[Federal Register Volume 60, Number 89 (Tuesday, May 9, 1995)]
[Notices]
[Pages 24636-24638]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-11416]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA-225-94-6000]
Memorandum of Understanding Between the Food and Drug
Administration, the Uniformed Services University of the Health
Sciences, and the National Naval Medical Center
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA, the Uniformed Services
University of the Health Sciences, and the National Naval Medical
Center. The purpose of the MOU is to establish an agreement in support
of a clinical investigation program study entitled ``Prevention of
Photochemical Retinal Injuries During Extracapsular Cataract Surgery.''
[[Page 24637]] DATES: The agreement became effective August 19, 1993.
FOR FURTHER INFORMATION CONTACT: Sandy Cordes, Center for Devices and
Radiological Health (HFZ-20), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-3516.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and memoranda of understanding
between FDA and others shall be published in the Federal Register, the
agency is publishing notice of this memorandum of understanding.
Dated: May 2, 1995.
William B. Schultz,
Deputy Commission for Policy.
Memorandum of Understanding Between Uniformed Services University of
the Health Sciences and Food and Drug Administration and the National
Naval Medical Center, Bethesda, Maryland
I. General
A. The National Naval Medical Center, Bethesda, Maryland, herein
referred to as the Naval Activity, has established this agreement
for the purpose of conducting clinical investigation in support of
education and training and patient care. This program requires
collaboration with Uniformed Services University of the Health
Sciences, Bethesda, Maryland and the Food and Drug Administration,
Rockville, Maryland.
B. It is mutually beneficial to the Naval Activity and to the
Uniformed Services University of the Health Sciences and the Food
and Drug Administration to allow physicians, dentists, and other
support personnel to participate in Navy patient care and research
to enhance the quality of patient care and to contribute to their
education and training. This agreement is in support of a Clinical
Investigation Program study entitled ``PREVENTION OF PHOTOCHEMICAL
RETINAL INJURIES DURING EXTRACAPSULAR CATARACT SURGERY.''
II. Understanding
A. Insofar as the Commander deems it appropriate and consonant with
this command's basic mission, the Naval Activity will:
1. Provide that all research to be conducted at the Naval
Activity will be reviewed and approved in accordance with applicable
National Naval Medical Center, Health Sciences Education and
Training Command, Chief, Bureau of Medicine and Surgery, Secretary
of the Navy, and Department of Defense instructions.
2. Appoint personnel, as deemed appropriate, to participate in
clinical investigation in accordance with Federal Personnel Manual
(FPM), chapter 213 (appendix C), chapter 53; FPM Supplement 990-1
(subchapter IV) and Navy Civilian Manpower Management Instruction
(CMMI) 213 (appendix C).
3. Ensure the credentialing of those physicians, dentists, and
scientists, who would be participating in direct patient management.
4. Require that all data accrued/generated at the Naval Activity
becomes the property of the Department of the Navy. Upon execution
of this Memorandum of Understanding, data may be exchanged between
the participating institutions. Any materials compiled or published
by the Naval Activity staff, relative to their clinical experience
received at the Naval Activity, must clearly state that opinions or
assertions contained herein are those of the writer and are not to
be construed as official or reflecting the views and opinions of the
Department of the Navy.
5. Permit upon request the inspection of appropriate clinical
facilities and other research areas by agencies charged with the
responsibility for the accreditation of the institution and proper
management of said protocols.
6. Determine the efficacy of certain interventions to be
effective in decreasing the incidence of photochemical retinal
injuries during routine extracapsular cataract surgery.
7. Recruit for study 960 NNMC cataract patients.
B. Uniformed Services University of the Health Sciences will:
1. Provide the names of the physicians, dentists, and scientists
who will participate in the research program entitled ``Prevention
of Photochemical Retinal Injuries During Extracapsular Cataract
Surgery''.
2. Provide instruction, supervision, control, and evaluation of
their participants in this research effort.
3. Assist on the clinical trial planning, data management,
statistical analysis and interpretations using computing equipment
available at USUHS.
C. Food and Drug Administration will:
1. Provide the names of the scientists who will participate in
the research program entitled ``Prevention of Photochemical Retinal
Injuries During Extracapsular Cataract Surgery''.
2. Provide instruction, supervision, control, and evaluation of
their participants in this research effort.
3. Provide optical radiation metrology for the operating
microscope, and perform scientific analysis of the data.
III. Liability
Insomuch as National Naval Medical Center, Bethesda and the Food
and Drug Administration and the Uniformed Services University of the
Health Sciences are instrumentalities of the United States, all
claims arising hereunder will be handled in accordance with the
Federal Tort Claims Act and all federal health care providers acting
within the scope of this Memorandum of Understanding will be covered
by the Gonzales Act and the Federal Employees Liability Reform and
Tort Compensation Act.
IV.
All inventions conceived or reduced to practice under this
Memorandum of Understanding by a government employee shall be
reported to the Patent Counsel for each Agency of each government
employee. Upon receipt of a disclosure, counsel shall confer,
determine who shall prepare the application and decide, subject to
review by higher authority, upon a division of royalties. This
division shall fairly reflect relative contributions of each
agency's employees, the risks and costs incurred, and the ability to
proceed with testing and development, including licensing.
V. Reviews
A. This agreement will continue in effect until the termination
date as indicated on the DD Form 1144, or until it is canceled or
terminated.
B. This agreement will be reviewed annually on the anniversary
date and may be modified, cancelled, or renegotiated upon 90 days
notice by either party, or earlier by mutual consent. Changes in
funding responsibility will be accomplished in accordance with the
guidelines of NAVCOMPT Manual, paragraphs 075002 and 075022.
VI. Amendment
It is agreed that the changes to this Memorandum of
Understanding, except for dates, must be forwarded to the Naval
Health Sciences Education and Training Command, National Naval
Medical Center, Bethesda, Maryland 20889-5022 in the form of an
amendment signed by authorized agents of the institutions which hold
final approval authority. If this Memorandum of Understanding is of
the type that must have final approval by the Naval Health Science
Education and Training Command, proposed changes are not to be
effected without the written approval of the Naval Health Sciences
Education and Training Command.
VII. Effective Period
The effective period of this memorandum of understanding shall
be from 29 July 1992 to 28 July 1996 and may be renewed without
change, except for dates, on a year to year basis upon mutual
written agreement of all parties.
[[Page 24638]] VIII. Termination
Termination may be effected by either participating institution
upon written notice when deposited in the United States mail and
directed to the party, notice being given at the address set forth
below.
D. M. Lichtman
RADM, MC, USN
Commander
National Naval Medical Center
Bethesda, Maryland 20889-5000
Date August 19, 1993
(Original signature August 6, 1992)
D. Bruce Burlington, M.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, Maryland 20857
Date August 19, 1993
[FR Doc. 95-11416 Filed 5-8-95; 8:45 am]
BILLING CODE 4160-01-F