59238 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 

* Kauffmann-White scheme for designation of 

Salmonella serotypes

the list published in the Federal 

Register on November 6, 2003. 

I. Pathogens Often Transmitted by Food 

Contaminated by Infected Persons Who 

Handle Food, and Modes of 

Transmission of Such Pathogens 

The contamination of raw ingredients 

from infected food-producing animals 

and cross-contamination during 

processing are more prevalent causes of 

foodborne disease than is contamination 

of foods by persons with infectious or 

contagious diseases. However, some 

pathogens are frequently transmitted by 

food contaminated by infected persons. 

The presence of any one of the 

following signs or symptoms in persons 

who handle food may indicate infection 

by a pathogen that could be transmitted 

to others through handling the food 

supply: diarrhea, vomiting, open skin 

sores, boils, fever, dark urine, or 

jaundice. The failure of food-handlers to 

wash hands (in situations such as after 

using the toilet, handling raw meat, 

cleaning spills, or carrying garbage, for 

example), wear clean gloves, or use 

clean utensils is responsible for the 

foodborne transmission of these 

pathogens. Non-foodborne routes of 

transmission, such as from one person 

to another, are also major contributors 

in the spread of these pathogens. 

Pathogens that can cause diseases after 

an infected person handles food are the 

following:

Noroviruses 

Hepatitis A virus 

Salmonella Typhi*

Shigella species

Staphylococcus aureus

Streptococcus pyogenes

II. Pathogens Occasionally Transmitted 

by Food Contaminated by Infected 

Persons Who Handle Food, But Usually 

Transmitted by Contamination at the 

Source or in Food Processing or by 

Non-foodborne Routes 

Other pathogens are occasionally 

transmitted by infected persons who 

handle food, but usually cause disease 

when food is intrinsically contaminated 

or cross-contaminated during processing 

or preparation. Bacterial pathogens in 

this category often require a period of 

temperature abuse to permit their 

multiplication to an infectious dose 

before they will cause disease in 

consumers. Preventing food contact by 

persons who have an acute diarrheal 

illness will decrease the risk of 

transmitting the following pathogens:

Campylobacter jejuni

Cryptosporidium parvum

Entamoeba histolytica

Enterohemorrhagic Escherichia coli

Enterotoxigenic Escherichia coli

Giardia lamblia

Nontyphoidal Salmonella

Taenia solium

Vibrio cholerae 01 

Yersinia enterocolitica

References 

1. World Health Organization. Health 

surveillance and management 

procedures for food-handling personnel: 

report of a WHO consultation. World 

Health Organization technical report 

series; 785. Geneva: World Health 

Organization, 1989. 

2. Frank JF, Barnhart HM. Food and 

dairy sanitation. In: Last JM, ed. MaxcyRosenau public health and preventive 

medicine, 12th edition. New York 

Appleton-Century-Crofts, 1986:765–806. 

3. Bennett JV, Holmberg SD, Rogers 

MF, Solomon SL. Infectious and 

parasitic diseases. In: Amler RW, Dull 

HB, eds. Closing the gap: the burden of 

unnecessary illness. New York: Oxford 

University Press, 1987:102–114. 

4. Centers for Disease Control and 

Prevention. Locally acquired 

neurocysticercosis—North Carolina, 

Massachusetts, and South Carolina, 

1989–1991. MMWR 1992; 41:1–4. 

5. Centers for Disease Control and 

Prevention. Foodborne Outbreak of 

Cryptosporidiosis-Spokane, 

Washington, 1997. MMWR 1998; 47:27.

Dated: September 24, 2004. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention 

(CDC).

[FR Doc. 04–22260 Filed 10–1–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

Clinical Pharmacology Subcommittee 

of the Advisory Committee for 

Pharmaceutical Science; Notice of 

Meeting

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public.

Name of Committee: Clinical 

Pharmacology Subcommittee of the 

Advisory Committee for Pharmaceutical 

Science.

General Function of the 

Subcommittee: To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues.

Date and Time: The meeting will be 

held on November 3, 2004, from 8 a.m. 

to 5:30 p.m., and on November 4, 2004, 

from 8 a.m. to 1:30 p.m.

Location: Center for Drug Evaluation 

and Research Advisory Committee 

Conference Room, rm. 1066, 5630 

Fishers Lane, Rockville, MD.

