[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Rules and Regulations]
[Pages 60254-60257]
[FR Doc No: 2016-21031]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 730, 732, 734, 736, 738, 740, 742, 743, 746, 747, 748,
750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772, and 774

[Docket No. 160808698-6698-01]
RIN 0694-AH09

Updated Statements of Legal Authority for the Export
Administration Regulations

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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SUMMARY: This rule updates the Code of Federal Regulations (CFR) legal
authority paragraphs in the Export Administration Regulations (EAR) to
cite the most recent Presidential notice extending an emergency
declared pursuant to the International Emergency Economic Powers Act.
This is a procedural 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 September 1, 2016.

FOR FURTHER INFORMATION CONTACT: William Arvin, Regulatory Policy
Division, Bureau of Industry and Security, Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    Authority for all parts of the EAR other than part 745 rests, in
part, on Executive Order 13222 of August 17, 2001--National Emergency
with Respect to Export Control Regulations, 66 FR 44025, 3 CFR, 2001
Comp., p. 783 and on annual notices extending the emergency declared in
that executive order. This rule revises the authority paragraphs for
the affected parts of the EAR to cite the most recent such notice,
which the President signed on August 4, 2016.
    This rule is purely procedural and makes no changes other than to
revise CFR authority paragraphs 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 Final 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.

15 CFR Parts 732, 740, 748, 750, and 758

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

15 CFR Part 734

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

15 CFR Parts 736, 738, 770, and 772

    Exports.

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 743

    Administrative practice and procedure, Reporting and recordkeeping
requirements.

15 CFR Parts 746 and 774

    Exports, Reporting and recordkeeping requirements.

15 CFR Part 747

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

15 CFR Part 754

    Agricultural commodities, Exports, Forests and forest products,
Horses, Petroleum, Reporting and recordkeeping requirements.

15 CFR Part 756

    Administrative practice and procedure, Exports, Penalties.

15 CFR Part 760

    Boycotts, Exports, Reporting and recordkeeping requirements.

15 CFR Part 762

    Administrative practice and procedure, Business and industry,
Confidential business information, Exports, Reporting and recordkeeping
requirements.

15 CFR Part 764

    Administrative practice and procedure, Exports, Law enforcement,
Penalties.

15 CFR Part 766

    Administrative practice and procedure, Confidential business
information, Exports, Law enforcement, Penalties.

15 CFR Part 768

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements, Science and technology.

    Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 746,
747, 748, 750, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772 and 774
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. 4601 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; 42 U.S.C. 2139a; ; 15 U.S.C.
1824a; 50 U.S.C. 4305; 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 September 18, 2015, 80 FR 57281 (September 22,
2015); Notice of November 12, 2015, 80 FR 70667 (November 13, 2015);
Notice of January 20, 2016, 81 FR 3937 (January 22, 2016); Notice of
May 3, 2016, 81 FR 27293 (May 5, 2016); Notice of August 4, 2016, 81
FR 52587 (August 8, 2016).

PART 732--[AMENDED]

0
2. The authority citation for 15 CFR part 732 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR
52587 (August 8, 2016).

PART 734--[AMENDED]

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

    Authority: 50 U.S.C. 4601 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
November 12, 2015, 80 FR 70667 (November 13, 2015); Notice of August
4, 2016, 81 FR 52587 (August 8, 2016).

PART 736--[AMENDED]

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

    Authority: 50 U.S.C. 4601 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 November 12, 2015, 80 FR 70667 (November 13,
2015); Notice of May 3, 2016, 81 FR 27293 (May 5, 2016); Notice of
August 4, 2016, 81 FR 52587 (August 8, 2016).

PART 738--[AMENDED]

0
5. The authority citation for 15 CFR part 738 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 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. 3201 et
seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C.
4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR
58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR,
2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8,
2016).

PART 740--[AMENDED]

0
6. The authority citation for 15 CFR part 740 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22
U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of
August 4, 2016, 81 FR 52587 (August 8, 2016).

PART 742--[AMENDED]

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

    Authority:  50 U.S.C. 4601 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 November 12, 2015, 80 FR 70667 (November 13, 2015); Notice
of August 4, 2016, 81 FR 52587 (August 8, 2016).

PART 743--[AMENDED]

0
8. The authority citation for 15 CFR part 743 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 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 4, 2016, 81 FR
52587 (August 8, 2016).

PART 746--[AMENDED]

0
9. The authority citation for 15 CFR part 746 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22
U.S.C. 287c; Sec 1503, Pub. L. 108-11, 117 Stat. 559; 22 U.S.C.
6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 12854, 58 FR
36587, 3 CFR, 1993 Comp., p. 614; E.O. 12918, 59 FR 28205, 3 CFR,
1994 Comp., p. 899; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; E.O. 13338, 69 FR 26751, 3 CFR, 2004 Comp., p 168; Presidential
Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp., p. 320;
Presidential Determination 2007-7, 72 FR 1899, 3 CFR, 2006 Comp., p.
325; Notice of May 3, 2016, 81 FR 27293 (May 5, 2016); Notice of
August 4, 2016, 81 FR 52587 (August 8, 2016).

