Federal Register / Vol. 65, No. 201 / Tuesday, October 17, 2000 / Notices 61339

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Annual Survey of Refugees

(ASR).

OMB No.: 0970–0033.

Description: The Refugee Act of 1980,

and the Refugee Assistance amendments

enacted in 1982 and 1986, stress the

achievement of employment and selfsufficiency by refugees as soon as

possible after their arrival in the U.S.

The Annual Survey of Refugees collects

information on the economic

circumstances of a random sample of

refugees, Amerasians, and entrants who

arrived in the U.S. during the previous

five years focusing on their education,

training, labor force participation, and

welfare utilization rates. From their

responses, ORR reports on the economic

adjustment of refugees to the American

economy. These data are used by

Congress in its annual deliberations of

refugee admissions and funding and by

program managers in formulating

policies for the future direction of the

Refugee Resettlement Program.

Respondents: Approximately 2,000

refugees.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses per

respondents

Average burden hours per

response

Total burden

hours

ASR Telephone Survey ................................................................................... 2,000 1 40 minutes 1,350

Estimated Total Annual Burden Hours: .................................................... 1,350

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, 370 L’Enfant

Promenade, SW., Washington, DC

20447, Attn: ACF Reports Clearance

Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: October 11, 2000.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 00–26657 Filed 10–16–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1379]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Procedures for the Safe Processing

and Importing of Fish and Fishery

Products

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 November

16, 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.

Procedures for the Safe Processing and

Importing of Fish and Fishery Products

(OMB Control Number 0910–0354)—

Extension

FDA regulations in part 123 (21 CFR

part 123) mandate the application of

Hazard Analysis and Critical Control

Point (HACCP) principles to the

processing of seafood. HACCP is a

preventive system of hazard control

designed to help ensure the safety of

foods. The regulations were issued

under FDA’s statutory authority to

regulate food safety, including section

402(a)(1) and (a)(4) of the Federal Food,

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

342(a)(1) and (a)(4)), and became

effective on December 18, 1997.

Certain provisions in part 123 require

that processors and importers of seafood

collect and record information. The

HACCP records compiled and

maintained by a seafood processor

primarily consist of the periodic

observations recorded at selected

monitoring points during processing

and packaging operations, as called for

in a processor’s HACCP plan (e.g., the

values for processing times,

temperatures, acidity, etc. as observed at

critical control points). The primary

purpose of HACCP records is to permit

a processor to verify that products have

been produced within carefully

established processing parameters

(critical limits) that ensure that hazards

have been avoided. HACCP records are

normally reviewed by appropriately

trained employees at the end of a

production lot or at the end of a day or

week of production to verify that control

limits have been maintained, or that

appropriate corrective actions were

taken if the critical limits were not

maintained. Such verification activities

are essential to ensure that the HACCP

system is working as planned. A review

of these records during the conduct of

periodic plant inspections also permits

FDA to determine whether the products

have been consistently processed in

conformance with appropriate HACCP

food safety controls.

Section 123.12 requires that importers

of seafood products take affirmative

steps and maintain records that verify

that the fish and fishery products they

offer for import into the United States

61340 Federal Register / Vol. 65, No. 201 / Tuesday, October 17, 2000 / Notices

were processed in accordance with the

HACCP and sanitation provisions set

forth in part 123. These records are also

to be made available for review by FDA

as provided in § 123.12(c).

The time and costs of these

recordkeeping activities will vary

considerably among processors and

importers of fish and fishery products,

depending on the type and number of

products involved, and the nature of the

equipment or instruments required to

monitor critical control points. The

burdens have been estimated using

typical small seafood processing firms

as a model because these firms represent

a significant proportion of the industry.

The burden estimate in table 1

includes only those collections of

information under the seafood HACCP

regulations that are not already required

under other statutes and regulations. For

example, the current good

manufacturing practices provisions in

21 CFR part 110 already require that all

food processors ensure good sanitary

practices and conditions, monitor the

quality of incoming materials, monitor

and control food temperatures to

prevent bacterial growth, and perform

certain corrective actions and

verification procedures. Furthermore,

the estimate does not include

collections of information that are a

usual and customary part of businesses’

normal activities. For example, the

tagging and labeling of molluscan

shellfish (21 CFR 1240.60) is a

customary and usual practice among

seafood processors. Consequently the

estimates in table 1 account only for

new information collection and

recording requirements attributable to

part 123.

In the Federal Register of July 21,

2000 (65 FR 45382), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency per

Recordkeeping2

Total Annual

Records

Hours per

Recordkeeper3 Total Hours Total Operating andMaintenance Costs

123.6(a), (b), and

(c) 243 1 243 16 3,888 $58,320

123.6(c)(5) 4,850 4 19,400 0.30 5,820 $87,300

123.8(a)(1) and (c) 4,850 1 4,850 4 19,400 $291,000

123.12(a)(2)(ii) 1,000 80 80,000 0.20 16,000 $240,000

123.6(c)(7) 4,850 280 1,358,000 0.30 407,400 $6,111,000

123.7(d) 1,940 4 7,760 0.10 1,940 $29,100

123.8(d) 4,850 47 227,950 0.10 227,795 $341,925

123.11(c) 4,850 280 1,358,000 0.10 135,800 $2,037,000

123.12(c) 1,000 80 80,000 0.10 8,000 $120,000

123.12(a)(2) 50 1 50 4 200 $3,000

123.10 243 1 24 24 5,832 $87,480

Total 627,075 $9,406,125

1There are no capital costs associated with this collection of information.

2Based on an estimated 280 working days per year.

3Estimated average time per 8-hour work day unless one time response.

The above estimates include the information collection requirements in the following sections:

§ 123.16 Smoked Fish—process controls (see § 123.6(b)),

§ 123.28(a) Source Controls—molluscan shellfish (see § 123.6(b)), and

§ 123.28(c), (d) Records—molluscan shellfish (see § 123.6(c)(7)).

Dated: October 6, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26607 Filed 10–16–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

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: Advisory

Committee for Pharmaceutical Science.

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 November 15 and 16, 2000,

from 8:30 a.m. to 5:30 p.m.

Location: University of Maryland,

Shady Grove Campus, Auditorium, 9640

Gudelsky Dr., Rockville, MD 20850.

Contact Person: Nancy Chamberlin,

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, or e-mail:

CHAMBERLINN@cder.fda.gov, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12539.

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

Agenda: On November 15, 2000, the

committee will: (1) Discuss approaches

to reducing the regulatory burden for

chemistry, manufacturing, and controls

supplements; and (2) hear reports and

provide direction to the Advisory

Committee for Pharmaceutical Science’s

Subcommittee on Orally Inhaled and

Nasal Drug Products, and to the

Subcommittee on Nonclinical Studies.

On November 16, 2000, the committee

will: (1) Discuss the FDA guidance

entitled ‘‘A Guidance for Industry,

Waiver of In Vivo Bioavailability and

Bioequivalence Studies for ImmediateRelease Solid Oral Dosage Forms Based

on a Biopharmaceutics Classification

System,’’ see the FDA Internet web

address www.fda.gov/cder/guidance/

3618fnl.htm under the heading of

‘‘Biopharmaceutic Guidances;’’ the FDA

draft guidance entitled ‘‘A Guidance for

Industry, BA and BE Studies for Orally

Administered Drug Products-General

Considerations,’’ see the FDA Internet