[Federal Register Volume 81, Number 248 (Tuesday, December 27, 2016)]
[Rules and Regulations]
[Pages 95047-95050]
[FR Doc No: 2016-31018]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2016-0478, FRL-9957-08-Region 2]

Approval and Promulgation of Implementation Plans; New York
Prevention of Significant Deterioration of Air Quality and
Nonattainment New Source Review; Infrastructure State Implementation
Plan Requirements

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve revisions to the New York State Implementation Plan
(SIP) amending existing nonattainment New Source Review (NNSR) and
attainment New Source Review (Prevention of Significant Deterioration
of Air Quality, PSD) program requirements that the New York State
Department of Environmental Conservation (NYSDEC) submitted to EPA on
October 12, 2011. Specifically, the SIP revision includes new
requirements pertaining to the regulation of particulate matter with an
aerodynamic diameter less than or equal to 2.5 micrometer
(PM2.5) and the regulation of Greenhouse Gases (GHGs) under
New York's Part 231, ``New Source Review for New and Modified
Facilities;'' Part 201, ``Permits and Registrations;'' and amendments
to Part 200, ``General Provisions,'' of Title 6 of the Official
Compilation of Codes, Rules and Regulations of the State of New York (6
NYCRR). The SIP revision will make the SIP consistent with existing
federal requirements. The EPA is also taking final action to approve
certain elements of New York SIP revisions submitted to demonstrate
that the State meets the requirements of section 110(a)(1) and (2) of
the Clean Air Act (CAA) for the 2008 lead (Pb), 2008 ozone, and 2010
sulfur dioxide (SO2) national ambient air quality standards
(NAAQS).

DATES: This rule is effective on January 26, 2017.

ADDRESSES: EPA has established a docket for this action under Docket ID
number EPA-R02-OAR-2016-0478. All documents in the docket are listed on
the http://www.regulations.gov Web site.

FOR FURTHER INFORMATION CONTACT: Frank Jon, Air Programs Branch,
Environmental Protection Agency, 290 Broadway, 25th Floor, New York,
New York 10007-1866,<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, references to
``EPA,'' ``we,'' ``us,'' or ``our,'' are intended to mean the
Environmental Protection Agency. The supplementary information is
arranged as follows:

I. What is the background for this action?
II. What sections of New York's rules are we approving in this
action?
III. What are EPA's responses to comments to EPA's proposal?
IV. What action is EPA taking?
V. Incorporation By Reference.
VI. Statutory and Executive Order Reviews.

I. What is the background for this action?

    On October 12, 2011, the New York State Department of Environmental
Conservation (NYSDEC) submitted to EPA Region 2 a new set of revisions
to the New York State Implementation Plan (SIP). This submittal
consists of revisions to Title 6 of the New York Code of Rules and
Regulations (6 NYCRR) Part 231, New Source Review for New and Modified
Facilities; 6 NYCRR Part 200, General Provisions; and 6 NYCRR Part 201,
Permits and Certificates. New York undertook this rulemaking to comply
with EPA's May 16, 2008 NSR final rule for the regulation of
particulate matter with an aerodynamic diameter less than or equal to
2.5 micrometers (PM2.5). Also, the revisions implement EPA's
October 20, 2010 final rule that establishes the PM2.5
increments, significant impact levels, and significant monitoring
concentrations. New York's rulemaking implements PM2.5
provisions that were not previously included in the November 17, 2010
EPA SIP approval of Part 231. This SIP revision also incorporates
provisions that conform to EPA's June 3, 2010 final rule for Greenhouse
Gases (GHGs) under its PSD and Title V programs, establishing major
source applicability threshold levels for GHG emissions and other
conforming changes such as the establishment of global warming
potential values for calculating CO2 equivalents under New
York's PSD and Title V programs. In today's action, the EPA is taking
final action to approve those revisions by issuing a full approval, as
proposed (see 81 FR 63448 (September 15, 2016)).
    The EPA is also taking action to approve certain elements of New
York SIP revisions as meeting CAA section 110(a) requirements for the
2008 Pb, 2008 ozone, and 2010 SO2 NAAQS. NYSDEC submitted a
SIP for the 2008 Pb NAAQS on October 13, 2011, as supplemented on
February 24, 2012, and for the 2008 ozone NAAQS on April

4, 2013 and the 2010 SO2 NAAQS on October 3, 2013.
    Under CAA sections 110(a)(1) and (2), states are required to submit
SIPs that provide for the implementation, maintenance and enforcement
of the NAAQS. The EPA refers to these types of SIP submissions as the
``infrastructure'' SIPs. States must make infrastructure SIP
submissions within 3 years after the promulgation of a new or revised
NAAQS. On November 12, 2008 (73 FR 66964), EPA promulgated a revised
NAAQS for Pb, which is 0.15 micrograms per cubic meter of air ([mu]g/
m\3\) maximum not to be exceeded on a rolling 3-month average. On March
27, 2008 (73 FR 16436), EPA revised the level of the 8-hour ozone NAAQS
from 0.08 parts per million (ppm) to 0.075 ppm. On June 22, 2010 (75 FR
35520), EPA promulgated a revised NAAQS for SO2 at a level
of 75 ppb, based on a 3-year average of the annual 99th percentile of
1-hour daily maximum concentrations.
    This final action pertains only to the portions of the
infrastructure SIPs submitted for the 2008 Pb, 2008 ozone, and 2010
SO2 NAAQs pertaining to CAA sections 110(a)(2)(C);
110(a)(2)(D)(i)(II) prong 3 (PSD); and 110(a)(2)(J). The reader is
referred to the September 15, 2016 proposed rulemaking for a detailed
discussion of New York's submittals and EPA's review and proposed
actions.

II. What sections of New York's rules are we approving in this action?

    With respect to 6 NYCRR Part 200, the EPA is taking final action to
approve into the New York SIP revisions to Section 200.1, specifically,
subparts 200.1(bj), 200.1(bl), 200.1(cj), 200.1(cu) through 200.1(cv),
together with revisions to Section 200.9, Table 1, as delineated in the
New York October 12, 2011 submittal to EPA.
    With respect to 6 NYCRR Part 201, the EPA is taking final action to
approve into the New York SIP revisions to subpart 201-2.1(b)(21) with
the exception of changes to the definitions in subparts 201-
2.1(b)(21)(i) and 201-2.1(b)(21)(v) which were withdrawn by the NYSDEC.
    With respect to 6 NYCRR part 231, the EPA is taking final action to
approve all of part 231 into the New York SIP except certain revisions
to part 231 which were withdrawn by the NYSDEC. The withdrawn revisions
which are not being approved into the New York SIP are, as identified
in EPA's September 15, 2016 proposal, certain portions of subpart 231-
5.5(b)(3) and 231-6.6(b)(3), 231-10.1(d), 231-12.7 containing the
Significant Impact Levels (SILs) for PM2.5, Section 231-13.5
Table 5 containing the GHG major source thresholds for sources that are
major for GHG only and subpart 231-12.4(a)(1) containing the
PM2.5 Significant Monitoring Concentration (SMC) of 4 [mu]g/
m\3\. However, EPA approves New York's replacement of the SMC value
with zero (0) until future regulatory changes are made.

