[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Rules and Regulations]
[Page 53864-53867]
[DOCID:fr02se10-12]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 746, 747,
748, 750, 752, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772,
and 774

[Docket No. 100824381-0381-02]
RIN 0694-AF00

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 legal
authority citations for the Export Administration Regulations (EAR) to
include the citation to the President's Notice of August 12, 2010--
Continuation of Emergency Regarding Export Control Regulations.

DATES: The rule is effective September 2, 2010.

ADDRESSES: Comments concerning this rule should be sent to
publiccomments @bis.doc.gov, fax<PHONE_NUMBER>, or to Regulatory
Policy Division, Bureau of Industry and Security, Room H2705, U.S.
Department of Commerce, Washington, DC 20230. Please refer to
regulatory identification number (RIN) 0694-AF00 in all comments, and
in the subject line of e-mail comments.

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

SUPPLEMENTARY INFORMATION:

Background

    Since the Export Administration Act of 1979, as amended (50 U.S.C.
app. sections 2401-2420 (2000)), expired in August 2001, parts 730-744
and 746-774 of the EAR (15 CFR Parts 730-774) have been continued in
force pursuant to Executive Order 13222 of August 17, 2001, 3 CFR, 2001
Comp., p. 783 (2002) and the annual notices continuing the
international emergency declared in that executive order. This rule
revises authority citations paragraphs in the Code of Federal
Regulations (CFR) to include the President's notice of August 12,
2010--Continuation of Emergency Regarding Export Control Regulations
(74 FR 50681, August 16, 2010), which is the most recent such annual
notice. This rule is purely procedural, and makes no changes other than
to revise CFR authority citations paragraphs. 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. 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)(3)(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. 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 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.

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, 752, 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 Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

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.

0
Accordingly, parts 730, 732, 734, 736, 738, 740, 742, 743, 744, 746,
747, 748, 750, 752, 754, 756, 758, 760, 762, 764, 766, 768, 770, 772
and 774 of the EAR (15 CFR parts 700-774) are amended as follows:

PART 730--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151
note; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s),
185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C.
1824a; 50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
E.O. 11912, 41 FR 15825, 3 CFR, 1976 Comp., p. 114; E.O. 12002, 42
FR 35623, 3 CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 20947, 3 CFR,
1978 Comp., p. 179; E.O. 12214, 45 FR 29783, 3 CFR, 1980 Comp., p.
256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12854,
58 FR 36587, 3 CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 28205, 3
CFR, 1994 Comp., p. 899; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp.,
p. 950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 356; E.O.
12981, 60 FR 62981, 3 CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR
54079, 3 CFR, 1996 Comp. p. 219; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p.
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224,
66 FR 49079, 3 CFR, 2001 Comp., p. 786; E.O. 13338, 69 FR 26751, May
13, 2004; Notice of August 12, 2010, 75 FR 50681 (August 16, 2010);
Notice of November 6, 2009, 74 FR 58187 (November 10, 2009).

PART 732--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 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 12, 2010, 75
FR 50681 (August 16, 2010).

PART 734--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 13020, 61
FR 54079, 3 CFR, 1996 Comp. p. 219; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Notice of August 12, 2010, 75 FR 50681 (August 16, 2010);
Notice of November 6, 2009, 74 FR 58187 (November 10, 2009).

PART 736--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 2151 note; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p.
950; E.O. 13020, 61 FR 54079, 3 CFR, 1996

Comp. p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69
FR 26751, May 13, 2004; Notice of August 12, 2010, 75 FR 50681
(August 16, 2010); Notice of November 6, 2009, 74 FR 58187 (November
10, 2009).

PART 738--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c; 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 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 12, 2010, 75 FR 50681 (August 16, 2010).

PART 740--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 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 12, 2010, 75 FR 50681 (August 16, 2010).

PART 742--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; Sec 1503, Public Law 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 of May 7, 2003, 68 FR 26459, May 16, 2003;
Notice of August 12, 2010, 75 FR 50681 (August 16, 2010); Notice of
November 6, 2009, 74 FR 58187 (November 10, 2009).

PART 743--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 744--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179;
E.O. 12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59
FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 12947, 60 FR 5079, 3 CFR,
1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 208; E.O. 13222,
66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 49079, 3
CFR, 2001 Comp., p. 786; Notice of August 12, 2010, 75 FR 50681
(August 16, 2010); Notice of November 6, 2009, 74 FR 58187 (November
10, 2009).

