[Federal Register: December 15, 2006 (Volume 71, Number 241)]
[Rules and Regulations]
[Page 75422-75431]
[DOCID:fr15de06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 70 and 71

[EPA-HQ-OAR-2003-0179; FRL-8257-3]
RIN 2060-AN74

Final Rule Interpreting the Scope of Certain Monitoring
Requirements for State and Federal Operating Permits Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; notice of final action on interpretation.

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SUMMARY: The purpose of this action is to finalize interpretation of
certain existing federal air program operating permits regulations. We
proposed an interpretation of these rules on June 2, 2006, and
requested comment. This final interpretation responds to the comments
we received. The final interpretation is that the plain language and
structure of certain sections of the operating permits regulations do
not provide an independent basis for requiring or authorizing review
and enhancement of existing monitoring in title V permits. We believe
that other rules establish a basis for such review and enhancement.
Such other rules include the monitoring requirements in certain other
sections of the federal operating permits regulations (i.e., periodic
monitoring), existing federal air pollution control standards, and
regulations implementing State requirements to meet the ambient air
quality standards.
    This final interpretation clarifies the permit content requirements
relative to the operating permits regulations and facilitates permit
issuance ensuring that air pollution sources can operate and comply
with requirements.

Dates: Effective Date: The final rule interpretation is effective on
January 16, 2007.

ADDRESSES: The Electronic Docket ID No. EPA-HQ-OAR-2003-0179 contains
the comments received and regulatory background materials including the
Responses to Comments document. All documents in the docket are listed
in the Federal Docket Management System (FDMS) index at http://www.regulations.gov.
 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 either electronically at http://www.regulations.gov
 or in hard copy at the EPA Docket Center, Public

Reading Room, EPA West, Room B102, 1301 Constitution Avenue, NW.,
Washington, DC 20004. The normal business hours are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. The telephone
number is<PHONE_NUMBER>.

    Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate; however, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to visit the Public Reading Room to
view documents. Consult EPA's Federal Register notice at 71 FR 38147
(July 5, 2006) or the EPA Web site at http://www.epa.gov/epahome/dockets.htm
 for current information on docket operations, locations

and telephone numbers. The Docket Center's mailing address for U.S.
mail and the procedure for submitting comments to
http://www.regulations.gov are not affected by the flooding and will remain

the same.

FOR FURTHER INFORMATION CONTACT: Peter Westlin, Environmental
Protection Agency, Office of Air Quality Planning and Standards, Mail
code: D243-05, 109 TW Alexander Drive, Research Triangle Park, NC
27711; telephone:<PHONE_NUMBER>; facsimile number<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information presented in this preamble
is organized as follows:

I. General Information
    A. Does This Action Affect Me?
    B. How Can I Get Copies of This Document and Other Related
Information?
    C. What Is the Procedure for Judicial Review?
II. Background
III. What revisions did we make as a result of comments received on
the proposed interpretation?
IV. What are our responses to significant comments?
    A. The proposed interpretation is correct in principle and
consistent with the plain language of the rule and the Clean Air
Act.
    B. The proposed interpretation is incorrect in principle and
inconsistent with the plain language of the rule and the Clean Air
Act.
    C. The effect of rule on previous permit decisions is not
minimal and resultant conditions should be removed from permits.
    D. The authority for the permitting authorities to fill periodic
monitoring gaps should be reinstated.
    E. Existing monitoring requirements in current rules are
inadequate and case-by-case review and revision are necessary.
    F. The Agency should provide further clarification or regulatory
action on the

effect of monitoring policies on enforcement.
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

I. General Information

A. Does This Action Affect Me?

    Categories and entities potentially affected by this action include
facilities currently required to obtain title V permits under State,
local, tribal, or federal operating permits programs, and State, local,
and tribal governments that issue such permits pursuant to approved
part 70 and part 71 programs. If you have any questions regarding the
applicability of this action, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. How Can I Get Copies of This Document and Other Related Information?

