80_FR_76619 80 FR 76383 - Updated Statements of Legal Authority for the Export Administration Regulations

80 FR 76383 - Updated Statements of Legal Authority for the Export Administration Regulations

DEPARTMENT OF COMMERCE
Bureau of Industry and Security

Federal Register Volume 80, Issue 236 (December 9, 2015)

Page Range76383-76384
FR Document2015-30753

This rule updates the Code of Federal Regulations (CFR) legal authority citations in the Export Administration Regulations (EAR) to cite the most recent Presidential notice continuing an emergency declared pursuant to the International Emergency Economic Powers Act. This is a non-substantive rule that only updates authority paragraphs of the EAR. It does not alter any right, obligation or prohibition that applies to any person under the EAR.

Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015)
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Rules and Regulations]
[Pages 76383-76384]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30753]


=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 730, 734, 736, 742, 744, and 745

[Docket No. 151123999-5999-01]
RIN 0694-AG78


Updated Statements of Legal Authority for the Export 
Administration Regulations

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: This rule updates the Code of Federal Regulations (CFR) legal 
authority citations in the Export Administration Regulations (EAR) to 
cite the most recent Presidential notice continuing an emergency 
declared pursuant to the International Emergency Economic Powers Act. 
This is a non-substantive rule that only updates authority paragraphs 
of the EAR. It does not alter any right, obligation or prohibition that 
applies to any person under the EAR.

DATES: The rule is effective December 9, 2015.

FOR FURTHER INFORMATION CONTACT: William Arvin, Regulatory Policy 
Division, Bureau of Industry and Security, email 
william.arvin@bis.doc.gov or telephone: (202) 482-2440.

SUPPLEMENTARY INFORMATION:

Background

    The authority for parts 730, 734, 736, 742, 744, and 745 of the EAR 
rests, in part, on Executive Order 12938 of November 14, 1994--
Proliferation of Weapons of Mass Destruction, 59 FR 59099, 3 CFR, 1994 
Comp., p. 950 and on annual notices continuing the emergency declared 
in that executive order. This rule revises the authority citations for 
the affected parts to cite the most recent such notice, which the 
President signed on November 12, 2015.
    This rule is purely non-substantive, and makes no changes other 
than to revise CFR authority citations for the purpose of making the 
authority citations current. It does not change the text of any section 
of the EAR, nor does it alter any right, obligation or prohibition that 
applies to any person under the EAR.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). This rule 
does not impose any regulatory burden on the public and is consistent 
with the goals of Executive Order 13563. This rule has been determined 
to be not significant for purposes of Executive Order 12866.
    2. Notwithstanding any other provision of law, no person is 
required to respond to, nor shall any person be subject to a penalty 
for failure to comply with, a collection of information subject to the 
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et 
seq.) (PRA), unless that collection of information displays a currently 
valid Office of Management and Budget (OMB) Control Number. This rule 
does not involve any collection of information.
    3. This rule does not contain policies with Federalism implications 
as that term is defined under Executive Order 13132.
    4. The Department finds that there is good cause under 5 U.S.C. 
553(b)(B) to waive the provisions of the Administrative Procedure Act 
requiring prior notice and the opportunity for public comment because 
they are unnecessary. This rule only updates legal authority citations. 
It clarifies information and is non-discretionary. This rule does not 
alter any right, obligation or prohibition that applies to any person 
under the EAR. Because these revisions are not substantive changes, it 
is unnecessary to provide notice and opportunity for public comment. In 
addition, the 30-day delay in effectiveness otherwise required by 5 
U.S.C. 553(d) is not applicable because this rule is not a substantive 
rule. Because neither the Administrative Procedure Act nor any other 
law requires that notice of proposed rulemaking and an opportunity for 
public comment be given for this rule, the analytical requirements of 
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not 
applicable. Accordingly, no Regulatory Flexibility Analysis is required 
and none has been prepared.

List of Subjects

15 CFR Part 730

    Administrative practice and procedure, Advisory committees, 
Exports, Reporting and recordkeeping requirements, Strategic and 
critical materials.

[[Page 76384]]

15 CFR Part 734

    Administrative practice and procedure, Exports, Inventions and 
patents, Research, Science and technology.

