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
Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 2601 

Trade Association.’’ In this final 

guidance, FDA is announcing that: (1) 

We intend to proceed with a 

Certification Referral Program to NOAA 

SIP, without a 24-month test period, (2) 

we intend to expand the program to 

include all fish and fishery products for 

export to the EU and EFTA, and (3) we 

intend to stop issuing EU Export 

Certificates effective February 17, 2009. 

The agency intends to adopt this 

approach because the industry’s 

demand for EU Export Certificates 

continues to rise dramatically, and FDA 

can no longer justify the use of our 

limited food safety resources for 

issuance of EU Export Certificates. The 

implementation of this guidance should 

free up resources that the agency can 

allocate for higher priority public health 

activities that are intended to protect the 

U.S. consuming public, while still 

providing a mechanism for the industry 

to continue obtaining EU certification. 

Seafood processors and other entities 

involved in the exporting of seafood to 

the EU may obtain EU Export 

Certificates from the NOAA SIP. 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents FDA’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, 

NOAA SIP, 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. The guidance 

and 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 guidance document at 

http://www.cfsan.fda.gov/ 

guidance.html. 

Dated: January 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–785 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–2008–N–0661] 

Unique Device Identification System; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: ‘‘Unique Device Identification 

System.’’ The purpose of the public 

workshop is to obtain information to 

help us better understand the issues 

involved in the establishment of a 

unique device identification system 

(UDI system) and request comments on 

this topic. 

Dates and Time: The public workshop 

will be held on, February 12, 2009, from 

9 a.m. to 5 p.m. See section V of this 

document for additional dates 

associated with registration and 

participation in the workshop. 

Location: The public workshop will 

be held at the Marriott Gaithersburg 

Washingtonian Center, 9751 

Washingtonian Blvd., Gaithersburg, MD 

20878, 301–590–0044. 

Contact Person: Jay Crowley, Food 

and Drug Administration, Center for 

Devices and Radiological Health (HFZ– 

500), 1350 Piccard Dr., Rockville, MD 

20852, 240–276–2389, or Stephen 

Ripley, Food and Drug Administration, 

Center for Biologics Evaluation and 

Research (HFM–17), 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852, 

301–827–6210. 

Registration: Register electronically at 

http://www.fda.gov/cdrh/ocd/udi/ 

index.htmlby January 30, 2009. There is 

no registration fee for the public 

workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 8 a.m. 

If you need special accommodations 

due to a disability, please contact Jay 

Crowley (see Contact Person) by January 

30, 2009. 

Comments: Regardless of attendance 

at the public workshop, interested 

persons may submit written or 

electronic comments 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. 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. The deadline for submitting 

comments regarding this public 

workshop is February 27, 2009. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. What Does Section 226 of the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA) Require? 

On September 27, 2007, President 

George W. Bush signed into law FDAAA 

(Public Law 110–85). Section 226 of 

FDAAA amended the Federal Food, 

Drug, and Cosmetic Act (the act) by 

requiring the establishment of a UDI 

system. Specifically, section 226(a) of 

FDAAA created a new section 519(f) of 

the act (21 U.S.C. 360i(f)) stating that 

‘‘The Secretary shall promulgate 

regulations establishing a unique device 

identification system for medical 

devices requiring the label of devices to 

bear a unique identifier, unless the 

Secretary requires an alternative 

placement or provides an exception for 

a particular device or type of device. 

The unique identifier shall adequately 

identify the device through distribution 

and use, and may include information 

on the lot or serial number.’’ 

A UDI system may provide for early 

detection of the warning signs of a 

defective device and facilitate device 

recalls (Ref. 1) and other possible 

benefits of a UDI system have been 

suggested. 

B. Why Are We Holding a Public 

Workshop? 

The enactment of section 519(f) of the 

act has raised many questions for our 

consideration. For example, the statute 

requires the UDI to go on the device’s 

label, but it also allows for ‘‘alternative 

placement’’ and for exceptions. Thus, 


jlentini on PROD1PC65 with NOTICES