27356 Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadlines

A. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Officer (whose address is reflected in

section B, ‘‘Applications’’). It should be

postmarked no later than June 28, 1996.

The letter should identify the

announcement number, name of

principal investigator, and specify the

priority area to be addressed by the

proposed project. The letter of intent

does not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently, and will

ensure that each applicant receives

timely and relevant information prior to

application submission.

B. Applications

Applicants should use Form PHS–398

(OMB Number 0925–0001) and adhere

to the ERRATA Instruction Sheet for

Form PHS–398 contained in the Grant

Application Kit. Please submit an

original and five copies on or before July

26, 1996 to: Ron Van Duyne, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 321, MSE13, Atlanta, GA 30305.

C. Deadlines

1. Applications shall be considered as

meeting a deadline if they are either:

A. Received at the above address on

or before the deadline date, or

B. Sent on or before the deadline date

to the above address, and received in

time for the review process. Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be accepted

as proof of timely mailings.

2. Applications which do not meet the

criteria above are considered late

applications and will be returned to the

applicant.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked your name, address, and

phone number and will need to refer to

Announcement 657. You will receive a

complete program description,

information on application procedures,

and application forms. In addition, this

announcement is also available through

the CDC Home Page on the Internet. The

address for the CDC Home Page is

http://www.cdc.gov. If you have

questions after reviewing the contents of

all the documents, business

management technical assistance may

be obtained from Georgia Jang, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., MS–E13,

Atlanta, GA 30305, telephone (404)

842–6796; fax: 404–842–6513; internet:

glj2@opspgo1.em.cdc.gov. Programmatic

technical assistance may be obtained

from Roy M. Fleming, Sc.D., Associate

Director for Grants, National Institute

for Occupational Safety and Health,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Building 1, Room 3053, MS–D30,

Atlanta, GA 30333, telephone (404)

639–3343; fax: 404–639–4616; internet:

rmf2@niood1.em.cdc.gov.

There may be delays in mail delivery

as well as difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics (July 19–August 4). Therefore,

in order to receive more timely response

to questions please use INTERNET/EMail, follow all instructions in this

announcement and leave messages on

the contact person’s voice mail.

Please refer to announcement number

657 when requesting information and

submitting an application.

Potential applicants may obtain 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)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: May 24, 1996.

Donald L. Holderman,

Acting Director, National Institute for

Occupational Safety and Health Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96–13676 Filed 5–30–96; 8:45 am]

BILLING CODE 4163–19–P

[Announcement 660]

Tuberculin Skin Testing Demonstration

Projects; and Evaluation of Counseling

and Testing of Tuberculosis Patients

for Human Immunodeficiency Virus

Infection and Reporting of Test Results

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for a cooperative agreement

program for two projects: (1) Tuberculin

Skin Testing (TST) Demonstration

Projects; and (2) Evaluation of

Counseling and Testing of Tuberculosis

(TB) Patients for Human

Immunodeficiency Virus (HIV) Infection

and Reporting of Test Results.

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

areas of HIV Infection and

Immunization and Infectious Diseases.

(To order a copy of ‘‘Healthy People

2000,’’ see the section ‘‘WHERE TO

OBTAIN ADDITIONAL

INFORMATION.’’)

Authority

This program is authorized under

Section 317E of the Public Health

Service Act [42 U.S.C. 247b-6], as

amended.

Smoke-Free Workplace

CDC strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the non-use

of all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants are the official

public health agencies of States and

local governments or their bona fide

agents. This includes the District of

Columbia, American Samoa, the

Commonwealth of Puerto Rico, the

Virgin Islands, the Federated States of

Micronesia, Guam, the Northern

Mariana Islands, the Republic of the

Marshall Islands, the Republic of Palau,

and federally recognized Indian tribal

governments.
Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices 27357

Availability of Funds

Tuberculin Skin Testing Demonstration

Projects

Approximately $750,000 is available

in FY 1996 to fund approximately 8–10

awards. It is expected that the average

award will be $75,000, ranging from

$50,000–$200,000. Funding estimates

are subject to change. It is expected that

awards will begin on or about

September 1, 1996, and will be made for

a 12-month budget period within a

project period of up to 2 years. Funding

estimates may vary and are subject to

change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Evaluation of Counseling and Testing of

TB Patients for HIV Infection and

Reporting of Test Results

Approximately $750,000 per year is

available in FY 1996 to fund

approximately 4–6 awards. It is

expected that the average award will be

$125,000, ranging from $100,000–

$200,000. Funding estimates are subject

to change. It is expected that awards

will begin on or about September 1,

1996, and will be made for a 12-month

budget period within a project period of

up to 2 years. Funding estimates may

vary and are subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Purpose

The purpose of the TST

Demonstration Projects is: (1) Develop

model TST programs in health

departments and health care facilities;

(2) track and monitor TST data and TB

infections among health care workers;

and (3) pilot a microcomputer software

system developed by CDC to assist in

the collection , tracking, management,

and analysis of occupational TB

exposures and infections.

