Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Rules and Regulations 18081

applicable to title XVI by section

1631(d)(1) of the Social Security Act;

(2) A tax refund to which a person is

entitled to after notice to the Secretary

of the Treasury under 31 U.S.C.

§ 3720A;

(3) By authorities provided under the

Debt Collection Act of 1982, as

amended, 31 U.S.C. 3711, to the extent

applicable to debts arising under the

Social Security Act; or

(4) Any combination of the foregoing.

(e) Matters that were raised or that

could have been raised in a hearing

before an administrative law judge or in

an appeal to the United States Court of

Appeals under sections 1129 or 1140 of

the Social Security Act may not be

raised as a defense in a civil action by

the United States to collect a penalty

and assessment, as applicable, under

this part.

14. Section 498.129 is added to read

as follows:

§ 498.129 Notice to other agencies.

As provided in section 1129 of the

Social Security Act, when a

determination to impose a penalty and

assessment, as applicable, with respect

to a physician or medical provider

becomes final, the Office of the

Inspector General will notify the

Secretary of the final determination and

the reasons therefore.

15. Section 498.132 is revised to read

as follows:

§ 498.132 Limitations.

The Office of the Inspector General

may initiate a proceeding in accordance

with § 498.109(a) to determine whether

to impose a penalty and assessment, as

applicable—

(a) In cases brought under section

1129 of the Social Security Act, after

receiving authorization from the

Attorney General pursuant to

procedures agreed upon by the

Inspector General and the Attorney

General; and

(b) Within 6 years from the date on

which the violation was committed.

[FR Doc. 96–9926 Filed 4–23–96; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for 33 approved new

animal drug applications (NADA’s) from

American Cyanamid Co. to HoffmannLa Roche, Inc. In addition, the agency is

amending its regulations to correct some

errors. This action is being taken to

clarify and improve the accuracy of the

animal drug regulations.

EFFECTIVE DATE: April 24, 1996.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: American

Cyanamid Co., Berdan Ave., Wayne, NJ

07470, has informed FDA that it has

transferred ownership of, and all rights

and interests in, the following approved

NADA’s to Hoffmann-La Roche, Inc.,

Nutley, NJ 07110–1199.

NADA no. Ingredients

33–950 ......... Sulfamerazine.

35–688 ......... Chlortetracycline Calcium

Complex, Penicillin G Procaine, Sulfamethazine

35–805 ......... Chlortetracycline Hydrochloride, Sulfamethazine.

36–361 ......... Chlortetracycline Calcium

Complex, Amprolium ,

Ethopabate, Sodium Sulfate.

41–647 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–648 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–649 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–650 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–651 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–652 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–653 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

41–654 ......... Sulfamethazine,

Chlortetracycline Calcium

Complex.

46–920 ......... Bacitracin zinc.

48–486 ......... Robenidine Hydrochloride.

48–761 ......... Chlortetracycline Calcium

Complex.

48–762 ......... Chlortetracycline Calcium

Complex.

48–763 ......... Chlortetracycline Calcium

Complex.

55–040 ......... Chlortetracycline Hydrochloride.

NADA no. Ingredients

92–507 ......... Chlortetracycline Calcium

Complex, Robenidine Hydrochloride.

93–372 ......... Chlortetracycline Hydrochloride.

95–546 ......... Robenidine Hydrochloride,

Roxarsone.

96–933 ......... Bacitracin zinc, Robenidine

Hydrochloride.

97–085 ......... Robenidine Hydrochloride,

Bacitracin MD.

105–758 ....... Bacitracin zinc, Amprolium,

Ethopabate, Roxarsone.

114–794 ....... Bacitracin zinc, Amprolium,

Ethopabate.

121–553 ....... Monensin Sodium,

Chlortetracycline Hydrochloride.

123–154 ....... Monensin Sodium, Bacitracin

ZN, Roxarsone.

136–484 ....... Bacitracin zinc, Carbasone.

139–075 ....... Maduramicin ammonium.

139–190 ....... Bacitracin zinc, Salinomycin,

Sodium Roxarsone.

