[Federal Register Volume 61, Number 25 (Tuesday, February 6, 1996)]
[Notices]
[Pages 4439-4441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2426]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[INFO-96-09]
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. Intensive-Care Antimicrobial Resistance Epidemiology (Project
ICARE), Phase II--NEW--Antibiotic resistance is estimated to cost as
much as 4 billion dollars a year to the health care system in the
United States and the number of resistant microorganisms is increasing.
For example, data reported to the National Nosocomial Infections
Surveillance (NNIS) system demonstrated a 20-fold increase, between
January 1989 and March 1993, in the percentage of enterococci
associated with nosocomial infections that are resistant to vancomycin
(VRE). Additional analysis of NNIS data has demonstrated that other
antibiotic resistant nosocomial pathogens have also increased in recent
years. One of the major factors limiting the understanding of
antibiotic resistance among nosocomial pathogens is the lack of
information on the relationship between the amount and kind of
antibiotic used in hospitals and the emergence of resistance.
This proposed one year study, called Project ICARE, will collect
data on the amount of antibiotics used in 50 NNIS hospitals and the
antibiotic susceptibility patterns found in certain bacterial pathogens
isolated in these hospitals' microbiology laboratories between June
1996 and June 1997. Further, new mechanisms of resistance will be
studied on specific antibiotic-resistant isolates that will be sent to
CDC from these laboratories. A successful pilot study involving eight
NNIS hospitals was conducted between August 1994 and January 1995 to
study the feasibility of collecting such information.
After initially setting up the project with information on the
different intensive care units (ICUs) and wards, the hospital will
provide three different types of data each month: (1) summary of the
amount of parenteral and oral antibiotics, by generic group, reported
by the pharmacy, (2) summary of the number of isolates, by species,
susceptible, intermediate or resistant to various antibiotics reported
by the microbiology laboratory, and (3) actual isolates of resistant
pathogens to be sent to by the microbiology laboratory to CDC. For
antibiotics used and number of isolates in each of the susceptibility
categories, separate data are to be reported for each ICU, all other
inpatients, and outpatients (antibiotic use among outpatients is not
collected). Data collection forms for summary data from the
microbiology laboratory and pharmacy have been created to assist in
recording the data; however, the data
[[Page 4440]]
will be entered into a computer software created by CDC specifically
for Project ICARE. The software will be provided to the hospitals at no
cost. Data will be transmitted to CDC by floppy disk or by electronic
transfer when it become available in the NNIS system in 1996. The total
cost to respondents is estimated at $108,538.
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Avg.
No. of burden/ Total
Respondents No. of responses/ response burden
respondents respondent (in (in
hrs.) hrs.)
------------------------------------------------------------------------
Primary Contact............. 50 12 1 600
Pharmacist.................. 50 60 1.8 5400
Microbiologist.............. 50 60 0.35 1050
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Total................. ........... .......... ........ 7050
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2. Case-control Study of the Effect of Total Dietary Folate Intake
on the Clinical Manifestation of Vitamin B 12 Deficiency--New--
Fortification of grain products with folic acid has been recommended to
increase the intake of folate by women of reproductive age in order to
decrease the risk of neural tube birth defects. Fortification high
enough to increase the passive consumption of folic acid to the
recommended level of 400 g/day for all women would increase
the consumption by some segments of the population to well over the
presumed safe upper limit of 1000 g/day. There is concern,
based on case reports, that excess folate consumption may delay the
diagnosis of vitamin B 12 deficiency, especially in the elderly.
Delayed diagnosis of B 12 deficiency may lead to the development of
neuropsychiatric signs and symptoms, some of which may be irreversible.
There is no population-based estimate of the prevalence of B 12
deficiency among the elderly, nor is there any population-based data on
the frequency with which diagnosis of B 12 deficiency is complicated by
folate intake. The Food and Drug Administration has postponed folate
fortification pending more data on the potential risks of high levels
of folate consumption for the general population.
This is a pilot study to determine the size, feasibility, cost and
duration of a population-based survey; the population-based survey
would estimate the prevalence of vitamin B 12 deficiency in the general
population and estimate the impact of folate intake on its diagnosis.
This information is needed to assess the risk that may be posed by high
levels of fortification of the food supply with folate.
The proposed pilot study will seek to identify new cases of B 12
deficiency from the computerized laboratory records of a health
maintenance organization, determine the nature of the clinical
presentation of the cases by medical record review, and evaluate the
association of folic acid intake with type of clinical presentation by
dietary assessment. 70 individuals with B 12 deficiency and 70 normal
controls will participate in a telephone interview about their diet and
use of nutritional supplements in the year preceding the diagnosis. The
total cost to respondents is $10/respondent x $70 respondents = $700.