PART 746--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 287c; Sec 1503, Public Law 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, 3 CFR, 2001 Comp., p. 783;
Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May
16, 2003; Presidential Determination 2007-7 of December 7, 2006, 72
FR 1899 (January 16, 2007); Notice of August 12, 2010, 75 FR 50681
(August 16, 2010).

PART 747--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
Sec 1503, Public Law 108-11, 117 Stat. 559; E.O. 12918, 59 FR 28205,
3 CFR, 1994 Comp., p. 899; E.O. 13222, 3 CFR, 2001 Comp., p. 783;
Presidential Determination 2003-23 of May 7, 2003, 68 FR 26459, May
16, 2003; Notice of August 12, 2010, 75 FR 50681 (August 16, 2010).

PART 748--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 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 12, 2010, 75
FR 50681 (August 16, 2010).

PART 750--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
Sec 1503, Public Law 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; Presidential Determination 2003-23 of May 7, 2003, 68
FR 26459, May 16, 2003; Notice of August 12, 2010, 75 FR 50681
(August 16, 2010).

PART 752--[AMENDED]

0
14. The authority citation for 15 CFR part 752 is revised to read as
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp. p. 219; E.O. 13222, 66 FR
44025, 3 CFR, 2001 Comp., p. 783; Notice of August 12, 2010, 75 FR
50681 (August 16, 2010).

PART 754--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 30 U.S.C. 185(s), 185(u); 42
U.S.C. 6212; 43 U.S.C. 1354; 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 12, 2010, 75 FR 50681 (August
16, 2010).

PART 756--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 758--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 760--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 762--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 764--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 766--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 768--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 770--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 772--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
12, 2010, 75 FR 50681 (August 16, 2010).

PART 774--[AMENDED]

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

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 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 12, 2010, 75 FR 50681 (August 16, 2010).

    Dated: August 30, 2010.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2010-21957 Filed 9-1-10; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register Volume 88, Number 169 (Friday, September 1, 2023)]
[Notices]
[Pages 60480-60481]
[FR Doc No: 2023-18973]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002; Internal Agency Docket No. FEMA-B-2364]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before November 30, 2023.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2364, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances

that are more stringent in their floodplain management requirements.
The community may at any time enact stricter requirements of its own or
pursuant to policies established by other Federal, State, or regional
entities. These flood hazard determinations are used to meet the
floodplain management requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Nicholas A. Shufro,
Deputy Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Effingham County, Illinois and Incorporated Areas
          Project: 16-05-2969S Preliminary Date: July 21, 2022
------------------------------------------------------------------------
City of Altamont.......................  City Hall, 202 North 2nd
                                          Street, Altamont, IL 62411.
City of Effingham......................  City Hall, 201 East Jefferson
                                          Avenue, Effingham, IL 62401.
Unincorporated Areas of Effingham        Effingham County Courthouse,
 County.                                  101 North 4th Street, Suite
                                          304, Effingham, IL 62401.
Village of Dieterich...................  Village Hall, 103 West Section
                                          Street, Dieterich, IL 62424.
Village of Teutopolis..................  Village Hall, 106 West Main
                                          Street, Teutopolis, IL 62467.
Village of Watson......................  Village Hall, 104 North Monroe
                                          Street, Watson, IL 62473.
------------------------------------------------------------------------
             Itasca County, Minnesota and Incorporated Areas
  Project: 17-05-1527S Preliminary Date: November 20, 2020 and July 30,
                                  2021
------------------------------------------------------------------------
City of Bigfork........................  City Hall, 200 Main Avenue,
                                          Bigfork, MN 56628.
City of Bovey..........................  City Hall, 402 2nd Street,
                                          Bovey, MN 55709.
City of Cohasset.......................  City Hall, 305 Northwest First
                                          Avenue, Cohasset, MN 55721.
City of Coleraine......................  City Hall, 302 Roosevelt
                                          Avenue, Coleraine, MN 55722.
City of Deer River.....................  City Hall, 60 2nd Street SE,
                                          Deer River, MN 56636.
City of Grand Rapids...................  City Hall, 420 North Pokegama
                                          Avenue, Grand Rapids, MN
                                          55744.
City of Keewatin.......................  City Hall, 127 West Third
                                          Avenue, Keewatin, MN 55753.
City of LaPrairie......................  LaPrairie City Hall, 15 Park
                                          Drive, Grand Rapids, MN 55744.
City of Taconite.......................  Community Building, 26 Haynes
                                          Street, Taconite, MN 55786.
City of Warba..........................  City Hall, 130 South 2nd
                                          Avenue, Warba, MN 55793.
City of Zemple.........................  Zemple City Hall, 606 County
                                          Road 139, Deer River, MN
                                          56636.
Unincorporated Areas of Itasca County..  Itasca County Courthouse,
                                          Department of Environmental
                                          Services, 123 Northeast 4th
                                          Street, Grand Rapids, MN
                                          55744.
Leech Lake Band of Ojibwe..............  Leech Lake Band of Ojibwe
                                          Tribal Office, 190 Sailstar
                                          Drive NW, Cass Lake, MN 56633.
------------------------------------------------------------------------
              Hamilton County, Ohio and Incorporated Areas
        Project: 14-05-4456S Preliminary Date: February 03, 2023
------------------------------------------------------------------------
City of Forest Park....................  City Hall, 1201 West Kemper
                                          Road, Forest Park, OH 45240.
Unincorporated Areas of Hamilton County  Hamilton County Department of
                                          Planning and Development, 138
                                          East Court Street, Room 603,
                                          Cincinnati, OH 45202.
Village of Cleves......................  Administration Offices, 92
                                          Cleves Avenue, Cleves, OH
                                          45002.
------------------------------------------------------------------------

