Proposed Data Collections Submitted for Public Comment and Recommendations

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

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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.

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

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