[Federal Register Volume 62, Number 177 (Friday, September 12, 1997)]
[Notices]
[Pages 48065-48073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24225]


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DEPARTMENT OF ENERGY


Office of Environment, Safety and Health; Notice of Availability 
of Funds and Request for Applications To Deliver Special Medical Care 
in the Marshall Islands

AGENCY: Office of Environment, Safety and Health, Department of Energy.

ACTION: Request for applications.

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SUMMARY: The Department of Energy (DOE) Office of Environment, Safety 
and Health (EH) is requesting applications to provide special medical 
care to a specific group of citizens of the Republic of the Marshall 
Islands (RMI). This Notice of Availability of Funds and Request for 
Applications to Deliver Special Medical Care in the Marshall Islands is 
a follow-on to a more general, annual notice of potential availability 
of grants and cooperative agreements for epidemiology and other health 
studies published in the Federal Register on October 16, 1996.

DATES: The deadline for receipt of applications is October 27, 1997.

ADDRESSES: Applications may be submitted to Mr. Neil Barss at the U.S. 
Department of Energy, Office of International Health Programs, EH-63/
270CC, 19901 Germantown Road, Germantown, Maryland 20874-1290.

FOR FURTHER INFORMATION CONTACT: Requests for application forms, the 
additional program information described below, and any other requests 
for information in response to this Notice should be directed to Mr. 
Barss, U.S. Department of Energy, Office of International Health 
Programs, EH-63/270CC, 19901 Germantown Road, Germantown, Maryland 
20874-1290; telephone: (301) 903-4024; facsimile: (301) 903-1413; or 
email: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Purpose
III. Background
IV. Program Requirements
V. Applications
VI. Application Format and Instructions
VII. Application Review, Evaluation Criteria and Award Information
VIII. DOE's Role
IX. Applicants

I. Introduction

    A Draft Notice of Availability of Funds and Request for 
Applications for the Department of Energy Medical Program in the 
Republic of the Marshall Islands was published in the Federal Register 
on May 29, 1997 (62 FR 29125). A public meeting was held July 8, 1997 
to receive comments and questions on the Draft Notice. A Notice of 
Potential Applicant Visit to Honolulu, Hawaii, and the Republic of the 
Marshall Islands was published in the Federal Register on September 5, 
1997 (62 FR 46954). In addition, the following information will be made 
available in conjunction with the application forms:
    (1) A transcript of the public meeting;
    (2) Answers to questions of general interest raised at and 
submitted in written form after the public meeting;
    (3) The ``Memorandum Of Understanding Between The U.S. Army Space 
And Strategic Defense Command (USASSDC) U.S. Army Kwajalein Atoll/
Kwajalein Missile Range (USAKA/KMR) And The U.S. Department of Energy 
Office Of International Health Programs'';
    (4) A tabulation of DOE medical equipment used currently by 
Brookhaven National Laboratory and associated location and functional 
status;
    (5) Marshall Islands Medical Program reports provided to the U.S. 
Congress by DOE for the last five years;
    (6) A table illustrating distribution of DOE's Marshall Islands 
program budget for FY 1990 through FY 1997, which includes the DOE's 
special medical care program;
    (7) A list of predominant diseases observed in DOE patients by 
Brookhaven National Laboratory and the ICD-9 code associated with each 
disease;
    (8) The forms required by the Office of International Health 
Programs for budget planning, program progress and activity reporting, 
in addition to those specified in 10 CFR part 600; and
    (9) A report entitled, ``Medical Status of Marshallese Accidentally 
Exposed to 1954 Bravo Fallout Radiation: January 1988 through December 
1991'', DOE/EH-0493 and BNL-52470, July 1995.
    As noted above, DOE has arranged a site visit to Honolulu and the 
Republic of the Marshall Islands for potential applicants. Anyone who 
intends to participate in the site visit and has not contacted Mr. 
William Jackson for details and arrangements should do so immediately. 
Mr. Jackson can be reached by telephone at (808) 422-9211 or 422-9203, 
by facsimile at (808) 422-9217, or by e-mail at 
[email protected].

II. Purpose

    DOE provides a special medical care program for a specific group of 
RMI citizens in accordance with section 103(h) of the Compact of Free 
Association Act of 1985, as amended, which mandates that the United 
States ``shall continue to provide special medical care and logistical 
support thereto for the remaining * * * members of the population of 
Rongelap and Utrik [sic] who were exposed to radiation resulting from 
the 1954 United States thermonuclear `Bravo' test, pursuant to Public 
Laws 95-134 and 96-205.'' Section 104(a)(4) of Public Law 95-134, 
enacted in 1977, directed the Secretary of the Interior to provide for 
the populations residing on Rongelap and Utirik Atolls on March 1, 
1954, ``adequate medical care and treatment * * * of any radiation 
injury or illness directly related to the [''Bravo''] thermonuclear 
detonation * * *'' Section 104(a)(4) goes on to state that, ``The costs 
of such medical care and treatment shall be assumed by the 
Administrator of the Energy Research

[[Page 48066]]

and Development Administration,'' a precursor agency to DOE. Pursuant 
to this congressional mandate, DOE provides a special medical care 
program consisting of:
     Medical screening, diagnosis and treatment for radiation-
related diseases or illnesses (see Appendix A for definition) in an 
economically disadvantaged tropical environment in the central Pacific.
     Medical care and treatment of other diseases or illnesses 
as time and resources permit.
     Administrative management, cognizance and oversight of 
patients and patient records, clinical referrals and followups as 
medically appropriate.
    DOE is soliciting applications to provide medically appropriate 
care to the exposed population and a comparison group within applicable 
legal, financial and logistical constraints. By so doing, DOE is 
seeking ways to more effectively and efficiently deliver special 
medical care services in the Marshall Islands to an aging population. 
As used in this Notice, primary medical care means the community based 
medical services provided locally at each Atoll by medically trained 
individuals. Secondary medical care means those medical services 
provided at the U.S. Army Hospital at Kwajalein Atoll or by other 
providers, as described below. Tertiary medical care means medical 
services that are not currently available in the Marshall Islands and 
that must be provided to the patients outside the Marshall Islands.
    Subject to available funding, DOE intends to award one (1) 
cooperative agreement in support of the RMI special medical care 
program in FY 1998. The cooperative agreement award will be for a one 
(1) year budget period, and subject to available funding, may be 
negotiated and extended annually as continuation awards for up to four 
(4) additional years.
    The funding level for the implementation of the current DOE primary 
and secondary special medical care program is $1.1 million annually.

