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

Federal Register / Vol. 65, No. 201 / Tuesday, October 17, 2000 / Notices 61341

web address www.fda.gov/cder/

guidance/2762dft.htm under the

heading of ‘‘Biopharmaceutic Draft

Guidances;’’ and the FDA draft guidance

entitled ‘‘A Guidance for Industry,

Average, Population, and Individual

Approaches to Establishing

Bioequivalence,’’ see the FDA Internet

web address www.fda.gov/cder/

guidance/1716dft.htm under the

heading of ‘‘Biopharmaceutic Draft

Guidances;’’ (2) provide comments and

advice to the Clinical Pharmacology

Modeling and Simulation Working

Group; (3) receive updates on both FDA

intramural research and the Product

Quality Research Institute; and (4)

provide advice on scientific issues

specific to generic drugs.

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 November 6, 2000. Oral

presentations from the public will be

scheduled 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 November 6, 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: October 5, 2000.

Bernard A. Schwetz,

Acting Deputy Commissioner.

[FR Doc. 00–26606 Filed 10–16–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; Survey of IRB Chairs

Concerning the Implementation of

Pediatric Research Regulations

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995

for opportunity for public comment on

proposed data collection projects, the

National Institutes of Health (NIH) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: Survey of IRB Chairs

Concerning the Implementation of

Pediatric Research Regulations.

Type of Information Collection

Request: New.

Need and Use of Information

Collection: In order to assess the

protection of children who are enrolled

in clinical research, it is important to

determine how Institutional Review

Boards (IRBs) reviewing such research

interpret and implement the Federal

Regulations for research with children

set forth in 45 CFR 46 Subpart D. This

study aims to gather this information

through telephone interviews with

chairpersons of IRBs that review clinical

research with children. In addition, we

will solicit background information on

each IRB from the IRB coordinator. In

particular, the survey aims to assess

how IRBs assess risk/benefit levels of

research with children, when IRBs

permit children’s assent to be waived,

what information IRBs require children

to be presented during the asset process,

and which children are excluded from

participation in riskier research. In

addition, the survey will attempt to

determine how the recent NIH Policy

and Guidelines on the Inclusion of

Children as Participants in Research

Involving Human Subjects has affected

IRB review. Frequency of Response:

Once. Affected Public: Individuals. Type

of Respondents: IRB chairpersons and

IRB coordinators. The annual reporting

burden follows in the table below. The

annualized cost to respondents is

estimated at: $10,000. There are no

Capital Costs to report. There are no

Operating or Maintenance Cost to

report.

RESPONDENT AND BURDEN ESTIMATE INFORMATION

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses

per

respondent

Average

burden

hours per

response

Estimated

total annual

burden

hours

requested

IRB chairs ........................................................................................................................ 200 1 0.5 100

IRB coordinators .............................................................................................................. 200 1 0.5 100

Total .......................................................................................................................... .................... .................... .................... 200

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of collection of information on

those who are to respond, including the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

FOR FURTHER INFORMATION CONTACT: To

request more information on the

proposed project or to obtain a copy of

the data collection plans and

instruments, contact Dave Wendler,

Ph.D., Head, Unit on Vulnerable

Populations, Department of Clinical

Bioethics, NIH, Building 10, Room

1C118, 9000 Rockville Pike, Bethesda,

MD 20892, or call non-toll-free number

(301) 435–8726 or e-mail your request,

including your address, to:

DWendler@cc.nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

December 18, 2000.

Dated: October 4, 2000.

Ezekiel Emanuel,

Chief, Department of Clinical Bioethics.

[FR Doc. 00–26581 Filed 10–16–00; 8:45 am]

BILLING CODE 4140–01–M