[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)*
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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 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)
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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.
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Average
Number of Number of burden/ Total
Respondents respondents responses/ response (in burden (in
respondent hours) hours)*
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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
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*1,808 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.
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Average.
Number of Number of burden/ Total
Respondents respondents responses/ response burden (in
respondent (in hours) hours)
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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)
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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]]
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Average
Number of Number of burden/ Total
Respondents (form name) respondents responses/ response burden (in
respondent (in hours) hours)
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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
