[Federal Register Volume 83, Number 86 (Thursday, May 3, 2018)]
[Proposed Rules]
[Pages 19479-19483]
[FR Doc No: 2018-09211]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2018-0211; FRL 9977-27-Region 7]

Air Plan Approval; Missouri; Regional Haze Plan and Prong 4
(Visibility) for the 2012 PM2.5, 2010 NO2, 2010 SO2, and 2008 Ozone
NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to take
three actions regarding the Missouri State Implementation Plan (SIP).
The three SIP actions relate to how Missouri addresses transport as
related to visibility and the 2012 Fine Particulate Matter
(PM2.5), 2010 Nitrogen Dioxide (NO2), 2010 Sulfur
Dioxide (SO2), and 2008 Ozone National Ambient Air Quality
Standards (NAAQS). EPA is proposing approval of the portion of
Missouri's September 5, 2014, Five-year Progress Report for the State
of Missouri Regional Haze Plan and a subsequently submitted letter
dated July 31, 2017, which clarifies that the state was changing from
reliance on the Clean Air Interstate Rule (CAIR) to reliance on the
Cross State Air Pollution Rule (CSAPR) for certain regional haze
requirements; convert EPA's limited approval/limited disapproval of
Missouri's regional haze plan to a full approval; and approve the
states' submissions addressing the Clean Air Act (CAA or the Act)
provisions that prohibit emissions activity in one state from
interfering with measures to protect visibility in another state (prong
4) of Missouri's infrastructure SIP submittals for the 2012 Fine
Particulate Matter (PM2.5), 2010 Nitrogen Dioxide
(NO2), and 2010 Sulfur Dioxide (SO2) NAAQS.

DATES: Comments must be received on or before June 4, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No EPA-R07-
OAR-2018-0211 to https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tracey Casburn, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
[email protected].

SUPPLEMENTARY INFORMATION:
    Throughout this document ``we,'' ``us,'' and ``our'' refer to EPA.
This section provides additional information by addressing the
following:

I. Background Information
    A. Regional Haze SIPs and Their Relationship With CAIR and CSAPR
    B. Infrastructure SIPs
II. What are the prong 4 requirements?
III. What is EPA's analysis of how Missouri addressed prong 4 and
regional haze?
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. Background Information

A. Regional Haze SIPs and Their Relationship With CAIR and CSAPR

    Section 169A(b)(2)(A) of the CAA requires states to submit regional
haze SIPs that contain such measures as may be necessary to make
reasonable progress towards the natural visibility goal at Class 1
areas, including a requirement that certain categories of existing
major stationary sources built between 1962 and 1977 procure, install,
and operate BART as determined by the state. Under the Regional Haze
Rule (RHR), adopted in 1999, states are directed to conduct BART
determinations for such ``BART-eligible'' sources that may be
anticipated to cause or contribute to visibility impairment in a Class
I area.\1\ Rather than requiring source-specific BART controls, states
also have the flexibility to adopt an emissions trading program or
other alternative program as long as the alternative provides greater
reasonable progress towards improving visibility than BART.\2\ EPA
provided states with this flexibility in the 1999 RHR, and further
refined the criteria for assessing whether an alternative program
provides for greater reasonable progress in two subsequent
rulemakings.\3\
---------------------------------------------------------------------------

    \1\ See 64 FR 35714 (July 1, 1999).
    \2\ See 40 CFR 51.308(e)(2).
    \3\ See 70 FR 39104 (July 6, 2005) and 71 FR 60612 (October 13,
2006).
---------------------------------------------------------------------------

    EPA demonstrated that CAIR would achieve greater reasonable
progress than BART in revisions to the RHR made in 2005.\4\ In those
revisions, EPA amended its regulations to provide that states
participating in the CAIR cap-and-trade programs pursuant to an EPA-
approved CAIR SIP or states that remain subject to a CAIR Federal
Implementation Plan (FIP) need not require affected BART-eligible
electric generating units (EGUs) to install, operate, and maintain BART
for emissions of SO2 and nitrogen oxides (NOX).
As a result of EPA's determination that CAIR was ``better-than-BART,''
a number of states in the CAIR region, including Missouri, relied on
the CAIR cap-and-trade programs as an alternative to BART for EGU
emissions of SO2 and NOX in designing their
regional haze SIPs. These states also relied on CAIR as an element of a
long-term strategy (LTS) for achieving reasonable progress. However, in
2008, the United States Court of Appeals for the District of Columbia
Circuit (DC Circuit) remanded CAIR to EPA, which it did without vacatur
to preserve the environmental benefits provided by CAIR.\5\ On August
8, 2011, acting on the DC Circuit's remand, EPA promulgated CSAPR to
replace CAIR and issued FIPs to implement the rule in CSAPR-subject
states.\6\ Implementation of CSAPR was scheduled to begin on January 1,
2012, when CSAPR would have superseded the CAIR program.
---------------------------------------------------------------------------

