PLANNING GRANTS FOR MOLECULAR EPIDEMIOLOGY IN THE ENVIRONMENTAL GENOME PROJECT

Release Date:  April 20, 2001

RFA:  RFA-ES-01-005

National Institute of Environmental Health Sciences
 (http://www.niehs.nih.gov)

Letter of Intent Receipt Date:  June 13, 2001
Application Receipt Date:       July 13,2001

THIS 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 Request for Applications (RFA) is to build collaborations 
between scientists working in the fields of epidemiology, environmental health 
sciences, molecular biology, and biostatistics to plan novel and innovative 
molecular epidemiology studies of environmentally induced diseases. A focus on 
using high through-put technology in molecular epidemiology studies of 
environmental response genes is intended, as well as the development of new 
biostatistical methods to support such studies. This program is seen as 
integral to the National Institute of Environmental Health Science (NIEHS) 
Environmental Genome Project (EGP).

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, "Planning Grants for Molecular 
Epidemiology in the Environmental Genome Project" is related to the priority 
area of Environmental Health. Potential applicants may obtain a copy of 
"Healthy People 2010" at http://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. Foreign institutions are not eligible to apply for R21 
exploratory/planning grants but may participate as a subcontractor. 
Racial/ethnic minority individuals, women, and persons with disabilities are 
encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) exploratory/planning 
grant (R21) 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 three years. This RFA is a one-time solicitation. The anticipated 
award date is April, 2002. 

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

FUNDS AVAILABLE

NIEHS intends to commit approximately $2 million in FY 2002 to fund eight to 
ten new awards in response to this RFA. An applicant may request a project 
period of up to three years and a budget for direct costs of up to $150,000 
per year. Although the financial plan of NIEHS is to 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 applications of outstanding 
scientific and technical merit.

RESEARCH OBJECTIVES

Background 

An individual’s risk of disease is determined by the complex interplay between 
genetic susceptibility, environmental exposures and aging. The mission of the 
NIEHS is to study the interaction of these factors in determining the risk of 
environmentally induced diseases, such as asthma, birth defects, autoimmune 
diseases, and cancer. The rapid advances in molecular genetic technologies 
provide new opportunities to understand the genetic basis for individual 
differences in susceptibility to environmental exposure.

The NIEHS is expanding its research program on genetic susceptibility to 
environmentally associated diseases through the EGP. This project, which is 
making use of technology developed by the Human Genome Project, is aimed at 
the identification of allelic variants (polymorphisms) of environmental 
disease susceptibility genes in the U.S. population, developing a central 
database of polymorphisms for these genes, and fostering population-based 
studies of gene-environment interaction in disease etiology. By identifying 
those genes and allelic variants that affect individual response to 
environmental agents, scientists can better predict health risks and assist 
regulatory agencies in the development of environmental protection policies.  
While a host of genes that play a role in susceptibility to environmental 
exposure have been identified, the polymorphisms of these genes have not been 
systematically sought, identified, or reported. Currently epidemiological 
studies have focused on a limited number of genes when exploring gene-disease 
or gene-environment-disease relationships. Very soon thousands of genes will 
be sequenced and their function elucidated such that the knowledge of their 
metabolic and physiologic importance will be more complete. More advanced 
epidemiological and biostatistical methods must be developed to incorporate 
this information into future molecular epidemiology studies of disease risk.  

Currently work is underway in two sequencing centers to identify new single 
nucleotide polymorphisms in genes regulating DNA repair, cell cycle control, 
and drug metabolizing enzymes. Structure-function relationships of 
polymorphisms of interest are also being studied as part of the NIEHS Mouse 
Comparative Genome Centers and at individual research projects supported at 
universities around the U.S. More information about the EGP, including 
descriptions of currently funded projects, can be viewed at 
http://www.niehs.nih.gov/envgenom/home.htm.

