15992 Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of August 5, 

2008 (73 FR 45463), FDA published a 

notice announcing the availability of a 

draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4A: Microbiological 

Examination of Non-Sterile Products: 

Microbial Enumeration Tests General 

Chapter.’’ The notice gave interested 

persons an opportunity to submit 

comments by October 6, 2008. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4A: Microbiological 

Examination of Nonsterile Products: 

Microbial Enumeration Tests General 

Chapter’’ was submitted to the ICH 

Steering Committee and endorsed by the 

three participating regulatory agencies 

in November 2008. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Microbiological 

Examination of Nonsterile Products: 

Microbial Enumeration Tests General 

Chapter harmonization proposal 

originating from the three-party PDG. 

This guidance is in the form of an annex 

to the core ICH Q4B guidance. When 

implemented, the annex will provide 

guidance for industry and regulators on 

the use of the specific pharmacopoeial 

texts evaluated by the ICH Q4B process. 

Following receipt of comments on the 

draft, no substantive changes were made 

to the annex. 

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 on 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. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http://www.fda.gov/cber/ 

guidelines.htm. 

Dated: March 31, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7902 Filed 4–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0400] 

International Conference on 

Harmonisation; Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex 4C on 

Microbiological Examination of 

Nonsterile Products: Acceptance 

Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4C: Microbiological 

Examination of Nonsterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter.’’ 

The guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance provides the results of the 

ICH Q4B evaluation of the 

Microbiological Examination of 

Nonsterile Products: Acceptance 

Criteria for Pharmaceutical Preparations 

and Substances for Pharmaceutical Use 

General Chapter harmonized text from 

each of the three pharmacopoeias 

(United States, European, and Japanese) 

represented by the Pharmacopoeial 

Discussion Group (PDG). The guidance 

conveys recognition of the three 

pharmacopoeial methods by the three 

ICH regulatory regions and provides 

specific information regarding the 

recognition. The guidance is intended to 

recognize the interchangeability 

between the local regional 

pharmacopoeias, thus avoiding 

redundant testing in favor of a common 

testing strategy in each regulatory 

region. In the Federal Register of 

February 21, 2008 (73 FR 9575), FDA 

made available a guidance on the Q4B 

process entitled ‘‘Q4B Evaluation and 

Recommendation of Pharmacopoeial 

Texts for Use in the ICH Regions.’’ 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 74, No. 66 / Wednesday, April 8, 2009 / Notices 15993 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), 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 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. The 

guidance may also be obtained by mail 

by calling CBER at 1–800–835–4709 or 

301–827–1800. Send two self-addressed 

adhesive labels to assist the office in 

processing your requests. Requests and 

comments should be identified with the 

docket number found in brackets in the 

heading of this 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242; or Christopher 

Joneckis, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448, 301– 

827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of August 5, 

2008 (73 FR 45467), FDA published a 

notice announcing the availability of a 

draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4C: Microbiological 

Examination of Non-Sterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter.’’ 

The notice gave interested persons an 

opportunity to submit comments by 

October 6, 2008. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 4C: Microbiological 

Examination of Nonsterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter’’ 

was submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

November 2008. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Microbiological 

Examination of Nonsterile Products: 

Acceptance Criteria for Pharmaceutical 

Preparations and Substances for 

Pharmaceutical Use General Chapter 

harmonization proposal originating 

from the three-party PDG. This guidance 

is in the form of an annex to the core 

ICH Q4B guidance. When implemented, 

the annex will provide guidance for 

industry and regulators on the use of the 

specific pharmacopoeial texts evaluated 

by the ICH Q4B process. Following 

receipt of comments on the draft, no 

substantive changes were made to the 

annex. 

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 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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http://www.fda.gov/cber/ 

guidelines.htm. 

Dated: March 31, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7905 Filed 4–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration. 

[Docket No. FDA–2009–N–0167] 

Propylthiouracyl (PTU)-Related Liver 

Toxicity; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 


rwilkins on PROD1PC63 with NOTICES