[Federal Register Volume 79, Number 24 (Wednesday, February 5, 2014)]
[Notices]
[Pages 6892-6893]
[FR Doc No: 2014-02373]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-20-000]

Independent Market Monitor for PJM v. PJM Interconnection,
L.L.C.; Notice of Complaint

    Take notice that on January 27, 2014, pursuant to section 206 of
the Rules and

Practice and Procedure of the Federal Energy Regulatory Commission
(Commission), 18 CFR 385.206 (2013), Independent Market Monitor for PJM
(Market Monitor or Complainant), filed a formal complaint against PJM
Interconnection, L.L.C. (PJM or Respondent) requesting that the
Commission direct PJM to include rules in the tariff that provide: (i)
A requirement that Demand Resources (DR) must offer daily into the PJM
Day-Ahead Energy Market, and (ii) a cap on offers from DR at $1,000 per
MWh, consistent with the offer cap applicable to Generation Capacity
Resources.
    The Complainant states that copies of the complaint were served on
representatives of PJM and served to the parties in Docket No. ER14-
822-000.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). 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. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on February 18, 2014.

    Dated: January 28, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-02373 Filed 2-4-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Rules and Regulations]
[Pages 71991-71994]
[FR Doc No: 2023-23048]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 744

[Docket No.<PHONE_NUMBER>]
RIN 0694-AJ41

Entity List Additions

AGENCY: Bureau of Industry and Security, Department of Commerce.

ACTION: Final rule.

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SUMMARY: In this rule, the Bureau of Industry and Security (BIS) amends
the Export Administration Regulations (EAR) by adding 13 entities to
the Entity List under the destination of the People's Republic of China
(China). These entities have been determined by the U.S. Government to
be acting contrary to the national security or foreign policy interests
of the United States.

DATES: This rule is effective October 17, 2023.

FOR FURTHER INFORMATION CONTACT: Chair, End-User Review Committee,
Office of the Assistant Secretary for Export Administration, Bureau of
Industry and Security, Department of Commerce, Phone:<PHONE_NUMBER>,
Email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Entity List (supplement no. 4 to part 744 of the EAR (15 CFR
parts 730-774)) identifies entities for which there is reasonable cause
to believe, based on specific and articulable facts, that the entities
have been involved, are involved, or pose a significant risk of being
or becoming involved in activities contrary to the national security or
foreign policy interests of the United States, pursuant to Sec.
744.11(b). The EAR impose additional license requirements on, and limit
the availability of, most license exceptions for exports, reexports,
and transfers (in-country) when a listed entity is a party to the
transaction. The license review policy for each listed entity is
identified in the ``License Review Policy'' column on the Entity List,
and the impact on the availability of license exceptions is described
in the relevant Federal Register document that added the entity to the
Entity List. The Bureau of Industry and Security (BIS) places entities
on the Entity List pursuant to parts 744 (Control Policy: End-User and
End-Use Based) and 746 (Embargoes and Other Special Controls) of the
EAR.
    The End-User Review Committee (ERC), composed of representatives of
the Departments of Commerce (Chair), State, Defense, Energy and, where
appropriate, the Treasury, makes all decisions regarding additions to,
removals from, or other modifications to the Entity List. The ERC makes
all decisions to add an entry to the Entity List by majority vote and
makes all decisions to remove or modify an entry by unanimous vote.

Entity List Decisions

Additions to the Entity List

    The ERC determined to add Beijing Biren Technology Development Co.,
Ltd.; Guangzhou Biren Integrated Circuit Co., Ltd.; Hangzhou Biren
Technology Development Co., Ltd.; Light Cloud (Hangzhou) Technology
Co., Ltd.; Moore Thread Intelligent Technology (Beijing) Co., Ltd.;
Moore Thread Intelligent Technology (Chengdu) Co., Ltd.; Moore Thread
Intelligent Technology (Shanghai) Co., Ltd.; Shanghai Biren Information
Technology Co., Ltd.; Shanghai Biren Integrated Circuit Co., Ltd.;
Shanghai Biren Intelligent Technology Co., Ltd.; Superburning
Semiconductor (Nanjing) Co., Ltd.; Suzhou Xinyan Holdings Co., Ltd.;
and Zhuhai Biren Integrated Circuit Co., Ltd., all under the
destination of China, to the Entity List. These entities are involved
in the development of advanced computing integrated circuits (ICs). As
described in an upcoming amendment to regulations regarding advanced
computing items and supercomputer and semiconductor end use, advanced
computing ICs can be used to provide artificial intelligence
capabilities to further development of weapons of mass destruction,
advanced weapons systems, and high-tech surveillance applications that
create national security concerns. This activity is contrary to U.S.
national security and foreign policy interests under Sec.  744.11 of
the EAR. For all of these entities, BIS imposes a license requirement
for all items subject to the EAR, which will be reviewed under a
presumption of denial. They are also given a footnote 4 designation,
which means that ``items subject to the EAR,'' for the purpose of these
license requirements, include foreign-produced items that are subject
to the EAR pursuant to Sec.  734.9(e)(2) of the EAR.
    For the reasons described above, this final rule adds the following
13 entities, including aliases where appropriate, to the Entity List:

China

     Beijing Biren Technology Development Co., Ltd.;
     Guangzhou Biren Integrated Circuit Co., Ltd.;
     Hangzhou Biren Technology Development Co., Ltd.;
     Light Cloud (Hangzhou) Technology Co., Ltd.;
     Moore Thread Intelligent Technology (Beijing) Co., Ltd.;
     Moore Thread Intelligent Technology (Chengdu) Co., Ltd.;
     Moore Thread Intelligent Technology (Shanghai) Co., Ltd.;
     Shanghai Biren Information Technology Co., Ltd.;
     Shanghai Biren Integrated Circuit Co., Ltd.;
     Shanghai Biren Intelligent Technology Co., Ltd.;
     Superburning Semiconductor (Nanjing) Co., Ltd.;
     Suzhou Xinyan Holdings Co., Ltd.; and
     Zhuhai Biren Integrated Circuit Co., Ltd.

