Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 2599 

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 55 

1There 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 

Annual Frequency 

of Responses 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Same formulation/manufacturing 

process approach 2 2 2 5 10 

Same API/solubility approach 10 10 10 20 200 

Total burden hours 210 

1There 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 

[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 http:// 

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 


jlentini on PROD1PC65 with NOTICES
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. 

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 

http://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 

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 

AGENCY: Food and Drug Administration, 

HHS. 

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 http:// 

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

INFORMATION section for electronic 

access to the guidance. 

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 


jlentini on PROD1PC65 with NOTICES