82_FR_48962 82 FR 48760 - Implementation of the Federal Civil Penalties Inflation Adjustment Act and Adjustment of Amounts for 2017

82 FR 48760 - Implementation of the Federal Civil Penalties Inflation Adjustment Act and Adjustment of Amounts for 2017

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

Federal Register Volume 82, Issue 202 (October 20, 2017)

Page Range48760-48762
FR Document2017-22847

The National Aeronautics and Space Administration (NASA) has adopted as final the interim final rule concerning adjustments to civil monetary penalties within its jurisdiction for inflation. The interim rule was published on June 26, 2017, and applied a new methodology to calculate civil monetary penalties as mandated by the Federal Civil Penalties Adjustment Act Improvements Act of 2015, starting with an initial adjustment to previous unadjusted penalty amounts. The changes in the interim final rule made final by this rule are effective October 20, 2017 and applicable as of August 25, 2017. In addition, this final rule provides for 2017 inflation adjustments of monetary penalties amounts required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

Federal Register, Volume 82 Issue 202 (Friday, October 20, 2017)
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Rules and Regulations]
[Pages 48760-48762]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22847]


=======================================================================
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NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

14 CFR Parts 1264 and 1271

RIN 2700-AE30
[Document Number NASA-17-071: Docket Number-NASA-2017-0004]


Implementation of the Federal Civil Penalties Inflation 
Adjustment Act and Adjustment of Amounts for 2017

AGENCY: National Aeronautics and Space Administration.

[[Page 48761]]


ACTION: Final rule.

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

SUMMARY: The National Aeronautics and Space Administration (NASA) has 
adopted as final the interim final rule concerning adjustments to civil 
monetary penalties within its jurisdiction for inflation. The interim 
rule was published on June 26, 2017, and applied a new methodology to 
calculate civil monetary penalties as mandated by the Federal Civil 
Penalties Adjustment Act Improvements Act of 2015, starting with an 
initial adjustment to previous unadjusted penalty amounts. The changes 
in the interim final rule made final by this rule are effective October 
20, 2017 and applicable as of August 25, 2017. In addition, this final 
rule provides for 2017 inflation adjustments of monetary penalties 
amounts required by the Federal Civil Penalties Inflation Adjustment 
Act Improvements Act of 2015.

DATES: 
    Effective: This final rule is effective October 20, 2017.
    Applicable: This final rule is applicable as of August 25, 2017.

FOR FURTHER INFORMATION CONTACT: Bryan R. Diederich, Office of the 
General Counsel, NASA Headquarters, telephone (202) 358-0216.

SUPPLEMENTARY INFORMATION:

I. Background

A. The June 26, 2017, Interim Rule

    The Inflation Adjustment Act, as amended by the 2015 Act, requires 
Federal agencies to adjust the civil penalty amounts within their 
jurisdiction for inflation by July 1, 2016, and then by January 15 
every year thereafter.\1\ Agencies must make the initial 2016 
adjustments through an interim final rulemaking published in the 
Federal Register.\2\ Under the amended Act, any increase in a civil 
penalty made under the Act will apply to penalties assessed after the 
increase takes effect, including penalties whose associated violation 
predated the increase.\3\ The inflation adjustments mandated by the Act 
serve to maintain the deterrent effect of civil penalties and to 
promote compliance with the law.
---------------------------------------------------------------------------

    \1\ See 28 U.S.C. 2461 note.
    \2\ The statute also provides that, for the initial 2016 
adjustment, an agency may adjust a civil penalty by less than the 
otherwise required amount if (1) it determines, after publishing a 
notice of proposed rulemaking and providing an opportunity for 
comment, that increasing the civil penalty by the otherwise required 
amount would have a negative economic impact or that the social 
costs of increasing the civil penalty by the otherwise required 
amount outweigh the benefits, and (2) the Director of the Office of 
Management and Budget concurs with that determination. Inflation 
Adjustment Act section 4(c), codified at 28 UUSC 2461 note. NASA has 
chosen not to make use of this exception.
    \3\ Inflation Adjustment Act section 6, codified at 28 U.S.C. 
2461 note.
---------------------------------------------------------------------------

    On June 26, 2017, NASA published its interim final rule providing 
for the initial adjustment called for under the Act.\4\ The public 
comment period interim final rule closed on August 24, 2016, and the 
rule became effective on August 25, 2017. NASA received no comments on 
the interim final rule.
---------------------------------------------------------------------------

