Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Notices 68945

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, Executive Secretary, 

by telephone at 410–786–2881 or by email at Matkinson@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: On 

December 14, 1998, we published a 

notice in the Federal Register (63 FR 

68780) to describe the Medicare 

Coverage Advisory Committee (MCAC), 

which provides advice and 

recommendations to us about clinical 

issues. This notice announces a public 

meeting of the Committee. 

Meeting Topic: The Committee will 

address the data from and the quality of 

clinical evidence pertaining to the 

effects of lifestyle modification such as 

diet, exercise, stress reduction and 

group counseling as it relates to reversal 

or resolution of diseases such as 

coronary heart disease and diabetes. 

Background information about this 

topic, including panel materials, is 

available on the Internet at http://

www.cms.hhs.gov/coverage/.

Procedure: This meeting is open to 

the public. The Committee will hear 

oral presentations from the public for 

approximately 45 minutes. The 

Committee may limit the number and 

duration of oral presentations to the 

time available. If you wish to make 

formal presentations, you must notify 

the Executive Secretary named in the 

FOR FURTHER INFORMATION CONTACT

section and submit the following by the 

Deadline for Presentations and 

Comments date listed in the DATES

section of this notice: a brief statement 

of the general nature of the evidence or 

arguments you wish to present, and the 

names and addresses of proposed 

participants. A written copy of your 

presentation must be provided to each 

Committee member before offering your 

public comments. Your presentation 

must address the questions asked by us 

to the Committee. The questions will be 

available on our Web site at http://

www.cms.hhs.gov/mcac/

default.asp#meetings. If the specific 

questions are not addressed, your 

presentation will not be accepted. We 

request that you declare at the meeting 

whether or not you have any financial 

involvement with manufacturers of any 

items or services being discussed (or 

with their competitors). 

After the public and CMS 

presentations, the Committee will 

deliberate openly on the topic. 

Interested persons may observe the 

deliberations, but the Committee will 

not hear further comments during this 

time except at the request of the 

chairperson. The Committee will also 

allow a 15 minute unscheduled open 

public session for any attendee to 

address issues specific to the topic. At 

the conclusion of the day, the members 

will vote and the Committee will make 

its recommendation. 

Registration Instructions 

The Coverage and Analysis Group is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. You may register 

by contacting Maria Ellis at 410–786–

0309, mailing address: Coverage and 

Analysis Group, OCSQ; Centers for 

Medicare & Medicaid Services; 7500 

Security Blvd, Mailstop: C1–09–06; 

Baltimore, MD 21244, or by e-mail at 

Mellis@cms.hhs.gov. Please provide 

your name, address, organization, 

telephone and fax number, and e-mail 

address. 

You will receive a registration 

confirmation with instructions for your 

arrival at the CMS complex. You will be 

notified if the seating capacity has been 

reached. 

Because the meeting is located on 

Federal property, for security reasons, 

any persons wishing to attend this 

meeting must register by close of 

business on January 17, 2005. In order 

to gain access to the building and 

grounds, participants must show to the 

Federal Protective Service or guard 

service personnel, government-issued 

photo identification and a copy of their 

registration confirmation. Individuals 

who have not registered in advance will 

not be allowed to enter the building to 

attend the meeting. 

Special Accommodations: Persons 

attending the meeting who are hearing 

or visually impaired, or have a 

condition that requires special 

assistance or accommodations, are 

asked to notify the Executive Secretary 

by January 3, 2005 (see FOR FURTHER

INFORMATION CONTACT).

Authority: 5 U.S.C. App. 2, section 10(a).

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: November 17, 2004. 

Sean R. Tunis, 

Director, Office of Clinical Standards and 

Quality, Centers for Medicare & Medicaid 

Services.

[FR Doc. 04–26173 Filed 11–24–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Industry Exchange Workshop on Food 

and Drug Administration Clinical Trial 

Requirements; Public Workshop

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug 

Administration (FDA) Pacific Region, in 

cooperation with the Society of Clinical 

Research Associates (SoCRA), is 

announcing a workshop on FDA 

Clinical trial statutory and regulatory 

requirements. Topics for discussion 

include: Pre-IND (investigational new 

drug application) meetings and FDA 

meeting process, medical device, drug 

and biological product aspects of 

clinical research, investigator initiated 

research, informed consent 

requirements, adverse event reporting, 

how FDA conducts bioresearch 

inspections, ethics in subject 

enrollment, FDA regulation of 

Institutional Review Boards, FDA and 

confidence in the conduct of clinical 

research, and what happens after the 

FDA inspection. This 2-day workshop 

for the clinical research community 

targets sponsors, monitors, clinical 

investigators, institutional review 

boards, and those who interact with 

them for the purpose of conducting FDA 

regulated clinical research. The 

workshop will include both industry 

and FDA perspectives on proper 

conduct of clinical trials regulated by 

FDA.

Date and Time: The public workshop 

is scheduled for Wednesday, January 12, 

2005, from 8:15 a.m. to 4:15 p.m. and 

Thursday, January 13, 2005, from 8:15 

a.m. to 4 p.m.

Location: The public workshop will 

be held at the Holiday Inn Fisherman’s 

Wharf, 1300 Columbus Ave., San 

Francisco, CA 94133, 415–771–9000, 

FAX: 415–771–7006.

Contact: Marcia Madrigal, Small 

Business Representative, FDA, 1301 

Clay St., suite 1180–N, Oakland, CA 

94612–5217, FAX: 510–637–3977, email: marcia.madrigal@fda.gov.

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) and the registration fee of $485 

(member) or $560 (nonmember), $460 

(government employee nonmember) 

(includes a 1 year membership). The 

registration fee for FDA employees is 

waived. Make the registration fee 

payable to SoCRA, P.O. Box 101, 

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