    \4\ CAIR created regional cap-and-trade programs to reduce
SO2 and NOX emissions in 27 eastern states
(and the District of Columbia), including Alabama, that contributed
to downwind nonattainment or interfered with maintenance of the 1997
8-hour ozone NAAQS or the 1997 PM2.5 NAAQS. See 70 FR
39104.
    \5\ North Carolina v. EPA, 550 F.3d 1176, 1178 (DC Cir. 2008).
    \6\ CSAPR requires 28 eastern states to limit their statewide
emissions of SO2 and/or NOX in order to
mitigate transported air pollution unlawfully impacting other
states' ability to attain or maintain four NAAQS: The 1997 ozone
NAAQS, the 1997 annual PM2.5 NAAQS, the 2006 24-hour
PM2.5 NAAQS, and the 2008 8-hour ozone NAAQS. The CSAPR
emissions limitations are defined in terms of maximum statewide
``budgets'' for emissions of annual SO2, annual
NOX, and/or ozone-season NOX by each covered
state's large EGUs. The CSAPR state budgets are implemented in two
phases of generally increasing stringency, with the Phase 1 budgets
applying to emissions in 2015 and 2016 and the Phase 2 budgets
applying to emissions in 2017 and later years. See 76 FR 48208.
---------------------------------------------------------------------------

    Due to the DC Circuit's 2008 ruling that CAIR was ``fatally
flawed'' and its resulting status as a temporary measure following that
ruling, EPA could not fully approve regional haze SIPs to the

extent that they relied on CAIR to satisfy the EGU BART requirement. On
these grounds, EPA finalized a limited disapproval of Missouri's
regional haze SIP on June 7, 2012, triggering the requirement for EPA
to promulgate a FIP unless Missouri submitted, and EPA approved, a SIP
revision that corrected the deficiency.\7\ EPA finalized a limited
approval of Missouri's regional haze SIP on June 26, 2012, as meeting
the remaining applicable regional haze requirements set forth in the
CAA and the RHR.\8\
---------------------------------------------------------------------------

    \7\ See 77 FR 33642. EPA finalized limited disapprovals of
fourteen states' regional haze SIP submissions that relied on CAIR
in this action, including Missouri's.
    \8\ See 77 FR 38007.
---------------------------------------------------------------------------

    In the June 7, 2012 limited disapproval action, EPA also amended
the RHR to provide that participation by a state's EGUs in a CSAPR
trading program for a given pollutant--either a CSAPR federal trading
program implemented through a CSAPR FIP or an integrated CSAPR state
trading program implemented through an approved CSAPR SIP revision--
qualifies as a BART alternative for those EGUs for that pollutant.\9\
\10\ Since EPA promulgated this amendment, numerous states covered by
CSAPR have come to rely on the provision through either SIPs or
FIPs.\11\
---------------------------------------------------------------------------

    \9\ See 40 CFR 51.308(e)(4).
    \10\ Legal challenges to the CSAPR-Better-than-BART rule from
state, industry, and other petitioners are pending. Utility Air
Regulatory Group v. EPA, No. 12-1342 (D.C. Cir. filed August 6,
2012).
    \11\ EPA has promulgated FIPs relying on CSAPR participation for
BART purposes for Georgia, Indiana, Iowa, Kentucky, Michigan,
Missouri, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia,
and West Virginia, 77 FR at 33654, and Nebraska, 77 FR 40150, 40151
(July 6, 2012). EPA has approved Minnesota's and Wisconsin's SIPs
relying on CSAPR participation for BART purposes. See 77 FR 34801,
34806 (June 12, 2012) for Minnesota and 77 FR 46952, 46959 (August
7, 2012) for Wisconsin.
---------------------------------------------------------------------------

    Numerous parties filed petitions for review of CSAPR in the DC
Circuit, and on August 21, 2012, the court issued its ruling, vacating
and remanding CSAPR to EPA and ordering continued implementation of
CAIR.\12\ The DC Circuit's vacatur of CSAPR was reversed by the United
States Supreme Court on April 29, 2014, and the case was remanded to
the DC Circuit to resolve remaining issues in accordance with the high
court's ruling.\13\ On remand, the DC Circuit affirmed CSAPR in most
respects, but invalidated without vacating some of the CSAPR budgets as
to a number of states.\14\ The remanded budgets include the Phase 2
SO2 emissions budgets for Alabama, Georgia, South Carolina,
and Texas and the Phase 2 ozone-season NOX budgets for
eleven states. This litigation ultimately delayed implementation of
CSAPR for three years, from January 1, 2012, when CSAPR's cap-and-trade
programs were originally scheduled to replace the CAIR cap-and-trade
programs, to January 1, 2015. Thus, the rule's Phase 2 budgets that
were originally promulgated to begin on January 1, 2014, began on
January 1, 2017.
---------------------------------------------------------------------------

