Federal Register / Vol. 76, No. 31 / Tuesday, February 15, 2011 / Rules and Regulations 8649 

quality systems would include 

complaint-handling procedures. FDA’s 

QS requirements are flexible and FDA 

believes that these manufacturers will 

be able to conform their systems to FDA 

requirements with little difficulty or 

cost. Manufacturers are already required 

to report to FDA whenever they learn 

that their device may have caused or 

contributed to a death or serious injury 

to a patient. The costs of complying 

with these requirements will be 

relatively small, but will vary 

depending on the number and nature of 

the devices manufactured and the state 

of the firm’s existing quality system. 

Based on our understanding that the 

industry generally has in place 

measures to ensure quality, we believe 

most firms will be able to adapt their 

systems to meet FDA’s QS and MDR 

regulations for not more than $20,000. 

This cost would not be imposed by this 

final rule; it is an existing burden that 

manufacturers may not have fully 

incurred because of FDA’s exercise of 

enforcement discretion with 

manufacturers of MDDSs. 

Because manufacturers have not been 

required to register and list, we cannot 

be positive all firms have existing 

measures to ensure quality, and we 

cannot rule out the possibility that some 

manufacturers will face greater costs. If 

a manufacturer has no quality system in 

place, we estimate that it would cost 

less than $20,000 to establish a quality 

system plus the annual cost of a fulltime employee to manage such a system. 

Comments to the proposed rule 

estimated the cost of such an employee, 

including benefits, to be $143,000 per 

year. 

F. Premarket Notification 

With the issuance of this final rule 

and the classification of MDDSs into 

class I, a manufacturer of an MDDS 

would not need to comply with the 

PMA requirement that applies to class 

III devices or submit a premarket 

notification. For those MDDSs that 

exceed the limitations on 510(k) 

exemptions found in § 880.9, the 

required premarket notification for an 

MDDS will be far less complex than 

submission of a PMA. The cost of 

preparing and submitting such a 

notification would be several thousand 

dollars. The user fees for a premarket 

notification would be $4,348 for FY 

2011, increasing to $4,717 in 2012. In 

contrast, the cost of submitting a PMA 

can reach $1,000,000, plus user fees of 

an additional $236,298 in FY 2011, 

increasing to $256,384 in FY 2012. 

In summary, this device 

reclassification final rule will 

substantially reduce an existing legal 

burden on the manufacturers of MDDSs. 

The burden of compliance with the 

general controls provisions applicable to 

the manufacturers of all class I devices 

is attributable to statutory requirements 

that already apply but in the past have 

not been enforced for MDDSs. Because 

continued exercise of enforcement 

discretion may not be a viable long-term 

regulatory alternative, this final rule 

reduces the ultimate regulatory burden 

for manufacturers of MDDSs. 

Considering the cost of submitting a 

PMA plus the relevant user fees, the 

reduction could be $1,000,000 per 

device. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because reclassification of the 

affected devices from class III to class I 

will relieve manufacturers of the cost of 

complying with the premarket approval 

requirements of section 515 of the FD&C 

Act (21 U.S.C. 360e), the Agency 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

VII. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VIII. Paperwork Reduction Act of 1995 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

List of Subjects in 21 CFR Part 880 

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 880 is 

amended as follows: 

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES 

■ 1. The authority citation for 21 CFR 

part 880 continues to read as follows: 

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

360j, 371. 

■ 2. Section 880.6310 is added to 

subpart G to read as follows: 

§ 880.6310 Medical device data system. 

(a) Identification. (1) A medical 

device data system (MDDS) is a device 

that is intended to provide one or more 

of the following uses, without 

controlling or altering the functions or 

parameters of any connected medical 

devices: 

(i) The electronic transfer of medical 

device data; 

(ii) The electronic storage of medical 

device data; 

(iii) The electronic conversion of 

medical device data from one format to 

another format in accordance with a 

preset specification; or 

(iv) The electronic display of medical 

device data. 

(2) An MDDS may include software, 

electronic or electrical hardware such as 

a physical communications medium 

(including wireless hardware), modems, 

interfaces, and a communications 

protocol. This identification does not 

include devices intended to be used in 

connection with active patient 

monitoring. 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter, 

subject to the limitations in § 880.9. 

Dated: February 9, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–3321 Filed 2–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4022 

Benefits Payable in Terminated SingleEmployer Plans; Interest Assumptions 

for Paying Benefits 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This final rule amends 

Pension Benefit Guaranty Corporation’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans to 

prescribe interest assumptions under 

the regulation for valuation dates in 

March 2011. Interest assumptions are 

also published on PBGC’s Web site 

(http://www.pbgc.gov). 

