Extension of the Expiration Date for State Disability Examiner Authority To Make Fully Favorable Quick Disability Determinations and Compassionate Allowance Determinations, 73027-73028 [2016-25565]
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Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations
SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA–2016–0014]
RIN 0960–AH94
Extension of the Expiration Date for
State Disability Examiner Authority To
Make Fully Favorable Quick Disability
Determinations and Compassionate
Allowance Determinations
Social Security Administration.
Final rule.
AGENCY:
ACTION:
We are extending, until
December 28, 2018, the expiration date
of our disability examiner authority
(DEA) rule, which authorizes State
agency disability examiners to make
fully favorable determinations without
the approval of a State agency medical
or psychological consultant in claims
that we consider under our quick
disability determination (QDD) and
compassionate allowance (CAL)
processes. This is our last extension of
this rule because we will phase out the
use of DEA during the extension period
under section 832 of the Bipartisan
Budget Act of 2015 (BBA). This
extension provides us the time
necessary to take all of the
administrative actions we need to take
in order to reinstate uniform use of
medical and psychological consultants.
The current rule will expire on
November 11, 2016. In this final rule,
we are changing the November 11, 2016
expiration or ‘‘sunset’’ date to December
28, 2018, extending the authority for 2
years and 1 month. This is the final
extension of our DEA rule. On
December 28, 2018, at the conclusion of
this extension, the authority for this test
will terminate. We are making no other
changes.
DATES: This final rule is effective
October 24, 2016.
FOR FURTHER INFORMATION CONTACT:
Kenneth Williams, Office of Disability
Policy, Social Security Administration,
6401 Security Boulevard, Baltimore, MD
21235–6401, (410) 965–0608, for
information about this notice. For
information on eligibility or filing for
benefits, call our national toll-free
number, 1–800–772–1213 or TTY 1–
800–325–0778, or visit our Internet site,
Social Security Online, at https://
www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
Background of the QDD and CAL
Disability Examiner Authority
On October 13, 2010, we published a
final rule that temporarily authorized
State agency disability examiners to
VerDate Sep<11>2014
14:53 Oct 21, 2016
Jkt 241001
make fully favorable determinations
without the approval of a State agency
medical or psychological consultant in
claims that we consider under our QDD
and CAL processes. 75 FR 62676.
We included in 20 CFR 404.1615(c)(3)
and 416.1015(c)(3) a sunset date, under
which the DEA would expire on
November 12, 2013, unless we decided
to terminate it earlier or extend it by
publication of a final rule in the Federal
Register. Since that time, we have
extended the DEA rule three times for
one year each. 78 FR 66638; 79 FR
51241; 80 FR 63092. The last extension
we published continues the DEA until
November 11, 2016. 80 FR 63092.
Explanation of Provision
This final rule extends the expiration
date of the DEA rule until December 28,
2018. Extending the DEA rule provides
us with the time necessary for an
orderly phase out of the DEA rule, and
will allow us to discontinue the use of
the DEA under section 832 of the
Bipartisan Budget Act of 2015 (BBA).1
At the conclusion of this extension, by
December 28, 2018, the authority for
this test will terminate.
Regulatory Procedures
Justification for Issuing a 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). Generally, the APA
requires that an agency provide prior
notice and opportunity for public
comment before issuing a final rule.
However, 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
final rule. 5 U.S.C. 553(b)(B). Good
cause exists because this final rule only
extends the expiration date of the
existing provisions. It makes no
substantive changes to the current rule.
The current regulations expressly
provide that we may extend or
terminate the current rule. Therefore,
we have determined that opportunity
for prior comment is unnecessary, and
we are issuing this rule as a final rule.
1 Pub. L. 114–74, section 832, 129 Stat. 584, 613.
Section 832 of the BBA amends section 221(h) of
the Social Security Act, 42 U.S.C. 421(h).
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Fmt 4700
Sfmt 4700
73027
In addition, for the reasons cited
above, we find good cause for
dispensing with the 30-day delay in the
effective date of this final rule. 5 U.S.C.
553(d)(3). We are not making any
substantive changes in our current rule,
but are only extending the expiration
date of the rule. For these reasons, we
find it unnecessary to delay the effective
date of our rule.
Executive Order 12866, as
Supplemented by Executive Order
13563
We consulted with the Office of
Management and Budget (OMB) and
determined that this final rule does not
meet the criteria for a significant
regulatory action under Executive Order
12866, as supplemented by Executive
Order 13563. Therefore, OMB did not
review it.
We also determined that this final
rule meets the plain language
requirement of Executive Order 12866.
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
The final rule does not create any new
or affect any existing collections and,
therefore, does 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).
Carolyn W. Colvin,
Acting Commissioner of Social Security.