    In addition to access to information in the docket as described
above, you may also access electronic copies of the final rule and
associated information through the Technology Transfer Network (TTN)
Web site. The TTN provides an information and technology exchange in
various areas of air pollution control. Following the Administrator
signing the notice, we will post the final rule on the Office of Air
and Radiation's Policy and Guidance page for newly proposed or
promulgated rules at http://www.epa.gov/ttn/oarpg/. You may access this

Federal Register document electronically through the EPA Internet under
the ``Federal Register'' listings at http://www.epa.gov/ttn/oarpg. If

you need more information regarding the TTN, call the TTN HELP line at
(919) 541-5384.
    You may access an electronic version of a portion of the public
docket through the Federal eRulemaking Portal. Interested persons may
use the electronic version of the public docket at http://www.regulations.gov

to: (1) Submit or view public comments, (2) access the index listing of
the contents of the official public docket, and (3) access those
documents in the public docket that are available electronically. Once
in the FDMS, use the Search for Open Regulations field to key in the
appropriate docket identification number or document title at the
Keyword window.

C. What Is the Procedure for Judicial Review?

    Under section 307(b)(1) of the Clean Air Act (CAA), judicial review
of the final rule is available by filing a petition for review in the
United States Court of Appeals for the District of Columbia Circuit by
February 13, 2007. Only those objections that were raised with
reasonable specificity during the period for public comment may be
raised during judicial review. Under section 307(b)(2) of the CAA, the
requirements that are the subject of the final rule amendments may not
be challenged later in civil or criminal proceedings brought by EPA to
enforce these requirements.
    Section 307(d)(7)(B) of the CAA further provides that ``[o]nly an
objection to a rule or procedure which was raised with reasonable
specificity during the period for public comment (including any public
hearing) may be raised during judicial review.'' This section also
provides a mechanism for us to convene a proceeding for
reconsideration, ``[i]f the person raising an objection can demonstrate
to the EPA that it was impracticable to raise such objection within
[the period for public comment] or if the grounds for such objection
arose after the period for public comment (but within the time
specified for judicial review) and if such objection is of central
relevance to the outcome of the rule.'' Any person seeking to make such
a demonstration to us should submit a Petition for Reconsideration to
the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a
copy to both the person(s) listed in the preceding FOR FURTHER
INFORMATION CONTACT section, and the Associate General Counsel for the
Air and Radiation Law Office, Office of General Counsel (Mail Code
2344A), U.S. EPA, 1200 Pennsylvania Ave., NW, Washington, DC 20004.

II. Background

    On June 2, 2006 (71 FR 32006), we proposed an interpretation of 40
CFR parts 70 and 71 regarding certain elements of those rules relative
to requirements for monitoring to assure compliance with applicable
requirements. In brief, the interpretation is that Sec. Sec.
70.6(c)(1) and 71.6(c)(1) and the Clean Air Act requirements which they
implement do not authorize Federal, State and local permitting
authorities to assess the sufficiency of or impose new monitoring
requirements. Instead, these sections require that each title V permit
contain, ``[c]onsistent with paragraph (a)(3) of this section,
compliance certification, testing, monitoring, reporting, and
recordkeeping requirements sufficient to assure compliance with the
terms and conditions of the permit''
    Sections 70.6(a)(3)(i)(A) and 71.6(a)(3)(i)(A) require that permits
contain ``[a]ll monitoring and analysis procedures or test methods
required under applicable monitoring and testing requirements,
including part 64 of this chapter and any other procedures and methods
that may be promulgated pursuant to sections 114(a)(3) and 504(b) of
the Act.'' The requirements in Sec. Sec.  70.6(a)(3)(i)(B) and
71.6(a)(3)(i)(B) continue that ``[w]here the applicable requirement
does not require periodic testing or instrumental or noninstrumental
monitoring (which may consist of recordkeeping designed to serve as
monitoring), [each title V permit must contain] periodic monitoring
sufficient to yield reliable data from the relevant time period that
are representative of the source's compliance with the permit, as
reported pursuant to [Sec.  70.6(a)(3)(iii) or Sec.  71.6(a)(3)(iii)].
Such monitoring requirements shall assure use of terms, test methods,
units, averaging periods, and other statistical conventions consistent
with the applicable requirement. Recordkeeping provisions may be
sufficient to meet the requirements of [Sec. Sec.  70.6(a)(3)(i)(B) and
71.6(a)(3)(i)(B)].''
    This final interpretation of the provisions of Sec. Sec.
70.6(c)(1) and 71.6(c)(1) does not affect the provisions of Sec. Sec.
70.6(a)(3)(i) and 71.6(a)(3)(i) that require the permitting authority
to incorporate the monitoring imposed by underlying applicable
requirements into permits and to add periodic monitoring during the
permitting process when the underlying requirements contains no
periodic testing, specifies no frequency, or requires only a one-time
test. The interpretation simply clarifies that Sec. Sec.  70.6(c)(1)
and 71.6(c)(1) do not provide any independent authority relative to
assessing and revising existing monitoring beyond what is required in
Sec. Sec.  70.6(a)(3)(i) and 71.6(a)(3)(i).

