HEALTH AND DEVELOPMENTAL CONSEQUENCES OF PRENATAL EXPOSURE TO METHAMPHETAMINE

Release Date:  January 25, 2001

RFA:  RFA-DA-01-005

National Institute on Drug Abuse
 (http://www.nida.nih.gov)

Letter of Intent Receipt Date:  March 19, 2001
Application Receipt Date:       April 19, 2001

THIS REQUEST FOR APPLICATIONS (RFA) 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 RFA.

PURPOSE

The purpose of this RFA is to support research on the health and development 
of children exposed to methamphetamine in utero.  In order to maximize the 
timeliness of the research, National Institute on Drug Abuse (NIDA) supports 
the establishment of collaborative Community Research Networks (CRNs) to meet 
this goal.

The aim of the CRNs is to forge partnerships between Research Directors (RDs) 
and Community Research Partners (CRPs).  The Research Directors will be 
researchers with capabilities to conduct longitudinal cohort studies on the 
effects of in utero exposure to illicit drugs.  The CRPs will be clinicians 
and researchers from communities where methamphetamine use is prevalent.  
CRPs may be from institutions where the research capacities needed for 
competitive research grants are not yet sufficiently developed or from 
institutions with developed research capacities, but without the necessary 
expertise in this particular area of research.  It is anticipated that the 
communities involved will reflect diversity in study populations and in 
geographic location.   

The CRNs will thus bring the experience, advances in methods, and lessons 
learned from research on consequences of in utero exposure to cocaine, 
opiates, marijuana, alcohol, and tobacco to the study of consequences of 
prenatal exposure to methamphetamine and methamphetamine analogs such as 
MDMA.  The RDs will have the scientific lead for the project and will 
collaborate with multiple CRPs to form a CRN.  It is expected that one to 
three CRNs will be funded, depending on the size and scope of the networks 
and the quality of the applications received.  

The RDs will be the recipients of the award and will provide scientific 
leadership and management for the research program including:

o  Generating the research agenda in collaboration with CRPs.

o  Establishing the collaborative infrastructure and the policies and 
procedures under which the CRN will operate.

o  Providing administrative and operations support for the CRN.

o  Assuming responsibility for data acquisition, management, and analysis.

o  Maintaining and coordinating communications with the CRPs.

o  Providing necessary training to CRPs to meet project goals.

o  Collaborating with CRPs on interpretation and dissemination of research 
findings.

The CRPs will be active participants in the research, including:

o  Contributing to the development of research questions and methods.

o  Implementing the research protocol as established with the RD.

o  Recruiting appropriate subjects from the community as required for 
specific studies.

o  Collecting and maintaining data to be forwarded to the RD.

o  Cooperating in all quality control activities.

o  Collaborating and participating actively in appropriate research training 
activities.

o  Participating in the interpretation and dissemination of research 
findings.

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 RFA, "Health and 
Developmental Consequences of Prenatal Exposure to Methamphetamine", 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, 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.  

MECHANISMS OF SUPPORT

This RFA will use the National Institutes of Health (NIH) research project 
(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 RFA may 
not exceed five years.  Modular budgeting procedures apply for grants up to 
$250,000.  See https://grants.nih.gov/grants/funding/modular/modular.htm for 
further information about modular budgets.  This RFA is a one-time 
solicitation.  Future unsolicited competing continuation applications will 
compete with all investigator-initiated applications and be reviewed 
according to the customary peer review procedures.  The anticipated award 
date is September 30, 2001.  Applicants are advised to contact NIDA program 
staff listed under INQUIRIES for additional information and specific 
application procedures.

FUNDS AVAILABLE

NIDA intends to commit approximately $1.5 million in FY 2001 to fund one to 
three new and/or competitive continuation grants in response to this RFA.  An 
applicant may request a project period of up to five years.  Because the 
nature and scope of the research proposed may vary, it is anticipated that 
the size of each award will also vary.  Although the financial plans of NIDA 
provide support for this program, awards pursuant to this RFA are contingent 
upon the availability of funds and the receipt of a sufficient number of 
meritorious applications.  

RESEARCH OBJECTIVES

Background

There are virtually no clinical research data available on the health and 
developmental consequences of prenatal exposure to methamphetamine and 
methamphetamine analogs such as MDMA.  Animal and tissue culture research, as 
well as clinical observations suggest, potential negative consequences of 
prenatal exposure.  Methamphetamine use in certain regions of the U.S. 
appears to be at very high levels.  Ethnographic and anecdotal reports 
suggest that some pregnant women have a perception that use of 
methamphetamine is not dangerous.  In light of the concerns and limited data, 
NIDA held a workshop on the topic in March 2000, with presentations of basic, 
clinical, epidemiologic, and ethnographic research and with participants from 
research, public health, and clinical-care environments in various parts of 
the country.  Feedback from participants at the meeting highlighted the 
urgency for NIDA to pursue a research agenda regarding the health and 
developmental consequences of prenatal methamphetamine exposure.  An overview 
and some highlights of the meeting was published in JAMA on May 3, 2000 (Vol. 
283, No. 17, Pp. 2225-2226).

