Federal Register / Vol. 60, No. 89 / Tuesday, May 9, 1995 / Notices 24635

distributing educational materials, and

supporting activities that advocate

preventing hepatitis B virus (HBV)

infection through vaccination,

education, testing, and treatment.

The Coalition’s information and

educational efforts are disease specific

and its mission is to improve hepatitis

B vaccination coverage levels and

reduce the incidence of HBV infection.

These activities are national in scope

and are not limited to local or regional

entities.

2. This Coalition is the only such

organization whose primary objective is

to provide hepatitis B information and

education to health care providers to

improve their immunization practices,

and to the public to increase awareness

and knowledge of the disease. The

Coalition has also demonstrated success

in reaching Southeast Asian

communities, a high risk group that has

not received culturally appropriate

education, outreach, and testing/

vaccination services from other health

care providers. In addition, the

Coalition has developed and tested

effective bilingual educational materials

for Asian/Pacific Islanders based on

their cultural, religious, and political

beliefs.

3. The Coalition has a demonstrated

history of regular written

communications such as newsletters or

‘‘Dear Colleague’’ letters. It has

sponsored and promoted regularly

scheduled local, regional, and national

meetings of its individual members to

share information, transfer skills, and

promote initiatives pertaining to the

prevention of HBV infection. It

successfully motivates other

organizations to participate in Coalition

activities.

4. Through emphasis on public and

provider education concerning hepatitis

B prevention issues, the Coalition has

demonstrated leadership in building

relationships with national

organizations, private and public sector

non-profit health care organizations,

professional health associations,

volunteer groups, advocacy groups,

minority organizations, and government

entities.

No other organization devoted to

addressing the wide-ranging needs for

education and professional

development on hepatitis B prevention

exists that has the experience and

demonstrated program successes, the

national reach, and the organizational

structure to provide to those audiences

who will benefit the most, the

information and education required to

improve vaccination coverage levels and

reduce disease incidence. The past

performance and ongoing success of this

Coalition make it uniquely qualified for

this project.

Executive Order 12372

This applicant is not subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order 12372.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number for this project is 93.185.

Where To Obtain Additional

Information

If you are interested in obtaining

additional information about this

project, please reference Announcement

Number 538, and contact Lisa Tamaroff,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., MS E–13,

Atlanta, GA 30305, telephone (404)

842–6796.

A copy of Healthy People 2000 (Full

Report; Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report;

Stock No. 017–001–00473–1) may be

obtained through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: May 3, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–11351 Filed 5–8–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[FDA 225–94–6001]

Memorandum of Understanding

Between the Food and Drug

Administration and the National

Institute of Standards and Technology

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 and

the National Institute of Standards and

Technology (NIST). The purpose of the

MOU is to collaborate in a program to

develop standard reference materials

(SRM’s) for a variety of biomaterials.

DATES: The agreement became effective

February 14, 1994.

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 Commissioner for Policy.

Memorandum of Understanding Between the

National Institute of Standards and

Technology and the Food and Drug

Administration, November 10, 1993

This memorandum of understanding

(MOU) between the U.S. Department of

Commerce, National Institiute of Standards

and Technology (NIST) and the U.S.

Department of Health and Human Services,

Food and Drug Administration (FDA) has

been implemented to facilitate the

development of Standard Reference Materials

(SRMs) for materials used in medical implant

applications. These materials are commonly

referred to as biomaterials.

Background

The National Institute of Standards and

Technology has, as one of its long-standing

programs, the development of and marketing

of standard reference materials required for

precision metrology in a variety of

applications. The Food and Drug

Administration is responsible for the

regulation of medical devices made from

biomaterials. For many of these biomaterials,

it has been determined that subtle variations

in chemical composition, trace element

content, crystalline structure or morphology,

homogeneity, surface topology and

chemistry, and other material characteristics

can significantly alter the response of living

tissue (i.e. the body) to a material, either as

an implant or by external contact. Thus the

availability of well-characterized reference

materials for use in generating baseline data

on the biological performance of a

biomaterial, is essential.

Overview

The parties to this MOU will collaborate in

a program to develop (SRMs) for a variety of

biomaterials. This collaboration will enable

NIST to enhance its activities in the

biomedical area and increase the utility of its

SRM Program by addressing many critical

measurement needs in the assessment of

biomaterials and medical devices. The SRM

Program at NIST will gain marketable SRMs

for biomaterials, an area in which NIST has

had no previous products. At the same time,
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.’’