908 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

evaluation. In table 1 of this document, 

row 1 shows that for 20 evaluations, the 

total burden for these 4 data 

components is 80 hours. 

Two data components ask for original 

data to be generated. One data 

component consists of a bioinformatics 

analysis which can be performed using 

publicly available databases. The other 

data component involves ‘‘wet’’ lab 

work to assess the new protein’s 

stability and the resistance of the 

protein to enzymatic degradation using 

appropriate in vitro assays (protein 

digestibility study). The paperwork 

burden of these two data components 

consists of the time it takes the company 

to assemble the information on these 

two data components to submit to FDA. 

We estimate that these two data 

components will take 16 hours to 

complete (8 hours for each component). 

In table 1 of this document, row 2 shows 

that for 20 evaluations, the total burden 

for these two data components is 320 

hours. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: December 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–213 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0081] (formerly 

Docket No. 2006D–0297) 

International Conference on 

Harmonisation; Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex on 

Test for Extractable Volume of 

Parenteral Preparations 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 2: Test for 

Extractable Volume of Parenteral 

Preparations 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 Test for 

Extractable Volume of Parenteral 

Preparations 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. 

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, Training, and 

Manufacturers Assistance (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 selfaddressed adhesive labels to assist the 

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 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–1), 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 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 909 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of December 

17, 2007 (72 FR 71417), 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 2: Test for 

Extractable Volume of Parenteral 

Preparations General Chapter.’’ The 

notice gave interested persons an 

opportunity to submit comments by 

February 15, 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 2: Test for 

Extractable Volume of Parenteral 

Preparations General Chapter’’ was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in June 

2008. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Test for Extractable 

Volume of Parenteral Preparations 

General Chapter harmonization 

proposal originating from the threeparty 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 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

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: December 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–155 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0306] (formerly 

Docket No. 2007D–0459) 

International Conference on 

Harmonisation; Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex on 

Test for Particulate Contamination: 

Subvisible Particles 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 3: Test for 

Particulate Contamination: Subvisible 

Particles 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 Test for 

Particulate Contamination: Subvisible 

Particles 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. 

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, Training, and 

Manufacturers Assistance (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 selfaddressed adhesive labels to assist the 

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 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–1), 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. 

mstockstill on PROD1PC66 with NOTICES