24636 Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Notices

FDA will be assuring the availability of wellcharacterized and uniform reference

materials for the comparative evaluation of

new materials and devices. Evaluation of

biological performance data based on

comparison to previously-used and

successful products will be both facilitated

and improved.

Program Description

1. Selection of Materials—Candidate

materials for SRM development will be

selected by mutual agreement between FDA

and NIST. The goal is to provide more

realistic calibration standards for the

determination of physical, chemical,

electrical, and biological characteristics and/

or properties of biomaterials. Criteria for

selection will include magnitude of the

current or potential utilization of the material

in biomedical applications, documented or

reasonably foreseeable variability in response

from ‘‘off-the-shelf’’ materials, criticality of

the medical application, cost of developing

and potential market for the SRM, and others

mutually agreeable to both parties. At the

time of selection, the properties and

characteristics to be controlled and measured

will be identified for each candidate SRM, as

will be the proposed unit size for

distribution.

1.a An initial listing of candidate materials

proposed at the time of the initial agreement

is given in Appendix A. Materials 1 & 2 were

developed as a collaborative research iniative

between FDA and the American Dental

Association (ADA) at both the FDA and NIST

laboratories. Material 1 has been provided to

NIST for consideration as an SRM. Material

2 which is currently being synthesized will

be provided on or about September 1993. No

development work has been done on

materials 3–8.

2. Production of Materials—SRMs will be

developed by any of several laboratories,

including NIST, FDA, NIH, commercial

materials suppliers, device manufacturers,

academic institutions, and others. A Material

Safety Data Sheet (MSDS) will be required

from the supplier of all component materials

and precursor/catalyst/ancillary materials

used in the production of SRMs developed

under this MOU.

3. Certification—NIST will determine and

specify what testing must be performed and

be the sole reviewer of the adequacy of data

used in the qualification of SRMs developed

under this MOU. NIST reserves the right to

refuse distribution of materials if the data are

inadequate. All SRMs developed under this

program will be supplied with NIST

certification for the properties/characteristics

deemed critical to the application.

4. Packaging—NIST will determine for

each SRM the appropriate source of

packaging, either in-house or contract.

Contract packagers will seal the entire

shipment in appropriate packages for

shipment to NIST.

5. Replenishment—NIST agrees to assume

the responsibility for replenishment of stocks

for SRMs for which the market is at a level

that is financially beneficial to the Standard

Reference Materials Program.

6. Program Funding—FDA does not

commit to providing any funding or

equipment to NIST or any selected SRM

producer, or to providing any laboratory

effort in the development, characterization,

or production of SRMs being developed

under this program.

Costs and Pricing

1. Initially, FDA will provide 900 grams of

hydroxyapatite (material 1, Appendix A) and

1000 grams of β-Tricalcium Phosphate

(material 2, Appendix A) to NIST for use as

an SRM. No compensation to FDA is required

for this initial supply of material. Monies

collected from the sale of the SRMs, which

is over and above the cost to produce,

characterize and package the materials will

be used for additional SRM development.

2. NIST will have final authority over all

matters pertaining to pricing policy and for

setting the price of individual SRMs.

General

1. SRMs developed in whole or in part by

FDA prior to or under this MOU, which

remain unsold and are deemed by NIST, to

be technologically obsolete or otherwise no

longer acceptable as SRMs, may be removed

from the NIST inventory without liability for

reimbursement to FDA by NIST. If FDA

desires such products returned to FDA, NIST

will do so at FDA’s expense after removal of

SRM certification.

2. The official representatives of the

respective organizations will be:

FDA: Director Division of Mechanics and

Materials Science Office of Science and

Technology Center for Devices and

Radiological Health

NIST: Chief Standard Reference Materials

Program Office of Measurement Services

Effective Dates

1. This MOU will become effective 30 days

after being signed by the appropriate

authorities at both NIST and FDA. It will

remain in effect until terminated.

2. Either NIST or FDA may unilaterally

terminate this MOU by providing the other

party written notice. It will become

ineffective 60 days after such notice is

delivered.

Approval/Acceptance

Signed:

D. Bruce Burlington, M.D.

Director, FDA/CDRH

Date: November 19, 1993

Approved:

Peter L.M. Heydemann, PhD.

Director, NIST/Technology Services

Date: January 14, 1994

Concur:

Thomas E. Gills

Chief, NIST/SRMP

Date: January 14, 1994

Appendix A

Purpose:

Development of a series of CalciumPhosphorous based SRMs for use in

determining the composition of mixtures of

calcium phosphate based biomaterials or

biomaterial coatings.

Proposed Calcium Phosphate Reference

Biomaterials

1. Ca3(PO4)3OH ................................................ Hydroxyapatite .................................................. Ca/P=1.67

2. Ca3(PO4)2 ...................................................... Tricalcium Phosphate (β) ................................. Ca/P=1.50

3. Ca3(PO4)2 ...................................................... Tricalcium Phosphate (amorphous) ................. CA/P=1.50

4. Ca4(PO4)2O ................................................... Tetracalcium Phosphate ................................... CA/P=2.0

5. Ca3(PO4)2 ...................................................... Tricalcium Phosphate (α) ................................. CA/P=1.50

6. Ca2P2O7 ........................................................ Calcium Pyrophosphate (α β γ) ........................ CA/P=1.0

7. CaO ............................................................... Calcium Oxide .................................................. NA

8. Ca10 (PO4) 5F2 .............................................. Fluorapatite ....................................................... CA/P=1.67

[FR Doc. 95–11415 Filed 5–8–95; 8:45 am]

BILLING CODE 4160–01–F

[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.

