31740 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 

800–328–6942 (Formerly: Centinela 

Hospital Airport Toxicology 

Laboratory). 

Pathology Associates Medical 

Laboratories, 110 West Cliff Dr., 

Spokane, WA 99204. 509–755–8991/ 

800–541–7891x7. 

Phamatech, Inc., 10151 Barnes Canyon 

Road, San Diego, CA 92121. 858–643– 

5555. 

Quest Diagnostics Incorporated, 3175 

Presidential Dr., Atlanta, GA 30340. 

770–452–1590/800–729–6432 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 400 

Egypt Road, Norristown, PA 19403. 

610–631–4600/877–642–2216 

(Formerly: SmithKline Beecham 

Clinical Laboratories; SmithKline BioScience Laboratories). 

Quest Diagnostics Incorporated, 7600 

Tyrone Ave., Van Nuys, CA 91405. 

866–370–6699/818–989–2521 

(Formerly: SmithKline Beecham 

Clinical Laboratories). 

S.E.D. Medical Laboratories, 5601 Office 

Blvd., Albuquerque, NM 87109. 505– 

727–6300/800–999–5227. 

South Bend Medical Foundation, Inc., 

530 N. Lafayette Blvd., South Bend, 

IN 46601. 574–234–4176 x276. 

Southwest Laboratories, 4625 E. Cotton 

Center Boulevard, Suite 177, Phoenix, 

AZ 85040. 602–438–8507/800–279– 

0027. 

St. Anthony Hospital Toxicology 

Laboratory, 1000 N. Lee St., 

Oklahoma City, OK 73101. 405–272– 

7052. 

STERLING Reference Laboratories, 2617 

East L Street, Tacoma, Washington 

98421. 800–442–0438. 

Toxicology & Drug Monitoring 

Laboratory, University of Missouri 

Hospital & Clinics, 301 Business Loop 

70 West, Suite 208, Columbia, MO 

65203. 573–882–1273. 

Toxicology Testing Service, Inc., 5426 

NW. 79th Ave., Miami, FL 33166. 

305–593–2260. 

U.S. Army Forensic Toxicology Drug 

Testing Laboratory, 2490 Wilson St., 

Fort George G. Meade, MD 20755– 

5235. 301–677–7085. 

*The Standards Council of Canada 

(SCC) voted to end its Laboratory 

Accreditation Program for Substance 

Abuse (LAPSA) effective May 12, 1998. 

Laboratories certified through that 

program were accredited to conduct 

forensic urine drug testing as required 

by U.S. Department of Transportation 

(DOT) regulations. As of that date, the 

certification of those accredited 

Canadian laboratories will continue 

under DOT authority. The responsibility 

for conducting quarterly performance 

testing plus periodic on-site inspections 

of those LAPSA-accredited laboratories 

was transferred to the U.S. HHS, with 

the HHS’ NLCP contractor continuing to 

have an active role in the performance 

testing and laboratory inspection 

processes. Other Canadian laboratories 

wishing to be considered for the NLCP 

may apply directly to the NLCP 

contractor just as U.S. laboratories do. 

Upon finding a Canadian laboratory to 

be qualified, HHS will recommend that 

DOT certify the laboratory (Federal 

Register, July 16, 1996) as meeting the 

minimum standards of the Mandatory 

Guidelines published in the Federal 

Register on April 13, 2004 (69 FR 

19644). After receiving DOT 

certification, the laboratory will be 

included in the monthly list of HHScertified laboratories and participate in 

the NLCP certification maintenance 

program. 

Elaine Parry, 

Director, Office of Program Services, 

SAMHSA. 

[FR Doc. E9–15648 Filed 7–1–09; 8:45 am] 

BILLING CODE 4160–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0339] 

Guidance for Industry on Updating 

Labeling for Susceptibility Test 

Information in Systemic Antibacterial 

Drug Products and Antimicrobial 

Susceptibility Testing Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Updating Labeling for 

Susceptibility Test Information in 

Systemic Antibacterial Drug Products 

and Antimicrobial Susceptibility 

Testing Devices.’’ The Food and Drug 

Administration Amendments Act of 

2007 (FDAAA) includes a requirement 

that FDA identify and periodically 

update susceptibility test interpretive 

criteria for antibacterial drug products 

and make those findings publicly 

available. This guidance describes how 

FDA will comply with the FDAAA 

requirement and procedures for 

application holders to update the 

labeling of antibacterial drug products 

and antimicrobial susceptibility testing 

(AST) devices. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002 or the 

Division of Small Manufacturers 

Assistance (HFZ–220), Center for 

Devices and Radiological Health, Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850–4307. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the guidance 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding antibacterial drug 

products: Edward Cox, Center for 

Drug Evaluation and Research, 

Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 

22, rm. 6212, Silver Spring, MD 

20993–0002, 301–796–1300; or 

Regarding AST devices: Freddie 

Poole, Center for Devices and 

Radiological Health (HFZ–440), 

Food and Drug Administration, 

2098 Gaither Rd., Rockville, MD 

20850, 240–276–0712. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Updating Labeling for Susceptibility 

Test Information in Systemic 

Antibacterial Drug Products and 

Antimicrobial Susceptibility Testing 

Devices.’’ Antibacterial susceptibility 

testing is used to determine if bacteria 

that are isolated from a patient with an 

infection are likely to be killed or 

inhibited by a particular antibacterial 

drug product at the concentrations of 

the drug that are attainable at the site of 

infection using the dosing regimen(s) 

indicated in the drug product’s labeling. 