III. What are EPA's responses to comments to EPA's proposal?

    In response to EPA's September 15, 2016 (81 FR 63448) proposed
approval, the EPA received no comments during the public comment
period.

IV. What action is EPA taking?

    The EPA is taking a final action to approve revisions of 6 NYCRR
parts 200, 201, and 231 to the New York State Implementation Plan (SIP)
as specified in Section II of this notice and submitted by the New York
State Department of Environmental Conservation (NYSDEC) on October 12,
2011, with the exception of the NYSDEC withdrawn items listed in
Section II of this notice.
    EPA is also taking final action to approve New York's
infrastructure SIP submittals for 2008 Pb, 2008 ozone, and 2010
SO2 for CAA Section 110(a)(2) elements and sub-elements, as
follows: 110(a)(2)(C), 110(a)(2)(D)(i)(II) prong 3, and 110(a)(2)(J).

V. Incorporation By Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of revised
versions of 6 NYCRR Part 200, 6 NYCRR Part 201 and 6 NYCRR Part 231
described in the proposed amendments to 40 CFR part 52 set forth below.
Therefore, these materials have been approved by EPA for inclusion in
the State Implementation Plan, have been incorporated by reference by
EPA into that plan, are fully federally enforceable under sections 110
and 113 of the CAA as of the effective date of the final rulemaking of
EPA's approval, and will be incorporated by reference by the Director
of the Federal Register in the next update to the SIP compilation.\1\
EPA has made, and will continue to make, these documents generally
available electronically through http://www.regulations.gov and/or in
hard copy at the appropriate EPA office (please contact the person
identified in the For Further Information Contact section of this
preamble for more information).
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    \1\ 62 FR 27968 (May 22, 1997)
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VI. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the CAA and
applicable Federal regulations. 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 Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is 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.);
     does 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);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is 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 Clean Air Act; and
     does 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).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175, because the SIP is not approved to
apply in Indian country located in the State, and EPA

notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law. Thus Executive Order 13175 does not
apply to this action.
    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 this action 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. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 27, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action 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 rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: November 22, 2016.
Judith A. Enck,
Regional Administrator, Region 2.
    Part 52, chapter I, title 40 of the Code of Federal Regulations 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 HH--New York

0
2. In Sec.  52.1670:
0
a. The table in paragraph (c) is amended by revising four entries for
``Title 6, Part 200, Subpart 200.1'', ``Title 6, Part 200, Subpart
200.9'', ``Title 6, Part 201, Subpart 201-2.1(b)(21)'', and ``Title 6,
Part 231''; and
0
b. The table in paragraph (e) is amended by:
0
i. Adding another entry titled ``Section 110(a)(2) Infrastructure
Requirements for the 2008 ozone NAAQS'' at the end of the table; and
0
ii. Adding two entries titled ``Section 110(a)(2) Infrastructure
Requirements for the 2008 Pb NAAQS'' and ``Section 110(a)(2)
Infrastructure Requirements for the 2010 SO2 NAAQS'' at the
end of the table.
    The additions read as follows:

Sec.  52.1670  Identification of plan.

* * * * *
    (c) * * *

                                EPA-Approved New York State Regulations and Laws
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                                                             State       EPA approval
          State citation              Title/subject     effective date       date               Comments
----------------------------------------------------------------------------------------------------------------
Title 6, Part 200, Subpart 200.1.  General Provisions,        10/15/11        12/27/16  The word odor is removed
                                    Definitions.                                         from the Subpart
                                                                                200.1(d) definition of
                                                                                ``air contaminant or
                                                                                air pollutant.''
                                                                                Redesignation of non-
                                                                                attainment areas to
                                                                                attainment areas
                                                                                (200.1(av)) does not
                                                                                relieve a source from
                                                                                compliance with
                                                                                previously applicable
                                                                                requirements as per
                                                                                letter of Nov. 13, 1981
                                                                                from H. Hovey, NYSDEC.
                                                                                Changes in definitions
                                                                                are acceptable to EPA
                                                                                unless a previously
                                                                                approved definition is
                                                                                necessary for
                                                                                implementation of an
                                                                                existing SIP
                                                                                regulation.
                                                                                EPA is including the
                                                                                definition of
                                                                                ``federally
                                                                                enforceable'' with the
                                                                                understanding that (1)
                                                                                the definition applies
                                                                                to provisions of a
                                                                                Title V permit that are
                                                                                correctly identified as
                                                                                federally enforceable,
                                                                                and (2) a source
                                                                                accepts operating
                                                                                limits and conditions
                                                                                to lower its potential
                                                                                to emit to become a
                                                                                minor source, not to
                                                                                ``avoid'' applicable
                                                                                requirements.
                                                                                EPA is approving
                                                                                incorporation by
                                                                                reference of those
                                                                                documents that are not
                                                                                already federally
                                                                                enforceable.
                                                                                EPA approval finalized
                                                                                at [Insert Federal
                                                                                Register citation].
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
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Title 6, Part 200, Subpart 200.9.  General Provisions,        10/15/11        12/27/16  EPA is approving
                                    Referenced                                           reference documents
                                    Material.                                            that are not Federally
                                                                                enforceable.
                                                                                EPA approval finalized
                                                                                at [Insert Federal
                                                                                Register citation].
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
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Title 6, Part 201, Subpart 201-    Permits and                10/15/11        12/27/16  EPA is including the
 2.1(b)(21).                        Registrations,                                       definition of ``Major
                                    Definitions.                                         stationary source or
                                                                                major source or major
                                                                                facility'' with the
                                                                                understanding that the
                                                                                definition applies only
                                                                                to provisions of Part
                                                                                231.
                                                                                Revisions are approved
                                                                                except for changes to
                                                                                the definitions in 201-
                                                                                2.1(b)(21)(i) and 201-
                                                                                2.1(b)(21)(v) withdrawn
                                                                                by NYSDEC as per July
                                                                                28, 2016 letter to EPA
                                                                                Region 2.
                                                                                EPA approval finalized
                                                                                at [Insert Federal
                                                                                Register citation].
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Title 6, Part 231................  New Source Review          10/15/11        12/27/16  Full approval except for
                                    for New and                                          certain revisions to
                                    Modified                                             231-5.5(b)(3), 231-
                                    Facilities.                                          6.6(b)(3), 231-10.1(d),
                                                                                231-12.4(a)(1), 231-
                                                                                12.7, and 231-13.5
                                                                                Table 5 withdrawn by
                                                                                NYSDEC as per July 28,
                                                                                2016 NYSDEC letter to
                                                                                EPA Region 2.
                                                                                The PM2.5 Significant
                                                                                Monitoring
                                                                                Concentration (SMC) is
                                                                                approved as 0 [mu]g/m3
                                                                                in 231-12.4(a)(1).
                                                                                EPA approval finalized
                                                                                at [Insert Federal
                                                                                Register citation].
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (e) * * *

