DEVELOPMENT, RECEIPT, & ASSIGNMENT OF APPLICATIONS
40

imposed for lack of success in attaining scientific goals. However, in certain 

situations, the NCI may take action to resolve problems or weaknesses that 

arise during the course of the project. (See “Monitoring Projects,” p. 70, for 

further information.)

Standards of Conduct

The NIH depends on the funded research community to utilize a system of 

self-regulation coupled with appropriate NIH oversight. Ethical concerns, 

such as human subjects protection (45 CFR Part 46), promotion of animal 

welfare (P.L. 99-158 Section 495), removal of financial conflict of interest 

(42 CFR Part 50, Subpart F), and prevention of scientific misconduct 

(42 CFR Part 50, Subpart A) are all a part of this self-regulation.

The principle of self-regulation requires a high level of trust in the 

fundamental integrity of the research community and sufficient oversight 

to enable the NIH to assure the public that self-regulation is providing 

adequate safeguards for the ethical integrity of science.

Development of Grant Application

The process of developing a grant application usually begins with 

the Principal Investigator (PI). The PI should work together with the 

authorized business official from his/her institution to ensure that all of 

the application requirements are met. Applicants should anticipate 2 or 

3 weeks to prepare a small project application. Complex proposals may 

require as much as a year. Both the PI and the authorized business official 

must sign and date Form Page 1 (also known as the “face page”) to certify 

that the application is complete and accurate. (See Exhibit A, p. 116, for an 

example of a grant application face page.)

Numerous resources are available from the NIH with important 

considerations and suggestions to assist the PI and the applicant institution 

in preparing a research grant application. Among these, the NCI offers the 

following two websites:

• Preparing Grant Applications (http://deainfo.nci.nih.gov/extra/extdocs/

apprep.htm)

• Grant Application and Review Process (http://www.cancer.gov/research_

funding/grants/)

Although many investigator-initiated (unsolicited) applications are 

received by the NIH for new, expanded, and/or high-priority programs, 

the NCI may encourage the submission of grant applications through the 

following types of solicitations:

• Program Announcements (PAs) notify the grantee community of 

continuing, new, or expanded program interests for which grant 

applications are invited. Applications in response to PAs are reviewed in 

the same manner as unsolicited grant applications by Scientific Review 

Groups (i.e., committees) of the Center for Scientific Review or NCI.

• Program Announcements Reviewed in an Institute (PARs) are 

announcements that contain special referral guidelines and are 
reviewed by a Scientific Review Group (SRG) in the IC (Institute and/or 

Center) within NIH.

• Requests for Applications (RFAs) are issued to invite grant applications 

in a well-defined scientific area to stimulate activity in an IC’s priority 

programs. The RFA identifies a single receipt date, the amount of funds 

earmarked for the initiative, the number of awards likely to be funded, 

and any specific criteria for scientific peer review. Applications received 

in response to a particular RFA are reviewed by an Institute’s SRG.

All PAs, PARs, and RFAs are published in the NIH Guide for Grants and 

Contracts (http://www.nih.gov/grants/guide/index.html) and, when 

appropriate, in scientific journals and periodicals.

Applicants anticipating submission of an application exceeding $500,000 

in direct costs in any year of the project must seek approval from the 

awarding IC’s Program Director at least 6 weeks prior to submission. If 

the requested amount is significantly greater than $500,000, approval 

should be sought even further in advance. (See NIH Guide Notice: http:

//grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.) 

Applications submitted in response to RFAs or other announcements that 

include specific budgetary limits are exempt from this requirement.

Allowable Costs

Research grant funds are awarded to supplement or complement the support 

of research at an institution. Grant funds may be used for:

• Allowable direct costs specifically incurred in the conduct of the research 

project.

• Facilities and administrative (F&A) costs (formerly known as indirect costs 

[overhead]) resulting from an institution providing support services.

These funds are not intended to replace support already being furnished by 

the institution or for expenses previously incurred.

Direct Costs

Allowable direct costs may include:

• Salaries and fringe benefits of the Principal Investigator, other key 

personnel, and supporting staff.

• Expenditures for project-related equipment and supplies.

• Fees and supporting costs for consultant services.

• Expenses for travel beneficial to the research.

• Research patient care costs.

• Alterations and renovations.

• Publications and other miscellaneous expenses.

• Contract services.

• Costs for consortium participants. 41REVIEW AND ADMINISTRATION
Facilities and Administrative Costs

In addition to direct costs, the HHS supports a policy of full reimbursement 

of facilities and administrative (F&A) costs for most grant programs, with 

a few exceptions (e.g., training, fellowships, career programs, cancer 

education grants, and foreign grants). F&A costs are not readily identifiable 

with a particular project or activity but are necessary to the general 

operation of the institution and the conduct of its research activities.

Allowable F&A costs may include:

• Depreciation use allowance.

• Facilities operations and maintenance.

• General administration and general expense.

• Departmental administration.

• Sponsored project administration.

• Libraries.

The grantee institution assigns the costs to an F&A cost pool from which 

they are appropriately distributed to all organizational activities on the 

basis of a rate. The rate is a ratio of the F&A costs to a direct cost base. The 

amount awarded for F&A costs is determined by multiplying the rate by 

the allowable costs in the direct cost base for the project.

Rate Agreement

In order to receive reimbursement for F&A costs, the grantee institution 

must prepare an annual F&A cost rate proposal, which is submitted to the 

cognizant Federal agency. The cognizant agency is that which provides 

the largest amount of funds to a grantee over a specific period and acts as 

a representative for all Federal agencies dealing with a grantee’s common 

costs (e.g., F&A costs and fringe benefits). After review and negotiation of 

the F&A cost rate proposal, the cognizant agency establishes an accepted 

rate, formalized as the F&A cost rate agreement for that institution. This 

agreement is then made available to all other interested Federal grantor 

agencies. The negotiated F&A cost rate is used to calculate the applicable 

amount of F&A costs for each award to the grantee institution.

The NIH Notice of Grant Award includes both direct costs and applicable 

F&A costs, which are calculated by the Grants Management Specialist. 

Typically, this award reflects the maximum total costs provided during 

the budget period even if a higher F&A rate is subsequently negotiated. 

If the amount required for F&A costs decreases because of either a new, 

lower negotiated rate or post-award budgetary changes in the direct costs 

of the grant, the excess F&A funds awarded generally may be rebudgeted 

to support allowable direct costs for the project, subject to specific 

requirements set forth in the applicable cost principles.

42
Receipt and Assignment of Applications

The Referral section of the Center for Scientific Review (CSR) serves as the 

central receiving point for all competing applications, whether solicited or 

unsolicited. Within the CSR, all competing applications undergo a brief 

evaluation to determine what area of research each represents. CSR referral 

officers then assign each application to a specific NIH Institute for possible 

funding.

The evaluation of scientific and technical merit will be carried out by a 

Scientific Review Group in either CSR or an appropriate Institute or Center 

(IC). Applicants are notified by mail of these assignments, usually within 6 

to 8 weeks of submission. Figure 9 below provides a typical timeframe from 

the date of receipt of an application through assignment.

Return of Incomplete and Late Grant Applications

A grant application is considered incomplete and will be returned to the 

submitting institution if:

• It is illegible.

• It fails to follow the instructions provided on the appropriate application 

form.

• It fails to follow specific instructions provided in an RFA or PA.

• The material presented is insufficient to permit an adequate review.

Information regarding the submission of competing Grant Applications 

(PHS 398), Noncompeting Grant Progress Reports (PHS 2590), and 

SBIR/STTR Grant Applications can be accessed at the following website: 

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

43REVIEW AND ADMINISTRATION

FIGURE 9 Development, Receipt, and Assignment of Applications

Applicant 

investigator 

develops and 

submits grant 

application to 

NIH/CSR

CSR

Assignment 

Office

NCI assigns to 

appropriate 

NCI Program 

Director

CSR-SRG

NCI-SRG

CSR assigns 

application to 

NIH Institute

CSR assigns 

application to 

Scientific 

Review Group

1ST MONTH 2ND MONTH 3RD MONTH
Grant Application Identification Number

Each new application received is assigned an identification number and 

checked for completeness, and duplicates are forwarded to the appropriate 

Institute and Integrated Review Group (IRG).

The following is an example of a grant application identification number:

The above number identifies a new (Type 1) application for a traditional 

research project (R01) assigned to the NCI (CA). The serial number, which 

is assigned sequentially by the CSR, indicates that it is the 100,228th 

application assigned to the NCI. The suffix (01) shows that this is the first 

year of requested support for this project. The next part of the suffix is used 

to identify an amended application (A1) or a supplement (S1).

Grant Application Referral

Once the NCI has been assigned an application by the CSR, NCI referral 

officers examine and direct each application to the appropriate NCI Program 

Director. It is the responsibility of the Program Director to then follow the 

progress of his/her assigned application(s) through the peer review process. 

The NCI establishes an official electronic file for each application and enters 

fiscal and scientific information into the NIH/NCI data systems.

44

 Application

Type

Activity

Code

Administering

Organization

Serial

No.

Suffix

Grant Year

Suffix

Other

1 R01 CA 100228 01 A1 or S1
There are nine grant application types that may be used to identify the 

stages in the life cycle of a grant. The grant type defines the procedures and 

specifies the documents required to process the grant award.

Type 1–New

Request for support of a project that has not yet been funded.

Type 2–Competing Continuation

Request for an additional period of support based on a previously 

funded project. Competing continuation applications compete with 

other competing continuation, competing supplemental, and new 

applications for funds.

Type 3–Supplement

Request for additional funds, either for the current operating year or 

for any future year previously recommended, to cover increased costs 

(noncompeting) or to expand the scope of work (competing).

Type 4–Extension

Request for additional time and/or funds beyond those previously 

awarded. Typically limited to certain mechanisms, including Merit 

(R37), Developmental/Exploratory (R21/R33), and Fast-Track Small 

Business Grants SBIR/STTR (R42/R44). These grants do not compete for 

available funds.

Type 5–Noncompeting Grant Progress Report

Request to pay next budget increment of a current award; does not 

compete for available funds.

Type 6–Change of Institute or Division (Successor-inInterest and Name-Change Agreements)

Request for NIH’s acceptance of a change in business structure, such as 

successor-in-interest, name change, or merger.

Type 7–Change of Grantee or Training Institution

Request for support of a funded project to be transferred from one 

grantee or training institution to another.

Type 8–Change of Institute or Center

Noncompeting continuation (Type 5) to be transferred from one IC to 

another.

Type 9–Change of Institute or Center

Competing continuation (Type 2) that has been transferred from one IC 

to another.

45REVIEW AND ADMINISTRATION

APPLICATION TYPES
Integrated Review Group (IRG)

Review activities of the Center for Scientific Review (CSR) are organized into 

Integrated Review Groups (IRGs). Each IRG represents a cluster of study 

sections around a general scientific area. Applications generally are first 

assigned to an IRG and then to a specific study section within that IRG for 

evaluation of scientific merit. These study sections, also known as Scientific 

Review Groups (SRGs), are the first level of the dual peer-review system of 

the NCI.

Scientific Review Group (SRGs)

Scientific Review Groups (SRGs) review research grant applications as 

formally mandated in 1974 by Section 475 of the Public Health Service Act. 

They function specifically in the following manner:

• Within the CSR, SRGs review and evaluate the scientific merit of 

research grant applications on specific topics (e.g., cell biology, clinical 

oncology, pathology, biochemistry, virology) regardless of the awarding 

NIH Institute. There are approximately 220 SRGs in the CSR, each 

composed of 12 to 18 individuals who advise the NIH on the scientific 

and technical merit of the applications they evaluate.

• Within the ICs, the SRGs review and evaluate the scientific merit of 

research grant applications that are closely related to the IC’s mission, as 

well as applications submitted in response to RFAs and other specialized 

programs.

All NIH SRG rosters may be found at the following website: 

http://era.nih.gov/roster/index.cfm.

The second level of the dual peer-review system of the NCI is the National 

Cancer Advisory Board (NCAB), as mandated by the National Cancer Act of 

1937 and incorporated into the Public Health Service Act in 1944. The NCAB 

reviews NCI grants through its members’ knowledge in each of the relevant 

programmatic areas, familiarity with NCI priorities and procedures, and 

awareness of the missions of the diverse Institutes in biomedical research 

and of the health needs of the American people. The NCAB is discussed in 

greater detail on p. 52.

The NCI Division of Extramural Activities (DEA) organizes and manages 

the peer review of grant and cooperative agreement applications that are 

highly mission-specific to the NCI. These include applications for program 

projects, Cancer Center Support Grants (CCSGs), multisite clinical trials, 

the NCI’s Clinical Trials Cooperative Groups, Ruth L. Kirschstein National 

Research Service Award (NRSA) grants, and cancer education grants.

For Program Project Grants (P01), Cancer Center Support Grants (P30), 

and Clinical Trials Cooperative Group (U10) applications, the NCI DEA 

uses a two-tiered peer-evaluation process. For these applications, the first 

46

PEER REVIEW
tier of evaluation usually includes a site visit or other means of interaction 

between the review panel members and the applicants. The site visit 

provides an in-depth evaluation of each component of the application. A 

site visit report is prepared, which includes the recommendations of the site 

visitors. The second-tier evaluation is carried out by a chartered “parent” 

Scientific Review Group, which assigns a priority score to the application 

after evaluating the application and the site visit report.

For applications that cannot be reviewed by an SRG or chartered NCI 

review committee due to conflict of interest or lack of expertise, a Special 

Emphasis Panel (SEP) (formerly Special Review Committee) is assembled 

to conduct the review. NCI Requests for Applications (RFAs) and Program 

Announcements Reviewed in an Institute (PARs) are usually evaluated by 

NCI SEPs. The composition of the panel is determined by the expertise 

needed to evaluate the submitted grant applications.

Figure 10 below illustrates a representative timeline for SRG review of 

applications. There are three review cycles, or “rounds,” annually. In each 

review cycle, a CSR Scientific Review Group may review between 50 and 100 

grant applications. The review cycle has been shortened for applications 

involving Acquired Immune Deficiency Syndrome (AIDS) research and for 

applications in the Small Business Innovation Research (SBIR) and Small 

Business Technology Transfer (STTR) Programs.

47REVIEW AND ADMINISTRATION

Scientific Review Administrators (SRAs)

Each Scientific Review Group (SRG) is organized and managed by a 

Scientific Review Administrator (SRA), the NIH staff scientist who serves as 

the Designated Federal Official (DFO) responsible for ensuring that grant 

applications are evaluated in an impartial environment.

FIGURE 10 SRG Review and Evaluation for Scientific Merit

3RD MONTH 4TH MONTH 5TH MONTH 6TH MONTH 7TH MONTH

Summary 

statements and 

letters forwarded 

to investigators

Summary 

statements 

forwarded to 

NCAB Site visit made

SRG 

members 

review and 

evaluate

Site visit report

SRG reviews, 

votes, and 

assigns priority 

scores or “not 

recommended 

for further 

consideration”

Summary 

statements 

prepared
The SRA’s major responsibilities include:

• Identifying what scientific and technical information is contained in the 

application and assigning individual reviewers to evaluate the contents.

• Managing SRG meetings.

• Nominating study section members.

• Selecting reviewers and site visitors to serve on the committee.

• Providing orientation for members of review groups.

• Explaining and interpreting NIH review policies and procedures.

• Managing projects site visits and subsequent SRG meetings.

• Preparing summary statements documenting the review outcome and 

SRG recommendations.

• Attending advisory board or council meetings to provide requested 

information in support of the SRG’s recommendations.

• Communicating with program staff on review issues.

• 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.

Project Site Visits

The purpose of a project site visit is to allow the reviewers an opportunity 

to gather information not available in the written application in order to 

evaluate its merit. The Scientific Review Administrator (SRA) assembles a 

project site visit team of reviewers whose number varies with the complexity 

of the program being evaluated. Site visits enable reviewers to meet with 

the Principal Investigator and other researchers, view the facilities, and 

raise questions or discuss objectives. The NCI Program Director generally 

participates in these visits to provide program information, if needed, 

and to gain a better understanding of the project and the reviewers’ 

recommendations. In some cases, the SRA, Program Director, or Grants 

Management Officer may request that a Grants Management Specialist 

take part in the site visit to provide business and administrative expertise. 