For the reasons stated in the
preamble, we are amending subpart Q of
part 404 and subpart J of part 416 of title
20 of the Code of Federal Regulations as
set forth below:
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73028
Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations
PART 404—FEDERAL OLD-AGE,
SURVIVORS AND DISABILITY
INSURANCE (1950—)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Subpart Q—[Amended]
21 CFR Part 874
■
1. The authority citation for subpart Q
of part 404 continues to read as follows:
[Docket No. FDA–2016–N–3287]
Authority: Secs. 205(a), 221, and 702(a)(5)
of the Social Security Act (42 U.S.C. 405(a),
421, and 902(a)(5)).
Medical Devices; Ear, Nose, and Throat
Devices; Classification of the
Eustachian Tube Balloon Dilation
System
2. Amend § 404.1615 by revising
paragraph (c)(3) to read as follows:
■
AGENCY:
Food and Drug Administration,
HHS.
§ 404.1615 Making disability
determinations.
ACTION:
*
SUMMARY:
*
*
*
*
(c) * * *
(3) A State agency disability examiner
alone if the claim is adjudicated under
the quick disability determination
process (see § 404.1619) or the
compassionate allowance process (see
§ 404.1602), and the initial or
reconsidered determination is fully
favorable to you. This paragraph (c)(3)
will no longer be effective on December
28, 2018 unless we terminate it earlier
by publication of a final rule in the
Federal Register; or
*
*
*
*
*
PART 416—SUPPLEMENTAL
SECURITY INCOME FOR THE AGED,
BLIND, AND DISABLED
Subpart J—[Amended]
3. The authority citation for subpart J
of part 416 continues to read as follows:
■
Authority: Secs. 702(a)(5), 1614, 1631, and
1633 of the Social Security Act (42 U.S.C.
902(a)(5), 1382c, 1383, and 1383b).
4. Amend § 416.1015 by revising
paragraph (c)(3) to read as follows:
■
§ 416.1015 Making disability
determinations.
jstallworth on DSK7TPTVN1PROD with RULES
*
*
*
*
*
(c) * * *
(3) A State agency disability examiner
alone if you are not a child (a person
who has not attained age 18), and the
claim is adjudicated under the quick
disability determination process (see
§ 416.1019) or the compassionate
allowance process (see § 416.1002), and
the initial or reconsidered
determination is fully favorable to you.
This paragraph (c)(3) will no longer be
effective on December 28, 2018 unless
we terminate it earlier by publication of
a final rule in the Federal Register; or
*
*
*
*
*
[FR Doc. 2016–25565 Filed 10–21–16; 8:45 am]
BILLING CODE 4191–02–P
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14:53 Oct 21, 2016
Jkt 241001
Final order.
The Food and Drug
Administration (FDA) is classifying the
Eustachian tube balloon dilation system
into class II (special controls). The
special controls that will apply to the
device are identified in this order and
will be part of the codified language for
the Eustachian tube balloon dilation
system’s classification. The Agency is
classifying the device into class II
(special controls) in order to provide a
reasonable assurance of safety and
effectiveness of the device.
DATES: This order is effective October
24, 2016. The classification was
applicable on September 16, 2016.
FOR FURTHER INFORMATION CONTACT:
Joyce Lin, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2462, Silver Spring,
MD, 20993–0002, 301–796–5544,
Joyce.Lin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
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Fmt 4700
Sfmt 4700
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA shall classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On December 17, 2015, Acclarent, Inc.
submitted a request for classification of
the ACCLARENT AERATM Eustachian
Tube Balloon Dilation System under
section 513(f)(2) of the FD&C Act.
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
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
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
E:\FR\FM\24OCR1.SGM
24OCR1
Agencies
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73027-73028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25565]
[[Page 73027]]
=======================================================================
-----------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
20 CFR Parts 404 and 416
[Docket No. SSA-2016-0014]
RIN 0960-AH94
Extension of the Expiration Date for State Disability Examiner
Authority To Make Fully Favorable Quick Disability Determinations and
Compassionate Allowance Determinations
AGENCY: Social Security Administration.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are extending, until December 28, 2018, the expiration date
of our disability examiner authority (DEA) rule, which authorizes State
agency disability examiners to make fully favorable determinations
without the approval of a State agency medical or psychological
consultant in claims that we consider under our quick disability
determination (QDD) and compassionate allowance (CAL) processes. This
is our last extension of this rule because we will phase out the use of
DEA during the extension period under section 832 of the Bipartisan
Budget Act of 2015 (BBA). This extension provides us the time necessary
to take all of the administrative actions we need to take in order to
reinstate uniform use of medical and psychological consultants. The
current rule will expire on November 11, 2016. In this final rule, we
are changing the November 11, 2016 expiration or ``sunset'' date to
December 28, 2018, extending the authority for 2 years and 1 month.
This is the final extension of our DEA rule. On December 28, 2018, at
the conclusion of this extension, the authority for this test will
terminate. We are making no other changes.
DATES: This final rule is effective October 24, 2016.
