INTEGRATING AGING AND CANCER RESEARCH

RELEASE DATE:  September 24, 2002 

PA NUMBER: PA-02-169

EXPIRATION DATE:  September 25, 2005, unless reissued

National Institute on Aging (NIA)
 (http://www.nia.nih.gov/)
National Cancer Institute (NCI)
 (http://www.nci.nih.gov/)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE

The National Institute on Aging (NIA) and the National Cancer Institute (NCI) 
invite research grant applications (R01s) for studies directed at cancer in 
older persons.  The majority of cancers affect older persons 
disproportionately because aging is a high risk factor for malignant tumors. 
The focus for this research solicitation is on the older adult age group in 
the U.S. population in which cancer primarily occurs, that is, persons aged 
65 years and older. Close to 60% of all newly diagnosed malignant tumors and 
71% of all cancer deaths occur in persons in this age group according to the 
NCI Surveillance, Epidemiology, and End Results (SEER) program data for 1995-
1999. The age-adjusted cancer incidence rate for persons 65 years and older 
(2208.1 per 100,000 population) is ten times greater than the rate for 
persons under 65 years (229.2 per 100,000 population). The age-adjusted 
cancer mortality rate (1140.1 per 100,000 population) for persons 65 years 
and older is over 16 times greater than the rate for persons under 65 (70.8 
per 100,000 population).  

The cancer statistics showing the disproportionately high burden of cancer 
for older Americans foretell a greater consequence when cast against the 
changing demographics of the aging population in the United States. The 
number of older persons diagnosed with cancer is expected to increase because 
of the overall aging of the U.S. population and an unprecedented expansion of 
the 65 years and older age group.  In just three decades, 20% of the U.S. 
population will be age 65 years and older. Age shifts within the 65 years and 
older segment of the population will increase the proportion of persons 85 
years and older from our current 4.3 million to 8.9 million individuals over 
the next decades. Three factors mainly contribute to our nation"s changing 
age structure of the population--changing mortality patterns, decreased 
fertility, and the aging of the "Baby Boom" cohort born between 1946 and 1964 
(75 million persons).  These factors, in particular the aging of the "Baby 
Boom" generation, will have far-reaching effects on the future overall health 
status and cancer burden of Americans.  This phenomenon must be factored into 
our cancer research efforts.

The impetus for this announcement is based on the magnitude of the cancer 
problem of older persons as indicated by the NCI SEER data and the expanding 
U.S. aging population.  Research is needed across the scientific spectrum of 
cancer control for early detection, diagnosis, prevention, treatment, 
prognosis and survivorship. Clinical studies and the biology interface of 
aging and cancer research are included in this initiative. Little is known 
about how age-associated problems affect cancer patient evaluation, 
prevention and treatment strategies, and care.  Studies are needed on the 
assessment of the effectiveness of different prevention and treatment 
relative to the type of malignancy, the stage of disease, and significant 
features and characteristics of old age and the aging process.

Scientific advances in the associations between aging and the development of 
cancer facilitate the convergence of research perspectives to identify the 
molecular alterations in carcinogenesis that are related to the aging 
process. The biology of aging and cancer relationship is well recognized. 
There is an overlap between cancer and aging that should be addressed in 
tumor initiation, progression, and maintenance. Research achievements and 
refined technologies in the biology of both aging and cancer in many areas 
hold promise for enhancing the knowledge base on the relationship between 
aging and the natural history of tumors. 

RESEARCH OBJECTIVES

This research initiative is directed at human aging and cancer. The objective 
is to expand the knowledge base on aging- and age-related aspects of cancer 
in older persons. The NIA/NCI co-sponsored workshop, Exploring the Role of 
Cancer Centers for Integrating Aging and Cancer Research, provides an 
excellent background useful for this Program Announcement (PA). Insights and 
research recommendations from the NIA/NCI workshop, convened on the NIH 
Campus, Bethesda, MD, June 13-15, 2001, are indicated in the PA research 
scope. Applicants are advised to obtain the NIA/NCI Workshop Report from one 
of the following websites -- 
http://www.nia.nih.gov/ResearchInformation/ConferencesAndMeetings/WorkshopReport/
 or 
http://www3.cancer.gov/cancercenters to assist in developing a research application.  