139–235 ....... Bacitracin zinc, Salinomycin,

Sodium Roxarsone.

140–859 ....... Chlortetracycline Calcium

Complex, Salinomycin Sodium.

140–867 ....... Chlortetracycline Calcium

Complex, Roxarsone,

Salinomycin Sodium.

Accordingly, the agency is amending

the regulations in part 558 (21 CFR part

558) to reflect the change of sponsor.

FDA is also correcting some errors that

have been incorporated into the

agency’s codified regulations. The errors

in the regulations are as follows:

In § 558.95(b)(1)(xiii)(b) the reference

to the limitations cited in (e)(1)(vii)(b) is

incorrect; the correct cite is ‘‘paragraph

(b)(1)(vii)(b) of this section’’. In

§ 558.355(b)(9) the cited reference

‘‘paragraphs (f)(1)(xv), (xvi), and (xvii)’’

incorrectly listed the sponsor, ‘‘(xvii)’’

should refer to sponsor 012799. The

agency is correcting this error by

removing ‘‘(xvii)’’ from § 558.355(b)(9)

and adding sponsor 012799 to

§ 558.355(b)(10).

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:
18082 Federal Register / Vol. 61, No. 80 / Wednesday, April 24, 1996 / Rules and Regulations

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.58 [Amended]

2. Section 558.58 Amprolium and

ethopabate is amended in the table in

paragraph (d)(1), in the entry for (iii),

under the ‘‘Limitations’’ and the

‘‘Sponsor’’ columns by removing

‘‘010042’’ wherever it appears and

adding in its place ‘‘000004’’.

§ 558.78 [Amended]

3. Section 558.78 Bacitracin zinc is

amended in paragraph (a)(2), and in the

table in paragraph (d)(1) in the entries

for (i), (ii), (v), and (vi) under the

‘‘Sponsor’’ column, and in paragraph

(d)(2)(ii) by removing ‘‘010042’’ and

adding in its place ‘‘000004’’.

§ 558.95 [Amended]

4. Section 558.95 Bambermycins is

amended in paragraph (b)(1)(xiii)(b) by

removing ‘‘(e)(1)(vii)(b)’’ and adding in

its place ‘‘(b)(1)(vii)(b)’’.

§ 558.120 [Amended]

5. Section 558.120 Carbarsone (not

U.S.P.) is amended in paragraph

(c)(1)(iii)(b) by removing ‘‘010042’’ and

adding in its place ‘‘000004’’.

§ 558.128 [Amended]

6. Section 558.128 Chlortetracycline is

amended in paragraph (a) by removing

‘‘010042’’ and adding in its place

‘‘000004’’.

§ 558.145 [Amended]

7. Section 558.145 Chlortetracycline,

procaine penicillin, and sulfamethazine

is amended in paragraphs (a)(1) and

(a)(2) by removing ‘‘010042’’ and adding

in its place ‘‘000004’’.

§ 558.340 [Amended]

8. Section 558.340 Maduramicin

ammonium is amended in paragraph (a)

by removing ‘‘010042’’ and adding in its

place ‘‘000004’’.

§ 558.355 [Amended]

9. Section 558.355 is amended in

paragraphs (b)(8), (b)(9), (f)(1)(iv)(b),

(f)(1)(v)(b), (f)(1)(xiv)(b), (f)(1)(xv)(b),

and (f)(1)(xvi)(b) by removing ‘‘010042’’

and adding in its place ‘‘000004’’, in

paragraph (b)(9) by removing ‘‘, (xvi),

and (xvii)’’ and adding in its place ‘‘and

(xvi)’’, and by adding paragraph (b)(10)

to read as follows:

§ 558.355 Monensin.

* * * * *

(b) * * *

(10) To 012799: 45 and 60 grams per

pound, as monensin sodium, paragraph

(f)(1)(xvii) of this section.

* * * * *

§ 558.515 [Amended]

10. Section 558.515 Robenidine

hydrochloride is amended in paragraphs

(a), (d)(1)(iii)(b), (d)(1)(iv)(b), and

(d)(1)(v)(b) by removing ‘‘010042’’ and

adding in its place ‘‘000004’’ and in

paragraph (d)(1)(vi)(b) by removing ‘‘No.