    \12\ EME Homer City Generation, L.P. v. EPA, 696 F.3d 7, 38 (DC
Cir. 2012).
    \13\ EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584
(2014).
    \14\ EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (DC
Cir. 2015).
---------------------------------------------------------------------------

    On November 10, 2016, EPA published a notice of proposed rulemaking
(NPRM) explaining the Agency's belief that the potentially material
changes to the scope of CSAPR coverage resulting from the DC Circuit's
remand will be limited to the withdrawal of the FIP provisions
providing SO2 and annual NOX budgets for Texas
and ozone-season NOX budgets for Florida. This is due, in
part, to EPA's approval of the portion of Alabama's October 26, 2015,
SIP submittal adopting Phase 2 annual NOX and SO2
budgets equivalent to the Federally-developed budgets and to
commitments from Georgia and South Carolina to submit SIP revisions
adopting Phase 2 annual NOX and SO2 budgets equal
to or more stringent than the Federally-developed budgets.\15\ Since
publication of the NPRM, Georgia and South Carolina have submitted
these SIP revisions to EPA.\16\ In the NPRM, EPA also proposed to
determine that the limited changes to the scope of CSAPR coverage do
not alter EPA's conclusion that CSAPR remains ``better-than-BART'';
that is, that participation in CSAPR remains available as an
alternative to BART for EGUs covered by the trading programs on a
pollutant-specific basis. On September 21, 2017, Administrator Pruitt
signed the final action, ``Interstate Transport of Fine Particulate
Matter: Revision of Federal Implementation Plan Requirements for
Texas.'' In this action, the agency removed Texas from CSAPR and
affirmed the continued validity of the Agency's 2012 determination that
participation in CSAPR meets the Regional Haze Rule's criteria for an
alternative to the application of source-specific BART.
---------------------------------------------------------------------------

    \15\ See 81 FR 78954.
    \16\ Georgia's rulemaking to adopt the Phase 2 annual
NOX and SO2 budgets became state effective on
July 20, 2017, and the State will submit a SIP revision to EPA in
the near future. South Carolina submitted a SIP revision to EPA for
parallel processing on May 26, 2017, to adopt the Phase 2 annual
NOX and SO2 budgets and that action was
finalized by EPA in October 2017. See 82 FR 47936.
---------------------------------------------------------------------------

    On July 31, 2017, the State of Missouri submitted a letter to EPA
clarifying that the state had intended its Five-year Progress Report to
revise its regional haze SIP to rely on its participation in the CSAPR
trading programs for NOX and SO2 to satisfy the
requirements of 40 CFR 51.308(d)(3) and 51.308(e) with respect to
emissions of NOX and SO2 from electric generating
units, pursuant to the option provided in 40 CFR 51.308(e)(4) (the
``CSAPR-better-than-BART'' provision). This letter has been added to
the docket for this action and to the docket for the original action
approving the Five-year progress report (EPA-R07-OAR-2015-0581).
    EPA was not aware, at the time it approved Missouri's Five-year
Progress Report, that the state intended that submission to also serve
as a SIP revision substituting reliance on CAIR with reliance on CSAPR
pursuant to 40 CFR 51.308(e)(4). With this understanding, we are now
proposing to take an additional action on Missouri's Five-year Progress
Report and to approve that submission, in conjunction with the
clarification letter, as satisfying the SO2 and
NOX requirements in 40 CFR 51.308(d)(3) and (e) for EGUs
formerly subject to CAIR. If EPA finalizes this proposal, we would also
convert the limited approval/limited disapproval of Missouri's regional
haze plan to a full approval.

B. Infrastructure SIPs

    By statute, SIPs meeting the requirements of sections 110(a)(1) and
(2) of the CAA are to be submitted by states within three years (or
less, if the Administrator so prescribes) after promulgation of a new
or revised NAAQS to provide for the implementation, maintenance, and
enforcement of the new or revised NAAQS. EPA has historically referred
to these SIP submissions, which are made for satisfying the
requirements of sections 110(a)(1) and 110(a)(2), as ``infrastructure
SIP'' submissions. Sections 110(a)(1) and (2) require states to address
basic SIP elements such as for monitoring, basic program requirements,
and legal authority that are designed to assure attainment and
maintenance of the newly established or revised NAAQS. More
specifically, section 110(a)(1) provides the procedural and timing
requirements for infrastructure SIPs. Section 110(a)(2) lists specific
elements that states must meet for the infrastructure SIP requirements
related to a newly established or revised NAAQS. The

