Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64955

date include: Human Cloning and 

Human Dignity: An Ethical Inquiry (July 

2002); Beyond Therapy: Biotechnology 

and the Pursuit of Happiness (October 

2003); Being Human: Readings from the 

President’s Council on Bioethics

(December 2003); Monitoring Stem Cell 

Research (January 2004), and 

Reproduction and Responsibility: The 

Regulation of New Biotechnologies

(March 2004).

DATES: The meeting will take place 

Thursday, December 2, 2004, from 9 

a.m. to 4:30 p.m. ET; and Friday, 

December 3, 2004, from 8:30 a.m. to 

12:30 p.m. ET.

ADDRESSES: The Stephen Decatur 

House, 1610 H Street, NW., Washington, 

DC 20002. Phone 202–842–0920. 

Agenda: The meeting agenda will be 

posted at http://www.bioethics.gov.

Public Comments: The Council 

encourages public input, either in 

person or in writing. At this meeting, 

interested members of the public may 

address the Council, beginning at 11:30 

a.m., on Friday, December 3. Comments 

are limited to no more than five minutes 

per speaker or organization. As a 

courtesy, please inform Ms. Diane 

Gianelli, Director of Communications, 

in advance of your intention to make a 

public statement, and give your name 

and affiliation. To submit a written 

statement, mail or e-mail it to Ms. 

Gianelli at one of the addresses given 

below.

FOR FURTHER INFORMATION CONTACT: Ms. 

Diane Gianelli, Director of 

Communications, The President’s 

Council on Bioethics, Suite 700, 1801 

Pennsylvania Avenue, Washington, DC 

20006. Telephone: 202/296–4669. Email: info@bioethics.gov. Web site: 

http://www.bioethics.gov.

Dated: November 3, 2004. 

Yuval Levin, 

Acting Executive Director, The President’s 

Council on Bioethics.

[FR Doc. 04–24945 Filed 11–8–04; 8:45 am] 

BILLING CODE 4150–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–04–0012] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

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) 498–1210 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Human 

Resources and Housing Branch, New 

Executive Office Building, Room 10235, 

Washington, DC 20503 or by fax to (202) 

395–6974. Written comments should be 

received within 30 days of this notice. 

Proposed Project 

National Nosocomial Infections 

Surveillance (NNIS) System—

Reinstatement with change—National 

Center for Infectious Disease (NCID), 

Centers for Disease Control and 

Prevention (CDC). 

The NNIS system, which was 

instituted in 1970, is an ongoing 

surveillance system currently involving 

345 hospitals that voluntarily report 

nosocomial infections data to CDC, who 

aggregate the data into a national 

database. The data are collected using 

surveillance protocols developed by 

CDC for high risk patient groups (ICU, 

high-risk nursery, and surgical patients). 

Instructional manuals, training of 

surveillance personnel and computer 

surveillance software are among the 

support that CDC provides without cost 

to participating hospitals to ensure the 

reporting of accurate and uniform data. 

In the very near future this data 

collection will be merged with two 

other collections to form the National 

Healthcare Safety Network (NHSN). 

This network will be a computer-based 

system. Since this system will be 

phased in over time, CDC will need to 

continue using the forms within this 

clearance request until the 

transformation has been completed. 

The purpose of the NNIS system is to 

provide national data on the incidence 

of nosocomial infections and their risk 

factors, and on emerging antibiotic 

resistance. The data are used to 

determine: (1) The magnitude of various 

nosocomial infection problems; (2) 

trends in infection rates among patients 

with similar risks; and (3) changes in 

the epidemiology of nosocomial 

infections resulting from new medical 

therapies and changing patient risks. 

New to the NNIS system is the 

monitoring of antibiotic resistance and 

antimicrobial use in groups of patients. 

Data from the monitoring of antibiotic 

resistance and antimicrobial use in the 

NNIS system will be used to describe 

the epidemiology of antibiotic resistance 

and understand the role of antimicrobial 

therapy to the growing problem of 

antibiotic resistance. The NNIS system 

can also serve as a sentinel system for 

the detection of nosocomial infection 

outbreaks in the event of national 

distribution of a contaminated medical 

product or device. 

The respondent burden is not the 

same in each hospital since the 

hospitals can select from a wide variety 

of surveillance options. A typical 

hospital will monitor patients for 

infections in two ICUs and surgical site 

infections following three surgical 

operations. The respondent burden 

includes the time and cost to: (1) Collect 

data on nosocomial infections in 

patients in these groups and the 

denominator data to characterize risk 

factors in the patients who are being 

monitored; (2) to enter the data as well 

as a surveillance plan into the 

surveillance software; (3) send the data 

to CDC by electronic transmission; and 

(4) complete a short annual survey and 

administrative forms. The total 

annualized burden is 66,775 hours.

