21392 Federal Register / Vol. 61, No. 92 / Friday, May 10, 1996 / Proposed Rules

(b) Special requirements for horses

traveling through countries of transit. In

addition to meeting all of the applicable

requirements of this subpart, horses

shipped to the United States through a

country or countries of transit must

meet the following conditions:

(1) If a horse intended for importation

into the United States will travel

through a country or countries of transit

but will not be offloaded in the country

or countries of transit, then, prior to the

horse’s shipment from the country of

origin, the owner of the horse, or the

owner’s representative, must certify that

the horse will be shipped directly to the

United States. The certification must

read as follows: ‘‘The horse will be sent

directly from the premises of origin to

the premises of destination without

coming into contact with other equine

animals not accompanied by an official

health certificate, in vehicles cleaned

and disinfected in advance with a

disinfectant officially recognized in the

country of origin.’’ This certification

must be signed by the owner of the

horse or the owner’s representative, and

the signed certification must be

presented to an inspector at the port of

entry in the United States. If, after the

certification is signed, an unscheduled

offloading of a shipment of horses

occurs in a country of transit, then the

horses must meet all of the requirements

of paragraphs (b)(2) and (b)(3) of this

section.

(2) If a horse intended for importation

into the United States will travel

through a country or countries of transit

and will be offloaded in the country or

countries of transit, then the horse must

be offloaded in a facility that is capable

of being cleaned and disinfected and

that is approved by the country of

transit’s Ministry of Agriculture for the

offloading of in-transit horses. Within

the facility, the horse must be kept

separate from all other horses. All

horses offloaded in a country or

countries of transit must undergo a

veterinary inspection and receive a

health certificate from a salaried

veterinary officer of the national

government of each country of transit in

which the horse is offloaded. The

veterinary inspection must be

performed no earlier than 24 hours

before the horse is reloaded on a

transport vehicle for shipment. If, after

performing the inspection, the salaried

veterinary officer of the national

government of the country of transit

finds the horse intended for importation

into the United States to be free of

evidence of communicable diseases and

fit to travel, the veterinary officer must

complete the form shown in paragraph

(b)(3) of this section.

(3) A completed certificate of

inspection, as shown below, must

accompany any horse offloaded in a

country of transit to the U.S. port of

arrival and be produced for the

inspector at the port of arrival upon the

horse’s arrival in the United States.

Certification of Inspection of Import Animals

1. Permit No. llllllllllllll

2. Consignor’s Name (Last name, first name,

middle initial or business name) lllll

3. Consignor’s Street Address (Mailing address) llllllllllllllllll

4. Consignor’s City/Town lllllllll

5. Consignor’s Country llllllllll

6. Consignee’s Name (Last name, first name,

middle initial or business name) lllll

7. Consignee’s City/Town llllllll

8. Consignor’s State lllllllllll

9. Species of Animals Certified for Import l

10. Country of Origin llllllllll

11. Breed of Animals Certified for Import l

12. Number of Animals Inspected lllll

13. Country of Transit/City in Which Inspection Occurred llllllllllllll

14. Date of Arrival in and Date of Departure

from Country of Transit lllllllll

15. Name of Veterinarian Performing Inspection in Country of Transit llllllll

The animals described on this form have

been given a careful veterinary inspection

and found to be free from evidence of

communicable disease and, in my opinion,

fit to travel.

16. Signature of Veterinarian Performing Inspection in Country of Transit llllll

17. Date Issued lllllllllllll

18. Seal lllllllllllllllll

19. Remarks lllllllllllllll

(Approved by the Office of Management and

Budget under control number 0579–0040)

Done in Washington, DC, this 3rd day of

May 1996.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 96–11635 Filed 5–9–96; 8:45 am]

BILLING CODE 3410–34–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter 1

[Docket No. 96N–0094]

Uniform Compliance Date for Food

Labeling Regulations; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

proposed rule that appeared in the

Federal Register of April 15, 1996 (61

FR 16422). The document proposed to

establish January 1, 1998, as its new

uniform compliance date for all food

labeling regulations that are issued after

the publication of a final rule based on

the proposal and before January 1, 1997.

The document was published with an

editorial error. This document corrects

that error.

FOR FURTHER INFORMATION CONTACT:

Gerad L. McCowin, Center for Food

Safety and Applied Nutrition (HFS–

150), Food and Drug Administration,

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

202–205–4561.

