36236 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

isolates per month to the regional

laboratories, which measure

susceptibility to a panel of antibiotics.

Limited demographic and clinical

information corresponding to the

isolates are submitted directly by the

clinics to CDC.

During 1986–1997, GISP has

demonstrated the ability to effectively

achieve its objectives. The recent

emergence of resistance to

fluoroquinolones, commonly used

therapies for gonorrhea, has been

identified through GISP and makes

ongoing surveillance critical. Data

gathered through GISP are used to alert

the public health community to changes

in antimicrobial resistance in N.

gonorrhoeae which may impact

treatment choices, and to guide

recommendations made in CDC’s STD

Treatment Guidelines, which are

published every several years. There is

no cost to the respondents.

Respondent No. of respondents

No. of responses/respondents

Avg. burden (in

hrs.)

Total burden

(in hrs.)

Laboratory ....................................................................................................... 5 1056 1 5312

Clinic ............................................................................................................... 26 204 0.166 8846

Total ......................................................................................................... ........................ ........................ .......................... 6196

2. Tuberculosis Statistics and Program

Evaluation Activity, Contact Follow-up

(CDC 72.16) and Completion of

Preventive Therapy (CDC 72.21)—

(0920–0026)—Extension—The National

Center for HIV, STD and TB Prevention

(NCHSTP)—Tuberculosis (TB) is

transmitted when contagious TB

patients aerosolize Mycobacterium

tuberculosis and susceptible persons

(i.e., ‘‘contacts’’) are exposed. Some

contacts are especially endangered by

TB if they become infected—children

younger than 5 years old, and anyone

with an illness that weakens the

immune system (e.g., the acquired

immunodeficiency syndrome, AIDS).

The prompt evaluation of all contacts is

crucial for finding early TB cases and

latent infections. For latent TB

infections, treatment with isoniazid

preventive therapy can prevent new TB

cases from developing. Evaluation,

follow-up, and preventive therapy for

contacts comprise the most efficient

approach for finding and treating recent

TB infections and preventing future

cases. Therefore, it is one of the highest

priorities for the national TB control

strategy, second only to finding and

treating contagious cases. The local and

the state TB control programs and CDC

use Contact Follow-up (CDC 72.16) and

Completion of Preventive Therapy (CDC

72.21) to measure progress in achieving

the national goals for performance in

these areas. There is no cost to the

respondents.

Report No. of respondents

No. of responses/respondent (in

hrs.)

Avg. burden/response (in hrs.)Total burden

(in hrs.)

Contact Follow-up (1996), .............................................................................. 103 2 .5 103

Completion of Preventive Therapy (1995) ..................................................... 103 2 1 206

Total ......................................................................................................... ........................ ........................ .......................... 309

Dated: June 26, 1998.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning

and Evaluation,Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–17594 Filed 7–1–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Notice of Availability of Funds

Program Announcement 98077,

Programs To Prevent the Emergence

and Spread of Antimicrobial

Resistance in Food Animals

A. Purpose

The Centers for Disease Control and

Prevention (CDC) is implementing a

multifaceted effort to address the

problem of antimicrobial resistance. As

part of this, CDC, in collaboration with

the Food and Drug Administration

Center for Veterinary Medicine,

announces the availability of fiscal year

(FY) 1998 funds for a cooperative

agreement program to provide

assistance for the development and

evaluation of demonstration projects to

prevent and control the emergence and

spread of antimicrobial resistance in

food animals. CDC is committed to

achieving the health promotion and

disease prevention objectives of Healthy

People 2000, a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related to the priority

area of Immunization and Infectious

Diseases (For ordering a copy of Healthy

People 2000, see the section Where to

Obtain Additional Information).

The purpose of this program is to

develop, implement, and evaluate a

prudent antimicrobial use project to

reduce the emergence, prevalence, and

spread of antimicrobial resistance

among target pathogens in food animals.

The intention of this project is to

develop and evaluate a ‘‘prudent use of

antimicrobial agents’’ program in certain

food animal groups. It is hoped that this

project would serve as a model towards

the long-term goal of development of a

national campaign for prudent

antimicrobial use in food animals, and

that additional resources towards

achieving this goal would be provided

by veterinary and animal industry

organizations.