Savings Clause

    For the changes being made in this final rule, shipments of items
removed from eligibility for a License Exception or export, reexport,
or transfer (in-country) without a license (NLR) as a result of this
regulatory action that were en route aboard a carrier to a port of
export, reexport, or transfer (in-country), on October 17, 2023,
pursuant to actual orders for export, reexport, or transfer (in-
country) to or within a foreign destination, may proceed to that
destination under the previous eligibility for a License Exception or
export, reexport, or transfer (in-country) without a license (NLR)
before November 16, 2023. Any such items not actually exported,
reexported or transferred (in-country) before midnight, on October 17,
2023, require a license in accordance with this final rule.

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S.
McCain National Defense Authorization Act for Fiscal Year 2019, which
included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-
4852). ECRA provides the legal basis for BIS's principal authorities
and serves as the authority under which BIS issues this rule.

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 or 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 regulation involves an
information collection approved by OMB under control number 0694-0088,
Simplified Network Application Processing System. BIS does not
anticipate a change to the burden hours associated with this collection
as a result of this rule. Information regarding the collection,
including all supporting materials, can be accessed at https://www.reginfo.gov/public/do/PRAMain.
    3. This rule does not contain policies with federalism implications
as that term is defined in Executive Order 13132.
    4. Pursuant to section 1762 of the Export Control Reform Act of
2018, this action is exempt from the Administrative Procedure Act (5
U.S.C. 553) requirements for notice of proposed rulemaking, opportunity
for public participation, and delay in effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required, and none
has been prepared.

List of Subjects in 15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

    Accordingly, part 744 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:

PART 744--END-USE AND END-USER CONTROLS

0
1. The authority citation for part 744 is revised to read as follows:

    Authority: 50 U.S.C. 4801-4852; 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; 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. 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 November 8, 2022, 87 FR 68015, 3 CFR, 2022 Comp., p. 563; Notice
of September 7, 2023, 88 FR 62439 (September 11, 2023).

0
2. Supplement no. 4 is amended under CHINA, PEOPLE'S REPUBLIC OF by
adding, in alphabetical order, entries for ``Beijing Biren Technology
Development Co., Ltd.;'' ``Guangzhou Biren Integrated Circuit Co.,
Ltd.;'' ``Hangzhou Biren Technology Development Co., Ltd.;'' ``Light
Cloud (Hangzhou) Technology Co., Ltd.;'' ``Moore Thread Intelligent
Technology (Beijing) Co., Ltd.;'' ``Moore Thread Intelligent Technology
(Chengdu) Co., Ltd.;'' ``Moore Thread Intelligent Technology (Shanghai)
Co., Ltd.'',

``Shanghai Biren Information Technology Co., Ltd.;'' ``Shanghai Biren
Integrated Circuit Co., Ltd.;'' ``Shanghai Biren Intelligent Technology
Co., Ltd.;'' ``Superburning Semiconductor (Nanjing) Co., Ltd.;''
``Suzhou Xinyan Holdings Co., Ltd.;'' and ``Zhuhai Biren Integrated
Circuit Co., Ltd.'' to read as follows:

