[Federal Register Volume 76, Number 136 (Friday, July 15, 2011)]
[Rules and Regulations]
[Pages 41667-41669]
[FR Doc No: 2011-17567]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0436; Directorate Identifier 2011-CE-009-AD;
Amendment 39-16752; AD 2011-15-05]
RIN 2120-AA64

Airworthiness Directives; Hawker Beechcraft Corporation Models
B300 and B300C (C-12W) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Hawker Beechcraft Corporation Models B300 and B300C (C-12W) airplanes.
This AD was prompted by an error found in the take-off speeds and field
lengths published in the FAA-approved airplane flight manual. This AD
requires a correction to the published data in the airplane flight
manual and the pilot's operating handbook to ensure it corresponds with
the published data in the pilot's checklist. This condition, if not
corrected, could result in a pilot taking off from shorter runways than
required by the airplane if the airplane loses an engine after takeoff
decision speed (V1). This could result in the airplane
running out of runway before take-off can be accomplished. We are
issuing this AD to correct the unsafe condition on these products.

DATES: This AD is effective August 19, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of August 19,
2011.

ADDRESSES: For service information identified in this AD, contact
Hawker Beechcraft Corporation, 9709 East Central, Wichita, Kansas
67201; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet:
https://www.hawkerbeechcraft.com/service_support/pubs/. You may review
copies of the referenced service information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jason Brys, Flight Test Engineer, FAA,
Wichita Aircraft Certification Office, 1801 S. Airport Road, Room 100,
Wichita, Kansas 67209; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM published in the Federal Register on April 29, 2011 (76 FR
23921). That NPRM proposed to require inserting an update to the
performance charts in the FAA-approved Airplane Flight Manual and the
Pilot's Operating Handbook, part number (P/N) 130-590031-245. The
required runway distances published in the current manual could be up
to 320 feet shorter than what is necessary. Hawker Beechcraft
Corporation determined data in the pilot's checklist (P/N 130-590031-
273) was correct. This condition, if not corrected, could result in
taking off from shorter runways than required by the airplane if the
airplane loses an engine after takeoff decision speed (V1).
This could result in the airplane running out of runway before take-off
can be accomplished.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Costs of Compliance

    We estimate that this proposed AD affects 46 airplanes of U.S.
registry.

    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                     Labor cost            Parts cost           product         operators
----------------------------------------------------------------------------------------------------------------
AFM page replacement..............  0.5 work-hour x $85    Not applicable.....          $42.50           $1,955
                                     per hour = $42.50.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2011-15-05 Hawker Beechcraft Corporation Models B300 and B300C (C-
12W) Airplanes: Amendment 39-16752; Docket No. FAA-2011-0436;
Directorate Identifier 2011-CE-009-AD.

(a) Effective Date

    This AD is effective August 19, 2011.

(b) Affected ADs

    None.

(c) Applicability

    (1) This AD applies to Hawker Beechcraft Corporation Models B300
and B300C (C-12W) airplanes, all serial numbers, that:
    (2) Are certificated in any category; and
    (3) Are modified per Hawker Beechcraft Drawing 130M000030 or Kit
Drawing 130-4014 that incorporate Pilot's Operating Handbook and FAA
Approved Flight Manual, part number (P/N) 130-590031-245.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 91, Charts.

(e) Unsafe Condition

    This AD was prompted by an error that was discovered in the
take-off speeds and field lengths published in the FAA-approved
flight manual. This AD is issued to correct the published data in
the airplane flight manual and the pilot's operating handbook and
ensure it corresponds with the published data in the pilot's
checklist. This condition, if not corrected, could result in taking
off from shorter runways than required by the airplane if the
airplane loses an engine after takeoff decision speed
(V1). This could result in the airplane running out of
runway before take-off can be accomplished.

(f) Compliance

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

(g) Action

    Within 14 days after the effective date of this AD, insert
Hawker Beechcraft Corporation Log of Temporary Changes, dated
February 2011; and Hawker Beechcraft Corporation Temporary Change to
the Pilot's Operating Handbook and FAA Approved Airplane Flight
Manual, Part Number (P/N) 130-590031-245TC5, dated February 2011;
into the airplane's Pilot's Operating Handbook and FAA Approved
Flight Manual, P/N 130-590031-245. The actions required by this
paragraph may be performed by the owner/operator (pilot) holding at
least a private pilot certificate and must be entered into the
aircraft records showing compliance with this AD in accordance with
14 CFR 43.9 (a)(1)-(4) and 14 CFR 91.417(a)(2)(v). The record must
be maintained as required by 14 CFR 91.417, 121.380, or 135.439.

