21074 Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations

received by NOAA, and there has been

a low level of NOAA activity under the

OTEC Act. During this 15 year period of

time, the availability and relatively low

price of fossil fuels, coupled with the

risks to potential investors, has limited

the interest in the commercial

development of OTEC projects.

NOAA is authorized, consistent with

the purposes and provisions of the

OTEC Act, to amend or rescind the

OTEC regulations. In particular, section

117 of the OTEC Act requires NOAA to

review the regulations on a periodic

basis. NOAA is authorized and directed

to revise the regulation as necessary and

appropriate to ensure that the

regulations do not impede the

development, evolution, and

commercialization of OTEC technology.

Given that a commercial OTEC

industry has yet to develop, Part 981

remains unused for the most part.

Removal of Part 981 at this time is

consistent with the purposes and

provisions of the OTEC Act in that it

will allow NOAA to evaluate the

suitability of these regulations at such

time as interest in the commercial

development of OTEC projects occurs.

At such time, NOAA will issue a

proposed rule appropriate to the then

current regulatory needs. Potential

Licensees will therefore be assured that

any future OTEC regulations will be up

to date, and will continue to provide

innovation and flexibility necessary for

an emerging OTEC industry.

NOAA is mindful of its responsibility

for licensing of commercial OTEC

facilities and plantships under the

OTEC Act, however, and will take

appropriate steps to review and process

an application should one be made. For

particular inquiries into the licensing of

OTEC projects in the interim period,

NOAA will provide copies of the

provisions of these OTEC regulations in

response to such inquiries. Thus, NOAA

will provide actual and timely notice of

applicable procedures and requirements

to particular individuals. See 5 U.S.C.

552(a). Accordingly, NOAA is removing

Part 981, the OTEC regulations, from

Title 15 of the CFR.

III. Miscellaneous Rulemaking

Requirements

Executive Order 12612: Federalism

Assessment

NOAA has concluded that this

regulatory action does not have

federalism implications sufficient to

warrant the preparation of a Federalism

Assessment under Executive Order

12612.

Executive Order 12866: Regulatory

Planning and Review

This regulatory action is not

significant for purposes of Executive

Order 12866.

Regulatory Flexibility Act

No licenses have been issued for

OTEC projects under 15 CFR Part 981.

When commercial interest in OTEC

projects occurs, NOAA will issue a

proposed rule appropriate to the

regulatory needs at that time. For

particular inquiries into the licensing of

OTEC projects in the interim period,

NOAA will provide actual and timely

notice of applicable procedures and

requirements to particular individuals.

See 5 U.S.C. 552(a). For these reasons,

the removal of Part 981 is not expected

to have a significant economic impact

on a substantial number of small

entities, and the Assistant General

Counsel for Legislation and Regulation

of the Department of Commerce has so

certified to the Chief Counsel for

Advocacy of the Small Business

Administration. As such, a Regulatory

Flexibility Analysis was not prepared.

Paperwork Reduction Act

This regulatory action does not

contain an information collection

requirement subject to review and

approval by OMB under the Paperwork

Reduction Act of 1980, 44 U.S.C. 3500

et seq.

National Environmental Policy Act

NOAA has concluded that this

regulatory action does not constitute a

major federal action significantly

affecting the quality of the human

environment. No applications for

licenses of commercial OTEC facilities

or plantships have yet been received by

NOAA, and Part 981 remains unused for

the most part. When commercial

interest in OTEC projects occurs, NOAA

will issue a proposed rule appropriate to

the regulatory needs at that time. For

particular inquiries into the licensing of

OTEC projects in the interim period,

NOAA will provide actual and timely

notice of applicable procedures to

particular individuals. See 5 U.S.C.

552(a). Therefore, and environmental

impact statement is not required.

Authority: Ocean Thermal Energy

Conversion Act of 1980, as amended, 42

U.S.C. 9101 et seq.

List of Subjects in 15 CFR Part 981

Administrative practice and

procedures, Energy, Environmental

protection, Intergovernmental relations,

Marine resources, Penalties, Reporting

and recordkeeping requirements.

Dated: May 2, 1996.

David Evans,

Acting Deputy Assistant Administrator for

Ocean Services and Coastal Zone

Management.

Accordingly, for the reasons set forth

above, Chapter IX of Title 15 of the Code

of Federal Regulations is amended as

follows:

PART 981—OCEAN THERMAL

ENERGY CONVERSION LICENSING

PROGRAM—[REMOVED]

1. Under the authority of the Ocean

Thermal Energy Conversion Act of 1980,

Part 981 is removed.

[FR Doc. 96–11464 Filed 5–8–96; 8:45 am]

BILLING CODE 3510–08–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P–0216]

Food Labeling: Nutrient Content Claim

for ‘‘Extra’’; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of March 22, 1996 (61 FR

11730). The document authorizes the

use, on food labels and in food labeling,

of the term ‘‘extra’’ as a synonym for the

term ‘‘added.’’ The document was

published with some errors. This

document corrects those errors.