This PA is directed to researchers in the extramural scientific community at 
large. The NIA and NCI intention, in issuing this particular PA, is to appeal 
to a broad-based community of investigators in cancer, aging, and other 
disciplines and professions throughout the nation, thereby underscoring the 
value of the creative ideas stemming from the cancer centers workshop and the 
urgent need to advance the knowledge base on cancer in older persons.  The PA 
increases the potential to produce innovative and much needed research at the 
aging/cancer interface.

A single or combination of research issues from the spectrum identified for 
this solicitation may be selected. Grant applications are not limited to 
these areas. The list is neither all-inclusive nor exclusive, nor is it in an 
order of priority.

AGE-RELATED AND AGING PROCESS IMPACT ON EARLY DETECTION, PREVENTION, 
DIAGNOSIS, PRE-TREATMENT EVALUATION, PROGNOSIS, AND TREATMENT OF TUMORS IN 
OLDER CANCER PATIENTS 

o Effects of multiple health problems such as other chronic diseases or 
concurrent diseases not related or antecedent to the cancer diagnosis on 
early detection, diagnosis, prognosis, and treatment of cancer patients 
(e.g., comorbidity may contribute to masking of signs and symptoms of 
disease, underdiagnosis, and undertreatment).

o Studies demonstrating and/or verifying effective management of older cancer 
patients with pre-existing chronic conditions and concurrent diseases (i.e., 
comorbidity). 

o Effects of aging processes and old age on disposition, efficacy, 
effectiveness, and tolerance of anti-cancer agents in older patients 
[activities of drug and biologic anti-cancer agents in older patients, the 
time course of absorption, distribution, metabolism, and excretion of drugs 
from the aged host (i.e., pharmacokinetics), the response of the aged host to 
anti-cancer drugs (pharmacodynamics)]. 

o Studies on the effects of age-related physiologic or pathophysiologic 
changes of older cancer patients with other serious comorbid health problems 
concurrent with their malignancy. 

o Studies of the clinical decision-making made by physicians for older 
persons with selected tumor type, histology, and stage in the context of 
patient age, comorbidities, and patient and family preferences. 

o Prospective and/or retrospective studies of treatment outcomes in older 
patients with varying age-related functional limitations (e.g., dose-limiting 
parameters that could predict and affect risk and severity of short-term and 
long-term side effects of therapy in older cancer patients and survivors)

--interdisciplinary studies from the perspectives of pharmacology of aging 
and the pharmacology of cancer.

--response of the older human host to the anti-cancer drug (organ system 
decline and their decrease in functional capacity).
--studies concerning problems that may arise in older cancer patients"use of 
medications for other health conditions.

o Age,race/ethnicity disparities in early diagnosis, treatment, quality of 
life, and survival of older patients.

o Research strategies to ascertain what factors influence older persons" 
response to signs and symptoms of cancer and the individual variations in 
actions that may result in delay of early detection of cancer. 

o Characterization of the treatment of older patients who are inadmissible to 
cancer treatment protocols and how their outcomes compare with older patients 
admitted to and treated on protocol.

AGING/CANCER HUMAN BIOLOGY RESEARCH INTERFACE. 

o Characterization of the biological aging/cancer relationship for 
individuals diagnosed with different tumors for which peak incidence and 
mortality rates are highest (e.g., colon, rectum, prostate, pancreas, lung, 
bladder, stomach, and breast) in older persons. 

o Studies in human biology of cancer and aging that are clinically relevant 
and reveal which aspects of tumor biology and tumor growth vary by age (e.g., 
peculiarities of the aged host, various types of tumors presenting 
differently according to age). These investigations have the potential to 
provide information that could lead to tailored therapeutic approaches.   

o Variations in tumor cellular and molecular properties in biopsy or surgical 
specimens related to age, race, and ethnicity and their relationship to tumor 
progression and metastases.

o Epigenetic studies that explore the differences in cancers affecting 
younger and older persons (e.g., altered DNA methylation patterns that 
increase with aging, silencing of tumor suppressor genes associated with 
promoter hypermethylation).

o Translational research to facilitate the transfer of new technologies (to 
the clinical setting) for early detection risk assessment and prevention of 
cancer in older persons.

o Development and/or evaluation of strategies to prevent, reverse or retard 
the progression of precancerous lesions in older persons.

o Development of analytical techniques to identify older persons at increased 
risk as indicated by genetic and/or metabolic phenotypes. 

o Intervention strategies to prevent cancer or pre-cancer progression in 
older persons.

o Innovative research projects on risk of multiple primary tumors (i.e., one 
or more malignant lesions in the same person that are not recurrences, 
extensions, or metastases of a previous malignancy)
 
--Studies to advance the methodology on assessment and reporting of multiple 
primary tumors.

