This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

54398

Vol. 62, No. 202

Monday, October 20, 1997

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1240

[Docket No. 97N–0418]

Revocation of Lather Brushes

Regulation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

revoke its regulation pertaining to the

treatment, sterilization, handling,

storage, marking, and inspection of

lather brushes. FDA is proposing to

revoke this regulation because it has

tentatively concluded that the

regulation is no longer necessary to

protect the public health.

DATES: Written comments by January 5,

1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Policy Development and

Coordination Staff (HF–23), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3380.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 19,

1949 (14 FR 278), the Federal Security

Agency issued a regulation to prohibit

‘‘interstate traffic’’ in lather brushes

unless the brushes complied with 42

CFR 71.151 or with certain requirements

in 42 CFR 72.21. 42 CFR 71.151 barred

importation of lather brushes made from

animal hair or bristles, unless the

brushes were permanently marked with

the manufacturer’s name or identifying

mark and a U.S. medical officer had

determined that the brushes were free of

anthrax spores. The regulation also

directed medical officers to sample

brushes from each shipment, subject

them to laboratory analysis, and to issue

a certificate if the shipment appeared to

be free of spores. If the shipment

contained anthrax spores, the shipment

would be denied entry into the United

States.

The Federal Security Agency was

abolished in a reorganization in 1953,

and its functions were transferred to the

then newly-created Department of

Health, Education, and Welfare. The

department later became the

Department of Health and Human

Services.

42 CFR 72.21, which applied

primarily to lather brushes

manufactured in the United States,

established specific treatment,

sterilization, handling, storage, and

marking requirements for these

products; and it required that persons

engaged in processing or handling of

hair or bristles for use in lather brushes,

as well as persons manufacturing lather

brushes, permit inspections by

authorized representatives of the

Surgeon General. The rule was

transferred, without change, from title

42 to title 21 of the Code of Federal

Regulations on February 6, 1975 (40 FR

5620), and, as a result, became § 1240.70

(21 CFR 1240.70).

In the Federal Register of August 9,

1983 (48 FR 36143 at 36144), the

Centers for Disease Control (CDC), now

known as the Centers for Disease

Control and Prevention, proposed to

revoke various foreign quarantine

regulations, including 42 CFR 71.151.

The preamble to that proposal explained

that:

The proposed regulations will no longer

require lather brushes made from animal hair

or bristles, imported into the United States,

to carry identifying markings or to be

certified as treated and stored to prevent

possible contamination with spores of

Bacillus anthracis. No case of cutaneous

anthrax in the United States has been

associated with lather brushes since 1930,

and the continuation of existing requirements

is unnecessary to protect the public health.

Should the importation of anthrax in lather

brushes become a threat to public health in

the future, inspection and control measures

authorized under provisions of the

regulations will be implemented.

CDC revoked 42 CFR 71.151 on January

11, 1985 (50 FR 1516), without any

further discussion.

In the Federal Register of June 12,

1989 (54 FR 24890), FDA issued a final

rule amending various regulations to

correct outdated cross-references and

typographical errors and to make other

corrections. This rule revised § 1240.70,

without explanation, to eliminate the

reference to 42 CFR 71.151. Yet, in all

other respects, § 1240.70 has remained

essentially unchanged since 1949.

Recently, FDA has been reexamining

its regulations to determine whether any

are obsolete or no longer necessary. One

regulation that caught the agency’s

attention is § 1240.70. The agency is

unaware of any reliance on the lather

brush requirements in this regulation or

of any current concerns associated with

lather brushes. Additionally, CDC’s

decision to remove 42 CFR 71.151

because no case of cutaneous anthrax in

the United States has been associated

with lather brushes since 1930 suggests

that § 1240.70 also is no longer

necessary to protect the public health.

Consequently, FDA is proposing to

revoke this regulation.

II. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). Executive Order

12866 directs agencies to assess all costs

and benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages). The agency

believes that this proposed rule is

consistent with the principles identified

in the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The proposed rule, if finalized,

would eliminate certain manufacturing

requirements for lather brushes.

Consequently, the proposed rule would

not impose any additional regulatory

burdens on small entities, and so, under

the Regulatory Flexibility Act, no

further analysis is required.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type
Federal Register / Vol. 62, No. 202 / Monday, October 20, 1997 / Proposed Rules 54399

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Request for Comments

Interested persons may, on or before

January 5, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 1240

Communicable diseases, Public

health, Travel restrictions, Water

supply.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 1240 be amended as

follows:

PART 1240—CONTROL OF

COMMUNICABLE DISEASES

1. The authority citation for 21 CFR

part 1240 continues to read as follows:

Authority: 42 U.S.C. 216, 243, 264, 271.

