Federal Register / Vol. 65, No. 100 / Tuesday, May 23, 2000 / Notices 33329

Program Announcement 00078, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, NE MS K–

40, Atlanta, GA 30341, telephone (770)

488–5403, e-mail: lid1@cdc.gov.

Dated: May 17, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Center for Disease Control, and Prevention

(CDC).

[FR Doc. 00–12882 Filed 5–22–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0356]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Survey of

Incidence of Gastroenterological

Parasitic Infections in the United

States as a Result of Consumption of

Raw Fish

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.

DATES: Submit written comments on the

collection of information by June 22,

2000.

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: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Survey of Incidence of

Gastroenterological Parasitic Infections

in the United States as a Result of

Consumption of Raw Fish

Under section 903(b)(2) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

393(b)(2)), FDA has the responsibility to

conduct research relating to foods and

to conduct educational and public

information programs relating to the

safety of the nation’s food supply. The

‘‘Survey of Incidence of

Gastroenterological Parasitic Infections

in the United States as a Result of

Consumption of Raw Fish’’ will provide

information on the actual frequency of

occurrence of fish-borne helminth

illnesses. Detailed information will be

obtained from the target population of

clinical gastroenterologists who are

likely to have encountered and treated

food-borne parasitic infections.

Respondents will also be asked to

provide demographic information about

the most recent cases. The information

will be used to better evaluate the need

for control of helminth parasites in fish

intended for raw consumption and to

evaluate effective means for control

where such controls are found

necessary. A national representative

sample of 1,000 clinical

gastroenterologists will be selected by a

random procedure and interviewed by

questionnaire.

In theFederal Register of February 22,

2000 (65 FR 8713), the agency requested

comments on the proposed collections

of information. One comment was

received. The comment commended the

concept of conducting the survey, but

requested that the survey gather

information sufficient to determine

whether implicated fish were from

commercial or recreational sources.

The comment’s point is that because

the purpose of the survey is to help

determine whether infection from fishborne helminth parasites is a hazard

that is responsibly likely to occur in the

United States in commercial species of

fish, data on parasite infections from

noncommercial species could skew the

outcome. While the comment’s point is

valid in theory, it is highly unlikely that

recreational species are a significant

source of parasite infections. It is more

likely that commercial species intended

for raw consumption, as in sushi and

sashimi, provide an appreciable risk of

parasite infection. Consequently, the

agency does not regard differentiation

between commercial and recreational

sources to be critical to the success of

the survey. As a practical matter,

moreover, information on whether an

infection was from a commercially or

recreationally obtained fish is probably

not available through the kind of survey

that is being conducted. Consequently,

FDA does not contemplate any change

in the survey.

Any findings of significant levels of

infection will guide FDA in evaluating

its current policy that fish intended for

raw consumption should have been

previously frozen to eliminate the

hazard from live parasites. This

recommendation is adhered to by many

members of the seafood industry. To the

extent that parasite infection from raw

fish is demonstrated through this survey

to be a hazard reasonably likely to

occur, the agency would focus its

attention to such actions as increased

consumer education, which would

apply to raw fish from any source, and

to ensuring the implementation of

hazard analysis critical control points

controls for fish sold for raw

consumption.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

500 1 500 .50 250

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

33330 Federal Register / Vol. 65, No. 100 / Tuesday, May 23, 2000 / Notices

This is a one-time survey. The burden

estimate is based on FDA’s experience

with conducting similar surveys.

Dated: May 15, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–12854 Filed 5–22–00; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Psychopharmacological Drugs

Advisory Committee; 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:

Psychopharmacological Drugs Advisory

Committee

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 19, 2000, 8 a.m. to 5 p.m.

Location: Holiday Inn, Versailles

Ballrooms I, II, and III, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Sandra L. Titus or

LaNise S. Giles, Center for Drug

Evaluation and Research (HFD–21),

5600 Fishers Lane (for express delivery,

5630 Fishers Lane, Rm. 1093) Rockville,

MD 20857, 301–827–7001, or e-mail

Tituss@cder.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area) code 12544.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will consider

the safety and efficacy of new drug

application (NDA) 20–825, ZeldoxTM

(ziprasidone hydrochloride capsules,

Pfizer, Inc.), proposed for the

management of psychotic disorders.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 17, 2000. Oral

presentations from the public will be

scheduled on July 19, 2000, between

approximately 1 p.m. to 2 p.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 17, 2000, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 11, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–12855 Filed 5–22–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[FDA 225–00–2000]

Memorandum of Understanding

Between the Food and Drug

Administration, U.S. Department of

Health and Human Services, and the

Food Safety and Inspection Service,

U.S. Department of Agriculture,

Regarding the Listing or Approval of

Food Ingredients and Sources of

Radiation Used in the Production of

Meat and Poultry Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of a memorandum of

understanding (MOU) between FDA and

the Food Safety and Inspection Service,

U.S. Department of Agriculture (FSIS).

The purpose of the agreement is to

establish the working relationship to be

followed by FDA and FSIS in

responding to requests for the

sanctioning of the use of food

ingredients and sources of radiation

subject to regulation by FDA and

intended for use in the production of

meat and meat food products.

DATES: The agreement became effective

January 31, 2000.

FOR FURTHER INFORMATION CONTACT:

Arletta M. Beloian, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3082.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and MOU’s between FDA and others

shall be published in the Federal

Register, the agency is publishing notice

of this MOU.

Dated: May 16, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

The MOU is set forth in its entirety as

follows:

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