Applicants should address the

problem of antimicrobial resistance

through interventions potentially

including, but not limited to:

1. Promoting more judicious

antimicrobial use (e.g., using

antimicrobial agents only when needed,

using appropriate doses of antimicrobial

agents),

2. Reducing transmission of

antimicrobial resistant microorganisms
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36237

among food animals through good

management practices,

3. Preventing colonization and

infection of animals by pathogens

through the use of probiotics,

4. Improving the ability to provide

effective narrow spectrum therapy by

rapidly and accurately diagnosing

resistant microorganisms through the

use of improved laboratory testing

procedures and improved quality and

flow of laboratory data.

It is envisioned that funded projects

will use a combination of approaches to

achieve judicious antimicrobial use and

other changes that will result in

decreased appearance and spread of

resistance. Funded projects will also be

expected to conduct a multifaceted

evaluation of many aspects of the

program, including assessing the costs

and any cost-savings associated with

any proposed intervention.

B. Eligible Applicants

Applications may be submitted by

public and private, nonprofit

organizations and governments and

their agencies in the United States.

Thus, universities, colleges, research

institutions, hospitals, other public and

private non profit organizations,

including State and local governments

or their bona fide agents, federally

recognized Indian tribal governments,

Indian tribes or Indian tribal

organizations, and small, minority- and/

or women-owned businesses are eligible

to apply. Only one eligible application

from an organization/government/

agency will be accepted. Applicants

from each organization/government/

agency are encouraged to coordinate

and combine their efforts prior to

submitting their application.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 which

engages in lobbying activities shall not be

eligible to receive Federal funds constituting

an award, grant, contract, loan, or any other

form.

C. Availability of Funds

Approximately $120,000 is available

in FY 1998 to fund one or two awards.

These resources will be provided to

support demonstration projects in food

animals (e.g. swine, poultry, beef cattle,

dairy cattle). It is expected that the

average annual award for projects will

be range from $40,000 up to $70,000

and will be made for a 12-month budget

period within a project period of up to

3 years. Funding estimates may change.

It is expected that awards will begin on

or about September 30, 1998.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress and

availability of funds.

Use of Funds

Restrictions on Lobbying. Applicants

should be aware of restrictions on the

use of HHS funds for lobbying of

Federal or State legislative bodies.

Under the provisions of 31 U.S.C.

Section 1352 (which has been in effect

since December 23, 1989), recipients

(and their subtier contractors) are

prohibited from using appropriated

Federal funds (other than profits from a

Federal contract) for lobbying Congress

or any Federal agency in connection

with the award of a particular contract,

grant, cooperative agreement, or loan.

This includes grants/cooperative

agreements that, in whole or in part,

involve conferences for which Federal

funds cannot be used directly or

indirectly to encourage participants to

lobby or to instruct participants on how

to lobby.

In addition, the FY 1998 Department

of Labor, Health and Human Services,

and Education, and Related Agencies

Appropriations Act (Public Law 105–78)

states in Section 503 (a) and (b) that no

part of any appropriation contained in

this Act shall be used, other than for

normal and recognized executivelegislative relationships, for publicity or

propaganda purposes, for the

preparation, distribution, or use of any

kit, pamphlet, booklet, publication,

radio, television, or video presentation

designed to support or defeat legislation

pending before the Congress or any

State legislature, except in presentation

to the Congress or any State legislature

itself. No part of any appropriation

contained in this Act shall be used to

pay the salary or expenses of any grant

or contract recipient, or agent acting for

such recipient, related to any activity

designed to influence legislation or

appropriations pending before the

Congress or any State legislature.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A, below, and CDC shall be

responsible for conducting activities

under B, below.

A. Recipient Activities

Recipients are responsible for the

following:

1. Develop study protocol to include

utilizing the selected food animal (e.g.,

beef cattle, dairy cattle, swine, poultry);

defining foodborne pathogens of interest

(e.g., Salmonella, Campylobacter), and

describing the partnerships (e.g.,

including a veterinary diagnostic

laboratory, veterinary professional

associations, and animal commodity

groups).

2. Providing a descriptive analysis of

the selected study population.