    \4\ 82 FR 28760.
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B. 2017 Inflation Adjustment

    After the initial adjustment, the Act requires agencies to make 
subsequent annual adjustments for inflation ``notwithstanding section 
553 of title 5, United States Code.'' Section 553 refers to the 
Administrative Procedure Act, which might otherwise require a delay for 
advance notice and opportunity for public comments on future annual 
inflation adjustments. The first of these subsequent adjustments is for 
2017. Because of a delay in publishing NASA's 2016 inflation 
adjustments as an interim final rule, the time for making the 2017 
adjustment was reached while NASA was in the process of publishing its 
2016 adjustments. Accordingly, in adopting as final the interim rule 
published on June 26, 2017, NASA is adjusting the penalty amounts to 
reflect the 2017 adjustments required by law.
    The 2017 annual adjustments are based on the percent change between 
the U.S. Department of Labor's Consumer Price Index for All Urban 
Consumers (``CPI-U'') for the month of October preceding the date of 
the adjustment, and the CPI-U for October of the prior year (28 U.S.C. 
2461 note, section (5)(b)(1)). Based on that formula, the cost-of-
living adjustment multiplier for 2017 is 1.01636. Pursuant to the 2015 
Act, adjustments are rounded to the nearest dollar.

II. The Final Rule

    This rule makes final the interim final rule published June 26, 
2017. In addition, this rule makes the required 2017 inflation 
adjustment. These adjusted amounts are reflected in the following 
table.

----------------------------------------------------------------------------------------------------------------
                                                                                                      Penalty
                                                                                    Penalty in      reflecting
                      Law                              Penalty description         June 26, 2017       2017
                                                                                   interim rule     adjustment
----------------------------------------------------------------------------------------------------------------
Program Fraud Civil Remedies Act of 1986......  Maximum Penalties for False              $10,781         $10,957
                                                 Claims.
Department of the Interior and Related          Minimum Penalty for use of                18,936          19,246
 Agencies Appropriations Act of 1989, Public     appropriated funds to lobby or
 Law 101-121, sec. 319.                          influence certain contracts.
Department of the Interior and Related          Maximum Penalty for use of               189,361         192,459
 Agencies Appropriations Act of 1989, Public     appropriated funds to lobby or
 Law 101-121, sec. 319.                          influence certain contracts.
Department of the Interior and Related          Minimum penalty for failure to            18,936          19,246
 Agencies Appropriations Act of 1989, Public     report certain lobbying
 Law 101-121, sec. 319.                          transactions.
Department of the Interior and Related          Maximum penalty for failure to           189,361         192,459
 Agencies Appropriations Act of 1989, Public     report certain lobbying
 Law 101-121, sec. 319.                          transactions.
----------------------------------------------------------------------------------------------------------------

    This rule codifies these civil penalty amounts by amending parts 
1264 and 1271 of title 14 of the CFR.

III. Legal Authority and Effective Date

    NASA issues this rule under the Federal Civil Penalties Inflation 
Adjustment Act of 1990,\5\ as amended by the Debt Collection 
Improvement Act of 1996,\6\ and further amended by the Federal Civil 
Penalties Inflation Adjustment Act Improvements Act of 2015,\7\ which 
requires NASA to adjust the civil penalties within its jurisdiction for 
inflation according to a statutorily prescribed formula.
---------------------------------------------------------------------------

    \5\ Public Law 101-410, 104 Stat. 890 (1990).
    \6\ Public Law 104-134, section 31001(s)(1), 110 Stat. 1321, 
1321-373 (1996).
    \7\ Public Law 114-74, section 701, 129 Stat. 584, 599 (2015).
---------------------------------------------------------------------------

    The Administrative Procedure Act (APA) generally requires an agency 
to publish a rule at least 30 days before its effective date.\8\ NASA's 
publication of the June 26, 2017, interim final rule met

[[Page 48762]]

this requirement. As explained above, the adjustments required for 
years subsequent to 2017 are not subject to the requirements of the 
Administrative Procedure Act. Moreover, the 2017 adjustments are made 
according to a statutory formula that does not provide for agency 
discretion. Accordingly, a delay in effectiveness of the 2017 
adjustments is not required.
---------------------------------------------------------------------------

    \8\ See 5 U.S.C. 533(d).
---------------------------------------------------------------------------

