This Program Announcement expires on March, 2004, unless reissued.

RESEARCH ON AUTISM AND AUTISM SPECTRUM DISORDERS

Release Date:  February 13, 2001

PA NUMBER:  PA-01-051 (see replacement PA-04-085)

National Institute on Deafness and Other Communication Disorders
National Institute of Mental Health
National Institute of Child Health and Human Development
National Institute of Neurological Disorders and Stroke
National Institute of Environmental Health Sciences

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT 
INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS 
THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

The purpose of this program announcement is to encourage grant 
applications for the support of research designed to elucidate the 
diagnosis, epidemiology, etiology, genetics, treatment, and optimal 
means of service delivery in relation to Autistic Disorder ("autism") 
and autism spectrum disorders (Rett's Disorder, Childhood 
Disintegrative Disorder, Asperger's Disorder, Pervasive Developmental 
Disorder-Not Otherwise Specified, or "Atypical Autism").

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 Program 
Announcement (PA), Research on Autism and Autism Spectrum Disorders, 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/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and 
non-profit organizations, public and private, such as universities, 
colleges, hospitals, laboratories, units of State and local 
governments, and eligible agencies of the Federal government.  
Racial/ethnic minority individuals, women, and persons with 
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) R01 award 
mechanism.  Responsibility for the planning, direction, and execution 
of the proposed project will be solely that of the applicant.  The 
total project period for an application submitted in response to this 
PA may not exceed five years.

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined 
by the NIH. Complete and detailed instructions and information on 
Modular Grant applications can be found at 
https://grants.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Although it has long been recognized that the pervasive developmental 
disorders, including autism, are highly variable in their clinical 
manifestations and likely the result of multiple etiologies, only 
recently have efforts been directed toward a meaningful subtyping of 
this group of disorders. Current classification systems (e.g., DSM-IV) 
include five separate diagnoses under the pervasive developmental 
disorders: Autistic Disorder, Rett's Disorder, Childhood Disintegrative 
Disorder, Asperger's Disorder and Pervasive Developmental Disorder Not 
Otherwise Specified (also called "Atypical Autism"). 

Autistic disorder, or "autism," is considered the most classic of the 
pervasive developmental disorders in that it was the first of these 
disorders to be recognized as a distinct disorder.  These disorders 
share a cluster of impairments in reciprocal social interaction and 
communication and/or the presence of stereotyped behavior, interests 
and activities.  These complex disorders are usually of lifelong 
duration and affect multiple aspects of development, learning, and 
adaptation in the community, and thus represent a pressing public 
health need. The etiologies of these disorders are poorly understood, 
but are thought to include genetic, metabolic, immunologic and 
infectious or other environmental influences.

Etiology research involving these requires well integrated, multi-
disciplinary, methodologically-rigorous scientific approaches and 
access to a sufficient number of well-characterized patients with these 
disorders.  Basic research into the pathophysiology of autism and 
autism spectrum disorders, including research on brain mechanisms and 
genetics, is of special interest.  Also of interest are clinical and 
applied investigations that may lead to the development of diagnostic 
research instruments, treatments, and intervention strategies.  
Specific areas of interest thus include epidemiology, early 
identification and diagnosis, genetic studies, brain mechanisms, 
communication skills, cognitive neuroscience, psychosocial (behavioral) 
interventions, pharmacological and other biological interventions, and 
services.

Areas of interest include, but need not be limited to, the following:

o  Epidemiology: Development of new screening tools for use in a 
variety of settings; research on the expression of the full range of 
autism spectrum disorders; studies on their developmental course; 
studies that characterize the range of expression within families; 
research on co-occurring features; and studies to determine risk 
factors in the etiology of autism, including environmental exposures 
during pregnancy and early childhood.  

o  Early Identification and Diagnosis:  Key diagnostic features 
associated with various stages of development; assessment of comorbid 
features including hyperactivity, attentional dysfunctions, epilepsy, 
and obsessive and compulsive symptoms; assessment and further 
differentiation of subtypes of autistic spectrum disorders including 
Autistic Disorder, Asperger's Disorder, Rett's Disorder, and Childhood 
Disintegrative Disorder; and, developmental factors relevant to 
reliable and valid diagnosis.