§ 1240.70 [Removed]

2. Section 1240.70 Lather brushes is

removed.

Dated: October 10, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–27694 Filed 10–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Parts 1000, 1003, and 1005

[Docket No. FR–4170–N–14]

Native American Housing Assistance

and Self-Determination Negotiated

Rulemaking Committee; Meetings

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Negotiated Rulemaking

Committee meetings.

SUMMARY: This notice announces the

final implementation meetings

sponsored by HUD to develop the

regulations necessary to carry out the

Native American Housing Assistance

and Self-Determination Act of 1996

(NAHASDA) (Pub. L. 104–330,

approved October 30, 1996).

DATES: The meetings will be held on

October 27, 28 and 29, 1997. The

October 27 and 28, 1997 meetings will

begin at approximately 8:30 a.m. and

end at approximately 5:00 p.m., local

time. The October 29, 1997 meeting will

begin at approximately 8:30 a.m. and

end at approximately noon, local time.

ADDRESS: The meetings will be held at

the Loews L’Enfant Plaza Hotel, 480

L’Enfant Plaza East, SW, Washington,

DC 20024; telephone 1–800–635–5065

or (202) 484–1000; FAX (202) 863–4497

(With the exception of the ‘‘800’’

telephone number, these are not toll-free

numbers).

FOR FURTHER INFORMATION CONTACT:

Karen Garner-Wing, Acting Deputy

Assistant Secretary for Native American

Programs, Department of Housing and

Urban Development, 1999 Broadway,

Suite 3390, Denver, CO; telephone (303)

675–1600 (this is not a toll-free

number). Hearing or speech-impaired

individuals may access this number via

TTY by calling the toll-free Federal

Information Relay Service at 1–800–

877–8339.

SUPPLEMENTARY INFORMATION: The

Secretary of HUD established the Native

American Housing Assistance & SelfDetermination Negotiated Rulemaking

Committee (Committee) to negotiate and

develop a proposed rule implementing

NAHASDA. The proposed rule was

published on July 2, 1997 (62 FR 35718)

and provided for a 45-day public

comment period. The public comment

deadline was August 18, 1997.

The Committee met from August 22–

29, 1997 in Denver, Colorado and from

September 21–26, 1997 in Arlington,

Virginia to consider the public

comments submitted on the proposed

rule. The Committee is meeting for a

final time to discuss issues left

unresolved and to reach consensus on

the Committee’s final report to the

Secretary of HUD.

The meeting dates are: October 27, 28,

and 29 1997. The agenda planned for

the meetings includes: (1) discussion of

the draft Committee report; (2)

discussion of issues left unresolved; and

(3) approval of a final Committee report

for submission to the Secretary of HUD.

The meetings will be open to the

public without advance registration.

Public attendance may be limited to the

space available. Members of the public

may make statements during the

meetings, to the extent time permits,

and file written statements with the

Committee for its consideration. Written

statements should be submitted to the

address listed in the FOR FURTHER

INFORMATION section of this notice.

Summaries of Committee meetings will

be available for public inspection and

copying at the address in the same

section.

Dated: October 14, 1997.

Kevin Emanuel Marchman,

Acting Assistant Secretary for Public and

Indian Housing.

[FR Doc. 97–27674 Filed 10–17–97; 8:45 am]

BILLING CODE 4210–33–P

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Part 9

RIN 1512–AA07

[Notice No. 856]

Establishment of the San Francisco

Bay Viticultural Area and the

Realignment of the Boundary of the

Central Coast Viticultural Area (97–

242)

ACTION: Notice of proposed rulemaking.

SUMMARY: The Bureau of Alcohol,

Tobacco and Firearms (ATF) has

received a petition proposing the

establishment of a viticultural area in

the State of California to be known as

San Francisco Bay. The proposed area is

located mainly within five counties

which border the San Francisco Bay and

partly within two other counties. These

counties are: San Francisco, San Mateo,

Santa Clara, Alameda, Contra Costa, and

partly in Santa Cruz and San Benito

Counties. The proposed San Francisco

Bay viticultural area encompasses

approximately 3,087 square miles total

containing nearly 6,000 acres planted to

grapes and over 70 wineries. In

conjunction with the petition, ATF

received a proposal to amend the

boundaries of the current Central Coast

viticultural area to include the proposed

San Francisco Bay viticultural area. As

the current boundaries already

encompass part of the proposed San

Francisco Bay viticultural area,

approximately 1,278 square miles

would be added to Central Coast with

an additional 3,027 acres planted to

grapes and 21 more wineries.

DATES: Written comments must be

received by January 20, 1997.

ADDRESSES: Send written comments to:

Chief, Wine, Beer, and Spirits

Regulations Branch, Bureau of Alcohol,