                           EPA-Approved Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable
                                   geographic or         New York
       Action/SIP element          nonattainment      submittal date   EPA approval date        Explanation
                                        area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Section 110(a)(2)                Statewide........  04/04/2013.......  12/27/2016,        This action addresses
 Infrastructure Requirements                                            [Insert Federal    the following CAA
 for the 2008 ozone NAAQS.                                              Register           elements:
                                                                        citation].         110(a)(2)(C),
                                                                                (D)(i)(II) prong 3,
                                                                                and (J).
Section 110(a)(2)                Statewide........  10/13/11, and      12/27/2016,        This action addresses
 Infrastructure Requirements                         supplemented on    [Insert Federal    the following CAA
 for the 2008 Pb NAAQS.                              2/24/12.           Register           elements:
                                                                        citation].         110(a)(2)(C),
                                                                                (D)(i)(II) prong 3,
                                                                                and (J).
Section 110(a)(2)                Statewide........  10/03/2013.......  12/27/2016,        This action addresses
 Infrastructure Requirements                                            [Insert Federal    the following CAA
 for the 2010 SO2 NAAQS.                                                Register           elements:
                                                                        citation].         110(a)(2)(C),
                                                                                (D)(i)(II) prong 3,
                                                                                and (J).
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-31018 Filed 12-23-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 235 (Wednesday, December 7, 2011)]
[Notices]
[Pages 76417-76422]
[FR Doc No: 2011-31341]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0608]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; MedWatch: The Food
and Drug Administration Medical Products Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
6, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0291.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT:
    Jonna Capezzuto, Office of Information Management, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, (301)
796-3794<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

MedWatch: The FDA Medical Products Reporting Program--(OMB Control
Number 0910-0291)--Extension

I. Background

    To ensure the marketing of safe and effective products,
postmarketing adverse outcomes and product problems must be reported
for all FDA-regulated human health care products, including drugs, both
prescription and over-the-counter (OTC); biologics; medical devices;
dietary supplements and other special nutritional products (e.g.,
infant formula and medical foods); and cosmetics. In addition, FDA has
regulatory responsibility for tobacco products and an interest in
receiving reports about adverse outcomes and product problems for these
products.
    Under sections 505, 512, 513, 515, 519 and 903 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355, 360b, 360c, 360e,
360i and 393) and section 351 of the Public Health Service Act (42
U.S.C. 262), FDA has the responsibility to ensure the safety and
effectiveness of drugs, biologics, and devices. Under section 502(a) of
the FD&C Act (21 U.S.C. 352(a)), a drug or device is misbranded if its
labeling is false or misleading. Under section 502(f)(2) of the FD&C
Act, it is misbranded if it fails to bear adequate warnings, and under
section 502(j), it is misbranded if it is dangerous to health when used
as directed in its labeling. Under section 502(t)(2) of the FD&C Act,
devices are considered to be misbranded if there has been a failure or
refusal to give required notification or to furnish required material
or information required under section 519. Requirements regarding
mandatory reporting of adverse events or product problems have been
codified in parts 310, 314, 600, and 803 (21 CFR 310, 314, 600, and
803), specifically Sec. Sec.  310.305, 314.80, 314.98, 600.80, 803.30,
803.50, 803.53, 803.56, and specified in sections 760 and 761 of the
FD&C Act (21 U.S.C. 379aa and 379aa-1). Mandatory reporting of adverse
reactions for human cells, tissues, and cellular and tissue-based
products (HCT/Ps) has been codified in 21 CFR 1271.350.
    FDA regulates the safety (i.e., adulteration) of dietary
supplements under section 402 of the FD&C Act (21 U.S.C. 342). Dietary
supplements do not require premarket approval by FDA and the Agency
bears the burden to gather and review evidence that a dietary
supplement may be adulterated under section 402 of the FD&C Act after
that product is marketed. Under section 761(b)(1) of the FD&C Act, a
dietary supplement manufacturer, packer, or distributor whose name
appears on the label of a dietary supplement marketed in the United
States is required to submit to FDA any serious adverse event report it
receives regarding use of the dietary supplement in the United States.
    Mandatory reporting, since 1993, has been supplemented by voluntary
reporting by health care professionals, their patients, and consumers
via the MedWatch reporting process. To carry out its responsibilities,
the Agency needs to be informed when an adverse event, product problem,
error with use of a human medical product or evidence of therapeutic
failure (inequivalence) is suspected or identified in clinical use.
When FDA receives this information from either health care
professionals or patients, the report becomes data that will be used to
assess and evaluate the risk associated with the product, and then take
whatever action is necessary to reduce, mitigate, or eliminate the
public's exposure to the risk through regulatory and public health
interventions.
    To implement these provisions for reporting on human medical
products during their postapproval and marketed lifetimes, two forms
are available from the Agency. FDA Form 3500 is used for voluntary
(i.e., not mandated by law or regulation) reporting by health care
professionals and the public. FDA Form 3500A is used for mandatory
reporting (i.e., required by law or regulation).
    Respondents to this collection of information are health care
professionals; medical care organizations and other user-facilities
(e.g., extended care facilities, ambulatory surgical centers);
consumers; manufacturers of biological, dietary supplement, and drug
products or medical devices; and importers.

II. Use of FDA Form 3500 (Voluntary Version)

    The voluntary version of the form is used to submit all reports not
mandated by Federal law or regulation. Individual health professionals
are not required by law or regulation to submit reports to the Agency
or the manufacturer, with the exception of certain adverse reactions
following immunization with vaccines as mandated by the National
Childhood Vaccine Injury Act of 1986. Those mandatory reports are not
submitted to FDA on the 3500 or 3500A form but are submitted to the
joint FDA/Centers for Disease Control and Prevention Vaccines Adverse
Event Reporting System (VAERS) on the VAERS-1 form (see http://vaers.hhs.gov/resources/vaers_form.pdf).
    Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries.
    Under Federal law and regulation (section 761(b)(1) of the FD&C
Act), a dietary supplement manufacturer, packer, or distributor whose
name appears on the label of a dietary supplement marketed in the
United States is required to submit to FDA any serious adverse event
report it receives regarding use of the dietary supplement in the
United States. However, FDA bears the burden to gather and review
evidence that a dietary supplement may be adulterated under section 402
of the FD&C Act after that product is marketed. Therefore, the Agency
depends on the voluntary reporting by health professionals and
especially by consumers of suspected serious adverse events and product
quality problems associated with the use of dietary supplements.

