38426 Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Rules and Regulations

Dated: June 9, 2000.

Kenneth S. Apfel,

Commissioner of Social Security.

PART 404–FEDERAL OLD-AGE,

SURVIVORS AND DISABILITY

INSURANCE (1950— )

Accordingly, the interim final rules

amending 20 CFR Part 404 published at

64 FR 57774 on October 27, 1999, are

adopted as final without change.

[FR Doc. 00–15644 Filed 6–20–00; 8:45 am]

BILLING CODE 4191–02–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F–1421]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers;

Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

food additive regulations that provide

for the safe use of tetradecanoic acid,

lithium salt as a stabilizer for

polypropylene and certain

polypropylene copolymers intended for

use in contact with food. When the

regulation was last amended, the

regulation published with some errors.

This document corrects those errors.

DATES: This rule is effective June 21,

2000.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: FDA has

discovered that two errors have become

incorporated into the agency’s current

food additive regulations. In an

amendment to 21 CFR 178.2010,

published in the Federal Register of

December 27, 1999 (64 FR 72273), there

were errors regarding the food type VI–

B. This document corrects those errors.

Publication of this document constitutes

final action under the Administrative

Procedure Act (5 U.S.C. 553). FDA has

determined that notice and public

comment are unnecessary because this

amendment is nonsubstantive.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.2010 is amended in the

table in paragraph (b) under the heading

‘‘Limitations’’ by revising the entry for

‘‘Tetradecanoic acid, lithium salt’’ to

read as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *

Substances Limitations

*******

Tetradecanoic acid, lithium salt (CAS Reg. No. 20336–96–3) For use only at levels not to exceed 0.15 percent by weight of polypropylene and polypropylene copolymers complying with

§ 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.1b, 3.1c,

3.2a, and 3.2b. The finished polymers may only be used in contact

with food of Types I, II, IV–B, VI–B, VII–B, and VIII as described in

table 1 of § 176.170(c) of this chapter under conditions of use B

through H as described in table 2 of § 176.170(c) of this chapter, and

with food of Types III, IV–A, V, VI–A, VI–C, VII–A, and IX described

in table 1 of § 176.170(c) of this chapter under conditions of use C

through G as described in table 2 of § 176.170(c) of this chapter.

*******

Dated: June 7, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–15561 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 349

[Docket No. 98N–0002]

RIN 0910–AA01

Ophthalmic Drug Products for Overthe-Counter Human Use; Amendment

of Final Monograph

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

monograph for over-the-counter (OTC)

ophthalmic drug products (the

regulation that establishes conditions

under which these drug products are

generally recognized as safe and

effective and not misbranded). The

amendment adds a new warning and

revises an existing warning for

ophthalmic vasoconstrictor drug

products. These products contain the

ingredients ephedrine hydrochloride,

naphazoline hydrochloride,

phenylephrine hydrochloride, or