o  Genetic Studies:  Large-scale linkage studies of affected relative 
pairs or extended pedigrees to identify chromosomal regions harboring 
disease susceptibility genes; family-based association analysis and 
other linkage disequilibrium  approaches that aim to identify a 
specific susceptibility gene; high-resolution mapping and positional 
cloning studies; resolution of locus heterogeneity; analysis of the 
interaction of autism susceptibility gene(s) with environmental 
exposures and/or genes responsive to environmental insult, testing for 
potential candidate genes.

o  Brain Mechanisms:  Studies of brain mechanisms underlying the 
development, regulation, and modulation of behaviors characterizing 
autism and autism spectrum disorders, particularly those mechanisms 
involving communication and social interaction; studies of brain 
mechanisms and biological factors underlying autistic regression, or 
the loss of previously acquired skills; studies of brain mechanisms 
involved in the development of abnormal electroencephalograms and 
epilepsy and studies to clarify the subtypes of seizures and seizure 
disorders in autism; studies to define the neurobiological basis of 
neurological abnormalities and neuropsychiatric symptoms, including 
motor stereotypies, gait abnormalities, akinesias, dyskinesias, 
obsessive/compulsive traits, and the exacerbation of these symptoms, 
including the role of neuroimmune/autoimmune factors; studies that seek 
to define basic processing deficits using neuropsychological and 
cognitive neuroscience techniques; studies to develop animal models of 
brain dysfunction in autism and autism spectrum disorders, based on 
either genetic or environmental factors or their interaction.

o  Communication Skills:  Longitudinal, developmental studies of 
behaviors that are precursors to later communication (e.g., imitation, 
joint attention, early vocalization) and their emergence in children 
with autism and autistic spectrum disorders; sensory, motor and social-
cognitive impairments that impact upon interaction and communication; 
predictors of loss of or regression in expressive language abilities; 
the nature of severe spoken language deficits when other areas of 
function, such as written language skills, are relatively preserved; 
interventions designed to remediate communication and related deficits.

o  Cognitive Science:  Developmental studies of relevant behaviors 
during infancy including attention to social and nonsocial stimuli, 
affective behavior, gaze, vocalization, imitation, initiative, 
reciprocity, attachment, play, compliance, and self- recognition and 
their emergence in children with autism and autistic spectrum 
disorders; research on the delays and deviations in social behavior and 
cognition during preschool and middle school, including empathy, 
receptive social cognitive deficits (i.e., difficulties understanding 
others), and expressive difficulties; studies leading to more 
sophisticated tests of higher cognitive functioning, especially in 
social, communicative, reasoning, and problem-solving areas, as well as 
tests of basic attentional, emotional and cognitive deficits that may 
underlie these deficits or be precursors to them; studies of theory of 
mind, of unconventional verbal behaviors, and of the sensory-motor 
factors involved in relevant social cognition; and the development, 
validation and refinement of interventions designed to address deficits 
in complex social and cognitive abilities or their developmental 
precursors.

o  Psychosocial Interventions:  Studies developing new treatments 
(e.g., behavioral, cognitive-behavioral) and studies validating, 
refining and comparing approaches to the treatment of autism and autism 
spectrum disorders, as well as studies that analyze and define the 
critical features of effective intervention; studies that relate 
characteristics of individuals (or diagnostic subtypes) to treatment 
outcomes; research on relevant contextual factors including physical 
environments, parent-child and sibling-child relationship factors, and 
peer-child interactions; studies addressing generalization or the 
transfer of learning from one setting to another.