III. Use of FDA Form 3500A (Mandatory Version)

A. Drug and Biologic Products

    In sections 505(j) and 704 (21 U.S.C. 374) of the FD&C Act,
Congress has required that important safety information relating to all
human prescription drug products be made available to the FDA so that
it can take appropriate action to protect the public health when
necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the FD&C Act. These
statutory requirements regarding mandatory reporting have been codified
by FDA under 21 parts 310 and 314 (drugs) and 600 (biologics) of the
Code of Federal Regulations. Parts 310, 314, and 600 mandate the use of
FDA Form 3500A for reporting to FDA on adverse events that occur with
drugs and biologics. Mandatory reporting of adverse reactions for HCT/
Ps has been codified in 21 CFR 1271.350.
    The majority of the mandatory reports for drug products, which at
inception of FDA Form 3500A's use were received by the Agency on the
paper version of FDA Form 3500A (by mail or FAX), are now submitted and
received by the Agency via an electronic submission route. In that
case, the FDA Form 3500A is not used.

B. Medical Device Products

    Section 519 of the FD&C Act requires manufacturers and importers of
devices

intended for human use to establish and maintain records, make reports,
and provide information as the Secretary of Health and Human Services
may by regulation reasonably require to assure that such devices are
not adulterated or misbranded and to otherwise assure its safety and
effectiveness. The Safe Medical Device Act of 1990, signed into law on
November 28, 1990, amends section 519 of the FD&C Act. The amendment
requires that user facilities such as hospitals, nursing homes,
ambulatory surgical facilities, and outpatient treatment facilities
report deaths related to medical devices to FDA and to the
manufacturer, if known. Serious illnesses and injuries are to be
reported to the manufacturer or to FDA if the manufacturer is not
known. These statutory requirements regarding mandatory reporting have
been codified by FDA under 21 CFR part 803, which mandates the use of
FDA Form 3500A for reporting to FDA on medical devices. The Medical
Device User Fee and Modernization Act of 2002, Public Law 107-250,
signed into law October 26, 2002, amended section 519 of the FD&C Act.
The amendment (section 303) required FDA to revise the MedWatch forms
``to facilitate the reporting of information * * * relating to
reprocessed single-use devices, including the name of the reprocessor
and whether the device has been reused.''

C. Nonprescription Drug Products and Dietary Supplements

    Section 502(x) in the FD&C Act implements the requirements of the
Dietary Supplement and Nonprescription Drug Consumer Protection Act,
which became law (Pub. L. 109-462) on December 22, 2006. These
requirements apply to manufacturers, packers, and distributors of
nonprescription (OTC) human drug products marketed without an approved
application. The law requires reports of serious adverse events to be
submitted to FDA by manufacturers of dietary supplements and
nonprescription drugs.

IV. Proposed Modifications to Existing Forms 3500 and 3500A

A. General Changes

    The proposed modifications to FDA Form 3500 and FDA Form 3500A
reflect changes that will bring the form into conformation, since the
previous authorization in 2008, with current regulations, rules, and
guidances.

B. Changes Proposed for FDA Form 3500

    No additional fields will be added and no fields deleted. There are
no proposed formatting changes to the location or distribution of the
fields. Modifications are proposed to several field labels and
descriptions to better clarify for reporters the range of reportable
products, including tobacco products and food (e.g., food allergens
causing allergic or anaphylaxis reactions). Descriptive text in the
field labels and instructions were modified to permit a better
understanding of data requested. For section E, field E4, the label
``Other'' will be renamed ``Unique Identifier '' in
anticipation of the use of this product information by the Agency for
specific characterization and identification of the medical device. The
form remains a one-sided, one-page form with instructions for use on
the reverse side and a self-addressed, postage-paid return mailer.

C. Changes Proposed for FDA Form 3500A

    Certain formatting changes are proposed to allow mandatory
reporters to better utilize available space for data entry and
facilitate specification of the device product's coding. In section D,
field D2, it is proposed that the same field be used to request the
procode (D2b) to correspond to the existing common device name (D2a).
The D4 field currently named ``Other'' will be renamed ``Unique
Identifier .'' Section H, currently named ``Device
Manufacturers Only'' will be renamed ``Manufacturers Only.'' Field H1
will have the ``Other'' checkbox removed and field H6, renamed ``Event
Problem and Evaluation Codes,'' will have patient code and device code
boxes added, as in the existing form's field F10. In section G, field
G5, STN  will be relabeled BLA . Given the need to
contact mandatory reporters in a timely manner, the Agency proposes
that a field be added to FDA Form 3500A to request an email address for
the mandatory reporter, to supplement the phone number and mailing
address currently included on the form. This change is proposed for
fields E1 and G1.

V. Proposed Addition of Consumer Version of FDA Form 3500

    FDA supports and encourages direct reporting to the Agency by
consumers (patients and their caregivers) of suspected serious adverse
outcomes and other product problems associated with human medical
products (http://www.fda.gov/Safety/ReportaProblem/default.htm.) Since
the inception of the MedWatch program, launched in July 1993 by then
FDA Commissioner David Kessler, the program has been promoting and
facilitating voluntary reporting by both the general public and health
care professionals (Ref. 1). FDA has further encouraged voluntary
reporting by requiring inclusion of the MedWatch toll-free telephone
number or the MedWatch Internet address on all outpatient drug
prescriptions dispensed, as mandated by section 17 of the Best
Pharmaceuticals for Children Act (Pub. L. 107-109).
    On March 25, 2008, section 906 of the FDA Amendments Act amended
section 502(n) of the FD&C Act and mandated that published direct-to-
consumer advertisements for prescription drugs include the following
statement printed in conspicuous text (this includes vaccine products):
``You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-(800)
FDA-1088.'' Most private vendors of consumer medication information,
the drug product-specific instructions dispensed to consumers at
outpatient pharmacies, remind patients to report ``side effects'' to
FDA and provide contact information to permit reporting via the
MedWatch process and FDA Form 3500.
    Currently, the non-health care professional public may submit
voluntary reports using FDA Form 3500 (http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm). This reporting form was created 20
years ago and modeled after an earlier version of the Agency's
reporting form for health care professionals. FDA Form 3500 is provided
in paper and electronic formats (HTML version at http://www.fda.gov/medwatch/report.htm and fillable pdf version at http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/ucm082725.pdf), and
is used to report to the Agency about serious adverse events, product
problems, product use errors, and therapeutic failure (therapeutic
inequivalence). Reporting is supported for all FDA-regulated human
medical care products, including drugs, biologicals, medical devices,
special nutritional products, dietary supplements, cosmetics, and
nonprescription (OTC) human drug products marketed without an approved
application.
    Qualitative assessment by social scientists, and comments and
feedback from the public, have recognized that FDA Form 3500 is written
and formatted at a literacy/comprehensibility level that far exceeds