[FR Doc. 2023-18973 Filed 8-31-23; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 82, Number 185 (Tuesday, September 26, 2017)]
[Notices]
[Pages 44803-44807]
[FR Doc No: 2017-20521]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5319]

Devices Proposed for a New Use With an Approved, Marketed Drug;
Public Hearing; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing on a potential approach for device sponsors
who seek to obtain marketing authorization for their products that are
labeled for a new use with an approved, marketed drug when the sponsor
for the approved drug does not wish to pursue or collaborate on the new
use.

DATES: The public hearing will be held on November 16, 2017, from 9
a.m. to 5 p.m. The public hearing may be extended or may end early
depending on the level of public participation. Persons seeking to
attend or to present at the public hearing must register by October 26,
2017. Sections II and III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until January 15, 2018. Late, untimely filed comments
will not be considered.

ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the
public hearing participants (non-FDA employees) is through Building 1,
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

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-2017-N-5319 for ``Devices Referencing Drugs; Public Hearing;
Request for Comments.'' Received comments 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: John Barlow Weiner, Associate Director
for Policy, Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver
Spring, MD 20933,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Medical products are often intended and labeled for use in
conjunction with other medical products marketed by different sponsors
(as used in this document, ``sponsor'' includes an applicant or
manufacturer). In some cases, the medical products are of different
types (such as drug and device, biological product and device, or drug
and biological product). Typically, the different sponsors collaborate
when the two products are to be used together for a new intended use.
In some cases, products intended for use with one another comprise a
``combination product'' as the term is defined in 21 CFR 3.2(e).
Regardless of whether the products meet the definition of a combination
product, collaboration between the sponsors can facilitate product
development and obtaining marketing authorization for the products for
the combined use, and can, thereby, enable access to innovative
treatment options for patients. Inclusion of the combined use in the
labeling of both products helps ensure user understanding, and the
collaboration can also be important to ensuring the ongoing safety and
effectiveness of the products for the combined use.
    Sometimes, however, sponsors seek marketing authorization from FDA
for a medical product for a new use with the approved, marketed medical
product of another sponsor (i.e., not included in the labeling for the
approved, marketed product), and the sponsor of the approved, marketed
product does not wish to pursue the new use or work with the other
product sponsor. Generally, such proposed products have been devices
proposing new uses with approved, marketed drugs (referred to in this
notice as devices referencing drugs or DRDs), though other scenarios
have been proposed as well, such as drugs proposed for new uses with
cleared or approved, marketed devices. This notice focuses on DRDs.
    In FDA's experience, DRDs may be proposed: (1) To enhance the
safety or effectiveness of the marketed drug for its already approved
indication; (2) for use with the approved drug for an indication for
which the drug is not approved; or (3) to provide some other benefit,
such as increasing user comfort or convenience. Such new uses have
generally also involved a change in how the drug is used or
administered, such as a change in dose, route, or rate of
administration.
    FDA seeks to ensure that safe and effective medical products can be
brought onto the market in a timely manner. The Agency encourages
development of products that advance public health, particularly those
that significantly improve the safety or effectiveness of an existing
treatment or that address an unmet medical need. DRDs have the
potential to advance the public health by offering new uses with
approved, marketed drugs that might not otherwise be developed, because
the drug sponsor does not wish to pursue the new use. At the same time,
DRDs raise unique public health, scientific, regulatory, and legal
issues.
    FDA, in cooperation with the Drug Information Association, held a
public meeting in 2005 on combined uses of separately distributed
products.\1\ That meeting focused on the public health, legal,
regulatory, and scientific issues \2\ that arise when sponsors seek to
develop or market a product of one type (device, drug, or biological
product) that would be labeled for use with an approved product of a
different type, where the proposed use is not included in the labeling
for the approved product.
---------------------------------------------------------------------------

