Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting-Improving Human Subject Protection; Availability, 2599-2600 [E9-683]

Download as PDF 2599 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Same formulation/manufacturing process approach 1 1 1 5 5 Same API/solubility approach 5 5 5 10 50 Total burden hours 1 There 55 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES1 No. of Respondents Same formulation/manufacturing process approach Annual Frequency of Responses Total Annual Responses Hours per Response 2 2 2 5 10 10 Same API/solubility approach 10 10 20 200 Total burden hours 1 There 210 are no capital costs or operating and maintenance costs associated with this collection of information. The sources of the previous data are records of generic drug applications over the past 10 years. Dated: January 8, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–782 Filed 1–14–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting— Improving Human Subject Protection; Availability Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Adverse Event Reporting— Improving Human Subject Protection.’’ This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to institutional review boards (IRBs). FDA developed this guidance in response to concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event VerDate Nov<24>2008 18:58 Jan 14, 2009 Jkt 217001 reports are inhibiting, rather than enhancing, the ability of IRBs to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs. Elsewhere in this issue of the Federal Register, FDA is issuing the final rule entitled ‘‘Institutional Review Boards; Registration Requirements.’’ DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the 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 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 guidance document. ADDRESSES: [Docket No. FDA–2007–D–0202] (formerly Docket No. 2007D–0106) AGENCY: Total Hours FOR FURTHER INFORMATION CONTACT: Joseph Griffin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–2270, e-mail: Joseph.Griffin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a guidance for clinical investigators, sponsors, and IRBs entitled ‘‘Adverse Event Reporting—Improving Human Subject Protection.’’ Under the regulations in 21 CFR part 50 (Protection of Human Subjects), part 56 (21 CFR part 56) (Institutional Review Boards), part 312 (21 CFR part 312) (Investigational New Drug Application), and part 812 (21 CFR part 812) (Investigational Device Exemptions), an IRB must review and approve a clinical study before the study is initiated. Additionally, after an IRB’s initial review and approval, an IRB must conduct continuing review of the study at intervals appropriate to the degree of risk presented by the study, at least annually. The primary purpose of both the initial review of a study and the periodic review of the conduct of the study is to ensure the protection of the rights and welfare of human subjects. To do its job, an IRB must be informed of any unanticipated problems in the study and any changes in the research activity. This guidance discusses adverse event reporting to IRBs by sponsors and investigators and emphasizes the value of well-analyzed adverse event data to an IRB review. A notice announcing the draft version of this guidance published in the Federal Register on April 9, 2007 (72 FR 17562). After carefully considering all received comments, the agency is finalizing that guidance. The draft and the final have relatively minor substantive differences. The recommendations section in the final E:\FR\FM\15JAN1.SGM 15JAN1 2600 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices guidance is streamlined and reorganized to make the information clearer and more accessible, but there are no major policy differences. The final guidance also omits much of the background discussion about the origin and nature of the adverse event reporting problem that the guidance addresses because that information is tangential to the goals of the guidance. 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 adverse event reporting for the purpose of improving human subject protection. 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. jlentini on PROD1PC65 with NOTICES Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–D–0043] (formerly Docket No. 2004D–0510) Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association; Availability Food and Drug Administration, HHS. This 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 part 56 have been approved under OMB control number 0910–0130; the collections of information in part 312 have been approved under OMB control number 0910–0014; and the collections of information in part 812 have been approved under OMB control number 0910–0078. 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. 18:58 Jan 14, 2009 BILLING CODE 4160–01–S AGENCY: II. The Paperwork Reduction Act of 1995 VerDate Nov<24>2008 Dated: December 22, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–683 Filed 1–14–09; 8:45 am] ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.’’ The guidance provides information for seafood processors and other entities that are interested in obtaining export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). FDA is also announcing that it intends to stop issuing EU Export Certificates after February 17, 2009. DATES: Submit written or electronic comments on the guidance at any time. ADDRESSES: Submit written comments concerning 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 on the guidance to https:// www.regulations.gov. Submit written requests for single copies of the guidance to the Office of Food Safety (HFS–300), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 section for electronic access to the guidance. INFORMATION FOR FURTHER INFORMATION CONTACT: William Jones, Center for Food Safety and Applied Nutrition (HFS–325), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740– 3835, 301–436–2300. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 26, 2004 (69 FR 68948) (the November 26 notice), FDA announced the availability of a draft guidance entitled ‘‘Proposed Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Live and Perishable Fish and Fishery Products for Export to the European Union and the European Free Trade Association.’’ In the November 26 notice, FDA announced that it proposed to operate a Referral Program for a 24-month period to test the viability and effectiveness of such an arrangement. During this period, EU Export Certificates for shipments of live and perishable fish and fishery products destined for the EU, European Union Accession Partnership Countries (EUAPC), and EFTA Members would have been issued by the National Oceanic and Atmospheric Administration Seafood Inspection Program (NOAA SIP) under the Agricultural Marketing Act. In addition, FDA indicated that it intended to stop issuing EU Export Certificates for live and perishable fish and fishery products during this period. FDA sought comment on this referral program, including whether it should be expanded beyond live and perishable to all shipments of fish and fishery products destined for the EU, EU Accession Partnership Countries, and other countries with certificate requirements. Interested persons were initially given until December 27, 2004, to comment on the draft guidance. The comment period was subsequently extended until January 25, 2005 (69 FR 78038, December 29, 2004). The agency considered and modified the guidance as appropriate. The agency is announcing the availability of the final guidance document entitled ‘‘Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmosphere Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for the Export to the European Union and the European Free E:\FR\FM\15JAN1.SGM 15JAN1