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Avg. Total
No. Of Responses/ burden/ burden
Respondents respondents respondent respondent (in
(in hrs.) hrs.)
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Cases w/B 12 difficiency.......................................... 70 1 1 70
Normal controls................................................... 70 1 1 70
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Total....................................................... ........... .......... .......... 140
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3. Examination of Barriers to Participant Compliance in a Flexible
Sigmoidoscopy Screening Program, Imperial Cancer Research Fund, United
Kingdom--New--As part of an existing screening program, there is
significant project savings in this initiative. Colorectal cancer
accounts for approximately 9% of all newly diagnosed cancer worldwide.
Of all cancer mortality in industrialized nations, colorectal cancer is
second only to lung cancer, with the U.S. and Great Britain among the
highest in this category. Despite increasing evidence that the early
diagnosis of colorectal cancer through screening examination can
significantly prevent and/or reduce the burden of mortality, morbidity,
and associated costs, rates of participation in screening remain
extremely poor. This study, involving investigators at the Imperial
Cancer Research Fund (ICRF) of Great Britain, seeks to identify
barriers associated with low compliance in a mass, population-based
colorectal cancer screening trial utilizing flexible sigmoidoscopy.
The ICRF has a long history of conducting important mass screening
trials relative to cancer early detection and their investigators are
considered international experts in colorectal cancer screening.
Because the ICRF already has an ongoing population-based colorectal
screening program, significant project start-up and infrastructure cost
savings have been incorporated into this proposal. Subjects will
include randomly selected adults age 55-64 with no known history of
colorectal cancer in Glasgow.
The study involves assessment of demographic, environmental, and
psychosocial factors which may limit screening participation via
surveys and interviews. Informed consent will be obtained and a
complete explanation of all medical procedures will be given.
Phase I will involve initial identification, survey query, and
solicitation for screening. Phase II will involve telephone and
personal
[[Page 4441]]
interviews, and Phase III will involve final data analysis.
Participation in this study is voluntary and subsequent screening,
follow-up and treatment, if indicated, will be provided at no cost to
participants. Informed consent will be obtained where appropriate and
oversight will be provided by federal and local institutional review.
The total cost to respondents is estimated at $11,330.
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Avg.
No. of burden/ Total
Respondents No. of responses/ response burden
respondents respondent (in (in
hrs.) hrs.)
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Population-based sample of
adults aged 55-64.......... 6,000 1 .016 1000
Phase III................... 400 1 .0330 133
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Total................. ........... .......... ........ 1133
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4. Examination of Barriers to Participant Compliance in a Flexible
Sigmoidoscopy Screening Program. Kaiser Foundation, Oakland--New--With
colorectal cancer comprising the second highest mortality rate among
all U.S. cancers and ranked as the fourth most common form of cancer,
the active promotion of population-based screening and early detection
is becoming increasingly important. Recognizing the importance of
screening, American Cancer Society guidelines and the new US Preventive
Services Task Force guidelines recommend colorectal cancer screening
for individuals over the age of 50. Still, although early detection of
colorectal neoplasms has been effectively demonstrated to significantly
reduce morbidity and mortality and associated economic costs,
compliance is very low. This three-year study involving investigators
at one of the nation's largest Health Maintenance Organizations'
research foundation (Kaiser Foundation of Northern California) seeks to
identify barriers associated with low compliance in a colorectal cancer
screening program utilizing flexible sigmoidoscopy.
Phase I will target and recruit participants from an existing pool
of Health Maintenance Organization enrollees who are at a relatively
high age-related risk (ages 50-64) for developing colorectal cancers
via short survey and invitation to screening. In Phase II,
investigators will conduct telephone survey to identify the relative
impact of economic, psychological, and related factors on participation
and non-participation in the mass screening programs. In phase III,
investigators will analyze and widely disseminate results of the study
via publication in the professional literature. Results will also be
made available to participants upon request. Interventions designed to
mitigate the barriers identified through this study will be
incorportated into future screening efforts and general health
education/health promotion efforts.
Participation in this study is voluntary and subsequent follow-up
and treatment, if indicated, will be provided at no cost to
participants. Informed consent will be obtained where appropriate and
oversight will be provided by federal and institutional review. The
total cost to respondents is estimated at $13,330.
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Avg.
No. of burden/ Total
Respondents No. of responses/ response burden
respondents respondent (in (in
hrs.) hrs.)
------------------------------------------------------------------------
HMO Enrollees............... 4,000 1 0.33 1320
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Total................. ........... .......... ........ 1320
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Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 96-2426 Filed 2-5-96; 8:45 am]
BILLING CODE 4163-18-P