DATES: Effective March 1, 2011. 


jdjones on DSK8KYBLC1PROD with RULES
8650 Federal Register / Vol. 76, No. 31 / Tuesday, February 15, 2011 / Rules and Regulations 

1Appendix B to PBGC’s regulation on Allocation 

of Assets in Single-Employer Plans (29 CFR part 

4044) prescribes interest assumptions for valuing 

benefits under terminating covered single-employer 

plans for purposes of allocation of assets under 

ERISA section 4044. Those assumptions are 

updated quarterly. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion, 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: PBGC’s 

regulation on Benefits Payable in 

Terminated Single-Employer Plans (29 

CFR part 4022) prescribes actuarial 

assumptions—including interest 

assumptions—for paying plan benefits 

under terminating single-employer 

plans covered by title IV of the 

Employee Retirement Income Security 

Act of 1974. 

PBGC uses the interest assumptions in 

Appendix B to Part 4022 to determine 

whether a benefit is payable as a lump 

sum and to determine the amount to 

pay. Appendix C to Part 4022 contains 

interest assumptions for private-sector 

pension practitioners to refer to if they 

wish to use lump-sum interest rates 

determined using PBGC’s historical 

methodology. Currently, the rates in 

Appendices B and C of the benefit 

payment regulation are the same. 

The interest assumptions are intended 

to reflect current conditions in the 

financial and annuity markets. 

Assumptions under the benefit 

payments regulation are updated 

monthly. This final rule updates the 

benefit payments interest assumptions 

for March 2011.1

The March 2011 interest assumptions 

under the benefit payments regulation 

will be 2.50 percent for the period 

during which a benefit is in pay status 

and 4.00 percent during any years 

preceding the benefit’s placement in pay 

status. In comparison with the interest 

assumptions in effect for February 2011, 

these interest assumptions are 

unchanged. 

PBGC has determined that notice and 

public comment on this amendment are 

impracticable and contrary to the public 

interest. This finding is based on the 

need to determine and issue new 

interest assumptions promptly so that 

the assumptions can reflect current 

market conditions as accurately as 

possible. 

Because of the need to provide 

immediate guidance for the payment of 

benefits under plans with valuation 

dates during March 2011, PBGC finds 

that good cause exists for making the 

assumptions set forth in this 

amendment effective less than 30 days 

after publication. 

PBGC has determined that this action 

is not a ‘‘significant regulatory action’’ 

under the criteria set forth in Executive 

Order 12866. 

Because no general notice of proposed 

rulemaking is required for this 

amendment, the Regulatory Flexibility 

Act of 1980 does not apply. See 5 U.S.C. 

601(2). 

List of Subjects in 29 CFR Part 4022 

Employee benefit plans, Pension 

insurance, Pensions, Reporting and 

recordkeeping requirements. 

In consideration of the foregoing, 29 

CFR part 4022 is amended as follows: 

PART 4022—BENEFITS PAYABLE IN 

TERMINATED SINGLE-EMPLOYER 

PLANS 

■ 1. The authority citation for part 4022 

continues to read as follows: 

Authority: 29 U.S.C. 1302, 1322, 1322b, 

1341(c)(3)(D), and 1344. 

■ 2. In appendix B to part 4022, Rate Set 

209, as set forth below, is added to the 

table. 

Appendix B to Part 4022—Lump Sum 

Interest Rates for PBGC Payments 

* * * * * 

Rate set 

For plans with a 

valuation date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

209 3–1–11 4–1–11 2.50 4.00 4.00 4.00 7 8 

■ 3. In appendix C to part 4022, Rate Set 

209, as set forth below, is added to the 

table. 

Appendix C to Part 4022—Lump Sum 

Interest Rates for Private-Sector 

Payments 

* * * * * 

Rate set 

For plans with a 

valuation date Immediate 

annuity rate 

(percent) 

Deferred annuities 

(percent) 

On or after Before i1 i2 i3 n1 n2

*******

209 3–1–11 4–1–11 2.50 4.00 4.00 4.00 7 8 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 31 / Tuesday, February 15, 2011 / Rules and Regulations 8651 

Issued in Washington, DC, on this 8th day 

of February 2011. 

Vincent K. Snowbarger, 

Deputy Director for Operations, Pension 

Benefit Guaranty Corporation. 