The results from antibacterial 

susceptibility testing generally 

categorize bacteria as ‘‘susceptible,’’ 

‘‘intermediate,’’ or ‘‘resistant’’ to each 

antibacterial drug tested. When 

available, culture and susceptibility 

testing results are one of the factors that 

physicians consider when selecting an 

antimicrobial drug product for treating a 

Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 31741 

patient. The numerical values generated 

by susceptibility testing to determine 

whether a particular microorganism is 

susceptible to a particular antimicrobial 

drug—the antimicrobial susceptibility 

test interpretive criteria—are commonly 

referred to as breakpoints. These 

breakpoints are specified in the 

antimicrobial drug product’s label. The 

antimicrobial susceptibility test 

interpretive criteria can be used to 

interpret results from either manual or 

automated AST devices. 

On September 27, 2007, FDAAA 

(Public Law 110–85) was signed into 

law. Section 1111 of FDAAA requires 

FDA to identify and periodically update 

susceptibility test interpretive criteria 

for antibacterial drug products and to 

make those findings publicly available. 

By enacting section 1111 of FDAAA, 

Congress recognized the importance of 

maintaining updated susceptibility test 

interpretive criteria. 

In the Federal Register of June 12, 

2008 (73 FR 33438), FDA issued a draft 

guidance entitled ‘‘Updating Labeling 

for Susceptibility Test Information in 

Systemic Antibacterial Drug Products 

and Antimicrobial Susceptibility 

Testing Devices.’’ The draft guidance 

described procedures for FDA, drug 

application holders, and AST device 

manufacturers to ensure that updated 

susceptibility test information is 

available to health care providers. The 

draft guidance explained that where 

appropriate, FDA intends to identify 

susceptibility test interpretive criteria, 

quality control parameters, and 

susceptibility test methods by 

recognizing annually, in a Federal 

Register notice, standards developed by 

one or more nationally or 

internationally recognized standard 

development organizations. The draft 

guidance described, for holders of 

applications for approved antibacterial 

drug products, the option of relying on 

such standards to update their product 

labeling. The draft guidance explained 

that the agency intends to make the 

updated information available by 

publicly posting changes to the drug 

product labeling within 30 days 

following approval of a supplement that 

includes a change to the Microbiology 

subsection of the product labeling. The 

draft guidance also described, for 

manufacturers of in vitro diagnostic 

AST devices, the process for updating 

the susceptibility test information in 

their labeling to conform with updated 

labeling for a relevant antibacterial drug 

product. 

FDA has carefully reviewed 

comments received on the draft 

guidance (11 comments were submitted 

to the public docket). This final version 

of the guidance reflects our 

consideration of these comments, as 

well as our experience updating the 

labeling of susceptibility test 

information in systemic antibacterial 

drug products and AST devices. Most of 

the changes to the guidance were made 

to clarify statements in the draft 

guidance. The following changes in the 

final version of the guidance are 

noteworthy: 

• The guidance clarifies that FDA is 

not imposing new requirements by 

recommending that drug application 

holders submit revised labeling or an 

explanation of why revisions are not 

needed within a specific time period 

after FDA recognizes a standard that is 

different from the information in the 

Microbiology subsection of the labeling 

for the application holder’s drug 

product. (See 21 CFR 201.56(a)(2).) 

• The agency revised the 

recommended time period for 

submitting revised labeling by 

extending the period from 60 days to 90 

days. 

Certain requests that the guidance 

provide greater detail regarding the 

procedures for updating in vitro AST 

devices have not been addressed in this 

guidance but will be addressed when 

FDA updates ‘‘Class II Special Controls 

Guidance Document: Antimicrobial 

Susceptibility Test (AST) Systems; 

Guidance for Industry and FDA.’’ This 

guidance is being issued consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). The 

guidance represents the agency’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

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. 

III. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection of information in 

this guidance was approved under OMB 

control number 0910-0638. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: June 26, 2009. 

David Horowitz, 

Assitant Commissioner for Policy 

[FR Doc. E9–15682 Filed 7–1–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Environmental Health Sciences Special 

Emphasis Panel; Research Conference Grants 

with an Environmental Health Focus. 

Date: July 30, 2009. 

Time: 2 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIEHS/National Institutes of Health, 

Keystone Building, 530 Davis Drive, Research 

Triangle Park, NC 27709 (Telephone 

Conference Call). 

Contact Person: Linda K. Bass, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research and Training, Nat. Institute 

Environmental Health Sciences, P.O. Box 

12233, MD EC–30, Research Triangle Park, 

NC 27709. (919) 541–1307. 

bass@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund