Release Date:  March 30, 1999

RFA:  CA-99-002


National Cancer Institute

Letter of Intent Receipt Date:  June 17, 1999
Application Receipt Date:  July 23, 1999


The Diagnostic Imaging Program, Division of Cancer Diagnosis and Treatment of the
National Cancer Institute (NCI) invites applications for P20 planning grants that
lead to the establishment of In Vivo Cellular and Molecular Imaging Centers. 
This Request for Applications (RFA) invites applications for P20 Planning Grants.
A subsequent RFA will be issued to invite applications for P50 Center grants.

These initiatives are designed to capitalize on the extraordinary opportunity for
studying cancer non-invasively, and in many cases, quantitatively due to recent
advances in molecular imaging modalities, molecular and cellular biology.  They
will facilitate the interaction of scientists from a variety of fields such as,
but not limited to: imaging sciences, chemistry, radiopharmaceutical chemistry,
cell and molecular biology, pharmacology, computer science, biomedical
engineering, immunology and neuroscience, and provide resources to conduct
multidisciplinary research.

This RFA describes the three-year, P20 Planning Grant for Pre-In Vivo Cellular
and Molecular Imaging Centers (Pre-ICMICs).  There are Institutions that have
most of the separate scientific components necessary for productive interaction
but have no track-record of performing multidisciplinary scientific research. 
The P20 will provide time and funds for these investigators to accomplish two
phases of activity.  Phase I will be designed for the formal establishment of an
organizational and operational structure of the Pre-ICMIC.  Phase II will provide
the time and funds for the initiation of multidisciplinary Development projects,
and for these newly-formed groups to complete recruitment efforts necessary for
bringing in critical expertise.  Following completion of the P20 funding period,
grantees will be expected to compete for a P50 award (see below) that will be
competitively reviewed on the organizational and scientific progress made during
the planning stage.

A second RFA CA-99-004, will make available 5-year P50 grants that will directly
fund In Vivo Cellular and Molecular Imaging Centers.  This RFA is available at:  P50 grants will be
appropriate for those Institutions in which investigator-initiated
multidisciplinary research involving imaging and molecular technologies is
currently ongoing.  These efforts may be generating important preliminary data,
but the teams may be loosely associated, not consistently supported and therefore
lack the overall structure and resources necessary to take full advantage of
emerging opportunities.  The P50 Center grant will provide a formal framework
through which scientific synergy can occur on a stable and continuing basis, and
will provide: 1) an organizational structure specifically designed to facilitate
intellectual cross-fertilization between seemingly disparate groups of
investigators; 2) core facilities to support research activities; 3)
developmental funds for feasibility testing of new projects; and 4) career
development opportunities for new and established investigators.


The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA, Planning Grants: In Vivo Cellular
and Molecular Imaging Centers (PRE-ICMICs), is related to the priority area of
cancer.  Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No.017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800) or at


Applications for P20 Pre-ICMIC grants may be submitted by domestic non-profit and
for-profit organizations, public and private, such as universities, colleges,
hospitals and laboratories.  Applications from foreign institutions will not be
accepted.  Foreign components of applications from domestic organizations will
be accepted with adequate justification. Racial/ethnic minority individuals,
women, and persons with disabilities are encouraged to apply as Principal

No more than one Pre-ICMIC application will be accepted from any given
Institution, nor will Institutions be allowed to submit a P20 application in
response to this RFA and a P50 application in response to the ICMIC RFA at the
same time.  Each Institution must determine in advance whether it will submit a
P20 or a P50 grant.  The Pre-ICMIC (P20) and the ICMIC (P50) will each require
two distinct levels of existing resources.  Each Institution must evaluate its
existing research programs, and determine whether it will require a planning
phase, or whether it has sufficient resources to support a P50 ICMIC.  If an
Institution submits an application for a P20 Planning Grant, an application from
that same Institution for a P50 Center grant will not be accepted for the first
P50 receipt date.  However, P50 applications will be accepted from those
institutions for subsequent P50 receipt dates, which are anticipated to occur in
Fiscal years 2000, 2002, and 2003.