(h) Alternative Methods of Compliance (AMOCs)

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

 (i) Related Information

    For more information about this AD, contact Jason Brys, Flight
Test Engineer, FAA, Wichita ACO, 1801 S. Airport Road, Room 100,
Wichita, Kansas 67209; telephone:<PHONE_NUMBER>; fax: (316) 946-
4107.

(j) Material Incorporated by Reference

    You must use the following service information to do the actions
required by this AD, unless the AD specifies otherwise. The Director
of the Federal Register approved the incorporation by reference
(IBR) under 5 U.S.C. 552(a) and 1 CFR part 51 of the following
service information on the date specified:
    (1) Hawker Beechcraft Corporation Log of Temporary Changes,
dated February 2011, approved for IBR August 19, 2011.

    (2) Hawker Beechcraft Corporation Temporary Change to the
Pilot's Operating Handbook and FAA Approved Airplane Flight Manual,
P/N 130-590031-245TC5, dated February 2011, approved for IBR August
19, 2011.
    (3) For service information identified in this AD, contact
Hawker Beechcraft Corporation, 9709 East Central, Wichita, Kansas
67201; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; Internet:
https://www.hawkerbeechcraft.com/service_support/pubs/.
    (4) You may review copies of the service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.
    (5) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Kansas City, Missouri, on July 7, 2011.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2011-17567 Filed 7-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 159 (Monday, August 18, 2014)]
[Notices]
[Pages 48738-48739]
[FR Doc No: 2014-19465]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-89-000]

GDF Suez Energy Resources, NA (Complainant) v. New York
Independent System Operator, Inc. Consolidated Edison Company of New
York, Inc. (Respondents); Notice of Complaint

    Take notice that on August 11, 2014, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206, GDF Suez Energy Resources, NA (Suez),
filed a formal complaint against New York Independent System Operator,
Inc. (NYISO) and Consolidated Edison Company of New York, Inc. (ConEd),
alleging, among other things, that the Complainant paid over-charges
for electric service from NYISO during November/December 2012 billing
period based on consumption data

submitted by ConEd that Suez contends is erroneous, as more fully
explained in the complaint.
    The Complainant states that a copy of the complaint has been served
on the Respondents.
    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 September 2, 2014.

    Dated: August 11, 2014.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-19465 Filed 8-15-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10114]
[FR Doc No: 2021-03327]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4532-DR; Docket ID FEMA-2021-0001]

Vermont; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Vermont (FEMA-4532-DR), dated April 8, 2020, and
related determinations.

DATES: This change occurred on January 14, 2021.

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: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Paul F. Ford,
of FEMA is appointed to act as the Federal Coordinating Officer for
this disaster.
    This action terminates the appointment of W. Russell Webster as
Federal Coordinating Officer for this disaster.

    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,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03327 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 99 (Tuesday, May 23, 2023)]
[Notices]
[Page 33142]
[FR Doc No: 2023-10948]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-1895-000]

Solar Partners XI, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Solar Partners XI, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 6, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: May 17, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-10948 Filed 5-22-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 12, 2005 (Volume 70, Number 237)]
[Notices]
[Page 73463]
[DOCID:fr12de05-53]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-123-000]

Colorado Interstate Gas Company; Notice of Proposed Changes in
FERC Gas Tariff

December 6, 2005.
    Take notice that on November 30, 2005, Colorado Interstate Gas
Company (CIG) tendered for filing as part of its FERC Gas Tariff, First
Revised Volume No 1, Fortieth Revised Sheet No. 11A , to become
effective January 1, 2006.
    CIG states that copies of its filing have been sent to all firm
customers, interruptible customers, and affected state commissions.
    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 and 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. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    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 14 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 e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7223 Filed 12-9-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Rules and Regulations]
[Pages 22374-22376]
[FR Doc No: 2019-10187]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0720, EPA-R04-OAR-2018-0759; FRL-9993-71-Region 4]