III. Background

    As a result of the 1954 United States' thermonuclear ``Bravo'' test 
in the Marshall Islands, approximately 253 Marshallese people 
(hereinafter referred to as patients) on Rongelap and Utirik Atolls 
were exposed to high levels of radioactive fallout. Since 1956, DOE and 
its predecessor agencies have provided medical care to these patients. 
Within DOE, this special medical care program is currently administered 
by the Office of International Health Programs for the Assistant 
Secretary for Environment, Safety and Health.
    Currently, there are three programs providing medical care in the 
RMI:
     The RMI Ministry of Health national medical care program 
for approximately 60,000 people.
    This care is delivered at primary and secondary care facilities on 
Ebeye and Majuro islands, with smaller facilities in the remote outer 
islands that function as first aid stations, providing limited primary 
care and pharmaceutical capabilities (see Appendix B for details). Two-
way radio is the primary means of inter-atoll communications, and 
medical emergencies are transported by air from the outer islands to 
Ebeye or Majuro.
     The 177 Health Care Program (177 HCP), described in 
section 103(j) of the Compact of Free Association Act of 1985 as the 
Four Atoll Health Care Program.
    This program provides medical care for the people of the Atolls of 
Bikini, Enewetak, Rongelap, and Utirik who were affected by the 
consequences of the 1946-1958 U.S. nuclear testing program in the 
northern Marshall Islands, and their descendants. The program is 
administratively overseen by the Department of the Interior (DOI), is 
funded by the U.S. Congress through the DOI, and is currently 
implemented by Mercy International, Inc., under contract to the RMI 
Ministry of Health. The program serves approximately 10,600 individuals 
(see Appendix C for additional details) and provides primary medical 
care, secondary care referrals to the hospitals at Ebeye and Majuro, 
and tertiary care referrals to the Queen's Medical Center and Group in 
Honolulu, Hawaii.
    Since 1986, DOE patients have been referred to the 177 HCP for 
primary and continued medical care during the time between Brookhaven 
National Laboratory screening visits and for non-radiation related 
disease or injuries. Currently, the 177 HCP has not been able to 
adequately meet all the medical needs of the DOE patients.
     The special medical care program provided by DOE to 
approximately 238 patients in the Rongelap and Utirik communities.
    DOE's special medical care program currently provides biannual 
medical screening visits and full medical care for radiation-related 
conditions for the remaining 131 members of the original patient 
population, as well as medical treatment for approximately 107 people 
in a comparison group. From the inception of DOE's program, medical 
treatment has been delivered biannually by teams consisting of 
Brookhaven National Laboratory (BNL) employees supplemented with 
volunteer medical specialists. Logistical support for DOE's special 
medical care program has also been provided by a contractor, which is 
currently Bechtel Nevada Corporation.
    In 1995, DOE transitioned from biannual vessel-based medical 
missions to biannual land-based medical missions located at Kwajalein 
Island. Vessel-based missions were handicapped by the inability to keep 
a vessel equipped with state-of-the-art medical equipment. The land-
based approach has improved the quality of medical care delivery for 
the patient populations in Rongelap and Utirik and will also effect 
cost efficiencies. This approach makes available at the U.S. Army 
Hospital on Kwajalein Island in the Marshall Islands secondary medical 
care facilities and more sophisticated diagnostic equipment and 
improved laboratory capabilities, for example: use of ultrasound 
equipment; ability to perform immediate fine needle aspiration or 
thyroid surgery; availability of certified mammography equipment and 
other medical equipment that permits immediate followup, additional 
tests, and surgery when needed.
    As with vessel-based care, the land-based system includes visits to 
infirm patients in their homes at Mejatto and Utirik. Land-based 
medical assets have also added the ability to provide full diagnostics 
and tests of samples taken right after the visit to these remote 
islands, rather than (as previously) shipping such samples for analysis 
to the U.S. mainland.
    Those DOE patients with medical conditions that can be effectively 
managed in the Marshall Islands are either treated by the BNL medical 
personnel at the U.S. Army hospital on Kwajalein Island or are referred 
to the 177 HCP. Those DOE patients with radiation-related medical 
findings that cannot be managed in the Marshall Islands are referred to 
Straub Hospital and Clinic in Honolulu for tertiary evaluation and 
medical treatment.
    In January 1997, the RMI requested the DOE to compete the current 
special medical care program due to problems being experienced by the 
177 HCP and the RMI's desire to have more of the allocated budget spent 
on medical care services rather than on logistical support services.

IV. Program Requirements

A. General

    Note: The terms ``application'' and ``proposal'' are used 
synonymously herein.


[[Page 48067]]


    (1) The awardee will be required to execute a special medical care 
program within DOE requirements and budget; provide continuity with the 
medical program conducted since 1956; and operate in a highly visible 
international political environment and under rigorous oversight by the 
U.S. Congress.
    (2) A Primary Application (see definition in section VI. A., 
herein) shall describe the applicant's approach to the primary and 
secondary clinical medical elements, as well as the other elements of 
the special medical care program identified in section IV.B. herein, 
based on a budget of $1.1 million annually over a 5-year period. In 
preparing applications to deliver DOE's special medical care program in 
the RMI, potential applicants should consider innovative ways to:
    (a) Provide full-time medical services in the Marshall Islands to 
the Rongelap and Utirik communities, sufficient to cover the medical 
needs of the affected Marshallese citizens.
    (b) Collaborate and coordinate medical care delivery with local 
Marshallese health care providers.
    (c) Use telemedicine and other electronic technologies that enhance 
professional communications and maximize cost savings.
    (d) Use recruited volunteer medical professionals to maximize cost 
savings.
    (e) Provide medical services as much as possible within the 
Marshall Islands, thus reducing the need for expensive tertiary medical 
referrals.
    (f) Use current DOE contractor, subcontractor and interagency 
support (i.e., Bechtel Nevada Corporation, the Straub Hospital and 
Clinic, and the U.S. Army Hospital at Kwajalein; see Appendices D, E, 
and F, respectively, for currently provided services).
    (3) In addition, the applicant may submit an Optional Application 
(see definition in section VI.A., herein) for an alternative approach 
to replace a part or all of the following being provided by current DOE 
providers:
    (a) Tertiary medical care services for an annual average of 13 
patients, and/or
    (b) Related logistical support for an annual average of 13 patients 
receiving tertiary medical care services, and/or
    (c) Related logistical support for the primary and secondary 
medical care services of all the DOE patients within the Marshall 
Islands. Such an application should be based on an annual budget that 
does not exceed $800,000.
    For example, in FY 1996, DOE spent $259,000 on 13 patient referrals 
to the Straub Hospital and Clinic. For each patient, this cost involved 
both the medical services provided at the Straub Hospital and Clinic 
and the concomitant logistical services provided by Bechtel Nevada 
Corporation. Examples of patient logistical support costs include, as a 
minimum, the following:
     Patient travel costs to and from his/her local atoll to 
Majuro Atoll;
     Patient travel costs to and from Majuro Atoll to the 
tertiary care facility located outside the RMI (currently Straub 
Hospital and Clinic);
     Patient travel costs to and from Kwajalein Atoll for the 
medical services currently provided at the U.S. Army Hospital;
     Marshallese translator salaries and travel costs and/or 
patient family member escort travel costs; and
     Associated lodging, meal, and living expenses incurred for 
all individuals while the patient is in transit or being treated at any 
location.