3. Defining, collecting, and analyzing

baseline data, so that evaluation of the

interventions can be done. This

includes at a minimum collecting

prevalence data on antimicrobial

resistance among the target pathogens

and measuring antimicrobial agent

usage pattern before the intervention.

4. Designing and implementing an

intervention promoting judicious

antimicrobial use and other approaches

to reducing antimicrobial resistance: It

is anticipated that this will involve

developing coalitions among veterinary

professional societies, producers,

commodity groups, and others, as well

as implementing specific strategies.

These strategies may include peereducation of veterinarians, producers,

formulary guidelines, prescribing

restrictions, and strategies which are

likely to reduce transmission of

pathogens. The choice of strategies

should be justified based on the nature

of the study population, and the

infrastructure in which the study

population receives veterinary care.

5. Measuring the effects of the

intervention:

a. Measuring the change in rates of

antimicrobial resistance of organisms

over time. Organisms whose resistance

can be measured could include: human

foodborne pathogens, animal pathogens,

organisms that are opportunistic human

pathogens (e.g., Enterococcus), normal

animal fecal flora.

b. Measurement of antimicrobial

resistance should be accomplished by a

laboratory with proven ability to

perform measurements using a standard

approved methodology, yielding a

quantitative measure of resistance, such

as mean inhibitory concentration or

zone size.

c. As decreases in resistance as a

result of the program may take several

months to years to manifest themselves,

recipients are responsible for measuring

outcomes related to how well the

interventions have been implemented.

d. Measuring cost implications of the

intervention. This should include

impact of the intervention on direct

costs (e.g., costs of antibiotics,

veterinary care visits, duration of

illness, etc.) and indirect costs (e.g., lost

productivity, decreased feed efficiency,

etc.). Costs of the intervention program

must be differentiated from those of the

evaluation.

e. Consideration should be given to

parallel measurements in a non-
36238 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

intervention group of animals, to better

define the impact of the intervention.

6. Dissemination of research findings:

Disseminating research results by

appropriate methods such as

publication in journals, presentation at

meetings, conferences, etc.

B. CDC Activities

CDC, in collaboration with Food and

Drug Administration Center for

Veterinary Medicine, will provide

technical assistance in the design and

conduct of the research. This includes:

(1) providing technical assistance in the

design and conduct of the project,

including intervention methods and

analytic approach; (2) performing

selected laboratory tests as appropriate;

(3) assisting in data management, the

analysis of research data, and the

interpretation and dissemination of

research findings, as appropriate; (4)

assisting in the design of the evaluation

and in the identification of outcome

measures that will allow for later

analysis of economic benefits.

E. Application Content

All applicants must develop their

application in accordance with the

Form PHS–398 (revised 5/95),

information contained in this

cooperative agreement announcement,

and the instructions outlined below. In

order to ensure an objective, impartial,

and prompt review, applications which

do not conform to these instructions

may be disqualified.

General Instructions

1. All pages must be clearly

numbered.

2. A complete index to the application

and its appendixes must be included.

3. The original and two copies of the

application must be submitted

unstapled and unbound. Bound

materials (e.g., pamphlets, booklets, etc.)

will not be accepted in the narrative or

appendices. To submit such materials,

copy them onto 81⁄2′′ × 11′′ white paper,

one-side only.

4. All materials must be typewritten,

single spaced, and in unreduced type

(no smaller than font size 12) on 81⁄2′′

by 11′′ white paper, with at least 1′′

margins, headers, and footers.

5. All pages must be printed on one

side only.

Specific Instructions

The application narrative must not

exceed 15 pages (excluding budget and

appendixes). Unless indicated

otherwise, all information requested

below must appear in the narrative.

Materials or information that should be

part of the narrative will not be accepted

if placed in the appendices. The

application narrative must contain the

following sections in the order

presented below.

1. Abstract: Provide a brief (two pages

maximum) abstract of the project.

2. Background and Need: Discuss the

background and need for the proposed

project. Illustrate and justify the need

for the proposed project that is

consistent with the purpose and

objectives of this cooperative agreement

program.

