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completed unpublished quality 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
35872 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices 

environmental assessment by August 

20, 2009. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Blondell Anderson, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1304. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), 

notice is given that a food additive 

petition (FAP 9A4778) has been filed by 

Ajinomoto Co., Inc., c/o Ajinomoto 

Corporate Services LLC, 1120 

Connecticut Ave. NW., suite 1010, 

Washington, DC 20036. The petition 

proposes to amend the food additive 

regulations in part 172 Food Additives 

Permitted For Direct Addition to Food 

for Human Consumption (21 CFR part 

172) to provide for the safe use of N-[N- 

[3-(3-hydroxy-4-methoxyphenyl) 

propyl-a-aspartyl]-L-phenylalanine 1- 

methyl ester, monohydrate (CAS Reg. 

No. 714229–20–6) for use as a nonnutritive sweetener in tabletop 

applications and powdered beverage 

mixes. 

The potential environmental impact 

of this petition is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the agency finds 

that an environmental impact statement 

is not required, and this petition results 

in a regulation, the notice of availability 

of the agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

Dated: July 10, 2009. 

Laura M. Tarantino, 

Director, Office of Food Additive Safety, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. E9–17250 Filed 7–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

National Health and Nutrition 

Examination Survey (NHANES) Stored 

Biologic Specimens: Guidelines for 

Proposals to Use Samples and 

Proposed Cost Schedule 

ACTION: Notice and request for 

comments. 

SUMMARY: The National Health and 

Nutrition Examination Survey 

(NHANES) is a program of periodic 

surveys conducted by the National 

Center for Health Statistics (NCHS) of 

the Centers for Disease Control and 

Prevention (CDC). Examination surveys 

conducted since 1960 by NCHS, have 

provided national estimates of health 

and nutritional status of the United 

States civilian non-institutionalized 

population. To add to the large amount 

of information collected for the purpose 

of describing the health of the 

population in the most recent survey, 

serum, urine and limited plasma 

samples were collected and stored for 

future research projects. Specimens are 

currently available from NHANES III 

(conducted from 1988–1994) and from 

NHANES 1999–2008. In 1999, NHANES 

became a continuous survey with data 

release every two years. Specimens are 

available from two year survey cycles 

after the demographic file has been 

released to the public. Participants in 

the survey that began in 1999 signed a 

separate consent document agreeing to 

specimen storage allowing their biologic 

specimens to be used for approved 

research projects. 

Specimens are stored in two 

Specimen Banks. Surplus samples that 

were initially used for laboratory assays 

included in the surveys, have since been 

stored at ¥70 °C and have been through 

at least two freeze-thaw cycles. They are 

stored at a commercial repository under 

contract to NCHS. In addition, on 

average, six vials of sera were also 

stored in vapor-phase liquid nitrogen at 

the CDC and ATSTR Specimen 

Packaging, Inventory and Repository 

(CASPIR) Repository in Lawrenceville, 

GA. These specimens have not 

undergone a freeze-thaw cycle. The 

CASPIR Repository is considered a longterm repository for the NHANES 

specimens. NCHS is making both of 

these collections available for research 

proposals. The research proposals that 

can use the surplused specimens will 

receive higher priority. Proposals that 

request the specimens in CASPIR need 

to justify the use of the unthawed 

specimens. 

The purpose of this notice is to 

request comments on this program and 

the proposed cost schedule. After 

consideration of comments submitted, 

CDC will finalize and publish the cost 

schedule and accept proposals for use of 

the NHANES stored biologic samples. 

Please go to http://www.cdc.gov/nchs/ 

nhanes/proposal_guidelines.htm for 

final proposal guidelines. 

All interested researchers are 

encouraged to submit proposals. No 

funding is provided as part of this 

solicitation. Samples will not be 

provided to those projects requiring 

funding until the project has received 

funds. Approved projects that do not 

obtain funding will be canceled. A more 

complete description of this program 

follows. 

DATES: 

• Comment Receipt Date: August 20, 

2009. 

• Invitation to Submit Proposals: Can 

be submitted on an ongoing basis 

• Scientific Review Date: Within two 

months of proposal submission. 

• Institutional Review Date: Within 

one month of final proposal acceptance. 

• Anticipated distribution of samples: 

one month after IRB approval. 

ADDRESSES: To send comments and to 

request information, contact: Dr. 

Geraldine McQuillan, Division of Health 

and Nutrition Examination Surveys, 

National Center for Health Statistics, 

Centers for Disease Control and 

Prevention, 3311 Toledo Road, Room 

4204, Hyattsville, MD 20782, 

Phone: 301–458–4371, 

Fax: 301–458–4028, 

E-mail: gmm2@cdc.gov. 

Internet: http://www.cdc.gov/nchs/ 

about/major/nhanes/serum1b.htm. 

Authority: Sections 301,306 and 308 of the 

Public Health Service Act (42 U.S.C. 241, 

242k and 242M). 

SUPPLEMENTARY INFORMATION: 

The goals of NHANES are: (1) To 

estimate the number and percent of 


jlentini on DSKJ8SOYB1PROD with NOTICES