    \1\ Links to the Federal Register notice for the workshop,
presentations given, and a full transcript of the proceedings are
available at: https://www.fda.gov/combinationproducts/meetingsconferencesworkshops/ucm116623.htm.
    \2\ Although the issues discussed at the meeting were described
as public health or legal issues, they also included scientific and
regulatory issues.
---------------------------------------------------------------------------

    As reflected in the notice for that meeting and the presentations
and discussions at the meeting, devices intended for a new combined use
with a drug raise unique public health, scientific, regulatory and
legal issues when the sponsors for the two products do not work
together on the new combined use of the two products. Since that time,
FDA has gained greater experience with these issues and believes that
many of these issues for DRDs could be addressed under the approach
described below.
    FDA wishes to obtain further public input through a more focused
hearing

on the Agency's potential approach for premarket review of proposed
DRDs. The Agency is seeking this type of public engagement because of
the potential importance of the issue for the public health and the
need for input across the medical product industry and among public
health stakeholders regarding how FDA should proceed.

II. Purpose and Scope of the Public Hearing

    The purpose of the public hearing is to obtain comment from
stakeholders on the potential approach described below, for premarket
review of DRDs. As described above, DRDs, for purposes of this document
and hearing, are devices that are intended for a use with an approved,
marketed drug that is not in the labeling for the approved drug, where
the drug application is held by a different sponsor that does not wish
to pursue or collaborate on the new use with the device sponsor. The
approach described below might be appropriate, for example, for drug
delivery systems seeking to be labeled for use with an approved drug,
for an indication for which that drug has not been approved (e.g., to
administer the drug to treat a different disease or condition or a new
patient population). We also welcome comment on any public health,
scientific, regulatory, or legal considerations relating to DRDs and
other medical products seeking to be labeled for new uses with
approved, marketed medical products of a different type where the
sponsor for the approved, marketed product does not wish to pursue or
collaborate on the new use. The comments that FDA receives from this
public hearing may help inform the further development of this
approach.

A. A Potential Approach for Premarket Review of DRDs

    FDA strongly recommends collaboration between sponsors on new
combined uses of their medical products. The Agency is prepared to work
with sponsors to facilitate such collaboration. When sponsors work
together, they usually have an ongoing relationship that enables them
to resolve many of the public health, scientific, regulatory, and legal
issues that may arise as a result of two products being the
responsibility of two independent sponsors. Such collaboration also can
provide important information to support a regulatory decision (see
below). Where collaboration between sponsors is not feasible, for
example, because one sponsor does not wish to collaborate, FDA believes
that the following factors could help address many of the public
health, scientific, regulatory, and legal issues associated with DRDs.
In doing so, these factors could allow for a DRD to be reviewed and
approved via a device premarket authorization pathway \3\ without
approval of conforming labeling changes for the approved, marketed drug
through a new drug application (NDA) or supplement to an NDA (see
Section II.B Submission Considerations for further discussion).
---------------------------------------------------------------------------

    \3\ FDA has not determined at this time whether DRDs may be
reviewed through other device premarket authorization pathways
besides premarket approval applications (PMAs), but FDA intends to
consider this issue and welcomes comment on it.
---------------------------------------------------------------------------

