18134 Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices

recruiting into or retaining participants

in scientific studies.

E. Dissemination of Research Results

Externally awarded investigators are

urged to make special efforts to

disseminate relevant research results to

the communities who participated in

the studies and to the populations to

which they pertain, especially racial

and ethnic minority populations which

may have cultural, language, and

socioeconomic barriers to the easy

receipt of such information.

VI. Evaluation

CDC Inclusion Review Committee

Responsibility and Members

A CDC Inclusion Review Committee

(IRC) with representatives from the CDC

Office of the Associate Director for

Science, the CDC Office of the Associate

Director for Minority Health, and the

CDC Office of the Associate Director for

Women’s Health will review any

questions, issues, or comments

pertaining to this policy and

recommend necessary changes or

modifications to the Director, CDC. This

committee will meet regularly to review

compliance with this policy and

evaluate the impact of this policy on

research activities at CDC. The CDC IRC

may periodically conduct random

audits of research protocols to assess

compliance with this policy.

Dated: March 30, 1995.

Claire V. Broome,

Deputy Director, Centers for Disease Control

and Prevention (CDC) and Deputy

Administrator, Agency for Toxic Substances

and Disease Registry (ATSDR).

[FR Doc. 95–8718 Filed 4–7–95; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 525]

Continuation of the Development of

Technology for the Measurement of

Lead in Blood; Notice of Availability of

Funds for Fiscal Year 1995

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for a grant program for the

continuation of the development of new

and innovative technology, or

significant improvement of existing

technology, for the measurement of lead

in blood. CDC has supported such

development efforts under a grant

program since FY 1992 and under

Cooperative Research and Development

Agreements (CRADAs) since 1991.

State, community and physician officebased childhood lead poisoning

prevention programs have a need for

reasonably priced, accurate, precise,

portable, rugged, and easy-to-operate

instruments or analytical techniques to

measure the concentration of lead in

blood. Such programs screen large

numbers of infants and young children

and identify those with lead poisoning.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of

Environmental Health. (For ordering a

copy of ‘‘Healthy People 2000,’’ see the

section Where To Obtain Additional

Information.)

Authority

This program is authorized under

sections 301(a) [42 U.S.C. 241(a)] and

317B(b) [42 U.S.C. 247b-3(b)] of the

Public Health Service Act, as amended.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse 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 limited to

those organizations which are currently

developing innovative technology for

the measurement of lead in blood,

funded under CDC grant Announcement

269 (included in the application

package), or organizations which have a

current CDC Cooperative Research and

Development Agreement (CRADA)

dealing with blood lead measurement

technology. However, if funded, the

CDC CRADA dealing with blood lead

will be terminated.

Note: Eligible applicants are encouraged to

enter into contracts, including consortia

agreements, as necessary to meet the

requirements of the program and strengthen

the overall application.

Availability of Funds

Approximately $800,000 is available

in FY 1995 to fund up to three grants.

It is expected that the average award

will be $250,000, ranging from $100,000

to $500,000. It is expected that the

awards will begin on or about June 30,

1995, and will be made for a 12-month

budget period within a project period of

up to one year. Funding estimates may

vary and are subject to change.

Purpose

State and community health agencies

are the principal delivery points for

childhood lead screening and related

medical and environmental

management activities. Universal

screening of children is recommended

in ‘‘Preventing Lead Poisoning in Young

Children—a Statement by the Centers

for Disease Control,’’ (October 1991);

however, the lack of analytical systems

(methods plus instrumentation) which

are easy-to-operate, rugged, and suitable

for field use in screening programs have

made it difficult and costly for agencies

to develop programs for the elimination

of this totally preventable disease. This

program will provide financial support

for the continuation and possible

completion of the development and

validation of new and innovative

technology leading to better blood lead

measurement systems.

Program Requirements

The following are essential

requirements of the Grantee:

1. Provide a principal investigator

with the authority, responsibility, and

research experience to carry out the

objectives of the grant.

2. Provide qualified staff, laboratory

and/or production facilities, equipment,

and other resources necessary to carry

out the objectives of the grant.

3. Conduct a scientifically sound,

goal-oriented research and development

program which will yield all or portions

of practical analytical systems which

measure one or more chemicals in

complex solutions. Understand and

address the difficult analytical problem

presented by a blood sample matrix.

4. Publish the results of the research

effort in the peer-reviewed scientific

literature, or otherwise make the

research findings available for objective

evaluation and use.

5. Provide evidence of significant

progress under the previous grant or

CRADA for blood lead measurement

technology consistent with the goals

and objectives of the original grant or

CRADA, and clearly show that

successful completion could be

reasonably expected within the one year

project period.