The purpose of the Evaluation of

Counseling and Testing of TB Patients

for HIV Infection and Reporting of Test

Results is: (1) To assess current HIV

counseling and testing practices for TB

patients; (2) to evaluate the extent to

which TB patients are receiving

counseling and testing; (3) to

characterize TB patients who are not

being tested and barriers to testing; (4)

to evaluate the extent to which HIV

results on TB patients known to be

coinfected are reported to the State or

local health department TB program;

and (5) to characterize patients who

were tested but are not being reported

to the State or local health department

TB program, and barriers to reporting

HIV test results.

This project is intended to assist State

and local TB control and AIDS programs

to: (1) identify barriers to HIV

counseling and testing of TB patients

and to sharing data between TB and

AIDS programs; and (2) develop

guidelines and initiate programs that

will overcome these barriers within the

health department and the provider

community.

Program Requirements

In conducting activities to achieve the

purpose of the TST Demonstration

Projects, the recipient shall be

responsible for the activities listed

under A. (Recipient Activities), and

CDC will be responsible for the

activities under B. (CDC Activities):

A. Recipient Activities

1. Conduct a program for health

department personnel with direct

patient contact or contract with a

hospital to perform TST of hospital

employees. In conducting the program

the applicant will perform skin testing

at one or more health department

facilities or hospitals where health care

workers (HCWs) are potentially exposed

to TB.

Where employees have been exposed,

the applicant will:

a. Perform contact investigations of

HCWs exposed to an infectious TB

patient who was not recognized and

appropriately isolated.

b. Collect information on the

circumstances surrounding these HCW

exposures.

c. Initiate appropriate TST for

exposed HCWs, including baseline and

follow-up testing.

d. Clinically evaluate all employees

with a TST conversion.

The applicant in performing the TST

program for employees on a routine

basis will be required to:

a. Use a two-step Mantoux test for all

initial tests to minimize the likelihood

of interpreting a boosted reaction as a

true conversion due to recent infection.

b. Place and read a TB skin test on all

HCWs. This will include measures or

incentives likely to enhance workers’

compliance with such testing.

c. Perform subsequent Mantoux

testing annually (or more frequently if

appropriate for the level of risk in the

occupational group or facility) of all

employees whose initial skin tests were

negative.

d. Directly observe the reading of the

TB skin test (in mm of induration) by

personnel trained in correct placement

and reading of Mantoux skin tests.

e. Confidentially assess potential

pertinent demographic factors, (such as,

gender, race/ethnicity, country of birth,

and history of receipt of Bacille

Calmette-Guerin) and occupational

factors, (such as, occupation and

worksite) which may place HCWs at risk

for TB exposure.

2. Use CDC-developed software to

assist in the collection, tracking,

management, and analysis of data from

TST programs.

3. Follow CDC guidelines for TST. A

copy of the guidelines will be included

in the application kit.

4. Implement a research protocol

jointly developed with CDC for the TST

demonstration project.

5. Use CDC-developed skin test

software to enter all TST information

onto the software and send a diskette of

the database to CDC on a monthly basis.

6. Develop forms appropriate to their

sites for the collection of data including

HCW’s demographics, occupational

information, TST information, and

results of follow-up clinical evaluations

for persons with reactive skin tests.

7. Ensure that all data are kept

confidential and in secured files.

B. CDC Activities

1. Jointly develop a research protocol

for the TST demonstration project.

2. Provide technical assistance in

implementation of the TST program.

3. Provide one or more versions of

microcomputer software for use in the

project.

4. Train health department personnel

in the use of the software.

5. Develop a plan for data

management and for data transfer to

CDC.

6. Review site performance and

ensure compliance with the study

protocol.

7. Conduct data analysis and

summarize and present findings.

In conducting activities to achieve the

purpose of the Evaluation of Counseling

and Testing of TB Patients for HIV

Infection and Reporting of Test Results,

the recipient shall be responsible for the

activities listed under A. (Recipient

Activities), and CDC will be responsible

for the activities under B. (CDC

Activities):

A. Recipient Activities

1. Provide a joint training session to

personnel from TB and AIDS programs

in local and State health departments.

