28992 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

4.3.5 of the toy standard must comply 

with the third party testing 

requirements of section 14(a)(2) of the 

CPSA, unless listed in 16 CFR 1251.2. 

(c) Section 108(a) of the CPSIA 

permanently prohibits any children’s 

toy or child care article that contains 

concentrations of more than 0.1 percent 

of di-(2-ethylhexyl) phthalate (DEHP), 

dibutyl phthalate (DBP), or benzyl butyl 

phthalate (BBP). In accordance with 

section 108(b)(3) of the CPSIA, 16 CFR 

part 1307 prohibits any children’s toy or 

child care article that contains 

concentrations of more than 0.1 percent 

of diisononyl phthalate (DINP), 

diisobutyl phthalate (DIBP), di-n-pentyl 

phthalate (DPENP), di-n-hexyl phthalate 

(DHEXP), or dicyclohexyl phthalate 

(DCHP). Materials used in children’s 

toys and child care articles subject to 

section 108(a) of the CPSIA and 16 CFR 

part 1307 must comply with the third 

party testing requirements of section 

14(a)(2) of the CPSA, unless listed in 16 

CFR 1308.2. 

§ 1252.2 Definitions. 

In addition to the definitions given in 

sections 101, 106, and 108 of the CPSIA, 

the following definitions apply for this 

part 1252. 

Post-consumer wood waste describes 

wood waste that is comprised of 

materials that are recovered from their 

original use and subsequently used in a 

new product. Examples of this type of 

waste include recycled demolition 

wood, packaging materials such as 

pallets and crates, used wood from 

landscape care (i.e., from urban and 

highway trees, hedges, and gardens), 

discarded furniture, and waste wood 

from industrial, construction, and 

commercial activities. 

Pre-consumer wood waste describes 

wood materials that have been recycled 

from an industrial process before being 

made available for consumer use. 

Examples of this type of waste include 

trimmings from engineered wood 

product (EWP) panel manufacturing, 

sawdust from cutting logs, or remaining 

wood pieces from sawing a log into 

framing lumber. 

Unfinished means an EWP that does 

not have any surface treatments applied 

at manufacture, such as factory-applied 

coatings. Examples of such treatments 

may include paint or similar surface 

coating materials, wood glue, or metal 

fasteners, such as nails or screws. 

Untreated means an EWP that does 

not have any additional finishes applied 

at manufacture. Examples of such 

finishes may include flame retardants or 

rot resistant finishes. 

Virgin wood describes wood logs, 

fibers, chips, or layers that have not 

been recycled from a previous use. 

§ 1252.3 Determinations for engineered 

wood products. 

(a) The following engineered wood 

products do not exceed the lead content 

limits with a high degree of assurance 

as that term is defined in 16 CFR part 

1107: 

(1) Particleboard that is untreated and 

unfinished made from virgin wood or 

pre-consumer wood waste; 

(2) Hardwood plywood that is 

untreated and unfinished made from 

virgin wood or pre-consumer wood 

waste; and 

(3) Medium-density fiberboard that is 

untreated and unfinished made from 

virgin wood or pre-consumer wood 

waste. 

(b) The following engineered wood 

products do not exceed the ASTM F963 

elements solubility limits set forth in 16 

CFR part 1250 with a high degree of 

assurance as that term is defined in 16 

CFR part 1107: 

(1) Particleboard that is untreated and 

unfinished made from virgin wood or 

pre-consumer wood waste; 

(2) Hardwood plywood that is 

untreated and unfinished made from 

virgin wood or pre-consumer wood 

waste; and 

(3) Medium-density fiberboard that is 

untreated and unfinished made from 

virgin wood or pre-consumer wood 

waste. 

(c) The following engineered wood 

products do not exceed the phthalates 

content limits with a high degree of 

assurance as that term is defined in 16 

CFR part 1107: 

(1) Particleboard that is untreated and 

unfinished made from virgin wood or 

pre-consumer wood waste; 

(2) Hardwood plywood that is 

untreated and unfinished made from 

virgin wood or pre-consumer wood 

waste and does not contain polyvinyl 

acetate (PVAc) adhesive formulations; 

and 

(3) Medium-density fiberboard that is 

untreated and unfinished made from 

virgin wood or pre-consumer wood 

waste. 