Supplement No. 4 to Part 744--Entity List

* * * * *

----------------------------------------------------------------------------------------------------------------
                                                                              License review    Federal Register
        Country                     Entity             License requirement        policy            citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
CHINA, PEOPLE'S                                                 * * * * * *
 REPUBLIC OF.
                         Beijing Biren Technology      For all items        Presumption of     88 FR [INSERT FR
                          Development Co., Ltd.,        subject to the       denial.            PAGE NUMBER ] 10/
                          Building 13, Room 201, 9th    EAR. (See Sec.                          19/2023.
                          Floor, Wangjing East Area,    Sec.   734.9(e)(2)
                          Zone 4, Chaoyang District,    and 744.11 of the
                          Beijing, China.               EAR) \4\.
                                                                * * * * * *
                         Guangzhou Biren Integrated    For all items        Presumption of     88 FR [INSERT FR
                          Circuit Co., Ltd., Room       subject to the       denial.            PAGE NUMBER ] 10/
                          1061, Room 406, No. 1         EAR. (See Sec.                          19/2023.
                          Yichuang Street, Sino-        Sec.   734.9(e)(2)
                          Singapore Guangzhou           and 744.11 of the
                          Knowledge City, Huangpu       EAR) \4\.
                          District, Guangzhou, China.
                                                                * * * * * *
                         Hangzhou Biren Technology     For all items        Presumption of     88 FR [INSERT FR
                          Development Co., Ltd.,        subject to the       denial.            PAGE NUMBER ] 10/
                          Building A, Room 3029, 3rd    EAR. (See Sec.                          19/2023.
                          Floor, No. 482 Qianmo Road,   Sec.   734.9(e)(2)
                          Binjiang District,            and 744.11 of the
                          Hangzhou, China.              EAR) \4\.
                                                                * * * * * *
                         Light Cloud (Hangzhou)        For all items        Presumption of     88 FR [INSERT FR
                          Technology Co., Ltd., Room    subject to the       denial.            PAGE NUMBER ] 10/
                          403, Building 15, No. 1818-   EAR. (See Sec.                          19/2023.
                          2, Wenyi West Road, Yuhang    Sec.   734.9(e)(2)
                          Street, Yuhang District,      and 744.11 of the
                          Hangzhou, China.              EAR) \4\.
                                                                * * * * * *
                         Moore Thread Intelligent      For all items        Presumption of     88 FR [INSERT FR
                          Technology (Beijing) Co.,     subject to the       denial.            PAGE NUMBER ] 10/
                          Ltd., a.k.a, the following    EAR. (See Sec.                          19/2023.
                          two aliases:                  Sec.   734.9(e)(2)
                         --Moore Threads; and           and 744.11 of the
                         --Mo'er Xianchen.              EAR) \4\.
                         Room 209, Floor 2, No. 31,
                          Haidian Street, Haidian
                          District, Beijing, China;
                          and Building 14, B655, 4th
                          Floor, Cuiwei Zhongli,
                          Haidian District, Beijing,
                          China; and Units 04 and 05,
                          Floor 12, No. 3, Jinke
                          Road, Shanghai, China; and
                          Building B, B2-1405, No. 15
                          Keyuan Road, Nanshan
                          District, Shenzhen, China;
                          and Building 6 Floors 1 and
                          3, Wangjing East Road,
                          Chaoyang District, Beijing,
                          China; and R&D Center
                          Building, No. R2505, Floors
                          1-14 and 16-28, East Lake
                          New Technology Development
                          Zone, Wuhan, China; and
                          Building 4, Room 1502,
                          Floor 15, Taiwei Smart
                          Chain Center, Xi'an, China;
                          and Building 1, Room 31816,
                          3rd Floor, Puyan Street,
                          Binjiang District,
                          Hangzhou, China.
                         Moore Thread Intelligent      For all items        Presumption of     88 FR [INSERT FR
                          Technology (Chengdu) Co.,     subject to the       denial.            PAGE NUMBER ] 10/
                          Ltd., Building 2, No. 23-     EAR. (See Sec.                          19/2023.
                          32, 12th Floor, Block E5,     Sec.   734.9(e)(2)
                          Chengdu High-tech Zone,       and 744.11 of the
                          Pilot Free Trade Zone,        EAR) \4\.
                          Chengdu, China.
                         Moore Thread Intelligent      For all items        Presumption of     88 FR [INSERT FR
                          Technology (Shanghai) Co.,    subject to the       denial.            PAGE NUMBER ] 10/
                          Ltd., Units 1-5, 12th         EAR. (See Sec.                          19/2023.
                          Floor, No. 2, Jinke Road,     Sec.   734.9(e)(2)
                          Pilot Free Trade Zone,        and 744.11 of the
                          Shanghai, China.              EAR) \4\.
                                                                * * * * * *
                         Shanghai Biren Information    For all items        Presumption of     88 FR [INSERT FR
                          Technology Co., Ltd.,         subject to the       denial.            PAGE NUMBER ] 10/
                          Building 2, No. 692 Yongjia   EAR. (See Sec.                          19/2023.
                          Road, Xuhui District,         Sec.   734.9(e)(2)
                          Shanghai, China.              and 744.11 of the
                                                        EAR) \4\.
                         Shanghai Biren Integrated     For all items        Presumption of     88 FR [INSERT FR
                          Circuit Co., Ltd., Building   subject to the       denial.            PAGE NUMBER ] 10/
                          16, Room 1301, 13th Floor,    EAR. (See Sec.                          19/2023.
                          No. 2388 Chenhang Highway,    Sec.   734.9(e)(2)
                          Minhang District, Shanghai,   and 744.11 of the
                          China.                        EAR) \4\.
                         Shanghai Biren Intelligent    For all items        Presumption of     88 FR [INSERT FR
                          Technology Co., Ltd.,         subject to the       denial.            PAGE NUMBER ] 10/
                          a.k.a., the following two     EAR. (See Sec.                          19/2023.
                          aliases:                      Sec.   734.9(e)(2)
                         --Biren; and                   and 744.11 of the
                         --Biren Technology.            EAR) \4\.
                         Building 16, Room 1302, 13th
                          Floor, No. 2388 Chenhang
                          Highway, Minhang District,
                          Shanghai, China.
                                                                * * * * * *

                         Superburning Semiconductor    For all items        Presumption of     88 FR [INSERT FR
                          (Nanjing) Co., Ltd.,          subject to the       denial.            PAGE NUMBER ] 10/
                         No. 8, Lanhua Road, Room       EAR. (See Sec.                          19/2023.
                          806, Building 4, Pukou        Sec.   734.9(e)(2)
                          District, Nanjing, China.     and 744.11 of the
                                                        EAR) \4\.
                                                                * * * * * *
                         Suzhou Xinyan Holdings Co.,   For all items        Presumption of     88 FR [INSERT FR
                          Ltd., a.k.a., the following   subject to the       denial.            PAGE NUMBER ] 10/
                          one alias:                    EAR. (See Sec.                          19/2023.
                         --Shanghai Xinzhili            Sec.   734.9(e)(2)
                          Enterprise Development Co.,   and 744.11 of the
                          Ltd.                          EAR) \4\.
                         Modern Logistics Building
                          (no. 112), Room 139, No. 88
                          Modern Avenue, Suzhou
                          Industrial Park, Free Trade
                          Pilot Zone Suzhou Area,
                          Suzhou, China; and Building
                          C, No. 888 Huanhu West 2nd
                          Road, Lingang New Area,
                          Shanghai, China.
                                                                * * * * * *
                         Zhuhai Biren Integrated       For all items        Presumption of     88 FR [INSERT FR
                          Circuit Co., Ltd., Building   subject to the       denial.            PAGE NUMBER ] 10/
                          18, Room 419, No. 1889        EAR. (See Sec.                          19/2023.
                          Huandao East Road, Hengqin    Sec.   734.9(e)(2)
                          New District, Zhuhai,         and 744.11 of the
                          China.                        EAR) \4\.
                                                                * * * * * *
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
 * * * * * * *
\4\ For this entity, ``items subject to the EAR'' includes foreign-produced items that are subject to the EAR
  under Sec.   734.9(e)(2) of the EAR. See Sec.   744.11(a)(2)(ii) for related license requirements and license
  review policy.

Thea D. Rozman Kendler,
Assistant Secretary for Export Administration.
[FR Doc. 2023-23048 Filed 10-17-23; 8:45 am]
BILLING CODE 3510-33-P


[Federal Register: October 13, 2006 (Volume 71, Number 198)]
[Notices]
[Page 60505]
[DOCID:fr13oc06-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2082-027]

PacifiCorp; Oregon and California; Notice of Intention To Hold
Public Meetings for Discussion of the Draft Environmental Impact
Statement for the Klamath Hydroelectric Project

October 5, 2006.
    On September 25, 2006, Commission staff delivered the Draft
Environmental Impact Statement (DEIS) for the relicensing of the
Klamath Hydroelectric project to the Environmental Protection Agency
and mailed it to resource and land management agencies, interested
organizations, and individuals.
    The DEIS was noticed in the Federal Register on September 29, 2006
(71 FR 57503) and comments are due November 24, 2006. The DEIS
evaluates the environmental consequences of the issuance of a new
license for the continued operation and maintenance of the Klamath
Hydroelectric, located primarily on the Klamath River, in Klamath
County, Oregon and Siskiyou County, California. The existing project
occupies a total of 219 acres of land administered by the U.S. Bureaus
of Land Management and Reclamation. It also evaluates the environmental
effects of implementing the licensee's proposals, agency and NGO
recommendations, staff's recommendations, and the no-action
alternative.
    Four public meetings, which will be recorded by an official
stenographer, are scheduled as follows.
    Date: Tuesday, November 14, 2006.
    Time: 9 a.m.-12 noon (PST).
    Place: Shilo Inn.
    Address: 2500 Almond Street, Klamath Falls, Oregon.