Air Plan Approval; GA and TN; Interstate Transport (Prongs 1 and
2) for the 2010 1-Hour NO2 Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving State
Implementation Plan (SIP) revisions submitted by the State of Georgia,
through the Georgia Environmental Protection Division (Georgia EPD),
via a letter dated July 24, 2018, and the State of Tennessee, through
the Tennessee Department of Environment & Conservation (TDEC), via a
letter dated May 14, 2018, for the purpose of addressing the Clean Air
Act (CAA or Act) ``good neighbor'' interstate transport (prongs 1 and
2) infrastructure SIP requirements for the 2010 1-hour Nitrogen Dioxide
(NO2) National Ambient Air Quality Standard (NAAQS). The CAA
requires that each state adopt and submit a SIP for the implementation,
maintenance, and enforcement of each NAAQS promulgated by EPA, commonly
referred to as an ``infrastructure SIP.'' Specifically, EPA is
approving these SIP revisions addressing prongs 1 and 2 to ensure that
air emissions in each of these two states do not significantly
contribute to nonattainment or interfere with maintenance of the 2010
1-hour NO2 NAAQS in any other state.

DATES: This rule is effective June 17, 2019.

ADDRESSES: EPA has established dockets for these actions under Docket
Identification Nos. EPA-R04-OAR-2018-0720 and EPA-R04-OAR-2018-0759.
All documents in these dockets are listed on the www.regulations.gov
website. Although listed in the index, some information may not be
publicly available, i.e., Confidential Business Information or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically through
www.regulations.gov or in hard copy at the Air Regulatory Management
Section, Air Planning and Implementation Branch, Air and Radiation
Division (formerly the Air, Pesticides and Toxics Management Division),
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Evan Adams of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Adams can be
reached by phone at<PHONE_NUMBER> or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On January 22, 2010, EPA established a new 1-hour primary NAAQS for
NO2 at a level of 100 parts per billion (ppb), based on a 3-
year average of the 98th percentile of the yearly distribution of 1-
hour daily maximum concentrations. See 75 FR 6474 (February 9, 2010).
This NAAQS is designed to protect against exposure to the entire group
of nitrogen oxides (NOX). NO2 is the component of
greatest concern and is used as the indicator for the larger group of
NOX. Emissions that lead to the formation of NO2
generally also lead to the formation of other NOX.
Therefore, control measures that reduce NO2 can generally be
expected to reduce population exposures to all gaseous NOX
which may have the co-benefit of reducing the formation of ozone and
fine particles both of which pose significant public health threats.
For comprehensive information on the 2010 1-hour NO2 NAAQS,
please refer to the February 9, 2010, Federal Register notice. See 75
FR 6474.
    Whenever EPA promulgates a new or revised NAAQS, CAA section
110(a)(1) requires states to make SIP submissions to provide for the
implementation, maintenance, and enforcement of the NAAQS. This
particular type of SIP submission is commonly referred to as an
``infrastructure SIP.'' These submissions must meet the various
requirements of CAA section 110(a)(2), as applicable. Due to ambiguity
in some of the language of CAA section 110(a)(2), EPA believes that it
is appropriate to interpret these provisions in the specific context of
acting on infrastructure SIP submissions. EPA has previously provided
comprehensive guidance on the application of these provisions through a
guidance document for infrastructure SIP submissions and through
regional actions on infrastructure submissions. Unless otherwise noted
below, EPA is following that existing approach in acting on this
submission. In addition, in the context of acting on such
infrastructure submissions, EPA evaluates the submitting state's
implementation plan for compliance with statutory and regulatory
requirements, not for the state's implementation of its SIP. EPA has
other authority to address any issues concerning a state's
implementation of the regulations that comprise its SIP.
    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct
components, commonly referred to as ``prongs,'' that must be addressed
in infrastructure SIPs. The first two prongs, which are codified in
section 110(a)(2)(D)(i)(I), are provisions that prohibit any source or
other type of emissions activity in one state from contributing
significantly to nonattainment of the NAAQS in another state (prong 1)
and from interfering with maintenance of the NAAQS in another state
(prong 2). EPA sometimes refers to

