Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control And Prevention

[INFO-99-14]

Proposed Data Collections Submitted for Public Comment and

Recommendations

In compliance with the requirement of section 3506 (c) (2) (A) of

the Paperwork Reduction Act of 1995, the Centers for Disease Control

and Prevention is providing opportunity for public comment on proposed

data collection projects. To request more information on the proposed

projects or to obtain a copy of the data collection plans and

instruments, call the CDC Reports Clearance Officer on (404) 639-7090.

Comments are invited on: (a) Whether the proposed collection of

information is necessary for the proper performance of the functions of

the agency, including whether the information shall have practical

utility; (b) the accuracy of the agency's estimate of the burden of the

proposed collection of information; (c) ways to enhance the quality,

utility, and clarity of the information to be collected; and (d) ways

to minimize the burden of the collection of information on respondents,

including through the use of automated collection techniques for other

forms of information technology. Send comments to Seleda Perryman, CDC

Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24,

Atlanta, GA 30333. Written comments should be received within 60 days

of this notice.

Proposed Project

1. An Evaluation Study of Tuberculosis Control and Prevention

Measures Implemented in Large City and County Jails--New--The Centers

for Disease Control and Prevention (CDC), National Center for HIV, STD,

TB Prevention (NCHSTP), Division of TB Elimination, Field Services

proposes to conduct a survey to determine the extent that jails have

implemented the 1996 recommendations of the Advisory Council for the

Elimination of Tuberculosis, Prevention and Control of Tuberculosis in

Correctional Facilities [MMWR 1996:45 (No. RR-8)]. The purpose of this

evaluation is to determine to what extent the recommendations have been

implemented and to identify barriers for implementation of the

recommendations. The objectives are to define the knowledge of the

recommendations among correctional staff, to identify barriers for the

adoption and implementation of the recommendations, and to initiate a

dialogue between public health and correctional officials on how to

utilize the study results for improving TB control and prevention in

the jails.

This project will assess the types and adequacy of the TB control

measures that are in place in jails. The first component of this

project is a survey of the largest jails to define the size of the TB

problem in their populations, to review the infection control

procedures that are in place, and determine the tracking mechanisms for

information concerning skin test results and completion of therapy. The

second component consists of on-site observation of the infection

control process to observe the processing and evaluation of inmates and

the infection control infrastructure (e.g., isolation procedures).

The evaluation project will be voluntary and only correctional

staff will participate; no prisoners will be interviewed or asked to

complete a written survey. The total cost to respondents is $0.00.

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Hours per

Respondents Number of Responses per response (in Total burden

respondents respondent hrs.) hours

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Mail survey including initial contact........... 50 1 2 100

Site visits..................................... 10 1 12 120

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Total....................................... .............. .............. .............. 220

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2. Gene-Environment Interactions in Beryllium Sensitization and

Disease Among Current and Former Beryllium Industry Workers--NEW

National Institute for Occupational Safety and Health (NIOSH) Beryllium

is a light weight metal with wide application in modern technology. The

size of the USA workforce at risk of beryllium exposure is estimated at

approximately 30,000, with exposed workers in primary production,

nuclear power and weapons, aerospace, scrap metal reclaiming, specialty

ceramics, and electronics industries. Demand for beryllium is growing

worldwide, which means that increasing numbers of workers are likely to

be exposed. An acute pneumonitis due to occupational exposure to

beryllium was common in the 1940s and 1950s, but has virtually

disappeared with improvements in work-site control measures. Even with

the improved controls, as many as 5% of currently-exposed workers will

develop chronic beryllium disease (CBD).

CBD is a chronic granulomatous lung disease mediated through a

poorly understood immunologic mechanism in workers who become

sensitized. Sensitization can be detected using a blood test, that is

used by the industry as a screening tool. The screening test for

sensitization was first reported in 1989, but many questions remain

about the natural history of sensitization and disease, as well as

exposure risk factors. Sensitized workers, identified through workplace

screening programs, undergo clinical diagnostic tests to determine

whether they have CBD. The proportion of sensitized workers who have

beryllium disease at initial clinical evaluation has varied from 41-

100% in different workplaces. Sensitized workers often develop CBD with

follow-up, but whether all sensitized workers will eventually develop

beryllium disease is unknown. Early diagnosis at the subclinical stage

and careful follow-up seems prudent in that CBD usually responds to

corticosteroid treatment. However, the efficacy of screening in

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preventing adverse outcomes of the disease has not yet been evaluated.

While recent research has suggested that a genetic determinant of the

immune response could be a susceptibility factor, this has not been

well characterized.