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.’’
Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Notices 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.
24638 Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Notices

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

Health Resources and Services

Administration

Final Review Criteria for Cooperative

Agreements for Basic/Core Area

Health Education Centers Programs

and Model State-Supported Area

Health Education Centers Programs

for Fiscal Year 1995

The Health Resources and Services

Administration (HRSA) announces the

final review criteria for fiscal year (FY)

1995 Cooperative Agreements for Basic/

Core Area Health Education Centers

(AHEC) Programs authorized under

section 746(a)(1) and Model StateSupported Area Health Education

Centers Programs authorized under

section 746(a)(3), title VII of the Public

Health Service Act, as amended by the

Health Professions Education Extension

Amendments of 1992, Public Law 102–

408, dated October 13, 1992.

Purpose and Eligibility

In general, an area health education

centers program shall be a cooperative

program of one or more allopathic or

osteopathic medical schools and one or

more public or nonprofit private

regional area health education centers.

Section 746(a)(1) of the PHS Act

authorizes Federal assistance to schools

of allopathic or osteopathic medicine

which have cooperative arrangements

with one or more public or nonprofit

private area health education centers for

the planning, development and

operation of area health education

centers programs.

To be eligible to receive support for

an area health education centers

cooperative agreement, the applicant

must be a public or nonprofit private

accredited school of allopathic or

osteopathic medicine or consortium of

such schools, or the parent institution

on behalf of such school(s).

Section 746(a)(3) authorizes Federal

assistance to any school of allopathic or

osteopathic medicine that is operating

an area health education centers

program and that is not receiving

financial assistance under section

746(a)(1), title VII of the PHS Act.

The statutory authority for the Model

State-Supported AHEC Program

contains explicit language regarding

activities and agreements between the

medical and osteopathic schools which

develop AHEC programs and the freestanding, community-based area health

education centers which provide

training sites and resources for the

activities. To accomplish these specific

tasks, a system of subcontracts is

developed between the health

professions schools and the

independent AHEC centers in the

communities. The principal objective of

the legislation for the Model StateSupported AHEC Program is to

encourage State coordination and

support for AHEC activities.

Review Criteria

The program announcement,

published in the Federal Register at 59

FR 67303 on December 29, 1994,

proposed two additional review criteria

for this program. No comments were

received during the 30 day comment

period. Therefore, the review criteria

remain as proposed and are included as

the last two criteria in the list below.

These review criteria apply to the Basic/

Core AHEC Programs, section 746(a)(1)

and the Model State-Supported AHEC

Programs, section 746(a)(3).

The review of applications will take

into consideration the following criteria:

1. The degree to which the proposed

project adequately provides for the

program requirements set forth in

sections 746(a)(1) and 746(a)(3);

2. The capability of the applicant to

carry out the proposed project

activities in a cost-efficient manner;

3. The extent of the need of the area to

be served by the proposed area health

education center;

4. The potential of the proposed AHEC

program and participating centers to

continue on a self-sustaining basis;

and

5. The extent to which the proposed

project adequately responds to AHEC

Program performance measures and

outcome indicators.

Additional Information

If additional programmatic

information is needed, please contact:

Louis Coccodrilli, M.P.H., Acting Chief,

AHEC and Special Programs Branch,

Division of Medicine, Bureau of Health

Professions, Health Resources and

Services Administration, Parklawn

Building, Room 9A–25, 5600 Fishers

Lane, Rockville, Maryland 20857,

Telephone: (301) 443–6950, FAX: (301)

443–8890.

The Cooperative Agreement for Basic/

Core Area Health Education Centers

Programs is listed at 93.824 and the

Model State-Supported Area Health

Education Centers Programs is listed at

93.107 in the Catalog of Federal

Domestic Assistance. These programs

are not subject to the provisions of

Executive Order 12372,

Intergovernmental Review of Federal

Programs (as implemented through 45

CFR part 100) or the Public Health

System Reporting Requirements.

Dated: May 1, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–11287 Filed 5–8–95; 8:45 am]

BILLING CODE 4160–15–P

Public Health Service

Statement of Organization, Functions,

and Delegations of Authority; Office of

the Assistant Secretary for Health

Part H, Public Health Service (PHS),

Chapter HA (Office of the Assistant

Secretary for Health), of the Statement

of Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (DHHS) (42 FR 61318,

December 2, 1977, as amended most

recently at 60 FR 18846, April 13, 1995)

is amended to reflect changes in the

Office of Management and Budget,

Office of the Assistant Secretary for

Health.

Office of the Assistant Secretary for

Health

Under Chapter HA, Office of the

Assistant Secretary for Health, Section

HA–20, Functions, after the title and

statement for the Office of Management

and Budget (HAU), Administrative

Services Center (HAU1) at the end of the

statement add:

Carries out the authorities of the PHS

Claims Officer under the Federal Claims

Collection Act, the Federal Tort Claims

Act, and the Military Personnel and

Civilian Employees’ Claims Act.

Under the Division of Property

Management (HAU17) at the end of the

statement add:

Administers logistics activities of the

PHS to assure a coordinated effort

toward achieving the goals and

objectives established by the Assistant

Secretary for Health.