Evaluation Criteria

The applications will be reviewed and

evaluated according to the following

criteria:

1. Understanding of the Problem (30%)

By progress under previous grant or

CRADA agreement, the Applicant has
Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices 18135

demonstrated understanding of whole

blood matrix effects, interferences, and

contamination issues. Applicant’s

prototype instrument(s) and/or

experimental data address CDC criteria

of accuracy, precision, compactness,

ruggedness and ease of use, as described

in grant Announcement 269 and/or

CRADA agreement.

2. Technical Progress and Approach to

Remaining Problems (30%)

Sound technical approach, as

demonstrated by analytical performance

of applicant’s prototype instruments or

experimental data. Performance should

meet CDC criteria, or show evidence of

adequate performance attainable under

this announcement.

3. Management Plan (20%)

Applicant should describe a plan to

finalize the development of their

instrument as a manufacturable,

marketable, commercial product. Key

points include appropriate business

resources or collaborations, market

research, field testing, regulatory

compliance, distribution and support, or

plans to sell the technology to a third

party for final production and

marketing.

4. Program Personnel (10%)

The extent to which the proposal has

described (a) the qualifications and

commitment of the applicant including

training and experience in chemistry,

biochemistry, biomedical engineering or

other relevant scientific disciplines, (b)

detailed allocations of time and effort of

staff devoted to the project.

5. Collaboration (5%)

While collaboration is not required, it

is encouraged if necessary to

accomplish the research objectives in a

timely manner. If applicable, the

applicant should have demonstrated the

ability to collaborate with other research

centers, manufacturers, or commercial

interests to conduct the described

research and development plan.

Evidence of collaborative relationships

include jointly developed plans for

developing separate components of the

analytical system and written

commitments of support from other

program-related entities that describe

the collaborative activities or serious

negotiation or agreements with

companies experienced in the

development, marketing and support of

clinical instruments.

6. Publication of the Research Effort

(5%)

The purpose of this grant is to

encourage the rapid development and

deployment of measurement systems for

blood lead which will be useful in lead

poisoning prevention screening

programs. Therefore, an explanation of

how the grantee plans to encourage the

publication of the research findings or

otherwise make the information

available to the public is required.

Research which results only in findings

of academic interest with no practical

application to the objectives of the grant

is not acceptable.

7. Budget Justification (Not Scored)

The budget will be evaluated for the

extent to which it is reasonable, clearly

justified, and consistent with the

intended use of grant funds. The

adequacy of existing and proposed

facilities to support program activities

also will be evaluated.

8. Human Subjects Review (Not Scored)

The applicant must clearly indicate

whether or not human subjects will be

involved in their research.

Executive Order 12372 Review

This program is not subject to the

Executive Order 12372 review.

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 93.197.

Other Requirements

Human Subjects

If the proposed project involves

research on 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. Assurance 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.

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by this grant will be subject

to review by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act.

Application Submission and Deadline

The original and five copies of the

application form PHS 398 (OMB

Number 0925–0001) must be submitted

to Henry S. Cassell, III, 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–13, Atlanta, GA 30305, on or

before May 31, 1995.

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 the 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.

Where to Obtain Additional

Information

A complete program description,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from Adrienne Brown,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6630.

Programmatic technical assistance may

be obtained from Dayton T. Miller,

Ph.D. or Robert L. Jones, Ph.D.,

Nutritional Biochemistry Branch,

Division of Environmental Health

Laboratory Sciences, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway NE., Mailstop F–

18, Atlanta, GA 30341–3724, telephone

(404) 488–4452.

Please refer to Announcement 525

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)

referenced in the ‘‘Introduction’’
18136 Federal Register / Vol. 60, No. 68 / Monday, April 10, 1995 / Notices

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

A copy of ‘‘Preventing Lead Poisoning

in Young Children—a Statement by the

Centers for Disease Control,’’ (October

1991) may be obtained from the Lead

Poisoning Prevention Branch, Division

of Environmental Hazards and Health

Effects, National Center for

Environmental Health, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mailstop F–

28, Atlanta, GA 30333, telephone (404)

488–7330.

Dated: April 3, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–8717 Filed 4–7–95; 8:45 am]

BILLING CODE 4163–18–P

CDC Advisory Committee on the

Prevention of HIV Infection: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announced the following committee

meeting.

Name: CDC Advisory Committee on the

Prevention of HIV Infection.

Times and Dates: 9 a.m.–4:30 p.m., May 8,

1995; 9 a.m.–12 noon, May 9, 1995.

Place: Sheraton Colony Square Hotel, 188

14th Street, NE, Atlanta, Georgia 30061.

Status: Open to the public, limited only by

the space available.