the level recommended for the general public by health literacy experts
and does not conform to recommendations in the Plain Writing Act of
2010 (http://www.gpo.gov/fdsys/pkg/PLAW-111publ274/pdf/PLAW-111publ274.pdf).
    The proposed consumer version of the voluntary FDA Form 3500 will
request no new data from the voluntary reporter not already included in
the existing FDA Form 3500 that is currently used for reporting from
both health care professionals and consumers (patients). Certain
existing fields not considered essential data for the consumer report
but present on the standard (i.e., health care professional) version of
FDA Form 3500 have been eliminated to facilitate and expedite consumer
submissions and reduce reporting burden. The formatting and plain
language used are compatible with the intent of the Plain Writing Act
and is expected to provide non-health care professionals with a second
option to the existing FDA Form 3500 that will reduce the burden of
reporting by facilitating their understanding of the requested data and
further clarify the voluntary reporting process.
    The proposed consumer version of FDA Form 3500 evolved from several
iterations of draft versions, with input from human factors experts,
from other regulatory agencies and with extensive input from consumer
advocacy groups and the general public. The Agency recognizes that many
consumer reporters have a preference for accessing a copy of the
voluntary reporting form on the Internet or submitting to FDA using an
electronic version of the form. The Agency currently supports voluntary
reporting with the forms submitted by mail, by FAX, by telephone via
the toll free 800 number and online at http://www.fda.gov/medwatch/report.htm. It is the Agency's expectation that an approved consumer
version of the voluntary form will be provided for consumer use by
these same channels.
    In the Federal Register of September 9, 2011 (76 FR 55919), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Comments were received from seven
individuals and organizations.

VI. Response to Comments

1. 3500 Form

    (Comment 1) One comment observed that it may be difficult for FDA
to identify the pregnancy status of the person experiencing the
reported adverse event and suggested that the Agency add a separate
field for documenting pregnancy status.
    (Response) FDA agrees that documenting pregnancy status is
important; however, FDA does not plan to add an additional checkbox for
pregnancy to the forms at this time. In 2005, FDA proposed adding
checkboxes for both ``Product Used During Pregnancy'' and ``Product
Used During Breast Feeding'' to section B.5 of both forms. FDA received
comments expressing concern that these new data fields introduced
divergence from International Council on Harmonisation standards and
appeared to duplicate information that is usually provided in the
narrative section and in coded adverse event terms. The pregnancy
status data can also be captured in field B7 as ``Other Relevant
History''. FDA agreed with the comments and did not include these
checkboxes with the 2005 revisions; FDA believes these reasons are
still valid.
    (Comment 2) One comment encouraged the FDA to use the voluntary
consumer version of the form to allow for electronic filing of reports
and to continue to promote the reporting process to the public, whether
by the traditional paper-based route or electronically.
    (Response) FDA agrees with the comment and expects to support both
the promotion of the use of the new consumer version of the voluntary
form and to explore methods of facilitating reporting and reducing
reporter burden by using online and other electronic means of report
submission.
    (Comment 3) One comment supported the plan to deploy a consumer
version of the voluntary form and suggested that its use also be
promoted to health care providers for their use. The comment also
encouraged the Agency to expedite a process for converting the paper-
based reporting process to allow for electronic submission of voluntary
reports using the consumer version of the form.
    (Response) FDA agrees that support of electronic submissions of
voluntary reports should be supported and facilitated. The new form was
designed as a consumer friendly option for use by non-health care
professionals. The standard FDA Form 3500 will continue to be the
primary form offered to health care professionals. FDA encourages the
continued use of FDA Form 3500 by health care professionals; however,
if a health care professional chooses to submit a report using the
consumer form, it will be accepted by FDA.
    (Comment 4) One comment stated that implementing a consumer
friendly version of FDA Form 3500 would not ``serve any value'' and
suggested that instead a more comprehensible form be created that would
be used by health care professionals and consumers.
    (Response) The Agency disagrees. The current FDA Form 3500 is
widely known, well accepted, and used by the range of health care
professionals. Assessment of, and feedback from, consumers has
demonstrated the demand and need for a modified form that would serve
those non-health care professional reporters, using both literacy-
appropriate language and formatting that will serve consumers but not
be optimal for health care professional reporting.
    (Comment 5) A comment suggested that for the proposed change to
field E4 from ``Other'' to ``Unique Identifier'' that the term used be
``UDI''.
    (Response) FDA agrees with this comment.
    (Comment 6) One comment supported the development of a consumer
friendly version of the voluntary form but observed that with the
anticipated increase in the number of consumer-initiated reports that
the Agency consider a process for ``broader sharing with industry
sponsors of adverse event reports made directly to FDA.''
    (Response) FDA agrees that adverse event report data should be more
readily available to the public (which includes industry). The current
mechanisms that FDA has to share reports with industry are the MedWatch
to Manufacturer Program and through requests to Freedom of Information.
In addition, as part of Phase II of the FDA Transparency Initiative,
FDA is planning to provide the public with online access (in a
searchable format) to public information from adverse event reports
submitted to FDA.

2. 3500A Form

    (Comment 7) One comment asked that no changes be made to the FDA
Form 3500A at the present time due to consideration of the costs and
expenditure of resources incurred by mandatory reporters who are often
using electronic systems to do their required reporting to FDA. In
addition, the comment noted that there are several proposed or not yet
finalized rules that might further impact the content of the mandatory
FDA Form 3500. A comment stated that they would ask for a 12-month
implementation time to allow for design, testing, and validation of any
software changes necessary.
    (Response) The Agency has considered the impact of implementing
changes to FDA Form 3500A and the need for mandatory reporters to
change their electronic systems to comply with the proposed changes.
FDA will allow