15 CFR Part 736

    Exports.

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

15 CFR Part 745

    Administrative practice and procedure, Chemicals, Exports, Foreign 
trade, Reporting and recordkeeping requirements.

    Accordingly, parts 730, 734, 736, 742, 744, and 745 of the EAR (15 
CFR parts 730-774) are amended as follows:

PART 730--[AMENDED]

0
1. The authority citation for 15 CFR part 730 is revised to read as 
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 
note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 
185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 
1824a; 50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 
E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42 
FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR, 
1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 
256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854, 
58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3 
CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., 
p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 
12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 
54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 
1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 
66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, 3 
CFR, 2004 Comp., p 168; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., 
p. 223; Notice of January 21, 2015, 80 FR 3461 (January 22, 2015); 
Notice of May 6, 2015, 80 FR 26815 (May 8, 2015); Notice of August 
7, 2015, 80 FR 48233 (August 11, 2015); Notice of September 18, 
2015, 80 FR 57281 (September 22, 2015); Notice of November 12, 2015, 
80 FR 70667 (November 13, 2015).

PART 734--[AMENDED]

0
2. The authority citation for 15 CFR part 734 is revised to read as 
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 
FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 
783; E.O. 13637, 78 FR 16129, 3 CFR, 2014 Comp., p. 223; Notice of 
August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of November 
12, 2015, 80 FR 70667 (November 13, 2015).

PART 736--[AMENDED]

0
3. The authority citation for 15 CFR part 736 is revised to read as 
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13026, 
61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 
CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., 
p. 168; Notice of May 6, 2015, 80 FR 26815 (May 8, 2015); Notice of 
August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of November 
12, 2015, 80 FR 70667 (November 13, 2015).

PART 742--[AMENDED]

0
4. The authority citation for 15 CFR part 742 is revised to read as 
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 
U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 
43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 
CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., 
p. 950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential 
Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320; 
Notice of August 7, 2015, 80 FR 48233 (August 11, 2015); Notice of 
November 12, 2015, 80 FR 70667 (November 13, 2015).

PART 744--[AMENDED]

0
5. The authority citation for 15 CFR part 744 is revised to read as 
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; 
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222, 
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3 
CFR, 2001 Comp., p. 786; Notice of January 21, 2015, 80 FR 3461 
(January 22, 2015); Notice of August 7, 2015, 80 FR 48233 (August 
11, 2015); Notice of September 18, 2015, 80 FR 57281 (September 22, 
2015); Notice of November 12, 2015, 80 FR 70667 (November 13, 2015).

PART 745--[AMENDED]

0
6. The authority citation for 15 CFR part 745 is revised to read as 
follows:

    Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3 
CFR, 1994 Comp., p. 950; Notice of November 12, 2015, 80 FR 70667 
(November 13, 2015).

    Dated: November 30, 2015.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2015-30753 Filed 12-8-15; 8:45 am]
BILLING CODE 3510-33-P



                                                            Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations                                       76383