Purpose: This committee charged with

advising the Director, CDC, regarding

objectives, strategies, and priorities for HIV

prevention efforts including maintaining

surveillance of HIV infection and AIDS, the

epidemiologic and laboratory study of HIV

and AIDS, information/education and risk

reduction activities designed to prevent the

spread of HIV infection, and other preventive

measures that become available.

Matters to Be Discussed: The Committee

will be updated on the ongoing

reorganization of CDC’s HIV/AIDS

prevention programs. Other discussions will

center around current HIV prevention

activities. Agenda items are subject to change

as priorities dictate.

Contact Person for More Information:

Connie Granoff, Committee Assistant, Office

of the Associate Director for HIV/AIDS, CDC,

1600 Clifton Road, NE, Mailstop E–40,

Atlanta, Georgia 30333, telephone (404) 639–

2918.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–8715 Filed 4–7–95; 8:45 am]

BILLING CODE 4163–18–M

National Committee on Vital and Health

Statistics (NCVHS) Subcommittee on

Mental Health Statistics: Meeting

Pursuant to Pub. L. 92–463, the

National Center for Health Statistics

(NCHS), Centers for Disease Control and

Prevention (CDC), announces the

following subcommittee meeting.

Name: NCVHS Subcommittee on Mental

Health Statistics.

Time and Date: 9 a.m.-5 p.m., May 17,

1995.

Place: Room 503A–529A, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201.

Status: Open.

Purpose: The Subcommittee will continue

to work in developing managed care

minimum data sets for enrollment and

encounter data.

Contact Person for More Information:

Substantive program information as well as

summaries of the meeting and a roster of

committee members may be obtained from

Gail F. Fisher, Ph.D., Executive Secretary,

NCVHS, NCHS, CDC, Room 1100,

Presidential Building, 6525 Belcrest Road,

Hyattsville, Maryland 20782, telephone

number 301/436–7050.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–8714 Filed 4–7–95; 8:45 am]

BILLING CODE 4163–18–M

Health Care Financing Administration

[MB–84–N]

RIN 0938–AG77

Medicaid Program; Rescission of the

Guidelines for Documenting Medicaid

Recipient Access to Immunizations

Under the Vaccines for Children (VFC)

Program

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice rescinds the

guidelines that we published in the

Federal Register on October 3, 1994,

that required States to document equal

access to immunizations for Medicaid

children if States elected to use lower

vaccine administration fees than the

maximum charges that were published

and applicable under the Vaccines for

Children program. These guidelines are

rescinded in response to public

comments on the October 3, 1994

notice. States indicated that there were

numerous problems regarding the

collection of useable data.

FOR FURTHER INFORMATION CONTACT:

Marge Sciulli, (410) 966–0691.

SUPPLEMENTARY INFORMATION:

I. Background

On October 3, 1994, we published in

the Federal Register a notice with

comment period (59 FR 50235) that

listed, by State, the interim regional

maximum charges that providers may

impose for the administration of

pediatric vaccines to Federally vaccineeligible children under the Vaccines for

Children (VFC) Program. (The VFC

Program, which became effective on

October 1, 1994, required States to

provide a program for the purchase and

distribution of pediatric vaccines to

registered providers.) State Medicaid

agencies may establish lower Medicaid

fees than the maximum charges.

According to the guidelines, States were

required to provide assurances of equal

access to immunizations for Medicaid

children to the same extent as for the

general population, unless their

Medicaid payment rates equaled the

maximum charges.

The October 3, 1994, notice allowed

States the option of using one or more

of the following guidelines to document

equal access to immunizations for

Medicaid children:

(1) Comparison of Ratios. In order for

a State to have used this guideline as an

equal access assurance, the ratio of

Medicaid children immunized to the

number of Medicaid children would

have to be equal to or greater than the

ratio of children in the general

population immunized to the number of

children in the general population.

(2) Comparison to Private Insurance.

In order for the State to have used this

guideline as an equal access assurance,

the Medicaid rates for the

administration of pediatric vaccines

would have to be set at a rate equal to

or greater than the private insurance

company’s rates up to the established

State maximum fee.

(3) Practitioner Participation. Under

this guideline, the State would have

compared the number of Medicaid

pediatric practitioners who are

Medicaid program-registered providers

to the total number of pediatric

practitioners providing immunizations

to children. The program-registered

providers must have at least one

Medicaid pediatric immunization claim

per month or an average of 12 such

claims during the year. The State would

have needed 50 percent participation to

show equal access through use of this

guideline.

(4) Other. States had the flexibility to

devise alternative measures of equal

access to immunizations. These

measures were to have been evaluated

by HCFA before being found acceptable.