68946 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 

1 ‘‘Establishment’’ refers to any structure, or 

structures under one ownership at one general 

physical location, or, in the case of a mobile 

establishment, traveling to multiple locations, that 

manufactures/processes, packs, or holds food. 

Transport vehicles are not establishments if they 

hold food only in the usual course of business as 

carriers. An establishment may consist of one or 

more contiguous structures, and a single building 

may house more than one distinct establishment if 

the establishments are under separate ownership.

Furlong, PA 18925. To register via the 

Internet go to http://www.socra.org/

FDA_Conference.htm. (FDA has verified 

the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register.)

The registrar will also accept payment 

by major credit cards. For more 

information on the meeting, or for 

questions on registration, contact 800–

SoCRA92 (800–762–7292), or 215–345–

7369 or via e-mail: socramail@aol.com. 

Attendees are responsible for their own 

accommodations. To make reservations 

at the Holiday Inn Fisherman’s Wharf, 

at the reduced conference rate, contact 

the Holiday Inn (see Location) before 

December 21, 2004.

The registration fee will be used to 

offset the expenses of hosting the 

conference, including meals, 

refreshments, meeting rooms, and 

materials. Space is limited, therefore 

interested parties are encouraged to 

register early. Limited onsite registration 

may be available. Please arrive early to 

ensure prompt registration.

If you need special accommodations 

due to a disability, please contact 

Marcia Madrigal at least 7 days in 

advance of the workshop.

SUPPLEMENTARY INFORMATION: The ‘‘FDA 

Clinical Trials Statutory and Regulatory 

Requirements’’ workshop helps fulfill 

the Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health by educating 

researchers on proper conduct of 

clinical trials. FDA has made education 

of the research community a high 

priority to assure the quality of clinical 

data and protect research subjects.

The workshop helps to implement the 

objectives of section 406 of the FDA 

Modernization Act (21 U.S.C. 393) and 

the FDA Plan for Statutory Compliance, 

which includes working more closely 

with stakeholders and ensuring access 

to needed scientific and technical 

expertise. The workshop also furthers 

the goals of the Small Business 

Regulatory Enforcement Fairness Act 

(Public Law 104–121) by providing 

outreach activities by Government 

agencies directed to small businesses.

Dated: November 18, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26092 Filed 11–24–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0509]

Draft Guidance and Protocol for 

Industry and Food and Drug 

Administration Staff: Certification of 

Fish and Fishery Products for Export 

to the European Union and the 

European Free Trade Association

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Guidance and Protocol for 

Industry and Food and Drug 

Administration Staff: Certification of 

Fish and Fishery Products for Export to 

the European Union and the European 

Free Trade Association.’’ The draft 

guidance describes how health 

certificates required for shipments of 

fish and fishery products from the 

United States to the European Union 

(EU), EU Accession Partnership 

Countries, and members of the 

European Free Trade Association 

(EFTA) should be issued. This draft 

guidance is not final nor is it in effect 

at this time.

DATES: Submit written or electronic 

comments on this draft guidance by 

December 27, 2004. General comments 

on agency guidance documents are 

welcome at any time. Submit written or 

electronic comments on the collection 

of information provisions by January 25, 

2005.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to 

Bruce Wilson, Center for Food Safety 

and Applied Nutrition (HFS–417), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1425, e-mail: 

bwilson1@cfsan.fda.gov. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

guidance may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance.

Submit written comments concerning 

the draft guidance and the proposed 

information collection provisions 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 draft guidance and the proposed 

information collection provisions to 

http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Tim 

Hansen, Center for Food Safety and 

Applied Nutrition (HFS–415), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–1405, e-mail: 

thansen@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Since 1993, the EU has required that 

an EU Export Certificate accompany all 

shipments of fish and fishery products 

that are shipped to the EU. For fish and 

fishery products generally, the 

certificates that FDA signs essentially 

attest that the products have been 

produced in accordance with a Hazard 

Analysis Critical Control Point 

(HACCP)-based safety system that is at 

least equivalent to the EU system of 

control. The FDA HACCP regulations 

have been deemed by the European 

Commission to be equivalent, in 

principle, to the EU system of control. 

In 1996, the EU also began requiring a 

different certificate specifically for 

shipments of live molluscan shellfish 

(e.g., oysters, clams, mussels). These 

certificates are based partly on 

equivalence to, and partly on 

consistency with, EU requirements.