3. Capacity and Personnel: Describe

applicant’s past experience in

conducting projects/studies similar to

that being proposed. Describe

applicant’s resources, laboratory and

other facilities, and professional

personnel that will be involved in

conducting the project. Include in an

appendix curriculum vitae for all

professional personnel involved with

the project. Describe plans for

administration of the project and

identify administrative resources that

will be assigned to the project. Provide

in an appendix letters of support from

all key participating non-applicant

organizations, individuals, etc., which

clearly indicate their commitment to

participate as described in the

operational plan. Do not include letters

of support from CDC personnel. Letters

of support from CDC will not be

accepted in the application.

4. Objectives and Technical

Approach: Describe specific objectives

for the proposed project which are

measurable and time-phased and are

consistent with the purpose and goals of

this cooperative agreement program.

Include a detailed timeline for

completion of key activities. Provide a

detailed operational plan for initiating

and conducting the project which

clearly and appropriately addresses all

Recipient Activities. Include a clear

description of applicant’s technical

approach/methods which are directly

relevant to the study objectives. Clearly

identify specific assigned

responsibilities/tasks for all key

professional personnel. Describe the

nature and extent of collaboration with

CDC and/or others during various

phases of the project. Clearly describe

the population to be studied (minimum

adequate numbers of animals are as

follows: dairy cows-100, turkeys or

chickens-5000, beef cattle-500, and

swine-250). Describe in detail a plan for

evaluating study results (including how

data on prescribing practices, costs, and

charges will be obtained) and for

evaluating progress toward achieving

project objectives. Justify the choice of

organisms and antimicrobial

susceptibility that will be used for

evaluation, and include a description

about how quality of laboratory

measurements will be assured.

5. Budget: Provide in an appendix a

budget and accompanying detailed

justification for the first year of the

project that is consistent with the

purpose and objectives of this program.

Provide estimated total budgets for

subsequent years. The last year may

involve only data collection and

analysis for purposes of evaluating the

program. If requesting funds for any

contracts, provide the following

information for each proposed contract:

(1) Name of proposed contractor, (2)

breakdown and justification for

estimated costs, (3) description and

scope of activities to be performed by

contractor, (4) period of performance,

and (5) method of contractor selection

(e.g., sole-source or competitive

solicitation). (See sample budget

included in application package.)

Note: If indirect costs are requested, a copy

of the applicant organization’s current

negotiated Federal indirect cost rate

agreement or cost allocation plan must be

provided.

F. Application Submission and

Deadline

The original and five copies of the

completed application PHS Form 398

(revised 5/95, OMB Control Number

0925–0001) must be submitted to the

address below on or before August 7,

1998:

Sharron P. Orum, Grants Management

Officer, ATTN: Gladys T.

Gissentanna, Grants Management

Branch, Procurement and Grants

Office, Centers for Disease Control

and Prevention (CDC), 255 East Paces

Ferry Road, NE., Room 314, Mailstop

E–18, Atlanta, Georgia 30305–2209

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1. a.

or 1. b. above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36239

G. Evaluation Criteria

The applications will be reviewed and

evaluated according to the following

criteria by an independent review group

appointed by CDC:

1. Background and Need (10 points):

Extent to which applicant’s

discussion of the background for the

proposed project demonstrates a clear

understanding of the purpose and

objectives of this cooperative agreement

program. Extent to which applicant

illustrates and justifies the need for the

proposed project that is consistent with

the purpose and objectives of this

program.

2. Capacity and Personnel (30 points

total):

a. Extent to which applicant describes

adequate resources and facilities (both

technical and administrative) for

conducting the project. This includes

the capacity to conduct quality

laboratory measurements. (10 points)

b. Extent to which applicant

documents that professional personnel

involved in the project are qualified and

have past experience and achievements

in research and programs related to that

proposed as evidenced by curriculum

vitae, publications, etc. (15 points)

c. Extent to which applicant includes

letters of support from non-applicant

organizations, individuals, etc. Extent to

which the letters clearly indicate the

author’s commitment to participate as

described in the operational plan. (5

points)

3. Objectives and Technical Approach

(60 points total):

a. Extent to which applicant describes

specific objectives of the proposed

project which are consistent with the

purpose and goals of this program and

which are measurable and time-phased.