                                           TIS, inspect the slider for play. If there is            DEPARTMENT OF COMMERCE                                necessary, to select regulatory
                                           play greater than 2.3 millimeters (0.09 inch),                                                                 approaches that maximize net benefits
                                           replace the slider with an airworthy slider              Bureau of Industry and Security                       (including potential economic,
                                           before further flight.                                                                                         environmental, public health and safety
                                           (f) Alternative Methods of Compliance
                                                                                                    15 CFR Parts 730, 734, 736, 742, 744,                 effects, distributive impacts, and
                                           (AMOCs)                                                  and 745                                               equity). This rule does not impose any
                                              (1) The Manager, Safety Management                    [Docket No. 151123999–5999–01]                        regulatory burden on the public and is
                                           Group, FAA, may approve AMOCs for this                                                                         consistent with the goals of Executive
                                                                                                    RIN 0694–AG78
                                           AD. Send your proposal to: Martin R. Crane,                                                                    Order 13563. This rule has been
                                           Aviation Safety Engineer, Safety Management              Updated Statements of Legal Authority                 determined to be not significant for
                                           Group, Rotorcraft Directorate, FAA, 10101                for the Export Administration                         purposes of Executive Order 12866.
                                           Hillwood Pkwy, Fort Worth, TX 76177;                     Regulations                                              2. Notwithstanding any other
                                           telephone (817) 222–5110; email 9-ASW-                                                                         provision of law, no person is required
                                           FTW-AMOC-Requests@faa.gov.                               AGENCY:  Bureau of Industry and
                                                                                                    Security, Commerce.                                   to respond to, nor shall any person be
                                              (2) For operations conducted under a 14                                                                     subject to a penalty for failure to comply
                                           CFR part 119 operating certificate or under              ACTION: Final rule.
                                                                                                                                                          with, a collection of information subject
                                           14 CFR part 91, subpart K, we suggest that
                                                                                                    SUMMARY:   This rule updates the Code of              to the requirements of the Paperwork
                                           you notify your principal inspector, or
                                                                                                    Federal Regulations (CFR) legal                       Reduction Act of 1995 (44 U.S.C. 3501
                                           lacking a principal inspector, the manager of
                                                                                                    authority citations in the Export                     et seq.) (PRA), unless that collection of
                                           the local flight standards district office or
                                           certificate holding district office, before              Administration Regulations (EAR) to                   information displays a currently valid
                                           operating any aircraft complying with this               cite the most recent Presidential notice              Office of Management and Budget
                                           AD through an AMOC.                                      continuing an emergency declared                      (OMB) Control Number. This rule does
                                                                                                    pursuant to the International Emergency               not involve any collection of
                                           (g) Additional Information                               Economic Powers Act. This is a non-                   information.
                                             (1) AgustaWestland Bollettino Tecnico No.              substantive rule that only updates                       3. This rule does not contain policies
                                           109–149, dated May 29, 2015, which is not                authority paragraphs of the EAR. It does              with Federalism implications as that
                                           incorporated by reference, contains                      not alter any right, obligation or                    term is defined under Executive Order
                                           additional information about the subject of              prohibition that applies to any person                13132.
                                           this AD. For service information identified in           under the EAR.
                                           this AD, contact AgustaWestland, Product                 DATES: The rule is effective December 9,
                                                                                                                                                             4. The Department finds that there is
                                           Support Engineering, Via del Gregge, 100,                2015.                                                 good cause under 5 U.S.C. 553(b)(B) to
                                           21015 Lonate Pozzolo (VA) Italy, ATTN:                                                                         waive the provisions of the
                                                                                                    FOR FURTHER INFORMATION CONTACT:
                                           Maurizio D’Angelo; telephone 39–0331–                                                                          Administrative Procedure Act requiring
                                                                                                    William Arvin, Regulatory Policy
                                           664757; fax 39–0331–664680; or at http://                                                                      prior notice and the opportunity for
                                                                                                    Division, Bureau of Industry and
                                           www.agustawestland.com/technical-
                                                                                                    Security, email william.arvin@                        public comment because they are
                                           bulletins. You may review a copy of the
                                                                                                    bis.doc.gov or telephone: (202) 482–                  unnecessary. This rule only updates
                                           service information at the FAA, Office of the                                                                  legal authority citations. It clarifies
                                                                                                    2440.
                                           Regional Counsel, Southwest Region, Room                                                                       information and is non-discretionary.
                                           6N–321, 10101 Hillwood Pkwy, Fort Worth,                 SUPPLEMENTARY INFORMATION:                            This rule does not alter any right,
                                           TX 76177.                                                Background                                            obligation or prohibition that applies to
                                             (2) The subject of this AD is addressed in                                                                   any person under the EAR. Because
                                           European Aviation Safety Agency (EASA) AD                   The authority for parts 730, 734, 736,
                                                                                                                                                          these revisions are not substantive
                                           No. 2015–0097, dated June 1, 2015. You may               742, 744, and 745 of the EAR rests, in
                                                                                                                                                          changes, it is unnecessary to provide
                                           view the EASA AD on the Internet at                      part, on Executive Order 12938 of
                                                                                                    November 14, 1994—Proliferation of                    notice and opportunity for public
                                           http://www.regulations.gov by searching for                                                                    comment. In addition, the 30-day delay
                                           and locating it in Docket No. FAA–2015–                  Weapons of Mass Destruction, 59 FR
                                                                                                    59099, 3 CFR, 1994 Comp., p. 950 and                  in effectiveness otherwise required by 5
                                           3783.
                                                                                                    on annual notices continuing the                      U.S.C. 553(d) is not applicable because
                                           (h) Subject                                              emergency declared in that executive                  this rule is not a substantive rule.
                                             Joint Aircraft Service Component (JASC)                order. This rule revises the authority                Because neither the Administrative
                                           Code: 6720, Tail Rotor Control System.                   citations for the affected parts to cite the          Procedure Act nor any other law
                                                                                                    most recent such notice, which the                    requires that notice of proposed
                                              Issued in Fort Worth, Texas, on December
                                                                                                    President signed on November 12, 2015.                rulemaking and an opportunity for
                                           2, 2015.
                                                                                                       This rule is purely non-substantive,               public comment be given for this rule,
                                           James A. Grigg,                                                                                                the analytical requirements of the
                                                                                                    and makes no changes other than to
                                           Acting Manager, Rotorcraft Directorate,                  revise CFR authority citations for the                Regulatory Flexibility Act (5 U.S.C. 601
                                           Aircraft Certification Service.                                                                                et seq.) are not applicable. Accordingly,
                                                                                                    purpose of making the authority
                                           [FR Doc. 2015–30973 Filed 12–8–15; 8:45 am]              citations current. It does not change the             no Regulatory Flexibility Analysis is
                                           BILLING CODE 4910–13–P                                   text of any section of the EAR, nor does              required and none has been prepared.
                                                                                                    it alter any right, obligation or
                                                                                                                                                          List of Subjects
                                                                                                    prohibition that applies to any person
                                                                                                    under the EAR.
wgreen on DSK2VPTVN1PROD with RULES