for sufficient time for design, testing, and validation of any software
changes as a result of any new data requirements that may follow from
new requirements based on final rules and regulations.
    (Comment 8) One comment stated that for mandatory reporters the
estimate of burden has been underestimated and fails to take into
consideration the effort by firms to collect facts, prepare
investigations, and evaluate the data.
    (Response) The Agency disagrees that the estimate for the average
time to complete a given report is low. This estimate is intended not
to represent the totality of the effort for completing the postmarket
drug and device safety surveillance process mandated by law, rule, and
regulation for application holders but a fair estimate of data
collection, organization, entry, and submission time for a given
``average'' report.
    (Comment 9) A comment suggested that for the proposed change to
field D4 from ``Other'' to ``Unique Identifier'' that the term used be
``UDI''.
    (Response) FDA agrees with this comment. We recommend changing this
to UDI.
    (Comment 10) A comment disagreed with requesting an email address
from the reporter in field E1, and a second comment expressed similar
reservations but suggested that, if used, the initial reporter
understand that this information is optional.
    (Response) FDA recognizes that an email address is one of several
elements in the contact information that may assist FDA and others in
effective postmarket safety surveillance and followup inquiries. The
reporter is not compelled to complete the information in this field in
order for the report to be considered complete and registered in the
appropriate database. A statement that this information is optional
will be made clear in the instructions for completing the form.
    (Comment 11) A comment disagreed with the proposed change in the
Section H heading from ``Device Manufacturers Only'' to ``Manufacturers
Only''.
    (Response) FDA agrees that this title should not be changed.
Section H should be titled ``Device Manufacturers Only'' as it
currently appears.
    (Comment 12) Two comments recommended the addition of a new
checkbox field in Section/field H2 named ``Final report'' that would be
used to ``reflect the best efforts of the manufacturer to retrieve and
analyze information pertaining to the reported event''.
    (Response) FDA disagrees that ``Final report'' should be added to
Section H2. This information can be added as part of the text narrative
in Section H10.
    (Comment 13) Two comments disagreed with the removal of field H1's
``Other'' checkbox and stated that there are rare examples of events
that do not meet the regulatory definition of death, serious injury, or
malfunction but are considered by the mandatory reporting entity to be
necessary and required reports. One comment suggested that if the
checkbox is removed, that specific instruction be provided for handling
reports that would have been compatible with an ``Other'' designation.
    (Response) FDA disagrees. FDA recommends removal of the ``Other''
checkbox. In lieu of the checkbox, FDA proposes that rare events that
fit the definition of ``Other significant adverse device experiences''
as specified in FD&C Act section 519(a)(3) can be submitted to the FDA
using the mailing address identified in 21 CFR 803.12(a).
    (Comment 14) One comment suggested changing the title of field B4
from ``Date of This Report'' to ``Date of First Contact With Initial
Reporter''.
    (Response) FDA disagrees. On August 21, 2009, FDA published a
proposed rule (74 FR 42203) to amend part 803 to require manufacturers,
importers, and user facilities to submit medical device reports to the
Agency in an electronic format (i.e., the 2009 proposed rule). Section
II(4)(D)(2) of the 2009 proposed rule specified that in the final rule,
FDA specifically proposed to change Sec. Sec.  803.32(b)(4),
803.42(b)(4), and 803.52(b)(4) from ``date of report by the initial
reporter'' to ``date of this report''. Further it states, ``This change
would make part 803 consistent with the way that other FDA Centers
interpret FDA Form 3500A, Block B4 and how Block B4 appears on FDA Form
3500A.''
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
     FDA Center FDA Form (21 CFR Section)           Number of       responses per     Total annual      Average burden per  response       Total hours
                                                   respondents       respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Biologics Evaluation and Research/
 Center for Drug Evaluation and Research:
    Form 3500.................................            28,952                 1            28,952  0.60............................            17,371
                                                                                (36 minutes)....................  ................
    Form 3500A (Sec.  Sec.   310.305, 314.80,                599                96            57,504  1.10............................
     314.98, and 600.80).
Center for Devices and Radiological Health:
    Form 3500.................................             4,585                 1             4,585  0.60............................             2,751
                                                                                (36 minutes)....................  ................
    Form 3500A (Sec.   803)...................             1,485               225           334,125  1.10............................           367,538
                                                                                (66 minutes)....................
Center for Food Safety and Applied Nutrition:
    Form 3500.................................               297                 1               297  0.6.............................               178
                                                                                (36 minutes)....................
    Form 3500A................................             1,039                 1             1,039  1.10............................             1,143
                                                                                (66 minutes)....................
        Total.................................  ................  ................  ................  ................................           452,234
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

VII. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Kessler, D.A., ``Introducing MEDWatch: A New Approach to
Reporting Medication and Device Adverse Effects and Product
Problems,'' Journal of the American Medical Association, 269: 2765-
2768, 1993.

    Dated: December 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31341 Filed 12-6-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Rules and Regulations]
[Pages 42033-42034]
[FR Doc No: 2018-17825]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2018-0214, FRL-9982-59--Region 10]

Air Plan Approval; ID, Incorporations by Reference Updates and
Rule Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is taking final action to approve revisions to Idaho's
State Implementation Plan (SIP) submitted by the Idaho Department of
Environmental Quality (IDEQ) on March 20, 2018 and April 12, 2018. The
submitted revisions update incorporation by reference of Federal
regulations in the Idaho's rules. The revisions also remove an interim
regulation that expired in 2003.

DATES: This final rule is effective September 19, 2018.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R10-OAR-2018-0214, at http://www.regulations.gov. All documents
in the docket are listed on the https://www.regulations.gov website.
Although listed in the index, some information is not publicly
available, e.g., CBI 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 through https://www.regulations.gov, or please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section for
additional availability information.

FOR FURTHER INFORMATION CONTACT: Randall Ruddick at<PHONE_NUMBER>, or
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, wherever ``we,''
``us,'' or ``our'' is used, it is intended to refer to EPA.

Table of Contents

I. Background
II. Final Action
III. Incorporation by Reference
IV. Statutory and Executive Orders Review

I. Background

    On March 20, 2018, the Idaho Department of Environmental Quality
(IDEQ) submitted revisions to the SIP provisions that incorporate by
reference (IBR) various portions of Federal regulations codified in the
Code of Federal Regulations (CFR) into the Rules for the Control of Air
Pollution in Idaho (IDAPA 58.01.01). Additionally, on April 12, 2018,
Idaho submitted a separate SIP revision to remove an expired interim
transportation conformity provision.
    On June 29, 2018, EPA proposed to approve Idaho's March 20, 2018,
and April 12, 2018, SIP submissions. Please see the proposed approval
for further explanation (83 FR 30626). The public comment period for
our proposed action ended July 30, 2018. We received three electronic
comments submitted through https://www.regulations.gov. We reviewed the
comments and have determined that they are not clearly related to the
subject of this action and thus are not adverse to this action.
Therefore, we are finalizing our action as proposed.

II. Final Action

    EPA is approving, and incorporating by reference where appropriate,
in Idaho's SIP, all revisions to IDAPA <IP_ADDRESS> Incorporations by
Reference (state effective March 28, 2018), except .03.f through .p, as
requested by Idaho on March 20, 2018. EPA is also approving, as
requested by Idaho on April 12, 2018, removal of IDAPA <IP_ADDRESS>2
Interim Conformity Provisions for Northern Ada County Former
Nonattainment Area for PM 10 from the Idaho SIP. We have determined
that the submitted SIP revisions are consistent with section 110 and
parts C and part D of Title I of the CAA.

