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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48716 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations 

availability of the revised guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays’’ that will serve as 

the special control for the device. 

Because FDA is amending the special 

control for this device type, the agency 

is publishing the final rule that 

designates the revised guidance 

document as the special control for HSV 

serological devices. 

II. Regulatory Background of the Device 

As a preamendments device, HSV 1 

and 2 serological assays were classified 

into class III in a final rule in the 

Federal Register of November 9, 1982 

(47 FR 50823) following the receipt of 

a classification recommendation from a 

classification panel and the issuance of 

a proposed rule as required by section 

513(b) of the FD&C Act. In the Federal 

Register of April 3, 2007 (72 FR 15829), 

FDA published a final rule to reclassify 

HSV 1 and 2 serological assays into 

class II. These assays are used as an aid 

in the clinical laboratory diagnosis of 

diseases caused by HSV 1 and 2. FDA 

identified the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Herpes Simplex 

Virus Types 1 and 2 Serological Assays’’ 

as the special control. Since April 3, 

2007, FDA believed it had become 

aware of sufficient additional safety and 

efficacy profile information to justify 

revision of the special controls to better 

provide assurance of the safety and 

effectiveness of the device. Accordingly, 

in the Federal Register of September 28, 

2010 (75 FR 59670), FDA issued a 

proposed rule to amend the special 

controls guidance for the device and 

replace it with a new guidance of the 

same name. FDA invited interested 

persons to comment on the proposed 

rule by November 29, 2010. No 

comments germane to this rule were 

received by the agency. 

III. Summary of the Reasons for 

Revising Special Controls 

The final rule revises the special 

controls for HSV 1 and 2 serological 

assays because the new special controls, 

in addition to general controls, provide 

reasonable assurance of the safety and 

effectiveness of the device. FDA 

believes there is sufficient additional 

safety and efficacy profile information 

to justify this revision of the special 

controls to better provide such 

assurance. We revised the existing 

guidance by rewriting the method 

comparison section and the sample 

selection inclusion and exclusion 

criteria section. The revisions defined 

and differentiated the required studies 

and the study populations for the 

assessment of the safety and 

effectiveness of the different types of 

HSV1 and HSV2 serological assays. 

Additionally, we made several 

corrections and clarifications 

throughout the document to ensure 

accuracy, consistency, and ease of 

reading. 

IV. Special Controls 

In addition to general controls, FDA 

believes that the revised guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays’’ (the class II special 

controls guidance document) is a 

special control that is adequate to 

address the risks to health associated 

with the use of the device. FDA believes 

that the revised class II special controls 

guidance document, which incorporates 

voluntary consensus standards and 

describes labeling recommendations, in 

addition to general controls, provides 

reasonable assurance of the safety and 

effectiveness of the device. 

Following the effective date of this 

final rule, any firm submitting a 510(k) 

for HSV 1 and 2 serological assays will 

need to address the issues covered in 

the special controls guidance. However, 

the firm need only show that its device 

meets the recommendations of the 

guidance or in some other way provides 

equivalent assurances of safety and 

effectiveness. 

V. FDA’s Findings 

As discussed previously in this 

document, FDA believes HSV 1 and 2 

serological assays should be classified 

into class II because special controls, in 

addition to general controls, provide 

reasonable assurance of the safety and 

effectiveness of the device and because 

there is sufficient information to 

establish special controls to provide 

such assurance. FDA, therefore, is 

finalizing the establishment of the 

revised class II special controls 

guidance document as a special control 

for the device. 

Section 510(m) of the FD&C Act 

provides that a class II device may be 

exempt from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if the agency determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this device, FDA believes that 

premarket notification is necessary to 

provide reasonable assurance of safety 

and effectiveness and, therefore, is not 

exempting the device from the 

premarket notification requirements. 

VI. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) 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. 

VII. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the changes to the 

guidance are minimal, the Agency 

certifies that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

The changes to the guidance include 

adding specific recommendations on 

appropriate comparators for tests for 

antibodies and antigens, as well as 

recommendations for sample selection 

inclusion and exclusion criteria to 

define the target populations for HSV 1 

and HSV 2 serological assays. These 

recommended changes increase the 

usefulness of the guidance while 

imposing a minimal burden. 