EFFECTIVE DATE: March 22, 1996.

FOR FURTHER INFORMATION CONTACT:

Joyce J. Saltsman, Center for Food Safety

and Applied Nutrition (HFS–165), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5916.

In FR Doc. 96–6942, appearing on

page 11730 in the Federal Register of

Friday, March 22, 1996, the following

corrections are made:

1. On page 11730, in the third

column, in the first full paragraph, in

the first line, the date ‘‘March 21, 1995’’

is corrected to read ‘‘March 21, 1994’’.

2. On page 11731, in the first column,

under section ‘‘V. Public Comment’’, in

the second paragraph, the fifth line, the

first word, ‘‘proposal’’, is corrected to

read ‘‘final rule.’’
Federal Register / Vol. 61, No. 91 / Thursday, May 9, 1996 / Rules and Regulations 21075

Dated: May 1, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–11516 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 510 and 522

Animal Drugs, Feeds, and Related

Products; Medetomidine

Hydrochloride Injection; Change of

Sponsor Name

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 new animal drug

application (NADA) filed by Orion

Corp. ORION–FARMOS. The NADA

provides for the use of medetomidine

hydrochloride injection in dogs for its

sedative and analgesic properties. The

regulations are also amended to reflect

a change of sponsor name.

EFFECTIVE DATE: May 9, 1996.

FOR FURTHER INFORMATION CONTACT:

Sandra K. Woods, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1616.

SUPPLEMENTARY INFORMATION: Orion

Corp. ORION–FARMOS, (formerly

Orion Corp. FARMOS), P.O. Box 425,

SF–20101 Turku, Finland, filed NADA

140–999, which provides for

intravenous or intramuscular use of

Domitor (medetomidine

hydrochloride) injection as a sedative

and analgesic in dogs over 12 weeks of

age to facilitate clinical examinations,

clinical procedures, minor surgical

procedures not requiring muscle

relaxation, and minor dental procedures

not requiring intubation. The drug

product is available by prescription. The

application is approved as of March 19,

1996, and the regulations are amended

in part 522 (21 CFR part 522) by adding

new § 522.1335 to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

Additionally, the firm has informed

FDA that it has changed its corporate

name from Orion Corp. FARMOS to

Orion Corp. ORION–FARMOS.

Accordingly, the agency is also

amending 21 CFR 510.600(c)(1) and

(c)(2) to reflect the change of sponsor

name.

In accordance with the freedom of

information provisions of part 20 (21

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

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness 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, between

9 a.m. and 4 p.m., Monday through

Friday.

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

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 5 years of

marketing exclusivity beginning March

19, 1996, because no active ingredient

(including any ester or salt of the active

ingredient) of the drug has been

approved in any other application under

section 512(b)(1) of the act.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 522

Animal drugs.

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 parts 510 and 522 are 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).

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the sponsor name ‘‘Orion

Corp. FARMOS, Research and

Development, Pharmaceuticals,’’ and by

adding in its place ‘‘Orion Corp.

ORION–FARMOS’’, and in the table in

paragraph (c)(2) in the entry for

‘‘052483’’ by removing the sponsor

name ‘‘Orion Corp. FARMOS, Research

and Development, Pharmaceuticals,’’

and adding in its place ‘‘Orion Corp.

ORION–FARMOS’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

4. New § 522.1335 is added to read as

follows:

§ 522.1335 Medetomidine hydrochloride

injection.

(a) Specifications. Each milliliter of

sterile aqueous solution contains 1.0

milligram of medetomidine

hydrochloride.

(b) Sponsor. See 052483 in

§ 510.600(c) of this chapter.

(c) Conditions of use—(1) Amount.

750 micrograms intravenously (IV) or

1,000 micrograms intramuscularly per

square meter of body surface. The IV

route is more efficacious for dental care.

(2) Indications for use. As a sedative

and analgesic in dogs over 12 weeks of

age to facilitate clinical examinations,

clinical procedures, minor surgical

procedures not requiring muscle

relaxation, and minor dental procedures

not requiring intubation. The

intravenous route of administration is

more efficacious for dental care.

(3) Limitations. Do not use in dogs

with cardiac disease, respiratory

disorders, liver or kidney diseases, dogs

in shock, dogs which are severly

debilitated, or dogs which are stressed

due to extreme heat, cold, or fatigue.

Allow agitated dogs to rest quietly

before administration. Do not repeat

dosing in dogs not responding

satisfactorily to treatment. Do not use in

breeding or pregnant animals. Federal

law restricts this drug to use by or on

the order of a licensed veterinarian.

Dated: April 15, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–11511 Filed 5–8–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Halofuginone Hydrobromide,

Bacitracin Methylene Disalicylate

AGENCY: Food and Drug Administration,

HHS.