(d) Accessible component parts of 

children’s products, children’s toys, and 

child care articles made with EWPs, 

listed in paragraphs (a) through (c) of 

this section are not required to be third 

party tested pursuant to section 14(a)(2) 

of the CPSA and 16 CFR part 1107. 

(e) Accessible component parts of 

children’s products, children’s toys, and 

child care articles made with engineered 

wood products not listed in paragraphs 

(a) through (c) of this section, or that 

contain post-consumer wood waste, are 

required to be third party tested 

pursuant to section 14(a)(2) of the CPSA 

and 16 CFR part 1107 and sections 101, 

106, or 108 of the CPSIA, as applicable. 

Alberta E. Mills, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2018–13392 Filed 6–21–18; 8:45 am] 

BILLING CODE 6355–01–P 

SOCIAL SECURITY ADMINISTRATION 

20 CFR Parts 404 and 416 

[Docket No. SSA–2018–0021] 

RIN 0960–AI36 

Extension of Sunset Date for Attorney 

Advisor Program 

AGENCY: Social Security Administration. 

ACTION: Final rule. 

SUMMARY: We are extending for one year 

our rule authorizing attorney advisors to 

conduct certain prehearing proceedings 

and to issue fully favorable decisions. 

The current rule is scheduled to expire 

on August 3, 2018. In this final rule, we 

are extending the sunset date to August 

2, 2019. We are making no other 

substantive changes. 

DATES: This final rule is effective June 

22, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Susan Swansiger, Office of Hearings 

Operations, Social Security 

Administration, 5107 Leesburg Pike, 

Falls Church, VA 22041, (703) 605– 

8500. For information on eligibility or 

filing for benefits, call our national tollfree number, 800–772–1213 or TTY 

800–325–0778, or visit our internet site, 

Social Security Online, at http://

www.socialsecurity.gov. 

SUPPLEMENTARY INFORMATION: 

Background of the Attorney Advisor 

Program 

On August 9, 2007, we issued an 

interim final rule permitting some 

attorney advisors to conduct certain 

prehearing proceedings and issue fully 

favorable decisions when the 

documentary record warrants doing so. 

72 FR 44763. We instituted this practice 

to provide more timely service to the 

increasing number of applicants for 

Social Security disability benefits and 

Supplemental Security Income 

payments based on disability. We 

considered the public comments we 

received on the interim final rule, and 

on March 3, 2008, we issued a final rule 

without change. 73 FR 11349. Under 

this rule, some attorney advisors may 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 28993 

1Our budget estimates indicate that we expect to 

receive approximately 582,000 hearing requests in 

fiscal year 2018 and 578,000 in fiscal year 2019 

(available at: https://www.ssa.gov/budget/ 

FY19Files/2019CJ.pdf). 

develop claims and, in appropriate 

cases, issue fully favorable decisions 

before a hearing. 

We originally intended the attorney 

advisor program to be a temporary 

modification to our procedures. 

Therefore, we included in sections 

404.942(g) and 416.1442(g) of the 

interim final rule a provision that the 

program would end on August 10, 2009, 

unless we decided to either terminate 

the rule earlier or extend it beyond that 

date by publication of a final rule in the 

Federal Register. Since that time, we 

have periodically extended the sunset 

date (see 74 FR 33327 extending to 

August 10, 2011; 76 FR 18383 extending 

to August 9, 2013; 78 FR 45459 

extending to August 7, 2015; 80 FR 

31990 extending to August 4, 2017; and 

82 FR 34400 extending to February 5, 

2018). As we noted above, the current 

sunset date for the program is August 3, 

2018. 83 FR 711. 

Explanation of Extension 

We published the final rule to adopt 

without change the interim final rule 

that we published on August 9, 2007. 

We stated our intent to monitor the 

program closely and to modify it if it 

did not meet our expectations. 73 FR 

11349. 

