40930 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Rules and Regulations

By the National Credit Union

Administration Board on July 23, 1997.

Becky Baker,

Secretary of the Board.

Accordingly, NCUA amends 12 CFR

chapter VII as follows:

PART 701—[AMENDED]

1. The authority citation for Part 701

is revised to read as follows:

Authority: 12 U.S.C. 1752(5), 1755, 1756,

1757, 1759, 1761a, 1761b, 1766, 1767, 1782,

1784, 1787, 1789. Section 701.6 is also

authorized by 15 U.S.C. 3717. Section 701.31

is also authorized by 15 U.S.C. 1601 et seq.;

42 U.S.C. 1981 and 3601–3610. Section

701.35 is also authorized by 42 U.S.C. 4311–

4312.

2. Section 701.21(c)(7)(ii)(C) is revised

to read as follows:

§ 701.21 Loans to members and lines of

credit to members.

* * * * *

(c) * * *

(7) * * *

(ii) * * *

(C) Expiration. After March 8, 1999, or

as otherwise ordered by the NCUA

Board, the maximum rate on federal

credit union extensions of credit to

members shall revert to 15 percent per

year. Higher rates may; however, be

charged, in accordance with paragraphs

(c)(7)(ii) (A) and (B) of this section, on

loans and line of credit balances

existing on or before March 8, 1999.

* * * * *

[FR Doc. 97–19935 Filed 7–30–97; 8:45 am]

BILLING CODE 7535–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

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 a

change of sponsor for 46 new animal

drug applications (NADA’s) from Solvay

Animal Health, Inc., to Fort Dodge

Animal Health, A Division of American

Cyanamid Co.

EFFECTIVE DATE: July 31, 1997.

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: Solvay

Animal Health, Inc., 1201 Northland

Dr., Mendota Heights, MN 55120, has

informed FDA that it has transferred the

ownership of, and all rights and

interests in, the following approved

NADA’s to Fort Dodge Animal Health,

A Division of American Cyanamid Co.,

P.O. Box 1339, Fort Dodge, IA 50501:

NADA No. Drug Name

006–417 .................................................................................................... Recovr

006–103 .................................................................................................... Follutein

006–707 .................................................................................................... Sulquin 6–50

008–274 .................................................................................................... Pig Scour Tablets

009–035 .................................................................................................... Ophtaine

011–141 .................................................................................................... Unistat-2

011–482 .................................................................................................... Vetame Tabs and Injection

011–879 .................................................................................................... Rubfrafer Injection

012–198 .................................................................................................... Vetalog Parenteral

012–258 .................................................................................................... Panalog Ointment (Solvaderm)

013–624 .................................................................................................... Vetalog Tabs

014–250 .................................................................................................... Novastat

031–448 .................................................................................................... Rheaform Bolus

031–553 .................................................................................................... Esb3 Powder & Solution

032–319 .................................................................................................... Furox Aerosol Spray

032–738 .................................................................................................... Pacitran Soluble

033–127 .................................................................................................... Vetisulid Bolus

033–318 .................................................................................................... Vetisulid Injectable

033–319 .................................................................................................... Vetisulid Tabs

033–373 .................................................................................................... Vetisulid Powder

034–536 .................................................................................................... Aklomix

034–537 .................................................................................................... Novastat-3

034–705 .................................................................................................... Equipoise

035–388 .................................................................................................... Novastat-W

039–666 .................................................................................................... Unistat-3

040–181 .................................................................................................... Vetisulid Oral Suspension

046–146 .................................................................................................... Vetalog Cream

046–147 .................................................................................................... Dirocide Syrup

049–892 .................................................................................................... Spanbolet II

055–060 .................................................................................................... Potassium G penicillin

055–064 .................................................................................................... Redicillin (Princillin)

055–066 .................................................................................................... Redicillin (Princillin)

055–071 .................................................................................................... Redicillin (Princillin)

065–130 .................................................................................................... Crystaline Pro Penicillin

065–174 .................................................................................................... Crysticillin 300 A.S. Vet

065–410 .................................................................................................... Tetra–Sal Soluble

091–192 .................................................................................................... Renografin 76

091–240 .................................................................................................... Renovist

091–327 .................................................................................................... Gastrogratin

093–512 .................................................................................................... Dirocide Tabs

096–676 .................................................................................................... Panalog Cream

099–388 .................................................................................................... Vetalog Oral Powder

126–232 .................................................................................................... Calfspan

131–808 .................................................................................................... Dirocide Syrup
Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Rules and Regulations 40931

NADA No. Drug Name

139–913 .................................................................................................... Equron

140–909 .................................................................................................... Sulka-S-Bolus

Accordingly, the agency is amending

the regulations in 21 CFR 510.600(c)(1)

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

sponsor. The drug labeler code assigned

to Solvay Animal Health is being

retained as the drug labeler code for the

new sponsor.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

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).

§ 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 entry for ‘‘Solvay Animal

Health, Inc.’’ and by alphabetically

adding a new entry for ‘‘Fort Dodge

Animal Health, A Division of American

Cyanamid Co., P.O. Box 1339, Fort

Dodge, IA 50501’’ and in the table in

paragraph (c)(2) in the entry for

‘‘053501’’ by removing the sponsor

name and address ‘‘Solvay Animal

Health, Inc., 1201 Northland Dr.,

Mendota Heights, MN 55120’’ and

adding in its place ‘‘Fort Dodge Animal

Health, A Division of American

Cyanamid Co., P.O. Box 1339, Fort

Dodge, IA 50501’’.

Dated: July 22, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20249 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524

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 a

change of sponsor for three approved

new animal drug applications (NADA’s)

from Syntex Animal Health, Inc.,

Division of Syntex Agribusiness, Inc., to

Medicis Dermatologics, Inc.

EFFECTIVE DATE: July 31, 1997.

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: Syntex

Animal Health, Inc., Division of Syntex

Agribusiness, Inc., 3401 Hillview Ave.,

P.O. Box 10850, Palo Alto, CA 94303,

has informed FDA that it has transferred

ownership of, and all rights and

interests in NADA’s 15–151

(fluocinolone acetonide, neomycin

sulfate cream), 15–152 (fluocinolone

acetonide cream), and 15–298

(fluocinolone acetonide solution) to

Medicis Dermatologics, Inc., 4343 East

Camelback Rd., suite 250, Phoenix, AZ

85018–2700. Accordingly, the agency is

amending the regulations in 21 CFR

524.981a, 524.981b, and 524.981c to

reflect the transfer of ownership. The

agency is also amending the regulations

in 21 CFR 510.600(c)(1) and (c)(2) by

alphabetically adding a new listing for

Medicis Dermatologics, Inc.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 524

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 524 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).

2. Section 510.600 is amended in the

table in paragraph (c)(1) by

alphabetically adding a new entry for

‘‘Medicis Dermatologics, Inc.’’ and in

the table in paragraph (c)(2) by

numerically adding a new entry for

‘‘099207’’ 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

* * * * * * *

Medicis Dermatologics, Inc., 4343 East Camelback Rd., suite 250,

Phoenix, AZ 85018–2700.

099207

* * * * * * *

(2) * * *