B. Project Description

    For the approximately 238 patients, whose general medical and 
demographic information is summarized in Appendix G, the awardee shall 
either itself implement or use subcontractors for the following special 
medical care program requirements:
The DOE Clinical Medical Program
    For this program element:
    (a) Conduct and implement a primary, secondary and tertiary 
clinical medical program for patients with radiation-related diseases 
and illnesses in a tropical and under-developed area of the world, 
together with the treatment of as much non radiation-related disease as 
medically indicated and as resources permit. The clinical medical 
program should be implemented by primary care medical professional(s) 
augmented by physicians with specialties including, but not limited to 
oncology, diagnostic radiology, gynecology, internal medicine, and 
endocrinology, as appropriate.
    (b) Provide the services of other medical specialists, as indicated 
by patient condition, including but not limited to the fields of: 
allergy/immunology, cardiology, dentistry, dermatology, emergency 
medicine, family practice, gastroenterology, geriatrics, hematology, 
infectious diseases and parasitology, nephrology, neurology, nuclear 
medicine, obstetrics, ophthalmology, pathology, physical medicine, 
pulmonary medicine, rheumatology, surgery, tropical medicine and 
therapeutic radiology.
    (c) Provide, in addition to the physician services specified in 
this section, nursing, pharmacy, radiology (including nuclear 
medicine), clinical laboratory, histology and pathology, inpatient, 
outpatient and technical medical support services.
    (d) Institute appropriate ethical safeguards to ensure patient 
informed consent in writing.
    (e) Provide appropriate gender medical personnel to accommodate 
Marshallese cultural sensitivities.
    (f) Conduct medical examinations in accordance with medical 
screening recommendations, published guidelines or standards (e.g., 
American Cancer Society, American College of Physicians, U.S. 
Preventive Services Task Force of the Department of Health and Human 
Services, etc.).
    (g) Provide radiology services that include:
    (1) Mammography utilizing a unit that is certified by the American 
College of Radiology and complies with U.S. Food and Drug 
Administration regulations.
    (2) Diagnostic equipment that has been inspected for radiological 
safety and approved for operation (e.g., chest x-ray, nuclear medicine 
imaging or therapy, mammography).
    (3) Therapy as clinically prescribed for the treatment of cancer.
    (h) Conduct examinations of the thyroid gland including:
    (1) Thyroid ultrasound measurements.
    (2) Palpation of the thyroid by a physician skilled in such 
technique.
    (3) Appropriate blood and chemistry tests of thyroid function 
(e.g., TSH, T3, T4).
    (i) Provide diagnostic and clinical laboratory services, as 
appropriate.
    (j) Utilize laboratory testing capabilities and services that 
comply with the requirements specified in the Clinical Laboratory 
Improvement Amendments of 1988 (documentation required).
    (k) Provide appropriate immunizations, as indicated by patient 
needs.
    (l) Provide pharmaceuticals, medical supplies or equipment based on 
the needs of the patients.
    (m) Provide pathological services for the identification of cancer.
Administrative Support
    For this program element:
    (a) Obtain insurance (and documentation thereof) for medical 
malpractice and comprehensive general liability, for $1 million per 
occurrence and $3 million aggregate for each insurance type for any 
U.S. licensed individual.
    (b) Implement non-medical administrative functions in support of 
the special medical care program, which shall at a minimum include the 
following:

[[Page 48068]]