III. What revisions did we make as a result of comments received on the
proposed interpretation?

    We made no regulatory revisions to parts 70 or 71 as a result to
the comments we received on the proposed interpretation.

IV. What are our responses to significant comments?

    A. The proposed interpretation is correct in principle and
consistent with the plain language of the rule and the Clean Air Act.
    Several commenters agreed that the interpretation is consistent
with section 504(b) of the Clean Air Act and noted that this is the
only provision of Title V that authorizes EPA to adopt new monitoring
requirements. They further noted that this section of the Act empowers
EPA to do so only through rulemaking. Other commenters wrote that the
1990 Clean Air Act Amendments and its legislative history are replete
with statements that Title V permits were not intended to provide an
opportunity for permit authorities to add substantive new requirements
for sources required to obtain operating permits. EPA's regulations at
40 CFR 70.1(b) of the 40 CFR part 70, Operating Permit Program, repeat
this principle clearly. The commenter said that EPA used this authority
and the authority in section 114(a) for enhanced monitoring by
promulgating 40 CFR part 64, the Compliance Assurance Monitoring Rule,
in 1997. Several commenters agreed with the conclusion with regards to
the Act and observed that, although the provisions in Sec. Sec.
70.6(c)(1) and 71.6(c)(1) require permitting officials to ensure that
permits contain certain elements related to compliance, like
monitoring, the prefatory language requiring that the elements be
``[c]onsistent with paragraph (a)(3)'' makes clear that the substance
of those elements is determined under Sec. Sec.  70.6(a)(3) and
71.6(a)(3).
    Other commenters indicated that language stating that the required
monitoring is ``sufficient to assure compliance'' is not an
authorization for permitting officials to make their own determinations
regarding the sufficiency of monitoring in existing rules and permits,
but a recognition that the monitoring required under Sec. Sec.
70.6(a)(3)(i) and 71.6(a)(3)(i)--i.e., existing monitoring as
supplemented by ``periodic monitoring,'' ``enhanced monitoring'' under
CAA section 114(a)(3), and/or any other monitoring procedures
established by rule under section 504(b)--are deemed sufficient to
assure compliance. One commenter agrees with EPA that the Act does not
compel EPA to provide such authority to itself or States. The commenter
continues that allowing EPA or State permitting agencies to change or
add to monitoring and compliance methods already established through
State and federal rulemakings and permitting proceedings is
inconsistent with Title V and with other substantive and procedural
requirements of the Act.
    Response: We generally agree with these commenters statements. We
have determined that the correct interpretation of Sec. Sec.
70.6(c)(1) and 71.6(c)(1) is that these provisions do not establish a
separate regulatory standard or basis for requiring or authorizing
review and enhancement of existing monitoring independent of any review
and enhancement that may be required under other portions of the rules.
Sections 70.6(c)(1) and 71.6(c)(1) constitute general provisions that
direct permitting authorities to include the monitoring required under
existing statutory and regulatory authorities in title V permits along
with other compliance related requirements. These provisions do not
require or authorize a new or independent assessment of monitoring
requirements to assure compliance. We disagree with the comment that
cites section 504(b) of the Clean Air Act as the only provision of
title V that authorizes EPA to adopt new monitoring requirements.
Congress granted EPA broad discretion to decide how to implement the
title V monitoring requirements. Two provisions of title V specifically
address rulemaking concerning monitoring (sections 502(b)(2) and
504(b)), and other provisions of title V refer to the monitoring
required in individual permits (sections 504(c) and 504(a)). As more
fully explained in the preamble for the proposed interpretation (71 FR
at 32012), taken together these provisions clearly authorize the Agency
to require improvements to the existing monitoring required by
applicable requirements in at least two ways. First, we may require
case-by-case monitoring reviews as described in the September 17, 2002
proposal. Alternatively, we may achieve any improvements in monitoring
through federal or State rulemakings that amend the monitoring
provisions of applicable requirements themselves.
    We have chosen the latter approach because we believe it is
preferable to an approach requiring case-by-case monitoring reviews
conducted without a structured process such as is included in part 64.
Consistent with this approach, we agree with commenters that the plain
language of Sec. Sec.  70.6(c)(1) and 71.6(c)(1), which begin with the
phrase ``[c]onsistent with'' 70.6(a)(3) and 71.6(a)(3), indicates that
the (c)(1) provisions include and gain meaning from the more specific
monitoring requirements in the (a)(3) provisions. Read in isolation,
the general language of Sec. Sec.  70.6(c)(1) and 71.6(c)(1) does not
provide any indication of what type of frequency of monitoring is
required. When read together with the more detailed periodic monitoring
rules, which specify that periodic monitoring must be ``sufficient to
yield reliable data from the relevant time period that are
representative of the source's compliance with the permit,'' these
provisions take on practical meaning.
    Finally, we also agree with commenters that the statute and our
regulations clearly support the interpretation that permitting
authorities are not required or authorized to assess or revise existing
monitoring requirements. Rather, under the authority of part 70 or 71,
permitting authorities are to impose monitoring requirements only where
the underlying rule contains no monitoring of a periodic nature.
    B. The proposed interpretation is incorrect in principle and is
inconsistent with the plain language of the rule and the Clean Air Act.
    Several commenters strongly opposed EPA's proposal. Two commenters
contended that by interpreting the Title V regulations neither to
require nor to authorize a permitting authority to include additional
monitoring in a Title V permit to supplement periodic, but inadequate,
monitoring obligations specified in an underlying applicable
requirement, EPA's proposed regulatory interpretation would violate the
plain statutory language requiring that each Title V permit include
monitoring that is sufficient to ``assure compliance'' with each
applicable requirement. One commenter indicated that EPA's proposed
interpretation would violate the plain language of CAA section 504(c)
requiring that ``[e]ach permit * * * shall set forth inspection, entry,
monitoring, compliance certification, and reporting requirements to
assure compliance with the permit terms and conditions.'' The commenter
continued that EPA's proposed interpretation would violate the plain
language of CAA section 504(a) requiring that ``[e]ach permit issued
under this subchapter shall include enforceable emission limitations
and standards, * * * a requirement that the permittee submit to the
permitting authority, no less often than every 6 months, the results of
any required monitoring, and such other conditions as are necessary