Training will include the latest CDC

recommendations for TB prevention and

control, the reasons for collaboration

between the two groups, surveillance

mechanisms and definitions, the

importance of and methods for
27358 Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices

maintaining confidentiality and

availability of services for counseling,

testing, and treating HIV-infected TB

patients.

2. Assess current practices and

policies of TB care providers who have

reported cases to the health department

in the past year, including policies and

practices for HIV counseling and testing

of TB patients, availability of services

for coinfected patients, referral for

services, reporting of coinfected

patients, and perceived barriers to

testing and reporting.

3. Implement a study protocol,

developed jointly with CDC, to

determine by medical record review

whether TB patients, age 25–44 years,

were offered HIV counseling and

testing, the results of such testing,

whether patients were questioned about

HIV risk factors, missed opportunities

for counseling and testing, and whether

HIV-positive patients were referred for

HIV-related services. If HIV status was

known to the TB care provider,

document the effect of this knowledge

on TB care and on contact

investigations. Other possible sources of

documentation of HIV counseling and

testing may include matching with the

AIDS registry and the HIV reporting

registry, HIV counseling and testing

records, sexually transmitted disease

registries and other public health

records depending on availability and

local confidentiality requirements. For

patients whose HIV test results were

already reported to the TB program, the

medical record review will ascertain

their mechanism through which the HIV

results was reported and their

subsequent HIV service referrals.

4. Evaluate the completeness of the

TB surveillance system by matching the

AIDS and TB registries.

5. Ensure that all data are kept

confidential and in secured files.

6. Based on the results of above

evaluations, describe barriers to

providing HIV counseling and testing to

TB patients and to reporting HIV results

to the TB program. Make

recommendations and initiate programs

to overcome identified barriers and to

improve coverage of HIV counseling and

testing, reporting of HIV test results and

provision of services (or referral for

services) for coinfected patients.

7. Participate in two meetings to be

held in Atlanta, GA, each one day in

length, one each year of the project,

with other study participants and staff

from the Division of TB Elimination and

the Division of HIV/AIDS Prevention,

CDC.

B. CDC Activities

1. Provide assistance in developing a

protocol for conducting the Recipient

Activities described above.

2. Plan and organize the annual

meetings for recipient representatives

and staff from the Division of TB

Elimination and the Division of HIV/

AIDS Prevention, CDC .

3. Provide technical consultation as

needed for training, implementing the

protocol, and interpreting and using the

results of the project.

4. Review site performance and

ensure compliance with the study

protocol.

5. Assist with data management.

Evaluation Criteria

Applications for the Tuberculin Skin

Testing Demonstration Projects will be

reviewed and evaluated according to the

following criteria (100 points

maximum):

A. The extent of the problem of TB,

HIV, MDR TB, and TB/AIDS in the

applicant’s area. (10 Points)

B. The extent to which an efficient

and effective TST program exists in the

facility proposed for the project. This

includes the compliance rate with the

TST testing program. If compliance rates

are sub-optimal, the extent to which the

applicant’s plan for improving

compliance during the project period is

likely to succeed. In addition, the degree

to which the applicant has met the CDC

Policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed research.

Specifically the following items will be

addressed:

a. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

b. The appropriateness of the

proposed justification when

representation is limited or absent.

c. Whether the design of the study is

adequate to measure differences when

warranted.

d. Whether the plans for recruitment

and outreach for study participants

include the process of establishing

partnerships with community(ies) and

recognition of mutual benefits is

documented. (30 Points)

C. Agreement by the applicant to pilot

test CDC-developed software and

provide diskettes of the database to CDC

on a monthly basis. The extent to which

the applicant’s data management plan

demonstrates an ability to ensure the

integrity of the data. (30 Points)

D. The extent to which the applicant

describes how the study will be

administered, including the size,

qualifications, duties and

responsibilities, and time allocation of

the proposed staff, the availability of the

facilities to be used, and a schedule for

accomplishing the activities, including

time frames. If a contract with a hospital

is proposed, a letter of support must be

included. (30 Points)

E. Other (Not Scored)

Budget

Consideration will be given to the

extent to which the budget is

reasonable, clearly justifiable, and

consistent with the intended use of

funds.

Human Subjects

Procedures adequate for the

protection of human subjects must be

documented: (1) Protections appear

adequate and there are no comments to

make or concerns to raise, (2)

protections appear adequate, but there

are comments regarding the protocol, (3)

protections appear inadequate and the

Objective Review Group (ORG) has

concerns related to human subjects, or

(4) disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate resulting in unacceptability

of the entire application.

