14272 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 

From To MEA 

*9500—MRA 

*7600—MCA FRIDA, AK FIX, W BND 

#MEA IS ESTABLISHED WITH A GAP IN NAVIGATION 

SIGNAL COVERAGE 

§ 95.6440 Alaska VOR Federal Airway V440 Is Amended to Read in Part 

WINOR, AK FIX ............................................................................ *FRIDA, AK FIX ........................................................................... #10000 

*9500—MRA 

*7600—MCA FRIDA, AK FIX, W BND 

#MEA IS ESTABLISHED WITH A GAP IN NAVIGATION 

SIGNAL COVERAGE 

From To MEA MAA 

§ 95.7001 Jet Routes 

§ 95.7537 Jet Route J537 Is Amended to Read in Part 

ROME, OR VOR/DME ...................................................... MULLAN PASS, ID VOR/DME ........................................ 22000 45000 

[FR Doc. 2012–5719 Filed 3–8–12; 8:45 am] 

BILLING CODE 4910–13–P 

SUSQUEHANNA RIVER BASIN 

COMMISSION 

18 CFR Part 806 

Review and Approval of Projects 

CFR Correction 

In Title 18 of the Code of Federal 

Regulations, Part 400 to End, revised as 

of April 1, 2011, on page 118, in § 806.6, 

(b)(1)(i) and (ii) are removed. 

[FR Doc. 2012–5837 Filed 3–8–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs for Use in Animal 

Feeds 

CFR Correction 

In Title 21 of the Code of Federal 

Regulations, Parts 500 to 599, revised as 

of April 1, 2011, on page 490, in 

§ 558.500, (e)(1)(i) is reinstated to read 

as follows; 

§ 558.500 Ractopamine. 

* * * * * 

(e) * * * 

(1) * * * 

Ractopamine in grams/ton Combination 

in grams/ton Indications for use Limitations Sponsor 

(i) 4.5 to 9 ........................... ...................... For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing 

swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for 

the last 45 to 90 lbs of gain prior to slaughter.

Feed continuously as sole 

ration.

000986 

* * * * * 

[FR Doc. 2012–5838 Filed 3–8–12; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2012–N–0165] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

Norovirus Serological Reagents 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying 

norovirus serological reagents into class 

II (special controls). The special control 

that will apply to these devices is the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Norovirus Serological Reagents.’’ The 

Agency is classifying these devices into 

class II (special controls) because 

special controls, in addition to general 

controls, will provide a reasonable 

assurance of safety and effectiveness of 

these devices and there is sufficient 

information to establish special 

controls. 

DATES: Effective Date: April 9, 2012. The 

classification was effective February 23, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Steven Gitterman, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5518, Silver Spring, 

MD 20993–0002, 301–796–6694. 

SUPPLEMENTARY INFORMATION: 

I. Legal Authority 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976, the 

date of enactment of the Medical Device 

Amendments of 1976 (the 1976 


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Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14273 

amendments), generally referred to as 

postamendments devices, are classified 

automatically by statute into class III 

without any FDA rulemaking process. 

These devices remain in class III and 

require premarket approval, unless and 

until the device is classified or 

reclassified into class I or II, or FDA 

issues an order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. The Agency 

determines whether new devices are 

substantially equivalent to previous 

marketed devices by means of 

premarket notification procedures in 

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

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

807) of FDA’s regulations. 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1), request FDA to classify 

the device under the criteria set forth in 

section 513(a)(1). FDA shall, within 60 

days of receiving such a request, classify 

the device by written order. This 

classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification (section 

513(f)(2) of the FD&C Act). 

II. Classification 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

February 14, 2011, classifying the 

RIDASCREEN® Norovirus 3rd 

Generation EIA into class III, because it 

was not substantially equivalent to a 

device that was introduced or delivered 

for introduction into interstate 

commerce for commercial distribution 

before May 28, 1976, or a device that 

was subsequently reclassified into class 

I or class II. On February 16, 2011, 

Lehnus and Associates Consulting, on 

behalf of R-Biopharm AG, submitted a 

petition requesting classification of the 

RIDASCREEN® Norovirus 3rd 

Generation EIA under section 513(f)(2) 

of the FD&C Act. The manufacturer 

recommended that the device be 

classified into class II (Ref. 1). 

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

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1). FDA classifies 

devices into class II if general controls 

by themselves are insufficient to 

provide reasonable assurance of safety 

and effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name norovirus serological reagents, 

and this device type is identified as 

devices that consist of antigens and 

antisera used in serological tests to 

detect the presence of norovirus 

antigens in fecal samples. These devices 

aid in the diagnosis of norovirus 

infection in the setting of an individual 

patient with symptoms of acute 

gastroenteritis when the individual 

patient is epidemiologically linked to 

other patients with symptoms of acute 

gastroenteritis and/or aid in the 

identification of norovirus as the 

etiology of an outbreak of acute 

gastroenteritis in the setting of 

epidemiologically linked patients with 

symptoms of acute gastroenteritis. 

