54492 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2010–N–0002] 

Oral Dosage Form New Animal Drugs; 

Tiamulin 

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 

Novartis Animal Health US, Inc. The 

supplemental NADA provides for use of 

an increased strength of tiamulin 

concentrate solution in the drinking 

water of swine for the treatment of 

certain bacterial respiratory and enteric 

diseases. 

DATES: This rule is effective September 

8, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Novartis 

Animal Health US, Inc., 3200 Northline 

Ave., suite 300, Greensboro, NC 27408, 

filed a supplement to NADA 140–916 

for DENAGARD (tiamulin) Liquid 

Concentrate administered in drinking 

water for the treatment of certain 

bacterial respiratory and enteric 

diseases in swine. The supplemental 

NADA provides for use of a 12.5 percent 

tiamulin concentrate solution. The 

supplemental NADA is approved as of 

June 14, 2010, and 21 CFR 520.2455 is 

amended to reflect the approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency has determined under 21 

CFR 25.33 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. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

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 part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 520.2455, revise paragraphs (a) 

and (b) to read as follows: 

§ 520.2455 Tiamulin. 

(a) Specifications. (1) Each gram of 

soluble powder contains 450 milligrams 

(mg) tiamulin hydrogen fumarate. 

(2) Each milliliter (mL) of solution 

contains 125 mg (12.5 percent) tiamulin 

hydrogen fumarate. 

(3) Each mL of solution contains 123 

mg (12.3 percent) tiamulin hydrogen 

fumarate. 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter for use as in 

paragraph (d) of this section. 

(1) No. 058198 for products described 

in paragraphs (a)(1) and (a)(2) of this 

section. 

(2) No. 059130 for products described 

in paragraphs (a)(1) and (a)(3) of this 

section. 

* * * * * 

Dated: September 1, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22277 Filed 9–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 524 

[Docket No. FDA–2010–N–0002] 

Ophthalmic and Topical Dosage Form 

New Animal Drugs; Gentamicin and 

Betamethasone Ophthalmic Solution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to codify the 

conditions of use of an approved new 

animal drug application (NADA) for 

gentamicin sulfate and betamethasone 

acetate ophthalmic solution. This action 

is being taken to comply with the 

Federal Food, Drug, and Cosmetic Act 

and to improve the accuracy of the 

regulations. 

DATES: This rule is effective September 

8, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8337, 

email: melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA has 

noticed that the approved conditions of 

use for GENTOCIN DURAFILM 

(gentamicin sulfate and betamethasone 

acetate) Ophthalmic Solution, 

sponsored by Intervet, Inc., 56 

Livingston Ave., Roseland, NJ 07068 

under NADA 34–267 are not codified. 

When this NADA was approved in 

1967, codification of approved 

conditions of use for NADAs was not 

required. Accordingly, the regulations 

are amended in 21 CFR part 524 by 

adding § 524.1044i to reflect the 

approval. This action is being taken to 

comply with section 512(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(i)) and to improve the 

accuracy of the regulations. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 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 part 524 is amended as follows: 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 524 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Add § 524.1044i to read as follows: 

§ 524.1044i Gentamicin and 

betamethasone ophthalmic solution. 

(a) Specifications. Each milliliter (mL) 

of solution contains gentamicin sulfate 

equivalent to 3 milligrams (mg) of 

gentamicin base and 1 mg 

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Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Rules and Regulations 54493 

betamethasone acetate equivalent to 

0.89 mg betamethasone alcohol. 

(b) Sponsor. See No. 000061 in 

§ 510.600(c) of this chapter. 

(c) Conditions of use in dogs—(1) 

Amount. Instill one or two drops of 

solution in the conjunctival sac three or 

four times a day. 

(2) Indications for use. For treatment 

of external bacterial infections of the eye 

(conjunctiva and cornea). 

(3) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian. 

