Agency Forms Undergoing Paperwork Reduction Act Review

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]]

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

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

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

* 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.

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

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

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

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 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

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

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.

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

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

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

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

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

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