48714 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations 

introductory text in §§ 946.143 and 

946.336. Authority for the change in the 

order’s rules and regulations is provided 

for in §§ 946.70 and 946.52, 

respectively. 

This action is not expected to increase 

costs associated with the order 

requirements. Rather, this action 

represents a cost savings for handlers 

and has the potential to increase 

industry returns. This change extends 

the one-year suspension of minimum 

quality, maturity, pack, marking, and 

inspection requirements indefinitely. 

Though inspections will not be 

mandated for russet potatoes handled 

under the order, handlers may at their 

discretion choose to have their potatoes 

inspected. Handlers are thus able to 

control costs—which are generally 

passed on to producers—based on the 

demands of their customers. The 

opportunities and benefits of this rule 

are equally available to all Washington 

potato handlers and growers, regardless 

of their size. 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

Chapter 35), the order’s information 

collection requirements have been 

previously approved by the Office of 

Management and Budget (OMB) and 

assigned OMB No. 0581–0178 

(Vegetable and Specialty Crop 

Marketing Orders). No changes in those 

requirements as a result of this action 

are necessary. Should any changes 

become necessary, they would be 

submitted to OMB for approval. 

This change continues the monthly 

reporting requirement for russet potato 

handlers. The reports provide the 

Committee with information necessary 

to track shipments and collect 

assessments. As with all Federal 

marketing order programs, reports and 

forms are periodically reviewed to 

reduce information requirements and 

duplication by industry and public 

sector agencies. In addition, USDA has 

not identified any relevant Federal rules 

that duplicate, overlap or conflict with 

this rule. 

Further, the Committee’s meeting was 

widely publicized throughout the 

Washington potato industry and all 

interested persons were invited to 

participate in Committee deliberations. 

Like all Committee meetings, the 

January 26, 2011, meeting was a public 

meeting, and all entities, both large and 

small, were able to express views on 

this issue. 

Comments on the interim rule were 

required to be received on or before July 

12, 2011. No comments were received. 

Therefore, for the reasons given in the 

interim rule, we are adopting the 

interim rule as a final rule, without 

change. 

To view the interim rule, go to: 

http: 

//www.regulations.gov/ 

#!documentDetail;D=AMS-FV-11-0024- 

0001. 

This action also affirms information 

contained in the interim rule concerning 

Executive Orders 12866 and 12988, the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35), and the E-Gov Act (44 

U.S.C. 101). 

After consideration of all relevant 

material presented, it is found that 

finalizing the interim rule, without 

change, as published in the Federal 

Register (76 FR 27850, May 13, 2011) 

will tend to effectuate the declared 

policy of the Act. 

List of Subjects in 7 CFR Part 946 

Marketing agreements, Potatoes, 

Reporting and recordkeeping 

requirements. 

Accordingly, the interim rule that 

amended 7 CFR 946.143 and 946.336 

and that was published at 76 FR 27850 

on May 13, 2011, is adopted as a final 

rule, without change. 

Dated: August 3, 2011. 

David R. Shipman, 

Acting Administrator, Agricultural Marketing 

Service. 

[FR Doc. 2011–20124 Filed 8–8–11; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520, 522, and 524 

[Docket No. FDA–2011–N–0003] 

New Animal Drugs; Change of 

Sponsor; Moxidectin 

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 (NADAs) 

for dosage form products containing 

moxidectin from Fort Dodge Animal 

Health, Division of Wyeth, a wholly 

owned subsidiary of Pfizer, Inc., to 

Boehringer Ingelheim Vetmedica, Inc. 

DATES: This rule is effective August 9, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Steven D. Vaughn, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7520 Standish Pl., 

Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth, a wholly owned subsidiary of 

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

NY 10017 has informed FDA that it has 

transferred ownership of, and all rights 

and interest in, the following three 

approved NADAs for dosage form 

products containing moxidectin to 

Boehringer Ingelheim Vetmedica, Inc., 

2621 North Belt Highway, St. Joseph, 

MO 64506–2002: NADA 141–099, 

NADA 141–220, and NADA 141–247. 

Accordingly, the Agency is amending 

the regulations in 21 CFR parts 520, 522, 

and 524 to reflect the transfer of 

ownership. 

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 Parts 520, 

522, and 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 520, 522, and 524 are 

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 § 520.1454, revise paragraphs (b) 

and (d) to read as follows: 

§ 520.1454 Moxidectin solution. 

* * * * * 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

* * * * * 

(d) Special considerations. See 

§ 500.25 of this chapter. 