contents of an infrastructure SIP submission may vary depending upon
the data and analytical tools available to the state, as well as the
provisions already contained in the state's implementation plan at the
time at which the state develops and submits the submission for a new
or revised NAAQS.
    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct
components, commonly referred to as ``prongs,'' that must be addressed
in infrastructure SIP submissions. The first two prongs, which are
codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit
any source or other type of emissions activity in one state from
contributing significantly to nonattainment of the NAAQS in another
state (prong 1) and from interfering with maintenance of the NAAQS in
another state (prong 2). The third and fourth prongs, which are
codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit
emissions activity in one state from interfering with measures required
to prevent significant deterioration of air quality in another state
(prong 3) or from interfering with measures to protect visibility in
another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to
include provisions ensuring compliance with sections 115 and 126 of the
Act, relating to interstate and international pollution abatement.
    Through this action, EPA is proposing to approve the prong 4
portion of Missouri's infrastructure SIP submissions for the 2010 1-
hour NO2, 2010 1-hour SO2, and 2012 annual
PM2.5 NAAQS. All other applicable infrastructure SIP
requirements for these SIP submissions have been or will be addressed
in separate rulemakings. A brief background regarding the NAAQS
relevant to this proposal is provided below. For comprehensive
information on these NAAQS, please refer to the Federal Register
notices cited in the following subsections.
1. 2010 1-Hour SO2 NAAQS
    On June 2, 2010, EPA revised the 1-hour primary SO2
NAAQS to an hourly standard of 75 parts per billion (ppb) based on a 3-
year average of the annual 99th percentile of 1-hour daily maximum
concentrations.\17\ States were required to submit infrastructure SIP
submissions for the 2010 1-hour SO2 NAAQS to EPA no later
than June 2, 2013. Missouri submitted an infrastructure SIP submission
for the 2010 1-hour SO2 NAAQS on July 08, 2013. This
proposed action only addresses the prong 4 element of that
submission.\18\
---------------------------------------------------------------------------

    \17\ See 75 FR 35520 (June 22, 2010).
    \18\ The other portions of Missouri's July 08, 2013,
SO2 infrastructure submission are being addressed in a
separate EPA action. See the docket for EPA-R07-OAR-2017-0515.
---------------------------------------------------------------------------

2. 2010 1-Hour NO2 NAAQS
    On January 22, 2010, EPA promulgated a new 1-hour primary NAAQS for
NO2 at a level of 100 ppb, based on a 3-year average of the
98th percentile of the yearly distribution of 1-hour daily maximum
concentrations.\19\ States were required to submit infrastructure SIP
submissions for the 2010 1-hour NO2 NAAQS to EPA no later
than January 22, 2013. Missouri submitted infrastructure SIP
submissions for the 2010 1-hour NO2 NAAQS on April 30, 2013.
This proposed action only addresses the prong 4 element of those
submissions.\20\
---------------------------------------------------------------------------

    \19\ See 75 FR 6474 (February 9, 2010).
    \20\ The other portions for Missouri's April 30, 2013,
NO2 infrastructure submissions are being addressed in a
separate EPA action. See the docket for EPA-R07-OAR-2017-0268.
---------------------------------------------------------------------------

3. 2012 PM2.5 NAAQS
    On December 14, 2012, EPA revised the annual primary
PM2.5 NAAQS to 12 micrograms per cubic meter ([mu]g/
m\3\).\21\ States were required to submit infrastructure SIP
submissions for the 2012 PM2.5 NAAQS to EPA no later than
December 14, 2015. Missouri submitted an infrastructure SIP submission
for the 2012 PM2.5 NAAQS on October 14, 2015. This proposed
action only addresses the prong 4 element of that submission.\22\
---------------------------------------------------------------------------

    \21\ See 78 FR 3086 (January 15, 2013).
    \22\ The other portions of Missouri's December 9, 2015,
PM2.5 infrastructure submission are being addressed in
separate EPA actions. See the docket for EPA-R07-OAR-2017-0513.
---------------------------------------------------------------------------

4. 2008 8-Hour Ozone NAAQS
    On March 12, 2008, EPA revised the 8-hour Ozone NAAQS to 0.075
parts per million.\23\ States were required to submit infrastructure
SIP submissions for the 2008 8-hour Ozone NAAQS to EPA no later than
March 12, 2011. Missouri submitted an infrastructure SIP for the 2008
8-hour Ozone NAAQS on July 8, 2013. This proposed action only addresses
the prong 4 element of that submission.\24\
---------------------------------------------------------------------------

    \23\ See 73 FR 16436 (March 27, 2008).
    \24\ The other portions of Missouri's July 8, 2013, ozone
infrastructure SIP submission are being addressed in a separate EPA
action. See the docket for EPA-R07-OAR-2015-0356.
---------------------------------------------------------------------------

