47804 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 

Date: September 9, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–22373 Filed 9–16–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0408] 

Draft Guidance for Industry on 

Microbiological Data for Systemic 

Antibacterial Drug Products— 

Development, Analysis, and 

Presentation; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Microbiological Data 

for Systemic Antibacterial Drug 

Products—Development, Analysis, and 

Presentation.’’ The draft guidance 

informs industry of FDA’s current 

thinking regarding the types of 

microbiological studies, assessments, 

and clinical trials needed to support an 

investigational new drug application 

(IND) and a new drug application (NDA) 

for a systemic antibacterial drug 

product. Recommendations in this 

guidance cover microbiological 

considerations in the three major areas 

of conducting general nonclinical 

studies; conducting animal and human 

studies and clinical trials; and 

establishing and updating in vitro 

susceptibility test methods, quality 

control (QC) parameters, and 

interpretive criteria. This guidance also 

recommends the content and format for 

presentation of microbiological data for 

antibacterial drug products in the 

Microbiology subsection of labeling. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by December 16, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 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 draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: Fred 

Marsik, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, rm. 6108, Silver Spring, 

MD 20993–0002, 301–796–7956; or 

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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Microbiological Data for Systemic 

Antibacterial Drug Products— 

Development, Analysis, and 

Presentation.’’ This guidance provides 

recommendations on the type of 

information to provide in submissions 

to the clinical microbiology section of 

INDs and NDAs for systemic 

antibacterial drug products. The in vitro 

microbiological data and in vivo animal 

studies (e.g., spectrum of activity in 

vitro and in appropriate animal models 

of human disease) support the 

justification of testing in humans. 

Sponsors usually submit data from 

nonclinical investigations to provide 

proof of concept of clinical activity 

before commencing human phase 2 

studies and clinical trials and to aid in 

the development of provisional 

interpretive criteria for use in phase 3 

clinical trials. Microbiological data 

submitted to an NDA will be used to 

substantiate the microbiological 

information contained in the labeling. 

Specific topics discussed in the 

guidance include validating in vitro 

susceptibility testing methods; 

mechanism of action studies; 

mechanism of resistance studies; use of 

animal models; clinical trial protocols; 

establishment of QC parameters and 

interpretive criteria; submission and 

placement of microbiology information 

in the NDA submission; format and 

content of the Microbiology subsection 

of the labeling; and revision of existing 

susceptibility testing methods, QC 

parameters, or interpretive criteria. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the microbiological data for systemic 

antibacterial drug products. 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. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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). 

(1) The draft guidance provides 

recommendations on the type of 

information to include in submissions 

of the clinical microbiology section of 

INDs and NDAs for systemic 

antibacterial drug products. The 

microbiology section of an NDA is 

required under 21 CFR 314.50(d)(4) and 

this information collection is approved 

under OMB Control Number 0910–0001. 

For INDs, this information is required 

under 21 CFR 312.23(a) and approved 

under OMB Control Number 0910–0014. 

(2) The draft guidance also 

recommends the types of data that 

should be submitted in a labeling 

supplement to update the microbiology 

information in approved labeling if an 

application holder chooses to update 

this information without relying on a 

standard recognized by FDA. The 

submission of labeling supplements is 

required under 21 CFR 314.70(b)(2)(v) 

and 201.56(a)(2) and this information 

collection is approved under OMB 

Control Numbers 0910–0001 and 0910– 

0572, respectively. 

(3) Appendix A of the draft guidance 

describes the content of the 

Microbiology subsection of labeling. 

This labeling is covered under 21 CFR 

201.57(c)(13)(i) and the information 

collection is approved under OMB 

Control Number 0910–0572. 

(4) The draft guidance also references 

the guidance for industry entitled 

‘‘Updating Labeling for Susceptibility 

Test Information in Systemic 

Antibacterial Drug Products and 

Antimicrobial Susceptibility Testing 

Devices’’ for updating labeling 

information. The information collection 

in this guidance has been approved 

under OMB Control Number 0910–0638. 


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Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices 47805 

III. 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. 

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: September 10, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22380 Filed 9–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0293] 

Guidance for Industry: Considerations 

for Allogeneic Pancreatic Islet Cell 

Products; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Considerations 

for Allogeneic Pancreatic Islet Cell 

Products’’ dated September 2009. The 

guidance document provides 

recommendations to manufacturers, 

sponsors, and clinical investigators 

involved in the transplantation of 

allogeneic pancreatic islet cell products 

for clinical investigations of the 

treatment of type 1 diabetes mellitus. 

The guidance identifies the types of data 

and information obtained during 

investigational new drug studies that 

may be helpful in establishing the 

safety, purity, and potency of a 

biological product in a biologics license 

application (BLA). The guidance 

announced in this notice finalizes the 

draft guidance of the same title, dated 

May 2008. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Valerie A. Butler, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Considerations for Allogeneic 

Pancreatic Islet Cell Products’’ dated 

September 2009. The guidance 

document provides recommendations to 

manufacturers, sponsors, and clinical 

investigators involved in the 

transplantation of allogeneic pancreatic 

islet cell products for clinical 

investigations of the treatment of type 1 

diabetes mellitus. The guidance 

identifies the types of data and 

information that may be obtained during 

investigational new drug studies to 

assist in establishing the safety, purity, 

and potency of a biological product in 

a BLA. However, the guidance is not 

intended to identify all of the product, 

preclinical, and clinical data that may 

be needed to successfully support a 

BLA. 

In the Federal Register of May 22, 

2008 (73 FR 29760), FDA announced the 

availability of the draft guidance of the 

same title, dated May 2008. FDA 

received a few comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. The guidance announced in 

this notice finalizes the draft guidance 

dated May 2008. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’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. Paperwork Reduction Act of 1995 

The guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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 collections of information in 

21 CFR part 211 has been approved 

under 0910–0139; the collections of 

information in 21 CFR part 312 has been 

approved under 0910–0014; the 

collections of information in 21 CFR 

parts 601 and 610 have been approved 

under 0910–0338; and the collections of 

information in 21 CFR part 1271 has 

been approved under 0910–0543 and 

0910–0559. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. 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. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm or http:// 

www.regulations.gov. 

Dated: September 11, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22426 Filed 9–16–09; 8:45 am] 

BILLING CODE 4160–01–S 


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