011716’’ and adding in its place ‘‘Nos.

000004 and 011716’’.

§ 558.550 [Amended]

11. Section 558.550 Salinomycin is

amended in paragraphs (b)(1)(vii)(c),

(b)(1)(ix)(c), (b)(1)(xv)(c), and

(b)(1)(xvi)(c) by removing ‘‘010042’’ and

adding in its place ‘‘000004’’.

§ 558.582 [Amended]

12. Section 558.582 Sulfamerazine is

amended in paragraph (a) by removing

‘‘010042’’ and adding in its place

‘‘000004’’.

Dated: April 4, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–10019 Filed 4–23–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

25 CFR Part 151

[1076–AD65]

Land Acquisitions

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Final Rule.

SUMMARY: This rule establishes a 30-day

waiting period after final administrative

decisions to acquire land into trust

under the Indian Reorganization Act

and other federal statutes. The

Department is establishing this waiting

period so that parties seeking review of

final decisions by the Interior Board of

Indian Appeals or of decisions of the

Assistant Secretary-Indian Affairs, will

have notice of administrative decisions

to take land into trust before title is

actually transferred. This notice allows

interested parties to seek judicial or

other review under the Administrative

Procedure Act and applicable

regulations.

EFFECTIVE DATE: April 24, 1996.

FOR FURTHER INFORMATION CONTACT:

Mary Jane Sheppard, Staff Attorney,

Office of the Solicitor, Division of

Indian Affairs, Room 6456, Main

Interior Building, 1849 C Street, NW,

Washington, DC 20240; Telephone (202)

208–6260.

SUPPLEMENTARY INFORMATION: On July

15, 1991, the proposed rule for offreservation land acquisitions for Indian

tribes was published in the Federal

Register (56 FR 32278–32280). On June

23, 1995, the final rule was published at

60 FR 32878. That rulemaking

supplemented the existing regulations

in part 151. This procedural rule adds

a subsection to existing 25 CFR 151.12,

Action on requests.

Background

In response to a recent court decision,

State of South Dakota v. U.S.

Department of the Interior, 69 F.3d 878

(8th Cir. 1995), the Department of the

Interior is establishing a procedure to

ensure the opportunity for judicial

review of administrative decisions to

acquire title to lands in trust for Indian

tribes and individual Indians under

section 5 of the Indian Reorganization

Act (IRA) (Pub. L. 73–383, 48 Stat. 984–

988, 25 U.S.C. 465). Following

consideration of the factors in the

current regulations and completion of

the title examination, the Department,

through Federal Register notice, or

other notice to affected members of the

public, will announce any final

administrative determination to take

land in trust. The Secretary will not

acquire title to the land in trust until at

least 30 days after publication of the

announcement. This procedure permits

judicial review before transfer of title to

the United States. The Quiet Title Act

(QTA), 28 U.S.C. 2409a, precludes

judicial review after the United States

acquires title. See, e.g., United States v.

Mottaz, 476 U.S. 834 (1986); North

Dakota v. Block, 461 U.S. 273 (1983);

Florida v. Department of Interior, 768

F.2d 1248 (11th Cir. 1985).

Section 5 of the IRA authorizes the

Secretary to acquire land in trust for

Indians and Indian tribes: (1) Within or

adjacent to an Indian reservation; or (2)

for purposes of facilitating tribal selfdetermination, economic development,

or Indian housing. State of South

Dakota, a case involving an offreservation trust land acquisition, held

Section 5 of the IRA unconstitutional on

the ground that it violates the

nondelegation doctrine. The court’s

decision was based in substantial part

on the understanding that judicial

review is not available to challenge the

Secretary’s action. The court noted that

‘‘judicial review is a factor weighing in

favor of upholding a statute against a

nondelegation challenge.’’ This rule

ensures that such review is available

before formal conveyance of title to land

to the United States, when the QTA’s

bar to judicial review becomes

operative. Judicial review is available