In FR Doc. 96–9319, appearing on

page 16422 in the Federal Register of

Monday, April 15, 1996, the following

correction is made:

1. On page 16422, in the first column,

after the ‘‘DATES’’ caption, a new

caption is added to read as follows:

‘‘ADDRESSES: Submit written

comments to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.’’

Dated: May 6, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11788 Filed 5–9–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 328

[Docket No. 95N–0341]

Over-the-Counter Drug Products

Intended for Oral Ingestion that

Contain Alcohol; Proposed

Amendment of Final Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a notice

of proposed rulemaking that would

amend the regulations for over-thecounter (OTC) drug products intended

for oral ingestion that contain alcohol as

an inactive ingredient by exempting

ipecac syrup from the maximum

concentration limits of 0.5 percent

alcohol or less when used by children

under 6 years of age. This proposal is

part of the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

June 10, 1996; written comments on the

agency’s economic impact

determination by June 10, 1996. The

agency is proposing that any final rule

based on this proposal become effective

on the date of its publication in the

Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch
Federal Register / Vol. 61, No. 92 / Friday, May 10, 1996 / Proposed Rules 21393

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

William E. Gilbertson, Center for Drug

Evaluation and Research (HFD–105),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2304.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 13,

1995 (60 FR 13590), the agency issued

a final rule establishing in § 328.10 (21

CFR 328.10) maximum concentration

limits for alcohol (ethyl alcohol) as an

inactive ingredient in OTC drug

products intended for oral ingestion.

The maximum concentration limit was

set at 0.5 percent for any OTC drug

product labeled for use by children

under 6 years of age, and 5 percent for

any OTC drug product labeled for use

by children 6 to under 12 years of age.

The final rule did not discuss ipecac

syrup, an OTC drug product used to

cause vomiting when poisoning occurs.

The United States Pharmacopeia

(USP) 23d Revision states that alcohol is

contained in ipecac syrup in

concentrations between 1.0 and 2.5

percent (Ref. 1). Alcohol is used in the

preparation of the syrup to ensure the

complete extraction of alkaloids as their

amine salts from ipecac powder and to

reject extraneous material when ipecac

syrup is prepared by percolation (Ref.

2).

Under § 201.308(c) (21 CFR

201.308(c)), OTC marketing of ipecac

syrup is limited to a 1-fluid-ounce (30

milliliters (mL)) package. The product’s

labeling must contain a statement

conspicuously boxed and in red letters

that states: ‘‘For emergency use to cause

vomiting in poisoning. Before using, call

physician, the Poison Control Center, or

hospital emergency room immediately

for advice.’’ The labeling also must

state: ‘‘Usual dosage: 1 tablespoon (15

milliliters) in persons over 1 year of

age.’’

As part of the rulemaking for OTC

poison treatment drug products (50 FR

2244, January 15, 1985), the agency

proposed a dose of 1 tablespoonful (15

mL or 1/2 bottle) of ipecac syrup for

children 1 to under 12 years of age. The

agency also proposed a dose of 1

teaspoonful (5 mL) for children 6

months to under 1 year of age, and that

ipecac syrup not be given to children

under 6 months of age unless directed

by a health professional. The agency

will finalize these directions for use in

a future issue of the Federal Register.

References

(1) United States Pharmacopeia 23d

Revision National Formulary 18, United

States Pharmacopeial Convention, Inc.,

Rockville, MD, pp. 834–835, 1994.

(2) ‘‘Solutions Using Mixed Solvent

Systems: Spirits, Elixirs, and Extracted

Products,’’ in Sprowls’ American Pharmacy,

7th ed., J. B. Lipincott Co., Philadelphia, pp.

100–101, 1974.

II. The Agency’s Proposed Amendment

The agency is proposing to exempt

ipecac syrup from the requirements of

§ 328.10(d), which limit alcohol content

to 0.5 percent or less in OTC drug

products intended for oral ingestion for

use by children 6 years of age or less.

Ipecac syrup is indicated for use in

potential life-threatening emergencies

with directions for use calling for a onetime treatment dose of 15 mL for

children 1 to under 12 years of age.