o  Pharmacological/Biological Intervention:  Studies aimed at 
developing and testing the efficacy and safety of  pharmacological 
agents that specifically target the core features of autism and 
autistic spectrum disorders; studies of the efficacy and safety of 
pharmacological and combined treatments for the most common and 
impairing psychopathology associated with autism (e.g., hyperactivity, 
impulsivity, aggression, self-injury, and obsessive-compulsive 
symptoms); new approaches to treatment that build on advances in 
neuroscience, genetics, immunology, and other neurobiologic fields; 
focused interventions that test specific theories or hypotheses 
regarding possible neuropathogenesis; studies that address the benefits 
of combined drug and psychosocial interventions.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear and compelling rationale and justification are 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 research involving human subjects should 
read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," published in the NIH Guide for 
Grants and Contracts on August 2, 2000 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  
The revisions relate to NIH defined Phase III clinical trials and 
require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, 
and to conduct and report analyses, as appropriate, by sex/gender 
and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age 
of 21) must be included in all human subjects research, conducted or 
supported by the NIH, unless there are scientific and ethical reasons 
not to include them.  This policy applies to all initial (Type 1) 
applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines on the Inclusion of Children as 
Participants in Research Involving Human Subjects" that was published 
in the NIH Guide for Grants and Contracts, March 6, 1998, and is 
available at the following URL address: 
https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program 
staff listed under INQUIRIES.  Program staff may also provide 
additional relevant information concerning the policy.

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.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an 
Internet site.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 
(rev. 4/98) and will be accepted at the standard application deadlines 
as indicated in the application kit.  Application kits are available at 
most institutional offices of sponsored research and may be obtained 
from the Division of Extramural Outreach and Information Resources, 
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, 
Bethesda, MD 20892-7910, telephone 301/710-0267, email: 
GrantsInfo@nih.gov.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any 
amended/revised version of the preceding grant application types 
requesting $500,000 or more in direct costs for any year are advised 
that he or she must contact the Institute or Center (IC) program staff 
before submitting the application, i.e, as plans for the study are 
being developed.  Furthermore, the application must obtain agreement 
from the IC staff that the IC will accept the application for 
consideration for award.  Finally, the applicant must identify, in a 
cover letter sent with the application, the staff member and Institute 
or Center who agreed to accept assignment of the application.  

This policy requires an applicant to obtain agreement for acceptance of 
both any such application and any such subsequent amendment.  Refer to 
the NIH Guide for Grants and Contracts, March 20, 1998 at 
https://grants.nih.gov/grants/guide/notice-files/not98-030.html.

The modular grant concept establishes specific modules in which direct 
costs may be requested as well as a maximum level for requested 
budgets. Only limited budgetary information is required under this 
approach. The just-in-time concept allows applicants to submit certain 
information only when there is a possibility for an award. It is 
anticipated that these changes will reduce the administrative burden 
for the applicants, reviewers and Institute staff. The research grant 
application form PHS 398 (rev. 4/98) is to be used in applying for 
these grants, with the modifications noted below.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS

The title and number of the program announcement must be typed on line 
2 of the face page of the application form and the YES box must be 
marked.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 
modules, up to a total direct cost request of $250,000 per year. 
(Applications that request more than $250,000 direct costs in any year 
must follow the traditional PHS 398 application instructions.) The 
total direct costs must be requested in accordance with the program 
guidelines and the modifications made to the standard PHS 398 
application instructions described below:
PHS 398.

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct 
Costs (in $25,000 increments up to a maximum of $250,000) and Total 
Costs [Modular Total Direct plus Facilities and Administrative (F&A) 
costs] for the initial budget period Items 8a and 8b should be 
completed indicating the Direct and Total Costs for the entire proposed 
period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form 
Page 4 of the PHS 398. It is not required and will not be accepted with 
the application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete 
the categorical budget table on Form Page 5 of the PHS 398. It is not 
required and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget 
Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm 
for sample pages.) At the top of the page, enter the total direct costs 
requested for each year. This is not a Form page.

o Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project. No individual salary 
information should be provided. However, the applicant should use the 
NIH appropriation language salary cap and the NIH policy for graduate 
student compensation in developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs 
(direct plus facilities and administrative) for each year, each rounded 
to the nearest $1,000. List the individuals/organizations with whom 
consortium or contractual arrangements have been made, the percent 
effort of all personnel, and the role on the project. Indicate whether 
the collaborating institution is foreign or domestic. The total cost 
for a consortium/contractual arrangement is included in the overall 
requested modular direct cost amount. Include the Letter of Intent to 
establish a consortium.
Provide an additional narrative budget justification for any variation 
in the number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information 
used by reviewers in the assessment of each individual's qualifications 
for a specific role in the proposed project, as well as to evaluate the 
overall qualifications of the research team. A biographical sketch is 
required for all key personnel, following the instructions below. No 
more than three pages may be used for each person. A sample 
biographical sketch may be viewed at: 
https://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the 
application. If the F&A rate agreement has been established, indicate 
the type of agreement and the date. All appropriate exclusions must be 
applied in the calculation of the F&A costs for the initial budget 
period and all future budget years.