(10 points)

b. Extent to which the applicant

identifies an appropriate population for

study, including whether the results of

a study in this population will be

generalizable to other populations in the

United States. Extent to which the

applicant identifies microbes/resistance

patterns for study that are of public

health importance. (10 points) Extent to

which applicant presents a detailed

operational plan for initiating and

conducting the project, which clearly

and appropriately addresses all

Recipient Activities. Extent to which

applicant clearly identifies specific

assigned responsibilities for all key

professional personnel. Extent to which

the plan clearly describes applicant’s

technical approach/methods for

developing and conducting the

proposed program and evaluation and

extent to which the plan is adequate to

accomplish the study objectives. The

extent to which applicant describes the

existence of or plans to establish

partnerships. (20 points)

c. Extent to which applicant describes

adequate and appropriate collaboration

with CDC and/or others during various

phases of the project. (10 points)

d. Extent to which applicant provides

a detailed and adequate plan for

evaluating study results (including

laboratory data, data on prescribing

practices, and data on direct costs and

charges and indirect costs), as well as

plans for evaluating progress toward

achieving project objectives. (10 points)

4. Budget (not scored):

Extent to which the proposed budget

is reasonable, clearly justifiable, and

consistent with the intended use of

cooperative agreement funds.

H. Other Requirements

Technical Reporting Requirements

Semiannual progress reports are

required and must be submitted no later

than 30 days after each semiannual

reporting period. The semiannual

progress reports must summarize the

following: (1) major accomplishments

including information on women

screened; (2) problems encountered in

program implementation; and (3) efforts

or proposed strategies to resolve

problems. The final progress report is

required no later than 90 days after the

end of the project period. All

manuscripts published as a result of the

work supported in part or whole by the

cooperative agreement will be submitted

with the progress reports.

An annual Financial Status Report

(FSR) must be submitted no later than

90 days after the end of each budget

period. The final financial status report

is due no later than 90 days after the end

of the project period.

An original and two copies of all

reports should be submitted to the

Grants Management Officer, Grants

Management Branch, CDC.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order 12372 (E.O.). E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC for each

affected State. A current list of SPOCs

is included in the application kit. Indian

tribes are strongly encouraged to request

tribal government review of the

proposed application. If SPOCs or tribal

governments have any process

recommendations on applications

submitted to CDC, they should forward

them to Sharron Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Mailstop E–18,

Room 314, Atlanta, Georgia 30305. The

due date for State process

recommendations is 30 days after the

application deadline date for new and

competing continuation awards (the

appropriation for this financial

assistance program was received late in

the fiscal year and would not allow for

an application receipt date that would

accommodate the 60-day State

recommendation process period). The

granting agency does not guarantee to

‘‘accommodate or explain’’ for State

process recommendations it receives

after that date.

The following additional

requirements, incorporated by reference,

are applicable to this program. For a

complete description of each, see

Attachment 2 (included in the

application kit).

AR98–2–Animal Subjects Requirements

AR98–9–Paperwork Reduction Act

Requirements

AR98–10–Smoke-Free Workplace

Requirements

AR98–15–Proof of Non-Profit Status

(See Eligibility Section)

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

Sections 301(a) and 317(k)(2) of the

Public Health Service Act, as amended

[42 U.S.C. 241(a) and 247b(k)(2)]. The

Catalog of Federal Domestic Assistance

Number is 93.283.

J. Where To Obtain Additional

Information

To receive additional written

information and to request an

application kit, call 1–888-GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest. If

you have any questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Gladys

T. Gissentanna, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers
36240 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 314, Mailstop E–18, Atlanta,

Georgia 30305, Telephone (404) 842–

6801, Email address: gcg4@cdc.gov.

Programmatic technical assistance

may be obtained from Frederick Angulo,

DVM, PhD, Medical Epidemiologist,

National Centers for Infectious Diseases,

Division of Bacterial and Mycotic

Diseases, Foodborne and Diarrheal

Diseases Branch, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop A–38,

Atlanta, Georgia 30333, Telephone (404)

639–2840, Facsimile: (404) 639–2205,

Email address: fja0@cdc.gov.

You may also obtain this

announcement from one of two Internet

sites on the actual publication date:

CDC’s homepage at http://www.cdc.gov

or at the Government Printing Office

homepage (including free on-line access

to the Federal Register at http://

www.access.gpo.gov).