to assure compliance with applicable requirements of this chapter.'' By
using the word ``shall'' in section 504(a) and (c), Congress clearly
stated its intent for monitoring sufficient to ``assure compliance''
with applicable requirements to be a mandatory element of each Title V
permit.
    This same commenter stated that EPA's proposed interpretation would
violate Congress's unambiguous directive that EPA ensure that a Title V
permitting authority possesses adequate authority to ``issue permits
and assure compliance by all [Title V sources] with each applicable
standard, regulation or requirement under this chapter.'' CAA section
502(b)(5)(A). If a permitting authority is prohibited from requiring
additional monitoring in a source's Title V permit when it determines
that existing monitoring is insufficient to assure compliance, the
commenter said that the permitting authority plainly cannot do what the
statute requires, namely, issue permits that ``assure compliance'' with
each applicable requirement. Several commenters believed that EPA's
proposed prohibition against supplemental monitoring would prevent EPA
from fulfilling its statutory duty to object to Title V permits that
lack monitoring sufficient to assure compliance, and would eliminate
the public's right to petition EPA to fulfill that duty when the agency
fails to object on its own accord. As EPA itself acknowledged in a D.C.
Circuit brief,

[i]n the absence of effective monitoring, emissions limits can, in
effect, be little more than paper requirements. Without meaningful
monitoring data, the public, government agencies and facility
officials are unable to fully assess a facility's compliance with
the Clean Air Act.\1\
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    \1\ Initial Brief of Respondent United States Environmental
Protection Agency, Appalachian Power Co., et al. v. Envtl.
Protection Agency, No. 98-1512 (D.C. Cir., Oct. 25, 1999).