    (1) Provision of non-medical personnel and administrative staff 
services to adequately support the medical personnel and services.
    (2) If the awardee intends to use DOE's contractors or the services 
of the U.S. Army Hospital at Kwajalein, the awardee will be required 
to:
    (i) Establish and maintain a working programmatic relationship with 
Bechtel Nevada Corporation.
    (ii) Establish and maintain a working programmatic relationship 
with the current secondary or tertiary referral facilities (U.S. Army 
Hospital at Kwajalein and Straub Hospital and Clinic in Honolulu). 
These services are currently provided pursuant to a Memorandum of 
Understanding between DOE and the U.S. Army Space and Strategic Defense 
Command at Kwajalein Atoll and a subcontract between Bechtel Nevada 
Corporation and Straub Hospital and Clinic, respectively.
    (3) As applicable, establish and maintain a working programmatic 
relationship with existing medical providers in the Marshall Islands 
and/or the 177 HCP (using the capabilities listed in Appendix C), to 
help implement the DOE special medical care program.
    (4) Provide current state-of-the-art methods for the consolidation, 
storage, management and retention of current and historical patient 
medical records and medical program operational records, which will 
include receipt of approximately 30 cubic feet of all hardcopy medical 
records, a similar volume of records compressed onto compact discs and 
an Oracle  database of current 
patients.
    (5) Protect the confidentiality of patient medical information and 
records.
    (6) Implement a continuing quality control and assurance program 
for all clinical medical and recordkeeping aspects of the program 
necessary to maintain compliance with applicable medical standards.
    (7) Develop and implement a transition phase with Brookhaven 
National Laboratory.
Direct Marshallese Involvement
    For this program element:
    (a) Interface, establish and maintain a working relationship with 
Marshallese appointed spokespersons and/or citizen advisory committees 
in the Rongelap and Utirik communities to:
    (1) Consult and inform before implementing any changes in the DOE 
special medical care program.
    (2) Establish a regular process that receives community and patient 
input and feedback on DOE special medical care program activities.
    (3) Consider Marshallese patient concerns and recommended 
improvements in the special medical care delivery;
    (4) Work with DOE to accommodate Marshallese concerns and 
improvements within a framework of DOE's legal mandate, funding and 
sound medical practice.
    (b) Develop and implement a Rongelap and Utirik community health 
outreach educational program that:
    (1) Develops educational materials (e.g., videotapes, brochures 
and/or handouts) that include DOE and Marshallese community 
representative input, to be used by health care providers that strive 
to accentuate awareness of, increase sensitivity to, and accommodate 
Marshallese traditional perceptions and attitudes towards the practice 
of ``Western-style'' medicine in the Marshall Islands.
    (2) Helps patients and their family members learn about the special 
medical care program activities and findings by preparing, distributing 
and explaining the annual medical activity report, which is required to 
be sent to DOE.
    (3) Utilizes Marshallese public health educational materials and 
brochures.
    (4) Develops public health and educational materials (e.g., 
handouts, brochures or videotapes) for Marshallese use that describes 
the types of special medical care being provided by the awardee.
    (5) Advises on the known relationships between radiation dose and 
health effects.
    (c) Develop and implement a training program for Marshallese 
medical and para-medical, and/or technical support professionals for 
the special medical care program that includes:
    (1) A needs assessment as to the types and number of professionals 
(physicians, physician assistants, nurses, support-service 
technicians).
    (2) Means to provide training and ``on-the-job'' practical 
experience in the Marshall Islands.
    (3) Consideration of available regional educational resources to 
meet these objectives.
    (d) Develop and implement a plan to build an infrastructure in the 
Marshall Islands for the special medical care program including:
    (1) Partnerships with local health care providers.
    (2) Facilitating the training of Marshallese health care 
professionals.
    (3) Acquisition, use, and maintenance of medical equipment.
Development of Procedures and Documentation
    The awardee will be required to provide the following:
    (a) Written protocol(s) and/or manuals describing procedures and 
associated forms to be used by the medical professionals for medical 
examinations, patient referrals, and overall administrative 
implementation of the special medical care program that includes:
    (1) Identities, qualifications, and biographies of medical or 
medical program experience for all persons providing medical, 
technical, nursing, and administrative support services.
    (2) The awardee's selection and qualification criteria for all 
personnel who will participate in or implement the program.
    (3) Involvement of local Marshallese medical, health, and support 
personnel, including:
    (i) Participation of medical and other health care or technical 
professionals.
    (ii) As applicable, selection and qualification criteria by which 
these personnel will be made eligible to participate.
    (iii) Provision of bilingual Marshallese/English speaking 
individuals for adequate communication, translation and the 
interpretation of examination results, and meaning between the patients 
(or their designated guardians) and the medical care providers.
    (4) Frequency and types of patient examinations.
    (5) Method(s) of patient examinations and treatments that afford 
personal privacy.
    (6) Method(s) by which patient informed consent and medical release 
will be obtained for any medical examination or treatment modality in a 
way that ensures patient understanding in Marshallese.
    (7) As applicable, method(s) by which a special medical care 
program physician will interface with existing medical care providers 
in the Republic of the Marshall Islands or the Pacific region and 
provide tertiary medical referrals as needed.
    (8) Method(s) by which medical services will be provided to those 
patients (currently, approximately 25) who habitually reside in the 
United States, such as other medical care insurance options in lieu of 
awardee provided medical services.
    (9) Method(s) by which the program referring physician will consult 
with and remain continually cognizant of the medical condition and 
results of a patient referred to another medical

[[Page 48069]]

professional or organization identified in items (7) or (8).
    (10) Method(s) to inform all patients (or their designated 
guardians) in Marshallese of individual medical results and any 
additional followup actions necessary.
    (11) Method(s) by which pharmaceuticals will be obtained, 
inventoried, managed, and dispensed.
    (12) Method(s) for retaining, storing, maintaining, or releasing 
(to honor a lawful request), patient tissue samples and specimens used 
for pathological classification of disease.
    (13) As applicable, method(s) by which the awardee will implement 
the working programmatic relationships with any current DOE provider of 
services or regional health care provider.
    (b) An annual summary report (in English and Marshallese) on the 
following:
    (1) Program activities, medical conditions, and statistical 
analyses of the findings.
    (2) Number of individuals remaining in the patient and comparison 
populations.
    (3) The overall health of the two populations and the 
identification of any special risks to their health.
    (4) Identification of all medical, nursing, technical 
practitioners, and support personnel that performed provider services.
    (5) Identification of patient related medical problems with 
recommendations for improvement or resolution.
    (6) Progress made on strategic plan initiatives.
    (7) Recommendations to improve programmatic functions.
    (c) A strategic plan that proposes and details ways to advance the 
special medical care program to:
    (1) Achieve partnership and coordination with the RMI medical and 
health care organizations.
    (2) Evolve medical partnerships and coordinate the awardee's 
resources, to the greatest extent possible, with local Marshallese or 
other U.S. Federal resources, to advance the DOE's special medical care 
program as follows:
    (i) Strengthen local health care delivery.
    (ii) Involve local personnel in medical activities.
    (iii) Share new skills and technical knowledge.
    (iv) Strengthen local land-based assets, such as radiologic, 
pathologic, and laboratory support services.
    (3) Maintain a cost effective special medical care program as the 
patient population ages and incurs greater needs for medical services.
Cost and Reporting Requirements
    (a) The awardee shall implement cost containment measures, 
maximization of financial savings, and negotiation of subcontracted 
services to maintain a high quality special medical care program in 
accordance with DOE budgetary constraints. At a minimum, the cost 
reporting requirements that will be required under the cooperative 
agreement will include, but not be limited to providing:
    (1) Budget, financial and programmatic activity reports. The 
contents and formats are to be specified and revised as necessary by 
DOE.
    (2) A monthly report of all program expenditures.
    (3) Fiscal planning and budget information in the format prescribed 
by DOE.
    (4) A separate itemized price list (detailing both direct and 
indirect costs) for all clinical medical examinations, treatments, 
services, or supplies to conduct and implement the special medical care 
program.
    (5) A separate itemized price list for the direct and indirect 
medical program and non-clinical administrative and program management 
aspects, salaries, and supplies for the proposed support services.
    (6) A separate itemized price list for any service that is 
anticipated to be subcontracted.
    (7) A separate itemized price list for any capital equipment that 
must be purchased to implement the special medical care program.
    (8) The formula or estimated cost for each of the following non-
priced listed items:
    (i) Special DOE requests (e.g., record duplication, statistical 
analysis of medical findings, special topical reports in response to 
RMI or congressional inquiries).
    (ii) Non-stocked medical or administrative items and supplies.
    (iii) Cost of any other service or expense that the provider 
intends to charge but does not appear on a price list.