Each of these lead investigators must be the principal investigator of a major,
peer-reviewed, research project, such as an R01, a P01, or their equivalent from
another funding agency. Applicants must therefore clearly define the scientific
areas to be represented within the Pre-ICMIC, and for each scientific area, one
or more investigators must be identified as assuming a leadership role.


Support of this program will be through the National Institutes of Health (NIH)
P20 Exploratory Grant Mechanism.  These exploratory studies may lead to
specialized or comprehensive centers (P50 - In Vivo Cellular and Molecular
Imaging Centers).  Responsibility for the planning, direction, and execution of
the proposed project will be solely that of the applicant.  The total project
period for a P20 application submitted in response to this RFA may not exceed 3
years.  The anticipated award date is Sept. 30, 1999.


This RFA is a one-time solicitation.  NCI anticipates making approximately six
3-year awards, and plans to set aside $2.4  million total for the initial year's
funding.  Annual budgets in the range of $300,000 - $500,000 total costs are
suggested - applications exceeding the $500,000 total cost limit will be
considered unresponsive to the RFA and will be returned without further
consideration.  Funding in response to this RFA is dependent upon the receipt of
a sufficient number of applications of high scientific merit. Although this
program is provided for in the financial plans of NCI, the award of grants
pursuant to this RFA is contingent upon the anticipated availability of funds for
this purpose.



Imaging sciences are at a stage in which human, anatomic imaging can occur in
vivo at submillimeter resolution, and significant advances have occurred in
molecular imaging modalities, including the nuclear medicine techniques of SPECT
and PET,  MR spectroscopy and optical imaging.  At the same time, a myriad of new
cancer-related genes and proteins are being uncovered at an increasing pace by
molecular and cellular biologists.  However, there remains a scientific gulf
between basic scientists who discover new cancer genes and intracellular
pathways, any of which could serve as a diagnostic or therapeutic target, and the
imaging scientists who could transform those discoveries into non-invasive means
for a greater understanding of neoplasia in humans.

Research Goals and Objectives:

The formation of multidisciplinary research teams will stimulate and streamline
cancer imaging research from inception to use in patient care.  Each Institution
will define the structure and research objectives that create the most
synergistic and creative scientific interactions.  An example of a ICMIC
structure is described below.  This is just an example, and other
multidisciplinary formats are acceptable.

Discovery, characterization and refinement of new genetic targets might occur in
the molecular biology core with that information provided to a chemistry core
where potential new imaging agents directed toward those targets will be
designed. A computing/database core would support the chemistry core through
molecular modeling and structure searches but would also obviously interface with
the other cores such as in data analysis or image display. A biochemistry core
might be responsible for aspects of agent development that encompass cell biology
and pharmacology as well. Receptor and enzyme purification and in vitro assays
would occur in this core, in addition to development of kinetic models for
studying complex issues involving agent delivery and metabolism. Animal work from
rodents to primates would occur in the imaging core, where the most promising
potential agents would be tested.

Pre-ICMICs will provide Institutions with the resources to set in place all of
the components that would make them eventually competitive for a P50 ICMIC grant. 
The success of a Pre-ICMIC will ultimately be determined by the quality and
dedication of the investigators involved in the project.  An appropriate Pre-
ICMIC Director must be selected, as well as a multidisciplinary leadership team
of investigators who are committed to the success of the Pre-ICMIC.  This group
of investigators will be responsible for the definition of the research goals and
objectives of the Pre-ICMIC, as well as ongoing activities.  The lead
investigators must each represent a major scientific component that will be
involved in the Pre-ICMIC, and each must have an independent, proven track record
of scientific accomplishment, but they do not need to demonstrate prior
interactive research amongst themselves.

During the course of the Pre-ICMIC award, the leadership team will be responsible
for the design and implementation of two phases of activity.

Phase I:  Establishment of an Organizational Structure (no longer than 6 months).

