Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[INFO-96-08]

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 for opportunity for public comment on

proposed data collection projects, the Centers for Disease Control and

Prevention (CDC) will publish periodic summaries of proposed 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) 639-3453.

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 Wilma Johnson, CDC

Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA

30333. Written comments should be received within 60 days of this

notice.

Proposed Projects

1. Metropolitan Atlanta Birth Defect and Risk Factor Surveillance

Program--(0920-0010)--Extension--Birth defects are the leading cause of

infant mortality in the United States, and they cause a great deal of

lifelong morbidity. One in 33 infants are born with a major birth

defect. Occasionally, medications or environmental agents have been

recognized as causes of birth defects, an example being the drug

thalidomide in the early 1960s. Unless surveillance of trends and

unusual patterns in birth defects is undertaken, new ``thalidomides''

may be introduced and fail to be recognized in a timely fashion. The

Metropolitan Atlanta Congenital Defects Program (MACDP) has conducted

such surveillance since 1967 using existing hospital and clinic medical

records.

The causes of the majority of birth defects, however, are not

known. Birth Defects Risk Factor Surveillance (BDRFS) (which began in

January, 1993) attempts to find the causes of a selected subset of

major anomalies, using an ongoing case-control study approach. BDRFS

draws its cases from the data collected by MACDP and conducts in-depth

interviews with the parents of affected infants and a comparison set of

randomly selected parents of unaffected infants.

The objectives of these two activities are: (1) To conduct

surveillance for congenital anomalies in metropolitan Atlanta; (2) to

gain new information on causes of birth defects; (3) to further

evaluate factors already suspected of influencing the occurrence of

birth defects; and (4) to develop and test methods (including the use

of biologic markers of exposure and susceptibility) in birth defect

surveillance that would be exportable to other birth defects

surveillance systems. The total cost to respondents is estimated at

$6,000.

[[Page 1767]]

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Average

Number of Number of burden/ Total

Respondents respondents responses/ response burden (in

respondent (in hours.) hours.)

----------------------------------------------------------------------------------------------------------------

BDRFS Parents Questionnaire................................. 600 1 1 600

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Total................................................. ........... ........... ........... 600

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2. Case-Control Study of Infant Pulmonary Hemorrhage in the United

States--New--The purpose of this proposed study is to conduct a

nationwide case-control study to investigate the association between

the presence of molds, particularly Stachybotrys atra (S. atra), in the

home environment and the development of pulmonary hemorrhage in

infants. From January 1993 to November 1994, a cluster of 18 infant

pulmonary hemorrhage cases were identified in Cleveland, Ohio. An

epidemiologic, clinical, and laboratory investigation conducted by

pediatric pulmonologists in Cleveland, the Ohio Department of Health

(ODH), the City of Cleveland Department of Public Health (CDPH), the

Cuyahoga County Board of Health (CCBH) with assistance from CDC,

uncovered evidence that suggested an etiological role for environmental

contaminants in the development of this disease. Of particular concern

are trichothecene derivatives, which are potent mycotoxins produced by

the fungus, S. atra. Trichothecene toxins have been indited as

etiologic agents in hemorrhagic disorders in animals, but these

compounds have not previously been associated with pulmonary hemorrhage

in humans. Although the investigation in Cleveland produced evidence

that exposure to toxin-laden spores from S. atra may be involved in the

etiology of pediatric pulmonary hemorrhage, there is not yet sufficient

data to indicate whether or not these mycotoxins are associated with

pulmonary hemorrhage in other areas of the U.S. There is no cost to

respondents.

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Average

Number of Number of burden/ Total

Respondents respondents responses/ response burden (in

respondent (in hours) hours)

----------------------------------------------------------------------------------------------------------------

Parents of a diagnosed infant (case)........................ 30 1 1 30

Parents of a well infant (control).......................... 30 1 1 30

Control recruitment telephone interview..................... 15 1 .167 3

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Total................................................. ........... ........... ........... 63

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3. National Passive Surveillance for Invasive Group A Streptococcal

Infections and the Streptococcal Toxic Shock Syndrome--(0920-0276)--

Reinstatement--The frequency and severity of invasive group A

streptococcal (GAS;S.pyogenes) infections has increased in the United

States since the mid-1980s. In 1992, nationwide passive surveillance

for invasive GAS infections was approved by OMB for a limited period

and a 3-page paper surveillance form was sent to State and local health

departments. Data obtained through surveillance was used to follow

trends in serotype distribution; clinical data contributed to

formulating the definition of the streptococcal toxic shock syndrome

(STSS) and to investigating the pathogenesis this and other severe

streptococcal syndromes such as necrotizing fasciitis.