Research on human populations describing the frequency of these polymorphisms 
and the support of molecular epidemiologic studies focused on elucidating the 
associations between genetic variants and environmental exposures are 
important parts of the EGP. As genetic technology develops, these molecular 
epidemiologic studies should be designed to incorporate appropriate 
innovations. Dialog between molecular biologists and environmental 
epidemiologists at the early stages is key in order to make progress. 

This RFA is intended to bring together multidisciplinary teams of scientists 
at institutions or consortiums of institutions to work on issues central to 
conducting molecular epidemiology studies of environmentally induced diseases 
such as asthma and other respiratory diseases, birth defects, neurological 
diseases, and cancer. These teams will include epidemiologists, 
biostatisticians, ethicists, molecular biologists experienced in using high 
through-put technologies, and toxicologists and/or other environmental health 
scientists. Partnerships with the biotechnology industry are encouraged to 
bring new technological advances in genomic and informatic sciences to the 
practice of epidemiology. 

The application for this planning grant should address four areas: (1) overall 
scientific theme, (2) strategies for crosstalk among the multidisciplinary 
team, (3) collaborations to integrate novel technologies and/or methodologies 
into epidemiologic research, and (4) pilot projects or small scale research 
projects for year 01 and strategies for developing pilot projects in future 
years. The work of each consortium should be theme related, focusing on issues 
related to quantifying the risk of environmentally induced diseases associated 
with specific gene and environmental factors and the interactions of these 
factors. This program is not meant to provide funds for carrying out the 
complex field work and analysis of these specific gene-environment 
interactions, but rather to identify the issues/needs related to carrying out 
molecular epidemiologic studies and to begin to address them within a 
multidisciplinary context. Each planning team can begin work on developing the 
collaborations and intellectual frameworks necessary to conduct future 
molecular epidemiologic studies as part of the EGP within this program. Plans 
for educating members of the multidisciplinary teams in the language of each 
field of science are a critical part of this planning activity. These 
activities may include seminars, journal clubs, working groups, as well as 
retreats and may be included in the scope of the proposal. It is intended that 
the teams will make use of novel technologies in planning for future studies. 
Due to the small size of these grants, funds should not be used for large 
purchases of new equipment, but rather could be used towards pay back 
arrangements for utilizing such equipment at specialized centers of research 
such as NIEHS Environmental Health Sciences Centers or General Clinical 
Research Centers. Research funds may be provided for pilot work, feasibility 
studies, or small scale research projects of a methodological or statistical 
nature. Pilot projects may be one to three years in duration. Details about 
these projects should be included in the application. They should be limited 
to three to four pages each, providing sufficient detail for peer-review, 
including a short introduction, hypothesis, experimental approach, expected 
results, and it’s significance to future studies for the Environmental Genome 
Project.  

Research conducted under this planning grant may include activities in these 
broad categories, but is not limited to:

o Validation of genotyping and gene expression assays in stored samples using 
new high through-put technologies.

o Determination of frequency distributions of allelic variants (polymorphisms) 
discovered as part of the EGP in human populations. 

o Development of new statistical methods and bioinformatics to analyze data 
generated from high through-put analysis of the human genome in 
epidemiological studies.

o Development of novel study designs to conduct molecular epidemiology as part 
of the EGP.

o Research on innovative study designs necessary to conduct molecular 
epidemiologic studies as part of the EGP.

o  Investigation of ethical issues associated with conducting molecular 
epidemiologic studies as part of the EGP.  

Some examples of relevant pilot or small scale research activities are 
designing and field testing novel strategies for collecting and storing blood 
and DNA specimens, inclusion of gene expression chips methodologies which 
contain relevant panels of genes and determining response patterns and 
chemical specific signatures in epidemiologic studies, use of strategies to 
pool DNA samples to estimate allele frequency, development of new methodologic 
paradigms to study multi-gene pathways, development of appropriate statistical 
approaches to handle large amounts of data from microarray or other genomic  
assays, and focus groups or other activities to assess the feasibility of 
conducting gene-environment studies in minority, low socioeconomic, or other 
hard to reach populations.  