B. Factors

    DRD sponsors should be able to address the following issues as
discussed below:
    1. Safety and Effectiveness of the New Use of the Drug. The DRD
sponsor is able to demonstrate the safety and effectiveness of the new
use of the drug that is included in the DRD labeling, by providing
substantial evidence that the drug will have the effect it purports or
is represented to have under the conditions of use described in the
proposed DRD labeling and showing that the drug is safe for use under
the conditions prescribed, recommended, or suggested in the proposed
DRD labeling, as this is the standard that applies to new uses of drugs
(see 21 U.S.C. 355(c) and (d)). If there are multiple approved versions
of the approved drug product(s) referenced in the DRD labeling
(including generic versions), the DRD sponsor is able to demonstrate
the generalizability of the new use with all such versions of the drug
product.
    2. User Confusion and Medication Error/Use Error. Given the
potential for user confusion or medication error/use error, for
example, due to certain differences in the labeling for the DRD and the
approved drug that it is referencing, the DRD sponsor is able to
demonstrate that the potential for user confusion or error has been
adequately addressed. The DRD labeling must provide adequate directions
for the new use with the approved, marketed drug.
    3. Postmarket Change Management. The DRD sponsor is able to
demonstrate that it is able to address safety or effectiveness issues
associated with changes to the approved, marketed drug, for example, by
demonstrating: That the likelihood of changes to the approved, marketed
drug is low; changes to the drug are unlikely to raise safety or
effectiveness issues with respect to the conditions of use with the
drug as described in the DRD labeling; and periodic testing will be
conducted and be adequate to assure ongoing safety and effectiveness of
the combined use. It is important that these issues be addressed
because the DRD sponsor does not have a relationship with the sponsor
for the approved, marketed drug, and, therefore, any changes to the two
products will not be coordinated or communicated in advance.
    4. Postmarket Safety. The DRD sponsor is able to demonstrate that
it has a postmarket safety plan to adequately address adverse events,
including medication errors, related to the drug when used with the
DRD. It is important that its postmarket safety plan allows the DRD
sponsor to adequately capture, report, and respond appropriately to
adverse events associated with the new drug use described in the DRD
labeling, because the DRD sponsor does not have a relationship with the
sponsor(s) of the approved, marketed drug and because the DRD sponsor
will often be uniquely positioned to understand and address adverse
events resulting from the new use of the drug described in the DRD
labeling.
    5. Data Reliance. The DRD sponsor is able to provide all
information needed to evaluate the safety and effectiveness of the new
use with the approved drug referenced in the DRD labeling, without
relying on any proprietary information for the approved drug (e.g., by
instead relying on non-product-specific published literature,
generalizable knowledge). The DRD sponsor may also be able to include
in its application safety and effectiveness data and information from
the marketing application for the drug that are publicly available, for
example, if the approved reference listed drug has been withdrawn from
sale, provided that FDA has determined that the approved reference
listed drug was not withdrawn from sale for reasons of safety or
effectiveness (see 21 U.S.C. 355(l) and 21 CFR 314.161 and 314.430).
Generally, a DRD sponsor would not have a right of reference to
proprietary information on the approved drug with which the DRD is
proposed to be used because the DRD sponsor has no relationship with
the sponsor of the approved drug.

C. Submission Considerations

    At the investigational stage, depending on the details of the
investigational plan, a DRD sponsor may seek to submit an
investigational new drug application (IND) or an investigational device
exemption application (IDE). Either way, the Center for Drug Evaluation
and Research

(CDER) and the Center for Devices and Radiological Health (CDRH) would
collaborate on the review. DRD sponsors should consult with CDER and
CDRH as to which application to submit for a particular investigation.
    FDA believes that a PMA would generally be the appropriate device
marketing application because, e.g., DRDs are expected to represent a
new intended use or raise different questions of safety or
effectiveness as compared to a legally marketed predicate device.
Generally, PMAs for DRDs would be reviewed by CDRH, and CDRH would
collaborate with CDER on the review of the DRD. CDRH would have the
lead on device-specific issues, and CDER would have the lead on drug-
specific issues. The Centers would identify any review aspects where
review considerations overlap, to ensure Agency alignment on how to
address these considerations and communicate about them to DRD
sponsors.