Following the site visit, reports based on the site visit team’s observations 

and findings are prepared for presentation at the parent Scientific Review 

Group meeting.

Approximately 1 percent of the research grant applications reviewed by 

CSR require a project site visit before the study section can complete its 

assessment. This action may require deferral of the review to the next review 

cycle. Large, complex applications evaluated by NCI, such as those for Cancer 

Center Support, Program Projects, and Clinical Trials Cooperative Groups, 

routinely require a project site visit by a team of 10 to 30 expert consultants, 

as well as several members from the appropriate NCI “parent” committee. 

The composition of the team depends on the number of individual program 

components and disciplines involved. 48
Scientific Review Group Meetings (SRGs)

Scientific Review Groups (SRGs) meet 1 to 3 months before each meeting 

of the National Cancer Advisory Board (NCAB). NCI Program Directors and 

Grants Management Specialists may be present as observers at the meetings 

but do not participate in the discussion or vote. Before every meeting, each 

reviewer is assigned several applications that fall into his/her field of special 

competence to examine, evaluate, and summarize. The reviewer makes 

an initial recommendation to the review group about the merit of each 

application. For applications that require a site visit, two or more members 

of the site visit team, usually IRG members, will summarize their findings 

and recommendations for the full parent committee (e.g., proposed budget 

and project period).

Applications are evaluated for:

• Significance: Does this study address an important problem? If the aims 

of the application are achieved, how will scientific knowledge or clinical 

practice be advanced? What will be the effect of these studies on the 

concepts, methods, technologies, treatments, services, or preventative 

interventions that drive this field?

• Approach: Are the conceptual or clinical framework, design, methods, 

and analyses adequately developed, well integrated, well reasoned, and 

appropriate to the aims of the project? Does the applicant acknowledge 

potential problem areas and consider alternative tactics?

• Innovation: Is the project original and innovative? For example: 

does the project challenge existing paradigms or clinical practice or 

address an innovative hypothesis or critical barrier to progress in the 

field? Does the project develop or employ novel concepts, approaches, 

methodologies, tools, or technologies for this area?

• Investigators: Are the investigators appropriately trained and well 

suited to carry out this work? Is the work proposed appropriate to the 

experience level of the Principal Investigator and other researchers? Does 

the investigative team bring complementary and integrated expertise to 

the project (if applicable)?

• Environment: Does the scientific environment in which the work will 

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

studies benefit from unique features of the scientific environment or 

subject populations or employ useful collaborative arrangements? Is 

there evidence of institutional support?

In addition to the above criteria, and in accordance with NIH policy, all 

applications will also be reviewed with respect to the following:

• The adequacy of plans to include women, children, minorities, and 

their subgroups as appropriate for the scientific goals of the research. 

Plans for the recruitment and retention of subjects are also evaluated.

• The reasonableness and duration of the proposed budget in relation to 

the proposed research. 49REVIEW AND ADMINISTRATION
• The adequacy of the proposed protection for humans, animals, and/or 

the environment to the extent that they may be adversely affected by 

the project proposed in the application.

• Responsiveness to any specific criteria set forth in announcements or 

requests (e.g., Requests for Applications [RFAs]).

At present, the review committee may make one of the following 

recommendations regarding scoring an application:

• Scoring: Applications that are judged to have significant and substantial 

merit are assigned a priority score. The NIH uses a scale of 1.0 (highest 

merit) to 5.0 (lowest merit) to score applications during the initial or first 

level of the scientific review process. Those applications that score in the 

upper half (1.0 to 3.0) with respect to scientific merit are recommended 

for the second level of peer review (Advisory Council/Board) by the 

SRG.

• Not Scoring: Applications that are considered to be in the lower half 

are designated as unscored and are not given a numerical score. These 

applications are not discussed in the review meeting. Not scoring an 

application requires unanimous consent.

• Not Recommended for Further Consideration (NRFC): Applications that 

lack significant and substantial merit or have serious ethical problems 

in the protection of human subjects from research risks or in the use 

of vertebrate animals are designated Not Recommended for Further 

Consideration (NRFC). Applications designated as NRFC do not proceed 

to the second level of peer review (Advisory Councils/Boards) because 

they cannot be funded.

• Deferral (DF): Applications may be deferred if additional information is 

needed to make a definitive recommendation.

All SRG members who participate in person or by teleconference, 

videoconference, or virtual meeting (as members of an Internet-assisted 

meeting) in the evaluation of an application may vote and score the 

applications. (SRG members with a conflict of interest may not participate 

in the discussion of an application and may not vote on or score the 

application for which the conflict exists).

Priority Scores

To determine the priority score, each SRG member assigns a numerical 

rating that reflects the reviewer’s assessment of the overall impact the 

project could have on the field. This assessment is based on consideration 

of the five review criteria (significance, approach, innovation, investigators, 

and environment), with the emphasis on each criterion varying from one 

application to another, depending on the nature of the application and 

its relative strengths. The numerical ratings range from 1.0 (best) to 5.0 

(worst), with increments of 0.1. A score of 3.0 is the midpoint score; the 

range of scores from 1.0 to 3.0 represents the upper half of the applications, 50 while applications with scores greater than 3.0 represent the lower half.
After the review meeting, the SRA averages the individual reviewers’ ratings 

for each scored application and multiplies by 100 to provide a three-digit 

number that is the priority score. Generally, 4 to 5 months will have 

elapsed since the Principal Investigator submitted the application (see 

Figure 10, p. 47).

Percentile Rank

In addition to a priority score, most applications reviewed by the CSR 

receive a percentile rank. The conversion of priority scores to percentile 

rankings (along a 100.0 percentile band) is based on scores assigned to 

applications reviewed during the current plus the past two review rounds. 

Applications reviewed by a standing study section are ranked against all 

applications reviewed by that same study section over the three consecutive 

rounds. Applications reviewed by NCI review groups receive priority scores 

only, and percentile ranks are not calculated for these applications.

The overall intent of percentile ranking (or “percentiling”) is to improve 

the comparability of scored applications across SRGs and to minimize 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.

Summary Statements

During the 6 to 8 weeks after each SRG meeting, the Scientific Review 

Administrator (SRA) prepares summary statements reflecting the judgment 

of the reviewers (see Exhibit B, p. 117). The summary statement includes 

a concise statement of the proposed research and an evaluation of its 

merit. Summary statements of scored applications contain a priority score 

and, where applicable, a percentile. They also include Committee Budget 

Recommendations, which may indicate budget items recomended by the 

reviewers for reduction or elimination, as well as a recommendation for 

duration of support. Projects may be recommended for support for up to 

5 years.

Early Notification to Applicant

Once the priority scores and percentiles are calculated by the SRA, a 

transmittal (and final) notification letter is sent to the Principal Investigator 

(PI) by the Program Director. The PI may obtain an electronic copy of 

his/her summary statement through the NIH eRA Commons (https://

commons.era.nih.gov/commons/).

However, due to the presence of confidential information pertaining to 

the PI, the grantee’s business official does not have direct access to the 

summary statement. The grantee business official is, however, sent a copy 

of the notification letter.

51REVIEW AND ADMINISTRATION
National Cancer Advisory Board

The second level of the dual peer-review system is the NCI’s principal 

advisory body, the National Cancer Advisory Board (NCAB). The NCAB 

members are appointed by the President. Scientific experts and advocates 

on the NCAB advise the NCI Director on issues related to all aspects of the 

National Cancer Program (see the National Cancer Act of 1971) and provide 

a second level of review for NCI grant applications.

The NCAB is responsible for the final external review of all grant applications 

referred to the NCI except for the following:

• 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 fellowship applications.

• Applications with percentiles in the bottom half of those reviewed by CSR.

• 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 Cancer Program. 

It also recommends support of meritorious projects to the NCI Director. In 

addition, the NCAB advises the Director with regard to the National Cancer 

Program as a whole.

Legislative Authority

On January 4, 1973, in accordance with the Federal Advisory Committee 

Act (P.L. 92-463), the Secretary of the Department of Health, Education, 

and Welfare chartered the NCAB. The NCAB’s mandate is continuous, and 

the Board is rechartered every 2 years.

The National Cancer Act of 1971 (P.L. 92-218) and the Health Research 

Extension Act of 1985 (P.L. 99-158) specify that two-thirds of the NCAB 

members be appointed from among the leading representatives of the 

health and scientific disciplines relevant to cancer. The remaining onethird of the members shall be appointed from the public and include 

leaders in the fields of public policy, law, health policy, economics, and 

management.

Composition

The NCAB is composed of 18 members, who—by virtue of their training, 

experience, and background—are especially qualified to evaluate the 

programs of the NCI. These members serve overlapping terms of 6 years. 

The President also designates one of the appointed members to serve as 

Chair for a term of 2 years.

Ex officio members of the Board include the:

• Secretary of HHS.

• Director of the Office of Science and Technology Policy.

• Director of the NIH.

52
• Chief Medical Director of the Department of Veterans Affairs.

• Director of the National Institute of Environmental Health Sciences.

• Secretary of Labor.

• Commissioner of the Food and Drug Administration.

• Administrator of the Environmental Protection Agency.

• Chair of the Consumer Product Safety Commission.

• Assistant Secretary of Defense for Health Affairs.

• Director of the National Institute for Occupational Safety and Health.

• Director of the Office of Science, Department of Energy.

Pre-NCAB Meetings

Approximately 2 weeks before a meeting of the NCAB, the Executive 

Secretary calls a meeting with NCI staff members to discuss and review the 

materials that are to be presented to the NCAB in closed session. The closedsession materials are compiled in the Special Actions Booklet prepared by the 

Division of Extramural Activities (DEA) staff from the material provided by 

NCI program staff. The Special Actions Booklet identifies applications with:

• Concerns with respect to human subjects, animal welfare, gender/

minority/children, or biohazards.

• Foreign applications.

• All appeals.

• Recommendations for MERIT (Method to Extend Research in Time) 

award nominations and extensions.

• Other staff recommendations.

• Any special information that needs to be brought to the attention of 

the NCAB.

In addition, special issues related to the pending NCAB meeting are 

brought to the attention of the program staff.

NCAB Meetings

The NCAB meets at the call of the NCI Director or the Board Chair no 

fewer than four times a year, and the meetings usually last 2 days. Meetings 

of the NCAB that are scheduled for January/February, May/June, and 

September/October include application review. The November/December 

NCAB meeting is reserved for review of NCI programs.

NCAB meetings are open to the public when general program 

activities and plans are discussed. By HHS regulation, scheduled NCAB 

meeting dates are published well ahead of time in the Federal Register

(http://www.gpoaccess.gov/fr/index.html). Attendance at the closed 

grant application review sessions is limited to NCAB members, SRAs, 

the NCI Director, appropriate NCI staff, and designated representatives 

of the Secretary, HHS. SRAs and appropriate NCI staff members attend 

NCAB meetings to provide, when necessary, specific details or additional 

information on projects under discussion by the NCAB.

53REVIEW AND ADMINISTRATION
Approximately 6 to 8 weeks before the NCAB meeting, summary statements 

within the competitive range for applications to be reviewed at the upcoming 

meeting are made available to all NCAB members via the NIH Electronic 

Council Book. NCAB members are not given access to summary statements 

from their own institutions. By the time the NCAB meets, approximately 

1,500 summary statements, as well as other relevant materials about the 

applications, will have been made available to the NCAB.

Furthermore, the NCI’s Division of Extramural Activities prepares and 

distributes special reports for review by the NCAB that detail grant 

applications involving human subjects, animal welfare, biohazard 

risks, foreign grants, and inadequate representation/justification of 

gender/minorities/children. In addition to these special reports, NCAB 

members also receive MERIT (Method to Extend Research in Time) award 

nominations and extensions, as well as appeal letters from PIs who disagree 

with the SRG’s recommendation(s).

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 assigned NCI Program Director. Most of the NCAB members’ concerns 

are resolved through correspondence with the Program Director. If not, 

they are discussed during the closed session of the NCAB meeting.

During the closed session, the NCAB acts on all applications brought 

before it. Some applications are reviewed and discussed on an individual 

basis. For example, applications may be brought to the NCAB’s attention 

by NCI program staff concerned with some aspect of the SRG review, such 

as the recommended funding level, period of support, or the percentile/

priority score assigned. NCAB members themselves may bring up other 

applications for discussion. The NCAB’s options are discussed in the 

following paragraphs.

Expedited NCAB Review

An expedited NCAB approval process is used for percentiled R01s reviewed 

by CSR and for all R21s, except:

• Those applications submitted in response to an RFA or PA with a setaside.

• Applications with foreign institution involvement.

• Applications whose summary statement expresses concerns with 

regard to human subjects, animal welfare, biohazards, or inadequate 

representation/justification of gender/minorities/children.

The NCAB members approve grant applications using the NIH Electronic 

Council Book. A notification letter is then sent by the Grants Administration 

Branch notifying the PI of the NCAB approval and plans for expedited 

funding.

54
Recommendations

In most cases, the NCAB concurs with the SRG’s recommendations. 

However, the NCAB may vote to change the SRG recommendations in the 

following 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 SRG. If, after deferral and a second 

review, the NCAB 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.

• The NCAB may recommend that an application receiving a favorable 

recommendation in initial review not be considered for support for 

reasons other than lack of scientific or technical merit.

• In the case of a split vote from the SRG, the NCAB may accept the 

minority opinion without returning the application for further review.

In all cases of nonconcurrence with SRG recommendations, the NCAB must 

communicate its rationale for questioning or disagreeing with the decision 

to the SRA of the IRG within 10 working days after the NCAB meeting.

Once it has acted on those applications given special attention, the NCAB 

considers a motion for en bloc concurrence with the SRGs’ recommendations 

as presented in the summary statements. NCAB members do not attend 

discussions or vote on applications from their own institutions or affiliated 

institutions and are required to sign conflict-of-interest statements. This 

allows them to participate in the en bloc concurrence without risking a 

conflict of interest.

In special circumstances, the second level of review is completed using 

the mail ballot process, whereby summary statements are forwarded to the 

NCAB members and they communicate concurrence or nonconcurrence. 

Conflict-of-interest guidelines are maintained during this process.

Post-NCAB Meetings

After each NCAB meeting, NCI staff members meet to discuss and review the 

NCAB’s recommendations. Applicants who will be funded are subsequently 

notified at the time of the award negotiation. Ideally, approximately 8 to 

9 months will have elapsed since the Principal Investigator submitted the 

application (see Figure 11 on the following page).

Appeals to Referral and Review of Applications

Effective with the applications submitted beginning with the June 1997 

NCAB, the NIH abolished appeal of review actions beyond the Institute level. 

Once an appeal has been sent to the NCAB, there is no further administrative 

mechanism of redress offered to applicants who are unhappy with the 

outcome of their review other than to submit an amended application.

55REVIEW AND ADMINISTRATION
Funding Decisions

Around October 1, the beginning of a new Federal fiscal year, the NCI 

Executive Committee discusses program priorities and preliminary funding 

allocations for the coming fiscal year. In order to determine the program 

allocations, the following considerations are taken into account:

• Congressional mandates

• New scientific opportunities

• New initiatives

• Program priorities

• Previous commitments, such as noncompeting continuations

• Other projected needs

• Anticipated availability of funds

Final allocations and funding decisions cannot be made until the actual 

amount of the appropriation is known.

Generally, the NCI Executive Committee meets in October/November to 

establish funding policy for grant applications submitted for the year’s 

first funding cycle, which begins with the September/October meeting of 

the NCAB. If Congress has passed an appropriations bill by this time, the 

funding policy for the entire year may be established.

When establishing paylines for the year, the NCI allocates funds available 

for competing grants among the three funding cycles. Thus, applicants with 

the same priority score or percentile ranking are normally paid regardless 

of the cycle in which they competed. The funding policy is reconsidered at 

least two more times during the year to coincide with the NCAB’s schedule 

of grant review cycles.

Grant applications are grouped by mechanism for funding through one of 

two processes: (1) a mechanism that is used solely by one Division (training 

grants, for example) will have a separate budget within the Division. The 

56

FIGURE 11 NCAB Review and NCI Funding Determinations

8TH MONTH

NCAB 

reviews 

and makes 

suggestions

NCI funding 

policy 

established

Applications 

selected for 

funding

NCI FUNDING DETERMINATIONS
Division Director is responsible for establishing an annual funding plan 

for Division-controlled programs; and (2) mechanisms that are common to 

more than one Division (traditional research grants [R01], program project 

grants [P01], etc.), which compete for funds from a common budget “pool.” 