* * * * * 

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: 21 U.S.C. 360b. 

■ 4. In § 522.1450, redesignate 

paragraph (d) as paragraph (e); add new 

paragraph (d); and revise paragraph (b) 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations 48715 

and newly redesignated paragraphs 

(e)(1) and (e)(3) to read as follows: 

§ 522.1450 Moxidectin solution. 

* * * * * 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

* * * * * 

(d) Special considerations. See 

§ 500.25 of this chapter. 

(e) * * * 

(1) Amount. Administer 0.2 mg/kg of 

body weight (0.2 mg/2.2 pound) as a 

single, subcutaneous injection. 

* * * * * 

(3) Limitations. Do not slaughter cattle 

within 21 days of treatment. Because a 

withholding time for milk has not been 

established, do not use in female dairy 

cattle 20 months of age and older. A 

withdrawal period has not been 

established for pre-ruminating calves. 

Do not use in calves to be processed for 

veal. 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 5. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

§ 524.1451 [Redesignated as § 524.1450 

and Amended] 

■ 6. Redesignate § 524.1451 as 

§ 524.1450 and revise paragraphs (a), 

(b), and (e)(1) to read as follows: 

§ 524.1450 Moxidectin. 

(a) Specifications. Each milliliter 

contains 5 milligrams (mg) moxidectin 

(0.5 percent solution). 

(b) Sponsor. See No. 000010 in 

§ 510.600(c) of this chapter. 

* * * * * 

(e) * * * 

(1) Amount. Administer topically 0.5 

mg per kilogram of body weight. 

* * * * * 

Dated: August 3, 2011. 

Elizabeth Rettie, 

Deputy Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 2011–20182 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2010–N–0429] 

Immunology and Microbiology 

Devices; Reclassification of the Herpes 

Simplex Virus Serological Assay 

Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

special controls for the herpes simplex 

virus (HSV) serological assay device 

type, which is classified as class II 

(special controls). These device types 

are devices that consist of antigens and 

antisera used in various serological tests 

to identify antibodies to herpes simplex 

virus in serum, and the devices that 

consist of herpes simplex virus antisera 

conjugated with a fluorescent dye 

(immunofluorescent assays) used to 

identify herpes simplex virus directly 

from clinical specimens or tissue 

culture isolates derived from clinical 

specimens. 

DATES: This rule is effective September 

8, 2011. 

FOR FURTHER INFORMATION CONTACT: Haja 

Sittana El Mubarak, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg 66, Rm. 5519, Silver Spring, 

MD 20993–0002, 301–796–6193. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 301 et 

seq.), as amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Pub. L. 94–295), Safe 

Medical Devices Act (SMDA) (Pub. L. 

101–629), Food and Drug 

Administration Modernization Act 

(FDAMA) (Pub. L. 105–115), and the 

Medical Device User Fee and 

Modernization Act (MDUFMA) (Pub. L. 

107–250), established a comprehensive 

system for the regulation of medical 

devices intended for human use. 

Section 513 of the FD&C Act (21 U.S.C. 

360c) established three categories 

(classes) of devices, defined by 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 FD&C Act, 

FDA refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as preamendments 

devices. FDA classifies these devices 

after it takes the following steps: (1) 

Receives a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) publishes the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) publishes 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution before May 28, 1976, 

generally referred to as postamendments 

devices are classified automatically by 

statute (section 513(f) of the FD&C Act) 

into class III without any FDA 

rulemaking process. Those devices 

remain in class III until FDA does the 

following: (1) Reclassifies the device 

into class I or II; (2) issues an order 

classifying the device into class I or II 

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

the FD&C Act; or (3) issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a legally 

marketed device that has been classified 

into class I or class II. The agency 

determines whether new devices are 

substantially equivalent to previously 

marketed devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and 21 CFR part 807 of 

the regulations. 

Under the 1976 amendments, class II 

devices were defined as devices for 

which there was insufficient 

information to show that general 

controls themselves would provide 

reasonable assurance of safety and 

effectiveness, but for which there was 

sufficient information to establish 

performance standards to provide such 

assurance. SMDA broadened the 

definition of class II devices to mean 

those devices for which the general 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but for which 

there is sufficient information to 

establish special controls to provide 

such assurance, including performance 

standards, postmarket surveillance, 

patient registries, development and 

dissemination of guidelines, 

recommendations, and any other 

appropriate actions the agency deems 

necessary (section 513(a)(1)(B) of the 

FD&C Act). 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 


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