In 1994, the Surveillance Committee of the Council of State and

Territorial Epidemiologists (CSTE) met to discuss changes in the

National Public Health Surveillance System. It was proposed that

invasive GAS infections and STSS be added to the list of reportable

diseases. This proposal was approved by CSTE in the spring of 1995. The

proposed surveillance method includes hospital laboratory based

reporting of culture confirmed invasive GAS infections (i.e., infection

associated with a GAS isolate from a normally sterile site) to the

State or local health department with electronic transmission of data

to CDC. Cases would be defined as having STSS based on a consensus

definition published in 1993 by the Working Group on Severe

Streptococcal Infections. Clinical data needed to establish whether

STSS was present would be obtained from physicians or medical records

and recorded electronically or on a 1-page paper form. Data from

surveillance will be used to continue to monitor trends in disease

occurrence, and to identify clusters of infection or other settings

where public health interventions may result in prevention of disease.

This system is likely to reduce the reporting burden compare with

the previous approved surveillance in that the basic data collected on

all cases includes only patient demographics, site of infection,

clinical diagnosis, and outcome. Health departments, at their

discretion, may also collect data needed to define a patient as having

STSS, which includes obtaining data on seven clinical findings and can

be recorded on a single page. Thus, both routine data collection and

definition of STSS will require less time and effort than previously

required to complete the 3-page reporting form. Electronic data

transmission, through NETSS or a comparable system, will also

facilitate reporting by States to CDC through and established and

accepted system. The total cost to respondents is $20,000, based on an

average hourly salary for those who complete and submit the reports.

[[Page 1768]]

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Number of Average

Respondents Number of responses/ burden per Total

respondents respondent response burden

----------------------------------------------------------------------------------------------------------------

State Health Departments.................................... 50 40 .5 1000

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Total................................................. ........... ........... ........... 1000

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4. National Nosocomial Infections Surveillance (NNIS) System--

(0920-0012)--Extension--The National Nosocomial Infections Surveillance

(NNIS) system is currently the only source for national data on

nosocomial (hospital-associated) infections in the United States. It

first began collecting data in 1970. It is a collaborative project

between the Hospital Infections Program of the Centers for Disease

Control and Prevention (CDC) and voluntarily participating hospitals in

the United States. The goals of the system are to: (1) Develop

comparative nosocomial infection rates that can be used by hospitals to

assess quality of care, (2) describe the scope and magnitude, including

trends, of the nosocomial infection problem in the U.S., (3) identify

risk factors associated with these infections, (4) assist hospitals in

the effective use of surveillance data to improve the quality of

patient care, and (5) conduct collaborative research studies. Data are

collected using protocols developed by CDC that define the specific

populations of patients at risk, risk factors, and outcomes. The

decision about which component(s) to use is made by each hospital

depending on its own needs for surveillance data. The data are

collected by trained surveillance personnel, assisted by hospital

personnel, and are entered into IDEAS, a surveillance software which

makes the data available for analysis at the hospital's convenience.

The data are currently transmitted to CDC by floppy disk, then

aggregated into a national database. During 1996, it will become

possible for some hospitals to transmit the data to CDC through the

NNIS telecommunications system. This system is expected to be used by

all participating hospitals by 1997, resulting in reduced response

time. NNIS methodology, which has been published, is the standard

nosocomial infection surveillance methodology and is used at least in

part by most U.S. hospitals. The total cost for respondents is

estimated at $11,395.

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Average

Number of Number of burden/ Total

Respondents respondents responses/ response burden (in

respondent (in hours) hours)

----------------------------------------------------------------------------------------------------------------

Hospitals................................................... 251 12 0.16 481

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Total................................................. ........... ........... ........... 481

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5. Emergency Epidemic Investigations--(0920-0008)--Extension--

During most emergency situations, CDC specialists (epidemiologist,

biostatisticians, laboratory specialists, etc.) work under the aegis of

a State or local health department. Usually such investigations are

completed by the State or local government, with technical assistance

from CDC. Occasionally, an investigation must be continued or is

multistate or global. In these cases, CDC collects or sponsors the

collection of information from the public. This request, therefore, is

for the extension of OMB approval to collect data in such emergency

situation. There is no cost to the respondent.

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Average

Number of Number of burden/ Total

Respondents respondents responses/ response burden (in

respondents (in hours) hours)

----------------------------------------------------------------------------------------------------------------

General Public.............................................. 16,550 1 0.31 5131

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Wilma G. Johnson,

Acting Associate Director for Policy Planning and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 96-827 Filed 1-22-96; 8:45 am]

BILLING CODE 4163-18-P