    Date: Wednesday, November 15, 2006.
    Time: 9 a.m.-12 noon (PST).
    Place: Yreka Community Theatre.
    Address: 812 North Oregon Street, Yreka, California.

    Date: Wednesday, November 15, 2006.
    Time: 7-10 p.m. (PST).
    Place: Yreka Community Theatre.
    Address: 812 North Oregon Street, Yreka, California.

    Date: Thursday, November 16, 2006.
    Time: 7-10 p.m. (PST).
    Place: Red Lion Hotel.
    Address: 1929 Fourth Street, Eureka, California.
    At these meetings, resource agency personnel and other interested
persons will have the opportunity to provide oral and written comments
and recommendations regarding the DEIS for the Commission's public
record.
    For further information, please contact John Mudre at e-mail
address<EMAIL_ADDRESS>or by telephone at<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-16974 Filed 10-12-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 240 (Thursday, December 15, 2022)]
[Notices]
[Page 76630]
[FR Doc No: 2022-27192]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-N-1048; FDA-2012-N-0386; FDA-2019-N-0430; FDA-
2019-N-5553; FDA-2021-N-0555; FDA-2013-N-0242; and FDA-2019-N-1517]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Medical Devices; Humanitarian Use              0910-0332      10/31/2025
 Devices................................
Tobacco Product Establishment                  0910-0650      10/31/2025
 Registration and Submission of Certain
 Health Information.....................
Generic Clearance for Quick Turnaround         0910-0876      10/31/2025
 Testing of Communication Effectiveness.
Right to Try Act: Reporting Requirements       0910-0893      10/31/2025
Medical Device Labeling Regulations.....       0910-0485      11/30/2025
Current Good Manufacturing Practices for       0910-0667      11/30/2025
 Positron Emission Tomography (PET)
 Drugs..................................
Abbreviated New Animal Drug Applications       0910-0669      11/30/2025
------------------------------------------------------------------------

    Dated: December 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27192 Filed 12-14-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 100 (Tuesday, May 24, 2022)]
[Proposed Rules]
[Pages 31438-31439]
[FR Doc No: 2022-10054]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 147

[Docket No. FAA-2015-3901; Notice No. 15-10 and Notice No. 19-02]
RIN 2120-AK48

Aviation Maintenance Technician Schools; Withdrawal

AGENCY: Federal Aviation Administration (FAA), Transportation (DOT).

ACTION: Notice of proposed rulemaking and supplemental notice of
proposed rulemaking; withdrawal.

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

SUMMARY: The FAA is withdrawing a previously published notice of
proposed rulemaking (NPRM) that would have modernized and reorganized
the required curriculum subjects for certificated Aviation Maintenance
Technician Schools (AMTS), relocated course content items from the
appendices into each school's operations specifications, and updated
curriculum requirements to meet current industry needs. The FAA is also
withdrawing the subsequently published supplemental notice of proposed
rulemaking (SNPRM) that would have expanded the scope of the NPRM to
allow competency-based training and satellite training locations and
replaced the national passing norms specified in the quality of
instruction requirements with a standard pass rate. The FAA is
withdrawing these regulatory actions because they have been superseded
by the Aircraft Certification, Safety, and Accountability Act.

DATES: The NPRM published on October 2, 2015 (80 FR 59674), is
withdrawn as of May 24, 2022. The SNPRM published on April 16, 2019 (84
FR 15533), is withdrawn as of May 24, 2022.

FOR FURTHER INFORMATION CONTACT: For technical questions concerning
this action, contact Tanya Glines, Aircraft Maintenance Division,
Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On October 2, 2015, the FAA published an NPRM (Notice No. 15-10) to
modernize the curriculum requirements for certificated AMTSs. The FAA
proposed to revise the required curriculum subjects listed in the
appendices of part 147 and to relocate the course content items from
the part 147 appendices to each school's operations specifications. The
FAA proposed these revisions because the existing curriculum
requirements are outdated, do not meet current industry needs, and
could be changed only through notice and comment rulemaking. These
amendments would have ensured that AMTS students receive up-to-date
foundational training to meet the demands of the aviation industry. The
comment period for the NPRM was originally scheduled to close on
December 31, 2015, but was subsequently extended to February 1, 2016
(80 FR 72404).
    On April 16, 2019, the FAA published an SNPRM (Notice No. 19-02),
expanding the scope of the NPRM to propose the allowance of competency-
based training and satellite training locations and to replace the
national passing norms specified in the quality of instruction
requirements with a standard pass rate. The FAA proposed these
revisions based on public comments received on the NPRM. The comment
period for the SNPRM closed on June 17, 2019.

Reason for Withdrawal

    The FAA is withdrawing the NPRM (Notice No. 15-10) and SNPRM
(Notice No. 19-02) due to Section 135 of the Aircraft Certification,
Safety, and Accountability Act, Public Law 116-260, which was enacted
on December 27, 2020 (the ``Act''). Section 135, Promoting Aviation
Regulations for Technical Training, requires the FAA to issue interim
final regulations in accordance with the requirements of Section 135.
Additionally, Section 135 provides that current part 147 and any
regulations issued under section 624 of the FAA Reauthorization Act of
2018 (Pub. L. 115-254) shall have no force or effect on or after the
effective date of the interim final regulations. The proposed
requirements contained in the NPRM (Notice No. 15-10) and SNPRM (Notice
No. 19-02) would have significantly exceeded the scope of the statutory
mandate. Accordingly, to comply with Section 135, the FAA is
withdrawing the NPRM (Notice No. 15-10) and SNPRM (Notice No. 19-02).
Instead of finalizing these proposals, the FAA published an interim
final rule concurrently with this notice of withdrawal that establishes
requirements for certificated AMTSs in accordance with Section 135 of
the Act.

