[Federal Register Volume 63, Number 144 (Tuesday, July 28, 1998)]
[Notices]
[Pages 40289-40292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[30DAY-18-98]


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. An Epidemiologic Study of the Relation Between Maternal and 
Paternal Preconception Exposure to Ionizing Radiation and Childhood 
Leukemia (0920-0364), Revision.
    The National Center for Environmental Health proposes an extension 
of a case-control study of the relation between maternal and paternal 
preconception exposure to ionizing radiation and childhood leukemia. 
The study is designed to determine whether preconception gonadal doses 
from ionizing radiation are higher in the parents of children with 
leukemia than in parents of healthy children. This hypothesis is based 
on previous study findings that, compared with control groups, children 
with leukemia were more likely to have fathers who worked at the 
Sellafield nuclear facility in Great Britain and to have received 
higher doses of ionizing radiation prior to the conception of the 
child. Funding for the study is being provided to the University of 
Colorado Health Sciences Center by the National Center for 
Environmental Health of the Centers for Disease Control and Prevention.
    The study is designed as a multi center case-control study. Cases 
will be children with leukemia and controls will be children without 
leukemia selected at random from the same population as the cases. In 
addition, the next older sibling will be used in a second control 
group. The main exposure of interest, paternal and maternal gonadal 
absorbed doses from ionizing radiation during the six-month time period 
before conception, will be quantified by taking detailed histories from 
the parents about medical, occupational, and environmental exposures 
that they had during the time period of interest. Gonadal doses will be 
estimated from the documentation of each exposure. By calculating the 
doses of ionizing radiation each parent received, we can compute odds 
ratios and confidence intervals for paternal and maternal doses 
separately and combined. These findings will clarify whether the 
previously determined risks can be detected in other populations with 
similar exposures. Consistency in the results of this study with those 
of a similar study in Great Britain would have a major impact on 
current medical practice and occupational exposure standards. If this 
study does not detect an elevated risk for leukemia, it will be 
unlikely that preconception gonadal doses from ionizing radiation that 
are received by the general public are related to childhood leukemia. 
Total annual burden hours are 1,125.

[[Page 40290]]



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                                                                                          Average               
                                                              Number of    Number of      burden/       Total   
                   Form name or activity                     respondents   responses/  response (in   burden (in
                                                                          respondents     hours)       hours)*  
----------------------------------------------------------------------------------------------------------------
Pediatric Oncologist Introduction of Study to Parent(s)                                                         
 (99%).....................................................            5          122         0.083           51
Request for Patient Information from Other Physicians (1%)                                                      
 (Atch 3)..................................................            6            1         0.166            1
Request for Participation (parents) (Atch 5)...............        2,508            1         0.166          418
Record Gathering in Home (parents).........................        1,968            1         0.5            984
Exposure Questionnaire (parents)(Atch 11, 12, and 13)......        1,968            1         1.666        3,280
Re-interview 10% (parents).................................          197            1         1.666         328 
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* 5,062 <divide> 4.5 yrs = 1,125 annual burden hrs.                                                             

2. Evaluation of NCIPC Recommendations on Bicycle Helmet Use; New

    The National Center for Injury Prevention and Control's (NCIPC) 
Division of Unintentional Injury Prevention (DUIP) intends to conduct a 
survey of 1,300 persons from its mailing lists and lists of recipients 
of recommendations on the use of bicycle helmets in preventing head 
injuries that was published in the Morbidity and Mortality Weekly 
Report of February 17, 1995.
    The purpose of this survey is to determine:
    I. The penetration of the recommendation's distribution,
    II. The usefulness of the bicycle helmet recommendations,
    III. How to improve the recommendation's content and format,
    IV. Potential future DUIP bicycle helmet promotional activities,
    V. Information needs and access points of DUIP's ``customers.''
    Results from this research will be used to: (1) Assist DUIP in 
producing an updated version of the helmet recommendations; (2) 
identify new helmet promotion programmatic directions; and (3) develop 
future materials that meet the needs of DUIP ``customers.''
    The study will be done by telephone. The total annual burden hours 
are 441.