IV. Regulatory Requirements

Regulatory Flexibility Act

    Because no notice of proposed rulemaking is required, the 
Regulatory Flexibility Act does not require an initial or final 
regulatory flexibility analysis.\9\
---------------------------------------------------------------------------

    \9\ 5 U.S.C. 603(a), 604(a).
---------------------------------------------------------------------------

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995,\10\ NASA 
reviewed this interim final rule. No collections of information 
pursuant to the Paperwork Reduction Act are contained in the interim 
final rule.
---------------------------------------------------------------------------

    \10\ 44 U.S.C. 3506.
---------------------------------------------------------------------------

List of Subjects in 14 CFR Parts 1264 and 1271

    Claims, Lobbying, Penalties.

    For the reasons stated in the preamble, the National Aeronautics 
and Space Administration adopts as final the interim rule amending 14 
CFR parts 1264 and 1271 which published on June 26, 2017, at 82 FR 
28760, with the following changes:

PART 1264--IMPLEMENTATION OF THE PROGRAM FRAUD CIVIL PENALTIES ACT 
OF 1986

0
1. The authority citation for part 1264 continues to read as follows:

    Authority: 31 U.S.C. 3809, 51 U.S.C. 20113(a).


Sec.  1264.102   [Amended]

0
2. In Sec.  1264.102, paragraphs (a) and (b), remove the number 
``$10,781'' and add in its place the number ``$10,957.''

PART 1271--NEW RESTRICTIONS ON LOBBYING

0
3. The authority citation for part 1271 continues to read as follows:

    Authority: Section 319, Pub. L. 101-121 (31 U.S.C. 1352); Pub. 
L. 97-258 (31 U.S.C. 6301 et seq.)


Sec.  1271.400  [Amended]

0
4. In Sec.  1271.400:
0
a. In paragraphs (a) and (b) remove the words ``not less than $18,936 
and not more than $189,361'' and add in their place the words ``not 
less than $19,246 and not more than $192,459.''
0
b. In paragraph (e), remove the two occurrences of ``$18,936'' and add 
in their place ``$19,246'' and remove ``189,361'' and add in its place 
``$192,459''.

Appendix A to Part 1271 [Amended]

0
5. In appendix A to part 1271, in the paragraph following paragraph (3) 
and in the last paragraph of the appendix, remove the words ``not less 
than $18,936 and not more than $189,361'' and add in their place the 
words ``not less than $19,246 and not more than $192,459''.

Nanette J. Smith,
NASA Federal Register Liaison Officer.
[FR Doc. 2017-22847 Filed 10-19-17; 8:45 am]
BILLING CODE P



