Federal Register / Vol. 62, No. 211 / Friday, October 31, 1997 / Notices 58973

issued a notice proposing changes to the

methodology currently used to

determine cigarette ratings for tar,

nicotine, and carbon monoxide. See 62

FR 48.158 (Sept. 12, 1997). The

proposed methodology would produce

tar, nicotine, and carbon monoxide

yields using both the current testing

parameters and more intensive smoking

conditions, thus producing a range of

potential yields for each cigarette. The

Commission requested comment on

those proposed changes to the testing

methodology, and on the feasibility of

generating the upper tier of tar, nicotine,

and carbon monoxide ratings through

mathematical formulas, rather than

actual testing on a smoking machine.

The Commission also placed on the

public record two different legends that

could be used in advertising to disclose

the ratings and sought comment on the

usefulness and feasibility of these

potential disclosure formats. Finally,

comment was requested on alternative

approaches that were considered but not

proposed by the Commission. The

deadline for submission of the requested

comments was November 17, 1997.

The Commission has received

requests for extension of this deadline

from the Food and Drug Administration,

the four largest cigarette manufacturers

(Brown & Williamson Tobacco

Corporation, Lorillard Tobacco

Company, Philip Morris Incorporated

and R.J. Reynolds Tobacco Company),

the American Lung Association, the

Commonwealth of Massachusetts and

the American Society of Addiction

Medicine.

In light of the importance and

complexity of the issues addressed by

the Commission’s Federal Register

notice, and the number of issues on

which comment is being requested, the

Commission has decided to extend the

filing deadline until January 20, 1998.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 97–28913 Filed 10–30–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0195]

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 December

1, 1997.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, 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 section 3507 of the

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

submitted the following proposed

collection of information to OMB for

review and clearance.

In a final rule entitled ‘‘Procedures for

the Safe Processing and Importing of

Fish and Fishery Products’’ (60 FR

65096, December 18, 1995), FDA issued

regulations in part 123 (21 CFR part

123) mandating 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 will become affective on

December 18, 1997.

Certain provisions in the regulations

require that processors and importers of

seafood collect and record information.

In the final rule (60 FR 65096 at 65177

and 65178), the agency requested

comments on the information collection

provisions of the new regulations. No

comments were received in response to

this request.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1, 5

21 CFR Section No. of Recordkeepers

Annual Frequency

of Recordkeeping2

Total Annual

Records

Hours per Recordkeeper3 Total Hours

123.6(a),(b),(c) ........................................ 4,850 1 4,850 16 77,6004

123.6(c)(5) .............................................. 4,850 4 19,400 0.30 5,820

123.8(a)(1),(c) ......................................... 4,850 1 4,850 4 19,400

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

123.6(c)(7) .............................................. 4,850 280 1,358,000 0.30 407,400

123.7(d) ................................................... 1,940 4 7,760 0.10 1,940

123.8(d) ................................................... 4,850 47 227,950 0.10 22,795

123.11(c) ................................................. 4,850 280 1,358,000 0.10 135,800

123.12(c) ................................................. 1,000 80 80,000 0.10 8,000

123.12(a)(2) ............................................ 1,000 1 1,000 4 4,0004

123.10 ..................................................... 4,850 1 24 24 116,4004

First year total burden hours ........... 815,155

Annual recurring burden hours ........ 617,155

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

2Based on an estimated of 280 working days per year.

3Estimated average time per 8 hour workday unless one time response.

4 Nonrecurring burdens.

5The 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))

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

123.9 Records control—general (see recording and records)
58974 Federal Register / Vol. 62, No. 211 / Friday, October 31, 1997 / Notices

The time and costs of these 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 food

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.

There were some inadvertent errors in

the total burden hours column of the

estimates for § 123.6(c)(5) and (c)(7) in

the final rule. These errors have been

corrected in this document, and the

totals for part 123 as a whole have been

adjusted accordingly.

Dated: October 27, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–28940 Filed 10–30–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Center for Research Resources

Special Emphasis Panel (SEP) meeting:

Name of SEP: General Clinical Research

Centers.

Date: December 18–19, 1997.

Time: 8:00 a.m.

Place: Georgetown University Conference

Center, 800 Reservoir Road, N.W.,

Washington, DC 20057, (202) 687–3200.

Contact Person: Dr. Jill Carrington,

Scientific Review Administrator, 6705

Rockledge Drive, MSC 7965, Room 6018,

Bethesda, MD 20892–7965, (301) 435–0822.

Purpose/Agenda: To evaluate and review

grant applications.

This meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.306, Laboratory Animal

Science and Primate Research, National

Institutes of Health, HHS)

Dated: October 24, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–28847 Filed 10–30–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Drug Abuse;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute on Drug Abuse

(NIDA) Special Emphasis Panel

meetings.

Purpose/agenda: To review and evaluate

grant applications.

Name of Committee: NIDA Special

Emphasis Panel (Training Grants).

Date: November 4, 1997.

Time: 10:00 a.m

Place: National Institutes of Health, The

Natcher Building, Conference Rm. H, 45

Center Drive, Bethesda, MD 20982.

Contact Person: Mark Swieter, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–42, Telephone (301) 443–2620.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

Name of Committee: NIDA Special

Emphasis Panel (Clinic Neuroscience and

Imaging).

Date: November 18, 1997.

Time: 1:00 p.m

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Mark Swieter, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–42, Telephone (301) 443–2620.

Name of Committee: NIDA Special

Emphasis Panel (AIDS Biomedical and

Clinical).

Date: November 19, 1997.

Time: 11:00 a.m

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Chevy Chase, MD 20818.

Contact Person: Khursheed Asghar, Ph.D.,

Scientific Review Administrator, Office of

Extramural Program Review, National

Institute on Drug Abuse, 5600 Fishers Lane,

Room 10–22, Telephone (301) 443–2620.

The meetings will be closed in accordance

with provisions set forth in secs. 552b(c)(4)

and 552b(c)(6), Title 5, U.S.C. The

applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, disclosure of

which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Numbers: 93.277, Drug Abuse

Research Scientist Development and

Research Scientist Awards; 93.278, Drug

Abuse National Research Service Awards for

Research Training; 93.279, Drug Abuse

Research Programs)

Dated: October 28, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–28922 Filed 10–30–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Dental Research;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Dental Research

Special Emphasis Panel (SEP) meetings:

Name of SEP: National Institute of Dental

Research Special Emphasis Panel—Review of

F32 grant (98–11).

Dates: November 18, 1997.

Time: 1:00 p.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).