The selection of applications to be funded from pool funds is discussed in 

the next section. An example of the distribution of NCI fiscal resources is 

found in Figures 12 and 12a (pp. 58 and 59), which display budget spending 

by funding mechanism for FY2004.

Funding Selections

Immediately following a meeting of the NCAB, NCI Program Directors are 

provided with an electronic “ranking list” of competing applications in their 

program areas to review for payment and to verify the program assignment. 

The approved grant applications are ranked in percentile or priority score 

order from most to least meritorious. Those percentiles or priority scores that 

fall within the payline move forward towards being funded. The payline is 

a virtual line that separates the applications that will be paid in rank order 

and those which may be selected based on programmatic relevance.

NCI Program Directors are also advised of the dollars available for each 

particular group of applications. Generally, Program Directors select grants 

for payment in straight priority or percentile score order. However, they 

may skip one or more applications that already receive support from 

other sources or for programmatic reasons and use the “saved” monies to 

fund applications that may be important to the program’s objectives but 

fall outside the payline. However, NCI Executive Committee approval is 

required to skip an application.

Additionally, approximately 8 to 10 percent of the competing budget is 

set aside for each round to fund exceptions. Four times a year (once for 

each round and a final time at the end of the year), the NCI Executive 

Committee meets to consider recommendations from NCI program staff to 

pay Research Project Grant (RPG) applications that are outside the paylines. 

Also, each Division Director has discretionary authority to select RPGs for 

payment as exceptions within a budget and parameters established by the 

NCI Executive Committee.

After review and discussion with the NCI Division Director, the NCI Program 

Director indicates on the ranking list the applications selected for funding. 

After the ranking list is signed by the Program Director, the Division 

Director, the Chief of the Extramural Financial Data Branch or designee, and 

the Grants Management Officer, it becomes an authorization (paylist) (see 

Exhibit C, p. 120). The Grants Management Officer and grants management 

staff use this paylist as the authority to complete the administrative review, 

negotiation, and award process.

A summarized general description of the three-step funding allocation 

process for research project grants, as well as a practical example of a funding 

allocation, is provided in Chapter 2 (p. 27) of this publication. 57REVIEW AND ADMINISTRATION
58

FIGURE 12 NCI FY2004 Extramural Funds (dollars in thousands)

Contracts:

R&D Contracts

Interagency Agreements

Cancer Control Contracts

Construction Contracts

Subtotal, Contracts

Grants:

Research Project Grants

Cancer Centers/SPOREs

Training Activities

Other Research Grants

Cancer Control Grants

Construction Grants

Subtotal, Grants

Total Extramural Funds

Total Intramural/RMS/Control In-House

*TOTAL NCI

$298,828

79,103

136,671

0

514,602

$2,161,359

409,288

66,264 

314,916

219,965

0

3,171,792

3,686,394

1,037,499

$4,723,893

8.1%

2.1%

3.7%

0%

14%

58.6%

11.1%

1.8%

8.5%

6.0%

0%

86%

MECHANISM AMOUNT % OF TOTAL

CONTRACTS

14%

GRANTS

86%
59REVIEW AND ADMINISTRATION

FIGURE 12a NCI Obligations by Mechanism FY2004 (dollars in thousands)

*EXCLUDES projects awarded with Stamp Out Breast Cancer funds. 

Research Project Grants:

Traditional Research Grants (R01)

Program Projects (P01)

FIRST Awards (R29)

MERIT Awards

RFAs (R01,R03,R21,U01,U19)

Cooperative Agreements (U01/U19)

Exploratory Grants - Phase I (R21)

Exploratory Grants - Phase II (R33)

Small Grants (R03)

AREA Grants (R15)

Shannon Awards (R55)

Program Evaluation

Subtotal, RPG Pool

SBIR/STTR Grants (R41,R42,R43,R44)

Subtotal, Research Project Grants (RPGs)

Centers and SPOREs:

Cancer Centers Grants (P30,P20)

SPOREs (P50,P20)

Center Cooperative Agreements (U54)

Subtotal, Centers

Other Research:

Career Program:

Temin & Minority Mentored Career Dev. (K01)

Estab. Invest. Award in CA Prevent. & Control (K05)

Preventive Oncology Awards (K07)

Mentored Clinical Scientist Development (K08)

Mentored Clinical Oncology Awards (K12)

Transitional Career Development (K22)

Mentored POR Career Development (K24)

Mid-Career Invest. & Patient Oriented Research (K24)

Mentored Quantitative Research Career Dev. (R25)

Institutional Curriculum Awards (K13)

Subtotal, Career Program

Cancer Education Program (R25)

Clinical Cooperative Groups (U10)

Minority Biomedical Support (S06)

Scientific Evaluation (U09)

Continuing Education (T15)

Research Resource Grants (R24,U24)

Exploratory Cooperative Agreements (U56)

Conference Grants (R13)

Subtotal, Other Research Grants

Subtotal, Research Grants

Ruth Kirschstein–NRSA Training (F31,F32,F33,T32, & T36)

Cancer Control Grants

Construction Grants (C06)

Subtotal, All Grants

R&D Contracts:

SBIR Contracts

Subtotal, Contracts

Intramural Research Program:

NIH Management Fund

Subtotal, Intramural Research

RMS:

NIH Management Fund

Subtotal, RMS

Cancer Prevention & Cancer Control Contracts:

In-House

NIH Management Fund

Subtotal, Prevention and Control

*Total NCI

$ 1,277,187

344,491

53

37,888

168,538

31,376

77,968

42,931

18,067

4,560

58,721

2,061,780

99,579

2,161,359

245,761

149,366

14,161

409,288

15,770

2,396

11,393

17,243

8,791

5,333

7,911

3,061

712

1,597

74,207

32,214

154,357

3,853

10,240

344

26,572 

11,331

1,798

314,916

2,885,563 

66,264

219,965

0

3,171,792

358,248

3,321

361,569

589,597

119,342

708,939

151,545

20,033

171,578

153,033

145,316

11,666

310,015

4,723,893

RESEARCH GRANTS AMOUNT % OF TOTAL 

27.0%

7.3%

0.0%

0.8%

3.6%

0.7%

1.7%

0.9%

0.4%

0.1%

0.0%

1.2%

43.6%

2.1%

45.8%

5.2%

3.2%

0.3%

8.7%

0.3%

0.1%

0.2%

0.4%

0.2%

0.1%

0.2%

0.1%

0.0%

0.0%

1.6%

0.7%

3.3%

0.1%

0.2%

0.0%

0.6%

0.2%

0.0%

6.7%

61.1%

1.4%

4.7%

0.0%

67.1%

7.6%

0.1%

7.7%

12.5%

2.5%

15.0%

3.2%

0.4%

3.6%

3.2%

3.1%

0.2%

6.6%

100.0%
Role and Responsibilities of NCI Program Directors

The NCI currently has more than 200 extramural Program Directors, each 

of whom is assigned responsibility for a certain programmatic and scientific 

approach to cancer research (see Figure 13 on the following page). For 

example, there are Program Directors for chemical carcinogenesis, tumor 

biology, biochemistry and pharmacology, immunology, radiation, clinical 

oncology, cancer prevention, and other areas.

The Program Director is responsible for the programmatic and scientific 

aspects of his/her portfolio, including:

• 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 field through 

the issuance of RFAs and PAs and recommending exception funding.

• Making recommendations to the NCI, NIH, and HHS 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 

discuss research in a specific program field.

In addition to these general scientific activities, Program Directors 

collaborate with Grants Management Specialists in providing oversight of 

the NCI grants program.

Role and Responsibilities of the NCI Grants Management Officer

The 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. The GMO is 

responsible for:

• 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, or requests 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.

60

AWARD NEGOTIATION AND ISSUANCE
FIGURE 13 NCI Extramural Grants Program

61REVIEW AND ADMINISTRATION

PROGRAMS

Biological Carcinogenesis

Cancer Cell Biology

Cancer Immunology/

Hematology/Oncology

Chemical & Physical 

Carcinogens

Mouse Models of Human Cancers

Radiation Effects

Tumor Biology & Metastasis

PROGRAMS

Applied Research

Behavioral Research

Cancer Surveillance Res.

Cancer Survivorship

Epidemiology & Genetics Research

PROGRAMS

AIDS Cancers

Biochem. & Pharmacology 

(including Drug Discovery)

Biological Response Modifiers

Cancer & Nutrition

Clinical Oncology

Clinical Trials

Diagnostic Imaging

Diagnostics Research

Imaging Technology Dev.

Molecular Imaging

Radiotherapy Dev.

Surgical Oncology

Technology Dev.

Executive Secretary, NCAB

Research Analysis

Minority Programs

Peer Review of Grants & 

Contracts

Committee Management

Grants Policy

Grants Management

Grant Award Issuance

Grants Policy

Grant Files

Grants Finance

Grantee Performance 

Monitoring

Division 

of Cancer 

Prevention

(DCP)

PROGRAMS

Cancer Centers

Cancer Training

Comprehensive 

Minority Bio. Prog.

Organ Systems

NCI Executive 

Committee

OFFICE OF THE 

DIRECTOR

National Cancer

Institute

National Cancer 

Advisory Board (NCAB)

Board of Scientific 

Advisors (BSA)

PROGRAMS

Patient Navigator Research 

Program

The Effects of Racialism on 

Cancer Care Delivery

Reducing Health Disparities in 

Geographic Regions of High 

Cervical Cancer Mortality

Special Populations Networks/

Community Networks Program

GRANTS

REVIEW 

RESPONSIBILITY

GRANTS

PROGRAM

RESPONSIBILITY

GRANTS 

ADMINISTRATIVE 

RESPONSIBILITY

Division of 

Extramural 

Activities 

(DEA)

Office of 

Management 

(OM)

Grants 

Administration

Branch

(GAB)

PROGRAMS

Basic Prevention Science

Breast & Gynecologic Cancer

Cancer Biomarkers

Chemopreventive Agent Dev.

Community Oncology & Prevention Trials

Early Detection

Gastrointestinal & Other Cancers

Lung & Upper Aerodigestive Cancer

Nutritional Science

Prostate & Urologic Cancer

Division of 

Cancer

Biology

(DCB)

Division 

of Cancer 

Treatment 

and Diagnosis 

(DCTD)

Division of 

Cancer Control 

and Population 

Sciences 

(DCCPS)

Office of 

Centers, 

Training and 

Resources 

(OCTR)

Center to 

Reduce 

Cancer Health 

Disparities 

(CRCHD)
• 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 made 

known to the grantee.

• Providing continuing surveillance of the financial and management 

aspects of grants through reviews of reports, correspondence, site visits, 

or other appropriate means.

The Grants Management Specialist is a member of the GMO’s staff and is the 

individual most likely to be the point of contact for the business aspects of 

the grant application. A specialist maintains an annual portfolio assignment 

that includes an average of 200 grants. For these grants, the specialist will 

perform many of the duties listed above for the GMO.

Most business and management decisions have an impact on programmatic 

and scientific matters, and vice versa. Therefore, a close working relationship 

between the Program Director and Grants Management Specialist is essential 

to 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 needs in a 

timely and prudent manner while exercising their responsibility as stewards 

of public funds.

Pre-Award Activities

After funding decisions are made and paylists are developed, NCI Program 

Directors complete their review of each application selected for funding. As 

a result of this review, Program Directors may contact applicants to request 

additional or updated information regarding various issues, such as:

• Other support.

• Overlap with other projects.

• Resolution of scientific concerns expressed by the initial reviewers 

regarding the involvement of human subjects.

• Use of live vertebrate animals.

• Minority and gender representation.

• Potential biohazard problems.

Grants management staff may contact applicants to request additional 

information regarding assurances and certifications or missing application 

documentation.

The Grants Management Specialist and Program Director continually work 

together throughout this pre-award phase of the award process. For example, 

Program Directors document their review and resolution of problems by 

completing and submitting to the Grants Management Specialist an NCI 

documentation control form for each application to be funded. 62
For applications reviewed by the Center for Scientific Review (CSR) and 

scored within a certain range, the NIH requests the following Just-in-Time 

(JIT) information:

• Updated other support

• Certification of Institutional Review Board (IRB) approval

• Required Education in the Protection of Human Subjects 

(http://grants.nih.gov/grants/policy/hs_educ_faq.htm)

• Certification of Institutional Animal Care and Use Committee (IACUC) 

approval

These requests are not a guarantee of funding.

Grants Management Review

Upon receiving a documentation control form from the Program Director 

and verifying selection for funding, the Grants Management Specialist 

begins the process of developing an award (see Figure 14 below). This 

involves a cost analysis of the proposed categorical budget, if applicable, 

a review for administrative compliance with HHS and NIH policies, and 

negotiations with the grantee’s business official and/or the Principal 

Investigator. Examples of these activities are outlined below.

Cost Analysis

The Grants Management Specialist reviews applications that include 

categorical budgets for:

• Reasonableness of costs.

• Adherence to cost principles.

• Relationship of costs to the proposed project.

• Financial management capabilities of new applicant institutions.

• 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).

63REVIEW AND ADMINISTRATION

9TH MONTH 10TH MONTH

Final

review and

negotiations

Congressional

liaison

notified

Award

received by 

institution

Investigator

begins

work

“Paylists”

forwarded

to GMO

AWARD

ISSUED

FIGURE 14 Award Negotiation and Issuance
The extent of this analysis is a matter of judgment, based on factors such as:

• The applicant’s previous experience in managing grant funds.

• The 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 Review

In addition to analyzing the budget, the Grants Management Specialist 

determines that all necessary assurances and reporting requirements have 

been met and that the applicant is in compliance with all appropriate 

rules and policies as well as NIH and HHS requirements. 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

• HHS-approved entity identification number (EIN) for the applicant institution

• Facilities and administrative costs

• Financial Status Reports (FSRs)

• Invention statements

• Lobbying certification and disclosure

• Assessment of applicant institution’s management capability

• Appropriate choice of mechanism (grant/contract/

cooperative agreement)

• Misconduct in science assurance

• No delinquency on Federal debt certification

• Peer review recommendations

• Administrative notes from peer reviewers on the summary statement

• Program income

• Availability of proposed project staff

• Recombinant DNA compliance

64
• Scientific and budgetary overlap with other support

• Time and effort overcommitment

Negotiation

The primary purpose of negotiating an award is to establish the appropriate 

funding level, resolve identified problems, and agree on specialized terms 

and conditions of award, if needed. The degree and form of the negotiation 

depend on a variety of factors, such as the dollar amount and complexity 

of the project, nature of the problems identified, and fulfillment of 

new-grantee requirements. The Grants Management Specialist can 

usually complete negotiations and obtain needed information through 

correspondence with the grantee institution. However, it may become 

necessary for NCI staff to visit the grantee institution to address certain 

issues or problems in person.

Preparation of Awards and Obligation of Funds

The Notice of Grant Award (NGA) is the official letter notifying the applicant 

that the project has been funded (see Exhibit D, p. 121). Once the NGA is 

signed by the Grants Management Officer (GMO), it is either transmitted 

via e-mail or mailed, dependent upon whether the grantee institution is 

registered with the NIH eRA Commons (https://commons.era.nih.gov/

commons/).

The Notice of Grant Award includes:

• The name and address of the grantee institution.

• The title of the project.

• The name of the Principal Investigator.

• The period of support.

• The amount recommended for future years of support.

• Any special terms and conditions of award.

In addition, all competing/noncompeting award notices, except those 

in the Streamlined Noncompeting Award Process (SNAP) and modular 

populations, show the authorized direct costs by budget category 

(e.g., personnel, supplies). The NGA provides approval for the expenditure 

of funds in the grant application and/or agreed upon during negotiations. 

Associated facilities and administrative (F&A) costs are also included on 

the NGA.

If the awarding office has determined that a prospective grantee is financially 

unstable, has a history of poor performance, or has a management system 

that does not meet the agency’s standards, the awarding office may impose 

restrictive terms and conditions. The awarding office may also delay issuing 

the award until all the agency’s standards have been satisfied.

In signing the grant award, the Grants Management Officer certifies that:

• The choice of the award mechanism is appropriate under applicable policy.