                                             48760             Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations

                                               Dated: October 16, 2017.                              part 313, became effective August 18,                 Congressional Review Act
                                             Dale L. Aultman,                                        2009 (74 FR 41592). For Fiscal Year                      This final rule is not major under the
                                             Secretary, Farm Credit Administration Board.            2010, the only year in which EDA made                 Congressional Review Act (5 U.S.C. 801
                                             [FR Doc. 2017–22721 Filed 10–19–17; 8:45 am]            awards under CTAA, EDA awarded                        et seq.).
                                             BILLING CODE 6705–01–P                                  $36,768,000 in grants to 36 recipients.
                                                                                                     The CTAA Program was subsequently                     Executive Order No. 13132
                                                                                                     repealed by section 222 of the Trade                    This final rule does not contain
                                             DEPARTMENT OF COMMERCE                                  Adjustment Assistance Extension Act of                policies that have federalism
                                                                                                     2011 (Pub. L. 112–40) ‘‘because it was                implications.
                                             Economic Development Administration                     considered duplicative of other federal
                                                                                                     programs. . . .’’ See CRS Report                      Paperwork Reduction Act
                                             13 CFR Part 313                                         R41922, Trade Adjustment Assistance                      The Paperwork Reduction Act of 1995
                                                                                                     (TAA) and Its Role in U.S. Trade Policy,              (44 U.S.C. 3501 et seq.) (‘‘PRA’’)
                                             [Docket No.: 170828819–7819–01]                         Aug. 5, 2013, p. 14. With the                         requires that a Federal agency consider
                                             RIN 0610–AA70                                           elimination of the CTAA Program by                    the impact of paperwork and other
                                                                                                     Congress, EDA’s implementing                          information collection burdens imposed
                                             Elimination of Regulations                              regulations are now unnecessary.                      on the public and, under the provisions
                                             Implementing Community Trade                               This elimination of 13 CFR part 313                of PRA section 3507(d), obtain approval
                                             Adjustment Assistance Program                           is a ‘‘deregulatory action’’ pursuant to              from OMB for each collection of
                                                                                                     the April 5, 2017, OMB guidance                       information it conducts, sponsors, or
                                             AGENCY:  Economic Development                                                                                 requires through regulations.
                                             Administration, U.S. Department of                      memorandum implementing Executive
                                                                                                     Order 13771. Since the program is                     Notwithstanding any other provision of
                                             Commerce.                                                                                                     law, no person is required to respond to,
                                             ACTION: Final rule.
                                                                                                     already defunct, there are no cost
                                                                                                     savings associated with this elimination.             nor shall any person be subject to a
                                                                                                                                                           penalty for failure to comply with a
                                             SUMMARY:   Through this final rule, the                 Classification                                        collection of information subject to the
                                             Economic Development Administration
                                                                                                                                                           PRA unless that collection displays a
                                             (‘‘EDA’’), U.S. Department of Commerce,                 Administrative Procedure Act and
                                                                                                                                                           currently valid OMB Control Number.
                                             eliminates the regulations implementing                 Regulatory Flexibility Act
                                                                                                                                                           This final rule does not require the
                                             the Community Trade Adjustment
                                                                                                        Pursuant to 5 U.S.C. 553(b)(B), there              collection of any information.
                                             Assistance (‘‘CTAA’’) Program.
                                             Established in 2009 under the Trade Act                 is good cause to waive prior notice and               List of Subjects in 13 CFR Part 313
                                             of 1974, the CTAA Program was                           an opportunity for public comment on
                                                                                                     this action, as notice and comment are                  Trade adjustment assistance for
                                             subsequently eliminated by Congress in                                                                        communities, Impacted community,
                                             2011. Implementing regulations for this                 unnecessary. This rule removes obsolete
                                                                                                     regulations implementing the CTAA                     Petition and affirmative determination
                                             now-defunct Program are thus                                                                                  requirements, Strategic plan,
                                             unnecessary. This final rule is a                       Program, which has been eliminated by
                                                                                                     Congress. Therefore, public comment                   Implementation grant.
                                             ‘‘deregulatory action’’ pursuant to the
                                             April 5, 2017, Office of Management                     would serve no purpose and is                         ■ For the reasons discussed above, and
                                             and Budget (‘‘OMB’’) guidance                           unnecessary. There is also good cause                 under the authority of 19 U.S.C. 2341–
                                             memorandum implementing Executive                       under 5 U.S.C. 553(d)(3) to waive the                 2372, EDA is removing and reserving 13
                                             Order 13771.                                            30-day delay in effectiveness. This rule              CFR part 313.
                                             DATES: This rule is effective October 20,               does not alter the rights or
                                                                                                     responsibilities of any party, and                    PART 313—[REMOVED AND
                                             2017.                                                                                                         RESERVED]
                                                                                                     delaying implementation of this rule
                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                     serves no purpose.
                                             Jeffrey Roberson, Deputy Chief Counsel,                                                                         Dated: October 16, 2017.
                                             Office of the Chief Counsel, Economic                      Because prior notice and an
                                                                                                                                                           Dennis Alvord,
                                             Development Administration, U.S.                        opportunity for public comment are not
                                                                                                     required pursuant to 5 U.S.C. 553, or                 Deputy Assistant Secretary for Regional
                                             Department of Commerce, 1401                                                                                  Affairs.
                                             Constitution Avenue NW., Suite 72023,                   any other law, the analytical
                                                                                                                                                           [FR Doc. 2017–22782 Filed 10–19–17; 8:45 am]
                                             Washington, DC 20230; telephone: (202)                  requirements of the Regulatory
                                                                                                     Flexibility Act (5 U.S.C. 601 et seq.) are            BILLING CODE 3510–24–P
                                             482–1315.
                                             SUPPLEMENTARY INFORMATION:
                                                                                                     inapplicable. Therefore, a regulatory
                                                                                                     flexibility analysis has not been
                                             Background                                              prepared.                                             NATIONAL AERONAUTICS AND
                                               The CTAA Program was enacted as                                                                             SPACE ADMINISTRATION
                                                                                                     Executive Orders No. 12866, 13563, and
                                             part of the Trade Act of 1974 (19 U.S.C.                13771                                                 14 CFR Parts 1264 and 1271
                                             2101 et seq.) by the Trade and
                                             Globalization Adjustment Assistance                        This final rule was drafted in                     RIN 2700–AE30
                                             Act of 2009, which was included as                      accordance with Executive Orders
                                             subtitle I (letter ‘‘I’’) of title I of Division        12866, 13563, and 13771. OMB has                      [Document Number NASA–17–071: Docket
                                                                                                     determined that this rule is not                      Number–NASA–2017–0004]
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                                             B of the American Recovery and
                                             Reinvestment Act of 2009 (Pub. L. 111–                  significant for purposes of Executive                 Implementation of the Federal Civil
                                             5). CTAA was intended to help                           Orders 12866. This final rule is a                    Penalties Inflation Adjustment Act and
                                             communities respond to job losses                       ‘‘deregulatory action’’ pursuant to the               Adjustment of Amounts for 2017
                                             resulting from international trade                      April 5, 2017, OMB guidance
                                             impacts. EDA’s implementing                             memorandum implementing Executive                     AGENCY:National Aeronautics and
                                             regulations for CTAA, located at 13 CFR                 Order 13771 (M–17–21).                                Space Administration.


