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. 


erowe on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 47 / Friday, March 9, 2012 / Rules and Regulations 14275 

ACTION: Correcting amendments. 

SUMMARY: The Pension Benefit Guaranty 

Corporation published a final rule 

document in the Federal Register on 

September 15, 2011 (at 76 FR 56973), 

amending its regulations on Benefits 

Payable in Terminated Single-Employer 

Plans and Allocation of Assets in 

Single-Employer Plans to prescribe 

interest assumptions under those 

regulations. This document corrects an 

inadvertent error in that final rule 

relating to the prescribed interest 

assumption under the allocation 

regulation, applicable to plans with 

valuation dates during the fourth 

quarter of 2011. 

DATES: Effective March 9, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion 

(Klion.Catherine@PBGC.gov), Manager, 

Regulatory and Policy Division, 

Legislative and Regulatory Department, 

Pension Benefit Guaranty Corporation, 

1200 K Street NW., Washington, DC 

20005, 202–326–4024. (TTY/TDD users 

may call the Federal relay service toll 

free at 1–800–877–8339 and ask to be 

connected to 202–326–4024.) 

SUPPLEMENTARY INFORMATION: The 

Pension Benefit Guaranty Corporation 

published a final rule document in the 

Federal Register of September 15, 2011 

(at 76 FR 56973), amending its 

regulations on Benefits Payable in 

Terminated Single-Employer Plans and 

Allocation of Assets in Single-Employer 

Plans to prescribe interest assumptions 

under those regulations. The rule 

inadvertently misstated the prescribed 

interest assumptions under the 

allocation regulation, applicable to 

plans with valuation dates during the 

fourth quarter of 2011. The errors 

appeared both in the preamble and in 

the amendatory instructions. 

In the preamble, the first full 

paragraph in the second column on p. 

56974 should have read as follows: 

The fourth quarter 2011 interest 

assumptions under the allocation regulation 

will be 4.09 percent for the first 20 years 

following the valuation date and 4.30 percent 

thereafter. In comparison with the interest 

assumptions in effect for the third quarter of 

2011, these interest assumptions represent no 

change in the select period (the period during 

which the select rate (the initial rate) 

applies), a decrease of 0.13 percent in the 

select rate, and a decrease of 0.04 percent in 

the ultimate rate (the final rate). 

List of Subjects in 29 CFR Part 4044 

Employee benefit plans, Pension 

insurance, Pensions. 

In consideration of the foregoing, 

29 CFR part 4044 is corrected by making 

the following correcting amendment: 

PART 4044—ALLOCATION OF 

ASSETS IN SINGLE-EMPLOYER 

PLANS 

■ 1. The authority citation for part 4044 

continues to read as follows: 

Authority: 29 U.S.C. 1301(a), 1302(b)(3), 

1341, 1344, 1362. 

■ 2. In appendix B to part 4044, the 

entry for October–December 2011 is 

corrected to read as follows: 

Appendix B to Part 4044—Interest 

Rates Used To Value Benefits 

* * * * * 

For valuation dates occurring in the months— 

The values of it are: 

it for t = it for t = it for t = 

*******

October–December 2011 ................................................. 0.0409 1–20 0.0430 >20 N/A N/A 

*******

Issued in Washington, DC, on this 6th day 

of March 2012. 

Laricke Blanchard, 

Deputy Director for Policy, Pension Benefit 

Guaranty Corporation. 

[FR Doc. 2012–5786 Filed 3–8–12; 8:45 am] 

BILLING CODE 7709–01–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. 

ACTION: Correcting amendments. 

SUMMARY: The Pension Benefit Guaranty 

Corporation published a final rule 

document in the Federal Register on 

June 15, 2011 (at 76 FR 34847), 

amending its regulations on Benefits 

Payable in Terminated Single-Employer 

Plans and Allocation of Assets in 

Single-Employer Plans to prescribe 

interest assumptions under those 

regulations. This document corrects an 

inadvertent error in that final rule 

relating to the prescribed interest 

assumption under the allocation 

regulation, applicable to plans with 

valuation dates during the third quarter 

of 2011. 

DATES: Effective March 9, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion 

(Klion.Catherine@PBGC.gov), Manager, 

Regulatory and Policy Division, 

Legislative and Regulatory Department, 

Pension Benefit Guaranty Corporation, 

1200 K Street NW., Washington, DC 

20005, 202–326–4024. (TTY/TDD users 

may call the Federal relay service toll 

free at 1–800–877–8339 and ask to be 

connected to 202–326–4024.) 

SUPPLEMENTARY INFORMATION: The 

Pension Benefit Guaranty Corporation 

published a final rule document in the 

Federal Register of June 15, 2011 (at 76 

FR 34847), amending its regulations on 

Benefits Payable in Terminated SingleEmployer Plans and Allocation of 

Assets in Single-Employer Plans to 

prescribe interest assumptions under 

those regulations. The rule 

inadvertently misstated the prescribed 

interest assumptions under the 

allocation regulation, applicable to 

plans with valuation dates during the 

third quarter of 2011. The errors 

appeared both in the preamble and in 

the amendatory instructions. 

In the preamble, the third full 

paragraph in the second column on p. 

34847 should have read as follows: 

The third quarter 2011 interest 

assumptions under the allocation regulation 

will be 4.22 percent for the first 20 years 

following the valuation date and 4.34 percent 

thereafter. In comparison with the interest 

assumptions in effect for the second quarter 

of 2011, these interest assumptions represent 

no change in the select period (the period 

during which the select rate (the initial rate) 

applies), an increase of 0.26 percent in the 

select rate, and an increase of 0.02 percent in 

the ultimate rate (the final rate). 

List of Subjects in 29 CFR Part 4044 

Employee benefit plans, Pension 

insurance, Pensions. 


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