the prong 1 and prong 2 conjointly as the ``good neighbor'' provision
of the CAA. The third and fourth prongs, which are codified in section
110(a)(2)(D)(i)(II), are provisions that prohibit emissions activity in
one state from interfering with measures required to prevent
significant deterioration of air quality in another state (prong 3) and
from interfering with measures to protect visibility in another state
(prong 4). Section 110(a)(2)(D)(ii) requires SIPs to include provisions
ensuring compliance with sections 115 and 126 of the Act, relating to
interstate and international pollution abatement.
    EPA's most recent infrastructure SIP guidance, the September 13,
2013, ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2),'' did
not explicitly include criteria for how the Agency would evaluate
infrastructure SIP submissions intended to address section
110(a)(2)(D)(i)(I). With respect to certain pollutants, such as ozone
and particulate matter (PM), EPA has addressed interstate transport in
eastern states in the context of regional rulemaking actions that
quantify state emission reduction obligations. For NO2, EPA
has considered available information from states such as current air
quality, emissions data and trends, and regulatory provisions that
control source emissions to determine whether emissions from one state
interfere with the attainment or maintenance of the NAAQS in another
state. EPA's actions on Georgia's and Tennessee's CAA section
110(a)(2)(D)(i)(I) interstate transport SIP revisions for the 2010
NO2 NAAQS are informed by these considerations.
    In notices of proposed rulemaking (NPRMs) for Georgia (published on
March 11, 2019, at 84 FR 8645), and Tennessee (published on March 11,
2019, at 84 FR 8643), EPA proposed to approve the Georgia and Tennessee
SIP submissions on the basis that their SIPs adequately address prong 1
and prong 2 requirements for the 2010 1-hour NO2 NAAQS. The
details of the Georgia and Tennessee submissions and the rationale for
EPA's actions are explained in the NPRMs.\1\
---------------------------------------------------------------------------

    \1\ EPA notes that it is only making a determination that the
States' already-approved SIPs meet certain CAA requirements. EPA is
not approving or removing any rules from the Georgia or Tennessee
SIP.
---------------------------------------------------------------------------

    Comments on both proposed rulemakings were due on or before April
10, 2019. EPA received no comments on the NPRM related to the Georgia
submittal and one comment on the NPRM related to the Tennessee
submittal.\2\ The sole comment on the Tennessee submittal is not a
significant comment requiring a response because it is generalized and
unsupported.\3\
---------------------------------------------------------------------------

    \2\ The comment on the Tennessee submittal is located in the
docket for this action.
    \3\ See, e.g., Home Box Office, Inc. v. FCC, 567 F.2d 9, 35 n.58
(D.C. Cir. 1977) (citing Portland Cement Ass'n v. Ruckelshaus, 486
F.2d 375, 393-94 (D.C. Cir. 1973) (``In determining what points are
significant, the `arbitrary and capricious' standard of review must
be kept in mind. Thus only comments which, if true, raise points
relevant to the agency's decision and which, if adopted, would
require a change in an agency's proposed rule cast doubt on the
reasonableness of a position taken by the agency. Moreover, comments
which themselves are purely speculative and do not disclose the
factual or policy basis on which they rest require no response.
There must be some basis for thinking a position taken in opposition
to the agency is true.''); Public Citizen, Inc. v. FAA, 988 F.2d.
186, 197 (D.C. Cir. 1993) (citing Home Box Office, Inc. v. FCC, 567
F.2d 9, 35 n.58 (D.C. Cir. 1977)) (``We reiterate that to require
response by the agency, comments must do more than simply state that
the agency's premises or conclusions are wrong; they must explain
why and on what basis the agency assertedly has erred.'').
---------------------------------------------------------------------------

II. Final Actions

    As described above, EPA is approving the infrastructure SIP
submissions transmitted under cover letter by the Georgia EPD on July
24, 2018, and TDEC on May 14, 2018, addressing prongs 1 and 2 of
section 110(a)(2)(D)(i)(I) for the 2010 1-hour NO2 NAAQS.
EPA is approving these infrastructure SIP revisions because they are
consistent with section 110 of the CAA.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. These actions merely
approve state law as meeting Federal requirements and do not impose
additional requirements beyond those imposed by state law. For that
reason, these actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Are not Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory actions because SIP approvals are exempted under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIPs are not approved to apply on any Indian reservation land
or in any other area where EPA or an Indian tribe has demonstrated that
a tribe has jurisdiction. In those areas of Indian country, these rules
do not have tribal implications as specified by Executive Order 13175
(65 FR 67249, November 9, 2000), nor will they impose substantial
direct costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing these actions and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. These actions are not ``major rules'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of these actions must be filed in the United

States Court of Appeals for the appropriate circuit by July 16, 2019.
Filing a petition for reconsideration by the Administrator of these
final rules does not affect the finality of these actions for the
purposes of judicial review nor does it extend the time within which a
petition for judicial review may be filed and shall not postpone the
effectiveness of such rules or actions. These actions may not be
challenged later in proceedings to enforce their requirements. See
section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements.

