83_FR_13925 83 FR 13862 - Extension of Expiration Dates for Two Body System Listings

83 FR 13862 - Extension of Expiration Dates for Two Body System Listings

SOCIAL SECURITY ADMINISTRATION

Federal Register Volume 83, Issue 63 (April 2, 2018)

Page Range13862-13863
FR Document2018-06671

We are extending the expiration dates of the following body systems in the Listing of Impairments (listings) in our regulations: Special Senses and Speech and Congenital Disorders That Affect Multiple Body Systems. We are making no other revisions to these body systems in this final rule. This extension ensures that we will continue to have the criteria we need to evaluate impairments in the affected body systems at step three of the sequential evaluation processes for initial claims and continuing disability reviews.

Federal Register, Volume 83 Issue 63 (Monday, April 2, 2018)
[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Pages 13862-13863]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06671]


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SOCIAL SECURITY ADMINISTRATION

20 CFR Part 404

[Docket No. SSA-2018-0007]
RIN 0960-AI18


Extension of Expiration Dates for Two Body System Listings

AGENCY: Social Security Administration.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are extending the expiration dates of the following body 
systems in the Listing of Impairments (listings) in our regulations: 
Special Senses and Speech and Congenital Disorders That Affect Multiple 
Body Systems. We are making no other revisions to these body systems in 
this final rule. This extension ensures that we will continue to have 
the criteria we need to evaluate impairments in the affected body 
systems at step three of the sequential evaluation processes for 
initial claims and continuing disability reviews.

DATES: This final rule is effective on April 2, 2018.

FOR FURTHER INFORMATION CONTACT: Cheryl A. Williams, Director, Office 
of Medical Policy, 6401 Security Boulevard, Baltimore, MD 21235-6401, 
(410) 965-1020. 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 http://www.socialsecurity.gov.

SUPPLEMENTARY INFORMATION:

Background

    We use the listings in appendix 1 to subpart P of part 404 of 20 
CFR at the third step of the sequential evaluation process to evaluate 
claims filed by adults and children for benefits based on disability 
under the title II and title XVI programs.\1\ 20 CFR 404.1520(d), 
416.920(d), 416.924(d). The listings are in two parts: Part A has 
listings criteria for adults and Part B has listings criteria for 
children. If you are age 18 or over, we apply the listings criteria in 
Part A when we assess your impairment or combination of impairments. If 
you are under age 18, we first use the criteria in Part B of the 
listings when we assess your impairment(s). If the criteria in Part B 
do not apply, we may use the criteria in Part A when those criteria 
consider the effects of your impairment(s). 20 CFR 404.1525(b), 
416.925(b).
---------------------------------------------------------------------------

    \1\ We also use the listings in the sequential evaluation 
processes we use to determine whether a beneficiary's disability 
continues. See 20 CFR 404.1594, 416.994, and 416.994a.
---------------------------------------------------------------------------

Explanation of Changes

    In this final rule, we are extending the dates on which the 
listings for the following two body systems will no longer be effective 
as set out in the following chart:

------------------------------------------------------------------------
                                  Current expiration       Extended
             Listing                     date           expiration date
------------------------------------------------------------------------
Special Senses and Speech (2.00   April 29, 2018....  April 24, 2020.
 and 102.00).
Congenital Disorders That Affect  April 5, 2018.....  April 3, 2020.
 Multiple Body Systems (10.00
 and 110.00).
------------------------------------------------------------------------

    We continue to revise and update the listings on a regular basis, 
including those body systems not affected by this final rule.\2\ We 
intend to update the two listings affected by this final rule as 
quickly as possible, but may not be able to publish final rules 
revising these listings by the current expiration dates. Therefore, we 
are extending the expiration dates listed above.
---------------------------------------------------------------------------

    \2\ Since we last extended the expiration dates of the listings 
affected by this rule in August 2016 (81 FR 51100), we have 
published final rules revising the medical criteria for evaluating 
mental disorders (81 FR 66137 (2016)) and human immunodeficiency 
virus (HIV infection (81 FR 86915 (2016)).
---------------------------------------------------------------------------

Regulatory Procedures

Justification for Final Rule

    We follow the Administrative Procedure Act (APA) rulemaking 
procedures specified in 5 U.S.C. 553 in promulgating 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 regulation. The 
APA provides exceptions to the notice-and-comment requirements 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. 5 U.S.C. 553(b)(B). This final 
rule only extends the date on which two body system listings will no 
longer be effective. It makes no substantive changes to our rules. Our 
current regulations \3\ provide that we may extend, revise, or

[[Page 13863]]

promulgate the body system listings again. Therefore, we have 
determined that opportunity for prior comment is unnecessary, and we 
are issuing this regulation as a final rule.
---------------------------------------------------------------------------

    \3\ See the first sentence of appendix 1 to subpart P of part 
404 of 20 CFR.
---------------------------------------------------------------------------

    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 to 
the listings in these body systems. Without an extension of the 
expiration dates for these listings, we will not have the criteria we 
need to assess medical impairments in these two body systems at step 
three of the sequential evaluation processes. We therefore find it is 
in the public interest to make this final rule effective on the 
publication date.

