Federal Register / Vol. 63, No. 77 /Wednesday, April 22, 1998 / Notices 19923

Dated: April 16, 1998.

Kathy Cahill,

Associate Director for Policy Planning and

Evaluation, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–10640 Filed 4–21–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–12–98]

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. Follow-Up Study of Children With

Developmental Disabilities—New—

National Center for Environmental

Health—In the mid-1980’s, 10-year-old

children were identified as having one

or more of five developmental

disabilities: mental retardation, cerebral

palsy, epilepsy, hearing impairment, or

vision impairment. These children were

identified (mainly from special

education records in the public schools)

in the metro-Atlanta area as part of a

study to develop surveillance methods

for these conditions in school-age

children. A follow-up study is proposed

to trace, locate, and interview these

children, who are now in their early

twenties, to assess their status with

regard to educational attainment,

employment, living arrangements,

services received, functional limitations,

adaptive behavior, social participation,

health, and quality of life. Previous

studies (published mostly in the mid1980’s) on the post-secondary school

experiences of former recipients of

special education services were either

limited to one type of impairment (e.g.,

mild mental retardation) or were

restricted to a narrow range of outcomes

(e.g., employment and education) or did

not incorporate a comparison group of

persons who were not in special

education. The proposed study is a onetime, in-person interview and includes

a contemporaneous comparison group

of persons who, at age 10 years, were in

regular education classes in the same

schools as were the persons with

developmental disabilities. A base of

1,608 identified children and 650

comparison persons will be used to find

a total of 1,600 who will be interviewed.

The data generated from this study will

be used to estimate the burden of

secondary health conditions, limited

social participation, and economic

disadvantage among young adults with

long-standing developmental

impairments. This information will be

helpful to efforts aimed at the

prevention of various secondary

problems in this population. Total

annual burden hours are 1,312.

Activity Number of

respondents

Number of

responses/

respondent

Avg. burden/responses

(in hrs.)

Total burden

(in hrs.)

Contacting/Scheduling call ............................................................................. 1,290 1 0.166 215

Face-to-face Interview .................................................................................... 1,097 1 1 1,097

2. Model Performance Evaluation

Program for Retroviral and AIDSRelated Testing—(0920–0274)—

Revision—Public Health Practice

Program Office (PHPPO). The CDC

Model Performance Evaluation Program

(MPEP) currently assesses the

performance of laboratories that test for

human immunodeficiency virus type 1

(HIV–1) antibody, human Tlymphotropic virus types I and II

(HTLV–I/II) antibody, perform CD4 Tcell testing or T-lymphocyte

immunophenotyping (TLI) by flow

cytometry or alternate methods, perform

HIV–1 ribonucleic acid (RNA)

determinations (viral load), and test for

HIV–1 p24 antigen through the use of

mailed sample panels. The CDC MPEP

is proposing to use annual data

collection documents to gain updated

information on the characteristics of

testing laboratories and their testing

practices. Two data collection

instruments, or survey questionnaires,

will be used. The first data collection

instrument will be concerned with

laboratories that perform HIV–1

antibody (Ab) testing, HTLV–I/II Ab

testing, HIV–1 viral RNA

determinations, and HIV–1 p24 antigen

(Ag) testing. Laboratories enrolled in the

MPEP will be mailed a survey

questionnaire and be asked to complete

the sections pertinent to their

laboratory’s testing. The survey

instrument will collect demographic

information related to laboratory type,

primary purpose for testing, types of

specimens tested, minimum education

requirements of testing personnel,

laboratory director, and laboratory

supervisor, and training required of

testing personnel. The demographic

section will be followed by more

specific sections related directly to HIV–

1 Ab testing, HTLV–/II Ab testing, HIV–

1 RNA, and HIV–1 p24 Ag testing.

Included in the latter sections will be

questions related to the types of tests

performed, the algorithm of testing, how

test results are interpreted, how results

are reported, how specimens may be

rejected for testing, if some testing is

referred to other laboratories, and what

quality control and quality assurance

procedures are conducted by the

laboratory. Similarly, the TLI survey

questionnaire will also collect

demographic information about each

laboratory, as well as the type(s) of flow

cytometer used, educational and

training requirements of testing

personnel, the types of monoclonal

antibodies used in testing, how

specimens are received, prepared, and

stored, how test results are recorded and

reported to the test requestor, and what

quality control and quality assurance

procedures are practiced. Information

collected through the use of these

instruments will enable CDC to

determine if laboratories are conforming

to published recommendations and

guidelines, whether education and

training requirements of testing

personnel are conforming to current

legislative requirements, and whether

problems in testing can be identified

through the collection of information.

Information collected through the

survey instruments will then be

compared statistically with the

performance evaluation results reported

by the enrolled laboratories to

determine if characteristics of

laboratories that perform well can be

distinguished from laboratories not

performing as well. Upon enrolling in

the MPEP, participants are assigned an
19924 Federal Register / Vol. 63, No. 77 /Wednesday, April 22, 1998 / Notices

MPEP number used to report testing

results and survey questionnaire

responses, allowing the individual

responses of each laboratory participant

to be treated in confidence. When

participants respond to the surveys by

sending CDC completed questionnaires,

the collected information is developed

into aggregate reports. A copy of the

completed report is provided to each

participating laboratory. Total annual

burden hours are 668.