We explained in the 2008 final rule 

that the number of requests for hearings 

had increased significantly in recent 

years. From 2008 to the present, the 

number of pending hearing requests has 

continued to remain at a high level, and 

we anticipate that we will receive 

several hundred thousand hearing 

requests in fiscal year 2018 and in fiscal 

year 2019.1 We are extending the 

program at this time while we continue 

to consider our options with respect to 

the program. 

To preserve the maximum degree of 

flexibility and manage our hearingslevel workloads effectively, we have 

decided to extend the attorney advisor 

rule until August 2, 2019. As before, we 

reserve the authority to end the program 

earlier, to extend it by publishing a final 

rule in the Federal Register, or to 

discontinue it altogether. 

Regulatory Procedures 

Justification for Issuing Final Rule 

Without Notice and Comment 

We follow the Administrative 

Procedure Act (APA) rulemaking 

procedures specified in 5 U.S.C. 553 

when developing regulations. Section 

702(a)(5) of the Social Security Act, 42 

U.S.C. 902(a)(5). The APA provides 

exceptions to its notice and public 

comment procedures when an agency 

finds there is good cause for dispensing 

with such procedures because they are 

impracticable, unnecessary, or contrary 

to the public interest. We have 

determined that good cause exists for 

dispensing with the notice and public 

comment procedures for this rule. 5 

U.S.C. 553(b)(B). Good cause exists 

because this final rule only extends the 

expiration date of an existing rule. It 

makes no substantive changes to the 

rule. The current regulations expressly 

provide that we may extend or 

terminate this rule. Therefore, we have 

determined that opportunity for prior 

comment is unnecessary, and we are 

issuing this rule as a final rule. 

In addition, because we are not 

making any substantive changes to the 

existing rule, we find that there is good 

cause for dispensing with the 30-day 

delay in the effective date of a 

substantive rule provided by 5 U.S.C. 

553(d)(3). To ensure that we have 

uninterrupted authority to use attorney 

advisors to address the number of 

pending cases at the hearing level, we 

find that it is in the public interest to 

make this final rule effective on the date 

of publication. 

Executive Order 12866 as 

Supplemented by Executive Order 

13563 

We consulted with the Office of 

Management and Budget (OMB) and 

although we do not believe that this will 

be a significant regulatory action under 

Executive Order (E.O.) 12866, as 

supplemented by E.O. 13563, OMB has 

reviewed this final rule. 

Regulatory Flexibility Act 

We certify that this final rule will not 

have a significant economic impact on 

a substantial number of small entities 

because it affects individuals only. 

Therefore, the Regulatory Flexibility 

Act, as amended, does not require us to 

prepare a regulatory flexibility analysis. 

Paperwork Reduction Act 

These rules do not create any new or 

affect any existing collections and, 

therefore, do not require Office of 

Management and Budget approval 

under the Paperwork Reduction Act. 

(Catalog of Federal Domestic Assistance 

Program Nos. 96.001, Social Security— 

Disability Insurance; 96.002, Social 

Security—Retirement Insurance; 96.004, 

Social Security—Survivors Insurance; 

96.006, Supplemental Security Income.) 

List of Subjects 

20 CFR Part 404 

Administrative practice and 

procedure, Blind, Disability benefits, 

Old-age, Survivors and Disability 

Insurance, Reporting and recordkeeping 

requirements, Social security. 

20 CFR Part 416 

Administrative practice and 

procedure, Reporting and recordkeeping 

requirements, Supplemental Security 

Income (SSI). 

Nancy A. Berryhill, 

Acting Commissioner of Social Security. 

For the reasons stated in the 

preamble, we are amending subpart J of 

part 404 and subpart N of part 416 of 

Chapter III of title 20 of the Code of 

Federal Regulations as set forth below: 

PART 404—FEDERAL OLD-AGE, 

SURVIVORS AND DISABILITY 

INSURANCE (1950– ) 

Subpart J—[Amended] 

■ 1. The authority citation for subpart J 

of part 404 continues to read as follows: 