Areas of Research Focus  

The focus of research solicited by this RFA is the health and development in 
the first three years of life, of children prenatally-exposed to 
methamphetamine (and methamphetamine analogs such as MDMA).  It is expected 
that in most cases proposed research will involve longitudinal cohort study 
designs, although other study approaches will be considered if justified 
scientifically. 

Research should take into account important factors that may co-vary with 
illicit drug use, such as maternal variables (e.g., physical/mental health) 
and environmental context factors (e.g., home environment, parenting, 
exposure to violence).  Applications should provide explicit discussion as to 
how these factors will be incorporated into the plans for data analyses.  
Applicants should consider multiple infant and child outcome domains (e.g., 
attention, physiological functioning, cognition, medical status, specific 
physical and mental health consequences, social development) and should 
provide justification for the specific domains and measures selected.  
Applications should explicitly identify how the research will quantify levels 
of exposure to methamphetamine and to other relevant substances.  

In addition, applications should address proposed solutions to scientific and 
practical challenges associated with multiple clinical research sites, such 
as variation in characteristics of study samples (e.g., cultural, 
environmental factors), and in operational characteristics of study sites.  
To the extent possible and appropriate, investigators are encouraged to 
consider hypotheses regarding mechanisms (e.g., biological, environmental) 
underlying associations between prenatal methamphetamine exposure and child 
outcome.  Also, to the extent possible and appropriate, investigators are 
encouraged to incorporate consideration of gender differences in their 
research designs and analyses.   

SPECIAL REQUIREMENTS

Applications should be submitted with RDs as Principal Investigators.  To 
promote the effectiveness of collaborative activities among RDs and CRPs, the 
following documentation, in detail, should be included in all applications.

o  CRPs' agreements to participate in the study.

o  Identification of the specific procedures the RD will employ to meet RD 
responsibilities relative to the CRPs, as identified in the Purposes section 
of this RFA.

o  Identification of the specific ways in which each CRP will fulfill CRP 
roles and responsibilities identified in the Purpose section of this RFA.

o  Capabilities of each CRP to recruit and retain the sample designated in 
the application.

o  Applications must have all CRPs clearly identified, and cooperative 
relationships established and documented.

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 is 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 these policies.

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.

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS  

The National Advisory Council on Drug Abuse recognizes the importance of 
research involving the administration of drugs to human subjects and has 
developed guidelines relevant to such research.  Potential applicants are 
encouraged to obtain and review the recommendations of the Council before 
submitting an application that will administer compounds to human subjects.  
The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov/ 
under Funding or may be obtained by calling (301) 443-2755.

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes a 
descriptive title of the proposed research; the name, address and telephone 
number of the Principal Investigator; the identities of all other personnel 
and participating institutions; and the number and title of the RFA in 
response to which the application may be submitted.  Letters of intent should 
be submitted by RDs, who will be the Principal Investigators on applications. 
Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains will allow NIDA staff to estimate the potential review workload and 
to plan the review.  

Send the letter of intent (by receipt date listed above) to:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants.  These forms are available at most institutional 
offices of sponsored research and 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.

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

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.

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 their 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 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; and
- 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.

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.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  Type the RFA 
number on the label.  Failure to use this label could result in delayed 
processing of the application such that it may not reach the review committee 
in time for review.  In addition, the RFA title and number must be typed on 
line 2 of the face page of the application form, and the YES box must be 
marked.

The sample RFA label available at 
https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typewritten original of the application, including the 
Checklist, and three signed photocopies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must be 
sent to:

Director, Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Rockville, MD  20852-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

Applications must be received by the application receipt date listed in the 
heading of this RFA.  If an application is received after that date, it will 
be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA 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 substantial 
revisions of applications already reviewed, but such applications must 
include an introduction addressing the previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and 
for responsiveness by NIDA.  Incomplete and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIDA in accordance with the review criteria stated below.  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 the applications 
under review, will be discussed, assigned a priority score, and receive a 
second level review by the National Advisory Council on Drug Abuse.

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

(4)  Investigator:  Is the investigator appropriately trained and well suited 
to carry out this work?  Is the work proposed appropriate to the 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?

(6)  Partnership Development:  Is there sufficient evidence of partnership 
arrangements to indicate likelihood of effective collaboration on study 
planning, research training, data collection, quality control, and 
interpretation and dissemination of research findings? 

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 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.

o  The adequacy of the proposed plan to share data.

Schedule

Letter of Intent Receipt Date:    March 19, 2001
Application Receipt Date:         April 19, 2001
Peer Review Date:                 June/July 2001
Council Review:                   September 2001
Earliest Anticipated Start Date:  September 30, 2001

AWARD CRITERIA

Award criteria that will be used to make award decisions include scientific 
merit (as determined by peer review), availability of funds, and programmatic 
priorities.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or answer questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Vincent Smeriglio, Ph.D.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301) 443-2151
FAX:  (301) 594-6566
E-mail:  vs24o@nih.gov

Direct inquiries regarding review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
E-mail:  tl25u@nih.gov

Direct inquiries regarding fiscal matters to:

Gary Fleming, J.D., M.A.
Grants Management Branch
Office of Planning and Resource Management
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
E-mail:  gf6s@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.279.  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 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, 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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