Conclusion

    The FAA has determined that Notice Nos. 15-10 and 19-02 have been
superseded by the Aircraft Certification, Safety, and Accountability
Act. Therefore, the FAA withdraws Notice No. 15-10, published at 80 FR
59674 on October 2, 2015, and Notice No. 19-02, published at 84 FR
15533 on April 16, 2019, as directed.
    Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and
44703 in Washington, DC.

Robert C. Carty,
Deputy Executive Director, Flight Standards Service.
[FR Doc. 2022-10054 Filed 5-23-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48752-48754]
[FR Doc No: 2013-19261]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70114; File No. SR-BX-2013-044]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing of Proposed Rule Change to Its Excess Order Fee Under Rule
7018(d)

August 5, 2013.
    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 July 26, 2013, NASDAQ OMX BX, Inc. (``BX'' or ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the Exchange. 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.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes changes to its Excess Order Fee under Rule
7018(d). While these amendments are effective upon filing, the Exchange
has designated the proposed amendments to be operative on August 1,
2013. The text of the proposed rule change is also available on the
Exchange's Web site at http://nasdaqomxbx.cchwallstreet.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange 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. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In 2012, BX introduced an Excess Order Fee, imposed on MPIDs that
have characteristics indicative of inefficient order entry
practices.\3\ As BX explained at the time, inefficient order entry
practices may place excessive burdens on the systems of BX and its
members and may negatively impact the usefulness and life cycle cost of
market data.\4\ Market participants that flood the

market with orders that are rapidly cancelled or that are priced away
from the inside market do little to support meaningful price discovery.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release Nos. 67007 (May 17, 2012),
77 FR 30579 (May 23, 2012) (SR-BX-2012-033) (establishing fee);
67272 (June 27, 2012), 77 FR 39530 (July 3, 2012) (SR-BX-2012-042)
(modifying terms and conditions of fee).
    \4\ See generally Recommendations Regarding Regulatory Reponses
to the Market Events of May 6, 2010, Joint CFTC-SEC Advisory
Committee on Emerging Regulatory Issues, at 11 (February 18, 2011)
(``The SEC and CFTC should also consider addressing the
disproportionate impact that [high frequency trading] has on
Exchange message traffic and market surveillance costs. . . . The
Committee recognizes that there are valid reasons for algorithmic
strategies to drive high cancellation rates, but we believe that
this is an area that deserves further study. At a minimum, we
believe that the participants of those strategies should properly
absorb the externalized costs of their activity.'').
---------------------------------------------------------------------------

    In general, the determination of whether to impose the fee on a
particular MPID has been made by calculating the ratio between (i)
entered orders, weighted by the distance of the order from the national
best bid or offer (``NBBO''), and (ii) orders that execute in whole or
in part. The fee has been imposed on MPIDs with an ``Order Entry
Ratio'' of more than 100. The Order Entry Ratio is calculated, and the
Excess Order Fee imposed, on a monthly basis. BX is now proposing to
modify the fee, such that it will be calculated and assessed on the
basis of all of a member's trading activity on BX, rather than on an
MPID basis. The purpose of this change is to ensure that members do not
act in a manner inconsistent with the intent of the fee by spreading
inefficient order activity across multiple MPIDs in a manner that
allows the MPIDs to avoid a charge that would not be avoided if all of
the member's activity were aggregated. Thus, the change replaces the
term ``MPID'' with the term ``member'' throughout the text of Rule
7018(d). The rule, as amended, will operate as follows:
    For each member, the Order Entry Ratio will be the ratio of (i) the
member's ``Weighted Order Total'' to (ii) the greater of one (1) or the
number of displayed, non-marketable orders \5\ sent to BX by the member
during the month that execute in full or in part.\6\ The Weighted Order
Total is the number of displayed, non-marketable orders sent to BX by
the member, as adjusted by a ``Weighting Factor.'' The applicable
Weighting Factor is applied to each order based on its price in
comparison to the NBBO at the time of order entry:
---------------------------------------------------------------------------

    \5\ The fee focuses on displayed orders since they have the most
significant impact on investor confusion and the quality of market
data.
    \6\ Thus, in an extreme case where no orders entered by the
member executed, this component of the ratio would be assumed to be
1, so as to avoid the impossibility of dividing by zero.

------------------------------------------------------------------------
                                                              Weighting
             Order's price versus NBBO at entry                 factor
------------------------------------------------------------------------
Less than 0.20% away.......................................           0x
0.20% to 0.99% away........................................           1x
1.00% to 1.99% away........................................           2x
2.00% or more away.........................................           3x
------------------------------------------------------------------------

    Thus, in calculating the Weighted Order Total, an order that was
more than 2.0% away from the NBBO would be equivalent to three orders
that were 0.50% away. Due to the applicable Weighting Factor of 0x,
orders entered less than 0.20% away from the NBBO would not be included
in the Weighted Order Total, but would be included in the ``executed''
orders component of the Order Entry Ratio if they execute in full or
part.\7\ In addition, members with a daily average Weighted Order Total
of less than 100,000 during the month will not be subject to the Excess
Order Fee. Finally, the fee is based on orders received by BX during
regular market hours (generally, 9:30 a.m. to 4:00 p.m.),\8\ and will
exclude orders received at other times, even if they execute during
regular market hours.
---------------------------------------------------------------------------

    \7\ An analogous fee of The NASDAQ Stock Market LLC (``NASDAQ'')
includes an exclusion from both components of the ratio for orders
sent by market makers in securities in which they are registered,
through the MPID applicable to the registration. Although BX rules
currently allow for market maker registration, BX does not currently
have any registered market makers. Accordingly, BX has not deemed it
necessary to adopt a comparable exclusion. In the event that market
maker participation in BX increases, BX will evaluate the
advisability of adopting an exclusion.
    \8\ Regular market hours may be different in some circumstances,
such as on the day after Thanksgiving, when regular market hours on
all exchanges traditionally end at 1:00 p.m.
---------------------------------------------------------------------------