                                                                                                                                                          15 CFR Part 730
                                                                                                    Rulemaking Requirements                                 Administrative practice and
                                                                                                       1. Executive Orders 13563 and 12866                procedure, Advisory committees,
                                                                                                    direct agencies to assess all costs and               Exports, Reporting and recordkeeping
                                                                                                    benefits of available regulatory                      requirements, Strategic and critical
                                                                                                    alternatives and, if regulation is                    materials.


                                      VerDate Sep<11>2014    15:17 Dec 08, 2015   Jkt 238001   PO 00000   Frm 00029   Fmt 4700   Sfmt 4700   E:\FR\FM\09DER1.SGM   09DER1


                                           76384            Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Rules and Regulations

                                           15 CFR Part 734                                          3 CFR, 1994 Comp., p. 950; E.O. 13020, 61             PART 745—[AMENDED]
                                                                                                    FR 54079, 3 CFR, 1996 Comp., p. 219; E.O.
                                             Administrative practice and                            13026, 61 FR 58767, 3 CFR, 1996 Comp., p.             ■ 6. The authority citation for 15 CFR
                                           procedure, Exports, Inventions and                       228; E.O. 13222, 66 FR 44025, 3 CFR, 2001             part 745 is revised to read as follows:
                                           patents, Research, Science and                           Comp., p. 783; E.O. 13637, 78 FR 16129, 3
                                           technology.                                              CFR, 2014 Comp., p. 223; Notice of August               Authority: 50 U.S.C. 1701 et seq.; E.O.
                                                                                                                                                          12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
                                           15 CFR Part 736                                          7, 2015, 80 FR 48233 (August 11, 2015);
                                                                                                                                                          950; Notice of November 12, 2015, 80 FR
                                                                                                    Notice of November 12, 2015, 80 FR 70667
                                               Exports.                                                                                                   70667 (November 13, 2015).
                                                                                                    (November 13, 2015).
                                                                                                                                                            Dated: November 30, 2015.
                                           15 CFR Part 742
                                                                                                    PART 736—[AMENDED]                                    Kevin J. Wolf,
                                               Exports, Terrorism.                                                                                        Assistant Secretary for Export
                                           15 CFR Part 744                                          ■ 3. The authority citation for 15 CFR                Administration.
                                                                                                    part 736 is revised to read as follows:               [FR Doc. 2015–30753 Filed 12–8–15; 8:45 am]
                                             Exports, Reporting and recordkeeping
                                                                                                      Authority: 50 U.S.C. app. 2401 et seq.; 50          BILLING CODE 3510–33–P
                                           requirements, Terrorism.
                                                                                                    U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O.
                                           15 CFR Part 745                                          12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
                                              Administrative practice and                           950; E.O. 13020, 61 FR 54079, 3 CFR, 1996
                                                                                                    Comp., p. 219; E.O. 13026, 61 FR 58767, 3             DEPARTMENT OF HEALTH AND
                                           procedure, Chemicals, Exports, Foreign                                                                         HUMAN SERVICES
                                                                                                    CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
                                           trade, Reporting and recordkeeping                       44025, 3 CFR, 2001 Comp., p. 783; E.O.
                                           requirements.                                            13338, 69 FR 26751, 3 CFR, 2004 Comp., p.             Food and Drug Administration
                                              Accordingly, parts 730, 734, 736, 742,                168; Notice of May 6, 2015, 80 FR 26815
                                           744, and 745 of the EAR (15 CFR parts                    (May 8, 2015); Notice of August 7, 2015, 80           21 CFR Parts 510, 520, 522, 524, and
                                           730–774) are amended as follows:                         FR 48233 (August 11, 2015); Notice of                 558
                                                                                                    November 12, 2015, 80 FR 70667 (November
                                           PART 730—[AMENDED]                                       13, 2015).                                            [Docket No. FDA–2015–N–0002]
                                           ■ 1. The authority citation for 15 CFR                   PART 742—[AMENDED]                                    New Animal Drugs; Approval of New
                                           part 730 is revised to read as follows:                                                                        Animal Drug Applications;
                                             Authority: 50 U.S.C. app. 2401 et seq.; 50             ■ 4. The authority citation for 15 CFR                Withdrawals of Approval of New
                                           U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C.           part 742 is revised to read as follows:               Animal Drug Applications; Changes of
