35870 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 

ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued 

Respondents Form Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response (in 

hours) 

List of Blood Isolates ...................................... 6,000 1 1 

Manual Categorization of Positive Blood Cultures.6,000 1 1 

Exposures to Blood/Body Fluids .................... 600 50 1 

Healthcare Personnel Post-exposure Prophylaxis.600 10 15/60 

Healthcare Personnel Demographic Data ..... 600 200 20/60 

Healthcare Personnel Vaccination History .... 600 300 10/60 

Annual Facility Survey ................................... 600 1 8 

Healthcare Worker Survey ............................. 600 100 10/60 

Healthcare Personnel Influenza Vaccination 

Form.

600 500 10/60 

Healthcare Personnel Influenza Antiviral 

Medication Administration Form.

600 50 10/60 

Pre-season Survey on Influenza Vaccination 

Programs for Healthcare Workers.

600 1 10/60 

Post-Season Survey on Influenza Vaccination Programs for Healthcare Workers.600 1 10/60 

Central Line Insertion Practices Adherence 

Monitoring Form (CLIP).

6,000 100 10/60 

Laboratory Testing ......................................... 600 100 15/60 

MDRO Prevention Process and Outcome 

Measures Monthly Monitoring Form.

6,000 24 10/60 

MDRO or CDAD Infection Event Form .......... 6,000 72 30/60 

Laboratory Identified MDRO or CDAD Event 

Form (LabID).

6,000 240 30/60 

Registration Form ........................................... 6,000 1 5/60 

High Risk Inpatient Influenza Vaccine—Summary Form Method A.6,000 5 16 

High Risk Inpatient Influenza Vaccine—Numerator Data Form Method B.2,000 250 10/60 

High Risk Inpatient Influenza Vaccine—Summary Form Method B.2,000 5 4 

High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B.2,000 250 5/60 

Hemovigilance Module Annual Survey .......... 500 1 2 

Hemovigilance Module Monthly Reporting 

Plan.

500 12 2/60 

Hemovigilance Module Blood Product Incident Reporting—Summary Data.500 12 2 

Hemovigilance Module Monthly Reporting 

Denominators.

500 12 30/60 

Hemovigilance Incident .................................. 500 72 10/60 

Hemovigilance Adverse Reaction .................. 500 120 10/60 

Dated: July 13, 2009. 

Marilyn S. Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–17263 Filed 7–20–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60 Day–09–09CD] 

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. 

Alternatively, to obtain a copy of the 

data collection plans and instrument, 

call 404–639–5960 and send comments 

to Maryam I. Daneshvar, CDC Reports 

Clearance Officer, 1600 Clifton Road, 

NE., MS–D74, Atlanta, Georgia 30333; 

comments may also be sent by 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 a 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 35871 

use of information technology. Written 

comments should be received within 60 

days of this notice. 

Proposed Project 

Laboratory Medicine Best Practices 

Project (LMBP)—New—National Center 

for Preparedness, Detection, and Control 

of Infectious Diseases (NCPDCID), 

Centers for Disease Control and 

Prevention (CDC) 

Background and Brief Description 

CDC is seeking approval from the 

Office of Management and Budget 

(OMB) to collect information from 

healthcare organizations in order to 

conduct a systemic review of laboratory 

practice effectiveness. The purpose of 

information collection is to include 

completed unpublished quality 

improvement studies/assessments 

carried out by healthcare organizations 

(laboratories, hospitals, clinics) in 

systematic reviews of practice 

effectiveness. CDC has been sponsoring 

the Laboratory Medicine Best Practices 

(LMBP) initiative to develop new 

systematic evidence reviews methods 

for making evidence-based 

recommendations in laboratory 

medicine. This initiative supports the 

CDC’s mission of improving laboratory 

practices. 

The focus of the Initiative is on preand post-analytic laboratory medicine 

practices that are effective at improving 

health care quality. While evidencebased approaches for decision-making 

have become standard in healthcare, 

this has been limited in laboratory 

medicine. No single-evidence-based 

model for recommending practices in 

laboratory medicine exists, although the 

number of laboratories operating in the 

United States and the volume of 

laboratory tests available certainly 

warrant such a model. 

The Laboratory Medicine Best 

Practices Initiative began in October 

2006, when CDC convened the 

Laboratory Medicine Best Practices 

Workgroup (Workgroup), a 

multidisciplinary panel of experts in 

several fields including laboratory 

medicine, clinical medicine, health 

services research, and health care 

performance measurement. The 

Workgroup has been supported by staff 

at CDC and the Battelle Memorial 

Institute under contract to CDC. 

To date, the Laboratory Medicine Best 

Practices (LMBP) project work has been 

completed over three phases. During 

Phase 1 (October 2006–September 2007) 

of the project, CDC staff developed 

systematic review methods for 

conducting evidence reviews using 

published literature, and completed a 

proof-of-concept test. Results of an 

extensive search and review of 

published literature using the methods 

for the topic of patient specimen 

identification indicated that an 

insufficient quality and number of 

studies were available for completing 

systematic evidence reviews of 

laboratory medicine practice 

effectiveness for multiple practices, and 

hence for making evidence-based 

recommendations. These results were 

considered likely to be generalizable to 

most potential topic areas of interest. 

A finding from Phase 1 work was that 

laboratories would be unlikely to 

publish quality improvement projects or 

studies demonstrating practice 

effectiveness in the peer reviewed 

literature, but that they routinely 

conducted quality improvement projects 

and had relevant data for completion of 

evidence reviews. Phase 2 (September 

2007–November 2008) and Phase 3 

(December 2008–September 2009), 

involved further methods development 

and pilot tests to obtain, review, and 

evaluate published and unpublished 

evidence for practices associated with 

the topics of patient specimen 

identification, communicating critical 

value test results, and blood culture 

contamination. Exploratory work by 

CDC supports the existence of relevant 

unpublished studies or completed 

quality improvement projects related to 

laboratory medicine practices from 

healthcare organizations. The objective 

for successive LMBP evidence reviews 

of practice effectiveness is to 

supplement the published evidence 

with unpublished evidence to fill in 

gaps in the literature. 

Healthcare organizations and facilities 

(laboratory, hospital, clinic) will have 

the opportunity to voluntarily enroll in 

an LMBP network and submit readily 

available unpublished studies; quality 

improvement projects, evaluations, 

assessments, and other analyses relying 

on unlinked, anonymous data using the 

LMBP Submission Form. LMBP 

Network participants will also be able to 

submit unpublished studies/data for 

evidence reviews on an annual basis 

using this form. There is no cost to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

(in hours) 

Total burden 

(in hours) 

Healthcare Organizations ................................................................................ 150 1 40/60 100 

Total .......................................................................................................... ........................ ........................ ........................ 100 

Dated: July 15, 2009. 

Marilyn S. Radke, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. E9–17266 Filed 7–20–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–F–0303] 

Ajinomoto Co., Inc.; Filing of Food 

Additive Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Ajinomoto Co., Inc., has filed a 

petition proposing that the food additive 

regulations be amended to provide for 

the safe use of N-[N-[3-(3-hydroxy-4- 

methoxyphenyl) propyl-a-aspartyl]-Lphenylalanine 1-methyl ester, 

monohydrate (CAS Reg. No. 714229– 

20–6) for use as a non-nutritive 

sweetener in tabletop applications and 

powdered beverage mixes. Ajinomoto 

Co., Inc., also proposes that this additive 

be identified as advantame. 

DATES: Submit written or electronic 

comments on the petitioner’s 


jlentini on DSKJ8SOYB1PROD with NOTICES