7454 Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 

the frequency and severity of alopecia 

during chemotherapy in which 

alopecia-inducing chemotherapeutic 

agents are used. 

(b) Classification—Class II (special 

controls). The special controls for this 

device are: 

(1) Non-clinical performance testing 

must demonstrate that the device meets 

all design specifications and 

performance requirements, and that the 

device performs as intended under 

anticipated conditions of use. This 

information must include testing to 

demonstrate accuracy of the 

temperature control mechanism. 

(2) Performance testing must 

demonstrate the electromagnetic 

compatibility and electrical safety of the 

device. 

(3) Software verification, validation, 

and hazard analysis must be performed. 

(4) The patient contacting 

components of the device must be 

demonstrated to be biocompatible. 

Material names must be provided. 

(5) Labeling must include the 

following: 

(i) A statement describing the 

potential risk of developing scalp 

metastasis. 

(ii) Information on the patient 

population and chemotherapeutic 

agents/regimen for which the device has 

been demonstrated to be effective. 

(iii) A summary of the non-clinical 

and/or clinical testing pertinent to use 

of the device. 

(iv) A summary of the device 

technical parameters, including 

temperature cooling range and duration 

of cooling. 

(v) A summary of the device- and 

procedure-related adverse events 

pertinent to use of the device. 

(vi) Information on how the device 

operates and the typical course of 

treatment. 

(6) Patient labeling must be provided 

and must include: 

(i) Relevant contraindications, 

warnings, precautions, and adverse 

effects/complications. 

(ii) Information on how the device 

operates and the typical course of 

treatment. 

(iii) Information on the patient 

population for which there is clinical 

evidence of effectiveness. 

(iv) The potential risks and benefits 

associated with use of the device. 

(v) Postoperative care instructions. 

(vi) A statement describing the 

potential risk of developing scalp 

metastasis. 

Dated: February 8, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02878 Filed 2–11–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Part 41 

[Public Notice: 9439] 

RIN 1400–AD17 

Visas: Documentation of 

Nonimmigrants Under the Immigration 

and Nationality Act, as Amended 

AGENCY: Department of State. 

ACTION: Interim final rule; correction. 

SUMMARY: The Department of State 

published a Federal Register interim 

final rule on February 4, 2016, in 

Volume 81, No. 23, page 5906. The 

document contains an error in the 

Regulatory Findings. This document 

corrects the rule by replacing the text, 

‘‘included elsewhere in this edition of 

the Federal Register’’ with ‘‘published 

in the Federal Register on February 8, 

2016, 81 FR 6430.’’ There is also a 

correction in the ADDRESSES section, to 

provide the correct public notice 

number to find the rule to submit 

comments on www.regulations.gov. 

DATES: This correction is effective on 

February 19, 2016. Written comments 

must be received on or before April 4, 

2016. 

FOR FURTHER INFORMATION CONTACT: 

Paul-Anthony L. Magadia, U.S. 

Department of State, Visa Services, 

Legislation and Regulations Division, 

Washington, DC 20006, 202–485–7641; 

email: magadiapl@state.gov. 

SUPPLEMENTARY INFORMATION: The 

Department of State published an 

interim final rule on February 4, 2016 

(81 FR 5906); this document corrects 

text in the ADDRESSES section and in the 

discussion of Executive Order 12866. 

Correction 

In the FR Doc 2016–02191, appearing 

on page 5906 in the Federal Register of 

February 4, 2016 (81 FR 5906): 

1. In the second column of page 5906, 

third item under ADDRESSES, the term 

‘‘XXXX’’ is corrected to read ‘‘9428.’’ 

2. In the third column of page 5907, 

the first sentence of the discussion 

regarding ‘‘Executive Order 12866: 

Regulatory Review’’ is corrected to read: 

‘‘The costs of this rulemaking are 

discussed in the companion DHS rule, 

RIN 1651–AB09, published in the 

Federal Register on February 8, 2016, 

81 FR 6430.’’ 

Dated: February 9, 2016. 

David S. Newman, 

Director of Legal Affairs, Visa Services, 

Bureau of Consular Affairs, U.S. Department 

of State. 

[FR Doc. 2016–02962 Filed 2–11–16; 8:45 am] 

BILLING CODE 4710–06–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 the 

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 2016. The interest assumptions 

are used for paying benefits under 

terminating single-employer plans 

covered by the pension insurance 

system administered by PBGC. 

DATES: Effective March 1, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Catherine B. Klion (Klion.Catherine@

pbgc.gov), Assistant General Counsel for 

Regulatory Affairs, 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. The interest assumptions in 

the regulation are also published on 

PBGC’s Web site (http://www.pbgc.gov). 

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. 


srobinson on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Rules and Regulations 7455 

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. 

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 2016.1

The March 2016 interest assumptions 

under the benefit payments regulation 

will be 1.25 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 2016, 

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 2016, 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, add 

Rate Set 269 to the table to read as 

follows: 

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

*******

269 ........................ 3–1–16 4–1–16 1.25 4.00 4.00 4.00 7 8 

■ 3. In appendix C to part 4022, add 

Rate Set 269 to the table to read as 

follows: 

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

*******

269 ........................ 3–1–16 4–1–16 1.25 4.00 4.00 4.00 7 8 

Issued in Washington, DC, on this 4th day 

of February 2016. 

Judith Starr, 

General Counsel, Pension Benefit Guaranty 

Corporation. 

[FR Doc. 2016–02810 Filed 2–11–16; 8:45 am] 

BILLING CODE 7709–02–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 721 

[EPA–HQ–OPPT–2013–0399; FRL–9941–56] 

RIN 2070–AB27 

Significant New Use Rule on Certain 

Chemical Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is finalizing significant 

new use rules (SNURs) under the Toxic 

Substances Control Act (TSCA) for three 

chemical substances that were the 

subject of premanufacture notices 

(PMNs). This action requires persons 

who intend to manufacture (including 

import) or process any of the chemical 

substances for an activity that is 

designated as a significant new use by 

this rule to notify EPA at least 90 days 

before commencing that activity. The 

required notification would provide 

EPA with the opportunity to evaluate 

the intended use and, if necessary, to 

prohibit or limit the activity before it 

occurs. 

DATES: This final rule is effective April 

12, 2016. 


srobinson on DSK5SPTVN1PROD with RULES