II. What are the prong 4 requirements?

    The prong 4 requirement of CAA section 110(a)(2)(D)(i)(II) requires
a state's implementation plan to contain provisions prohibiting sources
in that state from emitting pollutants in amounts that interfere with
any other state's efforts to protect visibility under part C of the CAA
(which includes sections 169A and 169B). On September 13, 2013, the EPA
issued Guidance on the Infrastructure State Implementation Plan (SIP)
Elements Under Clean Air Act Sections 110(a)(1) and 110(a)(2) (``2013
Guidance'').\25\ EPA developed this document to provide states with
guidance for infrastructure SIPs for any new or revised NAAQS. The 2013
Guidance states that the prong 4 requirements are satisfied by an
approved SIP provision that EPA has found to adequately address any
contribution of that state's sources that impacts the visibility
program requirements in other states. The 2013 Guidance also states
that EPA interprets this prong to be pollutant-specific, such that the
infrastructure SIP submission need only address the potential for
interference with protection of visibility caused by the pollutant
(including precursors) to which the new or revised NAAQS applies.
---------------------------------------------------------------------------

    \25\ ``Guidance on the Infrastructure State Implementation Plan
(SIP) Elements Under Clean Air Act Sections 110(a)(1) and 110(a)(2);
Memorandum from Stephen D. Page, September 13, 2013.
---------------------------------------------------------------------------

    The 2013 Guidance lays out how a state's infrastructure SIP may
satisfy prong 4. One way that a state can meet the requirements is via
confirmation in its infrastructure SIP submission that the state has an
approved regional haze SIP that fully meets the requirements of 40 CFR
51.308 or 51.309. 40 CFR 51.308 and 51.309 specifically require that a
state participating in a regional planning process include all measures
needed to achieve its apportionment of emission reduction obligations
agreed upon through that process. A fully approved regional haze SIP
will ensure that emissions from sources under an air agency's
jurisdiction are not interfering with measures required to be included
in other air agencies' plans to protect visibility.
    Alternatively, in the absence of a fully approved regional haze
SIP, a state may meet the requirements of prong 4 through a
demonstration in its infrastructure SIP submission that emissions
within its jurisdiction do not interfere with other air agencies' plans
to protect visibility. Such an infrastructure SIP submission would need
to include measures to limit visibility-impairing pollutants and ensure
that the reductions conform with any mutually agreed regional haze RPGs
for mandatory Class I areas in other states.

III. What is EPA's analysis of how Missouri addressed prong 4 and
regional haze?

    Each of Missouri's infrastructure SIP submittals (2008 8-hour
Ozone, 2010 1-hour NO2, 2010 1-hour SO2, and 2012
annual PM2.5) relied on the State having a fully approved
regional haze SIP to satisfy its prong 4 requirements. However, at the
time of those submittals, EPA had not fully approved Missouri's
regional haze SIP, as the Agency issued a limited disapproval of the
State's original regional haze plan on June 7, 2012. As detailed
earlier in this notice, EPA is proposing to convert EPA's limited
approval/limited disapproval of Missouri's regional haze plan to a full
approval because final approval of Missouri's intended SIP revision
relying on CSAPR pursuant to 40 CFR 51.308(e)(4) would correct the
deficiencies that led to EPA's limited approval/limited disapproval of
the State's regional haze SIP. Because a state may satisfy prong 4
requirements through a fully approved regional haze SIP, EPA is
therefore also proposing to approve the prong 4 portion of Missouri's
2010 1-hour NO2, 2010 1-hour SO2, 2012 annual
PM2.5, and 2008 8-hour Ozone infrastructure SIP submissions.

IV. Proposed Action

    As described above, EPA is proposing to take the following actions:
(1) Approve the portion of Missouri's September 5, 2014 Five-year
Progress Report for the State of Missouri Regional Haze Plan which, as
clarified by the July 31, 2017 letter, identified the state's change
from reliance on CAIR to a reliance on the CSAPR FIP for certain
regional haze requirements; (2) convert EPA's limited approval/limited
disapproval of Missouri's regional haze plan to a full approval; and
(3) approve the state's infrastructure SIP submissions addressing the
CAA prong 4 requirements for the 2008 Ozone, 2012 PM2.5,
2010 NO2, and 2010 SO2 NAAQS.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. 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 application of those requirements would be inconsistent
with the CAA; 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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule 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, Administrative practice and procedure,
Air pollution control, Incorporation by reference, Intergovernmental
relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides.

    Dated: April 17, 2018.
Karen A. Flournoy,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, EPA proposes to amend 40
CFR part 52 as set forth below:

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 AA--Missouri

0
2. In Sec.  52.1320 the table in paragraph (e) is amended by revising
entry (70), and adding entry (74) in numerical order.
    The revision and addition reads as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (e)* * *

                                                   EPA-Approved Missouri Nonregulatory SIP Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                       Applicable geographic or
 Name of nonregulatory SIP revision       nonattainment area             State submittal date           EPA approval date            Explanation
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
(70) State Implementation Plan       Statewide..................  9/5/2014.........................  [date of final          Missouri submitted a
 (SIP) Revision for Regional Haze                                                                     publication in the      clarification letter to
 (2014 Five-Year Progress Report).                                                                    Federal Register]       its Five-year Progress
                                                                                [Final rule Federal     Report on July 31, 2017
                                                                                Register citation].     that is part of this
                                                                                action. [EPA-R07-OAR-2015-
                                                                                0581; FRL-9949-68-Region
                                                                                7]; [EPA-R07-OAR-2018-
                                                                                0211; FRL-9977-27-Region
                                                                                7.]