o The applicant should provide the name and phone number of the 
individual to contact concerning fiscal and administrative issues if 
additional information is necessary following the initial review. 

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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and 
technical merit by an appropriate scientific review group convened in 
accordance with the standard NIH peer review procedures.  As part of 
the initial merit review, all applications will receive a written 
critique and undergo a process in which only those applications deemed 
to have the highest scientific merit, generally the top half of 
applications under review, will be discussed, assigned a priority 
score, and 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 the application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals.  Each of these criteria will be addressed and 
considered in assigning the overall score, weighting them as 
appropriate for each application.  Note that the application does not 
need to be strong in all categories to be judged likely to have major 
scientific impact and thus deserve a high priority score.  For example, 
an investigator may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

(1) Significance:  Does this study address an important problem?  If 
the aims of the application are achieved, how will scientific knowledge 
be advanced?  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?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

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

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

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

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their 
subgroups, and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will 
also be evaluated.

o  The reasonableness of the proposed budget and duration in relation 
to the proposed research

o  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.

AWARD CRITERIA

Applications will compete for available funds with all other 
recommended applications. The following will be considered in making 
funding decisions:  Quality of the proposed project as determined by 
peer review, availability of funds, and program priority.

INQUIRIES

Inquiries are encouraged.  Questions and discussion of programmatic 
issues from potential applicants may be addressed to:

Judith Cooper, Ph.D.
Division of Extramural Research
National Institute on Deafness and Other Communication Disorders
Executive Plaza South, Room 400C-11 - MSC 7180
Bethesda, MD  20892-7180
Telephone:  (301) 496-5061
FAX:  (301) 402-6251
Email:  Judith_Cooper@nih.gov

Steve Foote, Ph.D.
National Institute of Mental Health
NSC, 6100 Executive Boulevard, Room 7204
Bethesda, MD  20857-MSC-9645
Telephone:  (301) 443-3563
FAX:  (301) 443-1731
Email:  Sfoote@mail.nih.gov

Marie Bristol-Power, Ph.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B09E, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1383
FAX:  (301) 496-3791
Email:  Bristolm@exchange.nih.gov

Deborah Hirtz, M.D.
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard
Bethesda, MD  20892
Telephone:  (301) 496-5821
FAX:  (301) 480-1080
Email:  dh83f@nih.gov

Cindy P. Lawler, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC  27709
Telephone: (919) 316-4671
FAX: (919) 541-5064
Email:  lawler@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Diana Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
Email:  Diana_Trunnell@nih.gov

Mary E. Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A07 - MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1305
FAX:  (301) 402-0915
Email:  md74u@nih.gov

Sara Stone
Chief, Grants Management Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, EPS-400-B MSC-7180
Bethesda, MD  20892-7180
Telephone:  (301) 402-0909
FAX:  (301) 402-1758
Email:  Sherry_Dabney@nih.gov

Gladys Melendez-Bohler
Grants Management Office
National Institute of Neurological Disorders and Stroke
NSC, Room 3262
Bethesda, MD  20892
Telephone:  (301) 496-3929
FAX:  (301) 402-0219
Email:  bohlerg@ninds.nih.gov

Laura Williams-Boyd
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
Research Triangle Park, NC  27709
Telephone: (919) 541-7629
FAX: (919) 541-2860
Email:  willia27@niehs.nih.gov

AUTHORITY AND REGULATIONS 

This program is described in the Catalog of Federal Domestic Assistance 
No. 93.173.  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 and Federal Regulations 42 
CFR 52 and 45 CFR Parts 74 and 92.  This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to 
provide a smoke-free workplace and promote the non-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, and 
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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