III. Incorporation by Reference

    In this rule, EPA is approving regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is incorporating by reference the provisions described above
in Section II. Final Action and set forth below, as amendments to 40
CFR part 52.
    Also in this rule, EPA is removing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is removing the incorporation by reference of IDAPA
<IP_ADDRESS>2 as described in Section II. Final Action and set forth
below, as amendments to 40 CFR part 52.
    EPA has made, and will continue to make, these documents generally
available electronically through www.regulations.gov and at the EPA
Region 10 office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

IV. Statutory and Executive Orders Review

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' 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);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is 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.);
     does 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);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is 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 it does not involve technical standards; and
     does not provide the 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 SIP does not apply on any Indian reservation land or in any
other area where the EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, this action
does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements, Sulfur oxides, Volatile
organic compounds.

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

    Dated: August 7, 2018.
Chris Hladick,
Regional Administrator, Region 10.

    For the reasons set forth in the preamble, 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 N--Idaho

0
2. In Sec.  52.670, the table in paragraph (c) is amended by:
0
a. Revising entry 107; and
0
b. Removing entry 582.
    The revision reads as follows:

Sec.  52.670  Identification of plan.

* * * * *
    (c) * * *

                                   EPA-Approved Idaho Regulations and Statutes
----------------------------------------------------------------------------------------------------------------
      State citation           Title/subject     State effective date    EPA approval date       Explanations
----------------------------------------------------------------------------------------------------------------
      Idaho Administrative Procedures Act (IDAPA) 58.01.01--Rules for the Control of Air Pollution in Idaho
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
107......................  Incorporation by      3/28/2018, 3/25/      8/20/2018 [Insert     Except Section
                            Reference.            2016, 3/20/2014, 3/   Federal Register      107.03.f through
                                                  30/2007, 7/1/1997,    citation].            107.03.p.
                                                  5/1/1994.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-17825 Filed 8-17-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Proposed Rules]
[Pages 4221-4222]
[FR Doc No: 2017-00284]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9443; Airspace Docket No. 16-ASO-17]

Proposed Amendment of Class E Airspace; Kyle-Oakley Field
Airport, Murray, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Murray, KY,
as the Calloway Non-Directional Beacon (NDB) has been decommissioned,
requiring airspace reconfiguration at Kyle-Oakley Field Airport.
Controlled airspace is necessary for the safety and management of
instrument flight rules (IFR) operations at the airport. This action
also would update the geographic coordinates of the airport, and update
the designation header.

DATES: Comments must be received on or before February 27, 2017.

ADDRESSES: Send comments on this proposal to: U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Bldg. Ground Floor Rm. W12-140, Washington, DC 20590; Telephone: 1-800-
647-5527, or<PHONE_NUMBER>. You must identify the Docket No. FAA-2016-
9443; Airspace Docket No. 16-ASO-17, at the beginning of your comments.
You may also submit and review received comments through the Internet
at http://www.regulations.gov. You may review the public docket
containing the proposal, any comments received, and any final
disposition in person in the Dockets Office between 9:00 a.m. and 5:00
p.m., Monday through Friday, except Federal holidays.
    FAA Order 7400.11A, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone:<PHONE_NUMBER>.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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 proposed 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 would amend Class E airspace at Kyle-Oakley Field
Airport, Murray, KY.

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers and be submitted
in triplicate to the address listed above. You may also submit comments
through the Internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2016-9443; Airspace Docket No. 16-ASO-17.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.regulations.gov.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, Georgia 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace
Designations and Reporting Points, dated August 3, 2016, and effective
September 15, 2016. FAA Order 7400.11A is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class E airspace extending upward
from 700 feet above the surface at Kyle-Oakley Field Airport, Murray,
KY. Airspace reconfiguration to within a 7 mile radius of the airport
is necessary due to the decommissioning of the Calloway NDB and
cancellation of the NDB approach, and for continued safety and
management of IFR operations at the airport. The geographic coordinates
of the airport would be adjusted to coincide with the FAAs aeronautical
database, and the airport designation header would be updated to
include the airport name.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11A, dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
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 proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

    Authority: 49 U.S.C. 106(f), 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 7400.11A, Airspace Designations and Reporting
Points, dated August 3, 2016, effective September 15, 2016, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO KY E5 Kyle-Oakley Field, Murray, KY [Amended]

Kyle-Oakley Field Airport, KY
    (Lat. 36[deg]39'52'' N., long. 88[deg]22'22'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7 mile radius of Kyle-Oakley Field Airport.

    Issued in College Park, Georgia, on December 29, 2016.
Debra L. Hogan,
Acting Manager, Operations Support Group Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2017-00284 Filed 1-12-17; 8:45 am]
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[Federal Register Volume 88, Number 246 (Tuesday, December 26, 2023)]
[Notices]
[Page 89012]
[FR Doc No: 2023-28362]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2023-0267]
RIN 2126-AB56

FMCSA Registration System Modernization

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of public meeting.

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SUMMARY: FMCSA announces a public meeting to engage stakeholders, which
includes motor carriers, brokers, freight forwarders, insurance
companies, financial institutions, process agents, blanket companies,
and third-party service providers; to get their perspective on
improving the registration experience with FMCSA.

DATES: The meeting will be held on January 17, 2024, from 8 a.m. to 4
p.m. A copy of the agenda, will be available in advance of the meeting
at https://www.fmcsa.dot.gov/registration/fmcsa-registration-modernization-stakeholder-day.

ADDRESSES: The meeting will be held at the DOT Headquarters Building,
1200 New Jersey Avenue SE, Washington, DC 20590-0001. Those interested
in attending this public meeting must register at https://www.fmcsa.dot.gov/registration/fmcsa-registration-modernization-stakeholder-day by 11:59 p.m. eastern standard time (EST), on January
8, 2024. Attendance is limited to 90 people. Attendees should arrive by
8:00 a.m. to allow sufficient time to clear security. A virtual
attendance option is not available for this meeting however, FMCSA will
be affording additional engagement opportunities in the future which
may include virtual attendance options.

FOR FURTHER INFORMATION CONTACT:
    Alex Vanjani, Director, Office of the Chief Technology Officer
(CTO), FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001;
(202) 510-7826; [email protected].
    Supreet Kaur, Project Manager, Office of the CTO, FMCSA, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001;<PHONE_NUMBER>;
[email protected].
    Services for individuals with disabilities: For information on
facilities or services for individuals with disabilities or to request
special assistance at the meeting, contact Alex Vanjani or Supreet Kaur
using one of the above means by 11:59 p.m. EST, on January 8, 2024.

SUPPLEMENTARY INFORMATION:

Background

    FMCSA is developing a new online registration system, to improve
the transparency and efficiency of FMCSA's registration procedures as
well as implement statutory requirements related to the registration
program. FMCSA seeks user perspectives on improving the registration
experience when engaging with FMCSA's registration system. During this
meeting, FMCSA will invite attendees to participate in breakout
sessions that will align with different groups of users the Agency
expects will use the new online registration system. FMCSA moderators
will facilitate discussions on what potential users would like to see,
as well as what would not be helpful from a user experience
perspective. The day will end with a general listening session, where
FMCSA representatives will receive comments and concerns about a new
online registration system.