FOR FURTHER INFORMATION CONTACT: Kenneth Williams, Office of Disability
Policy, Social Security Administration, 6401 Security Boulevard,
Baltimore, MD 21235-6401, (410) 965-0608, for information about this
notice. For information on eligibility or filing for benefits, call our
national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or
visit our Internet site, Social Security Online, at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
Background of the QDD and CAL Disability Examiner Authority
On October 13, 2010, we published a final rule that temporarily
authorized State agency disability examiners to make fully favorable
determinations without the approval of a State agency medical or
psychological consultant in claims that we consider under our QDD and
CAL processes. 75 FR 62676.
We included in 20 CFR 404.1615(c)(3) and 416.1015(c)(3) a sunset
date, under which the DEA would expire on November 12, 2013, unless we
decided to terminate it earlier or extend it by publication of a final
rule in the Federal Register. Since that time, we have extended the DEA
rule three times for one year each. 78 FR 66638; 79 FR 51241; 80 FR
63092. The last extension we published continues the DEA until November
11, 2016. 80 FR 63092.
Explanation of Provision
This final rule extends the expiration date of the DEA rule until
December 28, 2018. Extending the DEA rule provides us with the time
necessary for an orderly phase out of the DEA rule, and will allow us
to discontinue the use of the DEA under section 832 of the Bipartisan
Budget Act of 2015 (BBA).\1\ At the conclusion of this extension, by
December 28, 2018, the authority for this test will terminate.
---------------------------------------------------------------------------
\1\ Pub. L. 114-74, section 832, 129 Stat. 584, 613. Section 832
of the BBA amends section 221(h) of the Social Security Act, 42
U.S.C. 421(h).
---------------------------------------------------------------------------
Regulatory Procedures
Justification for Issuing a 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).
Generally, the APA requires that an agency provide prior notice and
opportunity for public comment before issuing a final rule. However,
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 final rule. 5 U.S.C.
553(b)(B). Good cause exists because this final rule only extends the
expiration date of the existing provisions. It makes no substantive
changes to the current rule. The current regulations expressly provide
that we may extend or terminate the current rule. Therefore, we have
determined that opportunity for prior comment is unnecessary, and we
are issuing this rule as a final rule.
In addition, for the reasons cited above, we find good cause for
dispensing with the 30-day delay in the effective date of this final
rule. 5 U.S.C. 553(d)(3). We are not making any substantive changes in
our current rule, but are only extending the expiration date of the
rule. For these reasons, we find it unnecessary to delay the effective
date of our rule.
Executive Order 12866, as Supplemented by Executive Order 13563
We consulted with the Office of Management and Budget (OMB) and
determined that this final rule does not meet the criteria for a
significant regulatory action under Executive Order 12866, as
supplemented by Executive Order 13563. Therefore, OMB did not review
it.
We also determined that this final rule meets the plain language
requirement of Executive Order 12866.
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
The final rule does not create any new or affect any existing
collections and, therefore, does 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).
Carolyn W. Colvin,
Acting Commissioner of Social Security.
For the reasons stated in the preamble, we are amending subpart Q
of part 404 and subpart J of part 416 of title 20 of the Code of
Federal Regulations as set forth below:
[[Page 73028]]
PART 404--FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE
(1950--)
Subpart Q--[Amended]
0
1. The authority citation for subpart Q of part 404 continues to read
as follows:
Authority: Secs. 205(a), 221, and 702(a)(5) of the Social
Security Act (42 U.S.C. 405(a), 421, and 902(a)(5)).
0
2. Amend Sec. 404.1615 by revising paragraph (c)(3) to read as
follows:
Sec. 404.1615 Making disability determinations.
* * * * *
(c) * * *
(3) A State agency disability examiner alone if the claim is
adjudicated under the quick disability determination process (see Sec.
404.1619) or the compassionate allowance process (see Sec. 404.1602),
and the initial or reconsidered determination is fully favorable to
you. This paragraph (c)(3) will no longer be effective on December 28,
2018 unless we terminate it earlier by publication of a final rule in
the Federal Register; or
* * * * *
PART 416--SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND
DISABLED
Subpart J--[Amended]
0
3. The authority citation for subpart J of part 416 continues to read
as follows:
Authority: Secs. 702(a)(5), 1614, 1631, and 1633 of the Social
Security Act (42 U.S.C. 902(a)(5), 1382c, 1383, and 1383b).
0
4. Amend Sec. 416.1015 by revising paragraph (c)(3) to read as
follows:
Sec. 416.1015 Making disability determinations.
* * * * *
(c) * * *
(3) A State agency disability examiner alone if you are not a child
(a person who has not attained age 18), and the claim is adjudicated
under the quick disability determination process (see Sec. 416.1019)
or the compassionate allowance process (see Sec. 416.1002), and the
initial or reconsidered determination is fully favorable to you. This
paragraph (c)(3) will no longer be effective on December 28, 2018
unless we terminate it earlier by publication of a final rule in the
Federal Register; or
* * * * *
[FR Doc. 2016-25565 Filed 10-21-16; 8:45 am]
BILLING CODE 4191-02-P