    Commenters further stated that EPA's interpretation violates CAA
section 114(a)(3), which requires ``enhanced monitoring'' by ``any
person which is the owner or operator of a major stationary source.''
The commenters noted that, in 1997, EPA implemented 40 CFR part 64,
compliance assurance monitoring or CAM, requiring enhanced monitoring
for a limited number of sources. Commenters indicated that EPA noted
that even though the CAM rule did not cover all stationary sources, the
rule satisfied section 114(a)(3) because ``all [T]itle V operating
permits * * * include monitoring to assure compliance with the permit *
* * includ[ing] all existing monitoring requirements as well as
additional monitoring (generally referred to as `periodic monitoring')
if current requirements fail to specify appropriate monitoring.'' 62 FR
54,900, 54,904 (Oct. 22, 1997). Although the CAM rule alone did not
satisfy the section 114 requirement for enhanced monitoring at all
major sources, EPA argued that the CAM rule together with Title V
requirements for monitoring sufficient to assure compliance at all
major sources did satisfy section 114. If the EPA interprets its Title
V regulations such that they neither require nor authorize permitting
authorities to enhance existing monitoring requirements, EPA's
regulations will no longer satisfy section 114's requirement for
enhanced monitoring at all major sources.
    Response: We disagree with commenters that our interpretation of
Sec. Sec.  70.6(c)(1) and 71.6(c)(1) is inconsistent with the plain
language of the Act. Congress granted EPA broad discretion to decide
how to implement the title V monitoring requirements and the ``enhanced
monitoring'' requirement of section 114(a)(3) of the Act. Two
provisions of title V of the Act specifically address rulemaking
concerning development and implementation of monitoring for assuring
compliance with applicable emissions limitations. First, section
502(b)(2) of the Act requires EPA to promulgate regulations
establishing minimum requirements for operating permit programs,
including ``[m]onitoring and reporting requirements.'' Second, section
504(b) authorizes EPA to prescribe ``procedures and methods'' for
monitoring ``by rule.'' Section 504(b) specifically provides: ``The
Administrator may by rule prescribe procedures and methods for
determining compliance and for monitoring and analysis of pollutants
regulated under this Act, but continuous emissions monitoring need not
be required if alternative methods are available that provide
sufficiently reliable and timely information for determining compliance
* * *.''
    Other provisions of title V refer to the monitoring required in
individual operating permits. Section 504(c) of the Act, which contains
the most detailed statutory language concerning monitoring, requires
that ``[e]ach [title V permit] shall set forth inspection, entry,
monitoring, compliance certification, and reporting requirements to
assure compliance with the permit terms and conditions.'' Section
504(c) further specifies that ``[s]uch monitoring and reporting
requirements shall conform to any applicable regulation under [section
504(b)] * * *.'' Section 504(a) more generally requires that ``[e]ach
[title V permit] shall include enforceable emission limitations and
standards, * * * and such other conditions as are necessary to assure
compliance with applicable requirements of this Act, including the
requirements of the applicable implementation plan.'' The statutory
monitoring provisions, particularly section 504(c) which specifically
requires that monitoring contained in permits to assure compliance
``shall conform to any applicable regulation under [section 504(b)],''
clearly contemplate that monitoring in permits must reflect current
regulations.
    We disagree with commenters that the interpretation with regards to
parts 70 and 71 will eviscerate the States' abilities to issue permits
that include effective monitoring requirements. There are numerous
other means available and outlined in the Act, including the
development of effective and complete monitoring regulations included
in State implementation plans developed to implement the national
ambient air quality standards. Further, there are existing and
developing requirements for monitoring under federal rules such as new
source performance standards (NSPS) of 40 CFR part 60, national
emissions standards for hazardous air pollutants (NESHAP) of 40 CFR
parts 61 and 63, acid rain rules of 40 CFR parts 72 through 78, and the
compliance assurance monitoring rule of 40 CFR part 64.
    With respect to the effect of this interpretation on State
authority to address inadequate monitoring, we disagree that by
finalizing this interpretation of the operating permits regulations we
have limited or usurped the authority State agencies have to revise
their own regulations or conduct case-by-case monitoring reviews
pursuant to State authority.
    We agree with commenters that there may be some monitoring required
under existing applicable requirements that could be improved; however,
we believe a better interpretation of the Act provides that we revise
such monitoring through notice and comment rulemaking. For example, the
interpretation that part 70 is not the vehicle for making changes to
existing monitoring in no way prohibits the States from developing and
implementing regulations in the context of the Act that include
appropriate monitoring requirements to assure compliance with State
regulations such as rules implementing the national