• The application was properly peer reviewed.

65REVIEW AND ADMINISTRATION
• 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 and 

account for Federal funds.

• The award is being made consistent with the terms and conditions 

specified for the particular program and the appropriate review 

recommendations.

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

• All review and award actions are clearly documented in the official grant 

files.

The award amount is forwarded to the Office of Financial Management, 

NIH, where it is recorded as an obligation in the NIH official accounting 

records. Once the NGA letter is sent to the grantee business office, it is their 

responsibility to distribute the NGA to the PI. In addition, copies of the 

NGA are distributed to appropriate NIH and NCI offices.

Congressional Notification

For all new and competing continuation awards, Congress must be alerted 

at least 72 hours before the issuance of the award so the appropriate 

representatives have the opportunity to notify their constituents. If the 

award exceeds $1 million, the White House may also be informed. This 

requirement is fulfilled by forwarding a copy of the NGA to the Office of 

Congressional Liaison, HHS.

Acceptance of Award

The grantee indicates acceptance of the general and special provisions of 

an award by drawing down or otherwise obtaining funds from the grant 

payment system (see “Post-Award Administration: Award Payment,” p. 68).

Continuation Support

A project may request support for up to 5 years, with the exception of a few 

unique programs. Awards are generally made on an annual basis, subject to 

the appropriation of funds by Congress. The initial award provides funds for 

the first 12-month period and indicates the support recommended for each 

budget period within the remainder of the project period.

Prior to the start date of each budget period, a Noncompeting Grant Progress 

Report, formerly referred to as a noncompeting continuation application (Form 

PHS 2590), must be submitted for evaluation of the project’s progress and to 

request continued funding. This progress report can be submitted in one of 

the following ways:

• eSNAP application: The electronic version of the Noncompeting Grant 

Progress Report is due 45 days prior to the budget start date and can be 

submitted via the NIH eRA Commons: 

https://commons.era.nih.gov/commons/

66
• Paper copy: This is due 60 days prior to the budget start date and mailed 

to the following address:

Division of Extramural Activities Support, OER

National Institutes of Health

6705 Rockledge Drive, Room 2207, MSC 7987

Bethesda, MD 20892-7987 (for U.S. Postal Service regular or Express Mail)

Bethesda, MD 20817 (for other courier/express mail delivery only)

Please refer to the following website for further information:

http://grants.nih.gov/grants/funding/2590/2590.htm

Program Directors review the Noncompeting Grant Summary Progress 

Report to determine whether scientific progress is adequate to justify 

continued support (see Exhibit E, p. 124). When all requirements are 

satisfied, an award for the next budget period is issued. This process is 

repeated each year of the project period.

Grants Management Specialists review all noncompeting progress reports, 

including those in the Streamlined Noncompeting Award Process (SNAP) 

population. The basic principle of the SNAP award is that total costs for 

the entire competitive segment are negotiated at the time of the initial 

competing award, thus eliminating the need to engage in annual total cost 

negotiations. As part of that negotiation, NCI staff ensure that proposed 

costs are allowable, allocable, reasonable, and necessary for the project. 

SNAP applications must include answers to the following three questions:

• Has there been a change in the “other support” of key personnel since 

the last reporting period? 

• Will there be, in the next budget period, a significant change in the level 

of effort for the PI or other personnel designated on the Notice of Grant 

Award from what was approved for this project?

• Is it anticipated that an estimated unobligated balance (including prior 

year carryover) will be greater than 25 percent of the current year’s total 

budget?

If responses to these questions are not readily apparent or are incomplete, 

the NCI sends a letter to the grantee business official requesting that the 

required information be provided in writing.

It is important to note that submitting Noncompeting Grant Progress 

Reports on time, but without required information, results in extra work for 

both NCI staff and the grantee. In addition, the submission of incomplete 

applications frequently delays issuance of an award.

Although a specific dollar amount is indicated on the Notice of Grant 

Award for each future year of recommended support, the amount awarded 

is subject to the availability of funds appropriated for the fiscal year, as 

well as other considerations related to scientific progress. Grants may be 

negotiated and awarded for less than the recommended level. Conversely, 

when the grantee can justify the need for additional funds, the NCI has the 

authority to grant the increase as long as the approved scope of the project 

is not being expanded.

67REVIEW AND ADMINISTRATION
If the grantee wants to request additional funds to expand the scope of 

the project, a competing supplemental application must be submitted 

according to established deadlines. These applications undergo dual review 

and compete for funds with all other investigator-initiated competing 

applications.

Award Payment

To minimize the impact of cash withdrawals on the public debt level and 

to reduce related financing costs, the U.S. Department of the Treasury has 

issued regulations governing the flow of cash to recipient organizations. 

Specifically, grantees should not request funds until actually needed for 

disbursement purposes. Grant payments are administered by the HHS 

Payment Management System. The grantee can access HHS grant funds by 

accessing SMARTLINK II via the Internet. Funds are deposited directly into 

the recipient’s bank account on the next business day. Figure 15 illustrates 

this process in detail.

Information on the Payment Management System is available from:

Division of Payment Management

P.O. Box 6021

Rockville, Maryland 20852

1-877-614-5533

http://www.dpm.psc.gov/default.aspx

Reporting Requirements

Reports by grantees are required at specific times, depending on the purpose 

of the reports and the needs of the programs. They are:

• Immediate reporting

♦ Financial Conflict of Interest.

♦ Inventions.

68

POST-AWARD ADMINISTRATION

FIGURE 15 Grant Payment Management System: SMARTLINK II

Grantee

Granteeʼs 

Bank

Federal Reserve 

Bank, Richmond

HHS Division 

of Payment 

Management

Benefits

Computer-to-computer 

system

User-friendly system

Full-screen entry

Convenient to use

Next workday access

to funds

Availability

All grantees

Equipment Requirements

Computer

Internet access
69REVIEW AND ADMINISTRATION

♦ 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 that materially impair the ability to 

meet the objectives of the award.

♦ Payback Agreement: A Ruth L. Kirschstein–National Research Service Award 

(Kirschstein–NRSA) Payback Agreement must be signed by each postdoctoral 

individual for whom the appointment covers the initial 12 months of 

postdoctoral NRSA support. A Payback Agreement is not required for any 

individual who has already received 12 months of postdoctoral support under 

an NRSA grant or award or for predoctoral or prebaccalaureate trainees.

♦ Certain types of correspondence with the Food and Drug Administration (FDA) 

when the NIH funds all or part of a clinical study involving an investigational 

new drug (IND) or investigational device exception (IDE).

• Annual reports

♦ Financial Status Report (FSR): HHS regulations under 45 CFR Part 74.73(d) and 

Part 92.41(b) dictate that Financial Status Reports (FSRs) must be submitted 

to the NIH within 90 calendar days after the last day of each budget period. 

FSRs are required annually for all projects not included in the streamlined 

noncompeting award process (SNAP) population. However, annual FSRs are 

required for all awards to Federal institutions and foreign organizations, 

including awards in the SNAP population. For the SNAP population, an FSR 

is required no later than 90 days after the expiration date of the competitive 

segment or after the grant transfers to a new institution (see Exhibit F, p. 125). 

http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-01-021.html.

♦ Non-Competing Grant Progress Report (see Exhibit E, p. 124).

♦ Statement of Appointment: This form must be submitted to the NIH 

awarding component prior to or at the start of each trainee’s appointment 

or reappointment. A stipend (or other allowance) may not be paid until the 

appointment form has been submitted.

♦ Kirschstein-NRSA Annual Payback Activities Certification (APAC): Individuals 

with an outstanding payback obligation must complete an APAC annually 

until their payback obligation is fulfilled.

• Final reports (due 90 calendar days after the final budget period)

♦ Final Progress Report.

♦ Financial Status Report.

♦ Invention Statement and Certification.

♦ Student Participation Report, for Academic Research Enhancement Award 

(AREA) grants (R15), which is an addendum to the progress report.

♦ Termination Notice for Kirschstein-NRSA grants, which is the basis for 

validating the total period of NRSA support and the amount of payback 

obligation (if any) for each NRSA trainee. A Termination Notice must be 

submitted for each trainee immediately upon the termination of support.

Electronic Transmittal of Financial Status Reports (FSRs)

To facilitate the submission of FSRs, the NIH has developed an interactive, 

computer-based communications system to enable grantee organizations to 

electronically transmit FSRs to the NIH. The electronic process eliminates 

the submission and processing of the hard-copy FSR.
The current electronic system has several advantages:

• FSRs transmitted via this system are processed within 72 hours.

• The system gives users immediate feedback because it can detect errors.

• Electronically submitted FSRs cannot be lost in the mail or sent to the 

wrong address.

• Users of the system can access current listings of grants for which FSRs 

are past due or for which FSRs will become due as of a specified time 

(terminating grants).

Grantees are encouraged to submit FSRs electronically. Information about 

the electronic transmittal of FSRs can be obtained by calling the NIH Office 

of Financial Management (OFM), Government Accounting Branch (GAB)—

the receipt point for FSRs for NIH grants and cooperative agreements.

Information about the electronic transmittal of FSRs is available from the 

following sources:

• http://www4.od.nih.gov/ofm/fsrfaq.pdf: A website established by the 

Office of Financial Management, with Frequently Asked Questions 

Concerning Financial Status Reports (FSRs)

• https://commons.era.nih.gov/commons/

The submission of timely and accurate FSRs is central to ensuring prudent 

and efficient stewardship of public resources.

Monitoring Projects

The Grants Management Specialist and Program Director are responsible 

for the continuous monitoring of the grants in their portfolio. Monitoring 

is accomplished through the review and assessment of information 

gathered from audit reports, progress reports, financial reports, site visits, 

correspondence, and peer review.

Under Federal regulation 45 CFR 74.53, the NCI and other HHS awarding 

agencies, the HHS Inspector General, the U.S. Comptroller General, and any 

duly authorized representative have the right of timely and unrestricted 

access to any books, documents, papers, or other records of recipients that 

are pertinent to the grant awards in order to make audits, examinations, 

excerpts, transcripts, and copies. The grantee is also required to allow 

timely and reasonable access to personnel for the purpose of interviewing 

and discussing these documents. The rights of access are not limited to the 

required retention period, but last as long as records are retained.

When problems or weaknesses are found, NCI staff work with the applicant 

or the grantee institution to resolve the issues. It is usually possible 

for a mutually agreeable course of action to be worked out so that the 

award process can proceed. However, it may be necessary for the Grants 

Management Officer, designated Specialist, and/or Program Director to 

visit the applicant or grantee institution(s) in order to evaluate scientific 

progress, management systems, and adequacy of policies, procedures, and 

controls if:

70
71REVIEW AND ADMINISTRATION

• Problems or weaknesses are found to be severe enough to threaten 

the ability of the Principal Investigator or the grantee institution to 

administer and/or complete the research project for which the grant 

was awarded.

• The applicant organization refuses to adopt required assurances and 

certifications that reflect national social and economic policy.

• The applicant fails to comply with the terms of award.

NCI staff may then take any of the following actions:

• Not issue the new or competing continuation award

• Withhold the next noncompeting continuation award

• Adjust the level of support awarded

• Place restrictions and/or special conditions on the award

• Pay grantees on a reimbursement rather than an advance basis

• Suspend or terminate the active grant

The names, titles, and telephone numbers of the responsible Grants 

Management Specialist and Program Director are printed on each NGA letter.

Rebudgeting

The grantee institution is permitted to rebudget between budget categories 

within the total costs awarded to meet unanticipated requirements, 

provided the expenditures: (1) are within the scope of the approved project; 

(2) enhance and do not impede the successful continuation or completion of 

the project; 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 

be consulted regarding current policies on rebudgeting and prior approval 

authority. The Grants Management Specialist assigned to the project may 

also be contacted for advice.

Audits

In general, grantees who expend $500,000 or more in Federal awards 

are required by OMB Circular A-133 (http://www.whitehouse.gov/omb/

circulars/a133/a133.html) to have an annual audit performed by a public 

accountant or a Federal, state, or local government audit organization 

that meets generally accepted Government auditing standards. This 

level has been increased from the previous level of $300,000 for 

fiscal years ending after December 31, 2003. (See NIH Guide Notice: 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.) 

This audit should include review of the internal controls that are maintained 

to provide reasonable assurance that:

• Financial operations are properly 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.

• Desired results and objectives are being achieved in an effective manner.

The Federal Government may, at its discretion, review the internal accounting 

and other control systems during or after NIH support of the grant activity.

Grant Appeals

HHS regulations provide grantee institutions with the opportunity to appeal 

certain post-award administrative decisions made with regard to direct, 

discretionary project grants or cooperative agreements by HHS agencies, 

including the NIH (45 CFR Part 16). There are two levels of appeal: (1) an 

informal NIH procedure; and (2) a formal departmental procedure.

An appeal may be submitted to the NIH Appeals Office only after the grantee 

has received a final written decision from the Institute or Center (IC). The 

appeal must be submitted to the NIH Appeals Office within 30 days of receipt 

of that decision. A Grant Appeals Board composed of knowledgeable NIH 

staff from ICs other than the involved IC will be convened and chaired by 

the NIH Appeals Officer. The Board will review the case and make the final 

NIH decision. Should that determination uphold the original NIH decision, 

the grantee may formally appeal that determination within 30 days to the 

Departmental Appeal Board.

The specific adverse determinations that may be appealed are:

• Termination, in whole or in part, of a grant for failure of the grantee to 

carry out its approved project in accordance with the applicable law and 

the terms and conditions of award or for failure of the grantee otherwise 

to comply with any law, regulation, assurance, term, or condition 

applicable to the grant.

• Determination that an expenditure not allowable under the grant has 

been charged to the grant or that the grantee has otherwise failed to 

discharge its obligation to account for grant funds.

• Denial (withholding) of a noncompeting continuation award for failure 

to comply with the terms of a previous award.

• Determination that a grant is void (i.e., a decision that an award is 

invalid because it was not authorized by statute or regulation or because 

it was fraudulently obtained).

Grant Closeout

The grant closeout process is initiated upon conclusion of grant support. 

Official procedures are begun by the Grants Administration Branch after NCI 

staff determine that all applicable administrative actions and required work 

of the grantee have been completed. The grantee is required to submit:

• A final financial status report (FSR).

72
73REVIEW AND ADMINISTRATION

• A final progress report.

• A final invention statement.

These final reports must to be submitted no later than 90 days after the expiration 

of the project period or after the grant transfers to a new institution.

Additional Post-Award Activities

A few of the more common post-award actions include, but are not limited to:

• Approving a change of research scope, aims, or objectives.

• Approving a change in the Principal Investigator or grantee institution.

• Providing administrative supplements, phaseout support, or interim 

support.

• Extending grant periods with or without additional funds.

• Reviewing audit and financial reports.

Please refer to the “References and Resources” section for further information.

Record Retention

By the Grantee

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 as follows:

• For awards not under SNAP: 3 years from the date the final annual FSR 

is submitted to the NIH.

• For awards under SNAP (except those to foreign organizations and 

Federal institutions): 3 years from the date the FSR for the entire 

competitive segment is submitted to the NIH. This rule applies to all 

records for the entire competitive segment.

• For foreign organizations and Federal institutions: must submit annual 

expenditure reports for all awards, including those under SNAP, and 

must retain records for these awards, including those under SNAP, for 

3 years from the date of submission of the annual FSR to the NIH.

If an audit or other action is in process at the expiration of the 3-year 

retention period, the records are to be retained until all issues arising from 

the audit have been resolved by the NCI.

By the NCI

In 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 

in an appeal or litigation, the retention period begins when the case is 

closed. There is a 3-year retention period for unfunded applications that 

begins upon notification to the applicant that an award will not be made 

or upon withdrawal of the grant application.
Research Project Grants • 76

Cancer Centers and Specialized • xx

Programs of Research Excellence • 80

Other Research Grants • 81

Training • 84

R&D Contracts • 85

Intramural Research • 86

Research Management and Support • 86

Cancer Prevention and Control • 86

Construction • 86

Comprehensive Minority • xx

Biomedical Program • 86
75

FUNDING MECHANISMS

CHAPTER
The NCI’s budget is organized according to the following nine major 

funding areas:

• Research Project Grants (including SBIR/STTRs)

• 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 of 

the funding mechanisms used by the NCI.

