Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Rules and Regulations 14215

the test and the basis for selecting

participants.

(b) NCAP testing. For purposes of

conducting an approved test program or

procedure designed to evaluate planned

components of the National Customs

Automation Program (NCAP), as

described in section 411(a)(2) of the

Tariff Act of 1930 (19 U.S.C. 411), the

Commissioner of Customs may impose

requirements different from those

specified in the Customs Regulations,

but only to the extent that such different

requirements do not affect the collection

of the revenue, public health, safety, or

law enforcement. In addition to the

requirement of paragraph (a)(1) of this

section, the imposition of any such

different requirements shall be subject

to the following conditions:

(1) Prior publication requirement. For

tests affecting the NCAP, notice shall be

published in the Federal Register not

less than thirty days prior to

implementing such test, followed by

publication in the Customs Bulletin.

The notice shall invite public comments

concerning any aspect of the test

program or procedure, and inform

interested members of the public of the

eligibility criteria for voluntary

participation in the test and the basis for

selecting participants; and,

(2) Post publication requirement.

Within a reasonable time period

following the completion of the test, a

complete description of the results shall

be published in both the Federal

Register and the Customs Bulletin.

Approved: February 21, 1995.

George J. Weise,

Commissioner of Customs.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

[FR Doc. 95–6525 Filed 3–15–95; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Social Security Administration

20 CFR Part 416

[Regulations No. 16]

RIN 0960–AC22

Supplemental Security Income for the

Aged, Blind, and Disabled;

Continuation of Benefits and Special

Eligibility for Certain Severely Impaired

Recipients Who Work; Appeal Rights

Following Mass Change Resulting in

Reduction, Suspension, or Termination

of State Supplementary Payments; and

Deemed Application Date Based on

Misinformation; Correction

AGENCY: Social Security Administration,

HHS.

ACTION: Correction to final rules.

SUMMARY: This document contains

corrections to the final rules published

in the Federal Register on Friday,

August 12, 1994 (59 FR 41400),

Monday, August 22, 1994 (59 FR

43035), and Wednesday, August 31,

1994 (59 FR 44918). We are correcting

incorrect paragraph redesignations and

related amendatory instructions, as well

as making one technical correction to a

paragraph in one regulatory section.

EFFECTIVE DATE: March 16, 1995.

FOR FURTHER INFORMATION CONTACT:

Regarding this Federal Register

document—Richard M. Bresnick, Legal

Assistant, Office of Regulations, Social

Security Administration, 6401 Security

Boulevard, Baltimore, MD 21235, (410)

965–1758; regarding eligibility or filing

for benefits—our national toll-free

number, 1–800–772–1213.

SUPPLEMENTARY INFORMATION: In the

final rules that appeared on page 41400

in the Federal Register issued of Friday,

August 12, 1994, we had incorrect

paragraph redesignations in amendatory

item 15. We indicated that in § 416.1402

we were redesignating paragraphs (i)

through (n) as paragraphs (h) through

(m). However, paragraph (n) had not yet

been published. Thus, paragraphs (i)

through (m) should have been

redesignated as paragraphs (h) through

(l). The new paragraph (n) was to be

contained in other final rules, ‘‘Deemed

Application Date Based on

Misinformation,’’ which were to be

published before these rules but were

not published until August 31, 1994 (59

FR 44918). We discovered this before

‘‘Deemed Application Date Based on

Misinformation’’ was published,

however, and changed the designation

of that new paragraph in the later rules

to paragraph (m) to reflect the proper

redesignation which should have been

made in the rules published on August

12, 1994.

In the interim, on August 22, 1994, we

published other final rules, ‘‘Appeal

Rights Following Mass Change

Resulting in Reduction, Suspension, or

Termination of State Supplementary

Payments’’ (59 FR 43035), which

contained a new paragraph designated

paragraph (n) in § 416.1402 which

would have been correct if the

regulations had been published in the

anticipated sequence. The amendatory

item 3 in these final rules contained

other incorrect paragraph designations

and instructions for punctuating

§ 416.1402. Further, similar incorrect

instructions for revising § 416.1402 were

contained under part 416 in amendatory

item 6 in the final rules published on

August 31, 1994. Also, paragraph (m) as

published in these rules was incorrectly

punctuated and did not have the word

‘‘and’’ following it. Therefore, we are

correcting all three amendatory items

and paragraph (m) itself to reflect the

correct paragraph designations,

punctuation, and ending word ‘‘and.’’

