83 FR 28992 - Extension of Sunset Date for Attorney Advisor Program

SOCIAL SECURITY ADMINISTRATION

Federal Register Volume 83, Issue 121 (June 22, 2018)

Page Range		28992-28994
FR Document		2018-13359

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.

Federal Register, Volume 83 Issue 121 (Friday, June 22, 2018)

[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 28992-28994]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13359]


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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.

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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 toll-free 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

[[Page 28993]]

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.
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    \1\ Our 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).
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    To preserve the maximum degree of flexibility and manage our 
hearings-level 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]

0
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).


0
2. In Sec.  404.942, revise paragraph (g) to read as follows:


Sec.  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]

0
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).

0
4. In Sec.  416.1442, revise paragraph (g) to read as follows:


Sec.  416.1442  Prehearing proceedings and decisions by attorney 
advisors.

* * * * *

[[Page 28994]]

    (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

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

(g) Sunset provision. The provisions by placing the device into a lower Under either procedure for De Novo
of this section will no longer be effective device class than the automatic class III classification, FDA is required to
on August 2, 2019, unless we terminate assignment. classify the device by written order
them earlier or extend them beyond that The automatic assignment of class III within 120 days. The classification will
date by notice of a final rule in the occurs by operation of law and without be according to the criteria under
Federal Register. any action by FDA, regardless of the section 513(a)(1) of the FD&C Act (21
[FR Doc. 2018–13359 Filed 6–21–18; 8:45 am] level of risk posed by the new device. U.S.C. 360c(a)(1)). Although the device
BILLING CODE 4191–02–P
Any device that was not in commercial was automatically within class III, the
distribution before May 28, 1976, is De Novo classification is considered to
automatically classified as, and remains be the initial classification of the device.
within, class III and requires premarket We believe this De Novo classification
DEPARTMENT OF HEALTH AND approval unless and until FDA takes an will enhance patients’ access to
HUMAN SERVICES action to classify or reclassify the device beneficial innovation, in part by
Food and Drug Administration (see 21 U.S.C. 360c(f)(1)). We refer to reducing regulatory burdens. When FDA
these devices as ‘‘postamendments classifies a device into class I or II via
21 CFR Part 866 devices’’ because they were not in the De Novo process, the device can
commercial distribution prior to the serve as a predicate for future devices of
[Docket No. FDA–2018–N–1929] date of enactment of the Medical Device that type, including for 510(k)s (see 21
Amendments of 1976, which amended U.S.C. 360c(f)(2)(B)(i)). As a result, other
Medical Devices; Immunology and the Federal Food, Drug, and Cosmetic device sponsors do not have to submit
Microbiology Devices; Classification of Act (FD&C Act). a De Novo request or PMA in order to
the Next Generation Sequencing FDA may take a variety of actions in market a substantially equivalent device
Based Tumor Profiling Test appropriate circumstances to classify or (see 21 U.S.C. 360c(i), defining
AGENCY: Food and Drug Administration, reclassify a device into class I or II. We ‘‘substantial equivalence’’). Instead,
HHS. may issue an order finding a new device sponsors can use the less-burdensome
to be substantially equivalent under 510(k) process, when necessary, to
ACTION: Final order. section 513(i) of the FD&C Act to a market their device.
SUMMARY: The Food and Drug predicate device that does not require
premarket approval (see 21 U.S.C. II. De Novo Classification
Administration (FDA or we) is
classifying the next generation 360c(i)). We determine whether a new On September 25, 2017, Memorial
sequencing based tumor profiling test device is substantially equivalent to a Sloan-Kettering Cancer Center
into class II (special controls). The predicate by means of the procedures Department of Pathology submitted a
special controls that apply to the device for premarket notification under section request for De Novo classification of the
type are identified in this order and will 510(k) of the FD&C Act and Part 807 (21 MSK–IMPACT (Integrated Mutation
be part of the codified language for the U.S.C. 360(k) & 21 CFR part 807, Profiling of Actionable Cancer Targets).
next generation sequencing based tumor respectively). FDA reviewed the request in order to
profiling test’s classification. We are FDA may also classify a device classify the device under the criteria for
through ‘‘De Novo’’ classification, a classification set forth in section
taking this action because we have
common name for the process 513(a)(1) of the FD&C Act.
determined that classifying the device
authorized under section 513(f)(2) of the We classify devices into class II if
into class II (special controls) will general controls by themselves are
FD&C Act (21 U.S.C. 360c(f)(2)). Section
provide a reasonable assurance of safety insufficient to provide reasonable
207 of the Food and Drug
and effectiveness of the device. We assurance of safety and effectiveness,
Administration Modernization Act of
believe this action will also enhance but there is sufficient information to
1997 established the first procedure for
patients’ access to beneficial innovative establish special controls that, in
De Novo classification (Pub. L. 105–
devices, in part by reducing regulatory combination with the general controls,
115). Section 607 of the Food and Drug
burdens. provide reasonable assurance of the
Administration Safety and Innovation
DATES: This order is effective June 22, Act modified the De Novo application safety and effectiveness of the device for
2018. The classification was applicable process by adding a second procedure its intended use (see 21 U.S.C.
on November 15, 2017. (Pub. L. 112–144). A device sponsor 360c(a)(1)(B)). After review of the
FOR FURTHER INFORMATION CONTACT: may utilize either procedure for De information submitted in the request,
Scott McFarland, Center for Devices and Novo classification. we determined that the device can be
Radiological Health, Food and Drug Under the first procedure, the person classified into class II with the
Administration, 10903 New Hampshire submits a 510(k) for a device that has establishment of special controls. FDA
Ave., Bldg. 66, Rm. 4676, Silver Spring, not previously been classified. After has determined that these special
MD, 20993–0002, 301–796–6217, receiving an order from FDA classifying controls, in addition to the general
Scott.McFarland@fda.hhs.gov. the device into class III under section controls, will provide reasonable
SUPPLEMENTARY INFORMATION: 513(f)(1) of the FD&C Act, the person assurance of the safety and effectiveness
then requests a classification under of the device.
I. Background section 513(f)(2). Therefore, on November 15, 2017,
Upon request, FDA has classified the Under the second procedure, rather FDA issued an order to the requester
next generation sequencing based tumor than first submitting a 510(k) and then classifying the device into class II. FDA
profiling test as class II (special a request for classification, if the person is codifying the classification of the
daltland on DSKBBV9HB2PROD with RULES

controls), which we have determined determines that there is no legally device by adding 21 CFR 866.6080. We
will provide a reasonable assurance of marketed device upon which to base a have named the generic type of device
safety and effectiveness. In addition, we determination of substantial next generation sequencing (NGS) based
believe this action will enhance equivalence, that person requests a tumor profiling test, and it is identified
patients’ access to beneficial innovation, classification under section 513(f)(2) of as a qualitative in vitro diagnostic test
in part by reducing regulatory burdens the FD&C Act. intended for NGS analysis of tissue

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Document Created: 2018-11-06 09:50:06
Document Modified: 2018-11-06 09:50:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This final rule is effective June 22, 2018.
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 toll-free number, 800-772-1213 or TTY 800-325-0778, or visit our internet site, Social Security Online, at http://www.socialsecurity.gov.
FR Citation		83 FR 28992
RIN Number		0960-AI36
CFR Citation		20 CFR 404 20 CFR 416
CFR Associated		Administrative Practice and Procedure; Blind; Disability Benefits; Old-Age; Survivors and Disability Insurance; Reporting and Recordkeeping Requirements; Social Security and Supplemental Security Income (Ssi)