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                                                                Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations                                                48761

                                             ACTION:   Final rule.                                   I. Background                                          which might otherwise require a delay
                                                                                                                                                            for advance notice and opportunity for
                                                                                                     A. The June 26, 2017, Interim Rule
                                             SUMMARY:   The National Aeronautics and                                                                        public comments on future annual
                                             Space Administration (NASA) has                           The Inflation Adjustment Act, as                     inflation adjustments. The first of these
                                             adopted as final the interim final rule                 amended by the 2015 Act, requires                      subsequent adjustments is for 2017.
                                             concerning adjustments to civil                         Federal agencies to adjust the civil                   Because of a delay in publishing
                                             monetary penalties within its                           penalty amounts within their                           NASA’s 2016 inflation adjustments as
                                             jurisdiction for inflation. The interim                 jurisdiction for inflation by July 1, 2016,            an interim final rule, the time for
                                             rule was published on June 26, 2017,                    and then by January 15 every year                      making the 2017 adjustment was
                                             and applied a new methodology to                        thereafter.1 Agencies must make the                    reached while NASA was in the process
                                             calculate civil monetary penalties as                   initial 2016 adjustments through an                    of publishing its 2016 adjustments.
                                             mandated by the Federal Civil Penalties                 interim final rulemaking published in                  Accordingly, in adopting as final the
                                             Adjustment Act Improvements Act of                      the Federal Register.2 Under the                       interim rule published on June 26, 2017,
                                             2015, starting with an initial adjustment               amended Act, any increase in a civil                   NASA is adjusting the penalty amounts
                                             to previous unadjusted penalty                          penalty made under the Act will apply                  to reflect the 2017 adjustments required
                                             amounts. The changes in the interim                     to penalties assessed after the increase               by law.
                                             final rule made final by this rule are                  takes effect, including penalties whose
                                                                                                                                                              The 2017 annual adjustments are
                                             effective October 20, 2017 and                          associated violation predated the
                                                                                                                                                            based on the percent change between
                                             applicable as of August 25, 2017. In                    increase.3 The inflation adjustments
                                                                                                                                                            the U.S. Department of Labor’s
                                             addition, this final rule provides for                  mandated by the Act serve to maintain
                                                                                                                                                            Consumer Price Index for All Urban
                                             2017 inflation adjustments of monetary                  the deterrent effect of civil penalties and
                                                                                                                                                            Consumers (‘‘CPI–U’’) for the month of
                                             penalties amounts required by the                       to promote compliance with the law.
                                                                                                       On June 26, 2017, NASA published its                 October preceding the date of the
                                             Federal Civil Penalties Inflation                                                                              adjustment, and the CPI–U for October
                                                                                                     interim final rule providing for the
                                             Adjustment Act Improvements Act of                                                                             of the prior year (28 U.S.C. 2461 note,
                                                                                                     initial adjustment called for under the
                                             2015.                                                                                                          section (5)(b)(1)). Based on that formula,
                                                                                                     Act.4 The public comment period
                                                                                                     interim final rule closed on August 24,                the cost-of-living adjustment multiplier
                                             DATES:
                                                                                                     2016, and the rule became effective on                 for 2017 is 1.01636. Pursuant to the
                                               Effective: This final rule is effective                                                                      2015 Act, adjustments are rounded to
                                                                                                     August 25, 2017. NASA received no
                                             October 20, 2017.                                                                                              the nearest dollar.
                                                                                                     comments on the interim final rule.
                                               Applicable: This final rule is                                                                               II. The Final Rule
                                             applicable as of August 25, 2017.                       B. 2017 Inflation Adjustment
                                                                                                        After the initial adjustment, the Act                 This rule makes final the interim final
                                             FOR FURTHER INFORMATION CONTACT:
                                                                                                     requires agencies to make subsequent                   rule published June 26, 2017. In
                                             Bryan R. Diederich, Office of the
                                                                                                     annual adjustments for inflation                       addition, this rule makes the required
                                             General Counsel, NASA Headquarters,
                                                                                                     ‘‘notwithstanding section 553 of title 5,              2017 inflation adjustment. These
                                             telephone (202) 358–0216.
                                                                                                     United States Code.’’ Section 553 refers               adjusted amounts are reflected in the
                                             SUPPLEMENTARY INFORMATION:                              to the Administrative Procedure Act,                   following table.