--Studies on age differences in host susceptibility to multiple primary 
tumors.
 
--Assessment of risk potential for treatment-induced multiple primary tumors.

o Studies to identify genetic or epigenetic changes associated with older 
persons/populations at low risk for cancer (i.e., age-resistant phenotype).

o Methods to distinguish age-related conditions in patients with and without 
clinically significant cancer (e.g., indolence versus aggressive tumor 
behavior in the context of the aged host) and physiologic changes. 

PATIENT, FAMILY, PROVIDER, AND QUALITY OF LIFE INTERACTION ISSUES.

o Studies on methods to apply techniques to enhance quality of cancer 
survival of older persons through prevention of short-term and long-term 
adverse physical and medical effects of cancer treatment. 

o Cancer caregiver(s) quality of life and functioning and their influence on 
the older cancer patient"s care and treatment.  Multidisciplinary 
collaboration among geriatricians, oncologists, psychologists, and oncology 
nurses is encouraged for instrument development for this research. 
 
o Psychological and social effects of cancer and its treatment on the older 
patient and family. 

o Pain and other symptoms associated with cancer and its treatment may occur 
and persist throughout any or all phases of the cancer trajectory (e.g., 
diagnosis, treatment, recovery, and/or survivorship of older cancer 
patients).  Studies that apply recent development of better methods of 
recognition and assessment that can be applied for optimal management to 
older patients with cancer are encouraged. 

--Develop and test the efficacy of current methods (pharmacological and 
nonpharmacological) for effective pain management strategies in older cancer 
patients.

--Test and facilitate the use of evidence-based guidelines for pain relief, 
physical and affective symptoms, and system clusters. 

--Develop generic guidelines for problems specific to the elderly such as 
limited functional reserve and/or comorbid conditions. 

--Develop standard protocols for documenting and reducing pain and symptom 
severity.  

o Evaluate pain management (medications and/or other therapeutic approaches) 
consequent to cancer therapy--postsurgery, postradiation, and during and 
after chemotherapy--for older cancer patients regarding adjustment to needs 
and appropriate administration in the context of age-associated issues (e.g., 
pharmacokinetics and pharmacodynamics of aging, drug-drug interactions, drug-
age interaction, other health problems, and type of neoplasm).
 
o Conduct epidemiological studies to characterize symptom burden, pain 
perception, response to pain and symptom therapy of older patients and 
investigations for ways to ameliorate these problems.

APPLICATION OF EXISTING DATA TO THE AGING/CANCER RESEARCH INTERFACE.

o Innovative studies utilizing aging and age-relevant cancer statistics, 
cancer treatment, cancer pathology, and cancer genetics databases that could 
be examined for insights to generate hypotheses at the aging/cancer research 
interface -- tissue bank data, treatment pattern data, tumor registry data, 
cancer etiology data, epidemiology data, tumor biology data, etc.

DEFINITION OF "OLD AGE" OR "OLDER PERSONS" FOR THIS ANNOUNCEMENT

While this PA focuses in particular on individuals 65 years and older because 
the highest cancer incidence and mortality rates are found in this age 
segment of the population and the research initiative seeks to increase the 
knowledge base on this segment of the U.S. population, applicants are 
expected to identify what is meant by "aged", "old", or "elderly" in the 
context of their research. It is recognized that for certain tumors or for 
selected race and/or ethnic population subgroups, age 65 years might not be 
entirely appropriate.  The age demarcation of 65 years is arbitrary and 
historically associated with entitlements and eligibility for various 
programs, it does include the age subgroups in which most major tumors 
primarily occur (i.e., person in their 60"s, 70"s, and 80"s). Comparative 
studies with younger age groups are welcome and may be included in 
investigations proposed. Within the age group of 65 years and older, 
distinctive age comparisons are also appropriate.  

MECHANISM OF SUPPORT 

This PA will use the NIH R01 award mechanism.  The applicant is solely 
responsible for planning, directing, and executing the proposed project.  

This PA uses just-in-time concepts.  It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an application with direct costs in each year of $250,000 
or less, use the modular format.  Otherwise follow the instructions for non-
modular research grant applications.

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic or foreign 
o Faith based or community based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support.  Individuals from underrepresented racial 
and ethnic groups as well as individuals with disabilities are always 
encouraged to apply for NIH programs.    