                                                                      * * * * * * *
(74) Sections 110(a)(2)              Statewide..................  7/8/2013; 8/30/2013; 7/8/2013; 10/ [date of final          This action approves the
 Infrastructure Prong 4                                            14/2015.                           publication in the      following CAA elements:
 Requirements for the 2008 Ozone,                                                                     Federal Register]       110(a)(2)(D)(i)(II)--prong
 2010 Nitrogen Dioxide, 2010 Sulfur                                                                   [Final rule Federal     4.
 Dioxide, and the 2012 Fine                                                                           Register citation].    [EPA-R07-OAR-2018-0211; FRL-
 Particulate Matter NAAQS.                                                                                9977-27-Region 7.]
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
3. Amend Sec.  52.1339 by revising Paragraph (a) and removing
paragraphs (c) through (e) to read as follows:

Sec.  52.1339  Visibility protection

    (a) The requirements of section 169A of the Clean Air Act are met
because the regional haze plan submitted by Missouri on August 5, 2009,
and supplemented on January 30, 2012, in addition to the 5-year
progress report submitted on September 5, 2014, and supplemented by
state letter on July 31, 2017, includes fully approvable measures for
meeting the requirements of the Regional Haze Rule including the
requirements of 40 CFR 51.308(d)(3) and 51.308(e) with respect to
emissions of NOX and SO2 from electric generating
units.
* * * * *
[FR Doc. 2018-09211 Filed 5-2-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Proposed Rules]
[Pages 55932-55934]
[FR Doc No: 2022-19724]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0179]

Prior Notice of Imported Food Questions and Answers (Edition 4);
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry entitled ``Prior Notice
of Imported Food Questions and Answers; Draft Guidance for Industry
(Edition 4).'' The draft guidance adds three additional questions. One
question relates to any effect systems recognition or equivalency
determinations have on prior notice requirements. The other two
questions relate to FDA's notice to a submitter of prior notice of an
FDA refusal for inadequate prior notice or hold if the food article is
from a foreign facility that is not registered, and address the
timeframe for making requests for FDA review of such a refusal or hold.
FDA is also making other technical and editorial changes.

DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2022 to ensure that we consider your comment
on this draft guidance before we begin work on the final version of the
guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0179 for ``Prior Notice of Imported Food Questions and
Answers; Draft Guidance for Industry (Edition 4).'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidance to the Division of Operational Policy, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Dr., Rockville, MD 20852. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn
Dr.,