Agencies

[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Notices]
[Pages 2599-2600]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0202] (formerly Docket No. 2007D-0106)


Guidance for Clinical Investigators, Sponsors, and Institutional 
Review Boards on Adverse Event Reporting--Improving Human Subject 
Protection; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Adverse Event 
Reporting--Improving Human Subject Protection.'' This guidance is 
intended to assist the research community in interpreting requirements 
for submitting reports of unanticipated problems, including certain 
adverse events reports, to institutional review boards (IRBs). FDA 
developed this guidance in response to concerns raised by the IRB 
community that increasingly large volumes of individual, unanalyzed 
adverse event reports are inhibiting, rather than enhancing, the 
ability of IRBs to adequately protect human subjects. The guidance 
provides recommendations to IRBs, sponsors, and investigators on 
improving the usefulness of the adverse event information submitted to 
IRBs. Elsewhere in this issue of the Federal Register, FDA is issuing 
the final rule entitled ``Institutional Review Boards; Registration 
Requirements.''

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, 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph Griffin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-2270, e-mail: 
Joseph.Griffin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for clinical 
investigators, sponsors, and IRBs entitled ``Adverse Event Reporting--
Improving Human Subject Protection.'' Under the regulations in 21 CFR 
part 50 (Protection of Human Subjects), part 56 (21 CFR part 56) 
(Institutional Review Boards), part 312 (21 CFR part 312) 
(Investigational New Drug Application), and part 812 (21 CFR part 812) 
(Investigational Device Exemptions), an IRB must review and approve a 
clinical study before the study is initiated. Additionally, after an 
IRB's initial review and approval, an IRB must conduct continuing 
review of the study at intervals appropriate to the degree of risk 
presented by the study, at least annually. The primary purpose of both 
the initial review of a study and the periodic review of the conduct of 
the study is to ensure the protection of the rights and welfare of 
human subjects. To do its job, an IRB must be informed of any 
unanticipated problems in the study and any changes in the research 
activity. This guidance discusses adverse event reporting to IRBs by 
sponsors and investigators and emphasizes the value of well-analyzed 
adverse event data to an IRB review.
    A notice announcing the draft version of this guidance published in 
the Federal Register on April 9, 2007 (72 FR 17562). After carefully 
considering all received comments, the agency is finalizing that 
guidance. The draft and the final have relatively minor substantive 
differences. The recommendations section in the final

[[Page 2600]]

guidance is streamlined and re-organized to make the information 
clearer and more accessible, but there are no major policy differences. 
The final guidance also omits much of the background discussion about 
the origin and nature of the adverse event reporting problem that the 
guidance addresses because that information is tangential to the goals 
of the guidance.
    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 adverse event reporting for the purpose of 
improving human subject protection. 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 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 part 56 have been approved under OMB 
control number 0910-0130; the collections of information in part 312 
have been approved under OMB control number 0910-0014; and the 
collections of information in part 812 have been approved under OMB 
control number 0910-0078.
    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: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-683 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-01-S

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