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Rosemary Yancik, Ph.D.
Geriatrics and Clinical Gerontology Program
National Institute on Aging 
Gateway Building, Room 3E327
Bethesda, MD 20892-9205
Telephone:  (301) 496-5278
FAX:  (301) 402 1784
Email: yancikr@nia.nih.gov

Patricia McCormick, Ph.D.
Cancer Centers Branch 
National Cancer Institute 
6116 Executive Boulevard
Suite 700, MSC 8345
Bethesda, MD 20892-8345
Telephone:  (301) 496-8531
FAX:  (301) 402-0181
Email: pm60y@nih.gov

o Direct your questions about financial or grants management matters to:
Cynthia Riddick
Grants and Contracts Management Office 
National Institute on Aging 
Gateway Building, Room 2N212
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email: RiddickC@nia.nih.gov

Ms. Eileen Natoli
Section Chief 
Grants Administration Branch
National Cancer Institute 
6120 Executive Blvd, EPS-243
Bethesda, MD  20892
Telephone:  (301) 496-8791
FAX:  (301) 496-8601
Email: natolie@gab.nci.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular grant format simplifies the preparation of the budget in 
these applications by limiting the level of budgetary detail.  Applicants 
request direct costs in $25,000 modules.  Section C of the research grant 
application instructions for the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm.

Applicants requesting more than $500,000 must carry out the following steps:

Contact the IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study, 

2) Obtain agreement from the IC staff that the IC will accept your 
application for consideration for award, and,
  
3) Identify, in a cover letter sent with the application, the staff member 
and IC who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be received by or mailed on or 
before the receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

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

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the appropriate national advisory council 
or board

REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your application in order to judge the likelihood that the 
proposed research will have a substantial impact on the pursuit of these 
goals: 
o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these criteria 
in assigning your application"s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) SIGNIFICANCE:  Does your study address an important problem? If the aims 
of your application are achieved, how do they advance scientific knowledge?  
What will be the effect of these studies on the concepts or methods that 
drive this field?

(2) APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Do you acknowledge potential problem areas and consider alternative 
tactics?

(3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project challenge 
existing paradigms or develop new methodologies or technologies?

(4) INVESTIGATOR: Are you appropriately trained and well suited to carry out 
this work?  Is the work proposed appropriate to your experience level as the 
principal investigator and to that of other researchers (if any)?

(5) ENVIRONMENT:  Does the scientific environment in which your work will be 
done contribute to the probability of success?  Do the proposed experiments 
take advantage of unique features of the scientific environment or employ 
useful collaborative arrangements?  Is there evidence of institutional 
support?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy of plans to include subjects from genders, all 
racial and ethnic groups (and subgroups), as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of subjects 
will also be evaluated. (See Inclusion Criteria included in the section on 
Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

OTHER REVIEW CRITERIA:  Projects must have a clear relevance to human aging 
to be considered under this Program Announcement.  The research must be 
focused on human cancer.

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

Responsiveness to the NIA/NCI Workshop Report:

High quality grant applications that are responsive to recommendations 
described in the NIA/NCI workshop report 
(http://www.nia.nih.gov/ResearchInformation/ConferencesAndMeetings/WorkshopReport/) 
will be considered for "exception" funding by the NCI.  "Exception funding" 
is used by the NCI to support applications whose priority scores are beyond, 
but close to the payline and not funded through the accelerated executive 
review process.  These applications will therefore, compete for a limited 
pool of dollars with those in other high-priority categories:  these include 
applications submitted by new investigators or those addressing cancer health 
disparities, or areas of extraordinary research opportunity designated by the 
NCI.  Decisions on exceptions are made three times a year. Contact the NCI 
program director for details.  In order to mark an application for 
consideration, investigators should cite the relevant section (s) of the 
Report and include the following language in the Background section of their 
grant applications:  "The research described in this application is 
responsive to recommendations in the NIA/NCI workshop report, Exploring the 
Role of Cancer Centers for Integrating Aging and Cancer Research."  

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: 
Research components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous data 
management, quality assurance, and auditing procedures.  In addition, it is 
NIH policy that all clinical trials require data and safety monitoring, with 
the method and degree of monitoring being commensurate with the risks (NIH 
Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, 
June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research, updated racial and ethnic categories in compliance with the new OMB 
standards, clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398, and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable, 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.866 and No. 93.397, and is not subject to 
the intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and to discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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