                                                                                                                                                                                                   Penalty
                                                                                                                                                                                Penalty in        reflecting
                                                                              Law                                                     Penalty description                     June 26, 2017         2017
                                                                                                                                                                               interim rule      adjustment

                                             Program Fraud Civil Remedies Act of 1986 .............................    Maximum Penalties for False Claims ..............           $10,781             $10,957
                                             Department of the Interior and Related Agencies Appropria-                Minimum Penalty for use of appropriated                      18,936              19,246
                                               tions Act of 1989, Public Law 101–121, sec. 319.                          funds to lobby or influence certain contracts.
                                             Department of the Interior and Related Agencies Appropria-                Maximum Penalty for use of appropriated                     189,361             192,459
                                               tions Act of 1989, Public Law 101–121, sec. 319.                          funds to lobby or influence certain contracts.
                                             Department of the Interior and Related Agencies Appropria-                Minimum penalty for failure to report certain                 18,936             19,246
                                               tions Act of 1989, Public Law 101–121, sec. 319.                          lobbying transactions.
                                             Department of the Interior and Related Agencies Appropria-                Maximum penalty for failure to report certain                189,361            192,459
                                               tions Act of 1989, Public Law 101–121, sec. 319.                          lobbying transactions.



                                               This rule codifies these civil penalty                Adjustment Act of 1990,5 as amended                    for inflation according to a statutorily
                                             amounts by amending parts 1264 and                      by the Debt Collection Improvement Act                 prescribed formula.
                                             1271 of title 14 of the CFR.                            of 1996,6 and further amended by the                      The Administrative Procedure Act
                                             III. Legal Authority and Effective Date                 Federal Civil Penalties Inflation                      (APA) generally requires an agency to
                                                                                                     Adjustment Act Improvements Act of                     publish a rule at least 30 days before its
                                               NASA issues this rule under the                       2015,7 which requires NASA to adjust                   effective date.8 NASA’s publication of
                                             Federal Civil Penalties Inflation                       the civil penalties within its jurisdiction            the June 26, 2017, interim final rule met
                                               1 See   28 U.S.C. 2461 note.                          of increasing the civil penalty by the otherwise         4 82 FR 28760.
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                                               2 The   statute also provides that, for the initial   required amount outweigh the benefits, and (2) the       5 Public Law 101–410, 104 Stat. 890 (1990).
                                             2016 adjustment, an agency may adjust a civil           Director of the Office of Management and Budget          6 Public Law 104–134, section 31001(s)(1), 110
                                             penalty by less than the otherwise required amount      concurs with that determination. Inflation
                                                                                                     Adjustment Act section 4(c), codified at 28 UUSC       Stat. 1321, 1321–373 (1996).
                                             if (1) it determines, after publishing a notice of
                                                                                                                                                              7 Public Law 114–74, section 701, 129 Stat. 584,
                                             proposed rulemaking and providing an opportunity        2461 note. NASA has chosen not to make use of this
                                             for comment, that increasing the civil penalty by       exception.                                             599 (2015).
                                             the otherwise required amount would have a                3 Inflation Adjustment Act section 6, codified at      8 See 5 U.S.C. 533(d).
                                             negative economic impact or that the social costs       28 U.S.C. 2461 note.