[FR Doc. 2011–3403 Filed 2–14–11; 8:45 am] 

BILLING CODE 7709–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2010–1093] 

RIN 1625–AA08 

Special Local Regulation; Mavericks 

Surf Competition, Half Moon Bay, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary special local 

regulation on certain navigable waters of 

Half Moon Bay in support of the 

Mavericks Surf Competition. This 

special local regulation is necessary to 

ensure the safety of participants and 

spectators during the event. Entry into 

this zone is prohibited unless 

authorized by the Captain of the Port 

San Francisco, CA. 

DATES: This rule is effective from 

February 15, 2011 through February 28, 

2011. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2010– 

1093 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–1093 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 temporary 

rule, call Lieutenant Junior Grade Liezl 

Nicholas at (415) 399–7436, or 

e-mail D11-PF-MarineEvents@uscg.mil. 

If you have questions on viewing the 

docket, call Renee V. Wright, Program 

Manager, Docket Operations, telephone 

(202)366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because 

immediate action is needed to provide 

for the safety of life and property on 

navigable waters. Because of the dangers 

posed by the surf conditions during the 

Mavericks Surf Competition, the special 

local regulation is necessary to provide 

for the safety of event participants, 

spectators, spectator craft, and other 

vessels transiting the event area. For the 

safety concerns noted, it is in the public 

interest to have these regulations in 

effect during the event. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Any delay in the effective date 

of this rule would expose mariners to 

the dangers posed by the surf conditions 

during the Mavericks Surf Competition. 

Basis and Purpose 

The Mavericks Surf Competition is a 

one day ‘‘Big Wave’’ surfing competition 

consisting of the top 24 big wave surfers 

and only occurs when 15–20 foot waves 

are sustained for over 24 hours and are 

combined with mild easterly winds of 

no more than 5–10 knots. Because 

weather conditions are integral to the 

occurrence of the Maverick Surf 

Competition, the exact date of the event 

cannot be determined in advance. The 

rock and reef ridges that make up the 

sea floor of the Pillar Point area 

combined with just the right weather 

conditions create the large waves that 

Mavericks is known for. Due to the 

treacherous terrain and un-navigable 

areas surrounding Pillar Point, the Coast 

Guard is establishing a special local 

regulation within a 1,000 yard radius of 

Pillar Point that restricts navigation near 

the surf competition area and 

neighboring treacherous terrain and 

identifies the safest area for spectator 

viewing on the water. 

Discussion of Rule 

The Coast Guard is establishing a 

special local regulation within a 1,000 

yard radius of Pillar Point in Half Moon 

Bay. The Mavericks Surf Competition 

will occur in the vicinity of Pillar Point 

in the navigable waters of Half Moon 

Bay, and the spectator viewing area will 

be located inside the following 

coordinates: 37°29.265′ N 122°30.165′ 

W, 37°29.248′ N 122°29.978′ W, and 

37°29.406′ N 122°30.081′ W (NAD 83). 

Competitors, participating agencies 

(Coast Guard, San Mateo Police Marine 

Patrol, Pillar Point Harbor Patrol, San 

Mateo Fire Marine Patrol) and the 

public (to include but not restricted to: 

Commercial sightseeing vessels, 

photographer platforms and recreational 

boaters) will be given 48 hours notice 

prior to the start of the one day 

competition. This action is necessary to 

ensure the safety of participants and 

spectators during the event. During the 

enforcement period, unauthorized 

persons (persons not classified as 

spectators, participants or participating 

agencies) or vessels are prohibited from 

transiting through, anchoring, blocking, 

or loitering in the regulated area without 

permission of the Captain of the Port 

(COTP) or their designated 

representative. 

The effect of the temporary special 

local regulation will be to regulate 

navigation in the vicinity of Pillar Point 

while the Mavericks Surf Competition is 

taking place. Except for persons or 

vessels authorized by the Coast Guard 

Patrol Commander (persons classified as 

spectators, participants or participating 

agencies), no person or vessel may 

transit within the bounds of the 

regulated area. These regulations are 

needed to keep spectators and vessels a 

safe distance away from the event 

participants and the un-navigable 

waters surrounding Pillar Point and to 

ensure the safety of participants, 

spectators, and transiting vessels. 

The Coast Guard will enforce the 

temporary special local regulation from 

8 a.m. to 3 p.m. on a date to be 

determined. Notification of the 

enforcement of the special local 

regulation will be provided to the public 

via broadcast notice to mariners, as well 

as through advertising on local media. 

Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on 13 of these statutes or 

executive orders. 

Regulatory Planning and Review 

This rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 


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