V. Applications

    This Notice of Availability of Funds and Request for Applications 
is issued pursuant to DOE regulations contained in 10 CFR part 602: 
Epidemiology and Other Health Studies Financial Assistance Program, as 
published in the Federal Register on January 31, 1995 (60 FR 5841). The 
Catalog of Federal Domestic Assistance number for 10 CFR part 602 is 
81.108, and its solicitation control number is EOHSFAP 10 CFR part 602. 
10 CFR 602 contains the specific requirements for applications, 
evaluation, and selection criteria, except as modified herein. Only 
those applications complying with the criteria and using the forms 
specified in 10 CFR 602 will be considered. Application forms may be 
obtained at the address previously cited. Applications will be peer 
reviewed by evaluators apart from DOE employees and contractors as 
described under section 10 CFR 602.9(c) and in section VII. of this 
Notice, and submission of an application constitutes agreement that 
this is acceptable to the care provider(s) and the submitting 
organization.

VI. Application Format and Instructions

A. General

    An application shall contain a proposal for the following:
     The primary and secondary clinical medical program;
     The other elements of the special medical care program 
(i.e., administrative support, direct Marshallese involvement, the 
development of procedures and documentation, the cost and reporting 
elements);
     Any proposed replacement for part or all of the secondary 
medical services provided at the U.S. Army Hospital on Kwajalein Island 
in the Kwajalein Atoll.
    For the purposes of this Notice, the proposal containing the above 
components will be referred to as the Primary Application and shall 
contain two volumes, one providing technical details and the other the 
costs.
    In addition, an Optional Application may be submitted for an 
alternative approach to replace a part or all of the following being 
provided by current DOE providers:
     Tertiary medical care services for an annual average of 13 
patients, and/or
     Related logistical support for an annual average of 13 
patients receiving tertiary medical care services, and/or
     Related logistical support for the primary and secondary 
medical care services of all the DOE patients within the Marshall 
Islands.
    The Optional Application shall also contain two volumes, one for 
the technical details and the other for the cost. The technical volumes 
for both the Primary and Optional Applications shall be:
     No more than one hundred (100) pages in length;
     One-sided, 12-point font size; and
     Submitted in black and white.
    Resumes of key personnel should be submitted as an appendix to the 
technical application(s) and will not be

[[Page 48070]]

counted against the page limit. Cost proposal volume(s) have no page 
limit and either one or both application(s) will be structured to 
include a five (5) year project period consisting of five one (1) year 
budget periods.
    The application(s) shall not merely offer to perform work in 
accordance with the program requirements but shall outline the actual 
work proposed as specifically as possible.

B. Specific Application Instructions

    All applicants must submit a Primary Application for the special 
medical care program, as described herein, based on a budget of $1.1 
million annually over a 5 year period. An Optional Application for an 
alternative approach as described herein may also be submitted, based 
on a budget that does not exceed $0.8 million annually over a 5-year 
period. If an Optional Application is not submitted, the DOE will 
assume that the applicant plans to utilize the current DOE provider 
logistical support, and the secondary and tertiary medical care 
services referenced herein. However, an applicant can propose in the 
Primary Application any replacement for the secondary medical services 
currently provided at the U.S.Army Hospital at Kwajalein Island (see 
paragraph (1)(n), as follows).
    (1) The technical volume of the Primary Application must include 
technical details and information that:
    (a) Demonstrate that the applicant has the experience and 
capability to plan, organize, implement, and manage the primary and 
secondary medical care services and all the other elements of the 
special medical care program described herein. This includes 
organizational structure, plans for self-assessment of the special 
medical care program, and envisioned relationship with DOE.
    (b) Demonstrate the competency of the applicant's personnel and the 
adequacy of its resources.
    (c) Identify technical and administrative staff, and detail their 
professional experience, as well as their level of program involvement. 
In the event that any of the proposed personnel are not currently 
employed by the applicant, letters of commitment from those individuals 
shall be submitted.
    (d) Itemize the medical diagnostic or laboratory equipment that the 
applicant intends to use for this special medical care program, and how 
the applicant will integrate such equipment with the Federal Government 
owned equipment listed in Appendix H.
    (e) Specify the location(s) where services will be obtained or 
performed.
    (f) Identify the recommendations or standards to be used to satisfy 
the requirements of section IV.B., paragraph (f) under the special 
medical care program element, DOE Clinical Medical Program, and any 
reason for exception(s) taken by the applicant to those standards.
    (g) Contain initial concepts for the training program development 
requirements of paragraph (c) under the special medical care program 
element, Direct Marshallese Involvement.
    (h) Contain initial concepts for the development and implementation 
of the applicant's plan to meet the Marshall Islands infrastructure 
requirements of paragraph (d) under the special medical care program 
element, Direct Marshallese Involvement.
    (i) Contain a short-term plan detailing milestones and deadlines 
stating:
    (i) Applicant's requirements for a transition phase with Brookhaven 
National Laboratory.
    (ii) When independence will be achieved to implement all elements 
of the special medical care program.
    (j) Contain initial concepts for the strategic plan required by 
paragraph (c) under the special medical care program element, 
Development of Procedures and Documentation, that includes milestones 
and deadlines for implementation.
    (k) Provide evidence of medical malpractice insurance for any 
individual licensed in the United States, required by paragraph (a) 
under the Administrative Support element of the special medical care 
program.
    (l) Provide applicant's plan to obtain malpractice insurance for 
any non-U.S. health care provider that the applicant intends to hire or 
provide.
    (m) Propose a plan to provide medical care services and associated 
logistical support for those Marshallese patients who do not habitually 
reside in the Marshall Islands.
    (n) Identify and propose, if the applicant desires, a replacement 
for any or all of the secondary medical care services provided at the 
U.S. Army Hospital on Kwajalein Island.
    (2) The cost volume of the Primary Application must include the 
following information that:
    (a) Provides a cost proposal for the first budget period year (year 
1) detailing expenses to implement the following:
    (i) The primary and secondary medical services of the DOE Clinical 
Medical program element of the special medical care program;
    (ii) The Administrative Support element of the special medical care 
program;
    (iii) The Direct Marshallese Involvement element of the special 
medical care program;
    (iv) The Development of Procedures and Documentation element of the 
special medical care program;
    (v) Establishment and maintenance of a working relationship with 
DOE providers of medical and logistics services;
    (vi) The medical care services, in combination with associated 
logistical support, for those Marshallese patients who do not 
habitually reside in the Marshall Islands;
    (vii) The costs to replace any or all of the secondary medical 
services currently provided at the U.S. Army Hospital on Kwajalein 
Island; and
    (viii) The identification and magnitude of any other cost the 
applicant intends to charge.
    (b) Contains estimated cost information supporting the applicant's 
special medical care project description for budget years 2 through 5.
    (3) If an Optional Application is submitted, the applicant shall 
demonstrate its approach to replacing the logistical support for the 
primary and secondary clinical medical program in the Marshall Islands, 
and/or the approach to replacing the tertiary medical care for an 
annual average of 13 patients currently provided by Straub Hospital and 
Clinic, as specified in Appendix E, and/or the logistical support of 
such tertiary medical care for the annual average of 13 patients. The 
technical volume of the Optional Application must include the following 
information that:
    (a) Demonstrates that the applicant has the experience and 
capability to plan, organize, implement, and manage the tertiary 
medical care services and logistical support requirements. This 
includes organizational structure, plans for self-assessment of the 
special medical care program, and envisioned relationship with DOE.
    (b) Demonstrates the competency of the applicant's personnel and 
the adequacy of its resources.
    (c) Identifies technical and administrative staff, and details 
their professional experience, as well as their level of program 
involvement. In the event that any of the proposed personnel are not 
currently employed by the applicant, letters of commitment from those 
individuals shall be submitted.
    (d) Itemizes the medical diagnostic or laboratory equipment that 
the applicant intends to use for tertiary medical care

