40098 Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices

Respondents No. of respondents

No. of responses/respondentAvg. burden

per response

(in hours)

Total burden

(in hours)

Nonresponse Studies ...................................................................................... 600 1 60/60 600

Total .......................................................................................................... ........................ ........................ ........................ 11,225

Dated: June 23, 2000.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–16435 Filed 6–28–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–45–00]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Officer at (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Projects

1. Survey of Laboratory Practices for

Nucleic Acid Amplification Tests for

Mycobacterium tuberculosis (M.tb

NAA)—New—As part of the continuing

effort to support public health objectives

of treatment, disease prevention and

surveillance programs, the Public

Health Practice Program Office

(PHPPO), Centers for Disease Control

and Prevention (CDC) seeks to collect

information from both public health and

private sector laboratories performing

nucleic acid amplification tests for

Mycobacterium tuberculosis.

Mycobacterium tuberculosis (TB)

infection has reemerged as a significant

public health concern in the United

States. Since TB is easily transmitted,

early detection of infection is imperative

for control and prevention. CDC

guidelines have advocated the use of the

acid-fast bacilli smear (AFB), followed

by culture, to confirm a diagnosis of

tuberculosis. However, research and

development have led to the design and

marketing of nucleic acid amplificationbased methods for the rapid detection of

Mycobacterium tuberculosis (M.tb)

directly from clinical sputum

specimens. Since the FDA approval of

two commercial M.tb NAA, CDC has

become keenly interested in the analytic

accuracy and clinical utility of these

tests, especially from the standpoint of

early detection and control of

tuberculosis.

Literature reports indicate variability

in sensitivities, specificities, and

predictive values for M.tb NAA,

depending on the experimental design,

the population being studied, and the

test methodology. Overall, both

sensitivity and specificity are reported

to be relatively high compared with

AFB smear and culture results.

However, there are several important

potential sources of error including

contamination problems inherent to

nucleic acid technology, crosscontamination with other mycobacteria,

sub-optimal laboratory practices, and

unknown factors. The use of M.tb NAA

tests for rapidly diagnosis may be useful

for controlling TB, particularly in high

prevalence populations. However, the

clinical utility and efficacy of M.tb NAA

tests remains in question. Because of the

uncertainty surrounding the analytical

accuracy and clinical validity of the

tests, the potential sources of error, and

the subsequent potential expense of

incorrect treatment.

The goal of the proposed project is to

collect laboratory practice data, in

conjunction with performance data,

through a survey administered to

current participants in the CDC’s M.tb

NAA Performance Evaluation Program,

to determine if laboratory practices are

associated with the risk of errors in

these tests. Information collected in the

survey will be on test methods, quality

assurance, quality control and reporting

practices, and test utilization. The

survey will also collect demographic

information regarding the types of

laboratories where testing is performed.

CDC will use this data as a primary

source of critical information to develop

laboratory guidelines and

recommendations for performance and

utilization of M.tb NAA tests. The

benefit of this data and the subsequent

recommendations to public health will

be the utilization of enhanced testing

practices in the control and elimination

of M. tuberculosis infection in the

United States. The total annualized

burden is estimated to be 55 hours.

Respondents No. of respondents

No. of responses/respondentAvg. burden

per response

(in hours)

Total burden

(in hours)

Laboratories ..................................................................................................... 110 1 30/60 55

Total .......................................................................................................... ........................ ........................ ........................ 55

Federal Register / Vol. 65, No. 126 / Thursday, June 29, 2000 / Notices 40099

Dated: June 23, 2000.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–16436 Filed 6–28–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement Number 00064]

Notice of Availability of Funds;

Announcement of a Cooperative

Agreement With the Minority Health

Professions Foundation To Enhance

Professional Education, Research

Infrastructure, and Community Service

in the Areas of Health Promotion and

Disease Prevention Partnering With

African American Institutions

A. Purpose

The Centers for Disease Control and

Prevention (CDC) and the Agency for

Toxic Substances and Disease Registry

(ATSDR) announce the availability of

fiscal year (FY) 2000 funds for a

cooperative agreement program with the

Minority Health Professions Foundation

(MHPF). The purpose of the program is

to assist the Minority Health Professions

Foundation in the following manner:

1. To improve the practice of public

health at member schools by

strengthening their public health

infrastructure;

2. To enhance the quantitative and

qualitative analytic research

infrastructure of the participating

institutions;

3. To strengthen the educational and

professional development of minority

health professionals and educators;

4. To support student training

initiatives, in order to introduce public

health to minority students;

5. To provide health education and

outreach for decreasing the needs of the

poor, minority, and under-served

populations; and

6. To enhance the interactions

between the Minority Health

Professions Foundation schools, the

historically black colleges and

universities and public health

institutions.