    The following example illustrates the calculation of the Order
Entry Ratio:
     A member enters 15,000,000 displayed, liquidity-providing
orders:
     10,000,000 orders are entered at the NBBO. The Weighting
Factor for these orders is 0x.
     5,000,000 orders are entered at a price that is 1.50% away
from the NBBO. The Weighting Factor for these orders is 2x.
     Of the 15,000,000 orders included in the calculation,
90,000 are executed.
     The Weighted Order Total is (10,000,000 x 0) + (5,000,000
x 2) = 10,000,000. The Order Entry Ratio is 10,000,000/90,000 = 111.
    If a member has an Order Entry Ratio of more than 100, the amount
of the Order Entry Fee will be calculated by determining the member's
``Excess Weighted Orders.'' Excess Weighted Orders are calculated by
subtracting (i) the Weighted Order Total that would result in the
member having an Order Entry Ratio of 100 from (ii) the member's actual
Weighted Order Total. In the example above, the Weighted Order Total
that would result in an Order Entry Ratio of 100 is 9,000,000, since
9,000,000/90,000 = 100. Accordingly, the Excess Weighted Orders would
be 10,000,000-9,000,000 = 1,000,000.
    The Excess Order Fee charged to the member will then be determined
by multiplying the ``Applicable Rate'' by the number of Excess Weighted
Orders. The Applicable Rate is determined based on the member's Order
Entry Ratio:

------------------------------------------------------------------------
                                                              Applicable
                     Order entry ratio                           rate
------------------------------------------------------------------------
101-1,000..................................................        0.005
More than 1,000............................................        0.01
------------------------------------------------------------------------

    In the example above, the Applicable Rate would be $0.005, based on
the member's Order Entry Ratio of 111. Accordingly, the monthly Excess
Order Fee would be 1,000,000 x $0.005 = $5,000.
    BX continues to expect that the impact of the fee, as modified,
will be narrow because the change will encourage potentially affected
market participants to modify their order entry practices in order to
avoid the fee, thereby improving the market for all participants.
Accordingly, BX does not expect to earn significant revenues from the
modified fee.
2. Statutory Basis
    BX believes that the proposed rule change is consistent with the
provisions of Section 6 of the Act,\9\ in general, and with Sections
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which BX operates or controls, and is not designed to permit
unfair discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    With respect to the Excess Order Fee, BX stated in its original
filing to institute the fee that it is reasonable because it is
designed to achieve improvements in the quality of displayed liquidity
and market data that will benefit all market participants. In addition,
although the level of the fee may theoretically be very high, the fee
is reasonable because market participants may readily avoid the fee by
making improvements in their order entry practices that reduce the
number of orders they enter, bring the prices of their orders closer to
the NBBO, and/or increase the percentage of their orders that execute.
Similarly, the change proposed herein is reasonable because it will
provide further incentive to members to improve order entry practices
by insuring that they cannot evade the fee by spreading activity across
multiple MPIDs.
    For similar reasons, the fee is consistent with an equitable
allocation of fees, because although the fee may apply to only a small
number of market

participants, the fee would be applied to them in order to encourage
better order entry practices that will benefit all market participants.
The change is also equitable because it will further encourage better
order entry practices across a wider group of market participants.
Finally, BX believes that the fee is not unfairly discriminatory.
Although the fee may apply to only a small number of market
participants, it will be imposed because of the negative externalities
that such market participants impose on others through inefficient
order entry practices. Accordingly, BX believes that it is fair to
impose the fee on these market participants in order to incentivize
them to modify their behavior and thereby benefit the market. The
change is likewise not unfairly discriminatory because it will
negatively affect members only if they have been evading the incentives
to improve order entry practices provided by the fee.

B. Self-Regulatory Organization's Statement on Burden on Competition

    BX does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.\11\ BX notes that
it operates in a highly competitive market in which market participants
can readily favor competing venues if they deem fee levels at a
particular venue to be excessive, or rebate opportunities available at
other venues to be more favorable. In such an environment, BX must
continually adjust its fees to remain competitive with other exchanges
and with alternative trading systems that have been exempted from
compliance with the statutory standards applicable to exchanges, while
also seeking to earn a reasonable profit from its trading and routing
services. Because competitors are free to modify their own fees in
response, and because market participants may readily adjust their
order routing practices, BX believes that the degree to which fee
changes in this market may impose any burden on competition is
extremely limited. With respect to the change to the Excess Order Fee,
BX believes that the change, like the original fee, will constrain
market participants from pursuing certain inefficient and potentially
abusive trading strategies. To the extent that this change may be
construed as a burden on competition, BX believes that it is
appropriate in order to allow BX to better achieve this purpose.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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 \12\ and paragraph (f) of Rule 19b-4
thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

    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.

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-BX-2013-044 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-BX-2013-044. 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 on official business
days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such
filing also will be available for inspection and copying at the
principal offices of the Exchange. 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-BX-2013-044, and should be submitted on or before August
30, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-19261 Filed 8-8-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Notices]
[Page 48616]
[DOCID:fr23se09-123]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
September 24, 2009 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Casey, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session, and determined that
no earlier notice thereof was possible.
    The subject matter of the Closed Meeting scheduled for Thursday,
September 24, 2009 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
A litigation matter; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: September 21, 2009.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-23017 Filed 9-21-09; 4:15 pm]


[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Pages 30882-30883]
[FR Doc No: 2017-13842]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4319-DR; Docket ID FEMA-2017-0001]

Kansas; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Kansas (FEMA-4319-DR), dated June 16, 2017,
and related determinations.