Applications for the Evaluation of

Counseling and Testing of TB Patients

for HIV Infection and Reporting of Test

Results will be reviewed and evaluated

according to the following criteria (100

points maximum):

A. Understanding the problem (10

points).

B. Plan for required activities. In

addition, the degree to which the

applicant has met the CDC Policy

requirements regarding the inclusion of

women, ethnic, and racial groups in the

proposed research. Specifically the

following items will be addressed:

a. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

b. The appropriateness of the

proposed justification when

representation is limited or absent.

c. Whether the design of the study is

adequate to measure differences when

warranted.

d. Whether the plans for recruitment

and outreach for study participants

include the process of establishing

partnerships with community(ies) and

recognition of mutual benefits is

documented. (50 points)

C. Collaboration (10 points).

D. Experience in related activities (10

points).

E. Personnel and management plan

(20 points).
Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices 27359

F. Other (Not Scored).

Budget

Consideration will be given to the

extent to which the budget is

reasonable, clearly justifiable, and

consistent with the intended use of

funds.

Human Subjects

Procedures adequate for the

protection of human subjects must be

documented: (1) Protections appear

adequate and there are no comments to

make or concerns to raise, (2)

protections appear adequate, but there

are comments regarding the protocol, (3)

protections appear inadequate and the

Objective Review Group (ORG) has

concerns related to human subjects, or

(4) disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate resulting in unacceptability

of the entire application.

Funding Priority

Funding priority for the Tuberculin

Skin Testing Demonstration Projects

may be given to ensure geographic

balance, urban and rural balance, high

and low prevalence of HIV infection,

and high and low TB morbidity areas.

Funding Priority for the Evaluation of

Counseling and Testing of TB Patients

for HIV Infection and Reporting of Test

Results will be given to applicants that

demonstrate a need to improve HIV

counseling and testing of TB patients

and reporting of test results. Funding

priority also may be given to ensure a

geographic balance, urban and rural

high and low prevalence of HIV

infection and high and low TB

morbidity.

Interested persons are invited to

comment on the proposed funding

priority. All comments received on or

before July 1, 1996, will be considered

before final funding priority is

established. If the funding priority

should change as a result of any

comments received, a revised

announcement will be published in the

Federal Register and revised

applications will be accepted prior to

the final selection of awards. Written

comments should be addressed to: Van

Malone, Grants Management Officer,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

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

Room 300, Mailstop E–15, Atlanta, GA

30305.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. 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. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them to Van Malone, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–15, Atlanta, GA 30305, not

later than 60 days after the application

deadline date. The Program

Announcement Number and Program

Title should be referenced on the

document. CDC does not guarantee to

‘‘accommodate or explain’’ State process

recommendations it receives after that

date. Indian tribes are strongly

encouraged to request tribal government

review of the proposed application. If

tribal governments have any tribal

process recommendations on

applications submitted to CDC, they

should forward them to Van Malone,

Grants Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–15, Atlanta, GA 30305. This

should be done no later than 60 days

after the application deadline date. CDC

does not guarantee to ‘‘accommodate or

explain ‘‘ for tribal process

recommendations it receives after that

date.

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 is 93.947, TB

Demonstration, Research, Public and

Professional Education Projects.

Other Requirements

Paperwork Reduction Act: Projects

that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review and

approval by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act.

Confidentiality: Applicants must have

in place systems to ensure the

confidentiality of all patient records.

Human Subjects: The applicant must

comply with the Department of Health

and Human Services Regulations, 45

CFR Part 46, regarding the protection of

human subjects. Assurances must be

provided to demonstrate that the project

will be subject to initial and continuing

review by an appropriate institutional

review committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of the IHS will be involved

or will support the research. If any

American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it.

Women, Racial and Ethnic Minorities:

It is the policy of the CDC to ensure that

women and racial and ethnic groups

will be included in CDC-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian, Alaska

Native, Asian, Pacific Islander, Black

and Hispanic. Applicants shall ensure

that women, racial and ethnic minority

populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15,

1995, pages 47947–47951 (a copy is

included in the application kit).