PART 747--[AMENDED]

0
10. The authority citation for 15 CFR part 747 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; Sec.
1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12918, 59 FR 28205, 3 CFR,
1994 Comp., p. 899; 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 4, 2016, 81 FR 52587 (August 8,
2016).

PART 748--[AMENDED]

0
11. The authority citation for 15 CFR part 748 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR
52587 (August 8, 2016).

PART 750--[AMENDED]

0
12. The authority citation for 15 CFR part 750 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; Sec.
1503, Pub. L. 108-11, 117 Stat. 559; 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, 2013 Comp., p. 223;
Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004 Comp.,
p. 320; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

PART 754--[AMENDED]

0
13. The authority citation for 15 CFR part 754 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10
U.S.C. 7420; 10 U.S.C. 7430(e); 15 U.S.C. 1824a; E.O. 11912, 41 FR
15825, 3 CFR, 1976 Comp., p. 114; E.O. 13222, 66 FR 44025, 3 CFR,
2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8,
2016).

PART 756--[AMENDED]

0
14. The authority citation for 15 CFR part 756 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 758--[AMENDED]

0
15. The authority citation for 15 CFR part 758 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 760--[AMENDED]

0
16. The authority citation for 15 CFR part 760 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 762--[AMENDED]

0
17. The authority citation for 15 CFR part 762 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 764--[AMENDED]

0
18. The authority citation for 15 CFR part 764 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 766--[AMENDED]

0
19. The authority citation for 15 CFR part 766 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 768--[AMENDED]

0
20. The authority citation for 15 CFR part 768 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 770--[AMENDED]

0
21. The authority citation for 15 CFR part 770 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 772--[AMENDED]

0
22. The authority citation for 15 CFR part 772 is revised to read as
follows:

    Authority:  50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4,
2016, 81 FR 52587 (August 8, 2016).

PART 774--[AMENDED]

0
23. The authority citation for 15 CFR part 774 is revised to read as
follows:

    Authority: 50 U.S.C. 4601 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. 3201 et
seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15 U.S.C. 1824a; 50 U.S.C.
4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR
58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR,
2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8,
2016).

    Dated: August 26, 2016.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2016-21031 Filed 8-31-16; 8:45 am]
 BILLING CODE 3510-33-P


[Federal Register Volume 78, Number 229 (Wednesday, November 27, 2013)]
[Proposed Rules]
[Pages 70900-70901]
[FR Doc No: 2013-28503]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0951; Airspace Docket No. 13-ASW-22]
RIN 2120-AA66

Proposed Modification of Area Navigation (RNAV) Route Q-20, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify RNAV route Q-20 in support of
the Houston Optimization of Airspace and Procedures in a Metroplex
(OAPM) project. This proposed action re-aligns Q-20 to incorporate the
FUSCO waypoint (WP) being relocated .48 nautical miles southwest to
match the intersection of Jet routes J-15 and J-183.

DATES: Comments must be received on or before January 13, 2014.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2013-
0951 and Airspace Docket No. 13-ASW-22 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy and ATC
Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2013-0951 and Airspace Docket No. 13-ASW-22) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2013-0951 and Airspace Docket No. 13-ASW-22.''
The postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Central Service Center, Operations
Support Group, Federal Aviation Administration, 2601 Meacham Blvd.,
Fort Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to modify Q-20 in support of the Houston
OAPM project. OAPM is intended to improve air traffic flows within an
entire region resulting in increased capacity and fuel efficiency and
reduced track distances. Q-20 extends between the Corona, NM, VHF
Omnidirectional Range/Tactical Air Navigation (VORTAC) navigation aid
and the Junction, TX, VORTAC navigation aid. This action would amend Q-
20 by relocating the FUSCO WP to match the intersection of Jet routes
J-15 and J-183, and re-designating FUSCO as a fix. The modification
would enable aircraft filed eastbound via J-15, J-183, or Q-20, to
file, after FUSCO, direct to a published transition to a Houston
Standard Terminal Arrival Route. This would simplify flight plan filing
and Flight Management Computer entries; thus, reducing the potential
for routing errors.
    High altitude RNAV routes are published in paragraph 2006 of FAA
Order 7400.9X dated August 7, 2013, and effective September 15, 2013,
which is incorporated by reference in 14 CFR 71.1. The RNAV route
listed in this document would be subsequently published in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This proposed regulation is within the scope of that

authority as it would modify the route structure as required to enhance
the safe and efficient flow of air traffic in the United States.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9X,
Airspace Designations and Reporting Points, dated August 7, 2013, and
effective September 15, 2013, is amended as follows:

Paragraph 2006 United States Area Navigation Routes.