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 requirements 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 does not have a significant 
economic impact on a substantial number of small entities because it 
affects only individuals. Therefore, a regulatory flexibility analysis 
is not required under the Regulatory Flexibility Act, as amended.

Paperwork Reduction Act

    This final rule does not create any new or affect any existing 
collections and, therefore, it does not require OMB's 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 in 20 CFR Part 404

    Administrative practice and procedure, Blind, Disability benefits, 
Old-age, Survivors and Disability Insurance, Reporting and 
recordkeeping requirements, Social Security.

Nancy Berryhill,
Deputy Commissioner for Operations, performing the duties and functions 
not reserved to the Commissioner of Social Security.
    For the reasons set out in the preamble, we are amending appendix 1 
to subpart P of part 404 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 P--[Amended]

0
1. The authority citation for subpart P of part 404 continues to read 
as follows:

    Authority: Secs. 202, 205(a)-(b) and (d)-(h), 216(i), 221(a) and 
(h)-(j), 222(c), 223, 225, and 702(a)(5) of the Social Security Act 
(42 U.S.C. 402, 405(a)-(b) and (d)-(h), 416(i), 421(a) and (h)-(j), 
422(c), 423, 425, and 902(a)(5)); sec. 211(b), Pub. L. 104-193, 110 
Stat. 2105, 2189; sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 
U.S.C. 902 note).

0
2. Amend appendix 1 to subpart P of part 404 by revising items 3 and 11 
of the introductory text before Part A to read as follows:

Appendix 1 to Subpart P of Part 404--Listing of Impairments

* * * * *
    3. Special Senses and Speech (2.00 and 102.00): April 24, 2020.
* * * * *
    11. Congenital Disorders That Affect Multiple Body Systems 
(10.00 and 110.00): April 3, 2020.
* * * * *
[FR Doc. 2018-06671 Filed 3-30-18; 8:45 am]
 BILLING CODE 4191-02-P



                                             13862                  Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations

                                             either of the following methods (pending the                 the definitions of ‘‘software,’’ ‘‘program,’’               FOR FURTHER INFORMATION CONTACT:
                                             adoption of internationally accepted                         and ‘‘microprogram.’’                                       Cheryl A. Williams, Director, Office of
                                             standards):                                               Items: The list of items controlled is                         Medical Policy, 6401 Security
                                                a. Doppler laser method,                                  contained in the ECCN heading.
                                                                                                                                                                      Boulevard, Baltimore, MD 21235–6401,
                                                b. Forward laser diffraction method.
                                                                                                         Dated: March 27, 2018.                                       (410) 965–1020. For information on
                                                j. Nucleic acid assemblers and synthesizers
                                             that are both:                                            Matthew S. Borman,                                             eligibility or filing for benefits, call our
                                                j.1 Partly or entirely automated; and                                                                                 national toll-free number, 1–800–772–
                                                                                                       Deputy Assistant Secretary for Export
                                                j.2. Designed to generate continuous                   Administration.                                                1213, or TTY 1–800–325–0778, or visit
                                             nucleic acids greater than 1.5 kilobases in                                                                              our internet site, Social Security Online,
                                                                                                       [FR Doc. 2018–06581 Filed 3–30–18; 8:45 am]
                                             length with error rates less than 5% in a                                                                                at http://www.socialsecurity.gov.
                                                                                                       BILLING CODE 3510–33–P
                                             single run.                                                                                                              SUPPLEMENTARY INFORMATION:

                                             ■ 14. In Supplement No. 1 to Part 774                                                                                    Background
                                             (the Commerce Control List), Category 2,                  SOCIAL SECURITY ADMINISTRATION                                   We use the listings in appendix 1 to
                                             ECCN 2D351 is revised to read as                                                                                         subpart P of part 404 of 20 CFR at the
                                             follows:                                                  20 CFR Part 404
                                                                                                                                                                      third step of the sequential evaluation
                                             2D351 Dedicated ‘‘software’’ for toxic gas                [Docket No. SSA–2018–0007]                                     process to evaluate claims filed by
                                                monitors and monitoring systems, and                   RIN 0960–AI18                                                  adults and children for benefits based
                                                their dedicated detecting ‘‘parts’’ and                                                                               on disability under the title II and title
                                                ‘‘components,’’ controlled by ECCN                     Extension of Expiration Dates for Two                          XVI programs.1 20 CFR 404.1520(d),
                                                2B351.                                                                                                                416.920(d), 416.924(d). The listings are
                                                                                                       Body System Listings
                                             License Requirements                                                                                                     in two parts: Part A has listings criteria
                                                                                                       AGENCY:    Social Security Administration.                     for adults and Part B has listings criteria
                                             Reason for Control: CB, AT
                                                                                                       ACTION:   Final rule.                                          for children. If you are age 18 or over,
                                                                           Country Chart (See                                                                         we apply the listings criteria in Part A
                                                   Control(s)              Supp. No. 1 to part         SUMMARY:    We are extending the                               when we assess your impairment or
                                                                                  738)                 expiration dates of the following body                         combination of impairments. If you are
                                                                                                       systems in the Listing of Impairments                          under age 18, we first use the criteria in
                                             CB applies to entire       CB Column 2                    (listings) in our regulations: Special
                                               entry.
                                                                                                                                                                      Part B of the listings when we assess
                                                                                                       Senses and Speech and Congenital                               your impairment(s). If the criteria in
                                             AT applies to entire       AT Column 1                    Disorders That Affect Multiple Body
                                               entry.                                                                                                                 Part B do not apply, we may use the
                                                                                                       Systems. We are making no other                                criteria in Part A when those criteria
                                             List Based License Exceptions (See Part 740               revisions to these body systems in this                        consider the effects of your
                                             for a Description of All License Exceptions)              final rule. This extension ensures that                        impairment(s). 20 CFR 404.1525(b),
                                             CIV: N/A                                                  we will continue to have the criteria we                       416.925(b).
                                             TSR: N/A                                                  need to evaluate impairments in the
                                                                                                       affected body systems at step three of                         Explanation of Changes
                                             List of Items Controlled
                                                                                                       the sequential evaluation processes for                          In this final rule, we are extending the
                                             Related Controls: N/A
                                                                                                       initial claims and continuing disability                       dates on which the listings for the
                                             Related Definitions: (1) For the purposes of
                                               this entry, the term ‘‘dedicated’’ means                reviews.                                                       following two body systems will no
                                               committed entirely to a single purpose or               DATES: This final rule is effective on                         longer be effective as set out in the
                                               device. (2) See Section 772.1 of the EAR for            April 2, 2018.                                                 following chart:

                                                                                     Listing                                                Current expiration date                         Extended expiration date

                                             Special Senses and Speech (2.00 and 102.00) .....................................      April 29, 2018 ................................    April 24, 2020.
                                             Congenital Disorders That Affect Multiple Body Systems (10.00 and                      April 5, 2018 ..................................   April 3, 2020.
                                               110.00).



                                                We continue to revise and update the                   Regulatory Procedures                                          requirements when an agency finds
                                             listings on a regular basis, including                    Justification for Final Rule                                   there is good cause for dispensing with
                                             those body systems not affected by this                                                                                  such procedures because they are
                                             final rule.2 We intend to update the two                    We follow the Administrative                                 impracticable, unnecessary, or contrary
                                             listings affected by this final rule as                   Procedure Act (APA) rulemaking                                 to the public interest.
                                             quickly as possible, but may not be able                  procedures specified in 5 U.S.C. 553 in                           We have determined that good cause
                                             to publish final rules revising these                     promulgating regulations. Section                              exists for dispensing with the notice and
                                             listings by the current expiration dates.                 702(a)(5) of the Social Security Act, 42                       public comment procedures. 5 U.S.C.
                                             Therefore, we are extending the                           U.S.C. 902(a)(5). Generally, the APA                           553(b)(B). This final rule only extends
                                                                                                       requires that an agency provide prior                          the date on which two body system
                                             expiration dates listed above.
                                                                                                       notice and opportunity for public                              listings will no longer be effective. It
                                                                                                       comment before issuing a final                                 makes no substantive changes to our
daltland on DSKBBV9HB2PROD with RULES




                                                                                                       regulation. The APA provides                                   rules. Our current regulations 3 provide
                                                                                                       exceptions to the notice-and-comment                           that we may extend, revise, or
                                               1 We also use the listings in the sequential              2 Since we last extended the expiration dates of             (81 FR 66137 (2016)) and human immunodeficiency
                                             evaluation processes we use to determine whether          the listings affected by this rule in August 2016 (81          virus (HIV infection (81 FR 86915 (2016)).
                                             a beneficiary’s disability continues. See 20 CFR          FR 51100), we have published final rules revising                3 See the first sentence of appendix 1 to subpart

                                             404.1594, 416.994, and 416.994a.                          the medical criteria for evaluating mental disorders           P of part 404 of 20 CFR.