[[Page 48071]]

services, and how the applicant will integrate such equipment with the 
Federal Government owned equipment listed in Appendix H.
    (e) Specifies the location(s) where tertiary medical care services 
will be obtained or provided. The applicant is free to propose tertiary 
referral locations of its choosing within or outside of the Marshall 
Islands.
    (f) Identifies the standards to be used to satisfy the requirements 
of section IV.B., paragraph (f) under the special medical care program 
element, DOE Clinical Medical Program, and any reason for exception(s) 
taken by the applicant to those standards.
    (g) If applicable, contains initial concepts for any tertiary 
medical care training program development requirements of paragraph (c) 
under the special medical care element, Direct Marshallese Involvement. 
This also includes any proposal to use local Marshallese individuals or 
companies to perform logistical support requirements.
    (h) Contains initial concepts for the development and 
implementation of the applicant's plan to meet the infrastructure 
requirements of paragraph (d) under the special medical care element, 
Direct Marshallese Involvement.
    (i) Contains a short-term plan detailing milestones and deadlines 
stating:
    (i) If applicable, applicant's requirements for a transition phase 
with Straub Hospital and Clinic and Bechtel Nevada Corporation,
    (ii) When independence will be achieved to implement all elements 
of the tertiary medical care services and the associated logistical 
requirements.
    (j) Contains initial concepts for the strategic plan required by 
paragraph (c) under the special medical care program element, 
Development of Procedures and Documentation, that includes milestones 
and deadlines for long-term implementation of any proposals to replace 
the tertiary medical and associated logistical support services.
    (k) Provides evidence of medical malpractice insurance for any 
individual licensed in the United States, required by paragraph (a) 
under the Administrative Support element of the special medical care 
program.
    (l) Provides applicant's plan to obtain malpractice insurance for 
any non-U.S. health care provider that the applicant intends to hire or 
provide.
    (4) The cost volume of the Optional Application must include the 
following information that:
    (a) Provides a cost proposal for the first budget period year (year 
1) detailing expenses to implement the following:
    (i) Tertiary medical care services for an annual average of 13 
patients, and/or
    (ii) Logistic support for an annual average of 13 patients 
receiving tertiary medical care services, and/or
    (iii) Logistic support for the primary and secondary medical 
services of all the DOE patients provided in the Marshall Islands.
    (iv) The identification and magnitude of any other tertiary medical 
service or logistical support cost the applicant intends to charge.
    (b) Contains estimated cost information supporting the applicant's 
special medical care program project description for budget years 2 
through 5.

VII. Application Review, Evaluation Criteria and Award Information

    Primary Applications will be subject to merit review (peer review) 
and will be evaluated against the following criteria, all of which are 
of equal importance. The peer review will be conducted by the Division 
of Research Grants (DRG) of the National Institutes of Health (NIH), 
utilizing standard NIH peer review procedures. The following criteria 
constitute a single case deviation from the Office of Environment, 
Safety and Health's merit review system (57 FR 55524, November 25, 
1992) and EH's program rule at 10 CFR 602.
    (a) The medical and technical merit of the proposed special medical 
care program.
    (b) The appropriateness of the proposed program.
    (c) Competency of the program personnel.
    (d) Organizational structure, plans for self-assessment and 
envisioned relationship with DOE.
    (e) Adequacy of equipment and associated physical resources.
    (f) Reasonableness and appropriateness of the proposed budget.
    In accordance with 10 CFR 602.9(e) and 10 CFR 600.8(c)(13), a 
program policy factor which DOE will consider in making an award is the 
merit of an applicant's Optional Application for an alternative 
approach to the provision of logistics for primary and secondary 
medical care services and the tertiary medical care services and 
associated logistic services as addressed in the ``Specific Application 
Instructions'' (see section VI., B, paragraphs (3) and (4)). The NIH 
will conduct the peer review and score any Optional Application using 
the identical procedure for evaluating the Primary Application. 
However, the resulting score will not be added to the applicant's score 
for the Primary Application, because the merit of the Optional 
Application is a program policy factor. The DOE selecting official will 
give the Primary Application predominant consideration, with lesser 
consideration being accorded the Optional Application.
    The resulting award may be for the Primary Application only, or for 
the Primary Application and all or any part of the Optional 
Application. An award will not be made for only an Optional 
Application.
    One cooperative agreement will be awarded for the first budget year 
only and may be negotiated and extended annually as continuation awards 
for up to four (4) additional years based on the following:
     Availability of appropriated funds;
     The awardee's continuation application, which will be 
submitted not later than 120 days before the end of each budget period, 
and
     The results of the DOE evaluations of the awardee's 
performance as described in section VIII., below.