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                                             48762                  Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations

                                             this requirement. As explained above,                       place the words ‘‘not less than $19,246               Administration, 10903 New Hampshire
                                             the adjustments required for years                          and not more than $192,459.’’                         Ave., Bldg. 66, Rm. 4524, Silver Spring,
                                             subsequent to 2017 are not subject to the                   ■ b. In paragraph (e), remove the two                 MD, 20993–0002, 301–796–6679,
                                             requirements of the Administrative                          occurrences of ‘‘$18,936’’ and add in                 kimberly.sconce@fda.hhs.gov.
                                             Procedure Act. Moreover, the 2017                           their place ‘‘$19,246’’ and remove                    SUPPLEMENTARY INFORMATION:
                                             adjustments are made according to a                         ‘‘189,361’’ and add in its place
                                             statutory formula that does not provide                     ‘‘$192,459’’.                                         I. Background
                                             for agency discretion. Accordingly, a                                                                                Upon request, FDA has classified the
                                                                                                         Appendix A to Part 1271 [Amended]                     device to detect and identify microbial
                                             delay in effectiveness of the 2017
                                             adjustments is not required.                                ■ 5. In appendix A to part 1271, in the               pathogen nucleic acids in cerebrospinal
                                                                                                         paragraph following paragraph (3) and                 fluid as class II (special controls), which
                                             IV. Regulatory Requirements                                                                                       we have determined will provide a
                                                                                                         in the last paragraph of the appendix,
                                             Regulatory Flexibility Act                                  remove the words ‘‘not less than                      reasonable assurance of safety and
                                                                                                         $18,936 and not more than $189,361’’                  effectiveness. In addition, we believe
                                               Because no notice of proposed
                                                                                                         and add in their place the words ‘‘not                this action will enhance patients’ access
                                             rulemaking is required, the Regulatory
                                                                                                         less than $19,246 and not more than                   to beneficial innovation, in part by
                                             Flexibility Act does not require an
                                                                                                         $192,459’’.                                           reducing regulatory burdens by placing
                                             initial or final regulatory flexibility
                                                                                                                                                               the device into a lower device class than
                                             analysis.9                                                  Nanette J. Smith,                                     the automatic class III assignment.
                                             Paperwork Reduction Act                                     NASA Federal Register Liaison Officer.                   The automatic assignment of class III
                                                                                                         [FR Doc. 2017–22847 Filed 10–19–17; 8:45 am]          occurs by operation of law and without
                                               In accordance with the Paperwork
                                                                                                         BILLING CODE P                                        any action by FDA, regardless of the
                                             Reduction Act of 1995,10 NASA
                                                                                                                                                               level of risk posed by the new device.
                                             reviewed this interim final rule. No
                                                                                                                                                               Any device that was not in commercial
                                             collections of information pursuant to
                                                                                                                                                               distribution before May 28, 1976, is
                                             the Paperwork Reduction Act are                             DEPARTMENT OF HEALTH AND
                                                                                                                                                               automatically classified as, and remains
                                             contained in the interim final rule.                        HUMAN SERVICES
                                                                                                                                                               within, class III and requires premarket
                                             List of Subjects in 14 CFR Parts 1264                       Food and Drug Administration                          approval unless and until FDA takes an
                                             and 1271                                                                                                          action to classify or reclassify the device
                                               Claims, Lobbying, Penalties.                              21 CFR Part 866                                       (see 21 U.S.C. 360c(f)(1)). We refer to
                                                                                                                                                               these devices as ‘‘postamendments
                                               For the reasons stated in the                             [Docket No. FDA–2017–N–5371]                          devices’’ because they were not in
                                             preamble, the National Aeronautics and                                                                            commercial distribution prior to the
                                             Space Administration adopts as final                        Medical Devices; Immunology and                       date of enactment of the Medical Device
                                             the interim rule amending 14 CFR parts                      Microbiology Devices; Classification of               Amendments of 1976, which amended
                                             1264 and 1271 which published on June                       the Device To Detect and Identify                     the Federal Food, Drug, and Cosmetic
                                             26, 2017, at 82 FR 28760, with the                          Microbial Pathogen Nucleic Acids in                   Act (the FD&C Act).
                                             following changes:                                          Cerebrospinal Fluid                                      FDA may take a variety of actions in