Meeting Information

    This meeting is intended for current and potential users of a new
online registration system. Breakout sessions will focus on the
following categories of registration IT system users:
     Motor carriers;
     Brokers and freight forwarders;
     Insurance companies/financial institutions and process
agents/blanket companies; and
     Third party service providers.
    The full meeting agenda will be available on the registration site
(see ADDRESSES above for instructions on meeting registration) in
advance of the meeting.

Robin Hutcheson,
Administrator.
[FR Doc. 2023-28362 Filed 12-22-23; 8:45 am]
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[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Rules and Regulations]
[Page 18072-18073]
[DOCID:fr09ap10-12]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 65

[Docket ID FEMA-2010-0003]

Changes in Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: Modified Base (1% annual-chance) Flood Elevations (BFEs) are
finalized for the communities listed below. These modified BFEs will be
used to calculate flood insurance premium rates for new buildings and
their contents.

DATES: The effective dates for these modified BFEs are indicated on the
following table and revise the Flood Insurance Rate Maps (FIRMs) in
effect for the listed communities prior to this date.

ADDRESSES: The modified BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Kevin C. Long, Acting Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-2820, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified BFEs have been published
in newspapers of local circulation and ninety (90) days have elapsed
since that publication. The Deputy Federal Insurance and Mitigation
Administrator has resolved any appeals resulting from this
notification.
    The modified BFEs are not listed for each community in this notice.
However, this final rule includes the address of the Chief Executive
Officer of the community where the modified BFE determinations are
available for inspection.
    The modified BFEs are made pursuant to section 206 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The modified BFEs are the basis for the floodplain management
measures that the community is required either to adopt or to show
evidence of being already in effect in order to qualify or to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    These modified BFEs, together with the floodplain management
criteria required by 44 CFR 60.3, are the minimum that are required.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities.
    These modified BFEs are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after these
elevations are made final, and for the contents in these buildings. The
changes in BFEs are in accordance with 44 CFR 65.4.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132,
Federalism.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 65

    Flood insurance, Floodplains, Reporting and recordkeeping
requirements.

0
Accordingly, 44 CFR part 65 is amended to read as follows:

PART 65--[AMENDED]

0
1. The authority citation for part 65 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  65.4  [Amended]

0
2. The tables published under the authority of Sec.  65.4 are amended
as follows:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Date and name of
         State and county             Location and  case      newspaper where     Chief executive officer   Effective date of  modification   Community
                                             No.           notice was published         of community                                             No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Mobile (FEMA Docket No: B-      Unincorporated areas   May 11, 2009; May     The Honorable Stephen      September 15, 2009.............       015008
     1059).                          of Mobile County (08-  18, 2009; Press-      Nodine, President,
                                     04-6003P).             Register.             Mobile County
                                                                                Commission, 205
                                                                                Government Street,
                                                                                Mobile, AL 36644.
    Montgomery (FEMA Docket No: B-  City of Montgomery     May 11, 2009; May     The Honorable Todd         September 15, 2009.............       010174
     1059).                          (08-04-6322P).         18, 2009;             Strange, Mayor, City of
                                                            Montgomery            Montgomery, 103 North
                                                            Advertiser.           Perry Street,
                                                                                Montgomery, AL 36104.
    Tuscaloosa (FEMA Docket No: B-  City of Northport (08- May 11, 2009; May     The Honorable Bobby        September 15, 2009.............       010202
     1059).                          04-6551P).             18, 2009;             Herndon, Mayor, City of
                                                            Tuscaloosa News.      Northport, 3500
                                                                                McFarland Boulevard,
                                                                                Northport, AL 35476.

    Tuscaloosa (FEMA Docket No: B-  Unincorporated areas   May 11, 2009; May     The Honorable W. Hardy     September 15, 2009.............       010201
     1059).                          of Tuscaloosa County   18, 2009;             McCollum, Probate Judge,
                                     (08-04-6551P).         Tuscaloosa News.      Tuscaloosa County, 714
                                                                                Greensboro Avenue,
                                                                                Tuscaloosa, AL 35401.
Connecticut: Tolland (FEMA Docket   Town of Coventry (09-  May 11, 2009; May     The Honorable Liz Woolf,   September 15, 2009.............       090110
 No: B-1059).                        01-0698P).             18, 2009; Journal     Chairperson, Coventry
                                                            Inquirer.             Town Council, Town Hall,
                                                                                1712 Main Street,
                                                                                Coventry, CT 06238.
Florida: Marion (FEMA Docket No: B- City of Ocala (08-04-  May 13, 2009; May     The Honorable Randy        September 15, 2009.............       120330
 1059).                              4557P).                20, 2009; Star-       Ewers, Mayor, City of
                                                            Banner.               Ocala, P.O. Box 1270,
                                                                                Ocala, FL 34478.
Illinois: Will (FEMA Docket No: B-  Unincorporated areas   May 11, 2009; May     The Honorable Lawrence M.  September 15, 2009.............       170695
 1059).                              of Will County (09-    18, 2009; The         Walsh, Will County
                                     05-1623P).             Herald-News.          Executive, 302 North
                                                                                Chicago Street, Joliet,
                                                                                IL 60432.
Nevada:
    Clark (FEMA Docket No: B-1059)  Unincorporated areas   May 12, 2009; May     The Honorable Rory Reid,   September 16, 2009.............       320003
                                     of Clark County (09-   19, 2009; Las Vegas   Chair, Clark County
                                     09-0526P).             Review-Journal.       Board of Commissioners,
                                                                                500 South Grand Central
                                                                                Parkway, Las Vegas, NV
                                                                                89106.
    Clark (FEMA Docket No: B-1059)  City of Henderson (09- May 12, 2009; May     The Honorable James B.     September 16, 2009.............       320005
                                     09-0526P).             19, 2009; Las Vegas   Gibson, Mayor, City of
                                                            Review-Journal.       Henderson, 240 South
                                                                                Water Street, Henderson,
                                                                                NV 89015.
Texas:
    Collin (FEMA Docket No: B-      Town of Prosper (09-   May 11, 2009; May     The Honorable Charles      September 15, 2009.............       480141
     1059).                          06-0211P).             18, 2009; Dallas      Niswanger, Mayor, Town
                                                            Morning News.         of Prosper, P.O. Box
                                                                                307, Prosper, TX 75078.
    El Paso (FEMA Docket No: B-     City of El Paso (09-   May 13, 2009; May     The Honorable John Cook,   September 17, 2009.............       480214
     1059).                          06-0832P).             20, 2009; El Paso     Mayor, City of El Paso,
                                                            Times.                City Hall, 10th Floor,
                                                                                Two Civic Center Plaza,
                                                                                El Paso, TX 79901.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

    Dated: March 22, 2010.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-8053 Filed 4-8-10; 8:45 am]
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