Contact Person: Hilda Scharen, Center 

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–7001, FAX 301–

827–6776, e-mail: 

SCHARENH@cder.fda.gov or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572) in the 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting.

Agenda: On November 3, 2004, the 

subcommittee will: (1) Receive topic 

updates for ongoing FDA activities 

previously presented to the 

subcommittee; (2) discuss and provide 

comments on the evidence for updating 

labels of approved drugs to include 

integrating pharmacogenetic, 

pharmacokinetic, and prognostic 

biomarkers for the purpose of 

optimizing therapeutic response and 

reducing risks of toxicity; and (3) 

discuss and provide comments on 

metabolism- and transporter-based drugdrug interactions included as 

recommendations in a draft guidance for 

industry being prepared by FDA. On 

November 4, 2004, the subcommittee 

will discuss and provide comments on 

a new critical path project related to 

general aspects of the transition of 

biomarkers to surrogate endpoints, with 

a focus on planning and process, rather 

than on specific biomarkers or surrogate 

endpoints.

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the subcommittee. Written 

submissions may be made to the contact 

person by October 25, 2004. Oral 

presentations from the public will be 

scheduled between approximately 12:30 

p.m. and 1 p.m. on November 3, 2004, 

and between 1 p.m. and 1:30 p.m. on 

November 4, 2004. Time allotted for 

each presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before October 25, 2004, and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Notices 59239

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation.

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets.

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Hilda 

Scharen at least 7 days in advance of the 

meeting.

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2).

Dated: September 24, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–22214 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0431]

Draft Guidance for Industry and the 

Food and Drug Administration; Current 

Good Manufacturing Practices for 

Combination Products; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Current Good 

Manufacturing Practices for 

Combination Products.’’ Once finalized, 

this guidance will provide guidance to 

industry and FDA staff on the 

applicability of current good 

manufacturing practices (CGMP) for 

combination products.

DATES: Submit written or electronic 

comments on the draft guidance by 

December 3, 2004. General comments 

on agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Combination Products (HFG–

3), 15800 Crabbs Branch Way, suite 200, 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on 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 to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

Patricia Y. Love, Office of Combination 

Products (HFG–3), Food and Drug 

Administration, 15800 Crabbs Branch 

Way, suite 200, Rockville, MD 20855, 

301–427–1934, FAX 301–427–1935, email: patricia.love@oc.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Current Good Manufacturing Practices 

for Combination Products.’’

Combination products are defined 

under 21 CFR 3.2(e). This draft guidance 

document makes recommendations for 

achieving compliance with applicable 

CGMPs for the drug, device, or 

biological product constituent parts of a 

combination product. In addition, the 

draft guidance document makes 

recommendations for achieving 

compliance with applicable CGMPs for 

combination products where the 

constituent parts of a combination 

product are joined together. The 

applicable regulations include the 

CGMP regulations for finished 

pharmaceuticals, or drug products, and 

most biological products (21 CFR parts 

210 and 211); the biological product 

regulations for biological products (21 

CFR parts 600–680); and the quality 

system regulations for devices (21 CFR 

part 820).

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on CGMP for combination products. 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. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

paper copies of mailed comments are to 

be submitted, 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 draft 

guidance and received comments are 

available for public examination in the 

Division of Dockets Management 

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

through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the draft guidance document 

at either http://www.fda.gov/oc/

combination/default.htm or http://

www.fda.gov/ohrms/dockets/

default.htm.

Dated: September 28, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22205 Filed 9–29–04; 1:51 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0440]

Draft Guidance for Industry on 

Computerized Systems Used in 

Clinical Trials; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Computerized 

Systems Used in Clinical Trials.’’ This 

document provides guidance about 

computerized systems that are used to 

create, modify, maintain, archive, 

retrieve, or transmit clinical data 

required to be maintained and/or 

submitted to FDA. This draft guidance, 

when finalized, will supercede the 

guidance of the same name issued in 

April 1999.

DATES: Submit written or electronic 

comments on the draft 

recommendations by January 3, 2005. 

General comments on agency guidance 

documents are welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Training and Communications, 

Division of Communications 

Management, Division of Drug 

Information (HFD–240), Center for Drug 

Evaluation and Research, 5600 Fishers 

Lane, Rockville, MD 20857; to the Office 

of Communication, Training, and 

Manufacturers Assistance (HFM–40), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852–1448; to the Office 

of Health and Industry Programs,