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                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
                          Form name                           respondents   responses/    response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Section A...................................................        1,500            1       0.0166           25
Sections B, C...............................................          500            1        .1666           83
Sections D, E, F............................................          500            1        .1666           83
Sections G, H, I............................................        1,500            1        .1666          250
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3. Multistate Case-Control Study of Childhood Brain Cancers; New

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
mandated pursuant to the 1980 Comprehensive Environmental Response 
Compensation and Liability Act (CERCLA), and its 1986 Amendments, The 
Superfund Amendments and Reauthorization Act (SARA), to prevent or 
mitigate adverse human health effects and diminished quality of life 
resulting from exposure to hazardous substances in the environment. 
Scientific knowledge is lacking concerning the reasons for the apparent 
rise in childhood brain cancer incidence during the last two decades in 
the U.S. and for explanations of childhood brain cancer in general. To 
date, most epidemiologic studies exploring the causes of childhood 
brain cancer have suffered from lack of statistical power due to the 
small numbers of cases available for the study. By combining recent 
childhood brain cancer data from multiple states, this study will help 
to better understand what environmental factors may be associated with 
childhood brain cancer, and therefore, to possibly develop well-focused 
prevention measures.
    This study will examine the association between environmental 
exposures and risk of childhood brain cancers by employing a population 
based case-control study of childhood brain cancer. Information to be 
collected includes proximity of parental residence to hazardous waste 
sites and other known or suspected risk factors. Other known or 
purported risk factors identified from the literature, will include 
both environmental and host factors during the prenatal as well as 
postnatal periods: parental occupation, parents' and child's dietary 
habits, parental history of smoking and drinking, mother's and child's 
exposure to radiation through medical care, residential use of 
pesticides or herbicides, mother's and child's history of viral 
infection, and family history of cancer and neurological disorders. 
This request is for a three-year OMB approval. Total annual burden 
hours are 603.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                              Number of    Number of      burden/       Total   
                        Respondents                          respondents   responses/  response (in   burden (in
                                                                           respondent     hours)       hours)*  
----------------------------------------------------------------------------------------------------------------
Screener for controls......................................       16,000            1          .05           800
Mothers of children with childhood brain cancers and                                                            
 controls (interview)......................................        1,200            1          .75           900
Mothers of children with early childhood brain cancers and                                                      
 controls (biological testing).............................          100            1         1.083          108
----------------------------------------------------------------------------------------------------------------
*1,808 <divide> 3 years = 603 annualized burden hours.                                                          


[[Page 40291]]

4. Exposure to Volatile Organic Compounds and Childhood Leukemia 
Incidence at United States Marine Corps Base, Camp Lejeune, North 
Carolina; New

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
mandated pursuant to the 1980 Comprehensive Environmental Response 
Compensation and Liability Act (CERCLA), and its 1986 Amendments, The 
Superfund Amendments and Reauthorization Act (SARA), to prevent or 
mitigate adverse human health effects and diminished quality of life 
resulting from exposure to hazardous substances in the environment. 
There is limited evidence that in utero exposure to volatile organic 
compounds (VOCs) such as trichloroethylene and tetrachloroethylene 
(PCE) in drinking water may be strongly associated with childhood 
leukemia (CL). In 1982, VOC contamination was identified in certain 
groundwater supply wells which supplied drinking water to housing units 
at U.S. Marine Corps Base Camp Lejeune in Jacksonville, North Carolina. 
During this phase of the proposed study, an attempt will be made to 
locate as many of the children born to base residents between 1968 and 
1985 as well as offspring from pregnancies that occurred during this 
time period but were not delivered at Camp Lejeune.
    The purpose of the proposed nested case-control study is to 
investigate the potential relationship between exposure to VOCs in 
drinking water and incidence of CL at Camp Lejeune. A secondary 
objective of the proposed study is to investigate the potential 
relationship between VOCs in drinking water and birth defects in this 
population. A brief screening questionnaire will be interviewer-
administered to identify potential cancer and birth defect cases. Some 
of the data to be collected by the questionnaire includes: confirmation 
of the name(s) of children and date(s) of birth; dates and location of 
residence on base during the pregnancy and/or at the time of delivery; 
current vital status of each child; the determination of diagnosis with 
cancer or birth defects before age 20. This request is for a 3-year OMB 
approval. Total annual burden hours are 1,750.