Extensive molecular epidemiologic studies including primary data collection 
will not be part of this RFA. More comprehensive molecular epidemiologic 
studies may be supported by future initiatives and/or by regular investigator 
initiated applications. Work done under this planning grant or similar 
activities will be considered important preliminary work towards these future 
studies.  

SPECIAL REQUIREMENTS

It is strongly recommended that each planning team include representative(s) 
for each of the following disciplines:

o  Epidemiology
o  Molecular Biology
o  Biostatistics/Bioinformatics
o  Environmental Health Sciences or Toxicology
o  Ethics 

It is required that scientists in least three of these disciplines be included 
in the application. Other disciplines, such as clinical sciences and 
behavioral/social scientists relevant to the disease under study, may be added 
to the team if necessary. Representatives from community-based organizations 
or advocacy groups should be considered as important team members. 

Grantees will meet together with program staff and other members of NIEHS 
involved in work relating to the Environmental Genome Project every year of 
the project period. Grantees should plan for an annual trip to NIEHS in 
Research Triangle Park, North Carolina for at least two investigators and 
budget appropriately.  

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 subpopulations 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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete 
copy of the updated Guidelines are available at 
http://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: http://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.

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 other key personnel 
and participating institutions, and the number and title of the RFA in 
response to which the application may be submitted. 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 allows NIEHS staff 
to estimate the potential review workload and plan the review.

The letter of intent is to be sent to:

Brenda Weis, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
111 T.W. Alexander Drive (for express/courier service)
Research Triangle Park, NC  27709
Telephone: (919)541-4964
Fax: (919)541-2503
Email: weis@niehs.nih.gov

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 301/435-0714, 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 $150,000 per year. 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 $150,000) 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 URL http://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 their 
role on the project. Indicate whether the collaborating institution is foreign 
or domestic. The total costs 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: 
http://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. 

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 is available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf and 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:

Brenda Weis, Ph.D.
Scientific Review Administrator
Scientific Review Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, EC-30
111 T.W. Alexander Drive (for express/courier service)
Research Triangle Park, NC  27709
Telephone: (919)541-4964
Fax: (919)541-2503
Email: weis@niehs.nih.gov

Applications must be postmarked by the application receipt date listed in the 
heading of this RFA. If an application is postmarked 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 
responsiveness by the NIEHS. 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 
the NIEHS in accordance with the review criteria stated below. As part of the 
initial merit review, a process will be used by the initial review group in 
which applications 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 
Environmental Health Sciences Council.   

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, 
weighing 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 planning grant 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: Does the Principal Investigator present a coherent and well 
designed strategy to enhance crosstalk in order to build a multidisciplinary 
research program in molecular epidemiology? 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? Do the pilot projects 
represent unique opportunities for enhancing our ability to integrate human 
genomic sciences into epidemiologic research? 

(4) Investigator: Are the required 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 (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 or the environment, to 
the extent they may be adversely affected by the project proposed in the 
application.

The initial review group will also examine the provisions for the protection 
of human subjects and the safety of the research environment.

Schedule

Letter of Intent Receipt Date:    June 13, 2001
Application Receipt Date:         July 13, 2001
Peer Review Date:                 October, 2001
Council Review:                   February, 2002
Earliest Anticipated Start Date:  April, 2002

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Gwen W. Collman, Ph.D.
Scientific Program Administrator
Chemical Exposures and Molecular Biology Branch
Office of Program Development
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T. W. Alexander Drive, MD EC-21
Research Triangle Park, NC  27709
Telephone:  (919) 541-4980
Fax:  (919) 316-4606
Email:  collman@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Dwight Dolby
Grants Management Specialist
Grants Management Branch
Office of Program Operations
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
111 T. W. Alexander Drive, MD EC-22
Research Triangle Park, NC  27709
Telephone:  (919) 541-7824
Fax:  (919) 541-2860
Email:  dolby@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.113. Awards are made under authorization of the Sections 301 and 405 of the 
Public Health Service Act as amended (42 USC 241 and 284) and administered 
under the 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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