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 The draft guidance 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draft guidance explained that where 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 The draft guidance explained 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draft guidance also described, for 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 

31742 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 

Dated: June 26, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–15689 Filed 7–1–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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 meetings. 

The meetings 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: Center for Scientific 

Review Special Emphasis Panel; Informatics 

Training for Global Health. 

Date: July 13, 2009. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Doubletree Hotel Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Dan D. Gerendasy, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5132, 

MSC 7843, Bethesda, MD 20892, 301–594– 

6830, gerendad@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Biology of 

Development and Aging SBIR/STTR Review. 

Date: July 13, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Dan D. Gerendasy, PhD, 

Scientific Review Administrator, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5132, 

MSC 7843, Bethesda, MD 20892, 301–594– 

6830, gerendad@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflicts: Integrative Neuroscience. 

Date: July 14–15, 2009. 

Time: 8 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Brian Hoshaw, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5181, 

MSC 7844, Bethesda, MD 20892, 301–435– 

1033, hoshawb@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Ethanol and Neurotoxicology. 

Date: July 15–16, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Christine L. Melchior, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5176, 

MSC 7844, Bethesda, MD 20892, (301) 435– 

1713, melchioc@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Neurodevices and Neuroimaging. 

Date: July 17, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Vilen A. Movsesyan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4040M, 

MSC 7806, Bethesda, MD 20892, 301–402– 

7278, movsesyanv@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Diversity 

Fellowships: Division of Translational and 

Clinical Sciences. 

Date: July 23, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Lee Rosen, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5116, MSC 7854, Bethesda, MD 

20892, (301) 435–1171, rosenl@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Infectious 

Disease Revision Grant Applications. 

Date: July 23–24, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892, 

(Virtual Meeting). 

Contact Person: Alexander D. Politis, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3210, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

1150, politisa@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; OBT 

Competitive Revision Applications. 

Date: July 23–24, 2009. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Cathleen L. Cooper, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4208, 

MSC 7812, Bethesda, MD 20892, 301–435– 

3566, cooperc@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Chronic 

Fatigue Syndrome, Fibromyalgia Syndrome, 

Temporomandibular Disorders. 

Date: July 28–29, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Lynn E. Luethke, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5166, 

MSC 7844, Bethesda, MD 20892, (301) 435– 

1018, luethkel@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Diabetes, 

Obesity, Nutrition and Reproductive 

Sciences. 

Date: July 30–31, 2009. 

Time: 8 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Krish Krishnan, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6164, 

MSC 7892, Bethesda, MD 20892, (301) 435– 

1041, krishnak@csr.nih.gov.