    Dated: May 6, 2019.
Mary S. Walker,
Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart L--Georgia

0
2. In Sec.  52.570, paragraph (e) is amended by adding an entry for
``110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour
NO2 NAAQS'' at the end of the table to read as follows:

Sec.  52.570   Identification of plan.

* * * * *
    (e) * * *

                                                     EPA-Approved Georgia Non-Regulatory Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                State
     Name of nonregulatory SIP      Applicable geographic  submittal date/            EPA approval date                         Explanation
             provision              or nonattainment area  effective date
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
110(a)(1) and (2) Infrastructure    Georgia..............        07/24/18  5/17/19 [Insert citation of             Addressing Prongs 1 and 2 of section
 Requirements for the 2010 1-hour                                           publication].                           110(a)(2)(D)(i) only.
 NO2 NAAQS.
--------------------------------------------------------------------------------------------------------------------------------------------------------

Subpart RR--Tennessee

0
3. In Sec.  52.2220, paragraph (e) is amended by adding an entry for
``110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour
NO2 NAAQS'' at the end of the table to read as follows:

Sec.  52.2220   Identification of plan.

* * * * *
    (e) * * *

                                                    EPA-Approved Tennessee Non-Regulatory Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Name of non-regulatory SIP      Applicable geographic       State
             provision              or nonattainment area  effective date             EPA approval date                         Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------
110(a)(1) and (2) Infrastructure    Tennessee............        05/14/18  5/17/19 [Insert citation of             Addressing Prongs 1 and 2 of section
 Requirements for the 2010 1-hour                                           publication].                           110(a)(2)(D)(i) only.
 NO2 NAAQS.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2019-10187 Filed 5-16-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Notices]
[Page 26297]
[FR Doc No: 2014-10437]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. S7-40-10; Release No. 72079]

Securities Exchange Act of 1934; In the Matter of Exchange Act
Rule 13p-1 and Form SD; Order Issuing Stay

May 2, 2014.
    On April 14, 2014, the United States Court of Appeals for the
District of Columbia Circuit issued a decision in National Association
of Manufacturers, et al. v. SEC, et al., No. 13-5252 (D.C. Cir. April
14, 2014). That case involved a challenge to Exchange Act Rule 13p-1
and Form SD.\1\ The rule and form were adopted pursuant to Section
13(p) of the Securities Exchange Act of 1934, which was added by
Section 1502 of the Dodd-Frank Wall Street Reform and Consumer
Protection Act.\2\ The Court of Appeals rejected all of the challenges
to the rule based on the Administrative Procedure Act and the Exchange
Act. The Court of Appeals, however, concluded that Section 13(p) and
Rule 13p-1 ``violate the First Amendment to the extent the statute and
rule require regulated entities to report to the Commission and to
state on their Web site that any of their products have `not been found
to be `DRC conflict free.' ' '' \3\ In so concluding, the Court of
Appeals specifically noted that there was no ``First Amendment
objection to any other aspect of the conflict minerals report or
required disclosures.'' \4\ In an order issued concurrently with the
decision, the Court of Appeals withheld the issuance of its mandate
until seven days after disposition of any timely petition for rehearing
or petition for rehearing en banc. As a result, the earliest date on
which the Court of Appeals's mandate is likely to issue is June 5,
2014. Under Rule 13p-1, the first reports are due to be filed on June
2, 2014.
---------------------------------------------------------------------------

    \1\ Conflict Minerals, 77 FR 56,274 (Sept. 12, 2012) (codified
at 17 CFR 240, 249b).
    \2\ Public Law 111-203, 124 Stat. 1376, 2213 (2010).
    \3\ Slip. Op. at 23.
    \4\ Slip. Op. at 17 n.8.
---------------------------------------------------------------------------

    Section 705 of the Administrative Procedure Act provides that an
agency may postpone the effective date of an action taken by it pending
judicial review when it finds that ``justice so requires.'' 5 U.S.C.
705. In light of the Court of Appeals's decision, the Commission finds
that it is consistent with what justice requires to stay the effective
date for compliance with those portions of Rule 13p-1 and Form SD that
would require the statements by issuers that the Court of Appeals held
would violate the First Amendment. Among other things, a stay of those
portions of the rule avoids the risk of First Amendment harm pending
further proceedings. Moreover, limiting the stay to those portions of
the rule requiring the disclosures that the Court of Appeals held would
impinge on issuers' First Amendment rights furthers the public's
interest in having issuers comply with the remainder of the rule, which
was mandated by Congress in Section 1502 and upheld by the Court of
Appeals.
    Accordingly, it is ordered, pursuant to Section 705 of the
Administrative Procedure Act, that the effective date for compliance
with those portions of Rule 13p-1 and Form SD subject to the Court of
Appeals's constitutional holding are hereby stayed pending the
completion of judicial review, at which point the stay will terminate.
For more detailed guidance regarding compliance, issuers should refer
to the statement issued by the staff on April 29, 2014, and any further
guidance subsequently provided.\5\
---------------------------------------------------------------------------