During the Phase I planning stage, the applicant group will define and implement
a structure for a Pre-ICMIC.  Organizational activities must occur, during which
the group will be expected to define:

1)  The organizational and operational structure of the Pre-ICMIC.  This will
include the establishment of a Scientific Steering Committee, composed of both
internal and external senior investigators, who will be responsible for the
overall scientific direction of the Program, as well as mechanisms for involving
a dynamic groups of investigators at all levels of experience.

2) A plan for interactive Pre-ICMIC activities that will occur regularly over the
entire course of the award.  These interactions will be determined by the
applicants, and emphasis will be placed on establishing creative, productive
interactions.  One example would be to establish a regularly scheduled forum at
which investigators present a potential research idea to the entire group. 
Colleagues with a wide range of expertise would provide the investigator with
immediate feedback on the scientific content, which would in turn provide a
valuable educational experience for the audience.  Meritorious ideas could be
further refined by "revising and resubmitting" for a later forum.  Most
importantly, the investigator would have an audience full of potential
collaborators who could be involved in a project from its inception.

3)  A description of the core facilities necessary to support the scientific
goals of the Pre-Program.  Access to equipment and reagents is often a problem,
especially for multi-disciplinary programs.  The establishment of core resources
dedicated to Pre-ICMIC-related Development Projects will provide this access. 
Initially, ICMIC core resources may simply be extensions of existing laboratories
or facilities, and the definition of a core resource would vary considerably
depending on the Development projects to be selected.

4) A model of the process for the selection, monitoring, funding and, if
necessary, termination of Development Projects to be implemented in Phase II (see

Phase II: Development Projects

The organizational structure set in place during Phase I should be used to select
two to three highly-interactive Developmental Projects to be accomplished in
Phase II.  These projects will be geared toward determining project feasibility,
proof of principle and acquisition of preliminary data.  These pilot studies must
demonstrate newly-established collaborative efforts between two or more groups
of investigators.  The P20 application should contain no more than six three-page
examples of possible Development projects.  These projects will not be reviewed
as traditional research projects.  Rather, the proposed Development projects will
serve as an indication of the priorities to be focused on by the group, a
reflection of the decision-making abilities of the scientific leadership, and the
initial ability of the group to interact productively and scientifically.  The
actual Development projects that are implemented may not necessarily be those
that are submitted with the application, since the Phase I selection process may
determine other projects to be more meritorious.  When the P20 groups submit
their P50 application, it is expected that the Development projects will have
generated sufficient data for meaningful interpretation. The results acquired
during this phase will be a critical focus of the P50 review, since these results
will be an important indication of how successfully the Pre-ICMIC group
functioned to implement innovative research.


Funded Pre-ICMIC groups will be required to include in their first non-competing
renewal (annual reports) 1) a description of the  activities that occurred during
Phase I;  2)  the organizational and operational structure that was implemented
including a detailed description of the process for selecting Development
projects, and decisions regarding the establishment of core facilities;  3) a
description of each of the Development projects that have been initiated, and the
progress made on each of those projects.  Subsequent non-competing renewals will
be required to include a detailed report of organizational and operational
activities as well as a progress report for each of the ongoing Development


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 is provided 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.

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

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


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 clear and compelling 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:


Prospective applicants are asked to submit, by June 17, 1999, 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 NCI staff to
estimate the potential review workload and avoid conflict of interest in the

The letter of intent is to be sent to the program staff listed under INQUIRIES.


The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  Applications 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: Application kits are also available at the following URL:


All applications must be submitted on the form PHS-398 (rev.4/98).


Applicants should submit two separate detailed budgets (Form Page 4-DD), and a
single summary budget for the entire proposed period of support (Form Page 5-EE). 
The budgets should appear in the following order:

Budget 1 (use Form Page 4-DD) should include all of the costs required for Phase
I.  The duration of Phase I may be determined by the applicants, but is not to
exceed 6 months.  Examples of acceptable Phase I costs would be salary support
for the Program Director and key personnel involved in organizing the Pre-ICMIC,
and costs associated with planning meetings.