DATES: Effective Date: June 16, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated June 16, 2017, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Kansas resulting from a severe winter storm, snowstorm, straight-
line winds, and flooding during the period of April 28 to May 3,
2017, is of sufficient severity and magnitude to warrant a major
disaster declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of Kansas.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State. You are
further authorized to provide snow assistance under the Public
Assistance program for a limited period of time during or proximate
to the incident period. Consistent with the requirement that Federal
assistance be supplemental, any Federal funds provided under the
Stafford Act for Hazard Mitigation will be limited to 75 percent of
the total eligible costs. Federal funds provided under the Stafford
Act for Public Assistance also will be limited to 75 percent of the
total eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, David G. Samaniego, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Kansas have been designated as
adversely affected by this major disaster:

    Cherokee, Cheyenne, Crawford, Decatur, Finney, Gove, Graham,
Grant, Greeley, Hamilton, Haskell, Kearny, Lane, Logan, Morton,
Neosho, Norton, Rawlins, Scott, Seward, Sheridan, Sherman, Stanton,
Stevens, Thomas, Wallace, and Wichita Counties for Public
Assistance.
    Greeley, Hamilton, Lane, Logan, Morton, Scott, Thomas, and
Wallace Counties for snow assistance under the Public Assistance
program for any continuous 48-hour period during or proximate to the
incident period.
    All areas within the State of Kansas are eligible for assistance
under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA);

97.046, Fire Management Assistance Grant; 97.048, Disaster Housing
Assistance to Individuals and Households In Presidentially Declared
Disaster Areas; 97.049, Presidentially Declared Disaster
Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidentially Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-13842 Filed 6-30-17; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: November 4, 2010 (Volume 75, Number 213)]
[Rules and Regulations]
[Page 67911-67912]
[DOCID:fr04no10-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0052; Airspace Docket No. 10-AEA-19]

Amendment of Class E Airspace; Jeannette, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E Airspace at Jeannette, PA.
Jeannette District Hospital will no longer be using the heliport
therefore reference to the Jeannette District Hospital Heliport in the
legal description is being removed. The boundaries, altitudes and
operating requirements will not change.

DATES: Effective 0901 UTC, December 6, 2010.
    The Director of the Federal Register approves this incorporation by
reference action under title 1, Code of Federal Regulations, part 51,
subject to the annual revision of FAA, Order 7400.9 and publication of
conforming amendments.

FOR FURTHER INFORMATION CONTACT: Richard Horrocks, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The Point in Space in the legal description of the Class E airspace
area for Jeannette, PA serves both the Monsour Medical Center Heliport
and the Jeannette District Hospital Heliport. The FAA is removing
reference only to the Jeannette District Hospital Heliport. This change
does not affect the boundaries, altitudes, or operating requirements of
the airspace, therefore, notice and public procedures under 5 U.S.C.
553(b) are unnecessary.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace extending upward from 700 feet
above the surface at Jeannette, PA, by removing the Jeannette District
Hospital Heliport reference from the legal description. The Point in
Space within the legal description will continue to serve Monsour
Medical Center Heliport.
    The Class E airspace designations are published in Paragraph 6005
of FAA order 7400.9U, signed August 18, 2010, and effective September
15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
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 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
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Jeannette, PA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 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 Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AEA PA E5 Jeannette, PA [Amended]

Monsour Medical Center Heliport Point In Space Coordinates
    (Lat. 40[deg]19'49'' N., long. 79[deg]37'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6-mile radius of the Point in Space coordinates, at Lat.
40[deg]19'49'' N., long. 79[deg]37'44'' W., serving the Monsour
Medical Center Heliport.

    Issued in College Park, Georgia, on October 19, 2010.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2010-27644 Filed 11-3-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 229 (Friday, November 27, 2020)]
[Notices]
[Pages 76156-76157]
[FR Doc No: 2020-26161]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2020-0089]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    Under part 235 of title 49 of the Code of Federal Regulations (CFR)
and 49 U.S.C. 20502(a), this document provides the public notice that
on November 12, 2020, BNSF Railway (BNSF) petitioned the Federal
Railroad Administration (FRA) seeking approval to discontinue or modify
a signal system. FRA assigned the petition Docket Number FRA-2020-0089.

Applicant: BNSF Railway, Mr. Jerad W. Fritz, AVP Signals, 2600 Lou Menk
Drive, Ft. Worth, TX 76131

    Specifically, BNSF requests permission to discontinue automatic cab
signals on the Chicago Division, Chicago Subdivision from Union Avenue
to Intermediate 36.1, Line Segment 71, milepost (MP) 2.3 to MP 36.1,
currently in use for suburban trains only.
    BNSF states the reason for the proposed discontinuance is a
positive train control system, compliant with 49 CFR part 236, subpart
I, Positive Train Control Systems, and certified accordingly, has been
placed in service within the limits described.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the

comment period and specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 11, 2021 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at www.dot.gov/privacyhttps://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2020-26161 Filed 11-25-20; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12941-12942]
[FR Doc No: 2023-04212]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1047]

Q13 Continuous Manufacturing of Drug Substances and Drug
Products; International Council for Harmonisation; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Q13
Continuous Manufacturing of Drug Substances and Drug Products.'' The
guidance was prepared under the auspices of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals for
Human Use (ICH). The guidance provides clarification on continuous
manufacturing (CM) concepts and describes scientific approaches and
regulatory considerations specific to CM of drug substances and drug
products. The guidance is intended to provide scientific and regulatory
considerations for the development, implementation, operation, and
life-cycle management of CM. The guidance replaces the draft guidance
entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug
Products'' issued on October 14, 2021. This guidance also replaces the
draft guidance entitled ``Quality Considerations for Continuous
Manufacturing'' issued on February 27, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on March 1, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2021-D-1047 for ``Q13 Continuous Manufacturing of Drug Substances
and Drug Products.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Sau Lee, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 4182, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug
Products.'' The guidance was prepared under the auspices of ICH. ICH
seeks to achieve greater regulatory harmonization worldwide to ensure
that safe, effective, high-quality medicines are developed, registered,
and maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to https://www.ich.org/).
    ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and consensus-driven process that results in
the development of ICH guidelines. The regulators around the world are
committed to consistently adopting these consensus-based guidelines,
realizing the benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of October 14, 2021 (86 FR 57159), FDA
published a notice announcing the availability of a draft guidance
entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug
Products.'' The notice gave interested persons an opportunity to submit
comments by December 13, 2021. After consideration of the comments
received and revisions to the guideline, a final draft of the guideline
was submitted to the ICH Assembly and endorsed by the regulatory
agencies on November 16, 2022.
    This final guidance provides guidance on the development,
implementation, operation, and life-cycle management of CM and provides
clarification on CM concepts and describes scientific approaches and
regulatory considerations specific to CM of drug substances and drug
products. This guidance also replaces the draft guidance entitled
``Quality Considerations for Continuous Manufacturing,'' issued on
February 27, 2019. Many of the principles in that guidance have been
incorporated in the guidance entitled ``Q13 Continuous Manufacturing of
Drug Substances and Drug Products,'' rendering the 2019 guidance
obsolete.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Q13 Continuous Manufacturing of Drug
Substances and Drug Products.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 relating to the submissions of
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
314 relating to the submissions of new drug applications and
abbreviated new drug applications have been approved under OMB control
number 0910-0001. The collections of information in 21 CFR part 601
relating to the submissions of biologics license applications have been
approved under OMB control number 0910-0338. The collections of
information in 21 CFR parts 210 and 211 relating to current good
manufacturing practice have been approved under OMB control number
0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04212 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 28, 2009 (Volume 74, Number 101)]
[Notices]
[Page 25531]
[DOCID:fr28my09-50]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8910-3, Docket EPA-HQ-OW-2005-0007]