Dated: September 1, 2010. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2010–22276 Filed 9–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2000–P–0924] (formerly 

Docket No. FDA–2000–P–1533) 

Cardiovascular Devices; 

Reclassification of Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

the device type, standard percutaneous 

transluminal coronary angioplasty 

(PTCA) catheters, from class III 

(premarket approval) into class II 

(special controls). Cutting/scoring PTCA 

catheters remain in class III and 

continue to require premarket approval 

applications (PMAs). FDA is 

reclassifying these devices in 

accordance with the Federal Food, Drug, 

and Cosmetic Act (the act). Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of a 

guidance document entitled ‘‘Guidance 

for Industry and FDA Staff: Class II 

Special Controls Guidance Document 

for Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters’’ that will serve as the special 

control for the reclassified device type. 

DATES: This final rule is effective 

October 8, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn O’Callaghan, Center for Devices 

and Radiological Health (HFZ–450), 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–6349. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 (the 

SMDA) (Public Law 101–629), and the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Public Law 105–115), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the act, devices 

that were in commercial distribution 

before May 28, 1976 (the date of 

enactment of the 1976 amendments), 

generally referred to as preamendments 

devices, are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f)) of the act (21 

U.S.C. 360c(f)) into class III without any 

FDA rulemaking process. Those devices 

remain in class III and require 

premarket approval, unless and until: 

(1) The device is reclassified into class 

I or II; (2) FDA issues an order 

classifying the device into class I or II 

in accordance with section 513(f)(2) of 

the act (21 U.S.C. 360c(f)(2)); or (3) FDA 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the act (21 U.S.C. 360c(i)), to 

a predicate device that does not require 

premarket approval. The agency 

determines whether new devices are 

substantially equivalent to previously 

offered devices by means of premarket 

notification (510(k)) procedures in 

section 510(k) of the act (21 U.S.C. 

360(k)) and part 807 of the regulations 

(21 CFR part 807). 

A preamendments device that has 

been classified into class III may be 

marketed, by means of premarket 

notification procedures, without 

submission of a PMA until FDA issues 

a final regulation under section 515(b) 

of the act (21 U.S.C. 360e(b)) requiring 

premarket approval. 

Reclassification of postamendments 

devices is governed by section 513(f)(3) 

of the act (21 U.S.C.360c(f)(3)). This 

section states that FDA may initiate the 

reclassification of a device classified 

into class III under section 513(f)(1) of 

the act, or that a manufacturer or 

importer of a device may petition the 

Secretary of Health and Human Services 

(the Secretary) for the issuance of an 

order classifying the device into class I 

or class II. FDA’s regulations in 21 CFR 

860.134 set forth the procedures for the 

filing and review of a petition for 

reclassification of such class III devices. 

In order to change the classification of 

the device, it is necessary that the 

proposed new class have sufficient 

regulatory controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. 

Under section 513(f)(3)(B)(i) of the 

act, the Secretary may, for good cause 

shown, refer a petition to a device 

panel. If a petition is referred to a panel, 

the panel shall make a recommendation 

to the Secretary respecting approval or 

denial of the petition. Any such 

recommendation shall contain: (1) A 

summary of the reasons for the 

recommendation, (2) a summary of the 

data upon which the recommendation is 

based, and (3) an identification of the 

risks to health (if any) presented by the 

device with respect to which the 

petition was filed. 

II. Regulatory History of the Device 

The PTCA catheter is a 

postamendments device classified into 

class III under section 513(f)(1) of the 

act. Therefore, the device cannot be 

placed in commercial distribution 

unless it is subject to an approved 

premarket approval application (PMA) 

under section 515 of the act (21 U.S.C. 

360e) or is reclassified. 

On September 21, 2000, FDA filed a 

petition submitted under section 

513(f)(3) of the act from COOK 

requesting reclassification of PTCA 

catheters from class III into class II. This 

reclassification petition did not include 

cutting or scoring PTCA catheters. In 

order to reclassify the PTCA catheter 

into class II, it is necessary that the 

proposed class have sufficient 

regulatory controls to provide 

reasonable assurance of safety and 

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