D. Questions for Commenters To Address

    FDA welcomes all feedback on the potential approach and on any
public health, scientific, regulatory, and legal issues raised by it.
We seek public comment on the factors and submission considerations
described in this notice, and propose the following questions in an
effort to prompt substantive input from stakeholders:
    1. Are there public health, scientific, regulatory, or legal issues
that should be considered with respect to this potential approach for
DRDs? If so, are there ways to address those issues?
    2. Is each of the factors and submission considerations described
above appropriate? If not, why not? What modifications would you
propose and why? Are there additional factors or submission
considerations that the Agency should take into account? Please provide
examples to illustrate your view.
    3. Should the approach described in this notice be limited to
certain situations, such as where the combined use would potentially
address an unmet medical need for a serious or life-threatening
condition? If so, please provide a detailed analysis in support of your
view, including its legal justification.
    4. With respect to the user confusion and medication error/use
error factor, are there other issues that DRD sponsors should address
or that FDA should consider, to ensure that the DRD labeling provides
adequate directions for the new use with the approved, marketed drug,
without approval of conforming labeling changes for the approved,
marketed drug? What issues should be considered with respect to
promotional activities by the DRD sponsor and/or by any sponsors for
the drug being referenced?
    5. With regard to the postmarket change management factor, what
would be examples of circumstances in which the DRD sponsor would be
able to adequately address this factor? What types of postmarket
changes to the drug should the DRD sponsor be prepared to identify and
address? What postmarket mechanisms, including specific testing or
monitoring, would be appropriate to ensure ongoing safety and
effectiveness of the combined use?
    6. When multiple versions of the drug, including generics, are
marketed, what challenges exist in identifying which versions of the
drug can be used with the DRD? How can DRD sponsors make this
information clear to health care providers, pharmacists, and patients?
    7. What challenges exist at the investigational application stage,
and how can those challenges be addressed? Are there circumstances
where an IND would be the more appropriate investigational application
for a clinical investigation of a DRD? Are there circumstances where an
IDE would be the more appropriate investigational application?
    8. How may this approach impact future product development?
    9. Would an approach similar to the potential approach presented in
this notice be appropriate for other types of combined uses (e.g.,
drugs referencing devices where the device sponsor does not wish to
collaborate on the new use)? If so, how should the factors, submission
considerations, or both be modified for other types of combined uses?
Are there additional factors that should be considered for other types
of combined uses?
    10. Are there other possible approaches that may be used to seek
marketing authorization for combined uses of drugs and devices where
product sponsors are unable or unwilling to collaborate? Please provide
a detailed analysis in support of your proposed approach, including its
legal justification.
    11. Recognizing that collaboration is preferable, what actions can
FDA and stakeholders take to encourage and facilitate collaboration
between device sponsors and sponsors of approved, marketed drugs to
develop new combined uses of their medical products?
    12. Would an approach similar to the potential approach presented
in this notice be appropriate in the case where a drug sponsor would
like to include in the drug labeling the use of one or more approved or
cleared companion diagnostics for its new drug in the same class as the
drugs for which the companion diagnostic is approved or cleared but
none of the companion diagnostic sponsors intend to add the new drug to
the device labeling? If so, how should the factors, submission
considerations, or both be modified? Are there additional factors that
should be considered? Are there other possible approaches that may be
used for such circumstance? Please provide a detailed analysis in
support of your proposed approach, including its legal justification.

III. Registration

    Registration and Requests for Oral Presentations: The FDA
Conference Center at the White Oak location is a Federal facility with
security procedures and limited seating. Attendance will be free and on
a first-come, first-served basis. If you wish to attend (either in
person or by webcast (see Streaming Webcast of the Public Hearing))
and/or present at the hearing, please register for the hearing and/or
make a request for oral presentations or comments at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm by
October 26, 2017 and provide complete contact information for each
attendee (i.e., name, title, affiliation, address, email address, and
telephone number). Those without email access can register by
contacting John Barlow Weiner by October 26, 2017 (see FOR FURTHER
INFORMATION CONTACT).
    FDA will try to accommodate all persons who wish to make a
presentation. Individuals wishing to present should identify the number
of the question, or questions, they wish to address. This will help FDA
organize the presentations. Individuals and organizations with common
interests should consolidate or coordinate their presentations and
request time for a joint presentation. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Once FDA notifies registered presenters of their scheduled
times, they are encouraged to submit an electronic copy of their
presentation to<EMAIL_ADDRESS>on or before November 2, 2017.
Persons registered to make an oral presentation are encouraged to
arrive at the hearing room early and check in at the onsite
registration table to confirm their designated presentation time. An

agenda for the hearing and any other background materials will be made
available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm.
    If you need special accommodations because of a disability, please
contact the Office of Combination Products at<PHONE_NUMBER> or
<EMAIL_ADDRESS>at least 7 days before the hearing.
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm572528.htm.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Dockets Management Staff (see ADDRESSES). A transcript
will also be available in either hard copy or on CD-ROM, after
submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
https://www.fda.gov.

