19922 Federal Register / Vol. 63, No. 77 /Wednesday, April 22, 1998 / Notices

Lowe’s cooperation and assistance in

completing its investigation.

Ms. Lowe has accepted the ORI

finding and has entered into an

Agreement with ORI in which she has

voluntarily agreed, for the three (3) year

period beginning April 6, 1998:

(1) To exclude herself from serving in

any advisory capacity to the Public

Health Service (PHS), including but not

limited to service on any PHS advisory

committee, board, and/or peer review

committee, or as a consultant; and

(2) That any institution that submits

an application for PHS support for a

research project on which Ms. Lowe’s

participation is proposed or which uses

her in any capacity on PHS supported

research or that submits a report of PHSfunded research in which she is

involved must concurrently submit a

plan for supervision of her duties to the

funding agency for approval. The

supervisory plan must be designed to

ensure the scientific integrity of Ms.

Lowe’s research contribution. The

institution also must submit a copy of

the supervisory plan to ORI.

No scientific publications were

required to be corrected as part of this

Agreement.

FOR FURTHER INFORMATION CONTACT:

Acting Director, Division of Research

Investigations, Office of Research

Integrity, 5515 Security Lane, Suite 700,

Rockville, MD 20852, (301) 443–5330.

Chris B. Pascal,

Acting Director, Office of Research Integrity.

[FR Doc. 98–10575 Filed 4–21–98; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–13–98]

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. Provider Survey of Partner

Notification and Partner Management

Practices following Diagnosis of a

Sexually-Transmitted Disease—New—

The National Center for HIV, STD, and

TB Prevention, Division of STD

Prevention. CDC is proposing to

conduct a national survey of physician’s

partner management practices following

the diagnosis of a sexually-transmitted

disease. Partner notification, a

technique for controlling the spread of

sexually-transmitted diseases, is one of

the five key elements of a long-standing

public health strategy to control

sexually-transmitted infections in the

U.S. At present, there is very little

knowledge about partner notification

practices outside public health settings

despite the fact that most STD cases are

seen in private health care settings. No

descriptive data currently exists that

allows the Centers for Disease Control

and Prevention to characterize partner

notification practices among the broad

range of clinical practice settings where

STDs are diagnosed, including acute or

urgent care, emergency room, or

primary and ambulatory care clinics.

The existing literature contains

descriptive studies of partner

notification in public health clinics, but

no baseline data exists as to the

practices of different physician

specialties across different practice

settings.

The CDC proposes to fill that gap

through a national sample survey of

7300 office managers and physicians

who treat patients with STDs in a wide

variety of clinical settings; a 70%

completion rate is anticipated (n=5110

surveys). This survey will provide the

baseline data necessary to characterize

infection control practices, especially

partner notification practices, for

syphilis, gonorrhea, HIV, and

chlamydia, and the contextual factors

that influence those practices. Findings

from the proposed national survey of

office managers and physicians will

assist CDC to better focus STD control

and partner notification program efforts

and to allocate program resources

appropriately. Without this information,

CDC will have little information about

STD treatment, reporting, and partner

management services provided by

physicians practicing in the U.S. With

changes underway in the manner in

which medical care is delivered and the

move toward managed care, clinical

functions typically provided in the

public health sector will now be

required of private medical providers.

At present, CDC does not have sufficient

information to guide future STD control

efforts in the private medical sector.

Data collection will involve a mail

survey of practicing physicians. The

questionnaire mailing will be followed

by a reminder postcard after one week,

a second mailing to non-respondents at

three weeks, telephone follow-up with

non-respondents at five weeks, and a

final certified mailing of the survey to

non-respondents at eight weeks. A study

specific computerized tracking and

reporting system will monitor all phases

of the study. Receipt of the completed

questionnaire or a refusal will be logged

into this computerized control system to

ensure that respondents who return the

survey are not contacted with

reminders. Total annual burden hours

are 2,555.

Respondents Sections Number of

respondents

Number of

responses/

respondent

Average burden/response

(in hrs.)

Total burden

(in hrs.)

Physicians ........................................................................... 2–4 5110 1 .083 426

Physicians ........................................................................... 5–10 5110 1 .417 2,129
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