                                           7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note;                                                                  Sponsorship
                                                                                                      Authority: 50 U.S.C. app. 2401 et seq.; 50
                                           22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30
                                                                                                    U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;          AGENCY:    Food and Drug Administration,
                                           U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
                                                                                                    42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
                                           U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a;                                                                  HHS.
                                           50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22             U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117
                                                                                                    Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR,                  Final rule; technical
                                                                                                                                                          ACTION:
                                           U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR,
                                                                                                    1978 Comp., p. 179; E.O. 12851, 58 FR 33181,          amendments.
                                           1976 Comp., p. 114; E.O. 12002, 42 FR 35623,
                                           3 CFR, 1977 Comp., p. 133; E.O. 12058, 43                3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
                                                                                                    FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.             SUMMARY:   The Food and Drug
                                           FR 20947, 3 CFR, 1978 Comp., p. 179; E.O.
                                           12214, 45 FR 29783, 3 CFR, 1980 Comp., p.                13026, 61 FR 58767, 3 CFR, 1996 Comp., p.             Administration (FDA) is amending the
                                           256; E.O. 12851, 58 FR 33181, 3 CFR, 1993                228; E.O. 13222, 66 FR 44025, 3 CFR, 2001             animal drug regulations to reflect
                                           Comp., p. 608; E.O. 12854, 58 FR 36587, 3                Comp., p. 783; Presidential Determination             application-related actions for new
                                           CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR               2003–23, 68 FR 26459, 3 CFR, 2004 Comp.,              animal drug applications (NADAs) and
                                           28205, 3 CFR, 1994 Comp., p. 899; E.O.                   p. 320; Notice of August 7, 2015, 80 FR 48233         abbreviated new animal drug
                                           12938, 59 FR 59099, 3 CFR, 1994 Comp., p.                (August 11, 2015); Notice of November 12,             applications (ANADAs) during
                                           950; E.O. 12947, 60 FR 5079, 3 CFR, 1995                 2015, 80 FR 70667 (November 13, 2015).                September and October 2015. FDA is
                                           Comp., p. 356; E.O. 12981, 60 FR 62981, 3                                                                      also informing the public of the
                                           CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR               PART 744—[AMENDED]                                    availability of summaries of the basis of
                                           54079, 3 CFR, 1996 Comp., p. 219; E.O.
                                           13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
                                                                                                                                                          approval and of environmental review
                                                                                                    ■ 5. The authority citation for 15 CFR                documents, where applicable. The
                                           228; E.O. 13099, 63 FR 45167, 3 CFR, 1998
                                                                                                    part 744 is revised to read as follows:               animal drug regulations are also being
                                           Comp., p. 208; E.O. 13222, 66 FR 44025, 3
                                           CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR                  Authority: 50 U.S.C. app. 2401 et seq.; 50         amended to reflect changes of
                                           49079, 3 CFR, 2001 Comp., p. 786; E.O.                   U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;          sponsorship of applications and the
                                           13338, 69 FR 26751, 3 CFR, 2004 Comp., p                 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22           voluntary withdrawals of approval of
                                           168; E.O. 13637, 78 FR 16129, 3 CFR, 2014                U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR,          applications that occurred in September
                                           Comp., p. 223; Notice of January 21, 2015, 80            1978 Comp., p. 179; E.O. 12851, 58 FR 33181,          and October 2015.
                                           FR 3461 (January 22, 2015); Notice of May 6,             3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
                                           2015, 80 FR 26815 (May 8, 2015); Notice of                                                                     DATES: This rule is effective December 9,
                                                                                                    FR 59099, 3 CFR, 1994 Comp., p. 950; E.O.
                                           August 7, 2015, 80 FR 48233 (August 11,                  12947, 60 FR 5079, 3 CFR, 1995 Comp., p.              2015, except for the amendments to 21
                                           2015); Notice of September 18, 2015, 80 FR               356; E.O. 13026, 61 FR 58767, 3 CFR, 1996             CFR 520.446, 520.2043, 558.625, and
                                           57281 (September 22, 2015); Notice of                    Comp., p. 228; E.O. 13099, 63 FR 45167, 3             558.630, which are effective December
                                           November 12, 2015, 80 FR 70667 (November                 CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR            21, 2015.
                                           13, 2015).                                               44025, 3 CFR, 2001 Comp., p. 783; E.O.                FOR FURTHER INFORMATION CONTACT:
wgreen on DSK2VPTVN1PROD with RULES