* * * * *

Q-20 CNX, NM to JCT, TX [Amended]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Corona (CNX), NM                             VORTAC                         (Lat. 34[deg]22'01'' N., long. 105[deg]40'41'' W.)
HONDS, NM                                    FIX                            (Lat. 33[deg]34'00'' N., long. 104[deg]51'12'' W.)
UNNOS, NM                                    WP                             (Lat. 32[deg]57'00'' N., long. 103[deg]56'00'' W.)
FUSCO, TX                                    FIX                            (Lat. 31[deg]10'38'' N., long. 101[deg]19'47'' W.)
Junction (JCT), TX                           VORTAC                         (Lat. 30[deg]35'53'' N., long. 99[deg]49'03'' W.)

                                                                      * * * * * * *

    Issued in Washington, DC, on November 19, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-28503 Filed 11-26-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)]
[Notices]
[Pages 826-828]
[FR Doc No: 2015-33310]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76811; File No. SR-DTC-2015-013]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Postponing the Date for Retirement of Computer to Computer Facility
Corporate Action Announcement Files, and Implementing a Fee Associated
With Its Use

December 31, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 24, 2015, The Depository Trust Company (``DTC'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II and III below, which Items have
been prepared by DTC. DTC filed the proposed rule change pursuant to
Section 19(b)(3)(A) of the Act \3\ and Rules 19b-4(f)(2) and (f)(4)
thereunder.\4\ The proposed rule change was effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2) and (f)(4).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of (i) the postponement of the
date for the retirement of DTC's proprietary computer to computer
facility (``CCF'') files for corporate action announcements (``CCF
Announcement Files'') until further notice; and (ii) the implementation
of a fee associated with the use of CCF Announcement Files.

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, DTC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. DTC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    The proposed rule change would (i) postpone the date for the
retirement of CCF Announcement Files until further notice, and (ii)
implement a fee associated with the use of CCF Announcement Files, as
described below.\5\
---------------------------------------------------------------------------

    \5\ Each term not otherwise defined herein has its respective
meaning as set forth in the Rules, By-Laws and Organization
Certificate of DTC (the ``Rules''), available at http://www.dtcc.com/legal/rules-and-procedures.aspx and the Guide to the
2015 DTC Fee Schedule (``Fee Schedule''), available at http://
www.dtcc.com/~/media/Files/Downloads/legal/fee-guides/
dtcfeeguide.pdf?la=en.
---------------------------------------------------------------------------

Background
    DTC handles essential aspects of processing corporate action \6\
events by routinely receiving and distributing information to its
Participants using CCF Announcement Files. There are three corporate
action event groups for which CCF files are available: Distributions,
Redemptions, and Reorganizations. Participants subscribe to the CCF
files for each event group separately.
---------------------------------------------------------------------------

    \6\ Corporate actions processed by DTC include but are not
limited to the restructuring of DTC-eligible securities resulting
from mergers, acquisitions, and reverse splits. DTC performs
corporate actions processing through its Mandatory and Voluntary
Reorganization Services. See DTC Operational Arrangements (``OA''),
available at http://www.dtcc.com/~/media/Files/Downloads/legal/
issue-eligibility/eligibility/operational-arrangements.pdf.
---------------------------------------------------------------------------

Postponement of the Date for Retirement
    Since 2011, DTC has informed Participants that CCF Announcement
Files will be retired in 2015, and has been supporting Participant
efforts to migrate to the ISO 20022 standard by providing a robust
online learning center, hosting ISO specific monthly

calls and offering a dedicated email box for client inquiries.\7\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 63886 (February 10,
2011), 76 FR 9070 (February 16, 2011) (File No. SR-DTC-2011-02);
Securities Exchange Act Release No. 68114 (October 26, 2012), 77 FR
66497 (November 5, 2011) (File No. SR-DTC-2012-08).
---------------------------------------------------------------------------

    The use of the ISO 20022 standard reduces risk and improves
transparency in the announcement and processing of corporate actions.
ISO 20022 is a standard that provides the financial industry with a
common language to capture business transactions and associated message
flows. ISO 20022 is a business-model-based standard for the development
of messages for the international financial services industry and can
support different messaging syntaxes, including XML. In contrast, CCF
files use proprietary function and activity codes which differ from the
market standard codes. With the ISO 20022 standard, corporate action
announcements are identified by a unique corporate action ID and are
event based. ISO 20022 standard messages provide more data elements
than the CCF files and they are available in near real-time throughout
the day.
    Certain Participants nevertheless have inquired whether DTC could
continue supporting CCF Announcement Files while they prepare to
transition to the ISO 20022 standard, which is provided to Participants
free of charge. Some Participants suggested that they were willing to
pay for continued use of CCF Announcement Files while they prepare to
migrate to ISO 20022 standard.
    In response to these Participant requests, with this proposed rule
change, DTC would postpone the date for the retirement of CCF
Announcement Files and implement a fee for a Participant's continued
receipt of the CCF Announcement Files. A new retirement date would be
announced, subject to a future proposed rule change and Important
Notice issued by DTC.
Implementation of a CCF File Fee
    To encourage full adoption of the ISO 20022 standard, DTC is
proposing to implement a fee for each event group of CCF Announcement
Files that a Participant receives (the ``CCF File Fee''). The CCF File
Fee would be $50,000 per event group, per twelve month period as set
forth below for each event group (the ``Fee Period''). The CCF File Fee
would be charged to the Account of the Participant, upon the
Participant's first receipt of CCF Announcement Files for a particular
event group during the Fee Period. The CCF File Fee would cover all CCF
Announcement Files within that event group during the Fee Period. In
addition, once a Participant that is part of an Affiliated Family \8\
is charged the CCF File Fee for a particular event group, the other
Participants that are part of the Affiliated Family will not be charged
the CCF File Fee for such event group during that Fee Period. The
amount of the CCF File Fee is based on DTC's analysis of industry-
standard pricing for equivalent data.
---------------------------------------------------------------------------