Ipecac syrup is usually used under the

advice of a health professional, and it is

not indicated for repeated or routine

use. Because the maximum amount of

ipecac syrup per packaged container

does not exceed 30 mL, the maximum

quantity of alcohol at a 2.5 percent

concentration contained in 30 mL of

ipecac syrup is 0.75 mL. If a child under

6 years old swallowed the entire

contents of a 30 mL container of ipecac

syrup, the ingested amount of alcohol

(0.75 mL) is insignificant. In addition,

the alcohol and the ipecac syrup are

generally vomited together with other

stomach contents. The agency

concludes that the benefit of ipecac

syrup as an emetic outweighs any risk

of adverse effects from ingestion of 0.75

mL of alcohol. Accordingly, the agency

is proposing to add a new paragraph to

§ 328.10 to state: ‘‘Ipecac syrup is

exempt from the provisions of

paragraph (d) of this section.’’ This

means that ipecac syrup may contain

more than 0.5 percent alcohol even

though labeled for use by children

under 6 years of age. The agency is

designating this new paragraph as

paragraph (f) and redesignating current

paragraph (f) as paragraph (g).

III. Analysis of Impacts

The agency has examined the

economic consequences of this

proposed rulemaking in conjunction

with other rules resulting from the OTC

drug review. In a notice published in

the Federal Register of February 8, 1983

(48 FR 5806), the agency announced the

availability of an assessment of these

economic impacts. The assessment

determined that the combined impacts

of all the rules resulting from the OTC

drug review do not constitute a major

rule according to the criteria established

by Executive Order 12291. Executive

Order 12291 has been superseded by

Executive Order 12866. FDA has

examined the impacts of the proposed

rule under Executive Order 12866 and

the Regulatory Flexibility Act (Pub. L.

96–354). 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;

distributive impacts; and equity). The

agency believes that this proposed rule

is consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and, thus, is not subject

to review under 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. This proposal has no effect on

the OTC marketing of ipecac syrup drug

products. Therefore, the agency certifies

that this proposal, if implemented, will

not have a significant economic impact

on a substantial number of small

entities.

The agency invites public comment

regarding any substantial or significant

economic impact that this rulemaking

would have on OTC drug products

intended for oral ingestion that contain

alcohol as an inactive ingredient.

Comments regarding the impact of this

rulemaking on OTC drug products

intended for oral ingestion that contain

alcohol as an inactive ingredient should

be accompanied by appropriate

documentation.

IV. Environmental Impact

The agency has determined under 21

CFR 25.24(c)(6) that this action is not of

a type 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.

V. Request for Comments

Interested persons may, on or before

June 10, 1996, submit to the Dockets

Management Branch (address above)

written comments or objections on the

proposed regulation. Written comments

on the agency’s economic impact

determination may be submitted on or

before June 10, 1996. Three copies of all

comments or objections are to be

submitted, except that individuals may

submit one copy. Comments or
21394 Federal Register / Vol. 61, No. 92 / Friday, May 10, 1996 / Proposed Rules

objections are to be identified with the

docket number found in brackets in the

heading of this document and may be

accompanied by a supporting

memorandum or brief. The agency has

determined that comments or objections

should be submitted within 30 days

because this proposal has no effect on

currently marketed products.

List of Subjects in 21 CFR Part 328

Drugs, Labeling, Alcohol.

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 328 be amended as follows:

PART 328—OVER-THE-COUNTER

DRUG PRODUCTS INTENDED FOR

ORAL INGESTION THAT CONTAIN

ALCOHOL

1. The authority citation for 21 CFR

part 328 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 355, 371).

2. Section 328.10 is amended by

redesignating paragraph (f) as paragraph

(g) and by adding new paragraph (f) to

read as follows:

§ 328.10 Alcohol.

* * * * *

(f) Ipecac syrup is exempt from the

provisions of paragraph (d) of this

section.

* * * * *

Dated: May 1, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11640 Filed 5–9–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Part 3500

[Docket No. FR–3780–N–07]

RIN 2502–AG40

Office of the Assistant Secretary for

Housing—Federal Housing

Commissioner; Mortgage Broker Fee

Disclosure Rule: Notice of Meeting of

Negotiated Rulemaking Advisory

Committee

AGENCY: Office of the Assistant

Secretary for Housing—Federal Housing

Commissioner, HUD.

ACTION: Notice of committee meeting.