Notice Regarding National Pollutant Discharge Elimination System
(NPDES) Multi-Sector General Permit (MSGP) for Storm Water Discharges
Associated With Industrial Activity

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: EPA previously announced the issuance in EPA Regions 1, 2, 3,
5, 6, 9, and 10 of the NPDES general permit for stormwater discharges
from industrial activity, also referred to as the 2008 Multi-Sector
General Permit (MSGP), in the Federal Register of September 29, 2008
(73 FR 56572). The permit was signed on September 29, 2008 and became
effective on September 29, 2008. On February 26, 2009 (74 FR 8789), EPA
issued the MSGP to certain states, federal facilities, and Indian
Country located in EPA Region 10 after receipt of certifications
pursuant to section 401 of the Clean Water Act (CWA). Today's notice of
availability provides notice of EPA's deletion of a portion of a
specific State's CWA Section 401 certification condition from Part
<IP_ADDRESS> of the 2008 MSGP for the State of Massachusetts.

FOR FURTHER INFORMATION CONTACT: For further information on this final
NPDES general permit, contact David Gray, EPA Region 1, Office of
Ecosystem Protection, Industrial Permits Branch at tel.:<PHONE_NUMBER>,
or Greg Schaner, EPA Headquarters, Office of Water, Office of
Wastewater Management at tel.:<PHONE_NUMBER>, or send questions via e-
mail to EPA's stormwater permit mailbox<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. General Information

    Pursuant to CWA Section 401(a) and EPA's implementing regulations,
EPA may not issue a NPDES permit (including the 2008 MSGP) until the
appropriate State certifications have been granted or waived. 40 CFR
124.53(a). Through the certification process, States were given the
opportunity, before the 2008 MSGP was issued, to add conditions to the
permit they believe are necessary to ensure that the permit complies
with the CWA and other appropriate requirements of State law, including
State water quality standards.
    The Massachusetts Department of Environmental Protection (MassDEP)
issued its initial Section 401 certification for the 2008 MSGP on
February 13, 2006; with subsequent modifications thereto dated June 8,
2006 and September 5, 2006. In a modified certification on March 27,
2009, MassDEP deleted tributlytin (included in certification condition
5) as a required benchmark monitoring parameter applicable to
Sector Q (Water Transportation) and Sector R (Ship and Boat Building
and Repair Yards). Pursuant to EPA's implementing regulations at 40 CFR
124.55(b), EPA may, at the request of a permittee, modify the 2008 MSGP
based on a modified certification received after final agency action on
the permit ``only to the extent necessary to delete any conditions
based on a condition in a certification invalidated by a court of
competent jurisdiction or by an appropriate State board or agency.'' 40
CFR 124.55(b). In accordance with this provision, EPA has removed the
monitoring parameter from the appropriate certification condition for
the 2008 MSGP.\1\ EPA's letter notifying the requesting permittee that
its request to delete a portion of the permit condition was granted,
and a copy of the 2008 MSGP reflecting the deletion, can be found in
the docket for the 2008 MSGP (Docket ID No. EPA-HQ-OW-2005-0007).\2\
---------------------------------------------------------------------------

    \1\ In addition, the regulations at 40 CFR 124.55(b) also
require that EPA receive a request from a permittee for the deleted
certification conditions to be removed from the permit. EPA received
such requests to remove deleted conditions from Hyannis Marina,
Hyannis, MA, on March 17, 2009.
    \2\ In addition, the permit may be found at: http://
cfpub.epa.gov/npdes/stormwater/msgp.cfm.
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B. How Can I Get Copies of These Documents and Other Related
Information?

    1. Docket. EPA has established an official public docket for this
action under Docket ID No. EPA-HQ-OW-2005-0007. The official public
docket is the collection of materials, including the administrative
record, for the final permit, required by 40 CFR 124.18. It is
available for public viewing at the Water Docket in the EPA Docket
Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC 20460. Although all documents in the docket are listed
in an index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Publicly
available docket materials are available electronically through
www.regulations.gov and in hard copy at the EPA Docket Center Public
Reading Room, open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER> and the telephone number for the Water Docket is
(202) 566-2426.
    2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through the
Federal Docket Management System (FDMS) found at http://
www.regulations.gov. You may use the FDMS to view public comments,
access the index listing of the contents of the official public docket,
and to access those documents in the public docket that are available
electronically. Once at the Web site, enter the appropriate Docket ID
No. in the ``Search'' box to view the docket.
    Certain types of information will not be placed in the EPA dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the docket
facility identified in Section B.1.

    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

    Dated: May 13, 2009.
Ira Leighton,
Acting Regional Administrator, EPA Region 1.
[FR Doc. E9-12472 Filed 5-27-09; 8:45 am]

BILLING CODE 6560-50-P