    \8\ An Affiliated Family means each Participant that controls or
is controlled by another Participant and each Participant that is
under the common control of any Person. For purposes of this
definition, ``control'' means the direct or indirect ownership of
more than 50% of the voting securities or other voting interests of
any Person. Rule 1, supra note 1 [sic].
---------------------------------------------------------------------------

    DTC has communicated with its Participants about the CCF File Fee
through several outreach efforts, including Important Notices \9\ and
customer surveys regarding the December 2015 date and the amount of the
CCF File Fee. DTC did not receive any objections during its outreach.
---------------------------------------------------------------------------

    \9\ See, e.g., Important Notice B#0354-15, available at http://
dtcc.com/~/media/Files/pdf/2015/3/25/0354-15.pdf; Important Notice
B# 1946-15, available at http://www.dtcc.com/globals/pdfs/2015/october/22/1946-15.
---------------------------------------------------------------------------

Implementation Schedule
    DTC would implement the CFF File Fee in three phases, divided by
event group. The timeline for the implementation of the fees would be
as follows:
     CCF Announcement Files for the Distributions event group
would be subject to a CCF File Fee beginning on January 1, 2016. The
Fee Period would run from January through December.\10\
---------------------------------------------------------------------------

    \10\ On December 30, 2015, staff of the Commission's Division of
Trading and Markets had a conversation with DTC's legal counsel to
confirm that the Fee Period for the Distributions event group would
run from January 1 through December 31, as provided in the proposed
rule text.
---------------------------------------------------------------------------

     CCF Announcement Files for the Redemptions event group
would be subject to a CCF File Fee beginning on July 1, 2016. The Fee
Period would run from July through June.\11\
---------------------------------------------------------------------------

    \11\ On December 30, 2015, staff of the Commission's Division of
Trading and Markets had a conversation with DTC's legal counsel to
confirm that the Fee Period for the Redemptions event group would
run from July 1 through June 30, as provided in the proposed rule
text.
---------------------------------------------------------------------------

     CCF Announcement Files for the Reorganizations event group
would be subject to a CCF File Fee at a future date to be announced by
Important Notice. The Fee Period would be announced by Important
Notice.
Implementation Date
    The proposed rule change would take effect on January 1, 2016.
2. Statutory Basis
    Section 17(A)(b)(3)(F) of the Act, requires, inter alia, that DTC's
Rules be designed to promote the prompt and accurate clearance and
settlement of securities transactions.\12\ By postponing the date for
the retirement of CCF Announcement Files until further notice, the
proposed rule change would allow Participants to minimize potential
business interruption by undertaking an orderly and organized migration
from CCF files to the ISO 20022 standard. The proposed rule change
thereby facilitates the transition to the ISO 20022 standard without
disrupting the announcement of corporate actions and the clearance and
settlement activities related thereto. In addition, by revising the Fee
Schedule to implement a fee for Participants that continue to receive
the CCF Announcement Files, the proposed rule change encourages
efficiencies in communicating information about corporate action events
and in Participants' transition to the industry-standard ISO 20022.
Therefore, DTC believes that the proposed rule change would promote the
prompt and accurate clearance and settlement of securities transactions
and is consistent with the requirements of the Act, in particular
Section 17(A)(b)(3)(F) of the Act, cited above.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Section 17A(b)(3)(D) of the Act requires that DTC's Rules provide
for the equitable allocation of reasonable dues, fees, and other
charges among its Participants.\13\ DTC believes that the proposed fee
would be consistent with this provision because it would apply equally
in accordance with Participant use of the CCF Announcement Files, and
is therefore equitable, and is based on industry-standard pricing, and
therefore, reasonable.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78q-1(b)(3)(D).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    DTC does not believe that the proposed rule change would have any
impact, or impose any burden, on competition, because the postponement
of the date for the retirement of CCF Announcement Files would apply
equally to all Participants, and the proposed fee would apply equally
in accordance with Participant use of the CCF Announcement Files.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not been

solicited or received. DTC will notify the Commission of any written
comments received by DTC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \14\ and subparagraphs (f)(2) and (f)(4) of Rule
19b-4 thereunder.\15\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(2) and (f)(4).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2015-013 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-DTC-2015-013. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of DTC and on DTCC's
Web site (http://dtcc.com/legal/sec-rule-filings.aspx). All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-DTC-2015-013 and should be
submitted on or before January 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
Jill M. Peterson,
Assistant Secretary.
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2015-33310 Filed 1-6-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Proposed Rules]
[Pages 30391-30394]
[FR Doc No: 2015-12859]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1425; Directorate Identifier 2014-NM-185-AD]
RIN 2120-AA64