III. Risks to Health 

FDA has identified the risks to health 

associated with this type of device as a 

false negative result and a false positive 

result. A false positive test result for an 

individual may lead to a potential delay 

in needed antibiotic treatment (when 

appropriate) and possibly less thorough 

laboratory evaluation for the true cause 

of illness; in the setting of an outbreak 

investigation, a false positive result may 

lead to unnecessary environmental 

interventions and/or significant patient 

restrictions. A false negative test result 

for an individual may lead to potentially 

unnecessary treatment for other causes 

of acute gastroenteritis, including 

possible antibiotic exposure; in the 

setting of an outbreak, a false negative 

result may lead to delay in recognizing 

the cause of the outbreak and additional 

spread of norovirus infection. 

FDA has identified the following 

recommended mitigation measures to 

address these risks to health associated 

specifically with this type of device. 

TABLE 1—RISKS TO HEALTH AND RECOMMENDED MITIGATION MEASURES

Identified risks Recommended mitigation measures 

A false positive test result for an individual may lead to a potential delay in needed antibiotic treatment (when appropriate) and possibly less thorough laboratory evaluation for the true cause of illness; in the setting of an outbreak investigation, a false positive result may lead to unnecessary 

environmental interventions and/or significant patient restrictions.

Performance Characteristics Labeling. 

A false negative test result for an individual may lead to potentially unnecessary treatment for other 

causes of acute gastroenteritis, including possible antibiotic exposure; in the setting of an outbreak, a false negative result may lead to delay in recognizing the cause of the outbreak and additional spread of norovirus infection.

Performance Characteristics Labeling. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of a guidance document that 

will serve as the special control for 

these devices. FDA believes that the 

special controls guidance document, in 

addition to general controls, addresses 

the risks to health identified previously 

and provides reasonable assurance of 

the safety and effectiveness of the 

device. Therefore, on February 23, 2011, 

FDA issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying this device by adding 

§ 866.3395. 

IV. 510(k) Premarket Notification 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for a norovirus serological 

reagents 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 

assurance of safety and effectiveness. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k), if 

FDA determines that premarket 

notification is not necessary to provide 


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14274 Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 

reasonable assurance of the safety and 

effectiveness of the device. For this type 

of device, FDA has determined because 

of the risks of false positives and false 

negatives that premarket notification is 

necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device and, therefore, this type of 

device is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the norovirus serological reagents 

they intend to market. 

V. Environmental Impact 

The Agency has determined under 

21 CFR 25.34(b) that this action is of 

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. 

VI. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (Pub. L. 96–354) 

(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 proposed rule is not a 

significant regulatory action as defined 

by 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 this rule is 

deregulatory and imposes no new 

burdens, the Agency proposes to certify 

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 proposed rule to result in any 

1-year expenditure that would meet or 

exceed this amount. 

VII. 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 or 

in addition to’’ certain federal 

requirements applicable to devices. 

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

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

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

The special controls established by this 

rulemaking create ‘‘requirements’’ to 

address each identified risk to health 

presented by these specific medical 

devices under 21 U.S.C. 360k, even 

though product sponsors may have 

flexibility in how they meet those 

requirements. Cf. Papike v. Tambrands, 

Inc., 107 F.3d 737, 740–42 (9th Cir. 

1997). 

VIII. Paperwork Reduction Act of 1995 

This final rule establishes as special 

controls a guidance document that 

refers to previously approved 

collections of information found in 

other FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice 

announcing the availability of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Norovirus Serological Reagents.’’ The 

notice contains an analysis of the 

paperwork burden for the guidance. 

IX. References 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

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

through Friday. 

1. Petition from R-Biopharm AG, c/o 

Lehnus and Associates, dated February 

15, 2011. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866.3395 is added to 

subpart D to read as follows: 

§ 866.3395 Norovirus serological reagents. 

(a) Identification. Norovirus 

serological reagents are devices that 

consist of antigens and antisera used in 

serological tests to detect the presence 

of norovirus antigens in fecal samples. 

These devices aid in the diagnosis of 

norovirus infection in the setting of an 

individual patient with symptoms of 

acute gastroenteritis when the 

individual patient is epidemiologically 

linked to other patients with symptoms 

of acute gastroenteritis and/or aid in the 

identification of norovirus as the 

etiology of an outbreak of acute 

gastroenteritis in the setting of 

epidemiologically linked patients with 

symptoms of acute gastroenteritis. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Norovirus Serological Reagents.’’ See 

§ 866.1(e) for the availability of this 

guidance document. 

Dated: March 5, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–5675 Filed 3–8–12; 8:45 am] 

BILLING CODE 4160–01–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4044 

Allocation of Assets in SingleEmployer Plans; Benefits Payable in 

Terminated Single-Employer Plans; 

Interest Assumptions for Valuing and 

Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 


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