In 1993, to ensure the smooth flow of 

trade in fish and fishery products to the 

EU, FDA began signing certificates for 

shipments of fish and fishery products 

to the EU. The FDA also signs 

certificates for shipments of fish and 

fishery products to EU Accession 

Partnership Countries and EFTA 

Members. A certificate is issued if it is 

determined that the establishment1 is in 

regulatory good standing with FDA. The 

Seafood Inspection Program of the 

National Oceanic and Atmospheric 

Administration (NOAA SIP) of the U.S. 

Department of Commerce also signs EU 

Export Certificates as one service that it 

offers U.S. seafood processors and other 

entities in its voluntary, fee-for-service 

seafood inspection program.

II. Significance of Guidance

FDA is providing this draft guidance 

to clarify the internal processes that 

FDA uses to issue these EU Export 

Certificates, the procedures that 

industry seeking these certificates 

should follow, the criteria that FDA 

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68947

generally intends to consider in 

determining whether to issue an EU 

Export Certificate, and related matters. 

This guidance, when finalized, is 

intended to supersede all previous 

protocols that were written by the 

various districts offices that provide EU 

certification for seafood products.

III. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act 

of 1995 (the PRA), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. ‘‘Collection of information’’

is defined in 44 U.S.C. 3502(3) and 5 

CFR 1320.3 and includes agency 

requests or requirements that members 

of the public submit reports, keep 

records, or provide information to a 

third party. Section 3506(c)(2)(A) of the 

PRA (44 U.S.C. 3506(c)(2)(A)) requires 

Federal agencies to provide a 60-day 

notice in the Federal Register

concerning each proposed collection of 

information before submitting the 

collection to OMB for approval. To 

comply with this requirement, FDA is 

publishing notice of the proposed 

collection of information set forth in 

this document.

FDA invites comments on the 

following topics: (1) Whether the 

proposed collection of information is 

necessary for the proper performance of 

FDA’s functions, including whether the 

information will have practical utility; 

(2) the accuracy of FDA’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) ways to enhance the quality, utility, 

and clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Title: Health Certificate for Fishery 

and Aquaculture Products Intended for 

Export to the European Community

Description: This draft guidance 

describes the procedures FDA staff 

should use to issue the EU certificates, 

as well as the procedures industry 

should use for requesting a certificate. 

As discussed in detail in the draft 

guidance, the EU requires that each 

shipment have a certificate issued by a 

‘‘competent authority’’ in the exporting 

country. The respondent (shipper) is 

asked to fill out a certificate-form (as 

required by the EU) that provides the 

following information: (1) The identity 

of the fishery product in terms of its 

physical state, type of packaging, 

number of packages, net weight, 

temperature required during storage and 

transport; (2) origin of the product, to 

include the name and registration 

number of the establishment(s) that 

processed, stored or harvested the 

product and is registered with FDA for 

export to the EU; (3) destination of the 

product and place of dispatch from the 

United States, the means of transport, 

the name and address of the dispatcher, 

the name of the consignee, and address 

at destination; and (4) date of certificate. 

Certifying agencies will retain this 

information for a reasonable period of 

time in case it becomes necessary to 

respond to questions about the 

shipment by officials in the importing 

country.

The proposed collection of 

information will take place when an 

establishment fills out a certificate and 

submits it to FDA for signature. 

Certificates in different languages may 

be downloaded from the Internet at: 

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

eucert.html.

Description of Respondents: The 

respondents to this collection of 

information are seafood industry firms 

that export seafood products to one or 

more of the countries within the EU. 

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Item No. of respondents 

No. of responses 

per respondent 

Total annual responses Hours per response Total hours 

Health Certificate for Fishery and 

Aquaculture Products Intended for 

Export to the European Community

928 26 24,500 0.25 6,125

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

Estimates of the annual FDA reporting 

burden were made using the number of 

firms that are currently on the EU 

Shippers List (928 respondents after 

subtracting the number of firms 

contracting with NOAA SIP in 2003), 

and the approximate total number of EU 

Health Certificates issued in 2003 by 

FDA (approximately 24,500). The 

estimated annual total hour burden is 

likely to be more accurate than the 

estimated number of responses per 

respondent, because the latter figure is 

the average obtained by dividing the 

recent total annual certificates by the 

current number of potential respondents 

(928). In practice, the frequency of 

shipments to the EU may vary widely 

among approved firms; some firms may 

export weekly to the EU, others may 

export only a few times a year or not at 

all.

IV. 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.

V. Electronic Access

An electronic version of this guidance 

is available on the Internet at http://

www.cfsan.fda.gov/guidance.html.

Dated: November 17, 2004.

Jeffrey Shuren,

Associate Commissioner for Policy.

[FR Doc. 04–26138 Filed 11–22–04; 1:33 pm]

BILLING CODE 4160–01–S