                                                                                                         AGENCY:    Food and Drug Administration,              appropriate circumstances to classify or
                                             PART 1264—IMPLEMENTATION OF
                                                                                                         HHS.                                                  reclassify a device into class I or II. We
                                             THE PROGRAM FRAUD CIVIL
                                                                                                                                                               may issue an order finding a new device
                                             PENALTIES ACT OF 1986                                       ACTION:   Final order.                                to be substantially equivalent under
                                             ■ 1. The authority citation for part 1264                   SUMMARY:   The Food and Drug                          section 513(i) of the FD&C Act (21
                                             continues to read as follows:                               Administration (FDA or we) is                         U.S.C. 360c(i)) to a predicate device that
                                                                                                         classifying the device to detect and                  does not require premarket approval.
                                               Authority: 31 U.S.C. 3809, 51 U.S.C.                                                                            We determine whether a new device is
                                             20113(a).                                                   identify microbial pathogen nucleic
                                                                                                         acids in cerebrospinal fluid into class II            substantially equivalent to a predicate
                                             § 1264.102        [Amended]                                 (special controls). The special controls              by means of the procedures for
                                                                                                         that will apply to the device type are                premarket notification under section
                                             ■ 2. In § 1264.102, paragraphs (a) and
                                                                                                         identified in this order and will be part             510(k) of the FD&C Act (21 U.S.C.
                                             (b), remove the number ‘‘$10,781’’ and
                                                                                                         of the codified language for the device               360(k)) and part 807 (21 CFR part 807).
                                             add in its place the number ‘‘$10,957.’’                                                                             FDA may also classify a device
                                                                                                         to detect and identify microbial
                                             PART 1271—NEW RESTRICTIONS ON                                                                                     through ‘‘De Novo’’ classification, a
                                                                                                         pathogen nucleic acids in cerebrospinal
                                             LOBBYING                                                                                                          common name for the process
                                                                                                         fluid’s classification. We are taking this
                                                                                                                                                               authorized under section 513(f)(2) of the
                                                                                                         action because we have determined that
                                             ■ 3. The authority citation for part 1271                                                                         FD&C Act. Section 207 of the Food and
                                                                                                         classifying the device into class II
                                             continues to read as follows:                                                                                     Drug Administration Modernization Act
                                                                                                         (special controls) will provide a
                                               Authority: Section 319, Pub. L. 101–121                                                                         of 1997 established the first procedure
                                                                                                         reasonable assurance of safety and
                                             (31 U.S.C. 1352); Pub. L. 97–258 (31 U.S.C.                                                                       for De Novo classification (Pub. L. 105–
                                                                                                         effectiveness of the device. We believe
                                             6301 et seq.)                                                                                                     115). Section 607 of the Food and Drug
                                                                                                         this action will also enhance patients’
                                                                                                                                                               Administration Safety and Innovation
                                             § 1271.400        [Amended]                                 access to beneficial innovative devices,
                                                                                                                                                               Act modified the De Novo application
                                                                                                         in part by reducing regulatory burdens.
nlaroche on DSK9F9SC42PROD with RULES




                                             ■4. In § 1271.400:                                                                                                process by adding a second procedure
                                             ■a. In paragraphs (a) and (b) remove the                    DATES: This order is effective October                (Pub. L. 112–144). A device sponsor
                                             words ‘‘not less than $18,936 and not                       20, 2017. The classification was                      may utilize either procedure for De
                                             more than $189,361’’ and add in their                       applicable on October 8, 2015.                        Novo classification.
                                                                                                         FOR FURTHER INFORMATION CONTACT:                         Under the first procedure, the person
                                                 95   U.S.C. 603(a), 604(a).                             Kimberly Sconce, Center for Devices                   submits a 510(k) for a device that has
                                                 10 44  U.S.C. 3506.                                     and Radiological Health, Food and Drug                not previously been classified. After


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Document Created: 2017-10-20 00:05:47
Document Modified: 2017-10-20 00:05:47
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.
DatesEffective: This final rule is effective October 20, 2017.
ContactBryan R. Diederich, Office of the General Counsel, NASA Headquarters, telephone (202) 358-0216.
FR Citation82 FR 48760 
RIN Number2700-AE30
CFR Citation14 CFR 1264
14 CFR 1271
CFR AssociatedClaims; Lobbying and Penalties

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