                                                                                                    13224, 66 FR 49079, 3 CFR, 2001 Comp., p.             George K. Haibel, Center for Veterinary
                                           PART 734—[AMENDED]                                       786; Notice of January 21, 2015, 80 FR 3461           Medicine (HFV–6), Food and Drug
                                                                                                    (January 22, 2015); Notice of August 7, 2015,         Administration, 7519 Standish Pl.,
                                           ■ 2. The authority citation for 15 CFR                   80 FR 48233 (August 11, 2015); Notice of
                                           part 734 is revised to read as follows:                                                                        Rockville, MD 20855, 240–402–5689,
                                                                                                    September 18, 2015, 80 FR 57281 (September
                                                                                                                                                          george.haibel@fda.hhs.gov.
                                             Authority: 50 U.S.C. app. 2401 et seq.; 50             22, 2015); Notice of November 12, 2015, 80
                                           U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099,            FR 70667 (November 13, 2015).                         SUPPLEMENTARY INFORMATION:



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Document Created: 2015-12-14 13:32:04
Document Modified: 2015-12-14 13:32:04
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.
DatesThe rule is effective December 9, 2015.
ContactWilliam Arvin, Regulatory Policy Division, Bureau of Industry and Security, email [email protected] or telephone: (202) 482-2440.
FR Citation80 FR 76383 
RIN Number0694-AG78
CFR Citation15 CFR 730
15 CFR 734
15 CFR 736
15 CFR 742
15 CFR 744
15 CFR 745
CFR AssociatedAdministrative Practice and Procedure; Advisory Committees; Exports; Reporting and Recordkeeping Requirements; Strategic and Critical Materials; Inventions and Patents; Research; Science and Technology; Terrorism; Chemicals and Foreign Trade

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