Airworthiness Directives; Lockheed Martin Corporation/Lockheed
Martin Aeronautics Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Lockheed Martin Corporation/Lockheed Martin Aeronautics Company
Model 188 series airplanes. This proposed AD was prompted by an
evaluation by the design approval holder (DAH) indicating that a
certain circumferential fuselage splice is subject to widespread
fatigue damage (WFD). This proposed AD would require an inspection for
corrosion and previous repairs, severed stringers, cracking, and loose
or distressed fasteners of the forward and aft ends of the stringer
splices of certain stringers, inspection for cracking and modification
of certain fastener holes common to the stringer and splice member at
the forward and aft ends of the splice, and related investigative and
corrective actions if necessary. We are proposing this AD to prevent
loss of residual strength of a certain circumferential fuselage splice,
which could lead to rapid decompression of the cabin and potential loss
of the airplane.

DATES: We must receive comments on this proposed AD by July 13, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Lockheed Martin Corporation/Lockheed Martin Aeronautics Company,
Airworthiness Office, Dept. 6A0M, Zone 0252, Column P-58, 86 S. Cobb
Drive, Marietta, GA 30063; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Internet http://www.lockheedmartin.com/ams/tools/TechPubs.html. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1425; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday,

except Federal holidays. The AD docket contains this proposed AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Office (phone:<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Carl Gray, Aerospace Engineer,
Airframe Branch, ACE-117A, FAA, Atlanta Aircraft Certification Office
(ACO), 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-
5554; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2015-1425;
Directorate Identifier 2014-NM-185-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Structural fatigue damage is progressive. It begins as minute
cracks, and those cracks grow under the action of repeated stresses.
This can happen because of normal operational conditions and design
attributes, or because of isolated situations or incidents such as
material defects, poor fabrication quality, or corrosion pits, dings,
or scratches. Fatigue damage can occur locally, in small areas or
structural design details, or globally. Global fatigue damage is
general degradation of large areas of structure with similar structural
details and stress levels. Multiple-site damage is global damage that
occurs in a large structural element such as a single rivet line of a
lap splice joining two large skin panels. Global damage can also occur
in multiple elements such as adjacent frames or stringers. Multiple-
site-damage and multiple-element-damage cracks are typically too small
initially to be reliably detected with normal inspection methods.
Without intervention, these cracks will grow, and eventually compromise
the structural integrity of the airplane, in a condition known as WFD.
As an airplane ages, WFD will likely occur, and will certainly occur if
the airplane is operated long enough without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.
    This proposed AD was prompted by an evaluation by the DAH
indicating that the circumferential fuselage splice at fuselage-station
(FS) 695 is subject to WFD. The root cause of this WFD is fatigue
cracks manifesting and growing simultaneously at similar structural
details and stress levels at the circumferential fuselage splice.
Fatigue cracking is increasingly likely as the airplane is operated and
aged, and without intervention, fatigue cracking could lead to loss of
residual strength of the circumferential fuselage splice at FS 695,
which could lead to rapid decompression of the cabin area and potential
loss of the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Lockheed Martin Electra Service Bulletin 88/SB-722,
dated April 30, 2014. This service bulletin describes procedures for
doing the following actions:
     A general visual inspection (GVI) for corrosion and
previous repairs, severed stringers, cracking, and loose or distressed
fasteners of the forward and aft ends of the stringer splices of
stringers 1-7 and 66-72, and corrective actions if necessary.
     At stringers 1-7 and 66-72, removing the four rivets
common to the stringer and splice member at the forward and aft ends of
the splice and doing a bolt hole eddy current (BHEC) inspection or an
equivalent inspection procedure for cracking in each of the fastener
holes, and corrective actions if necessary.
     Corrective actions for cracked holes include reaming to
the maximum permissible hole diameter of the next larger size rivet. If
a crack indication remains after reaming, this service information
specifies repairing the cracked stringer.
     If a severed stringer is found during the GVI, doing
related investigative actions of an eddy current surface scan
inspection for cracking of the fuselage skin at the skin-to-stringer
attachments immediately forward and aft of the stringer break and
confirming skin cracks with a dye penetrant inspection. Corrective
actions include repairing the severed stringer or skin cracks.
     For holes without crack indications, other specified
actions include modifying the fastener holes by reaming to a certain
maximum permissible hole diameter of the same size rivet and installing
replacement fasteners; or if original hole is larger than the maximum
permissible diameter, installing the next rivet size and type.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section of this
NPRM.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described

previously, except as discussed under ``Differences Between this
Proposed AD and the Service Information.''

