Federal Register / Vol. 62, No. 162 / Thursday, August 21, 1997 / Rules and Regulations 44409

For the Board.

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 97–22131 Filed 8–20–97; 8:45 am]

BILLING CODE 7905–01–P–M

RAILROAD RETIREMENT BOARD

20 CFR Part 367

RIN 3220–AB26

Collection of Debts

AGENCY: Railroad Retirement Board.

ACTION: Final rule.

SUMMARY: The Railroad Retirement

Board (Board) amends its regulations

pertaining to the collection of debts by

offset against Federal payments to

reflect amendments to section 3716 of

Title 31 by the Debt Collection

Improvement Act of 1996 (Pub. L. 104–

134).

DATES: Effective Date: This Regulation

will be effective August 21, 1997.

ADDRESSES: Secretary to the Board,

Railroad Retirement Board, 844 North

Rush Street, Chicago, Illinois 60611.

FOR FURTHER INFORMATION CONTACT:

Michael C. Litt, General Attorney,

Bureau of Law, Railroad Retirement

Board, 844 North Rush Street, Chicago,

Illinois 60611, (312) 751–4929, TDD

(312) 751–4701.

SUPPLEMENTARY INFORMATION: Part 367 of

the Board’s regulations provides for the

collection of debts by administrative

offset under the authority of the Debt

Collection Act of 1982, 31 U.S.C. 3716.

The Debt Collection Improvement Act of

1996 (Pub. L. 104–134) amended 31

U.S.C. 3716 to provide for referral of

delinquent Federal nontax debts to the

Department of Treasury for

administrative offset (‘‘Treasury Offset

Program’’), and to provide for the

mandatory referral of such debts over

180 days delinquent to the Treasury

Offset Program, subject to certain

exceptions. Accordingly, the Board

amends this part to implement the

provisions of Public Law 104–134.

Section 367.1 is revised to cite the

authority of Public Law 104–134 and its

provision for the referral of delinquent

Federal nontax debts to the Treasury

Offset Program.

Section 367.2 is amended to provide

that only nontax debts will be referred

to the Treasury Offset Program, and that

a debt will not be referred if the Board’s

records show that foreclosure is pending

on collateral securing the debt or if the

debt has been referred to the

Department of Justice or is otherwise in

litigation with the Board.

Section 367.3 is amended to provide

that the Board shall refer nontax debts

over 10 days delinquent to the Treasury

Offset Program and that in cases of

mandatory referral of delinquent debt,

unless otherwise directed by the

Secretary of Treasury, the Board is not

required to determine whether

administrative offset is feasible,

allowable, and appropriate.

The Board, with the concurrence of

the Office of Management and Budget,

has determined that this is not a

significant regulatory action under

Executive Order 12866. Therefore, no

regulatory impact analysis is required.

There are no new information

collections associated with this rule.

The Board published this rule as an

interim final rule on April 21, 1997 (62

FR 19219) and comments were invited

by June 20, 1997. No Comments were

received. Accordingly, the interim final

rule is adopted as a final rule without

change.

Dated: August 12, 1997.

By Authority of the Board.

For the Board.

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 97–22130 Filed 8–20–97; 8:45 am]

BILLING CODE 7905–01–P–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Doramectin

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 Pfizer,

Inc. The supplemental NADA provides

for use of doramectin in cattle to control

infections and to protect from

reinfection with Cooperia punctata and

Dictyocaulus viviparus for 28 days after

treatment. This supplemental NADA

also amends the wording of the claim

for protection against infection or

reinfection with Ostertagia ostertagi for

21 days and incorporates the claim into

the new indication statement.

EFFECTIVE DATE: August 21, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas Letonja, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017–5755, is sponsor of NADA 141–

061 that provides for the use of

Dectomax 1% injectable solution

(doramectin) for treatment and control

of certain gastrointestinal roundworms,

lungworms, eyeworms, grubs, lice, and

mange mites of cattle, and protection

against infection or reinfection with O.

ostertagi for up to 21 days. The firm

filed a supplemental NADA that

provides for added use in cattle to

control infections and to protect from

reinfection with C. punctata and D.

viviparus for 28 days after treatment.

The supplemental NADA also amends

the wording of the claim for ‘‘* * *

protection against infection or

reinfection with Ostertagia ostertagi for

21 days’’ and incorporates the claim

into the new indication statement. The

supplemental NADA is approved as of

July 18, 1997, and the regulations are

amended in 21 CFR 522.770(d)(2) to

reflect the approval. The basis of

approval is discussed in the freedom of

information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

data and information submitted to

support approval of this application

may be seen in the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, from 9

a.m. to 4 p.m., Monday through Friday.

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

Federal Food, Drug, and Cosmetic Act,

this supplemental approval for foodproducing animals qualifies for 3 years

of marketing exclusivity beginning July

18, 1997, because the supplement

contains substantial evidence of the

effectiveness of the drug involved,

studies of animal safety or, in the case

of food-producing animals, human food

safety studies (other than

bioequivalence or residue studies)

required for approval of the supplement

and conducted or sponsored by the

applicant. Exclusivity applies only to

the added indication to control

infections and to protect cattle from

reinfection with C. punctata and D.

viviparus for 28 days after treatment.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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.