• FY2004 Obligations: $2,161,359

• 45.8% of the NCI Budget

Research Project Grants (RPGs) are awards for investigator-initiated research 

proposals. Several types of awards are made in this category, which vary in 

the type of mechanism, type of applicant, total amount of support, and 

length of time allotted.

P01 – Research Program Project Grant

Research Program Project Grants (P01s) support an integrated, multiproject 

research approach involving a number of independent investigators who 

share knowledge and common resources. A P01 has a defined central 

research focus involving several disciplines or several aspects of one 

discipline. Each project should contribute or be directly related to the 

common theme of the total research effort, thus forming a system of 

research activities and projects directed toward a well-defined research 

program goal.

R01 – Research Project Grant

Research Project Grants (R01s) support discrete, specified research projects 

to be performed by the named investigator(s) in an area representing his/

her specific interest and competencies. This is generally referred to as a 

traditional research project grant.

R03 – Small Research Grant

Small Research Grants (R03s) provide research support specifically limited 

in time and amount for studies in categorical program areas. Small 

research grants provide flexibility for initiating studies that are generally 

for preliminary short-term projects. These grants are nonrenewable.

76

RESEARCH PROJECT GRANTS
R21 – Exploratory/Developmental Grant

Exploratory/Development Grants (R21s) support the development of pilot 

projects or feasibility studies to support creative, novel, high-risk/highpayoff research that may produce innovative advances in science. The 

levels of support and time are generally restricted.

R33 – Exploratory/Developmental Grant—Phase II

Phase II of the Exploratory/Development Grants (R33s) provides a second 

phase for the support of innovative, exploratory, and developmental 

research activities that may or may not have been initiated under the R21 

mechanism.

R37 – Method to Extend Research in Time (MERIT) Award

MERIT Awards (R37s) provide long-term grant support to investigators 

whose research competence and productivity are distinctly superior and 

who are highly likely to continue to perform in an outstanding manner. 

Investigators may not apply for a MERIT Award. After initial review, NCI 

staff and the National Cancer Advisory Board review competing R01 

applications to select MERIT awardees. An initial 5-year MERIT Award is 

followed by an opportunity for an extension of 1 to 5 years, based on an 

expedited review of the accomplishments during the initial period.

R41 – Small Business Technology Transfer (STTR) Grant—Phase I

Phase I Small Business Technology Transfer (STTR) awards (R41s) foster 

the transfer of new technology from a research institution setting to the 

commercial sector. R41s are limited in time and amount and are used to 

establish the technical merit and feasibility of ideas that have a potential 

for commercialization. According to STTR statutory guidelines, support for 

Phase I STTR awards may not exceed $100,000 for total costs for a period of 

1 year. The NIH is aware that not all STTR medical and behavioral research 

can be completed within the statutory guidelines; therefore, applicants 

are encouraged to propose a reasonable, appropriate, and justified budget 

and project period necessary to complete the Phase I research project. 

Deviations from the guidelines MUST be well justified.

R42 – Small Business Technology Transfer (STTR) Grant—Phase II

Phase II Small Business Technology Transfer (STTR) awards (R42s) 

continue the cooperative efforts initiated in Phase I, with the ultimate 

goal of achieving commercialization of the results. R42s support in-depth 

development of cooperative research and development projects between 

small, domestic, for-profit organizations and research institutions. 

Support for Phase II awards depends on feasibility and the potential for 

commercialization that has been established in Phase I (R41). Only Phase I 

awardees are eligible for Phase II awards.

According to the STTR statutory guidelines, Phase II awards may not exceed 

$750,000 in total costs and are not to exceed 2 years’ duration. The NIH is 

aware that not all STTR medical and behavioral research can be completed 

within the statutory guidelines; therefore, applicants are encouraged to 

77FUNDING MECHANISMS
propose a reasonable, appropriate, and justified budget and project period 

necessary to complete the Phase II research project. Deviations from the 

guidelines MUST be well justified.

R43 – Small Business Innovation Research (SBIR) Grant—Phase I

Phase I Small Business Innovation Research (SBIR) awards (R43s) support 

research efforts by for-profit, domestic, small businesses. R42s are limited 

in time and amount and are used to establish the technical merit and 

feasibility of ideas that have a potential for commercialization. These 

grants may also determine the quality of performance of the small business 

prior to providing further Federal support in Phase II (R44).

According to SBIR statutory guidelines, support for Phase I awards may not 

exceed $100,000 in total costs for a period of 6 months. The NIH is aware 

that not all SBIR medical and behavioral research can be completed within 

the statutory guidelines; therefore, applicants are encouraged to propose a 

reasonable, appropriate, and justified budget and project period necessary 

to complete the Phase I research project. Deviations from the guidelines 

MUST be well justified.

R44 – Small Business Innovation Research (SBIR) Grant—Phase II

Phase II Small Business Innovation Research (SBIR) awards (R44s) 

continue the cooperative efforts initiated in Phase I, with the ultimate 

goal of achieving commercialization of the results. R44s support in-depth 

development of research and development projects started in Phase I 

(R43). Awards are based on the results of Phase I, scientific/technical merit, 

and the commercial potential of the Phase II application. Only Phase I 

awardees are eligible for Phase II awards.

According to SBIR statutory guidelines, support for Phase II may not exceed 

$750,000 in total costs for 2 years. The NIH is aware that not all SBIR 

medical and behavioral research can be completed within the statutory 

guidelines; therefore, applicants are encouraged to propose a reasonable, 

appropriate, and justified budget and project period necessary to complete 

the Phase I research project. Deviations from the guidelines MUST be well 

justified.

R55 – James A. Shannon Directorʼs Award

Shannon Awards (R55s) provide a limited award to investigators to 

further develop, test, and refine research techniques; perform secondary 

analysis of available data sets; test the feasibility of innovative and creative 

approaches; and conduct other, discrete projects that can demonstrate 

their research capabilities and lend additional weight to their already 

meritorious applications.

R56 – High-Priority, Short-Term Project Award

High-Priority Awards (R56) provide limited interim support to enable an 

applicant to gather additional data for revision of a new or competing 

renewal application. The R56 will assist early-career-stage scientists trying 

to establish research careers, as well as more experienced scientists who just 

missed receiving funds. Applicants do not submit requests for an R56.

78
NCI program staff nominate previously reviewed R01 applications that are 

beyond the current NCI payline but, because of their merit, are eligible for 

funding. High-priority nominees are administratively reviewed by the NCI 

according to standard review criteria.

U01 – Research Project Cooperative Agreement

Cooperative Agreements (U01s) support discrete, specified, circumscribed 

projects to be performed by the named investigator(s) in an area representing 

their specific interests and competencies. This mechanism is utilized when 

substantial programmatic involvement is anticipated between the NCI and 

the recipient during performance of the contemplated activity.

U19 – Research Program Cooperative Agreement

Research Program Cooperative Agreements (U19s) support research 

programs that have multiple projects directed toward a specific major 

objective, basic theme, or program goal, requiring a broad-based, 

multidisciplinary, and often long-term, approach. Substantial Federal 

programmatic staff involvement is intended to assist investigators during 

performance of research activities, as defined in the terms and conditions 

of award. This mechanism can provide support for certain basic shared 

resources, including clinical components, which facilitate the total 

research effort.

U43 – Small Business Innovation Research (SBIR) 

Cooperative Agreement—Phase I (see R43)

Phase I SBIR Cooperative Agreements (U43s) support projects, limited 

in time and amount, to establish the technical merit and feasibility 

of research and development (R&D) ideas that may ultimately lead to 

commercial products or services. This mechanism is utilized when an 

assistance relationship and substantial programmatic involvement are 

anticipated between the NCI and the recipient during performance of 

the contemplated activity. Cooperative Agreement applications will 

be considered only for the topics specifically listed in the current SBIR 

Omnibus Solicitation.

Note: Phase I award levels and project periods are statutory guidelines. 

Therefore, applicants are encouraged to propose a budget and project that 

is appropriate for completion within the guidelines. Deviations from the 

guidelines MUST be well justified.

U44 – Small Business Innovation Research (SBIR) 

Cooperative Agreement—Phase II (See U43 and R44)

Phase II SBIR Cooperative Agreements (U44s) support in-depth development 

of R&D ideas for which feasibility has been established in Phase I (U43) and 

that are likely to result in commercial products or services.

Note: Phase II award levels and project periods are statutory guidelines. 

Therefore, applicants are encouraged to propose a budget that is 

appropriate for completion within the guidelines. Deviations from the 

guidelines MUST be well justified.

79FUNDING MECHANISMS
• FY2004 Obligations: $409,288,000

• 8.7% of the NCI Budget

The Cancer Research Centers Program contains diverse approaches to 

cancer research, incorporating all applicable disciplines.

P20 – Planning Grant

Planning Grants (P20s) support planning for new programs, expansion or 

modification of existing resources, and feasibility studies of new approaches. 

Such awards have been particularly useful in the development of cancer 

centers and Specialized Programs of Research Excellence (SPOREs).

P30 – Cancer Center Support Grant

Cancer Center Support Grants (P30s) provide support primarily for the research 

infrastructure of an active and unified Cancer Center for the purpose of:

• Consolidating and focusing cancer-related activities.

• Increasing research productivity.

• Promoting shared use of research resources and improved quality control.

• Stimulating and promoting interdisciplinary and collaborative research.

• Increasing the rate at which research discoveries are translated into 

medical benefits.

P50 – Specialized Center Grant

Specialized Center Grants (P50s) support any part of the full range of 

research and development, from very basic to clinical. Activities may 

involve ancillary support such as protracted patient care necessary to 

the primary research or R&D effort. The spectrum of activities comprises 

a multidisciplinary attack on cancer. Centers may also serve as regional 

or national resources for special research purposes. These grants differ 

from Program Project Grants (P01s) in that they are usually developed in 

response to an announcement of the programmatic needs of the NCI and 

later receive continuous attention from its staff.

Specialized Programs of Research Excellence (SPOREs) utilize the P50 

mechanism to support interdisciplinary teams of investigators who are 

dedicated to translational research focused on an organ-specific human 

cancer or a highly related group of human cancer types.

U54 – Specialized Center—Cooperative Agreement

Specialized Center Cooperative Agreements (U54s) support any part of 

the full range of research and development from very basic to clinical; 

they may involve ancillary supportive activities such as protracted patient 

care necessary to the primary research or R&D effort. The spectrum of 

activities comprises a multidisciplinary attack on a specific disease entity or 

biomedical problem area. These differ from Program Project Grants (P01s) 

80

CANCER CENTERS AND SPECIALIZED PROGRAMS

OF RESEARCH EXCELLENCE
in that they are usually developed in response to an announcement of the 

programmatic needs of an Institute or Division and subsequently receive 

continuous attention from its staff. Centers may also serve as regional or 

national resources for special research purposes, with funding-component 

staff helping to identify appropriate priority needs.

At the NCI, U54s support comprehensive partnerships between MinorityServing Institutions (MSIs) and NCI-designated Cancer Centers for the 

benefit of both. These partnerships focus on cancer research and one or 

more target areas in cancer research training or career development at the 

MSI. They may also focus on cancer research in minority communities, 

with an emphasis on cancer education or cancer outreach.

• FY2004 Obligations: $314,916,000

• 6.7% of the NCI Budget

Other Research Grants include the Research Career Program (all “K” 

awards) and any research grants not funded as a Research Project Grant, 

Research Center, or Cancer Prevention and Control Grant, excluding Ruth 

L. Kirschstein National Research Service Awards.

K01 – Mentored Research Scientist Development Award

Mentored Research Scientist Development Awards (K01s) provide research 

scientists with a sponsored research experience that will help the applicant 

gain expertise in a new research area or demonstrably enhance the 

applicant’s scientific career. The NCI supports two K01 awards: the Howard 

Temin Award and the Mentored Career Development Award.

K05 – Senior Scientist Award

Senior Scientist Awards (K05s) support outstanding established scientists 

who have demonstrated a sustained high level of productivity, research 

accomplishments, and contributions to cancer prevention, control, and 

population sciences research. These awards provide protected time for 

awardees to devote to research and act as mentors for young investigators.

K07 – Academic Career Award

Academic Career Awards (K07s) support:

• Junior candidates who are interested in developing academic and 

research expertise in a specific area.

• Senior individuals with acknowledged scientific expertise and leadership 

skills who are interested in improving the curricula and enhancing 

research capability within an academic institution.

K08 – Mentored Clinical Scientist Development Award

Mentored Clinical Scientist Development Awards (K08s) support the 

development of outstanding clinical research scientists. These awards provide 

specialized study for clinically trained professionals who are committed to 

a career in research and have the potential to develop into independent 

81FUNDING MECHANISMS

OTHER RESEARCH GRANTS
investigators. The NCI provides support for the K08 through the Clinical 

Investigator Award and the Minorities in Clinical Oncology Award.

K12 – Mentored Clinical Scientist Development Program Award

Mentored Clinical Scientist Development Program Awards (K12s) support 

newly trained clinicians appointed by an institution for development of 

independent research skills and experience in a fundamental science within 

the framework of an interdisciplinary research and development program.

K22 – Career Transition Award

Career Transition Awards (K22s) support newly trained investigators (basic 

or clinical) to develop their independent research skills through a twophase program. The initial period involves an intramural appointment at 

the NIH, while the final period of support is conducted at an extramural 

institution. The award is intended to facilitate the establishment of a record 

of independent research by the investigator in order to sustain or promote 

a successful research career. The NCI supports two K22 awards:

• The NCI Scholars Program provides an opportunity for outstanding 

new investigators to begin independent research careers. They begin 

intramurally, within the special environment of the NCI, and then 

continue their careers extramurally at an institution of their choice.

• The NCI Transition Career Development Award is a fully portable 

mechanism that facilitates the transition of talented clinician cancer 

scientists, clinicians in patient-oriented cancer research, and researchers 

in cancer prevention, control, and population sciences from the 

mentored stage of their careers to junior faculty positions or the 

equivalent.

K23 – Mentored Patient-Oriented Research Career Development 

Award

Mentored Patient-Oriented Research Career Development Awards (K23s) 

provide support for the career development of investigators who focus 

their research endeavors on patient-oriented research. This mechanism 

provides support for a period of supervised study and research for clinically 

trained professionals who have the potential to develop into productive 

clinical investigators.

K24 – Mid-Career Investigator in Patient-Oriented Research 

Award

Mid-Career Investigator in Patient-Oriented Research Awards (K24s) 

provide clinicians the opportunity to dedicate time for patient-oriented 

research and to mentor other clinical investigators.

K25 – Mentored Quantitative Research Career Development 

Award

Mentored Quantitative Research Career Development Awards (K25s) 

support the career development of investigators with quantitative scientific 

and engineering backgrounds outside of biology or medicine who have 

82
made a commitment to focus their research endeavors on behavioral and 

biomedical research (basic or clinical).

K30 – Institutional Curriculum Award

Institutional Curriculum Awards (K30s) support the development, 

conduct, and evaluation of the curriculum designed to improve the quality 

of training available to aspiring clinical investigators.

R13 – Conference Grant

Conference Grants (R13s) support national or international scientific 

meetings, conferences, and workshops that are of value in promoting the 

goals of the National Cancer Program.

R15 – Academic Research Enhancement Award (AREA)

AREA Grants (R15s) support small-scale research projects conducted by 

faculty in domestic institutions that primarily award baccalaureate degrees. 

Awards are for up to $150,000 in direct costs (plus applicable F&A costs) for 

periods not to exceed 36 months.

R24 – Resource-Related Research Project

Resource-Related Research Projects (R24s) support research projects that 

will enhance the capability of resources to serve biomedical research.

R25 – Cancer Education Grant

Cancer Education Grants (R25s) support the development and 

implementation of programs related to education, information provision, 

training, technical assistance, coordination, or evaluation. The NCI 

supports the following two distinct Cancer Education programs:

• The NCI Cancer Education Grant Program (R25E) is a flexible, 

curriculum-driven program aimed at developing and sustaining 

innovative educational approaches that will ultimately reduce cancer 

incidence, mortality, and morbidity, as well as improve the quality of 

life of cancer patients. These awards address a need that is not fulfilled 

adequately by any other grant mechanism available at the NIH and are 

dedicated to areas of particular concern for the NCI.