Type of respondents Number of

respondents

Number of

respondents/

response

Average burden/response

(in hrs)

Total burden

(in hrs)

Enrollments (new) ........................................................................................... 100 1 0.05 5

Retroviral Survey ............................................................................................ 1,000 1 0.5 500

TLI Survey ...................................................................................................... 350 1 0.5 163

3. Evaluation of Educational

Brochures on Opportunistic Infections

Affecting People with HIV/AIDS—

New—The National Center for HIV, STD

and TB Prevention, Division of HIV/

AIDS Prevention, Intervention Research

and Support proposes to conduct

research to assure that intended

audiences (persons living with HIV/

AIDS) find the brochures clear,

informative and useful. Specifically, the

research will examine perceptions of the

appearance, quality, value, readability,

and clarity of the information provided.

Attention will be focused on identifying

information, language and/or formatting

issues which are confusing or unclear.

Further, although the intended audience

of the brochure series is all persons

living with HIV/AIDS, we propose to

use the limited resources available to

target those who are lower income. This

is warranted given their often more

restricted access to reliable information

sources, making the brochures a more

valuable resource for them. In addition,

the correlations between low socioeconomic status (SES) and low literacy

warrant attention to assuring the

readability and comprehension of the

materials among this group.

The information generated from this

research will enable NCHSTP to tailor

materials to the needs, wants and

preferences of individuals living with

HIV/AIDS. Additionally, the center is

committed to developing a standardized

process for including such audience

testing in subsequent materials

development projects. The proposed

process will provide the foundation for

establishing a standardized process for

such assessment. Total annual burden

hours are 275.

Form name Number of

respondents

Number of

responses/

respondent

Average burden/response

(in hrs.)

Total burden

(in hrs.)

Form A1 ............................................................................................................ 550 1 0.5 275

1Estimated time includes 10–15 minutes for reading one of the 11 information brochures and 10–15 minutes to complete the survey which will

be administered orally.

Dated: April 16, 1998.

Kathy Cahill,

Associate Director for Policy Planning and

Evaluation, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–10644 Filed 4–21–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

National Vaccine Advisory Committee,

Subcommittee on Future Vaccines,

Subcommittee on Immunization

Coverage, and Subcommittee on

Vaccine Safety: Meetings

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)

announces the following Federal

advisory committee meetings.

Name: National Vaccine Advisory

Committee (NVAC).

Times and Dates: 9 a.m.–2 p.m., May 7,

1998. 8:30 a.m.–1:30 p.m., May 8, 1998.

Place: Hubert H. Humphrey Building,

Room 800, 200 Independence Avenue, SW,

Washington, DC 20201.

Status: Open to the public, limited only by

the space available.

Notice: In the interest of security, the

Department has instituted stringent

procedures for entrance to the Hubert H.

Humphrey Building by non-government

employees. Thus, persons without a

government identification card should plan

to arrive at the building each day either

between 8 and 8:30 a.m. or 12:30 and 1 p.m.

so they can be escorted to the meeting.

Entrance to the meeting at other times during

the day cannot be assured.

Purpose: This committee advises and

makes recommendations to the Director of

the National Vaccine Program on matters

related to the Program responsibilities.

Matters To Be Discussed: Agenda items

include updates on the National Vaccine

Program Office (NVPO) activities and nontraditional sites for adult immunization:

NVAC recommendations and guidelines and

a presentation on a model system in San

Antonio, Texas. David Satcher, M.D., Ph.D.,

the Assistant Secretary for Health and

Surgeon General, will discuss his new role

and immunization as a key component in

enhancing the health of the Nation.

Committee discussions on the following:

initiatives in vaccine communication,

strategies for promoting travel vaccines, the

impact and effects of welfare reform on

immunization, vaccines as a response to

bioterrorism, the status of influenza

pandemic preparedness, joint vaccine

acquisition program—limited use vaccines;

reports from the Immunization Registries

Workgroup, Subcommittee on Immunization

Coverage, Subcommittee on Future Vaccines,

and Subcommittee on Vaccine Safety; and a

review of fiscal year 98 unmet needs.

Name: Subcommittee on Immunization

Coverage.

Time and Date: 2 p.m.–5 p.m., May 7,

1998.

Place: Hubert H. Humphrey Building,

Room 800, 200 Independence Avenue, SW,

Washington, DC 20201.

Status: Open to the public, limited only by

the space available.

Purpose: This subcommittee identifies and

proposes solutions that provide a

multifaceted and holistic approach to

reducing barriers that result in low

immunization coverage for children.

Matters To Be Discussed: Agenda items

include a review of recommendations from

the document, ‘‘Strategies to Sustain

Immunization Coverage,’’ and how to sustain

immunization coverage rates in children.

Name: Subcommittee on Future Vaccines.

Time and Date: 2 p.m.–5 p.m., May 7,

1998.