The National Institute of Occupational Safety and Health (NIOSH)

wants to determine how beryllium workers and former workers develop

beryllium disease and how to prevent it. Through the proposed study,

NIOSH has the opportunity to contribute to the scientific understanding

of this disease in the context of environmental and genetic etiologic

factors. The goals of this investigation are to: (1) Determine the

incidence of beryllium sensitization or disease over a 6-year period;

(2) seek an association with exposure measurements; (3) identify a

genetic determinant of susceptibility to CBD; and (4) characterize that

genetic determinant to ascertain if it is associated with clinical

impairment or progression of disease. Through a greater understanding

of the environmental and genetic risk factors associated with the onset

and progression of CBD, NIOSH will be able to develop strategies for

both primary and secondary prevention applicable to beryllium-exposed

workers. The total cost to respondents is $0.00.

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Hours per

Respondents Number of Responses per response (in Total burden

respondents respondent hrs.) hours

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Former Workers.............................. 175 1 0.5 87.5

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3. Health Message Development and Pretesting System--NEW--Office of

the Director, Office of Communications (OC). The Centers for Disease

Control and Prevention (CDC) is the federal government's principal

agency for research on preventable causes of death and disease,

including dissemination of information for the prevention and control

of certain diseases and injuries. The CDC provides communication

between the agency and a variety of audiences, including Congress,

other executive agencies, state and local governments, scientific and

medical communities and institutions, academic institutions, voluntary

organizations, the press, the general public, and members of the public

diagnosed with certain diseases. Because CDC is mandated to communicate

with these audiences about disease prevention and control, and because

CDC programs are based on solid science, a science-based data

collection system for developing and pretesting audience messages is

necessary. Special circumstance surround the timeliness of this data

collection system.

First of all, CDC receives mandates from Congress to provide the

public with certain health information within a specified time frame.

Secondly, CDC may need to act quickly in response to media interest in

specific health-related subjects. The media can quickly escalate health

issues in the public's mind and indeed, they often drive communication

efforts on health issues that are acute, controversial, or threatening.

In these situations, CDC will need to quickly conduct research to learn

the best way to counteract misinformation or reinforce correct

information through a health communication campaign. Thirdly, CDC

prevention and control recommendations are often part of consensus

conferences with multiple sister agencies and private and public sector

partners. Because we need to translate the scientific messages that may

be released from a consensus conference or alliance meeting, CDC is

often in need of fast and effective ways of testing these message

translations for the public and the media on a very short timeline.

Finally, many CDC programs are working with private or public sector

partners who can provide paid placement for CDC messages. CDC needs an

empirically-driven system of comparing messages across audience groups

and across disease problems to assist partners with selecting the most

effective messages for partnerships. Partners look to CDC to provide

this leadership in communication science and research. This means that

CDC needs a database system that can house the aggregate data from all

message pretesting and allow researchers to compare messages to each

other and to standardized effectiveness scores.

It is critical to CDC's mission and mandates to provide credible

and effective messages to the many audiences we serve. Formative

evaluation provides CDC with the most accepted and powerful tool

available to make health messages as useful as possible for the

audiences we serve. Without formative evaluation, CDC staff and experts

will be unable to empirically predict the effectiveness of health

materials and messages, and CDC would not be able to predict when

messages are insensitive, offensive, or create unintended negative

effects.

CDC needs a system that can not only test program messages using an

empirical and accepted methodology, but also provides access to a

system that is fast and effective at reaching a wide variety of

audiences and provides comparison data for decision-making. The

proposed system will allow CDC to provide audiences with the best

scientific health information, in ways that are relevant to the

audience, based on empirical communication research, and in a timely

fashion.

This OMB submission is for message development and pretesting

research of 130 messages per year for each of three years. The testing

system will provide message development and pretesting research for 15

Centers, Institutes and Offices at CDC and across a wide range of

program areas.

Response burden for each type of formative research method are

summarized below. The estimated annual total burden hours are 6,945

across 130 different studies (CDC-wide). The total cost to respondents

is $0.00.

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Number of

studies Number of Response per Hours per Total burden

Formative research method conducted respondents respondent response (in hours

across CDC per study hrs.)

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Focus Groups \1\................ 59 48 1 1.5 4,248

Central Location Intercept 22 125 1 0.25 687

Interviews \2\.................

In-depth Interviews............. 34 15 1 1.0 510

Omnibus Surveys \3\............. 15 1,000 1 .10 1,500

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Total....................... 130 1,188 .............. .............. 6,945

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\1\ Based on the average number of 6 focus groups conducted by CDC and other organizations for each specific

health program with 8 people per group.

\2\ Based on the industry average of 125 people per pretest session.

\3\ Based on the industry average of 1,000 people per omnibus poll and 6 minutes of telephone interview time.

Dated: April 2, 1999.

Nancy Cheal,

Acting Associate Director for Policy, Planning, and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 99-8725 Filed 4-8-99; 8:45 am]

BILLING CODE 4163-18-P