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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations 48717 

VIII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

U.S.C. 360k; See Medtronic Inc., v. Lohr 

518 U.S. 470 (1996); Riegel v. 

Medtronic, Inc., 552 U.S. 312 (2008). 

The special controls established by this 

final rule create ‘‘requirements’’ for 

specific medical devices under 21 

U.S.C. 360k, even though products 

sponsors have some flexibility in how 

they meet those requirements. Cf. 

Papike v. Tambrands, Inc., 107 F. 3d 

737, 740–742 (9th Cir. 1991). 

IX. Paperwork Reduction Act of 1995 

This final rule contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

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

3501–3520) is not required. This final 

rule establishes as special controls a 

guidance document that refers to 

currently approved collections of 

information found in other FDA 

regulations. These collections of 

information are subject to review by 

OMB under the PRA. The analysis of the 

paperwork burden for the guidance 

document is included in its notice of 

availability. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratory, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 866.3305 is amended by 

revising paragraph (b) to read as follows: 

§ 866.3305 Herpes simplex virus 

serological assays. 

* * * * * 

(b) Classification. Class II (special 

controls). The device is classified as 

class II (special controls). The special 

control for the device is FDA’s revised 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Herpes Simplex Virus Types 1 and 2 

Serological Assays.’’ For availability of 

the guidance revised document, see 

§ 866.1(e). 

Dated: August 3, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–20115 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2011–0759] 

Drawbridge Operation Regulations; 

Long Island, New York Inland 

Waterway From East Rockaway Inlet to 

Shinnecock Canal, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: The Commander, First Coast 

Guard District, has issued a temporary 

deviation from the regulation governing 

the operation of the Loop Parkway 

Bridge, mile 0.7, across Long Creek, and 

the Captree State Parkway (Robert 

Moses Causeway) Bridge, mile 30.7, 

across the State Boat Channel, at Long 

Island, New York. This deviation is 

necessary to facilitate the 2011 March of 

Dimes Motorcycle Run. The deviation 

allows the two bridges listed above to 

remain in the closed position during 

this public event. 

DATES: This deviation is effective from 

10:51 a.m. through 1:49 p.m. on 

September 25, 2011. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2011– 

0759 and are available online at 

http://www.regulations.gov, inserting 

USCG–2011–0759 in the ‘‘Keyword’’ 

box and then clicking ‘‘Search’’. They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Ms. Judy Leung-Yee, Project 

Officer, First Coast Guard District, 

telephone (212) 668–7165, judy.k.leungyee@uscg.mil. If you have questions on 

viewing the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

The Loop Parkway Bridge, mile 0.7, 

across Long Creek has a vertical 

clearance in the closed position of 21 

feet at mean high water and 25 feet at 

mean low water. The existing 

drawbridge operation regulations are 

listed at 33 CFR 117.799(f). 

The Captree State Parkway (Robert 

Moses Causeway) Bridge, mile 30.7, 

across the State Boat Channel has a 

vertical clearance in the closed position 

of 29 feet at mean high water and 31 feet 

at mean low water. The existing 

drawbridge operation regulations are 

listed at 33 CFR 117.799(i). 

Long Creek and the State Boat 

Channel both are both transited by 

commercial fishing and recreational 

vessel traffic. 

The owner of the two bridges, the 

State New York Department of 

Transportation, requested bridge 

closures to facilitate a public event, the 

March of Dimes Charity Motorcycle 

Run. 

Under this temporary deviation the 

Loop Parkway Bridge may remain in the 

closed position from 10:51 a.m. through 

11:49 a.m. and from 12:21 p.m. through 

1:49 p.m. on September 25, 2011, and 

the Captree State Parkway Bridge 

(Robert Moses Causeway) may remain in 

the closed position from 11 a.m. through 

1 p.m. on September 25, 2011, to 

facilitate a public event, the 2011 March 

of Dimes Motorcycle Run. 

Vessels that can pass under the closed 

draws during each respective closure 

may do so at any time. 

In accordance with 33 CFR 117.35(e), 

the bridge must return to its regular 

operating schedule immediately at the 

end of the designated time period. This 

deviation from the operating regulations 

is authorized under 33 CFR 117.35. 

Dated: July 29, 2011. 

Gary Kassof, 

Bridge Program Manager, First Coast Guard 

District. 

[FR Doc. 2011–20092 Filed 8–8–11; 8:45 am] 

BILLING CODE 9110–04–P 


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