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–17592 Filed 7–1–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Docket No. 98D–0375]

Draft Guidance for Staff, Industry and

Third Parties: Third Party Programs

Under the Sectoral Annex on Medical

Devices to the Agreement on Mutual

Recognition Between the United States

of America and the European

Community; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Draft Guidance for Staff, Industry and

Third Parties: Third Party Programs

Under the Sectoral Annex on Medical

Devices to the Agreement on Mutual

Recognition Between the United States

of America and the European

Community (MRA).’’ Under the Sectoral

Annex on Medical Devices (Medical

Devices Annex), FDA has agreed to

designate Conformity Assessment

Bodies (CAB’s). CAB’s will be third

parties (i.e., private individuals or

organizations outside of FDA)

authorized to perform premarket and

quality system evaluations consistent

with the Medical Devices Annex.

Assuming the MRA enters into force

and a final rule becomes effective, when

finalized, this draft guidance will apply

to CAB’s seeking to be designated under

the Medical Devices Annex, and it will

assist those who are interested in

participating in this program as CAB’s

or as applicants pursuing premarket and

quality system evaluations consistent

with the Medical Devices Annex.

DATES: Written comments by August 3,

1998.

ADDRESSES: Submit written comments

on the guidance to the Dockets

Management Branch, (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Comments should be identified

with the docket number found in

brackets in the heading of this

document. If you do not have access to

the World Wide Web, submit written

requests for single copies of the

guidance document entitled ‘‘Draft

Guidance for Staff, Industry and Third

Parties: Third Party Programs Under the

Sectoral Annex on Medical Devices to

the Agreement on Mutual Recognition

Between the United States of America

and the European Community (MRA)’’

on 3.5’’ diskette to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self addressed adhesive labels

to assist that office in processing your

request, or fax your request to 401–443–

8818. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: John

F. Stigi, Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850,

301–443–6597 or FAX 301–443–8818.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has participated in negotiations

on an international agreement on

medical devices concluded in June 1997

between the United States and the

European Community (EC). These

negotiations resulted in the drafting of

the MRA, which includes a special

section pertaining to medical devices

and is referred to as the Medical Devices

Annex. After completion of a 3-year

transition period, the Medical Devices

Annex provides for normal endorsement

of premarket and quality system

evaluation reports of conformity

assessment produced by equivalent

third parties, the CAB’s.

The MRA was signed in London on

May 18, 1998, but it has not entered into

force. FDA has published a proposed

rule on the portions of the MRA

affecting FDA-regulated products (63 FR

17744, April 10, 1998); the comment

period closed on May 11, 1998.

In order to establish confidence in the

conformity assessment process, CAB’s

will be required to participate in

rigorous joint activities to demonstrate

their proficiency to conduct evaluations.

Upon implementation of this program,

CAB evaluations will be exchanged and

normally endorsed by both FDA and the

EC for the marketing of medical devices.

FDA intends to use the National

Voluntary Conformity Assessment

System Evaluation (NVCASE)

administered by the National Institute of

Standards and Technology (NIST) of the

U.S. Department of Commerce to

recognize one or more accreditation

bodies that, in turn, will assess potential

U.S. CAB’s seeking to be designated

under the Medical Devices Annex, to

evaluate medical devices produced for

the EC market. FDA will consider the

recommendations made by the

recognized accreditation bodies under

NVCASE from June 1, 1998, to October

1, 1998, and then designate U.S. CAB’s

that meet criteria for technical

competence established in the Medical

Devices Annex. This draft guidance

provides information regarding the

process for CAB’s to become eligible for

designation under the Medical Devices

Annex.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on guidance for staff, industry, third

parties, and third party programs under

the sectoral annex on medical devices to

the Agreement on Mutual Recognition

Between the United States of America

and the European Community. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations, or both. This guidance is

not final nor is it in effect at this time.

The agency has adopted Good

Guidance Practices (GGP’s) that set forth

the agency’s policies and procedures for

the development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). This guidance is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

Persons interested in obtaining a copy

of the draft guidance may do so using

the World Wide Web. CDRH maintains