Differences Between This Proposed AD and the Service Information

    Although Lockheed Martin Electra Service Bulletin 88/SB-722, dated
April 30, 2014, specifies that crack indications should be confirmed by
an alternate inspection method, this proposed AD would not require that
action.
    Operators should note that, although the Accomplishment
Instructions of Lockheed Martin Electra Service Bulletin 88/SB-722,
dated April 30, 2014, describe procedures for submitting a report of
damage, this proposed AD would not require that action.
    Lockheed Martin Electra Service Bulletin 88/SB-722, dated April 30,
2014, does not describe corrective actions if any corrosion or previous
repair is found, and if any loose or distressed fastener is found. This
proposed AD would require repair.

Explanation of Proposed Compliance Time

    The compliance time for the modification specified in this proposed
AD for addressing WFD was established to ensure that discrepant
structure is replaced before WFD develops in airplanes. Standard
inspection techniques cannot be relied on to detect WFD before it
becomes a hazard to flight. We will not grant any extensions of the
compliance time to complete any AD-mandated service bulletin related to
WFD without extensive new data that would substantiate and clearly
warrant such an extension.

Costs of Compliance

    We estimate that this proposed AD affects 4 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Inspections and Modification........  18 work-hours x $85 per          $5,000           $6,530          $26,120
                                       hour = $1,530.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Lockheed Martin Corporation/Lockheed Martin Aeronautics Company:
Docket No. FAA-2015-1425; Directorate Identifier 2014-NM-185-AD.

(a) Comments Due Date

    We must receive comments by July 13, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Lockheed Martin Corporation/Lockheed Martin
Aeronautics Company Model 188A and 188C airplanes, certificated in
any category, serial numbers 1001 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval
holder (DAH) indicating that the circumferential fuselage splice at
fuselage-station (FS) 695 is subject to widespread fatigue damage
(WFD). We are issuing this AD to prevent loss of residual strength
of the circumferential fuselage splice at FS 695, which could lead
to rapid decompression of the cabin and potential loss of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspections, Modification, Related Investigative Actions, and
Corrective Actions

    Before the accumulation of 38,200 total flight hours or within
30 days after the effective date of this AD, whichever occurs later:
Do a general visual inspection for corrosion and previous repairs,
severed stringers, cracking, and loose or distressed fasteners of
the forward and aft ends of the stringer splices of stringers 1-7
and 66-72; remove the four rivets common to the stringer and splice
member at the forward and aft ends of the splice and do a bolt hole
eddy current inspection or an equivalent inspection procedure for
cracking in each of the fastener holes; modify the fastener holes;

and do all applicable related investigative and corrective actions
and other specified actions; in accordance with the Accomplishment
Instructions of Lockheed Martin Electra Service Bulletin 88/SB-722,
dated April 30, 2014, except as specified in paragraph (h) of this
AD. Do all applicable related investigative and corrective actions
and other specified actions before further flight. If any repairs
exceed the repair limits specified in Lockheed Martin Electra
Service Bulletin 88/SB-722, dated April 30, 2014, before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.

(h) Corrective Action

    (1) If, during any inspection required by paragraph (g) of this
AD, any corrosion or previous repair is found, before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.
    (2) If, during any inspection required by paragraph (g) of this
AD, any loose or distressed fastener is found, before further
flight, repair using a method approved in accordance with the
procedures specified in paragraph (j) of this AD.

(i) Exception

    Although Lockheed Martin Electra Service Bulletin 88/SB-722,
dated April 30, 2014, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
ACO, send it to the attention of the person identified in paragraph
(j)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For more information about this AD, Carl Gray, Aerospace
Engineer, Airframe Branch, ACE-117A, FAA, Atlanta ACO, 1701 Columbia
Avenue, College Park, GA 30337; phone:<PHONE_NUMBER>; fax: 404-474-
5605; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Lockheed Martin Corporation/Lockheed Martin Aeronautics Company,
Airworthiness Office, Dept. 6A0M, Zone 0252, Column P-58, 86 S. Cobb
Drive, Marietta, GA 30063; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Internet http://www.lockheedmartin.com/ams/tools/TechPubs.html. You may view this service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on May 19, 2015.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-12859 Filed 5-27-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Page 45953]
[FR Doc No: 2020-16545]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2020-62]

Petition for Exemption; Summary of Petition Received; Delta
Engineering

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 19, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0528
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Deana Stedman, AIR-673, Federal
Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198,
phone and fax<PHONE_NUMBER>, email<EMAIL_ADDRESS>    This notice is published pursuant to 14 CFR 11.85.

    Issued in Des Moines, Washington, on July 27, 2020.
James E. Wilborn,
Acting Manager, Transport Standards Branch.

Petition for Exemption

    Docket No.: FAA-2020-0528.
    Petitioner: Delta Engineering.
    Section(s) of 14 CFR Affected: Sec. Sec.  25.855, 25.857, and
25.858.
    Description of Relief Sought: Delta Engineering is seeking relief
from certain fire protection requirements in order to obtain
supplemental type certificate approval of a type design change for
multiple airplane models from multiple airplane manufacturers. The type
design change would allow the airplane operators to remove passenger
seats to transport cargo, subject to the FAA's conditions, on the floor
of the main deck of transport category airplanes without revenue
passengers onboard. COVID-19 has dramatically reduced the demand for
commercial air travel. Due to this extreme reduction in demand,
passenger carriers now have the capacity to carry cargo, including
critical medical cargo, in-cabin. The relief that would be provided by
this exemption would also support the need to replace the cargo
capacity provided on airplanes normally flown by passenger carriers.