IV. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with 21 CFR part 15. The hearing
will be conducted by a presiding officer, who will be accompanied by
FDA senior management from the Office of the Commissioner, the Center
for Drug Evaluation and Research, the Center for Devices and
Radiological Health, and the Center for Biologics Evaluation and
Research. Under Sec.  15.30(f), the hearing is informal and the rules
of evidence do not apply. No participant may interrupt the presentation
of another participant. Only the presiding officer and panel members
may pose questions; they may question any person during or at the
conclusion of each presentation. Public hearings under part 15 are
subject to FDA's policy and procedures for electronic media coverage of
FDA's public administrative proceedings (21 CFR part 10, subpart C).
Under Sec.  10.205, representatives of the media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see Transcripts). To the extent that the conditions for the
hearing, as described in this notice, conflict with any provisions set
out in part 15, this notice acts as a waiver of those provisions as
specified in Sec.  15.30(h).

    Dated: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20521 Filed 9-25-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 162 (Tuesday, August 23, 2022)]
[Notices]
[Pages 51693-51694]
[FR Doc No: 2022-18128]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002; Internal Agency Docket No. FEMA-B-2263]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and

where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before November 21, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2263, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
            Grant County, North Dakota and Incorporated Areas
          Project: 21-08-0007S Preliminary Date: April 8, 2022
------------------------------------------------------------------------
City of Carson.........................  Nodak Mutual Insurance
                                          Building, 100 Main Street
                                          South, Carson, ND 58529.
City of Leith..........................  Grant County Courthouse, 106
                                          2nd Avenue Northeast, Carson,
                                          ND 58529.
City of New Leipzig....................  City Hall, 19 1st Street East,
                                          New Leipzig, ND 58562.
Unincorporated Areas of Grant County...  Grant County Courthouse, 106
                                          2nd Avenue Northeast, Carson,
                                          ND 58529.
------------------------------------------------------------------------

[FR Doc. 2022-18128 Filed 8-22-22; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: June 30, 2006 (Volume 71, Number 126)]
[Notices]
[Page 37568]
[DOCID:fr30jn06-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[P-2299-057]

Modesto Irrigation District; Turlock Irrigation District; Notice
To Hold a Public Meeting To Discuss the 10-Year Fisheries Summary
Report for the Don Pedro Project

June 23, 2006.
    The Modesto Irrigation District and the Turlock Irrigation District
(licensees) filed a Fisheries Summary Report on March 25, 2005,
pursuant to Article 58 of the license, as amended \1\. The Commission
noticed the filing on June 24, 2005, and solicited comments, motions to
intervene, and protests. Comments were due by July 25, 2005, and
replies to comments were due August 25, 2005. Requests for additional
time to comment were filed and were granted by order issued September
20, 2005, with revised filing dates of November 22, 2005, for comments
and December 22, 2005, for responses to comments. Comments, responses
to comments, and motions to intervene were received.
---------------------------------------------------------------------------

    \1\ See 76 FERC ] 61, 117 (1996).
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    The Commission staff will conduct a public meeting based on the
filings of the licensees' report and comments received to date. The
meeting will allow Commission staff to discuss: (1) Information filed
with the Commission by the various parties concerning the 10-year
summary report on the licensees' chinook salmon studies, monitoring,
and non-flow mitigation efforts on the Tuolumne River since 1995; (2)
information on Central Valley steelhead to determine what effects, if
any, may be occurring; and (3) whether to require further monitoring
studies and changes in project structures and operations to protect
fishery resources in the Tuolumne River.
    The meeting will focus on the above topics to clarify information
currently in the project file. Commission staff will be prepared to
lead a discussion using information that has been filed by the various
parties. Commission staff asks all parties that participate to be
prepared to support their oral statements with documented information.
    The meeting will be held on Tuesday, July 25, 2006, from 9 a.m. to
5 p.m. (PST) at the John E. Moss Federal Building and Courthouse, 650
Capitol Mall, Stanford Room, 1st floor, Sacramento, California 95814.
The licensees, resource agency personnel, and other persons interested
in these issues are invited to participate. The meeting will be
recorded by a stenographer and become part of the formal record of the
Commission proceeding on the project.
    Special security precautions are employed at this Federal building.
Visitors must go through full security screening and are not permitted
to bring in cell phones or cameras with digital photo capability.
Laptops and PDAs must be booted up at the security entrance. Any
questions about this notice should be directed to Philip Scordelis at
the Federal Energy Regulatory Commission,<PHONE_NUMBER>, or by e-mail
at<EMAIL_ADDRESS>
Magalie R. Salas,
Secretary.
 [FR Doc. E6-10300 Filed 6-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40562-40563]
[FR Doc No: 2021-16089]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2016-0404; FRL-8801-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; National Study of Nutrient Removal and
Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener
Questionnaire (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), National Study of Nutrient
Removal and Secondary Technologies: Publicly Owned Treatment Works
(POTW) Screener Questionnaire (EPA ICR Number 2553.03, OMB Control
Number 2040-0294) to the Office of Management and Budget (OMB) for
review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through July 31, 2021. Public comments were previously requested via
the Federal Register on February 24, 2021 during a 60-day comment
period. No comments were received. This notice allows for an additional
30 days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may not conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.

