Federal Register / Vol. 62, No. 183 / Monday, September 22, 1997 / Notices 49519

ACTION: Notice of annual update of list

of infectious and communicable

diseases that are transmitted through

handling the food supply and the

methods by which such diseases are

transmitted.

SUMMARY: Section 103(d) of the

Americans with Disabilities Act of 1990,

Public Law 101–336, requires the

Secretary to publish a list of infectious

and communicable diseases that are

transmitted through handling the food

supply and to review and update the list

annually. The Centers for Disease

Control and Prevention (CDC) published

a final list on August 16, 1991 (56 FR

40897) and updates on January 13, 1994

(59 FR 1949), and August 15, 1996 (61

FR 42426). No new information that

would warrant additional changes has

been received; therefore the list, as set

forth in the first update and below,

remains unchanged.

EFFECTIVE DATE: September 22, 1997.

FOR FURTHER INFORMATION CONTACT: Dr.

Morris E. Potter, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention (CDC), 1600

Clifton Road, NE., Mailstop A–38,

Atlanta, Georgia 30333, telephone (404)

639–2237.

SUPPLEMENTARY INFORMATION: Section

103(d) of the Americans with

Disabilities Act of 1990, 42 U.S.C.

12113(d), requires the Secretary of

Health and Human Services to:

1. Review all infectious and

communicable diseases which may be

transmitted through handling the food

supply;

2. Publish a list of infectious and

communicable diseases which are

transmitted through handling the food

supply;

3. Publish the methods by which such

diseases are transmitted; and, .

4. Widely disseminate such

information regarding the list of

diseases and their modes of

transmissibility to the general public.

Additionally, the list is to be updated

annually.

Since the last publication of the list

on August 15, 1996 (61 FR 42426), CDC

has received no further information to

indicate that additional unlisted

diseases are transmitted through

handling the food supply. Therefore, the

list set forth below is unchanged from

the list published in the Federal

Register on January 13, 1994:

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:

Hepatitis A virus

Norwalk and Norwalk-like viruses

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

Entamoeba histolytica

Enterohemorrhagic Escherichia coli

Enterotoxigenic Escherichia coli

Giardia lamblia

Nontyphoidal Salmonella

Rotavirus

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. Maxcy-Rosenau

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. Locally

acquired neurocysticercosis—North Carolina,

Massachusetts, and South Carolina, 1989–

1991. MMWR 1992; 41:1–4.

Dated: September 15, 1997.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–25053 Filed 9–19–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0380]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by October 22,

1997.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed
49520 Federal Register / Vol. 62, No. 183 / Monday, September 22, 1997 / Notices

collection of information to OMB for

review and clearance.

Importer’s Entry Notice (OMB Control

Number 0910–0046—Extension)

Section 801 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

381) charges FDA with the

responsibility for assuring that foreignorigin FDA-regulated foods, drugs,

cosmetics, medical devices, and

radiological health products offered for

import into the United States meet the

same requirements of the act as do

domestic products, and for preventing

shipments from entering the country if

they are not in compliance.

The information collected by FDA

consists of the following: Product code,

an alpha-numeric series of characters

that identifies each product FDA

regulates; FDA country of origin, the

country where the FDA-registered or

FDA-responsible firm is located; FDA

manufacturer, the party who

manufactured, grew, assembled, or

otherwise processed the goods (if more

than one, the last party who

substantially transformed the product);

shipper, the party responsible for

packing, consolidating, or arranging the

shipment of the goods to their final

destination; quantity and value of the

shipment; and, if appropriate,

affirmation of compliance, a code that

conveys specific FDA information, such

as registration number, foreign

government certification, etc. This

information is collected electronically

by the entry filer via the U.S. Customs’

Automated Commercial System at the

same time he/she files an entry for

import with the U.S. Customs Service.

FDA uses the information to make

admissibility decisions about FDAregulated products offered for import

into the United States.

FDA estimates the burden of this

collection of information as follows:

TABLE I.—ESTIMATED ANNUAL REPORTING BURDEN

No. of respondents Annual frequency per

response Total annual responses Hours per response Total hours

2,505 1,212.54 3,037,426 0.07 229,693

There are no capital costs or operating and maintenance costs associated with this collection.

The source of the estimate for the

number of respondents is the number of

importers who submitted entry data for

foreign-origin FDA-regulated products

in 1996. The estimated reporting burden

is based on information obtained by

contacting several past respondents.

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25020 Filed 9–19–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Notice of a Cooperative Agreement

With the National Association of

People With AIDS

The Health Resources and Services

Administration’s (HRSA) HIV/AIDS

Bureau announces that it will enter into

an umbrella cooperative agreement with

the National Association of People with

AIDS (NAPWA).

The purpose of this cooperative

agreement is to assist NAPWA in

expanding and enhancing its HIV

training and technical assistance

activities with the ultimate goal of

improving the health status and access

to care for people infected with or

affected by HIV/AIDS. Activities will

include but not be limited to developing

materials, guides, and conferences for

HRSA’s Ryan White programs. HRSA

will provide consultation, including

administrative and technical assistance

as needed, for the execution and

evaluation of all aspects of this

cooperative agreement. HRSA will also

participate and/or collaborate with the

NAPWA in any workshops or symposia

to exchange current information,

opinions, and research findings to the

Ryan White grantees during this

agreement.

Authorizing Legislation

This cooperative agreement is

authorized under Section 2692 of the

PHS Act.

Background

Assistance will be provided to the

National Association of People with

AIDS. No other applications are

solicited. NAPWA is the only

organization capable of administering

this cooperative agreement because it

has:

1. Developed, expanded, and

managed an infrastructure to coordinate

and implement various programs within

local communities and organizations

that deal extensively with individuals

most directly affected by the HIV/AIDS

epidemic. The association established

national initiatives—e.g., conferences,

public policy education program

(including policy forums), technical

assistance programs and publications

(including newsletters, action alerts and

training manuals) that provide a

foundation upon which to develop,

promote, and manage HIV-related health

programs for Ryan White grantees aimed

at preventing and reducing unnecessary

morbidity and mortality rates.

2. Established itself and its members

as a national association of people

affected by HIV/AIDS who serve as

leaders and experts in planning,

developing, implementing, promoting,

and evaluating HIV-related education

and policy campaigns, both nationally

and locally, aimed at reducing the

impact of HIV in minority populations

and improving the minority

community’s overall well being.

3. Developed a base of critical

knowledge, skills, and abilities related

to serving HIV-infected individuals with

a range of HIV-related health and social

problems. NAPWA has worked with the

Federal Government, academic

institutions, and health groups on

mutually beneficial education, research,

and health endeavors relating to the goal

of reducing HIV-related mortality and

has the national leadership needed to

assist Ryan White health care

professionals to work more effectively

with people living with HIV/AIDS.

4. Developed national network of

individuals, community-based

organizations, and state, regional, and

national health and civil rights

organizations committed to addressing

the HIV service, treatment, and research

needs of individuals affected and

infected by HIV and AIDS.

Approximately $200,000 is available

in fiscal year (FY) 1997 for a 12-month

budget period within a project period of

3 years. Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.