• The NCI Cancer Education and Career Development Program (R25T) 

is an institutional grant program that supports the development and 

implementation of curriculum-dependent programs to train predoctoral 

and postdoctoral candidates in cancer research settings that are highly 

interdisciplinary and collaborative.

S06 – Minority Biomedical Research Support (MBRS)

Minority Biomedical Research Support (MBRS) grants provide funds to 

strengthen the biomedical research and research training capability of 

ethnic minority institutions, thus creating a more favorable environment 

for increasing the involvement of minority faculty and students in 

biomedical research. 83FUNDING MECHANISMS
T09 – Scientific Evaluation

Scientific Evaluation awards (T09s) provide funds to the Chair of a training 

committee for operation of a review group.

U09 – Scientific Review and Evaluation—Cooperative Agreement

Scientific Review and Evaluation Cooperative Agreements (U09s) provide 

funds to the Chair of an Integrated Review Group (IRG) for operation of 

the IRG.

U10 – Clinical Research—Cooperative Agreement

Clinical Research Cooperative Agreements (U10s) support clinical 

evaluations of various methods of therapy and/or prevention in specific 

disease areas. These represent cooperative programs between sponsoring 

institutions and participating Principal Investigators and are usually 

conducted under established protocols.

U13 – Conference—Cooperative Agreement

Conference Cooperative Agreements (U13s) support international, 

national, or regional meetings, conferences, and workshops with 

substantial NCI programmatic involvement.

U24 – Resource-Related Research Project—Cooperative Agreement

Resource-Related Research Project Cooperative Agreements (U24s) support 

projects that contribute to improving the capability of resources that serve 

biomedical research.

U56 – Exploratory Grant—Cooperative Agreement

Exploratory Grant Cooperative Agreements (U56s) support planning 

for new programs, expansion or modification of existing resources, and 

feasibility studies that explore various approaches to the development of 

interdisciplinary programs which offer potential solutions to problems 

of special significance to the mission of the NIH. These exploratory 

studies may lead to specialized or comprehensive centers. Substantial 

Federal programmatic staff involvement is intended to assist investigators 

during performance of the research activities, as defined in the terms and 

conditions of award.

• FY2004 Obligations: $66,264,000

• 1.4% of the NCI Budget

The Ruth L. Kirschstein National Research Service Award (Kirschstein–NRSA) 

is the primary mechanism for providing long-term, stable support for a wide 

range of promising scientists and research clinicians.

84

TRAINING
F31 – Ruth L. Kirschstein National Research Service Award 

Predoctoral Fellowship

The Ruth L. Kirschstein National Research Service Award Predoctoral 

Fellowship provides support for research training leading to a Ph.D. (or the 

equivalent research degree) or a combined M.D./Ph.D. (or other combined 

professional research doctoral degrees) in the biomedical or behavioral 

sciences.

F32 – Ruth L. Kirschstein National Research Service Award 

Postdoctoral Fellowship

Postdoctoral Individual National Research Service Awards (F32s) provide 

postdoctoral research training to individuals to broaden their scientific 

background and extend their potential for research in specified healthrelated areas.

F33 – Ruth L. Kirschstein National Research Service Award for 

Senior Fellows

The National Research Service Awards for Senior Fellows (F33s) provide 

opportunities for experienced scientists to make major changes in the 

direction of research careers, broaden scientific background, acquire new 

research capabilities, enlarge command of an allied research field, or take 

time from regular professional responsibilities to increase capabilities to 

engage in health-related research.

T32 – National Research Service Award Institutional Training 

Grants

National Research Service Award Institutional Training Grants (T32s) 

support training opportunities at the predoctoral or postdoctoral level at 

qualified institutions. Applicants must have staff and facilities available for 

the proposed program. After the award is made, the institution’s training 

Program Director is responsible for selecting the trainees and administering 

the program. This program does not support residencies.

T36 - MARC Ancillary Training Activities Grant

Minority Access to Research Careers (MARC) Ancillary Training Activities 

Grants (T36s) increase the number of well-trained minority scientists 

in biomedical disciplines and strengthen the research and teaching 

capabilities of minority institutions. The NCI co-funds these grants with 

the National Institute of General Medical Sciences.

• FY2004 Obligations: $358,248,000

• 7.6% of the NCI Budget

The contract mechanism is appropriate when a specific end-product is desired 

or a project needs to be conducted with the NCI’s direct involvement. 85FUNDING MECHANISMS

R&D CONTRACTS
• FY2004 Obligations: $708,939,000

• 15.0% of the NCI Budget

The NCI Intramural Research Program, which complements the Extramural 

Research Program, is housed on the NIH Campus in Bethesda, Md., and at 

NCI–Frederick in Frederick, Md.

• FY2004 Obligations: $171,578,000

• 3.6% of the NCI Budget

There are many activities that provide general management and support 

to the NCI’s cancer research efforts. Funding for research management and 

support (RMS) has remained relatively constant over the last several years.

• FY2004 Obligations: $529,980,000

• 11.2% of the NCI Budget

The NCI Cancer Prevention and Control Program supports research on 

methods of cancer prevention and control conducted through grants, 

contracts, and in-house research.

• FY2004 Obligations: $0

Although the NCI has the authority to fund Construction grants, there are 

currently no funds appropriated to this program. This program is still active 

within some other NIH Institutes.

C06 – Research Facilities Construction Grant

Research Facilities Construction Grants (C06s) provide matching Federal 

funds for up to 50% of allowable costs for construction or major remodeling 

to create new facilities for cancer research. In addition to basic research 

laboratories, construction grants may support the construction or renovation 

of animal facilities, limited clinical facilities, and core facilities that are an 

integral part of an overall cancer research effort. The request for NCI funding 

must be in excess of $150,000 and not over $4 million per application.

Although not a funding mechanism, the Comprehensive Minority 

Biomedical Branch (CMBB) coordinates the NCI’s efforts to broaden 

participation in cancer-related research and training activities by promoting 

diversity in the research workforce that includes individuals with disabilities, 

underserved segments of the general population, and individuals seeking 

CONSTRUCTION

COMPREHENSIVE MINORITY BIOMEDICAL PROGRAM

86

RESEARCH MANAGEMENT AND SUPPORT

CANCER PREVENTION AND CONTROL

INTRAMURAL RESEARCH
reentry. Located within the NCI’s Office of Centers, Training, and Resources, 

the ultimate goal of the CMBB is to significantly increase diversity among 

competitive NCI/NIH-funded cancer researchers. This goal is being 

implemented through the following CMBB initiatives:

• Research Supplements to Promote Diversity in Health-Related Research—

support provided to improve the diversity of the research workforce 

for the Investigator Supplement, Individuals in Postdoctoral Training, 

Graduate Research Assistants, Post-Baccalaureate and Post-Master’s 

Degree Students, Undergraduate Students, High School Students, and 

individuals with disabilities.

• Supplements to Promote Reentry Into Biomedical and Behavioral 

Research Careers—support of full- or part-time research by individuals 

with high potential to reenter an active research career after taking time 

off to attend to other responsibilities.

• Travel Award for Young Investigators—support of minority student and 

faculty researchers and young minority physicians to attend national 

American Association for Cancer Research (AACR) meetings.

• Historically Black Colleges and Universities Faculty in the Field 

of Cancer—support of meritorious faculty members from eligible 

institutions to attend annual meetings or special conferences on more 

focused scientific topics of the AACR.

• Ruth L. Kirschstein National Research Service Award Individual 

Predoctoral Fellowship Awards for Minority Students—support of 

minority students pursuing a Ph.D. or equivalent degree (F31).

• NCI Career Development Award for Underrepresented Minorities—

support of the career development of minority health professionals 

utilizing the K01, K08, K22, or K23 mechanisms.

• Continuing Umbrella of Research Experiences (CURE)—supplemental 

support of introductory science experiences at the high school, 

undergraduate, and pre- and postdoctoral levels, with the aim of developing 

well-trained underrepresented-minority scientists capable of conducting 

independent cancer research for the R25T, K12, and T32 mechanisms.

• Minority-Serving Institution/Cancer Center Partnership Program 

(MSI/CCP)—support of programs focused on collaborations between 

scientists and faculty at a minority-serving institution and an NCIdesignated Cancer Center.

For questions concerning the above programs, as well as new 

initiatives, contact the CMBB at 301-496-7344 or visit the website at: 

http://minorityopportunities.nci.nih.gov.

87FUNDING MECHANISMS

89

CROSS-CUTTING PUBLIC POLICIES

CHAPTER
90

There are numerous cross-cutting public policy requirements applicable to 

Federal grants, including those awarded by the NIH and the NCI. The term 

public policy indicates that the requirement is based on social, economic, 

and/or other objectives or considerations that may be attached or related to 

the expenditure of Federal funds by grantees, consortium participants, and 

contractors while conducting research or other specified activities.

In addition, NIH grantees are subject to requirements contained in NIH’s 

annual appropriations acts that apply to the use of NIH grant funds. Some of 

those have been part of appropriations acts for several years without change. 

However, current requirements are subject to change, while others may be 

added in the future.

The NIH upholds high ethical, health, and safety standards in both the 

conduct of the research it funds and the expenditure of public funds by its 

grantees. The public policy requirements specified in this section set many 

of those standards. The signature of the authorized organizational official 

on the application certifies that the organization is in compliance with or 

intends to comply with all required certifications and assurances applicable 

to the associated application package. These are outlined below.

Acknowledgment of Federal Funding

All HHS grantees must acknowledge Federal funding when issuing 

statements, press releases, requests for proposals, bid invitations, and 

other documents describing projects or programs funded in whole or in 

part with Federal money. Grantees are required to state: (1) the percentage 

and dollar amounts of the total program or project costs financed with 

Federal money; and (2) the percentage and dollar amount of the total costs 

financed by nongovernmental sources (NIH Grants Policy Statement, Part 

II, Subpart A: Terms and Conditions of NIH Grant Awards).

Age Discrimination—45 CFR Part 91

The Age Discrimination Act of 1975 prohibits discrimination on the basis 

of age in any program or activity receiving Federal financial assistance. The 

HHS implementing regulations are codified at 45 CFR Part 91.

Animal Welfare—9 CFR Parts 1–4

Animal Welfare refers to special requirements that apply to grants involving 

the use of live vertebrate animals in research, training, experimentation, 

testing, and related purposes. All grantees must comply with the PHS Policy 

on Humane Care and Use of Laboratory Animals. This policy does not affect 

applicable 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 with the Animal Welfare Act as amended (7 USC 2131 

et seq.) and other Federal statutes and regulations pertaining to animals, if 

applicable.
Architectural Barriers to the Handicapped (Elimination of)

The following policies set forth requirements to make facilities accessible 

to and usable by the physically handicapped and include minimum design 

standards:

• Architectural Barriers Act of 1968, as amended

• Federal Property Management Regulations 101-19.6 (41 CFR 101-19.6)

• Uniform Federal Accessibility Standards, issued by the General Services 

Administration (41 CFR 101-19.6, Appendix A)

The following requirements apply:

• All facilities constructed or renovated with NCI grant support must 

comply with these requirements.

• These minimum standards must be included in the specifications for 

any NCI-funded renovation or new construction.

• The grantee is responsible for conducting inspections to ensure 

compliance with these standards by any 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 the benefits of, or be subjected to discrimination 

under any program or activity receiving Federal financial assistance. The 

HHS implementing regulations are codified at 45 CFR Part 80.

Data and Safety Monitoring

The NCI requires oversight and monitoring of all human intervention 

studies to ensure the safety of participants and the validity and integrity 

of the data. This policy is in addition to any monitoring requirements 

imposed by 45 CFR Part 46, the FDA, and the NIH Guidelines for Research 

Involving Recombinant DNA Activities. The level of monitoring should be 

commensurate with the risks, size, and complexity of the clinical trial.

Oversight and monitoring under Phase III clinical trials must be in the 

form of Data Safety Monitoring Boards (DSMBs). A DSMB also may be 

appropriate for Phase I and II clinical 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 traditionally provided by Institutional Review Boards (IRBs). 

However, the IRB must be cognizant of the procedures used by DSMBs, 

which must provide periodic reports to investigators for transmittal to the 

local IRB.

91CROSS-CUTTING PUBLIC POLICIES
92

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 organization from participating in transactions. Grantees may be 

debarred or suspended if they are found to have seriously and willfully not 

complied with grant conditions or are found to have engaged in scientific 

misconduct. If debarred, a grantee may not receive Federal assistance funds 

and may not participate in covered transactions for the period covered by 

the debarment.

Drug-Free Workplace—45 CFR Part 76, Subpart F

The Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle 

D, as amended) requires that all organizations receiving grants from any 

Federal agency agree to maintain a drug-free workplace. Under this law, 

employees of grantees are prohibited from engaging in the unlawful 

manufacture, distribution, dispensing, possession, or use of a controlled 

substance at work. By signing the application, the authorized business 

official agrees that the grantee will provide a drug-free workplace and will 

comply with requirements to notify the NCI in the event that an employee 

is convicted of violating a criminal drug statute. Failure to comply with 

these requirements may be cause for debarment. HHS implementing 

regulations are set forth in 45 CFR Part 76, “Government-wide Debarment 

and Suspension (Non-procurement) and Government-wide Requirements 

for Drug-Free Workplace (Grants).”

DUNS Numbers

The Data Universal Numbering System (DUNS) Number, provided by 

Dun & Bradstreet, is a unique nine-digit code that helps identify and link 

companies worldwide. Since the DUNS number is site-specific, each physical 

location of an entity, such as branches, divisions and headquarters, may 

be assigned a DUNS number. As of October 1, 2003, a DUNS Number is a 

Federal requirement for any institution planning to submit a Federal grant 

or cooperative agreement application. Organizations can secure a DUNS 

number at no cost by telephone at 1-866-705-5711 or electronically at URL 

https://eupdate.dnb.com/requestoptions.html?cmid=EOE100537. Answers 

to frequently asked questions may also be found at http://grants.nih.gov/

grants/duns_qa.doc.

Final Reports

Grantees are required to submit a final Financial Status Report, Final 

Invention Statement and Certification, and final progress report within 

90 days following the end of grant support. Failure to submit timely and 

accurate final reports may affect future funding to the organization or 

awards to the PI.
Freedom of Information Act

Records and other information can be obtained by the general public from 

the Government under the Freedom of Information Act (FOIA) of 1966. 

However, there are certain rules and regulations the NCI must follow in 

handling requests for records under FOIA.

For further information, see http://www.nih.gov/icd/od/foia.

For more details, please contact:

NCI FOI Coordinator

9000 Rockville Pike

Building 31, Room 10A34

Bethesda, Maryland 20892

Telephone: (301) 496-2999

Fax: (301) 435-2931

Handicapped Discrimination—45 CFR Parts 84 and 85

Before a grant may be awarded, a domestic applicant organization must 

certify compliance with Section 504 of the Rehabilitation Act of 1973, as 

amended (29 USC 794). This Act provides that no handicapped individual 

in the United States shall, solely by reason of the handicap, be excluded 

from participation in, denied the benefits of, or subjected to discrimination 

under any program or activity receiving Federal financial assistance. The 

HHS implementing regulations are codified at 45 CFR Parts 84 and 85.

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

New concepts introduced by the Privacy Rule:

• An individual’s written authorization is required for the use or disclosure 

of protected health information (PHI) unless waived or excepted.

• The request must be for a specific research study—blanket authorization 

is not permitted.

• Authorization waivers can be granted by IRBs or Privacy Boards.

• A decedent’s information is protected, but authorization is not required.

• Accounting and reporting of disclosures are required when requested.

Additional information on HIPAA can be found at:

• The Office of Civil Rights website—http://www.hhs.gov/ocr/hipaa/.

• HIPAA Information for Researchers—

http://privacyruleandresearch.nih.gov.

• NIH Guide Notice published on February 5, 2003: “Impact of the HIPAA 

Privacy Rule on NIH Processes Involving the Review, Funding, and 

Progress Monitoring of Grants, Cooperative Agreements and Research 

Contracts”—http://grants2.nih.gov/grants/guide/notice-files/NOT-OD03-025.html.

