[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.

------------------------------------------------------------------------
                                                         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
                             -------------------------------------------
      Total.................  ...........  ..........  ........     7050
------------------------------------------------------------------------

    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.) 
----------------------------------------------------------------------------------------------------------------
Cases w/B 12 difficiency..........................................         70            1           1        70
Normal controls...................................................         70            1           1        70
                                                                   ---------------------------------------------
      Total.......................................................  ...........  ..........  ..........      140
----------------------------------------------------------------------------------------------------------------

    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.

------------------------------------------------------------------------
                                                         Avg.           
                                             No. of     burden/   Total 
         Respondents             No. of    responses/  response   burden
                              respondents  respondent     (in      (in  
                                                         hrs.)    hrs.) 
------------------------------------------------------------------------
Population-based sample of                                              
 adults aged 55-64..........      6,000            1       .016     1000
Phase III...................        400            1      .0330      133
                             -------------------------------------------
      Total.................  ...........  ..........  ........     1133
------------------------------------------------------------------------

    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.

------------------------------------------------------------------------
                                                         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
                             -------------------------------------------
      Total.................  ...........  ..........  ........     1320
------------------------------------------------------------------------

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