    \5\ On April 30, 2014, the National Association of
Manufacturers, the Chamber of Commerce, and Business Roundtable
filed a motion requesting that the Commission stay Rule 13p-1 in its
entirety. In accordance with the above order, the motion is denied.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-10437 Filed 5-6-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64435-64438]
[FR Doc No: 2023-20136]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3636]

Food and Drug Administration Information Technology Strategy;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comment.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of an information technology (IT) strategic plan
entitled the ``FDA Information Technology Strategy'' and a request for
comment on this IT Strategy. As part of our User Fee Program
commitments and Omnibus Bill requirements, FDA will develop and publish
an FDA Data and Technology Strategic Plan by September 29, 2023. This
plan will define and shape the future course of FDA's data and
technology capabilities, building on the existing FDA Modernization
Framework. The plan will also integrate Agency and center strategies.

DATES: Submit either electronic or written comments on the Strategy by
October 30, 2023, to ensure that the Agency considers your comments on
this Strategy for future iterations of the IT Strategy.

ADDRESSES: You may submit comments 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-2023-N-3636 for ``FDA IT Strategy.'' 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,<PHONE_NUMBER>.
     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>.
    Submit written requests for single copies of this IT strategy to
the Office of Digital Transformation, Food and Drug Administration, FDA
Library, 5630 Fishers Lane, Rm. 1087, Rockville, MD 20857. Send one
self-addressed adhesive label to assist that office in processing your
request or include a Fax number to which the strategy may be sent. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the draft strategy.

FOR FURTHER INFORMATION CONTACT: Casi Alexander, Office of Digital
Transformation, Food and Drug Administration, FDA Library, 5630 Fishers
Lane, Rm. 1087, Rockville, MD 20857,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a request for comment on its
draft strategy, entitled ``FDA Information Technology Strategy''.
    The Office of Digital Transformation (ODT) was established in
September 2021 and reports directly to the Office of the Commissioner.
ODT provides the vision and leadership in information technology, data,
and cybersecurity needed to advance FDA's mission and strategic
priorities. ODT has published a series of strategy documents known as
the FDA Modernization Framework. The framework includes the Technology
Modernization Action Plan, Data Modernization Action Plan, Enterprise
Modernization Action Plan, Cybersecurity Modernization Action Plan, and
the Leadership Modernization Action Plan. The FDA Modernization
Framework aims to develop an integrated technology, data,
cybersecurity, business, and leadership approach to advancing FDA's
public health mission in collaboration with industry.
    As part of FDA's fulfillment of requirements in section 3627 of the
Consolidated Appropriations Act, 2023 (Pub. L. 117-328), and
commitments described in section IV.A.2. of the ``PDUFA Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027''
(PDUFA VI commitment letter), FDA will work with industry while
developing a comprehensive framework for guiding the Agency's work and
allocating annual technology budgets and resources. The FDA IT
Strategy, covering Fiscal Years 2024-2026, defines and shapes the
future course of FDA's data and technology capabilities as FDA
transitions to the next phase of its journey. The Agency took a
collaborative approach to strategy development by gathering input from
numerous internal and external stakeholders that resulted in the draft
FDA IT Strategy. Stakeholder input is crucial for developing a
comprehensive plan that best meets the needs and goals of industry and
the Agency. Comments on the strategy will be considered for future
iterations of the FDA IT Strategy. Once adopted, this strategy will
serve as the basis for developing an internal operational plan with
objectives, tactics, and performance measures.
    As part of this effort, FDA will hold an FDA Digital Transformation
Symposium on December 4 to 7, 2023, to discuss this groundbreaking IT
Strategy and encourage further collaboration, innovation, and
transformation. On December 4 and 5, the Symposium will be shaped
around the six new strategic goals, highlighting supporting objectives
and initiatives. The FDA Digital Transformation Symposium will extend
to December 6 and 7 to engage IT vendors in a Reverse Industry Day and
other vendor-focused events. Registration information will be found on
www.FDA.gov for this event.