----------------------------------------------------------------------------------------------------------------
                                                                                          Average.              
                                                               Number of    Number of     burden/       Total   
                         Respondents                          respondents   responses/    response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Parent/Child born at Camp Lejeune; 1968-1985................        9,650            1          .15     1,447.50
Pregnancy at Camp Lejeune, delivery elsewhere; 1968-1985....        3,350            1          .15       502.50
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5. A Survey of Influenza A Outbreak Control Measured in U.S. Nursing 
Homes; New

    The Division of Viral and Rickettsial Diseases, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention--
Outbreaks of influenza A in nursing homes (NH) may result in the 
hospitalization of up to 25% of ill residents and the death of up to 
30% of those who are hospitalized. The rapid diagnosis of influenza A 
and the timely administration of currently available antiviral 
medications, amantadine and rimantadine, can lessen the impact of these 
outbreaks. However, it is unknown how often laboratory tests for the 
rapid diagnosis of influenza A are utilized and how frequently 
antivirals are used to control nursing home outbreaks of influenza A.
    The purpose of this survey is to determine how often rapid testing 
and antivirals are used to control influenza A outbreaks in NH's. A 
sample of NH's will be selected randomly from one state within each of 
nine influenza surveillance regions. The survey will be mailed to 
infection control personnel in the randomly selected NH's. The results 
will be used to identify where educational efforts should be directed 
to lessen the impact of influenza A on elderly institutionalized 
persons. Total annual burden hours are 170.

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                                                                                         Average                
                                                            Number of     Number of      burden/    Total burden
                       Respondents                         respondents   responses/     responses    (in hours) 
                                                                         respondent    (in hours)               
----------------------------------------------------------------------------------------------------------------
NH Medical Director.....................................         1017             1          0.16           170 
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6. Case Control Study of Tuberculosis Infection in Young Children, San 
Diego and New York City Tuberculosis Statistics and Program Evaluation; 
(0920-0400) Extension;

    National Center for HIV, STP, and TB Prevention (NCHSTP)--As a 
result of the rise of tuberculosis among children, CDC sponsored a 
Workshop on TB in Children a few years ago. Recommendations from the 
workshop included the need for further research concerning the 
epidemiology of TB in children, including children co-infected with 
HIV, improved diagnostic technologies, and the infectiousness of TB in 
children in health care settings. A contract with Columbia University 
(to study children in New York City) and with the University of 
California, San Diego, (to study children in San Diego) was approved in 
December, 1996. The contract consisted of three Modules. Module II, 
Studies of the Diagnosis of TB in Children, was canceled in December, 
1997, due to a lack of participant response. Module III, Reducing the 
Risk of Nosocomial Transmission of Tuberculosis in Pediatric Settings, 
has completed data collection and the results are being analyzed. Data 
collection for Module I, Epidemiology, Magnitude and Risk Factors for 
TB in children, including HIV-infected children, was not completed 
within the original OMB time frame. This is mainly due to the recent 
decline in TB incidence in children experienced in the last year in the 
two study areas.
    Data collection will need to be completed for Module I. The data 
collected to date is not useful, because the numbers are too small to 
be statistically significant to meet the study objectives.
    Clinicians will interview parents of pediatric TB cases and 
controls. Total annual burden hours are 49.

[[Page 40292]]



----------------------------------------------------------------------------------------------------------------
                                                                                          Average               
                                                               Number of    Number of     burden/       Total   
                   Respondents (form name)                    respondents   responses/    response    burden (in
                                                                            respondent   (in hours)     hours)  
----------------------------------------------------------------------------------------------------------------
Positive Tuberculin Skin Tests (TST's) Form.................           15            1        0.333            3
Negative TST's Form.........................................           46            1        0.333           46
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    Dated: July 22, 1998
Charles Gollmar,
Acting, Associate Director for Policy, Planning, and Evaluation, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 98-20082 Filed 7-27-98; 8:45 am]
BILLING CODE 4163-18-P