Rockville, MD 20857<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for
industry, entitled ``Prior Notice of Imported Food Questions and
Answers; Draft Guidance for Industry (Edition 4).'' This draft revised
guidance is being issued for public comment and has not yet been
finalized. Until edition 4 is finalized, ``Prior Notice of Imported
Food Questions and Answers; Guidance for Industry (Edition 3),''
updated most recently in 2016, remains in effect. We are issuing the
draft guidance consistent with our good guidance practices regulation
(21 CFR 10.115). The draft guidance, when finalized, will represent the
current thinking of FDA on this topic. It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternate approach if it satisfies the requirements of the applicable
statutes and regulations.
    FDA continues to believe that it is reasonable to maintain
responses to questions concerning prior notice of imported food in a
single document that is periodically updated in response to additional
questions or regulatory or policy changes. As in the previous editions,
the following indicators are used to help users identify revisions: (1)
the guidance is identified as a revision of a previously issued
document; (2) the revision date appears on the cover of the guidance;
(3) the edition number of the guidance is included in its title; and
(4) revised or added questions and answers are identified as such in
the body of the guidance.
    On November 7, 2008, we published a final rule in the Federal
Register requiring submission to FDA of prior notice of food, including
food for animals, that is imported or offered for import into the
United States (73 FR 66294). The rule implements section 801(m) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(m)),
which was added by section 307 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism
Act) (Pub. L. 107-188) and requires that FDA receive prior notice of
food imported or offered for import into the United States.
    On December 16, 2003, FDA issued a guidance entitled ``Prior Notice
of Imported Food Questions and Answers (Edition 1).'' FDA issued a
second and third edition on May 3, 2004, and June 16, 2016,
respectively. This draft will be the fourth edition of this document.
FDA is issuing this draft guidance entitled ``Prior Notice of Imported
Food Questions and Answers (Edition 4)'' as a level 1 guidance.
    The draft fourth edition guidance adds three additional questions.
One question relates to any effect systems recognition or equivalency
determinations have on prior notice requirements. The other two
questions relate to FDA's notice of a refusal under 801(m)(1) of the
FD&C Act (in accordance with Sec.  1.283 (21 CFR 1.283)) for inadequate
prior notice or a hold under 801(l) (in accordance with Sec.  1.285 (21
CFR 1.285)) if the food article is from a foreign facility that is not
registered, as well as address the timeframe for making requests for
FDA review of such a refusal or hold. The draft guidance is intended to
help clarify whether food imported from a country with which FDA has a
Systems Recognition Arrangement or equivalence determination is
exempted from prior notice requirements. The draft guidance also
intends to clarify when FDA will provide notice of the refusal or hold
to the relevant party, and when the 5-calendar-day clock to request a
review of the refusal or hold begins. We are also making other
technical amendments to the guidance due to the expanded capabilities
of the U.S. Customs and Border Protection's Automate Broker Interface
of the Automated Commercial Environment (ABI/ACE) system and FDA's 2017
technical amendments to the prior notice rule (82 FR 15627, March 20,
2017), such as replacing references to the Automated Commercial System
(ACS) and successor system with the ABI/ACE system, removing references
to requirements that certain prior notice submissions be submitted in
FDA's Prior Notice Systems Interface (FDA PNSI), and updating outdated
links and FDA contact information.
    The draft fourth edition guidance clarifies that the existence of a
Systems Recognition Arrangement with or an equivalence determination of
a foreign country does not exempt imported foods from that country from
FDA's prior notice requirements.
    FDA's policy on and practice of communicating prior notice refusals
and holds has changed over time. FDA previously stated that we intended
to provide notice regarding refusals to carriers. Those carriers could
then notify others, such as the entity that hired the carrier to
transport the article of food, of a problem with the prior notice (see
73 FR 66294 at 66365). Subsequently, FDA's Guidance for Industry
``Prior Notice of Imported Food Questions and Answers (Edition 3)'' was
published with the explanation that FDA will communicate the decision
to examine articles of food to CBP.
    The draft fourth edition clarifies that notification of these prior
notice refusals and holds will be communicated to CBP and provided to
the relevant party (i.e., the submitter of prior notice) upon arrival
of the article. FDA is clarifying its policy because providing advanced
notice of a refusal or hold to a submitter could create incentives for
bad actors, who may attempt to reroute their entries for the purpose of
evading FDA requirements and importing unsafe food.
    The draft fourth edition also clarifies the 5-calendar-day clock to
request a review of these refusals and holds. Under Sec. Sec.  1.283(d)
and 1.285(j), certain parties may, for the enumerated reasons, request
reviews of the prior notice refusals and holds within 5 calendar days
of the hold or refusal. The draft fourth edition clarifies that FDA
considers the 5-calendar-day clock to begin when FDA provides notice of
the refusal or hold to the submitter.
    Additionally, in 2016, CBP issued a notice announcing that ABI/ACE
would replace ACS as the sole electronic data interchange system
authorized by CBP for the processing of electronic entries of FDA-
regulated products (see 81 FR 30320, May 16, 2016). ABI/ACE became the
successor system to ACS. In 2017, we amended 21 CFR subpart I to
replace references to ACS and successor system with ABI/ACE (see 82 FR
15627). As part of this rulemaking, we eliminated some requirements for
submitting prior notice due to the expanded capabilities of ABI/ACE,
such as the requirement to submit articles that have been refused under
section 801(m)(1) of the FD&C Act or subpart I in FDA PNSI. Further,
ABI/ACE can now accommodate entries it previously could not, such as
articles of food arriving through international mail. Therefore, to
reflect these changes that were implemented in the rulemaking and the
expanded capabilities of ABI/ACE, we are replacing references in the
guidance to ACS and successor system with ABI/ACE. In addition, we are
providing clarification regarding how persons may submit prior notice
for articles of food imported or offered for import by international
mail.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Prior Notice
of Imported Food Questions and Answers (Edition 4).'' It does not
establish any rights for any person and is not binding on FDA or the

public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR 1.278 to 1.282 have been approved under OMB
control number 0910-0520.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/food/importing-food-products-united-states/prior-notice-imported-foods, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidance.

    Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19724 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26620-26621]
[DOCID:fr10my07-63]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-200-025]

Rockies Express Pipeline LLC; Notice of Tariff Filing and
Negotiated Rate

May 3, 2007.
    Take notice that on April 30, 2007, Rockies Express Pipeline LLC
(REX) tendered for filing as part of its FERC Gas Tariff, the following
tariff sheets, to be effective May 1, 2007:

Twentieth Revised Sheet No. 22
Ninth Revised Sheet No. 24

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically

should submit an original and 14 copies of the protest or intervention
to the Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-8926 Filed 5-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Notices]
[Pages 13668-13669]
[FR Doc No: 2019-06663]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-2730]