93CROSS-CUTTING PUBLIC POLICIES
94

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 the creation of human embryos for research purposes or for 

research in which human embryos are destroyed, discarded, or knowingly 

subjected to risk of injury or death greater than that allowed for research 

on 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 any organism not 

protected as a human subject under 45 CFR 46—as of the date of enactment 

of the governing appropriations act—that is derived by fertilization, 

parthenogenesis, cloning, or any other means from one or more 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, the NCI is 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://stemcells.nih.gov/research/nihresearch.

Lobbying (Anti-Lobbying)—45 CFR Part 93

Recipients of Federal grants, cooperative agreements, contracts, and loans 

are prohibited by 31 USC 1352, “Limitation on Use of Appropriated Funds 

to Influence Certain Federal Contracting and Financial Transactions,” 

from using Federal (appropriated) funds to pay any person to influence or 

attempt to influence any officer or employee of an agency, a Member of 

Congress, an officer or employee of Congress, or an employee of a Member 

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 describes types of 

activities that are not subject to this prohibition, such as legislative liaison 

activities and professional and technical services.

Applicants for NIH awards with total costs expected to exceed $100,000 are 

required to certify that:

• They have not made, and will not make, such a prohibited payment.

• They will be responsible for reporting the use of nonappropriated funds 

for such purposes.

• They will include these requirements in consortium agreements and 

contracts under grants that will exceed $100,000 and obtain necessary 

certifications from those consortium participants and contractors.

The signature of the authorized business official on the application serves 

as the required certification of compliance for the applicant organization. 

NIH-appropriated funds may not be used to pay the salary or expenses of 

an employee of a grantee, consortium participant, or contractor or those 

of an agent related to any activity designed to influence legislation or 

appropriations pending before Congress or any state legislature.
Misconduct in Science—42 CFR Part 50

Activities that constitute misconduct in science include fabrication, 

falsification, plagiarism, and other practices that seriously deviate from 

those commonly accepted within the scientific community for proposing, 

conducting, or reporting research. This does not include honest error or 

honest differences in interpretations or judgments of data. Each institution 

that receives or applies for a research, research training, or research-related 

grant under the Public Health Service Act must submit an annual assurance 

certifying that it is in compliance with the provisions set forth in 42 CFR 

Part 50.

Overdue Federal Debt—45 CFR Part 30, Subpart B, and 4 CFR 

Parts 101-105

The Federal Debt Collection Act (31 USC 3711) and the Federal Claims 

Collection Standards (4 CFR Parts 101-105) require the NIH to collect debts 

due to the Federal Government and, except where prohibited by law, to 

charge interest on all delinquent debts owed to the NIH by grantees (see 

also HHS claims collection regulations at 45 CFR Part 30). Debts may result 

from disallowances, recovery of funds, unobligated balances, or other 

circumstances. A major goal of OMB Circular A-129 is the collection of 

overdue Federal debt. Before a grant award can be made, the applicant 

organization must certify that it is not delinquent on the repayment of any 

Federal debt.

Patents and Inventions—37 CFR Part 401

Pursuant to the Bayh-Dole Act and Executive Order 12591 (April 10, 1987), 

all recipients of NIH research funding (i.e., all NIH grantees, contractors, 

consortium participants, and other organizations receiving funds under 

NIH grants and contracts, whether small businesses, large businesses, 

or nonprofit organizations) are subject to the same invention reporting 

requirements and regulations. These are included in the regulations issued 

by the Department of Commerce, found at 37 CFR Part 401.

Grantees have rights to inventions conceived or first reduced to actual 

practice in the performance of work under an NIH award. Grantee 

organizations must fulfill the requirements listed under the “Inventions and 

Patents” section under Part II, Subpart A, of the NIH Grants Policy Statement

(http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_

TOC54600135). Acknowledgment of Federal support in the development 

of a 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 must provide 

the awarding Institute a Final Invention Statement (Form HHS 568) within 

90 days following the expiration or termination of the project period. Any 

issues involving extramural subject invention reporting requirements 

should be directed to:

95CROSS-CUTTING PUBLIC POLICIES
96

Division of Extramural Reports and Technology Resources

Office of Policy for Extramural Research Administration

Office of Extramural Research

Building 31, Room 5B62

Bethesda, Maryland 20892

Telephone: (301) 435-1986

Privacy Act—45 CFR Part 5b

The Privacy Act of 1974, 5 USC 552a, provides certain safeguards for 

information about individuals maintained in a system of records, as 

identified by the Act (i.e., information may be retrieved by the individual’s 

name or other personal identifiers). These safeguards include the rights 

of individuals to determine what information is maintained about them 

in Federal agencies’ files (hard-copy or electronic) and how it is used, to 

have access to such records, and to correct, amend, or request deletion 

of information in their records that is inaccurate, irrelevant, or outdated. 

Records maintained by the NCI with respect to grant applications, grant 

awards, and the administration of grants are subject to the provisions of 

the Privacy Act.

Requests should be directed to:

NCI Privacy Act Coordinator

Building 31, Room 10A34

Bethesda, Maryland 20892

Program Fraud Civil Remedies Act—45 CFR Part 79

The Program Fraud Civil Remedies Act of 1986, Public Law 99-509, 

imposes civil penalties against persons who make false, fictitious, or 

fraudulent claims to the Federal Government for money (including money 

representing grants, loans, or other benefits).

Protection of Children

The Pro-Children Act of 1994, Public Law 103227, Title X, Part C, imposes 

restrictions on smoking in facilities where federally funded children’s 

services are provided. For services funded by Federal funds, either directly 

or through state or local governments, the Act specifies that smoking is 

prohibited in those indoor facilities used routinely for the provision of 

health care, daycare, early childhood development, education, or library 

services to persons under 18. Applicable Federal funds include grants, 

both discretionary and nondiscretionary; cooperative agreements; loans; 

loan guarantees; contracts; and funds for construction, maintenance, and 

operations awarded by the Department of Health and Human Services, 

Education, or Agriculture.

Protection of Human Subjects—45 CFR Part 46

The protection of human subjects is required of all research activities in 

which human subjects are involved. A human subject is defined in 45 CFR 

Part 46 as:
A living individual about whom an investigator (whether professional 

or student) conducting research obtains: (a) data through intervention 

or interaction with the individual; or (b) identifiable private 

information.

The regulation also extends to the use of human organs, tissues, and body 

fluids that can be linked to specific individuals by the investigator(s), even 

if these materials were collected by others. There is additional protection 

for certain classes of human research involving fetuses, pregnant women, 

human in vitro fertilization, and prisoners. The regulation exempts certain 

categories of research involving human subjects (listed in 45 CFR Part 

46.101[b]) that normally involve little or no risk.

Public Health Security and Bioterrorism Preparedness and 

Response Act of 2002

The Public Health and Bioterrorism Preparedness and Response Act of 

2002, Public Law 107-188, is designed to provide protection against misuse 

of select agents and toxins, whether inadvertent or the result of terrorist 

acts, against the United States homeland or other criminal acts. The Act 

was implemented, in part, through regulations published by the Centers 

for Disease Control and Prevention (CDC) at 42 CFR 73. Those regulations 

supersede the requirements at 42 CFR 76.2 (Interstate Shipment of 

Etiological Agents), which established certain shipping and handling 

requirements for laboratory facilities that send or receive select agents. 

Copies of these regulations are available from the Import Permit Program 

and Select Agent Program, respectively, at:

Centers for Disease Control and Prevention

1600 Clifton Road, MS E-79

Atlanta, Georgia 30333

Telephone: (404) 498-2255

http://www.cdc.gov/od/sap/docs/cdc-05a.pdf

Purchase of American-Made Equipment and Products

In accordance with the requirements of NIH appropriations acts, all 

equipment and products purchased with grant, cooperative agreement, or 

contract funds should be American-made to the greatest extent possible.

Salary Limitation

The Department of Health and Human Services (HHS) Appropriation Act 

for FY2004, Public Law 107-116, restricts the amount of direct salary of 

an individual under an NCI grant, cooperative agreement, or applicable 

contract to Executive Level I of the Federal Executive Pay Scale. For the 

latest information concerning salary limitations, see the NIH Guide for 

Grants and Contracts (http://www.nih.gov/grants/guide/index.html).

97CROSS-CUTTING PUBLIC POLICIES
98

Select Agent Rule

The Select Agent Rule was signed by the President on June 12, 2002, 

and establishes requirements regarding the possession, use, and transfer 

of select agents and toxins. The HHS lists these select agents and 

toxins in 42 CFR 73. This Rule includes the requirements concerning 

registration, security-risk assessments, safety plans, security plans, record 

keeping, inspections, etc. The CDC is the lead agency and provides the 

following website for more information on the Select Agent Program: 

http://www.cdc.gov/od/sap/index.htm.

Sex Discrimination—45 CFR Part 86

Section 901 of Title IX of the Education Amendments of 1972 (20 USC 

1681), as amended, provides that no person in the United States shall, on 

the basis of sex, be excluded from participation in, be denied the benefits 

of, or be subjected to discrimination under any educational program or 

activity receiving Federal financial assistance. The HHS implementing 

regulations are codified at 45 CFR Part 86.

Smoke-Free Workplace

The NIH strongly encourages all grant recipients to provide smoke-free 

workplaces and promote the nonuse of tobacco products. The NIH defines 

the term workplace to mean office space (including private offices and other 

work space), conference or meeting rooms, corridors, stairways, lobbies, 

restrooms, cafeterias, and other public spaces.

Suspension—45 CFR Part 76 and 45 CFR Part 92.43

A suspension is a temporary withdrawal of a grantee’s authority to obligate 

grant funds, pending either corrective action by the grantee, as specified 

by the NCI, or a decision by the NCI to terminate the award. The NIH will 

generally suspend (rather than immediately terminate) a grant and allow 

the grantee an opportunity to take appropriate corrective action prior to 

making a termination decision. The NIH may decide to terminate the grant 

if the grantee does not take appropriate corrective action during the period 

of suspension. However, the NIH may terminate without first suspending 

the grant if the deficiency is so serious as to warrant immediate termination 

or if concerns for public health or welfare require immediate action.

Termination—45 CFR Part 76 and 45 CFR Part 92.43

A termination is the permanent withdrawal of a grantee’s authority to 

obligate previously awarded grant funds before that authority would 

otherwise expire, including voluntary relinquishment of that authority by 

the grantee. The grant may be terminated without first being suspended 

if the deficiency is so serious as to warrant immediate termination or if 

concerns for public health or welfare require immediate action. A grant 

also may be terminated, partially or totally, by the grantee or by the NIH 

with the consent of the grantee.
USA PATRIOT Act

The Uniting and Strengthening America by Providing Appropriate Tools 

Required to Intercept and Obstruct Terrorism Act (USA PATRIOT Act), 

Public Law 107-56, amends 18 U.S.C. 10 and provides criminal penalties 

for possession of any biological agent, toxin, or delivery system of a type or 

in a quantity that is not reasonably justified by a prophylactic, protective, 

bona fide research, or other peaceful purpose. The Act also restricts access 

to specified materials. Restricted persons, as defined by the Act, may not 

possess, ship, transport, or receive any biological agent or toxin that is 

listed as a select agent. (For further information, see the definition of the 

“Public Health Security and Bioterrorism Preparedness and Response Act 

of 2002,” p. 97.)

99CROSS-CUTTING PUBLIC POLICIES
Publications • 102

Websites • 102
101

REFERENCES AND RESOURCES

CHAPTER
102

Most NCI publications are online at: https://cissecure.nci.nih.gov/ncipubs/

Hard copies of most NCI publications can be obtained from:

Office of Communications

National Cancer Institute

National Institutes of Health

Building 31, Room 10A16

Bethesda, MD 20892

Toll-free telephone: 1-800-4-CANCER

TTY (for persons with hearing impairments): 1-800-332-8615

• Catalog of Federal Domestic Assistance (CFDA):

http://www.cfda.gov/default.htm

• NCI Fact Book: http://www.nci.nih.gov/admin/fmb/

• NIH Grants Policy Statement (revised 12/1/03):

http://www.grants.nih.gov/grants/policy/nihgps_2003/index.html

• NIH “Welcome Wagon” Letter:

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

Information for new grantees (also helpful to established grantees)

The following NIH publications are also available at:

Division of Extramural Outreach and Information Resources

National Institutes of Health

6701 Rockledge Drive, Suite 6095

Bethesda, MD 20892-7910

Telephone: 301-435-0714

E-mail: GrantsInfo@nih.gov

• NIH Extramural Programs (funding for research and research training)

• Helpful Hints on Preparing a Research Grant Application for the NIH

• NIH Peer Review of Research Grant Applications

• The Project–Grant Application to the National Institutes of Health

• Ingredients of a Successful Grant Application to the National Institutes of 

Health: Case History

• Site Visits for the Review of Grant Applications to the NIH: Views of an 

Applicant and a Scientist Administrator

• Preparing a Research Grant Application to the National Institutes of Health: 

Selected Articles

PUBLICATIONS

WEBSITES

General

• All About Grants: http://www.niaid.nih.gov/ncn/grants/default.htm. 

Includes Grant Application Basics, How to Plan a Grant Application, 

and How to Write a Grant Application.
103REFERENCES AND RESOURCES

• NCI GAB Home Page: http://www3.cancer.gov/admin/gab. Includes 

links to the 100+ Years of Advances in the Fight Against Cancer PowerPoint 

presentation and an electronic version of Everything You Always Wanted 

to Know About the NCI Grants Process but Were Afraid to Ask, as well as 

GAB organizational and contact information.

• NCI Home Page: http://www.cancer.gov.

• NIH Home Page: http://www.nih.gov/. Links to offices within the Office 

of the Director, as well as to Institute and Center websites; each provides 

valuable tools and insights into Institute-specific areas of research 

emphasis.

Policy Guidance/Extramural Grant Program Information

• Applications and Forms: http://grants1.nih.gov/grants/forms.htm.

• Code of Federal Regulations (CFR): http://www.access.gpo.gov/nara/cfr/

cfr-table-search.html.

• Funding Opportunities: http://grants1.nih.gov/grants/oer.htm.

• Grants Policy and Guidance: http://grants1.nih.gov/grants/policy/

policy.htm. Includes links to the NIH Grants Policy Statement (current 

and prior versions), as well as policy resources, guidance documents, 

and other related links.

• NIH Grants Policy Statement: http://grants.nih.gov/grants/policy/nihgps_

2003/index.htm. An online version of up-to-date policy guidance with 

terms and conditions of NIH awards. Also provides information about 

NIH: its organization, staff, and grants process.

• NIH Guide for Grants and Contracts: http://grants.nih.gov/grants/guide. 

The official, weekly, online publication of NIH policies, procedures, and 

availability of funds.

• Office of the Federal Register, National Archives and Records 

Administration: http://www.gpoaccess.gov/nara/index.html.

• SBIR/STTR Omnibus: http://grants.nih.gov/grants/funding/sbir.htm.

• Types of Grant Programs (select programs only): http://grants.nih.gov/

grants/funding/funding_program.htm. Includes RPGs, Ruth L. 

Kirschstein National Research Service Awards, Research Training Grant 

Program, NIH Career Development Awards, Small Business Awards, and 

other programs.

• Just-In-Time: http://grants2.nih.gov/grants/policy/nihgps_2003/

NIHGPS_Part4.htm.

• Other Support: http://grants.nih.gov/grants/guide/notice-files/NOTOD-03-029.html.

• Prior Approval: http://grants.nih.gov/grants/policy/nihgps_2003/

NIHGPS_Part7.htm.
104

Electronic Research Administration

• CRISP: http://crisp.cit.nih.gov/. A searchable database of federally 

funded biomedical research projects conducted at universities, hospitals, 

and other research institutions.

• Edison Invention Reporting: http://www.iedison.gov/. Online invention 

reporting.

• Grants.gov: http://grants.gov/.

• NIH Electronic Research Administration (eRA): http://era.nih.gov/. 

Provides information on NIH’s eRA initiative, which strives for paperless 

electronic transfer of applications and administrative information. The 

NIH Commons may be accessed through this site.

Other

• A Straightforward Description of What Happens to Your Research 

Project Grant Application After It Is Received for Peer Review:

http://www.csr.nih.gov/review/peerrev.htm. A snapshot of the process 

for applications reviewed in the Center for Scientific Review.

• Award Data and Award Trends: http://grants1.nih.gov/grants/award/

award.htm.