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                                                                  Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations                                          13863

                                             promulgate the body system listings                     Insurance, Reporting and recordkeeping                and to ensure accuracy and clarity in
                                             again. Therefore, we have determined                    requirements, Social Security.                        the Agency’s regulations.
                                             that opportunity for prior comment is                   Nancy Berryhill,                                      DATES: This rule is effective April 2,
                                             unnecessary, and we are issuing this                                                                          2018.
                                                                                                     Deputy Commissioner for Operations,
                                             regulation as a final rule.                             performing the duties and functions not               FOR FURTHER INFORMATION CONTACT:
                                                In addition, for the reasons cited                   reserved to the Commissioner of Social                Karen Fikes, Center for Devices and
                                             above, we find good cause for                           Security.                                             Radiological Health, Food and Drug
                                             dispensing with the 30-day delay in the                    For the reasons set out in the                     Administration, 10903 New Hampshire
                                             effective date of this final rule. 5 U.S.C.             preamble, we are amending appendix 1                  Ave., Bldg. 66, Rm. 5244, Silver Spring,
                                             553(d)(3). We are not making any                        to subpart P of part 404 of chapter III of            MD 20993–0002, 301–796–9603.
                                             substantive changes to the listings in                  title 20 of the Code of Federal                       SUPPLEMENTARY INFORMATION: FDA is
                                             these body systems. Without an                          Regulations as set forth below.                       amending our regulations in 21 CFR
                                             extension of the expiration dates for                                                                         parts 890, 900, 1020, and 1040 to correct
                                                                                                     PART 404—FEDERAL OLD-AGE,                             typographical errors and to update
                                             these listings, we will not have the                    SURVIVORS AND DISABILITY
                                             criteria we need to assess medical                                                                            addresses, office titles, and wording to
                                                                                                     INSURANCE (1950–)                                     ensure accuracy and clarity in the
                                             impairments in these two body systems
                                             at step three of the sequential evaluation              Subpart P—[Amended]                                   Agency’s medical device regulations.
                                             processes. We therefore find it is in the                                                                        FDA is making nonsubstantive
                                             public interest to make this final rule                 ■ 1. The authority citation for subpart P             changes to the following regulations:
                                                                                                     of part 404 continues to read as follows:                1. FDA is revising
                                             effective on the publication date.
                                                                                                                                                           § 890.5525(b)(2)(i)(A) by replacing
                                                                                                       Authority: Secs. 202, 205(a)–(b) and (d)–           ‘‘Testing using a drug approved for
                                             Executive Order 12866, as                               (h), 216(i), 221(a) and (h)-(j), 222(c), 223, 225,
                                             Supplemented by Executive Order                         and 702(a)(5) of the Social Security Act (42
                                                                                                                                                           iontophoretic delivery, or a solution, if
                                             13563                                                   U.S.C. 402, 405(a)–(b) and (d)–(h), 416(i),           identified in the labeling, to
                                                                                                     421(a) and (h)–(j), 422(c), 423, 425, and             demonstrate safe use of the device as
                                                We consulted with the Office of                      902(a)(5)); sec. 211(b), Pub. L. 104–193, 110         intended’’ with ‘‘Testing using a drug
                                             Management and Budget (OMB) and                         Stat. 2105, 2189; sec. 202, Pub. L. 108–203,          approved for iontophoretic delivery, or
                                             determined that this final rule does not                118 Stat. 509 (42 U.S.C. 902 note).                   a solution if identified in the labeling,
                                             meet the requirements for a significant                 ■ 2. Amend appendix 1 to subpart P of                 to demonstrate safe use of the device as
                                             regulatory action under Executive Order                 part 404 by revising items 3 and 11 of                intended’’.
                                             12866, as supplemented by Executive                     the introductory text before Part A to                   2. FDA is revising § 900.3(b)(1) by
                                             Order 13563. Therefore, OMB did not                     read as follows:                                      replacing ‘‘Division of Mammography
                                             review it. We also determined that this                                                                       Quality and Radiation Programs
                                                                                                     Appendix 1 to Subpart P of Part 404—                  (DMQRP), Center for Devices and
                                             final rule meets the plain language                     Listing of Impairments
                                             requirement of Executive Order 12866.                                                                         Radiology Health (HFZ–240), Food and