VIII. DOE's Role

    In order for DOE to maintain appropriate oversight of the special 
medical care program, there must be substantial interaction between DOE 
and the awardee. DOE established the core requirements for this program 
and prepared this Notice of Availability of Funds and Request for 
Applications. DOE will conduct the selection and award process, which 
will include evaluations by persons outside the Federal Government. DOE 
will utilize the results of these evaluations and make one initial 
award. Continuation awards may be made based upon the availability of 
funds and other DOE performance criteria that will be set forth in any 
initial award. DOE will consult with program medical professionals and 
will coordinate meetings between medical care provider(s) and 
Marshallese community members. DOE will consult with representatives 
from the RMI national and local governments, the Department of the 
Interior, the Department of State and the Department of Health and 
Human Services on the special medical care program. To help evaluate 
program effectiveness, DOE will establish a program coordination 
committee as part of the cooperative agreement consisting of 
representatives from the awardee's organization, the DOE contracting 
office, the DOE Office of International Health Programs, and the 
Rongelap and Utirik communities. This committee will meet on a semi-
annual basis at a mutually agreed location.

[[Page 48072]]

    Finally, DOE will monitor and evaluate the performance and delivery 
of the special medical care program by conducting program reviews and 
considering the patients' level of satisfaction.

IX. Applicants

    Applicants for the cooperative agreement could include domestic or 
international nonprofit and for profit organizations, universities, 
medical centers, state or local government health care organizations, 
labor unions and other employee representative groups, small, minority 
and/or women-owned businesses, or other domestic or international 
health care organizations. Consortiums of interested organizations are 
encouraged to apply. Awardee(s) for the special medical care program 
will work cooperatively with Marshallese health care providers, current 
DOE providers (as applicable), other regional health care providers and 
designated Marshallese community representatives.

    Issued in Washington, D.C., on September 8, 1997.
Paul J. Seligman,
Deputy Assistant Secretary for Health Studies.

Appendix A--Definition of Radiation Related Diseases or Illnesses

    For the purposes of this Notice, applicants shall consider the 
following to be radiation related diseases or illnesses:
    (a) Any thyroid cancer, other tumor or thyroid nodule that has 
been found as a result of medical evaluation.
    (b) In accordance with the ``Radiation Exposure Compensation 
Act'', 42 U.S.C. 2210 note, the following are considered latently 
expressed diseases attributed to radiation:
    (1) Leukemia (other than chronic lymphocytic leukemia).
    And the following diseases, provided onset was at least 5 years 
after the first exposure to radiation:
    (2) Multiple myeloma.
    (3) Lymphomas, other than Hodgkin's disease.
    (4) Primary cancer of the thyroid, provided that the initial 
exposure occurred by age 20.
    (5) Primary cancer of the female breast, provided that the 
initial exposure occurred prior to age 40.
    (6) Primary cancer of the esophagus, provided low alcohol 
consumption and not a heavy smoker.
    (7) Primary cancer of the stomach.
    (8) Primary cancer of the pharynx, provided not a heavy smoker.
    (9) Primary cancer of the small intestine.
    (10) Primary cancer of the pancreas.
    (11) Primary cancer of the bile ducts.
    (12) Primary cancer of the gall bladder.
    (13) Primary cancer of the liver, except if cirrhosis or 
hepatitis B is indicated.

Appendix B--RMI Medical Program Information

    Available RMI medical facilities and services include:
    (a) Local dispensaries at Utirik and Mejatto provide limited 
medicine and first aid, and are staffed by medical personnel with 
MEDEX level training and experience (i.e., between a regional nurse 
and nurse-practitioner). Short-wave radio communications are 
maintained between the dispensaries and the off-island medical 
health care providers (up to 300 miles distant) to discuss serious 
medical conditions.
    (b) A small 34 bed community hospital is available with limited 
capabilities in a community of 12,000 living on Ebeye (an island of 
approximately 4 square miles located 2 miles from Kwajalein Island 
where the U.S. Army contractor-operated hospital facility that 
serves the base personnel is located).
    (c) A 75 bed hospital is available with limited capabilities to 
serve 29,000 living on the capital island of Majuro. This hospital 
also receives referrals from the entire national population of 
60,000.

Appendix C--The RMI 177 Health Care Program (HCP)

    For the DOE patients:
    (a) Currently implements DOE patient care in absence of 
Brookhaven National Laboratory.
    (b) Provides all non radiation-related care of DOE patients.
    (c) Provides access to DOE patient records.
    For the non-DOE patients:
    (a) Provides general medical care for the people of Rongelap, 
Utirik, Enewetak, and Bikini.
    (b) Serves a total population of approximately 10,600 (which 
includes the 238 DOE patients)
    (c) Refers its tertiary patients to the Queen's Medical Center 
and Group in Honolulu, Hawaii.

