Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13825

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs;

Oxytetracycline Injection; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that was published in the

Federal Register of July 10, 1996 (61 FR

36290), that amended the animal drug

regulations to reflect approval of a

supplemental abbreviated new animal

drug application (ANADA) held by

Boehringer Ingelheim Animal Health,

Inc. The regulation inadvertently failed

to specify that only Boehringer

Ingelheim’s oxytetracycline injection is

approved for subcutaneous use in cattle.

In addition, the preamble failed to

provide that the supplemental approval

was granted 3 years marketing

exclusivity for the new use. This

document corrects these errors.

EFFECTIVE DATE: July 10, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 10, 1996 (61 FR

36290), FDA published the approval of

Boehringer Ingelheim Animal Health,

Inc.’s supplemental ANADA 200–008

that provides for subcutaneous use of

oxytetracycline injection in addition to

the approved intravenous and

intramuscular use in beef and

nonlactating dairy cattle. The approval

document inadvertently failed to specify

that only Boehringer Ingelheim’s

oxytetracycline injection is approved for

subcutaneous use in cattle. Accordingly,

the agency is correcting 21 CFR

522.1660(c)(1)(iii) as set forth below.

In addition, the document did not

state that under section 512(c)(2)(F)(iii)

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360b(c)(2)(F)(iii)), as in

effect on May 22, 1996, the date of

approval, this approval for foodproducing animals qualifies for 3 years

of marketing exclusivity beginning May

22, 1996, because the supplement

contains reports of new clinical or field

investigations other than

bioequivalence, or residue studies, and

in the case of food producing animals,

human food safety studies (other than

bioequivalence or residue studies)

essential to the approval of the

supplement and conducted or

sponsored by the applicant.

§ 522.1660 [Corrected]

2. In FR Doc. 96–17541, appearing on

page 36290 in the Federal Register of

Wednesday, July 10, 1996, the following

correction is made. On page 36291, in

the first column, in line 2, amendment

‘‘2.’’ is corrected to read as follows:

2. Section 522.1660 Oxytetracycline

injection is amended in paragraph

(c)(1)(iii) by removing the first sentence

and adding two sentences in its place,

to read as follows:

§ 522.1660 Oxytetracycline injection.

* * * * *

(c) * * *

(1) * * *

(iii) Administer intramuscularly or

intravenously at the 3 to 5 milligrams

level, intramuscularly at the 9

milligrams level. Sponsor 000010, may

also administer subcutaneously at the 3

to 5 milligrams and 9 milligrams levels.

* * *

* * * * *

Dated: March 13, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation Center for Veterinary Medicine

[FR Doc. 97–7277 Filed 3–21–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Bureau of Prisons

28 CFR Part 527

RIN 1120–AA53

[BOP–1058–F]

Transfer of Inmates to State Agents for

Production on State Writs

AGENCY: Bureau of Prisons, Justice.

ACTION: Final rule.

SUMMARY: In this document, the Bureau

of Prisons is making various editorial or

procedural changes in order to update

its regulations on transfer of inmates to

state agents for production on state

writs.

EFFECTIVE DATE: March 24, 1997.

ADDRESSES: Office of General Counsel,

Bureau of Prisons, HOLC Room 754, 320

First Street, NW., Washington, DC

20534.

FOR FURTHER INFORMATION CONTACT: Roy

Nanovic, Office of General Counsel,

Bureau of Prisons, phone (202) 514–

6655.

SUPPLEMENTARY INFORMATION: The

Bureau of Prisons is amending its

regulations on transfer of inmates to

state agents for production on state writs

(28 CFR part 527, subpart D). A final

rule on this subject was published in the

Federal Register July 1, 1981 (46 FR

34549) and was amended October 1,

1985 (50 FR 40105).

The Bureau is making various

editorial or procedural changes in order

to update § 527.31. Specifically,

paragraph (a) is amended for the

purpose of removing the instruction that

the provisions of the rule may not be

used to avoid the use, or to circumvent

the intent, of the Interstate Agreement

on Detainers. This requirement is more

suitable for inclusion in implementing

instructions to staff rather than in the

regulatory text. Paragraph (c) is

amended by revising the provisions

governing how requests are to be made.

These provisions previously had read

that the request may be made by letter,

or in urgent cases by wire or phone. The

Bureau is revising this to require the

request to be made by letter.

Implementing instructions to staff

further address how the letter may be

received (for example, via facsimile

transmission). Consequently, the

regulation would not need to be further

amended in order to recognize

technological changes in accepting

requests. Paragraph (d) is amended for

editorial consistency (that is, in order to

use the phrase ‘‘institution staff’’ rather

than ‘‘institutional staff’’). Finally,

paragraph (h) is amended by removing

the phrase ‘‘in either the Regional or

Central Office’’ and redundant

regulatory information. Because the

provisions in paragraph (h) serve as a

cross-reference to the controlling

regulations for Central Inmate

Monitoring Cases, the inclusion of such

specific information is unnecessary.

Because these changes are either

administrative or editorial in nature, the

Bureau finds good cause for exempting

the provisions of the Administrative

Procedure Act (5 U.S.C. 553) requiring

notice of proposed rulemaking, the

opportunity for public comment, and

delay in effective date. Members of the

public may submit comments

concerning this rule by writing to the

previously cited address. These

comments will be considered but will

receive no response in the Federal

Register.

The Bureau of Prisons has determined

that this rule is not a significant

regulatory action for the purpose of E.O.

12866, and accordingly this rule was not

reviewed by the Office of Management

and Budget. After review of the law and

regulations, the Director, Bureau of

Prisons has certified that this rule, for

the purpose of the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.), does not have