This program addresses the

commitments of the CDC and ATSDR in

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010’’, a national

activity to reduce morbidity and

mortality, while improving the quality

of life. This announcement is related to

the 2010 objectives, which specify

improving the health of groups of

people bearing a disproportionate

burden of poor health, as compared to

the total population. The framework of

‘‘Healthy People 2010’’ consists of two

broad goals which are to:

1. Increase quality and years of

healthy life; and

2. Eliminate health disparities.

The goals of ‘‘Healthy People 2010’’

have been established as the Nation’s

prevention goals and as a scorecard for

monitoring health status. The nations

goals and objectives established in

‘‘Healthy People 2010’’ will build upon

the foundation for establishing a small

set of leading health indicators that

could be presented to the general public

and non-health professionals as an

introduction to ‘‘Healthy People’’.

‘‘Healthy People 2010’’ will be a tool for

monitoring America’s health. For the

conference copy of ‘‘Health People

2010’’ visit the internet site: <http://

www.health.gov/healthypeople>.

Eliminating disparities by the year

2010 will require new knowledge about

the determinants of disease and

effective interventions for prevention

and treatment. It will also require

improved access for all to the resources

that influence health. Reaching this goal

will necessitate improved collection and

use of standardized data to correctly

identify all high-risk populations and

monitor the effectiveness of health

interventions targeting these groups.

Research dedicated to a better

understanding of the relationships

between health status and income,

education, race and ethnicity, cultural

influences, environment, and access to

quality medical services will help us

acquire new insights into eliminating

the disparities and developing new

ways to apply our existing knowledge

toward this goal. Improving access to

quality health care and the delivery of

preventive and treatment services will

require working more closely with

communities to identify culturally

sensitive implementation strategies.

While the nation has made

remarkable progress in understanding

the causes and risks for developing

diseases that have important

implications for the health of all

Americans, the health status of the

nation’s minority and poor lag

considerably behind that of White

Americans. The contributing factors for

many disparities include inadequate

family incomes, lack of access to

medical care, and environmental

hazards. The greatest opportunities for

improvement and the greatest threats to

the future health status of the Nation

reside in the population groups that

have historically been disadvantaged

economically, educationally and

politically. In partnering with different

racial and ethnic groups, the CDC can

work closely with institutions,

organizations, and communities to help

eliminate disparities in health while

meeting the goals of ‘‘Healthy People

2010’’.

B. Eligible Applicants

Assistance will be provided only to

the Minority Health Professions

Foundation (MHPF). No other

applications are solicited.

The MHPF is the most appropriate

and qualified organization to provide

services specified under this

cooperative agreement because:

1. The MHPF is dedicated to

supporting the organizational growth of

minority health professional schools to

ensure the advancement of specific

research in minority health, the

education and professional

development of minority health care

professionals and educators, and the

continuing provision of health services

in minority and poor communities;

2. The MHPF represents twelve

member institutions which include

medical, dental, pharmacy, and

veterinary medicine schools in

historically African-American colleges

and universities. Collectively, these

institutions have trained one out of

every two African American physicians,

dentists, and pharmacists; and three out

of every four African American

veterinarians. The member institutions

have also trained a substantial number

of other minority and non-minority

health professionals;

3. The MHPF member institutions are

comprised of the Historically Black

Colleges and Universities (HBCUs) that

not only house the health professions

schools, but three of which house

schools of public health;

4. The primary objective of the MHPF

and the nine Historically Black Colleges

and Universities is to address the health

needs of African American and other

minority population groups;

5. The MHPF institutional members

have significantly fostered and

advanced dramatic growth and

expansion of its member institution’s

collaborative efforts, bolstered and

supported considerable increase in

public health, medical and scientific

research, and assisted in amplifying

minority health community education

and outreach nationally;

6. The MHPF and its member schools

have the capacity to conduct basic

sciences and clinical research, and are

attacking the various diseases and

conditions that disproportionately