Budget 2 (use Form Page 4-DD) is to detail the costs associated with Phase II for
the remainder of the first year.  Phase II  is specifically designed to implement
the organizational structure of the Pre-ICMIC,  initiate and carry out the
multidisciplinary Development projects that will be selected during Phase I of
the award, and complete necessary recruitment efforts.  However, since the
organizational structure and the final selection of the Development projects will
not be completed until after the award has been made and Phase I has been
completed, the budget for Phase II, by definition, will be projected rather than
absolute.  Acceptable Phase II costs would be continued salary support for the
Pre-ICMIC Director and other ongoing organizational costs.  In addition, it would
be reasonable to select one or two Development projects as examples for estimated
salary support for investigators involved in the Development projects, costs
associated with equipment, supplies and core facilities designed to support the
Development projects.

Biographical Sketches and Other Support:

All applications should describe the scientific and administrative experience of
key personnel and should include and follow the PHS-398 form instructions for
Biographical Sketches and Other Support information.  In this case, key personnel
includes the Pre-ICMIC Director, each of the investigators identified as a
primary scientific leader, and each of the investigators involved with a
submitted Development project.


This section is to include a detailed description of the quality and variety of
scientific resources available to accomplish the scientific goals of the Pre-

RESEARCH PLAN (not to exceed a total of 45 pages):

A) Major Research Objectives (8-10 pages).

This section should concisely describe the Pre-ICMICs major research objectives,
and should include descriptions of each of the scientific areas to be involved
in the Pre-ICMIC, how they will be integrated, and the unique scientific
opportunities that will be addressed.  A description of the Director chosen to
lead the Pre-ICMIC is to include his or her scientific qualifications and a
demonstration of administrative and scientific leadership abilities.  For each
major scientific subdivision, an experienced investigator that will assume
responsibility within the Pre-ICMIC must be identified.  Senior investigators
must demonstrate a strong track record of scientific accomplishment, and a
willingness to effectively collaborate, and the application should clearly define
the role that each of these investigators will play in Pre-ICMIC activities.  For
each participating investigator, a short description of his/her ongoing research
and its potential relevance to the Pre-ICMIC is required.

B) Phase I:  Organizational Activities (8-10 pages)

This section should include an example (model) of an organizational structure for
the Pre-ICMIC.  This model will not be a final structure, since that will be
determined during Phase I.  Instead, applicants should provide a detailed
description of the activities that will take place during the Phase I period, and
examples of how each topic might be addressed in the Phase II.  Activities to be
completed during Phase I include:
a) finalization of an organizational structure of the Pre-ICMIC.  This structure
will include the establishment of relevant committees, composed of both internal
and external senior investigators, who will be responsible for the overall
scientific direction of the Program.
b) Establishment of ongoing, interactive, multidisciplinary activities, such as
seminars, workshops, forums, etc.
c) Determine the process for the selection, implementation, monitoring, and if
necessary, termination of Development projects to be initiated in Phase II (see
d) Definition of the core facilities necessary to support the scientific goals
of the Pre-ICMIC, how these core facilities will be maintained, how the decision
to add or terminate a core facility will be made, and how resources will be
allocated to the selected Development projects.
e) Since the P20 Planning Grants are designed to support the organization of a
multidisciplinary group, it is expected that the critical mass of investigators
already exists at the Institution.  Recruitment of one or two investigators in
defined scientific area(s) may be required.  If this is the case, applicants must
identify the particular scientific area(s), and describe and justify recruitment
plans in detail.

C) Phase II:  Development Projects (may not exceed 24 pages total)

When the P20 application is submitted, it must contain no more than six three-
page examples of possible Development projects to be implemented during Phase II. 
These projects should be geared toward determining project feasibility, proof of
principle and acquisition of preliminary data.  These Development studies must
demonstrate collaborative efforts between two or more groups of investigators,
with a focus on imaging technologies, and newly-established collaborations.  Each
of these examples should include:

1) Title
2) Investigator names, and areas of scientific expertise
3) Hypothesis and Specific Aim(s)
4) Background and Significance.  Included in this section should be a description
of the unique scientific opportunity made possible by this collaboration.
5) Research Design and Methods

D) Institutional commitment (1-2 pages)

Examples of Institutional support could be contribution to the support of
salaries and/or equipment and reagent purchases required by investigators during
the Phase II planning stage.  The Institution could also make a commitment to the
Program to provide common laboratory and/or administrative space, both during the
planning phase and in the event that a successful P50 grant is awarded.  If
recruitment of investigator(s) is necessary, the Institutions plans for this
effort, and clear demonstration of its commitment must be included.