Form title Number of

respondents 

Number of

responses/

respondent 

Average

burden per

response

(in hrs.) 

Hospital Personnel List .............................................................................................................. 297 1 15/60 

Annual Participating Institution Survey ...................................................................................... 297 1 45/60 

NNIS Infection Worksheet: 

Hospitals with High Risk Nursery ....................................................................................... 100 240 (20×12) 25/60 

Hospitals without High Risk Nursery .................................................................................. 197 180 (15×12) 25/60 

Adult & Pediatric ICU Monthly Report ....................................................................................... 235 12 6 

High Risk Nursery Surveillance Monthly Report ....................................................................... 100 12 4 

Surgical Patient Surveillance-Operative Procedure Daily Report ............................................. 205 12 2 

Monthly Surveillance Plan ......................................................................................................... 277 12 25/60 

Supplementary Data Collection, Cesarean Patient Report ....................................................... 29 240 27/60 

64956 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 

Form title Number of

respondents 

Number of

responses/

respondent 

Average

burden per

response

(in hrs.) 

Supplementary Data Collection, Craniotomy Patient Report .................................................... 9 58 27/60 

Supplementary Data Collection, Spinal Fusion Patient Report ................................................ 18 60 27/60 

Supplementary Data Collection, Ventricular Shunt Patient ....................................................... 10 180 27/60 

AUR Surveillance Monthly Report: 

ICP ...................................................................................................................................... 30 12 (1×12) 2 

Laboratory Technician ........................................................................................................ 30 60 (5×12) 3 

Pharmacy Technician ......................................................................................................... 30 48 (4×12) 2 

AUR Surveillance Contact Information ...................................................................................... 40 1 10/60 

Antimicrobial Prescribing Practices ........................................................................................... 30 1 15/60 

Dated: November 3, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–24892 Filed 11–8–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–05AD] 

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 404–498–1210 or send 

comments to Seleda Perryman, CDC 

Assistant Reports Clearance Officer, 

1600 Clifton Road, MS–E11, Atlanta, GA 

30333 or send an e-mail to 

omb@cdc.gov.

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 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Helping to End Lead Poisoning 

(HELP): A Questionnaire Study of 

Medicaid Providers’ Beliefs, Barriers, 

Knowledge, and Cues to Action for 

Childhood Blood Lead Testing—New—

National Center for Environmental 

Health (NCEH), Centers for Disease 

Control and Prevention (CDC). 

According to the United States 

Department of Health and Human 

Services (DHHS), lead poisoning is one 

of the most serious environmental 

threats to children in the United States. 

Very high blood lead levels in children 

can cause encephalopathy, coma, and 

even death. At lower levels, lead 

poisoning is a silent attacker because 

most children who are lead poisoned do 

not show symptoms. Low levels of lead 

poisoning are often associated with 

reductions in IQ and attention span, and 

with learning disabilities, hyperactivity, 

and behavioral problems. Because of 

these subtle effects, the best way to 

determine if a child has lead poisoning 

is by giving the child a blood lead test. 

Children eligible for Medicaid are 

typically at highest risk for lead 

exposure. DHHS policies require blood 

lead testing for all children participating 

in federal health care programs. 

However, most children in or targeted 

by federal health care programs have not 

been tested. This study will help to 

provide some of the reasons why most 

children are not being tested. 

Although blood lead testing is 

important, it is ineffective unless it is 

performed when the child is young 

enough to receive the full benefits of 

effective environmental interventions. 

Thus, it was determined by CDC that 

more information is needed to 

understand the barriers Medicaid 

providers face when it comes to blood 

lead testing. 

HELP is a comparison study between 

two communities in Wisconsin. To 

determine why some areas in Wisconsin 

have high blood lead testing rates and 

others do not, Medicaid providers in 

two areas will be studied. Community 1 

has high and Community 2 has low 

blood lead testing rates. Questionnaires 

will be mailed to all Medicaid providers 

in these two Wisconsin communities. 

The questionnaires will be mailed from 

the Wisconsin Childhood Lead 

Poisoning Prevention Program in 

Milwaukee, Wisconsin. CDC will 

analyze the data from the 

questionnaires. CDC and the Wisconsin 

Childhood Lead Poisoning Prevention 

Program staff will use this information 

to understand the barriers Medicaid 

providers face concerning blood lead 

testing and to develop effective 

strategies that promote blood lead 

testing among Medicaid providers. 

There are no costs to respondents except 

their time to participate.

ANNUALIZED BURDEN TABLE

Respondents Number of

respondents 

Number of

responses per

respondent 

Average

burden per

response

(in hrs.) 

Total

burden

hours 

Targeted Medicaid Providers in Wisconsin ..................................................... 500 1 10/60 83 

Total ................................................................................................................. ........................ ........................ ........................ 83