[Federal Register Volume 61, Number 15 (Tuesday, January 23, 1996)]
[Notices]
[Pages 1766-1768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-827]



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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
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........          600
----------------------------------------------------------------------------------------------------------------

    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.

----------------------------------------------------------------------------------------------------------------
                                                                                          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
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........           63
----------------------------------------------------------------------------------------------------------------

    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
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........         1000
----------------------------------------------------------------------------------------------------------------

    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.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
                         Respondents                          respondents   responses/    response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Hospitals...................................................          251           12         0.16          481
                                                             ---------------------------------------------------
      Total.................................................  ...........  ...........  ...........          481
----------------------------------------------------------------------------------------------------------------

    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.

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

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