Authority: Secs. 201(j), 204(f), 205(a)–(b), 

(d)–(h), and (j), 221, 223(i), 225, and 702(a)(5) 

of the Social Security Act (42 U.S.C. 401(j), 

404(f), 405(a)–(b), (d)–(h), and (j), 421, 423(i), 

425, and 902(a)(5)); sec. 5, Pub. L. 97–455, 96 

Stat. 2500 (42 U.S.C. 405 note); secs. 5, 6(c)– 

(e), and 15, Pub. L. 98–460, 98 Stat. 1802 (42 

U.S.C. 421 note); sec. 202, Pub. L. 108–203, 

118 Stat. 509 (42 U.S.C. 902 note). 

■ 2. In § 404.942, revise paragraph (g) to 

read as follows: 

§ 404.942 Prehearing proceedings and 

decisions by attorney advisors. 

* * * * * 

(g) Sunset provision. The provisions 

of this section will no longer be effective 

on August 2, 2019, unless we terminate 

them earlier or extend them beyond that 

date by notice of a final rule in the 

Federal Register. 

PART 416—SUPPLEMENTAL 

SECURITY INCOME FOR THE AGED, 

BLIND, AND DISABLED 

Subpart N—[Amended] 

■ 3. The authority citation for subpart N 

continues to read as follows: 

Authority: Secs. 702(a)(5), 1631, and 1633 

of the Social Security Act (42 U.S.C. 

902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 

108–203, 118 Stat. 509 (42 U.S.C. 902 note). 

■ 4. In § 416.1442, revise paragraph (g) 

to read as follows: 

§ 416.1442 Prehearing proceedings and 

decisions by attorney advisors. 

* * * * * 


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28994 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

(g) Sunset provision. The provisions 

of this section will no longer be effective 

on August 2, 2019, unless we terminate 

them earlier or extend them beyond that 

date by notice of a final rule in the 

Federal Register. 

[FR Doc. 2018–13359 Filed 6–21–18; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2018–N–1929] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Next Generation Sequencing 

Based Tumor Profiling Test 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the next generation 

sequencing based tumor profiling test 

into class II (special controls). The 

special controls that apply to the device 

type are identified in this order and will 

be part of the codified language for the 

next generation sequencing based tumor 

profiling test’s classification. We are 

taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices, in part by reducing regulatory 

burdens. 

DATES: This order is effective June 22, 

2018. The classification was applicable 

on November 15, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Scott McFarland, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4676, Silver Spring, 

MD, 20993–0002, 301–796–6217, 

Scott.McFarland@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

next generation sequencing based tumor 

profiling test as class II (special 

controls), which we have determined 

will provide a reasonable assurance of 

safety and effectiveness. In addition, we 

believe this action will enhance 

patients’ access to beneficial innovation, 

in part by reducing regulatory burdens 

by placing the device into a lower 

device class than the automatic class III 

assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

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

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and Part 807 (21 

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

respectively). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act (21 U.S.C. 360c(f)(2)). Section 

207 of the Food and Drug 

Administration Modernization Act of 

1997 established the first procedure for 

De Novo classification (Pub. L. 105– 

115). Section 607 of the Food and Drug 

Administration Safety and Innovation 

Act modified the De Novo application 

process by adding a second procedure 

(Pub. L. 112–144). A device sponsor 

may utilize either procedure for De 

Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act (21 

U.S.C. 360c(a)(1)). Although the device 

was automatically within class III, the 

De Novo classification is considered to 

be the initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 21 

U.S.C. 360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or PMA in order to 

market a substantially equivalent device 

(see 21 U.S.C. 360c(i), defining 

‘‘substantial equivalence’’). Instead, 

sponsors can use the less-burdensome 

510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On September 25, 2017, Memorial 

Sloan-Kettering Cancer Center 

Department of Pathology submitted a 

request for De Novo classification of the 

MSK–IMPACT (Integrated Mutation 

Profiling of Actionable Cancer Targets). 

FDA reviewed the request in order to 

classify the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify 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 that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on November 15, 2017, 

FDA issued an order to the requester 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 866.6080. We 

have named the generic type of device 

next generation sequencing (NGS) based 

tumor profiling test, and it is identified 

as a qualitative in vitro diagnostic test 

intended for NGS analysis of tissue 


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