With these corrections, all the

paragraphs and amendatory instructions

will be correct. Make the corrections as

follows:

1. In the Federal Register issue of

August 12, 1994, in the second column

on page 41405, amendatory item 15

should read as follows:

15. Section 416.1402 is amended by

revising paragraphs (a) and (b), removing

paragraph (h), and redesignating paragraphs

(i) through (m) as paragraphs (h) through (l),

respectively to read as follows:

2. In the Federal Register issue of

August 22, 1994, in the first column on

page 43039, amendatory item 3 should

read as follows:

3. Section 416.1402 is amended by

removing the word ‘‘and’’ following the

semicolon at the end of paragraph (k),

replacing the period at the end of paragraph

(l) with a semicolon and adding the word

‘‘and’’ after the semicolon, and adding a new

paragraph (n) to read as follows:

3. In the Federal Register issue of

August 31, 1994, in the third column on

page 44927, amendatory item 6 under

part 416 should read as follows:

6. Section 416.1402 is amended by

removing the word ‘‘and’’ following the

semicolon at the end of paragraph (l) and

adding a new paragraph (m) to read as

follows:

§ 416.1402 Administrative actions that are

initial determinations.

* * * * *
14216 Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Rules and Regulations

(m) A claim for benefits under

§ 416.351 based on alleged

misinformation; and

* * * * *

Dated: March 7, 1995.

Neil J. Stillman,

Deputy Assistant Secretary for Information

Resources Management.

[FR Doc. 95–6502 Filed 3–15–95; 8:45 am]

BILLING CODE 4190–29–M

Food and Drug Administration

21 CFR Part 510

Animal Drugs, Feeds, and Related

Products; Change of Sponsor Name

and Address

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor name and address for

a new animal drug application (NADA)

from Zoecon Industries, Inc., to Sandoz

Agro, Inc.

EFFECTIVE DATE: March 16, 1995.

FOR FURTHER INFORMATION CONTACT:

Benjamin A. Puyot, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1646.

SUPPLEMENTARY INFORMATION: Due to a

merger with Zoecon Industries, Inc.,

12200 Denton Dr., Dallas, TX 75234,

and Sandoz Agro, Inc., 1300 East Touhy

Ave., Des Plaines, IL 60018, the firms

have requested that FDA publish a

notice of a change of sponsor name and

address for their new animal drug

application NADA 98–895, Starbar GX–

118 (N-(mercaptomethyl) phthalimide

S-(O,O dimethylphosphorodithioate)

emulsifiable liquid). Accordingly, the

agency is amending the regulations in

21 CFR 510.600(c)(1) and (c)(2) to reflect

the change of sponsor name and

address. The drug labeler code

‘‘011536’’ for Zoecon Industries, Inc., is

being retained for the new sponsor.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and record keeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

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

512, 701, 721, of the Federal Food, Drug, and

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

353, 360b, 371, 379e).

2. Section 510.600 is amended in the

table in paragraph (c)(1) by removing

the entry for ‘‘Zoecon Industries, Inc.,’’

and alphabetically adding a new entry

for ‘‘Sandoz Agro, Inc.,’’ and in the table

in paragraph (c)(2) in the entry for

‘‘011536’’ by revising the sponsor name

and address to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address

Drug

labeler

code

* * * * *

Sandoz Agro, Inc., 1300 East Touhy

Ave., Des Plaines, IL 60018 ......... 011536

* * * * *

(2) * * *

Drug

labeler

code

Firm name and address

* * * * *

011536 Sandoz Agro, Inc., 1300 East Touhy

Ave., Des Plaines, IL 60018

* * * * *

Dated: March 8, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–6528 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lincomycin Hydrochloride Soluble

Powder

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by The

Upjohn Co. The NADA provides for the

use of lincomycin hydrochloride soluble

powder to make medicated swine and

broiler chicken drinking water. The

supplement provides for use of a packet

containing the equivalent of 32 grams

(g) of lincomycin in addition to the

currently approved packet containing

the equivalent of 16 g of lincomycin.

EFFECTIVE DATE: March 16, 1995.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–2701.

SUPPLEMENTARY INFORMATION: The

Upjohn Co., Kalamazoo, MI 49001, filed

a supplement to NADA 111–636 for

Lincomix (lincomycin hydrochloride)

soluble powder. The supplemental

NADA provides for the use of an 80-g

packet containing the equivalent of 32 g

of lincomycin in addition to the

approved 40-g packet containing the

equivalent of 16 g of lincomycin. Both

packets are used to make a swine

drinking water containing 250

milligrams (mg) of lincomycin per

gallon used for the treatment of swine

dysentery and broiler chicken drinking

water containing 64 mg of lincomycin

per gallon for the control of necrotic

enteritis.

This supplemental NADA is approved

as of February 9, 1995, and the

regulations in § 520.1263c(a) (21 CFR

520.126c(a)) are amended to reflect the

approval.

This is a manufacturing supplement

to an approved NADA. The approval

does not require a summary of safety,

effectiveness data, or information.

Therefore, a freedom of information

summary as provided in part 20 (21 CFR

part 20) and § 514.11(e)(2)(ii) (21 CFR

514.11(e)(2)(ii)) is not required.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food-producing animals

does not qualify for marketing

exclusivity because the supplemental

application does not contain new

clinical or field investigations (other

than bioequivalence or residue studies)

and new human food safety studies

(other than bioequivalence or residue

studies) essential to the approval and

conducted or sponsored by the

applicant.

The agency has determined under 21

CFR 25.24(d)(1)(iii) that this action is 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.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under