[FR Doc. 2020-16545 Filed 7-29-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32836-32838]
[FR Doc No: 2017-15004]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0231]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed extension of the collection of
information concerning requirements relating to FDA's Adverse
Experience Reporting System (FAERS) for licensed biological products,
and general records associated with the manufacture and distribution of
biological products.

DATES: Submit either electronic or written comments on the collection
of information by September 18, 2017.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0231 for ``Adverse Experience Reporting for Licensed
Biological Products; and General Records.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed

collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on respondents, including
through the use of automated collection techniques when appropriate,
and other forms of information technology.
Adverse Experience Reporting for Licensed Biological Products; and
General Records--21 CFR Part 600
OMB Control Number 0910-0308--Extension
    Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to ensure its safe use. FDA issued the Adverse
Experience Reporting (AER) requirements in part 600 (21 CFR part 600)
to enable FDA to take actions necessary for the protection of the
public health in response to reports of adverse experiences related to
licensed biological products. The primary purpose of FDA's AERS is to
identify potentially serious safety problems with licensed biological
products. Although premarket testing discloses a general safety profile
of a biological product's comparatively common adverse effects, the
larger and more diverse patient populations exposed to the licensed
biological product provides the opportunity to collect information on
rare, latent, and long-term effects. In addition, production and/or
distribution problems have contaminated biological products in the
past. AER reports are obtained from a variety of sources, including
manufacturers, patients, physicians, foreign regulatory agencies, and
clinical investigators. Identification of new and unexpected safety
issues through the analysis of the data in AERS contributes directly to
increased public health protection. For example, evaluation of these
safety issues enables FDA to take focused regulatory action. Such
action may include, but is not limited to, important changes to the
product's labeling (such as adding a new warning), coordination with
manufacturers to ensure adequate corrective action is taken, and
removal of a biological product from the market when necessary.
    Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
Alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable, to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires that a
person who submits an adverse action report to the licensed
manufacturer rather than to FDA, maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
Alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires licensed manufacturers to
report each adverse experience not reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3 years from the date of
issuance of the biologics license, and then at annual intervals. The
majority of these periodic reports are submitted annually, since a
large percentage of currently licensed biological products have been
licensed longer than 3 years. Section 600.80(k) requires licensed
manufacturers to maintain for a period of 10 years records of all
adverse experiences known to the licensed manufacturer, including raw
data and any correspondence relating to the adverse experiences.
Section 600.81 requires licensed manufacturers to submit, at an
interval of every 6 months, information about the quantity of the
product distributed under the biologics license, including the quantity
distributed to distributors. These distribution reports provide FDA
with important information about products distributed under biologics
licenses, including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may require the licensed manufacturer
to submit distribution reports under this section at times other than
every 6 months. Under Sec.  600.82(a), an applicant of a biological
product or blood and blood component must notify FDA of a permanent
discontinuance of manufacture or an interruption in manufacturing or
disruption in supply, as applicable. Under Sec. Sec.  600.80(h)(2) and
600.81(b)(2), a licensed manufacturer may request a temporary waiver
for the requirements under Sec. Sec.  600.80(h)(1) and 600.80(b)(1),
respectively. Requests for waivers must be submitted in accordance with
Sec.  600.90. Under Sec.  600.90, a licensed manufacturer may submit a
waiver request for any requirements that apply to the licensed
manufacturer under Sec. Sec.  600.80 and 600.81. A waiver request
submitted under Sec.  600.90 must include supporting documentation.
    Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product,
including any recalls. These recordkeeping requirements serve
preventative and remedial purposes by establishing accountability and
traceability in the manufacture and distribution of products. These
requirements also enable FDA to perform meaningful inspections. Section
600.12 requires, among other things, that records be made concurrently
with the performance of each step in the manufacture and distribution
of products. These records must be retained for no less than 5 years
after the records of manufacture have been completed or 6 months after
the latest expiration date for the individual product, whichever
represents a later date. In addition, under Sec.  600.12, manufacturers
must maintain records relating to the sterilization of equipment and
supplies, animal necropsy records, and records in cases of divided
manufacturing responsibility with respect to a product. Under Sec.
600.12(b)(2), manufacturers are also required to maintain complete
records pertaining to the recall from distribution of any product.
Furthermore, Sec.  610.18(b) (21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for verification of cultures and
determination of freedom from extraneous organisms be recorded and
retained. The recordkeeping requirements for Sec. Sec.  610.12(g),
610.13(a)(2), 610.18(d), 680.2(f), and 21 CFR 680.3(f) are approved
under OMB control number 0910-0139.
    Respondents to this collection of information include manufacturers
of biological products (including blood and blood components) and any
person