Risk Evaluation and Mitigation Strategy: The Food and Drug
Administration's Application of Statutory Factors in Determining When a
Risk Evaluation and Mitigation Strategy Is Necessary; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Risk
Evaluation and Mitigation Strategy: FDA's Application of Statutory
Factors in Determining When a Risk Evaluation and Mitigation Strategy
Is Necessary.'' This guidance is intended to clarify how FDA applies
the factors set forth in the Federal Food, Drug, and Cosmetic Act (FD&C
Act) in determining whether a risk evaluation and mitigation strategy
(REMS) is necessary to ensure that the benefits of a drug outweigh its
risks. This guidance is one of several developed to fulfill performance
goals that FDA agreed to satisfy in the reauthorization of the
prescription drug user fee program (the Prescription Drug User Fee Act
(PDUFA) V). This guidance finalizes the draft guidance entitled ``FDA's
Application of Statutory Factors in Determining When a REMS Is
Necessary,'' issued September 21, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on April 5, 2019.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2730 for ``REMS: FDA's Application of Statutory Factors in
Determining When a REMS Is Necessary.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to

assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jason Bunting, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993, 301-796-
1292, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``REMS: FDA's Application of Statutory Factors in Determining
When a REMS Is Necessary.'' The Food and Drug Administration Amendments
Act of 2007 (FDAAA) (Pub. L. 110-85) created section 505-1 of the FD&C
Act (21 U.S.C. 355-1),\1\ which authorizes FDA to require a REMS for
certain drugs if FDA determines that a REMS is necessary to ensure that
the benefits of the drug outweigh its risks (see section 505-1(a) of
the FD&C Act). FDA can require a REMS before initial approval of a new
drug application or, should FDA become aware of ``new safety
information'' (as defined in section 505-1(b)(3) of the FD&C Act) about
a drug and determine that a REMS is necessary to ensure that the
benefits of the drug outweigh its risks, after the drug has been
approved (see section 505-1(a)(2) of the FD&C Act).
---------------------------------------------------------------------------

    \1\ Section 505-1 of the FD&C Act applies to applications for
prescription drugs submitted or approved under subsections 505(b)
(i.e., new drug applications) or (j) (i.e., abbreviated new drug
applications) (21 U.S.C. 355(b) or (j)) of the FD&C Act and to
applications submitted or licensed under section 351 (i.e.,
biologics license applications) of the Public Health Service Act (42
U.S.C. 262). In this document, unless otherwise specified, the term
``drug'' refers to drug and biological products (or biologics).
---------------------------------------------------------------------------

    FDA's determination as to whether a REMS is necessary for a
particular drug is a complex, drug specific inquiry, reflecting an
analysis of multiple, interrelated factors. Section 505-1(a) of the
FD&C Act, as added by FDAAA, requires FDA to consider the following six
factors \2\ in making a decision about whether to require a REMS:
---------------------------------------------------------------------------

    \2\ Section 505-1(a)(1) of the FD&C Act requires the Agency to
consider these factors in determining whether a REMS is necessary
for a new drug. FDA also generally considers these factors in
determining whether (based on new safety information), a REMS is
necessary for a drug that is the subject of an approved application.
---------------------------------------------------------------------------

     The seriousness of any known or potential adverse events
that may be related to the drug and the background incidence of such
events in the population likely to use the drug;
     The expected benefit of the drug with respect to the
disease or condition;
     The seriousness of the disease or condition that is to be
treated with the drug;
     Whether the drug is a new molecular entity;
     The expected or actual duration of treatment with the
drug; and
     The estimated size of the population likely to use the
drug.
    These six factors influence FDA's decisions with respect to whether
a REMS is required for a particular drug and what type of REMS might be
necessary (i.e., what specific elements or tools should be included as
part of the REMS). FDA makes decisions about requiring a REMS as part
of a benefit-risk determination for a drug after an evaluation that
includes integrated consideration of each of the statutory factors. All
six factors are considered together to inform FDA's REMS decision
making process and no single factor is determinative as to whether a
REMS is necessary. The relative importance or weight of each factor is
a case specific inquiry. This guidance describes how FDA considers each
of these factors in conducting its REMS analysis.
    This guidance finalizes the draft guidance entitled ``FDA's
Application of Statutory Factors in Determining When a REMS Is
Necessary,'' issued September 21, 2016 (81 FR 64911). Interested
persons were invited to comment by November 21, 2016. FDA received
comments related to how we weigh the six factors when determining if a
REMS is necessary, minor clarifying comments on how we apply the six
factors, and comments suggesting that FDA expand on which REMS elements
or tools should be used when it is determined that a REMS is necessary.
FDA has considered all of the public comments received in finalizing
this guidance. Clarifying edits were made to address the comments as
appropriate. Additionally, edits were made to streamline the guidance,
extraneous background information was removed, and the title was
modified for clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``REMS: FDA's Application of Statutory
Factors in Determining When a REMS Is Necessary.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: April 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06663 Filed 4-4-19; 8:45 am]
BILLING CODE 4164-01-P