45462 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 

indicated for use in pediatric patients or 

in a pediatric subpopulation that were 

approved on or after September, 27, 

2007, the enactment date of the 

Pediatric Medical Device Safety and 

Improvement Act of 2007. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Section of the Federal Food, 

Drug, and Cosmetic Act 

No. of 

Applicants 

Annual Frequency 

per Response 

Total Annual 

HDE Applications 

Hours per 

Response Total Hours 

515A(a)(2) 5 1 5 100 500 

520(m)(6)(A)(ii) 3 1 3 50 150 

520(m)(6)(A)(iii) 1 1 1 100 100 

520(m)(6)(C) 5 1 5 100 500 

Total 1,250 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA based these estimates on the 

number of original HDE applications 

that the Center for Devices and 

Radiological Health (CDRH) received in 

the period between October 1, 2004, and 

September 30, 2007. During that time, 

CDRH received 16 original HDE 

applications or about 5 per year. 

FDA estimates that for each year 

CDRH will receive five HDE 

applications and that three of these 

applications will be indicated for 

pediatric use. One HDE holder will 

notify the agency that the number of 

devices distributed in the year has 

exceeded the annual distribution 

number and five HDE holders will 

petition to have the annual distribution 

number modified due to additional 

information on the number of 

individuals affected by the disease or 

condition. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 803 have been approved under 

OMB control number 0910–0437; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814, subparts A, B, and C have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073; the collections of 

information in 21 CFR part 814, subpart 

H have been approved under OMB 

control number 0910–0332; and the 

collections of information in 21 CFR 

10.30 have been approved under OMB 

control number 0910–0183. 

V. 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. 

Dated: July 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17905 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0386] 

International Conference on 

Harmonisation; Draft Guidance on E2F 

Development Safety Update Report; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘E2F Development Safety Update 

Report.’’ The draft guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance describes the format, 

content, and timing of a development 

safety update report (DSUR) for an 

investigational drug. The DSUR would 

serve as a harmonized, annual clinical 

trial safety report that would be 

standard among the three ICH regions. 

The DSUR could be submitted in the 

United States in place of an annual 

report for an investigational new drug 

application (IND). The harmonized 

DSUR is intended to promote a 

consistent approach to annual clinical 

safety reporting among the ICH regions 

and enhance efficiency by reducing the 

number of reports generated for 

submission to the regulatory authorities. 

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 November 3, 2008. 

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; 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, 


dwashington3 on PRODPC61 with NOTICES
Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices 45463 

suite 200N, Rockville, MD 20852–1448. 

The draft 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 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: 

Regarding the draft guidance: Ellis F. 

Unger, Center for Drug Evaluation 

and Research (HFD–110), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 4170, 

Silver Spring, MD 20993, 301–796–

2240; or 

Peter F. Bross, Center for Biologics 

Evaluation and Research (HFM–

755), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–5102. 

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 June 2008, the ICH Steering 

Committee agreed that a draft guidance 

entitled ‘‘E2F Development Safety 

Update Report’’ should be made 

available for public comment. The draft 

guidance is the product of the E2F 

Expert Working Group of the ICH. 

Comments about this draft will be 

considered by FDA and the Efficacy 

Expert Working Group. 

The draft guidance describes the 

format, content, and timing of a DSUR 

for an investigational drug. The DSUR 

would serve as a harmonized, annual 

clinical trial safety report that would be 

standard among the ICH regions. The 

DSUR is patterned after the periodic 

safety update report (PSUR) (used for 

safety reporting in the postmarketing 

environment) and could be submitted in 

the United States in place of an annual 

report for an IND. The harmonized 

DSUR is intended to promote a 

consistent approach to annual clinical 

safety reporting among the ICH regions 

and enhance efficiency by reducing the 

number of reports generated for 

submission to the regulatory authorities. 

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 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 draft 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. 

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: July 28, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–17861 Filed 8–4–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0396] 

International Conference on 

Harmonisation; Draft Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex on 

Microbiological Examination of NonSterile Products: Microbial 

Enumeration Tests General Chapter; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft 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 draft guidance was 

prepared under the auspices of the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft guidance provides the results 


dwashington3 on PRODPC61 with NOTICES