DATES: Additional comments may be submitted on or before August 27,
2021.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2016-0404, online using www.regulations.gov (our preferred method), or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's
policy is that all comments received will be included in the public
docket without change including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Dr. Paul Shriner, Engineering and
Analysis Division (4303T), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-566-
1076; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents are available in the
public docket for this ICR that explain in detail the information that
the EPA will be collecting. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Nutrient pollution remains the single greatest challenge
to our Nation's water quality and presents a growing threat to public
health and local economies--contributing to toxic harmful algal blooms,
contamination of drinking water sources, and costly impacts on
recreation, tourism and fisheries. The National Study of Nutrient
Removal and Secondary Technologies, when completed, will provide a rich
database of nutrient removal performance at secondary treatment POTWs
nationwide, and will help POTWs understand the range of nutrient
removal performance and identify opportunities to optimize nutrient
removals based on data from their peers. It will also serve as a major
new resource for stakeholders to evaluate the most cost-effective
approaches to nutrient reduction at the watershed scale. EPA's Office
of Water is collecting data to evaluate the nutrient removals and
related technology performance of POTWs with conventional secondary
treatment. Due to multiple delays, most notably postponements in
fielding the screener questionnaire due to circumstances associated
with the coronavirus (COVID-19) pandemic, EPA is proposing to renew the
ICR for the screener questionnaire.
    The screener questionnaire is a one-time data collection that
solicits basic facility identification, characterization, and technical
information necessary to develop the future detailed questionnaire.
Questions include those necessary to identify and stratify the universe
of POTWs and, within that population, the secondary treatment POTWs not
designed specifically to remove nitrogen and phosphorus. EPA would
prepare a separate ICR for subsequent phases of the study.
    In this renewal EPA proposes three revisions to the currently
approved screener questionnaire ICR and supporting statement. First,
EPA has reduced the maximum number of respondents from 16,500 to 15,000
reflecting survey responses already received as of October 30, 2020.
Second, EPA has made minor clarifying edits to the survey questions
such as providing additional examples of certain technology
classifications. Third, EPA is revising the respondent burden
estimates. The original average burden estimate assumed it would take
one hour to complete the registration process and three hours to
complete the full questionnaire. EPA reviewed start and end times
associated with questionnaires submitted online and found that the
average time to complete the long version of the online questionnaire
was 1.1 hours and the time to complete the short version was 26
minutes. EPA revised the average burden to 2.25 hours for the
questionnaire and 15 minutes for registration (Questionnaire Section A)
based on this information. EPA solicits comment on these proposed
changes. A copy of the screener questionnaire is available at Docket ID
No. EPA-HQ-

OW-2016-0404 as part of this request for comments.
    Form Numbers: None.
    Respondents/affected entities: Approximately 15,000 POTWs that meet
the definition under 40 CFR 403.3(q), 50 POTWs for site visits, and 100
state and/or small municipal association contacts.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 12,000 (total).
    Frequency of response: One-time data collection.
    Total estimated burden: 8,747 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $398,120 (per year), which includes $8,800
annualized capital or operation & maintenance costs.
    Changes in Estimates: There is decrease of approximately 41,000
hours in the total estimated respondent burden compared with the ICR
currently approved by OMB. This decrease is due to screener
questionnaire responses already received, reduced number of total
respondents, and replacement of EPA's estimated respondent burdens with
the actual time respondents took to complete the screener
questionnaire.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-16089 Filed 7-27-21; 8:45 am]
BILLING CODE 6560-50-P