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.  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.

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

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

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda MD  20892-7399
Rockville, MD  20850 (for express/courier service)

Applications must be received by July 23, 1999.  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.


Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the NCI.  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 NCI in
accordance with the review criteria stated below.  As part of the initial merit
review, a process may 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 Cancer Advisory Board.

Review Criteria

The five criteria to be used in the evaluation of grant applications are listed

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques 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 by the reviewers in assigning the
overall score weighting them as appropriate for each application.

1.  Significance.
- Does this application bring together sufficient expertise to address important
scientific problems?
- If the Pre-ICMIC is established, how will scientific knowledge be advanced?
- What will be the effect of the Pre-ICMIC on the concepts or methods that drive
this field?

2.  Approach.
- Is the conceptual organizational and operational framework reasonable?
- Is it well-integrated and appropriate to the aims of the project?
- Does the applicant acknowledge potential problem areas and consider alternative
- Does the proposed approach support the possibility of the Pre-ICMIC being ready
to compete for a P50 ICMIC Grant within the time frame of the proposed planning

3.  Innovation.
- Does the Pre-ICMIC employ novel approaches or methods for facilitating
scientific interaction?
- Do the proposed Development projects establish new, multidisciplinary
collaborations, and are the projects original and innovative?
- Does the Pre-ICMIC group challenge existing paradigms or develop new
methodologies or technologies?

4.  Investigators.
- Is the Pre-ICMIC Director and lead investigators appropriately trained and well
suited to the organizational and scientific responsibilities associated with this
- If there are plans to recruit investigator(s), are those plans reasonable and
necessary and can those efforts be completed in a timely manner, such that the
recruited investigator(s) can make meaningful contributions to the Pre-ICMIC?

5.  Environment.
- Is there evidence of significant commitment of the institution to fulfilling
the objectives of the Pre-ICMIC?
- Does the scientific environment in which the work will be done contribute to
the probability of success?
- If collaborative arrangements are proposed, is there a convincing demonstration
that these interactions will be consistent enough to meet the needs of the Pre-

The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders and
minorities and their subgroups as appropriate for the scientific goals of the
research and plans for the recruitment and retention of subjects; the adequacy
of plans for including children as appropriate for the scientific goals of the
research, or justification for exclusion; the provisions for the protection of
human and animal subjects; and the safety of the research environment.


Pre-ICMIC awards will be based primarily on the basis of scientific merit as
determined by peer review, availability of funds, and programmatic priorities.


Letter of Intent Receipt Date:  June 17, 1999
Application Receipt Date:       July 23, 1999
Review by NCAB Advisory Board:  February 2000
Anticipated Award Date:         March 1, 2000


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:

Anne E. Menkens, Ph.D.
Diagnostic Imaging Program
National Cancer Institute
Executive Plaza North, Suite 800
Bethesda, MD  20892
Telephone:  (301) 496-9531
FAX:  (301) 480-5785

Direct inquiries regarding referral issues to:

Ms. Toby Friedberg
Division of Extramural Activities
National Cancer Institute
6130 Executive Boulevard, Room 636, MSC-7399
Bethesda, MD  20892-7399
Rockville, MD 20850 (for express/courier service)
Telephone:  (301) 496-3428
FAX:  (301) 402-0275

Direct inquiries regarding fiscal matters to:

Ms. Carolyn Mason
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD  20892-7340
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 496-7800 ext 259


This program is described in the Catalog of Federal Domestic Assistance No.
93.394.  Awards are made under authorization of sections 301 and 405 of the
Public Health Service Act,  as amended by 42 USC 241 and 284 and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 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, 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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