68948 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.

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0510]

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

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA or agency) is 

announcing the availability of the 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.’’ The draft guidance 

proposes a 24-month Referral Program 

in which European Union (EU) Export 

Certificates for all shipments of live and 

perishable fish and fishery products 

destined for the EU, EU Accession 

Partnership Countries, and members of 

the European Free Trade Association 

(EFTA) would be issued by the National 

Oceanic and Atmospheric 

Administration Seafood Inspection 

Program (NOAA SIP) under the 

Agricultural Marketing Act (AMA). 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draft guidance is not final nor is it in 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comments on this draft guidance by 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.

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 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 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 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. FDA also signs certificates for 

shipments of fish and fishery products 

to EU Accession Countries and EFTA 

Members. A certificate is issued if it is 

determined that the establishment1 is in 

regulatory good standing with FDA. The 

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.

The demand for EU Export 

Certificates by industry has risen 

dramatically in recent years and has 

caused significant resource allocation 

problems for FDA. The diversion of 

resources to lower priority, 

discretionary activities diminishes the 

agency’s ability to carry out public 

health activities and regulatory 

oversight that are intended to protect 

the U.S. consuming public.

II. Significance of Guidance

In order to expedite the exportation of 

live and perishable fish and fishery 

products, FDA is considering what parts 

of its current EU certification activities 

related to fish and fishery products 

could be conducted by NOAA SIP. FDA 

is, therefore, proposing 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 all 

shipments of live and perishable fish 

and fishery products destined for the 

EU, EU Accession Partnership 

Countries, and EFTA Members would 

be issued by the NOAA SIP under the 

AMA. The basis for issuing EU Export 

Certificates under the Referral Program 

would be, as it is now, whether the 

establishment or establishments in 

question are in regulatory good standing 

with FDA. FDA intends to cease to issue 

EU Export Certificates for live and 

perishable fish and fishery products 

during this period. FDA seeks 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. During this 24-

month period, however, both agencies 

intend to continue to issue EU Export 

Certificates for shipments of canned, 

frozen, dried, vacuum packed, etc., 

products, as requested by appropriate 

parties.

III. Electronic Access

An electronic version of this guidance 

is available on the Internet at http://

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

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.

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68949

Dated: November 17, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26139 Filed 11–22–04; 1:33 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for the opportunity for public comment 

on proposed data collection projects 

[Section 3506(c)(2)(A) of Title 44, 

United States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13], the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer at (301) 443–1129. 

Comments are invited on (a) whether 

the agency needs to collect the proposed 

information to properly perform its 

functions and whether the information 

has any practical utility; (b) whether the 

agency’s estimate of the burden of the 

proposed collection of information is 

accurate; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information for 

respondents (e.g., by using automated 

collection techniques or other forms of 

information technology). 

Proposed Project: Ryan White CARE 

Act Dental Reimbursement Program 

(OMB No. 0915–0151)—Revision 

The Dental Reimbursement Program 

(DRP) under Part F of the Ryan White 

CARE Act offers grants to accredited 

dental schools and programs that 

provide non-reimbursed oral health care 

to patients with HIV disease. The Ryan 

White CARE Act Amendments of 2000 

expanded eligibility of this program to 

accredited schools of dental hygiene, in 

addition to previously funded schools of 

dentistry and post-doctoral dental 

education programs. 

HRSA requests clearance to revise the 

DRP Application as the Dental Services 

Report that schools and programs will 

use, either to apply for funding of nonreimbursed costs incurred in providing 

oral health care to patients with HIV, or 

to report annual program data. Awards 

are authorized under section 2692(b) of 

the Public Health Service Act (42 U.S.C. 

§ 300ff–111(b). The Dental Services 

Report is intended to collect data in four 

different areas: program information, 

patient demographics and services, 

funding, and training. It also requests 

applicants to provide narrative 

descriptions of their services and 

facilities, as well as their links and 

collaboration with community-based 

providers of oral health services. 

The primary purpose of collecting this 

information annually, as part of the 

Dental Services Report, is to verify 

eligibility and determine reimbursement 

amounts for DRP applicants as well as 

to document the program 

accomplishments of Community-Based 

Dental Partnership Program (CBDPP) 

grant recipients. This information also 

allows HRSA to learn about (1) the 

extent of the involvement of dental 

schools and programs in treating 

patients with HIV, (2) the number and 

characteristics of clients who receive 

CARE Act-supported oral health 

services, (3) the types and frequency of 

the provision of these services, (4) the 

non-reimbursed costs of oral health care 

provided to patients with HIV, and (5) 

the scope of grant recipients’

community-based collaborations and 

training of providers. In addition to 

meeting the goal of accountability to 

Congress, clients, advocacy groups, and 

the general public, information 

collected in the Dental Services Report 

is critical for HRSA, State and local 

grantees, and individual providers, to 

help assess the status of existing HIVrelated health service delivery systems. 

The reporting burden for reviewing 

the Dental Services Report Instructions 

and completing the Report is estimated 

as:

Collection Number of

respondents 

Hours per

application 

Total burden

hours 

Dental Services Report ................................................................................................................ 125 20 2500 

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 14–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice.

Dated: November 18, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–26142 Filed 11–24–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[CGD 01–04–093] 

Notice, Announcement of Public 

Meeting and Extension of Comment 

Period; Letter of Recommendation, 

LNG Facility Weaver’s Cove, Fall River, 

MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting; and 

extension of public comment period. 

SUMMARY: In response to public 

comments on the proposed LNG facility 

at Weaver’s Cove, Fall River, MA, the 

Coast Guard is sponsoring a public 

hearing. Additionally, the Coast Guard 

is reopening the public comment period 

an additional 60 days. These actions 

will afford the public and the owner or 

operator additional time and 

opportunity to provide the Coast Guard 

with information regarding the 

proposed Weaver’s Cove LNG Facility.

DATES: Comments and related material 

must reach the Coast Guard on or before 

January 25, 2005.

ADDRESSES: The Commanding Officer, 

U.S. Coast Guard Marine Safety Office 

Providence maintains the public docket 

for this notice. Comments and 

documents will become part of this 

docket and will be available for 

inspection and copying at the same 

address between 8 a.m. and 3 p.m. 

Monday through Friday, except Federal 

holidays. You may submit comments 

and related material by: 

(1) Mail or delivery to Commanding 

Officer, U.S. Coast Guard Marine Safety