International Conference on Harmonisation; Draft Guidance on E2F Development Safety Update Report; Availability, 45462-45463 [E8-17861]

Download as PDF 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 dwashington3 on PRODPC61 with NOTICES 1There 1,250 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 This draft guidance also refers to previously approved collections of information found in FDA regulations.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 VerDate Aug<31>2005 14:19 Aug 04, 2008 Jkt 214001 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 https://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. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 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, E:\FR\FM\05AUN1.SGM 05AUN1 Federal Register / Vol. 73, No. 151 / Tuesday, August 5, 2008 / Notices dwashington3 on PRODPC61 with NOTICES 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 https:// 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 VerDate Aug<31>2005 14:19 Aug 04, 2008 Jkt 214001 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 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 45463 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 https://www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at https:// www.regulations.gov, https:// www.fda.gov/cder/guidance/index.htm, or https://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 E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45462-45463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17861]


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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,

[[Page 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 self-addressed 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 https://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 https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
https://www.regulations.gov, https://www.fda.gov/cder/guidance/index.htm, 
or https://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

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