                                                                                                     *      *      *      *       *                        Drug Administration, 1350 Piccard Dr.,
                                             Regulatory Flexibility Act                                3. Special Senses and Speech (2.00 and              Rockville, MD 20850, marked Attn:
                                                                                                     102.00): April 24, 2020.                              Mammography Standards Branch’’ with
                                                We certify that this final rule does not             *      *      *      *       *                        ‘‘Division of Mammography Quality
                                             have a significant economic impact on                    11. Congenital Disorders That Affect                 Standards, Center for Devices and
                                             a substantial number of small entities                  Multiple Body Systems (10.00 and 110.00):             Radiological Health, Food and Drug
                                             because it affects only individuals.                    April 3, 2020.                                        Administration, 10903 New Hampshire
                                             Therefore, a regulatory flexibility                     *      *      *      *       *                        Ave., Bldg. 66, Rm. 4445, Silver Spring,
                                             analysis is not required under the                      [FR Doc. 2018–06671 Filed 3–30–18; 8:45 am]           MD 20993, Attn: Program Management
                                             Regulatory Flexibility Act, as amended.                 BILLING CODE 4191–02–P                                Branch’’.
                                                                                                                                                              3. FDA is revising § 900.11(b)(2)(i) by
                                             Paperwork Reduction Act
                                                                                                                                                           replacing ‘‘42 U.S.C. 263b(c)(2)’’ with
                                               This final rule does not create any                   DEPARTMENT OF HEALTH AND                              ‘‘42 U.S.C. 263b(c)(4)’’.
                                             new or affect any existing collections                  HUMAN SERVICES                                           4. FDA is revising § 1020.30(c) by
                                             and, therefore, it does not require                                                                           replacing ‘‘Director of the Office of
                                             OMB’s approval under the Paperwork                      Food and Drug Administration                          Communication, Education, and
                                                                                                                                                           Radiation Programs of the Center for
                                             Reduction Act.
                                                                                                     21 CFR Parts 890, 900, 1020, and 1040                 Devices and Radiological Health’’ with
                                             (Catalog of Federal Domestic Assistance                                                                       ‘‘Director, Center for Devices and
                                             Program Nos. 96.001, Social Security-                   [Docket No. FDA–2018–N–0011]
                                                                                                                                                           Radiological Health’’.
                                             Disability Insurance; 96.002, Social Security-                                                                   5. FDA is revising § 1040.10(a)(3)(i) by
                                             Retirement Insurance; 96.004, Social
                                                                                                     Medical Devices; Technical
                                                                                                     Amendment                                             replacing ‘‘Food and Drug
                                             Security-Survivors Insurance; 96.006,                                                                         Administration, Center for Devices and
                                             Supplemental Security Income)                           AGENCY:    Food and Drug Administration;              Radiological Health, Director, Office of
                                             List of Subjects in 20 CFR Part 404                     HHS.                                                  Compliance, 10903 New Hampshire
                                                                                                           Final rule; technical
                                                                                                     ACTION:                                               Ave., Bldg. 66, Rm. 3521, Silver Spring,
daltland on DSKBBV9HB2PROD with RULES




                                               Administrative practice and                           amendment.                                            MD 20993–0002’’ with ‘‘Director, Center
                                             procedure, Blind, Disability benefits,                                                                        for Devices and Radiological Health,
                                             Old-age, Survivors and Disability                       SUMMARY:   The Food and Drug                          Food and Drug Administration, 10903
                                                                                                     Administration (FDA or Agency) is                     New Hampshire Ave., Bldg. 66, Silver
                                                                                                     amending certain medical device                       Spring, MD 20993–0002’’.
                                                                                                     regulations. This action is editorial in                 6. FDA is revising § 1040.10(f)(6)(ii)
                                                                                                     nature to correct typographical errors                by replacing ‘‘Director, Office of


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Document Created: 2018-11-01 09:08:18
Document Modified: 2018-11-01 09:08:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis final rule is effective on April 2, 2018.
ContactCheryl A. Williams, Director, Office of Medical Policy, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 965-1020. 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 http:// www.socialsecurity.gov.
FR Citation83 FR 13862 
RIN Number0960-AI18
CFR AssociatedAdministrative Practice and Procedure; Blind; Disability Benefits; Old-Age; Survivors and Disability Insurance; Reporting and Recordkeeping Requirements and Social Security

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