II. Requested Feedback

    Interested persons are invited to provide detailed comments to ODT
(see ADDRESSES) on the specific IT Strategy Goals and Objectives within
FDA's Agency-wide IT Strategy. To facilitate comment, FDA has developed
a series of questions in this section. The questions are not meant to
be exhaustive, and FDA is also interested in any other pertinent
information stakeholders would like to share on this topic. FDA
encourages stakeholders to provide the specific rationale and basis for
their comments, including any available supporting data and
information.
    1. Which goals and objectives are most important to you? Why?
    2. Describe up to five ways the FDA IT Strategy will impact your
industry?
    3. What gaps do you see in the FDA IT Strategy's goals or
objectives?
    4. What challenges or risks do you foresee in executing the FDA IT
Strategy?

III. FDA IT Strategy Goals and Objectives

    Goal 1: Create a Shared OneFDA Ecosystem: Establish greater access
to trusted data and shared resources across Centers, Offices, and
external stakeholders. Encourage and facilitate cross-functional
investment in technology to support enterprise business objectives for
speed, scale, and value through robust Agency level governance
processes, enhanced collaboration channels, and technology products and
services. Shift FDA's culture to make sharing across Centers and
Offices and with external stakeholders (where appropriate) the norm--
where prioritizing Agency-level public health outcomes improves results
for everyone.
Objectives
     Enhance Communication and Collaboration: Foster
information and resource sharing with internal and external
stakeholders to achieve both Agency and specific stakeholder outcomes,
using a variety of communication channels to reach broader audiences.
Enable collaboration and develop strong partnerships across Centers and
Offices through integrated technologies and platforms.
     Promote Transparency: Actively involve impacted
stakeholders in IT solution planning, development, and execution to
drive expected outcomes.
     Optimize Investments: Align the diverse needs across FDA
to the overarching strategy through stronger financial fidelity,
enhanced budget coordination, and improved financial planning. Ensure
effective IT resource utilization, transparency in IT budget
allocation, and measurement of results achieved.
     Strengthen Governance: Ensure the effective and efficient
use of IT in enabling FDA to achieve mission outcomes through
established standards, responsible procurement, and more robust
decision-making and accountability mechanisms.
    Goal 2: Strengthen IT Infrastructure: Continue to modernize and
secure the foundational IT infrastructure for all IT services and
solutions. Proactively provide the ability to adapt to changes in
workload demand, detect issues before they impact stakeholders, and
quickly resolve technology issues to avoid disruptions to day-to-day
operations.
Objectives
     Provide Flexible Infrastructure Offerings: Provide a
marketplace with usage-based models for users to identify and implement
the infrastructure solutions based on their business requirements with
an appropriate chargeback model.
     Accelerate Cloud Adoption: Empower users with cloud
offerings to meet their mission needs, e.g., scalability and agility.
Provide best practice guidance on cloud models, e.g., hybrid and
transition strategies based on the unique needs across Centers and
Offices.
     Ensure Service Availability: Provide stable access to IT
services through proactive, continuous monitoring of IT infrastructure
service performance (e.g., Service Level Agreements, Operating Level
Agreements) and feedback from FDA users to identify potential problems
and implement targeted improvements.
     Implement Zero Trust Approach: Establish a comprehensive
zero trust and risk-based approach to obtain optimal maturity level by
upgrading, modernizing, and enhancing FDA's security and cyber
defenses.
    Goal 3: Modernize Enterprise Services and Capabilities: Optimize
the IT services portfolio to support everyday needs with cross-cutting,
mission-critical offerings and benefit from economies of scale. Ensure
enterprise IT services are stable, resilient, and adaptive, with
opportunities for stakeholders to tailor solutions, where appropriate,
and feedback loops to drive continuous improvement.
Objectives
     Increase Business Alignment: Lead with a business-first
approach to modernizing enterprise services and capabilities to ensure
technology enables the capabilities defined in FDA's Business
Capability Model and supporting business processes.
     Scale Operations: Develop and drive adoption of enterprise
solutions for standard capabilities, e.g., Finance/Budget, Human
Resources, Acquisitions, Inspections, Freedom of Information Act
requests, and Complaints Management with continuous user testing, while
providing flexibility for customization where relevant. Manage the
lifecycle of applications within the enterprise portfolio.
     Increase Digital Maturity: Maximize the use of technology
(e.g., data, automation) in core business areas and enable processes to
improve their ability to adapt to changes and scale.
     Improve Customer Experience: Create customer-centric
solutions that enhance satisfaction by improving accessibility to IT
solutions, including external-facing systems (e.g., Electronic
Submission Gateway Next Generation), streamlining processes, and easing
adoption. Increase stakeholder engagement with FDA IT services by
prioritizing customer and employee feedback and establishing formal
feedback loops.
     Modernize FDA Cybersecurity Defenses: Upgrade, enhance,
and modernize FDA's critical cyber defenses and practices to address
the evolving threat landscape where risks to FDA's critical assets,
industry, and sensitive data exist.
     Reduce Technology Debt: Decommission legacy systems,
applications, and End-of-Life devices and reinvest in enterprise
solutions and business process improvements to minimize technical debt
and enterprise risk.
    Goal 4: Share Data for Mission Outcomes: Identify common data
assets critical to stakeholders across FDA and make them widely
available and consumable to drive operational efficiencies and
excellence. Leverage valuable data assets and insights to develop new
capabilities and services and enable public health innovation.
Objectives
     Enhance Data Governance: Implement Artificial Intelligence
(AI)-powered best practices for governance and data management that
improve data quality, security, and the speed and accuracy of insights
and decisions.
     Foster OneFDA Data Literacy: Educate the workforce on best
practices and the benefits of consuming, analyzing, and making data-
based decisions.