• Bioethics: http://www.nih.gov/sigs/bioethics/. A broad collage of 

annotated web links on education, research involving human participants 

and animals, medical and health care ethics, and the implications of 

applied genetics and biotechnology. May be useful for those looking to 

satisfy the educational requirements for training on the protection of 

human research participants.

• DUNS Number (Data Universal Numbering System): http://

www.dnb.com/us/. Grantee organizations are required to have a DUNS 

Number.

• Grant Writing Tips: http://grants.nih.gov/grants/grant_tips.htm.

• NIH Roadmap: http://nihroadmap.nih.gov.

Contacts

• Center for Scientific Review (Application Receipt, Referral and Review): 

http://www.csr.nih.gov/. Includes application receipt dates as well as 

review and award schedules.

• HHS Office for Human Research Protections (OHRP): http:

//www.hhs.gov/ohrp. This new office at the Department of Health 

and Human Services leads efforts for protecting human subjects in 

biomedical and behavioral research.

• NIH Institutes, Centers, and Offices (links): www.nih.gov/icd/.

• NIH Office of Financial Management (FSRs): http://ofm.od.nih.gov.

• NIH Office of Laboratory Animal Welfare (OLAW): http://grants.nih.gov/

grants/olaw/olaw.htm. Responsible for animal-related functions, 
105REFERENCES AND RESOURCES

including the Public Health Service Policy on Humane Care and Use 

of Laboratory Animals, administering an educational program for PHSsupported institutions and investigators, negotiating Animal Welfare 

Assurances, and evaluating compliance with PHS Policy.

• Office of Extramural Research: http://grants.nih.gov/grants/oer.htm. 

Host to information of interest to the extramural community.

• Payment Management System (PMS): http://www.dpm.psc.gov/.

Additional Assistance

http://grants1.nih.gov/grants/funding/haveques.htm

Can the answer to my question be found in a reference document? 

• NIH Guide for Grants and Contracts, grants.nih.gov/grants/guide/

index.html.

• PHS 398 grant application or PHS 416-1 Individual NRSA application 

instructions, grants.nih.gov/grants/forms.htm.

• Answers to Frequently Asked Questions About NIH Grants, 

grants.nih.gov/grants/funding/giofaq.htm.

• NIH Grants Policy Statement, grants.nih.gov/grants/policy/nihgps_2003/.

• 45 CFR Part 74, HHS Regulations, Administration of Grants.

• 45 CFR Part 92, HHS Regulations, Administration of Grants 

(state/local govt).

• 45 CFR Part 74 Appendix E, Cost Principles for Hospitals.

• 48 CFR Part 31.2, Cost Principles for Profit Organizations, 

www.access.gpo.gov/nara/cfr/cfr-table-search.html (for all 

Code of Federal Regulations).

• OMB circular A-21, Cost Principles for Education Institutions, 

www.whitehouse.gov/OMB/circulars/a021/a021.html.

• OMB circular A-87, Cost Principles for State, Local, and Tribal 

Governments, www.whitehouse.gov/OMB/circulars/a087/a087.html.

• OMB circular A-122, Cost Principles for Nonprofit Organizations,

www.whitehouse.gov/OMB/circulars/a122/a122.html.

• Information for New NIH Grantees, grants.nih.gov/grants/funding/

welcomewagon.htm.

Can my question be answered by an NIH awarding component official?

• If your question is related to administrative and/or fiscal issues, 

contact the grants management staff member named on the program 

announcement (PA), request for application (RFA), or notice of grant 

award (NGA).

• If your question is a scientific one, contact the NIH scientific program 

official identified on the PA, RFA, or NGA. 

107

GLOSSARY

CHAPTER
108

Application: A formal request for financial assistance for a project/activity 

submitted to the NIH on the appropriate application form:

• Form PHS 398 is used for all new competing applications (Type 1) or competing 

continuation applications (Type 2), except as shown in the table below. This 

form is also used for a competing supplemental application (Type 3) when 

requesting additional funds for a change of scope or expansion to meet the 

needs of a project.

• Most competing application forms have corresponding forms to be used 

when applying for noncompeting continuation support during an approved 

competitive segment. The form corresponding to PHS 398 is Form PHS 2590. 

These forms may be accessed at: http://grants1.nih.gov/grants/forms.htm.

Assistance: The award of money, property, services, or anything of value to a 

recipient in order to support or stimulate a public purpose authorized by Federal 

statute. Assistance relationships are expressed in less detail than acquisition 

relationships, and responsibilities for ensuring performance rest largely with the 

recipient or are shared with the NCI.

Award: The provision of funds by the NCI to an organization or an individual to 

carry out an activity or project based on an approved application and budget.

Budget: A categorical or modular 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): The CFDA is a 

government-wide compendium of Federal programs and activities that provides 

assistance or benefits to state and local governments; public, quasi-public, profit, 

and nonprofit institutions; and specialized groups and individuals. The catalog 

is compiled and published annually by the General Services Administration. 

(http://www.cfda.gov/default.htm).

Competitive Segment: The initial project period recommended for support 

(usually 1 to 5 years) or each extension of the prior project resulting 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 is carried out 

through a formalized agreement between the grantee and one or more other 

organizations that are separate legal entities administratively independent of 

the grantee.

Application Forms Use Form Number

Ruth L. Kirschstein National Research Service Award 

or Senior International Fellowship Award PHS 416-1

Health Services Project PHS 5161-1

Construction Grant PHS 424
Contract (Research & Development [R&D]): An instrument used by 

the NCI to procure cancer research services and other resources needed by the 

Federal Government. Contracts are legally binding documents and used when 

the principal purpose of the transaction is to acquire a specific service or endproduct for 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 NCI 

programmatic involvement is anticipated during performance of the activity.

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 the part of the grant review-and-award cycle in which the 

NCI has the most influence: award negotiation and issuance. This accounts for 

2 months of the 10- to 12-month grant review-and-award process.

Facilities and Administrative (F&A) Costs: Costs (previously known as 

indirect costs) that are incurred by a grantee for common or joint objectives and 

therefore cannot be identified with a particular project or program.

Federal Register: An official daily publication that provides a uniform system 

for communicating proposed and final regulations and legal notices issued 

by Federal agencies, including announcements of the availability of funds for 

financial assistance programs. The Code of Federal Regulations is an annually 

revised codification of the general and permanent rules published in the Federal 

Register (www.gpoaccess.gov/fr/index.html).

Financial Status Report (FSR): The FSR shows the status of awarded funds 

for the competitive segment as maintained in the official accounting records of 

the grantee institution.

• SNAP: The FSR is due no later than 90 days after the completion of the project 

period, excluding awards to Federal institutions or foreign organizations.

• Non-SNAP: The FSR is due no later than 90 days after the end of each budget 

period.

Grantees are required to submit FSRs for continued funding of their grant(s).

Grant: A financial assistance mechanism providing money, property, or both 

to an eligible entity to carry out an approved project or activity. Performance 

responsibility rests primarily with the recipient, and there is little or no Federal 

involvement or participation in the performance of activities.

Grantee: The organization or individual awarded a grant or cooperative agreement 

by the NCI that assumes legal, financial, and scientific responsibility and 

accountability for both the awarded funds and the performance of the grantsupported activity. A grantee organization can be public or private, nonprofit 

or for-profit, or an educational institution, hospital, corporation, domestic or 

foreign agency, or other legally accountable entity. 109GLOSSARY
Grants Management Officer (GMO): The individual designated by an 

awarding component to be responsible for ensuring that both the granting 

agency and grantees meet all requirements of laws, regulations, and formally 

established policies.

Grants Management Specialist (GMS): An individual selected by the Grants 

Management Officer to serve as the focal point of the awarding component for 

all business/management activities associated with the negotiation, award, and 

administration of a grant or cooperative agreement. He/she also interprets grant 

administration policy and provisions.

Indirect Costs: See Facilities and Administrative (F&A) Costs.

Institute/Center (IC): The NIH organizational component responsible for a 

particular grant program or set of activities. The NCI is an IC.

Institutional Animal Care and Use Committee (IACUC): A committee 

set up by an institution to review, at least once every 6 months, the institution’s 

program for humane care and use of animals. The IACUC reviews research 

protocols involving the care and use of animals at the institution and makes 

recommendations to the Institutional Official regarding any aspect of the 

institution’s animal program, facilities, or personnel training.

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

research institution to ensure the protection of the rights and welfare of human 

research subjects participating in research conducted under its auspices. The IRB 

makes an independent determination to approve, require modifications to, or 

disapprove research protocols based on whether human subjects are adequately 

protected, as required by Federal regulations and local institutional policy.

Integrated Review Group (IRG): A group of study sections or peer review 

committees that are arrayed by scientific discipline. Study sections or peer 

review committees of scientists advise on the scientific and technical merit of 

research applications submitted for support.

Modular Grants: An initiative that expands the existing reinvention initiatives 

that are designed to concentrate the focus of investigators, their respective 

institutions, peer reviewers, and NIH staff on the science the NIH supports 

rather than on budget details. Under modular budget proposals, applicants 

are instructed to prepare the budget request in direct-cost modules of $25,000 

(not including third-party F&A costs) 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 budget detail, thereby 

relieving administrative burdens on both NIH staff and grantee organizations 

and simplifying cost management for NIH program 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 contains or 

references all terms and conditions for the award and documents the obligation 

of Federal funds. The award notice may be in letter format and/or may be issued 

electronically.

110
Payline: A term used to describe the funding selection process for most competing 

grant applications at the NIH. If one visualizes a list of grant applications sorted 

in rank order by percentile or priority score (often called a “paylist”), one can 

imagine a line drawn under the last application on that list, which will be funded 

based entirely on the result of peer review. That virtual line is the “payline.” The 

payline separates the applications that will be paid in rank order from those that 

may be selected based on programmatic relevance, as exceptions, or not paid at 

all.

Peer Review (42 CFR Part 52h): A system of review of research applications 

that utilizes reviewers who are the professional peers of the Principal Investigator 

of the proposed project.

Percentile Score: A score that represents the relative position or rank of each 

priority score among the scores assigned by that particular study section at its 

last three meetings. The lower the numerical value of the percentile score, the 

better. The score range is from .1 to 99.9.

Pre-application: A statement in summary form of the intent of the applicant 

to request funds. Pre-applications are requested for all construction projects for 

which the need for Federal funding exists. It is used to determine the applicant’s 

eligibility; determine how well the proposed project can compete with other, 

similar applications; and eliminate any proposals for which there is little or no 

chance for funding before applicants incur significant expenditures in preparing 

an application.

Principal Investigator (PI): An individual designated by the recipient 

organization to direct the project or activity being supported by the grant. 

He/she is responsible and accountable to recipient organization officials for the 

proper conduct of the project or program. The organization is, in turn, legally 

responsible and accountable to the NCI for the performance and financial 

aspects of the grant-supported activity.

Prior Approval: Written approval from NCI’s Grants Management Officer 

required for specified post-award changes to the approved project or budget. 

Such approval must be obtained prior to undertaking the proposed activity or 

spending NCI funds.

Priority Score: The score determined by averaging the individual ratings given 

by each voting member of the IRG. Each IRG member assigns to the application 

a numerical rating that ranges from 1.0 (outstanding) to 5.0 (acceptable) that 

reflects his/her opinion of the scientific merit of the application. A composite 

score is then expressed on a scale of 100 to 499.

Procurement: The acquisition by purchase, lease, or barter of property or 

services for the direct benefit or use of the NCI or other Government agency. 

The procurement instrument most often used is a contract. A contract details 

the rights, duties, and obligations of each of the parties involved.

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 or announces 

the initiation of a new or modified activity/interest or mechanism of support 

and invites applications for grant or cooperative agreement support. PAs are 

GLOSSARY

111
published in the NIH Guide to Grants and Contracts (http://www.nih.gov/grants/

guide/index.html). Funds may or may not be set aside for PAs.

Program Official: The NCI official responsible for the programmatic, scientific, 

and/or technical oversight and monitoring of a grant. The program 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 may consist of one or 

more budget periods. The total project period comprises the initial competitive 

segment and any extensions.

Recipient: The organizational entity or individual receiving a grant or cooperative 

agreement. (See definition of “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 evaluation of the scientific 

progress of the project. In addition, the recommended funding level may be 

subject to correction of arithmetic errors and adjustments made in accordance 

with applicable grant policies (salary cap, funding plan reductions, etc.), as 

appropriate.

Request for Application (RFA): A formal announcement that invites 

grant or cooperative agreement applications in a well-defined scientific area to 

support specific program initiatives, indicating the amount of funds set aside 

for the competition and the estimated number of awards to be made. RFAs are 

published in the NIH Guide for Grants and Contracts (http://www.nih.gov/grants/

guide/index.html).

Research Project Grant (RPG): The award for an investigator-initiated 

research proposal.

Scientific Review Administrator (SRA): A Federal scientist who presides 

over a Scientific Review Group and is responsible for coordinating and reporting 

the review of each application assigned to his/her committee, thereby serving 

as an intermediary between the applicant institution and the reviewers of 

the application. The SRA prepares a summary statement for each application 

reviewed by his/her SRG.

Small Business: A business, including its affiliates, that is independently owned 

and operated and not dominant in its field of operation; has its principal place 

of business in the United States and is organized for profit; is at least 51 percent 

owned, or in the case of a publicly owned business, at least 51 percent of 

its voting stock is owned by U.S. citizens or lawfully admitted permanent 

resident aliens; has no more than 500 employees; and meets other regulatory 

requirements established by the Small Business Administration at 13 CFR Part 121.

Stipend: A payment made to an individual under a fellowship or training grant 

in accordance with preestablished levels to provide for the individual’s living 

expenses during the period of training. A stipend is not considered compensation 

for the services expected of an employee.

112
Streamlined Noncompeting Award Process (SNAP): A streamlined 

process that eliminates two of the financial documents that are part of the 

noncompeting progress report: a categorical budget for the next budget 

period and an estimated report of expenditures for the current budget period. 

Under SNAP, the GMO negotiates the direct costs for the entire competitive 

segment at the time of the competing award or, in the case of modular awards, 

determines the applicable number of modules for each budget period within the 

competitive segment. This eliminates the need for annual budget submissions 

and negotiations, if applicable, and reduces the information the NIH requires 

to review, approve, and monitor noncompeting awards. As a result, grantees 

are required to submit only limited portions of the PHS-2590, including an 

annual progress report. For awards under SNAP (other than awards to foreign 

organizations or Federal institutions), a Financial Status Report (FSR) is required 

only at the end of a competitive segment, rather than annually. If no further 

award is made, this report will serve as the final FSR.

Study Section: The component part of an Integrated 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 researcher employed by a foreign 

institution, with or without grant funds.

Success Rate: The number of funded applications divided by the number of 

applications reviewed by Scientific Review Groups.

Technical Assistance Review: An evaluation by NCI grants management 

staff to assess an institution’s business and financial management systems to 

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 Award may include 

both standard and special provisions that are considered necessary to attain the 

grant’s objectives, facilitate post-award administration of the grant, conserve 

grant funds, or otherwise protect the interests of the Federal Government.

Total Project Costs: The total allowable costs (both direct and facilities and 

administrative costs) incurred by the grantee to carry out a grant-supported 

project or activity. Total project costs include costs charged to the NCI grant and 

costs borne by the grantee to satisfy a matching or cost-sharing requirement.

GLOSSARY

113
Grant Application Face Page • 116

Summary Statement • 117

Ranking List • 120

Notice of Grant Award • 121

Progress Report Summary • 124

Financial Status Report • 125
115

EXHIBITS

CHAPTER

In 1936, a legion of volunteers 

known as The Women’s Field 

Army was formed to wage 

war on cancer. These historic 

posters advertised their efforts. 

In 1935, there were 15,000 

people active in cancer control 

throughout the United States. 

At the close of 1938, there 

were approximately 150,000!
EXHIBIT A Grant Application Face Page

116
EXHIBIT B Summary Statement

EXHIBITS

117
EXHIBIT B Summary Statement (continued)

118
EXHIBIT B Summary Statement (continued)

EXHIBITS

119
EXHIBIT C Ranking List

120
EXHIBIT D Notice of Grant Award

EXHIBITS

121
EXHIBIT D Notice of Grant Award (continued)

122
EXHIBIT D Notice of Grant Award (continued)

EXHIBITS

123
EXHIBIT E Progress Report Summary

124
EXHIBIT F Financial Status Report

EXHIBITS

125