Appendix D--Bechtel Nevada Corporation Logistical Capabilities to 
Support DOE'S Special Medical Care Program

    (a) Provides all logistics to transport and support medical 
program personnel to the Marshall Islands twice a year, which is 
currently limited to travel, lodging and per diem costs west of 
Honolulu.
    (b) Provides all logistics to transport and support ambulatory 
patients and their authorized medical escorts to medical facilities 
at Kwajalein.
    (c) Provides all logistics to transport medical personnel for 
subsidiary home visits to non-ambulatory infirm patients at Mejatto, 
Ebeye, Utirik, and Majuro.
    (d) Provides transportation and support to RMI medical personnel 
assigned to participate in the DOE special medical care program.
    (e) Operates and provides all logistics and support services for 
patients referred to the Straub Hospital and Clinic located in 
Honolulu, Hawaii, by Brookhaven National Laboratory. The services 
provided include:
    (1) Bilingual Marshallese/English speaking escorts to accompany 
patients.
    (2) Coordination of patient travel and medical appointment 
schedules.
    (3) Lodging and per diem arrangements and expenses.
    (4) Coordination between Brookhaven National Laboratory and the 
Straub Hospital and Clinic on medical services, as required.
    (f) Conducts market research on the availability of marine 
assets in the U.S. and Central Pacific Area to support a limited, 
sea-based medical program.
    (g) Issues and monitors the Straub Hospital and Clinic medical 
services subcontract.
    (h) Implements terms and conditions, including the making of 
payments and collections under DOE's agreements with other agencies, 
and instrumentalities of the RMI.
    (i) Implements requirements as directed by DOE during the course 
of the year.
    (j) Interfaces and coordinates with the U.S. Army at Kwajalein 
Island to provide the following in accordance with a Memorandum of 
Understanding between DOE and the U.S. Army:
    (1) Marine craft (currently a LCU) used to transport patients to 
and from Mejatto.
    (2) Hospital services as delineated in Appendix F.
    (3) Trailer rentals for medical use (currently 2, each 660 
square feet).
    (4) Housing, lodging, and dining facilities for patients and 
medical team members.
    (5) Maintenance of facilities and equipment.
    (6) Aircraft services limited to within Kwajalein Atoll at no 
cost.
    (7) Automotive services used to transport patients at Kwajalein 
Island.
    (8) Recreational services for medical team use.
    (9) Public services used to announce medical team activities at 
Kwajalein Atoll.
    (10) Ferry services between Kwajalein and Ebeye Islands at no 
cost.

Appendix E--Services Provided by the Straub Hospital and Clinic Located 
in Honolulu, Hawaii

    (a) Complete and comprehensive medical services for DOE patients 
that have radiation-related diseases, including but not limited to, 
nuclear medicine diagnostic imaging and techniques, diagnostic and 
radiation therapy facilities, chemotherapy, pathological and 
advanced surgical services.
    (b) Refers diseases diagnosed as non radiation-related back to 
the 177 HCP.
    (c) Provides certified and accredited medical personnel.
    (d) Provides price list as basis for charges.

    Note: Straub Hospital and Clinic is accredited by the Joint 
Commission for Accreditation of Health Care Organizations.

Appendix F--Secondary Medical Services Provided by U.S. Army Hospital 
on Kwajalein Island in the Kwajalein Atoll in the RMI

    In accordance with the Memorandum of Understanding between DOE 
and the U.S. Army, the following medical services are provided at 
the U.S. Army Hospital on Kwajalein Island:
    (a) Laboratory Services.
    (b) Mammography Screening.
    (c) X-ray Screening.
    (d) Proctosigmoidoscopy.
    (e) Limited Surgery (e.g., appendectomy, amputations for 
advanced diabetic conditions).

[[Page 48073]]

    (f) Professional Services (physicians, nurses, technicians).
    (g) Safety inspection and certification of mammography and x-ray 
equipment by Trippler Army Hospital technical staff.
    (h) Inpatient care and treatment.

    Note: Brookhaven National Laboratory is responsible to ensure 
that proper and current certification for the special medical 
equipment and services are in place prior to receiving services.

Appendix G--DOE Special Medical Program Information

1. Summary of Clinical Findings

    After 41 years of medical monitoring, the most prevalent health 
effect has been related to thyroid function and the appearance of 
thyroid-related nodules and cancer. There has been one case and 
death due to radiation-related leukemia, two pituitary tumors and 
two cases of basal cell carcinoma. The major non radiation-related 
diseases seen in the Rongelap and Utirik people have been Type II 
diabetes, hypertension, cardiovascular diseases, and their 
associated complications.
    The above information has been summarized from the report 
entitled, ``Medical Status of Marshallese Accidentally Exposed to 
1954 Bravo Fallout Radiation; January 1988 Through December 1991,'' 
by Brookhaven National Laboratory/Department of Energy, DOE/EH0493 
and BNL-52470, July 1995.

2. Patient Population Description

------------------------------------------------------------------------
                       Age range                          Male    Female
------------------------------------------------------------------------
30-39.................................................        1        1
40-49.................................................       57       59
50-59.................................................       28       35
60-69.................................................       15       19
70-79.................................................        8       12
80+...................................................        1        2
------------------------------------------------------------------------

3. Summary of Patient Location

    Patients in the Rongelap and Utirik populations are combined in 
the table below and represent approximate estimates of total 
patients in each location:

------------------------------------------------------------------------
                   Location                     Female    Male    Total 
------------------------------------------------------------------------
Ailinglaplap.................................        1        1        2
Ailingnae....................................        2        0        2
Arno.........................................        1        0        1
Ebeye........................................       40       33       73
Hawaii.......................................        9        4       13
Kili.........................................        1        0        1
Lib..........................................        1        0        1
Mainland USA.................................        4        2        6
Majuro.......................................       41       46       87
Mejatto......................................       19       12       31
Mejit........................................        1        1        2
Ujae.........................................        1        1        2
Unknown......................................        1        0        1
Utirik.......................................        6        8       14
Wotje........................................        1        1        2
                                              --------------------------
    Total....................................      129      109      238
------------------------------------------------------------------------

Appendix H--DOE Equipment Used by Brookhaven National Laboratory

(a) Johnson & Johnson
Ektachem DT60 II-DTSC II Module Chemistry Analyzer
K-Number 339 4116, Serial Number 60029378
(b) Kodak-Ektachem DT60 DTSC Module Chemistry Analyzer
K-Number 337 0137
(c) Ektachem DT60 Module Chemistry Analyzer
K-Number 322 1695
(d) Calposcope
(e) Ultramark 4 Plus with transducers
(f) Nikon Microscope
(g) Sereno Baker 9118c Blood Analyzer Machine
(h) Ektachem DT60II System
(i) Biorad Micromat Model 415
(j) Beckman TJ6 Centrifuge
(k) Portable defibrillator
(l) Hoag-Streit Slip Lamp system
(m) Sun computer workstation

[FR Doc. 97-24225 Filed 9-11-97; 8:45 am]
BILLING CODE 6450-01-P