Pre- and Post-test Counseling and

Partner Notification: Recipients are

required to provide HIV antibody testing

to determine a person’s HIV infection

status; therefore, they must comply with

State laws and regulations and CDC
27360 Federal Register / Vol. 61, No. 106 / Friday, May 31, 1996 / Notices

guidelines regarding pre- and post-test

counseling and partner notification of

HIV-seropositive patients. A copy of the

guidelines will be included in the

application kit. Recipients must also

comply with State and local health

department requirements relating to

specific reportable diseases or

conditions. Recipients must provide

referrals for HIV diagnosis and

treatment.

HIV/AIDS Requirements: Recipients

must comply with the document

entitled ‘‘Content of AIDS-Related

Written Materials, Pictorials,

Audiovisuals, Questionnaires, Survey

Instruments, and Educational Sessions’’

(June 1992), a copy of which is included

in the application kit. In complying

with the requirements for a program

review panel, recipients are encouraged

to use an existing program review panel

such as the one created by the State

health department’s HIV/AIDS

prevention program. If the recipient

forms its own program review panel, at

least one member must be an employee

(or a designated representative) of a

government health department

consistent with the Content guidelines.

The names of the review panel members

must be listed on the Assurance of

Compliance form (CDC 0.1113), which

is included in the application kit.

Application Submission and Deadline

The original and two copies of the

application must be submitted to: Van

Malone, Grants Management Officer,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

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

Room 300, Mailstop E–15, Atlanta, GA

30305, on or before July 29, 1996.

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 committee.

(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

that do not meet the criteria in 1.(a) or

1.(b) are considered late applications.

Late applications will not be considered

in the current competition and will be

returned to the applicant.

Where to Obtain Additional

Information

Business management technical

assistance may be obtained from Juanita

Dangerfield, Grants Management

Specialist, at telephone (404) 842–6577,

fax: (404) 842–6513, or INTERNET

address: <jdd2@opspgo1.em.cdc.gov>.

Programmatic technical assistance

may be obtained from Eugene McCray,

M.D., Division of Tuberculosis

Elimination, at telephone (404) 639–

8117.

Potential applicants may obtain 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)

referenced in the ‘‘INTRODUCTION’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Atlanta, Georgia, will be the host of

the 1996 Summer Olympics Games (July

19 through August 4, 1996). As a result

of this event, it is likely that the

Procurement and Grants Office (PGO)

may experience delays in the receipt of

both regular and overnight mail

deliveries. Contacting PGO employees

during this time frame may also be

hindered due to the possible telephone

disruptions.

To the extent authorized, please

consider the use of voice mail, e-mail,

and facsimile transmissions to the

maximum extent practicable. Please do

not fax lengthy documents or grant

applications.

This announcement will be available

on one of two Internet sites on the

publication date: CDC’s home page at

http://www.cdc.gov, or at the

Government Printing Office home page

(including free access to the Federal

Register) at http://www.access.gpo.gov.

Dated: May 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–13675 Filed 5–30–96; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96D–0148]

Medical Devices; Medical Device User

Facility and Distributor Reporting;

Guidance Documents; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of three guidance

documents entitled ‘‘Medical Device

Reporting: An Overview,’’ ‘‘Medical

Device Reporting for User Facilities,’’

and ‘‘Medical Device Reporting for

Distributors.’’ These guidance

documents provide information to help

facilitate compliance with the agency’s

Medical Device Reporting (MDR)

requirements. The agency is also

announcing the availability of the

following final MDR reporting forms:

FDA Form 3419, Semiannual User

Facility Report; FDA Form 3417,

Baseline Report; and FDA Form 3381,

Annual Certification. Elsewhere in this

issue of the Federal Register, FDA is

publishing a notice of availability of,

and requesting comments on, a draft

guidance document focusing on

reporting by manufacturers.

DATES: Written comments on the

guidance documents may be submitted

at any time.

ADDRESSES: Submit written comments

on the three guidance documents to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Comments on the

three guidance documents should be

kept separate and identified by their

respective titles. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

guidance documents and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Persons interested in obtaining copies

of the guidance documents and

reporting forms may use the World

Wide Web. FDA’s home page address

may be accessed at http://www.fda.gov

and then select the Medical Devices and

Radiological Health option. Next, select

the program areas option and scroll

down to Medical Device Reporting. The

documents will be listed and available

for downloading.

Anyone with a video terminal or

personal computer with a modem can

obtain these documents from the

electronic docket administered by

DSMA (1–800–252–1366 or 1–301–594–

2741) by making the following menu

choices: 5–Postmarket Surveillance; 2–

Medical Device Reports—Policies/

Guidelines.

Individuals unable to use the above

two options may request information

about obtaining paper copies of these

documents through the CDRH Facts-onDemand system by dialing 1–800–899–