whose name appears on the label of a licensed biological product. In
table 1, the number of respondents is based on the estimated number of
manufacturers that are subject to those regulations or that submitted
the required information to the Center for Biologics Evaluation and
Research and Center for Drugs Evaluation and Research, FDA, in fiscal
year (FY) 2016. Based on information obtained from the FDA's database
system, there were 93 manufacturers of biological products. This number
excludes those manufacturers who produce Whole Blood, components of
Whole Blood, or in-vitro diagnostic licensed products, because of the
exemption under Sec.  600.80(m). The total annual responses are based
on the number of submissions received by FDA in FY 2016. There were an
estimated 125,371 15-day Alert reports, 180,580 periodic reports, and
677 lot distribution reports submitted to FDA. The number of 15-day
Alert reports for postmarketing studies under Sec.  600.80(e) is
included in the total number of 15-day Alert reports. FDA received 81
requests from 40 manufacturers for waivers under Sec.  600.90
(including Sec. Sec.  600.80(h)(2) and 600.81(b)(2)), of which 79 were
granted. The hours per response are based on FDA experience. The burden
hours required to complete the MedWatch Form (Form FDA 3500A) for Sec.
600.80(c)(1), (e), and (f) are reported under OMB control number 0910-
0291.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
         21 CFR section              Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
----------------------------------------------------------------------------------------------------------------
600.80(c)(1), 600.80(d), and                  93        1,348.07         125,371               1         125,371
 600.80(e); postmarketing 15-day
 Alert reports..................
600.82; notification of                       18            1.61              29               2              58
 discontinuance or interruption
 in manufacturing...............
600.80(c)(2); periodic adverse                93        1,941.72         180,580              28       5,056,240
 experience reports.............
600.81 Distribution Reports.....              93            7.28             677               1             677
600.80(h)(2), 600.81(b)(2), and               40            2.03              81               1              81
 600.90; waiver requests........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       5,182,427
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection information.

    In table 2 the number of respondents is based on the number of
manufacturers subject to those regulations. Based on information
obtained from FDA's database system, there were 263 licensed
manufacturers of biological products in FY 2016. However, the number of
recordkeepers listed for Sec.  600.12(a) through (e) excluding (b)(2)
is estimated to be 114. This number excludes manufacturers of blood and
blood components because their burden hours for recordkeeping have been
reported under Sec.  606.160 in OMB control number 0910-0116. The total
annual records is based on the annual average of lots released in FY
2016 (7,198), number of recalls made (575), and total number of adverse
experience reports received (305,951) in FY 2016. The hours per record
are based on FDA experience.
    FDA estimates the burden of this recordkeeping as follows:

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                     Number of       Number of     Total annual         per
         21 CFR section            recordkeepers    records per       records      recordkeeper     Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
600.12; \2\ maintenance of                   114           63.14           7,198              32         230,336
 records........................
600.12(b)(2); recall records....             263            2.19             575              24          13,800
600.80(c)(1) and 600.80(k)......              93        3,289.79         305,951               1         305,951
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         550,087
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The recordkeeping requirements in Sec.   610.18(b) are included in the estimate for Sec.   600.12.

    The burden for this information collection has changed since the
last OMB approval. Because of an increase in the number of AER reports
we have received during the past 3 years, we have increased our
reporting and recordkeeping burden estimates.

    Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15004 Filed 7-17-17; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story; on 11/13/12 I was cut off by a 92yr old driver. I spent 5 weeks in the hospital. I had smoked cigarettes prior to this, and smoked cigarettes during week 4 of hospitalization. I returned to work 2/16/13, the Walgreens I work at is one of the busier stores in Pasco, I found myself very quickly becoming winded talking to the customer I would be ringing up, while greeting customers as they walked into my store, and answering the phone. When we would get deliveries, I would be winded and felt all around bad. Once I ordered an ecig from a friend in NJ, and started vaping, I noticed after a few weeks (time it took my body to expel the carcinogens from combustable cigarettes) I felt better, I wasn't becoming winded as I was before,and now I'm able to make it through a weekly delivery with 3 pallets of 24pk water. (72 cases of water make up 1 pallet)


[Federal Register: September 3, 2009 (Volume 74, Number 170)]
[Notices]
[Page 45634]
[DOCID:fr03se09-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

August 26, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP06-200-059.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline submits Ninth Revised Sheet 9
to its FERC Gas Tariff, Second Revised Volume 1.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0015.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 8, 2009.

    Docket Numbers: RP09-260-004.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Tres Palacious Gas Storage, LLC submits First Revised
Sheet 21 et al. to its FERC Gas Tariff, Original Volume 1.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0016.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 8, 2009.

    Docket Numbers: RP09-61-009.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Gulf Crossing Pipeline Company, LLC submits amendment
to negotiated rate letter agreement.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0079.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 8, 2009.

    Docket Numbers: RP96-320-114.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits amendment to
negotiated rate letter agreement.
    Filed Date: 08/24/2009.
    Accession Number: 20090825-0078.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 8, 2009.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-21251 Filed 9-2-09; 8:45 am]

BILLING CODE 6717-01-P