SUMMARY: The Department has

established a Negotiated Rulemaking

Advisory Committee to address certain

issues concerning indirect payments to

mortgage brokers and certain other

mortgage originators (retail lenders) and

volume-based compensation. The

committee, which consists of

representatives with a definable stake in

the outcome of a proposed rule, has

convened on 5 prior occasions in the

past 5 months. This notice announces

the time and place for the next meeting.

This meeting is open to the public.

DATES: The sixth meeting of the

committee will be held on May 20–21,

1996. On Monday, May 20, the meeting

will start at 9:00 a.m. and will end at

5:00 p.m., and on Tuesday, May 21, the

meeting will start at 9:00 a.m. and run

until approximately 4:00 p.m.

ADDRESSES: The next meeting of the

committee will be held in the

Headquarters of the American

Association of Retired Persons, 601 ‘‘E’’

Street, NW., Room 120, Floor 2–B,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

David R. Williamson, Director, Office of

Consumer and Regulatory Affairs,

Department of Housing and Urban

Development, 451 7th Street, SW.,

Room 5241, Washington, DC 20410–

8000); telephone number: (202) 708–

4560 (this is not a toll-free number); email through Internet at david—r.—

williamson@hud.gov. For hearing- and

speech-impaired persons, this number

may be accessed via TDD by calling the

Federal Information Relay Service at 1–

800–877–8339.

SUPPLEMENTARY INFORMATION: On

December 8, 1995 (60 FR 63008), HUD

published a notice announcing the

establishment and first meeting of the

Negotiated Rulemaking Advisory

Committee on Mortgage Broker

Disclosures, to discuss and negotiate a

proposed rule on the treatment under

RESPA, including disclosure

requirements, of payments to retail

lenders and of volume-based

compensation to mortgage brokers. The

committee convened in Washington,

DC, on December 13–14, 1995; January

18–19, 1996; February 22–23, 1996;

March 18–19, 1996; and April 8–9,

1996. The committee expects that the

upcoming meeting on May 20–21 will

be the last meeting for this rulemaking

effort.

This meeting is open to the public,

with limited seating available on a firstcome, first-served basis.

Authority: 42 U.S.C. 1437g, 3535(d).

Dated: May 3, 1996.

James E. Schoenberger,

Associate General Deputy Assistant Secretary

for Housing Federal Housing Commissioner.

[FR Doc. 96–11648 Filed 5–9–96; 8:45 am]

BILLING CODE 4210–27–U

DEPARTMENT OF THE INTERIOR

National Indian Gaming Commission

25 CFR Part 525

RIN 1076–AD67

Request for Comments on

Establishing Departmental Procedures

To Authorize Class III Gaming on

Indian Lands When a State Raises an

Eleventh Amendment Defense To Suit

Under the Indian Gaming Regulatory

Act

AGENCY: National Indian Gaming

Commission, Interior.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Department of the

Interior seeks comments on its authority

under the Indian Gaming Regulatory Act

(IGRA), 25 U.S.C. Section 2710, to

promulgate ‘‘procedures’’ to authorize

Class III gaming on Indian lands when

a State raises an Eleventh Amendment

defense to an action brought against it

pursuant to Section ll of the Act, 25

U.S.C. Section 2710(d)(7), and on other

related matters. This advance notice is

the result of the Supreme Court decision

in Seminole Tribe of Florida v. State of

Florida, 116 S.Ct. 1114 (1996).

DATES: Written public comment is

invited and will be considered in the

development of a proposed rule.

Comments on this advance notice of

proposed rulemaking must be received

no later than July 1, 1996, to be

considered.

ADDRESSES: Any comments concerning

this notice, including sections regarding

conformance with statutory and

regulatory authorities, may be sent to:

George Skibine, Director, Indian Gaming

Management Staff, 1849 C Street, N.W.,

MS–2070 MIB, Washington, D.C. 20240.

FOR FURTHER INFORMATION CONTACT:

George Skibine, Director, Indian Gaming

Management Staff, (202) 219–4066.

SUPPLEMENTARY INFORMATION:

Background

Congress enacted IGRA to provide a

statutory basis for the operation and

regulation of Indian gaming and to

protect Indian gaming as a means of

generating revenue for tribal

governments. 25 U.S.C. Section 2702;