     Improve Data Visibility and Accessibility: Prioritize
which data assets to make widely available first based on value to the
mission and the most significant number of stakeholders.
     Enable Advanced Data Analytics: Ensure experts can easily
combine and analyze information from various internal and external
sources to gain comprehensive insights.
     Enhance Secure Data Exchange: Improve interoperable and
secure data exchange and collaboration across FDA and its public health
partners.
    Goal 5: Adopt AI and Mission-Driven Innovations: Drive exploration
and address impacts of emerging technologies and trends, such as AI and
virtual reality, on FDA's IT portfolio and regulatory operations.
Proactively identify opportunities and risks to FDA's mission and
inform responsible use of technology. Enhance partnerships with
external experts to leverage these technologies and promptly respond to
their impact.
Objectives
     Balance Policy and Technology Value: Develop ethical
guidance for technology use while maximizing business value, such as
Guidance on AI Strategy. Ensure responsible actions by conducting
comprehensive research and analysis to fully understand technological
advancements' potential impacts and implications on society.
     Ensure Responsible Use of Innovations: Deploy
technological innovations, such as AI/Machine Learning, responsibly
with an understanding of regulatory impacts and effective risk response
strategies. Establish appropriate guardrails where necessary.
     Provide Proactive Thought Leadership: Lead as a partner in
creating novel use cases for emerging technologies through a deep
understanding of business processes, industry, and technology. Stay at
the forefront of technological advancements by harnessing industry
expertise and fostering collaboration.
     Foster Innovation: Create an environment where innovative
approaches are encouraged, identified, shared, and evaluated for use in
driving operational efficiency and developing new capabilities. Apply a
structured process to manage the innovation lifecycle from ideation to
investment to adoption (or project shutdown) to produce usable
innovations.
    Goal 6: Cultivate Talent and Leadership: Mature Agency-wide IT
competencies to deepen technology expertise and keep pace with the
accelerated rate of change in FDA's regulated industries and
technology. Develop holistic leaders equipped to lead through change
and drive FDA's digital transformation journey forward. Deliver
enterprise IT services with an Agency-first mindset. Given the
continued competition for talent, proactively build a robust talent
pipeline for targeted roles leveraging a combination of recruitment,
retention, and talent development strategies.
Objectives
     Instill OneFDA Mindset: Cultivate an Agency-first approach
to IT so that decisions promote and protect the health of the American
people first and foremost.
     Attract and Retain Talent: Build a diverse talent pipeline
through a compelling employee value proposition and total compensation
approach, talent acquisition, employee engagement, and talent
development strategies. Drive improvements across the employee
lifecycle from recruitment to retirement.
     Hire and Develop Resilient Leaders: Strengthen leadership
competencies required to drive holistic transformational IT initiatives
in a dynamic environment successfully.
     Develop Skills for the Future of Work: Develop IT skills
and competencies required to deliver current and future IT services
through upskilling, reskilling, and continuous learning.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the IT Strategy at https://www.regulations.gov.

    Dated: September 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20136 Filed 9-18-23; 8:45 am]
BILLING CODE 4164-01-P