ambient air quality standards (i.e., State Implementation Plans or
SIPs).
    We also are continuing to pursue the four-step strategy that we
described in the January 22, 2004 notice (69 FR 3202) including
improving existing monitoring where necessary through rulemaking
actions while reducing resource-intensive and poorly supported case-by-
case monitoring reviews. This clarifying interpretation of Sec. Sec.
70.6(c)(1) and 71.6(c)(1) is a first part of that strategy. A second
step included a notice published on February 16, 2005 (70 FR 7905), in
which we requested comment on potentially inadequate monitoring in
applicable requirements and on methods to improve such monitoring. We
are reviewing comments received in response to that notice and intend
to take appropriate action in response.
    A third element of that strategy is addressing the monitoring
required for implementation of the national ambient air quality
standard (NAAQS) for fine particulate matter (particulate matter with
an aerodynamic diameter of less than 2.5 micrometers,
PM2.5). In support of that final rule, we plan to issue
monitoring guidance that we will make available for public comment (see
proposal at 70 FR 65984, November 1, 2005). We intend that such
material would encourage States and Tribes to improve monitoring in
SIPs and TIPs relative to implementing the NAAQS. The last of the four
steps is to address requirements in existing rules that are not now
affected by 40 CFR part 64 (e.g., units with control measures other
than add-on devices) including potentially expanding the applicability
of part 64 and revising post-1990 NESHAP and NSPS. We agree and have
learned through implementing the operating permits and other regulatory
programs that there continue to be opportunities to improve monitoring
in existing requirements, achieve improved compliance, and assure
emissions reductions. We believe that the most effective route to
meeting these opportunities is through regulatory review and revisions,
as necessary. For example, recently published performance standards for
solid and hazardous waste incineration (70 FR 74870 and 70 FR 75348)
and commercial and industrial boilers (71 FR 9866) include not only
improved monitoring requirements relative to existing requirements but
also options for use of continuous emissions monitoring systems with
appropriate incentives.
    In sum, we believe that the plain language and structure of
Sec. Sec.  70.6(c)(1) and 71.6(c)(1) do not provide permitting
authorities an independent basis to perform case-by-case monitoring
reviews to resolve any such deficiencies. We believe that a
comprehensive regulatory development approach more accurately reflects
and is consistent with the Act's requirements for addressing improved
monitoring. Further response beyond what we note above regarding the
scope and effect of the periodic monitoring provisions of Sec. Sec.
70.6(a)(3)(i)(B) and 71.6(a)(3)(i)(B) is beyond the scope of the
proposal.
    C. The effect of the rule on previous permit decisions is not
minimal and resultant conditions should be removed from permits.
    Several commenters disagreed with the Agency's assertion that the
effect of this proposed interpretation would or should have minimal
effect on existing permits. One commenter recognized that EPA
acknowledges in this rulemaking that its responses relative to the
monitoring for the Pacificorp and Fort James Camas Mills facilities \2\
permit petitions were based on an improper interpretation of Sec.
70.6(c)(1). Further, the commenters disagreed with the Agency's
conclusion that this legal interpretation of the monitoring
requirements had a ``minimal'' effect on EPA's decisions relative to
those permits and hence ``follow-up activity with regard to the
Pacificorp or Fort James permits is unnecessary.'' The commenter
instead identified facility owners who believe that, in a number of
instances, the addition of monitoring terms by States have created
problems and should be revisited.
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    \2\ In the Matter of Pacificorp's Jim Bridger and Naughton
Electric Utility Steam Generating Plants, Petition No. VIII-00-1
(November 16, 2000) (Pacificorp) (available on the Internet at:
http://www.epa.gov/region07[fxsp0]/programs/artd/[fxsp0]air/title5/

[fxsp0]petitiondb/[fxsp0]petitions/[fxsp0]woc020.pdf), and
    In the Matter of Fort James Camas Mill, Petition No. X-1999-1
(December 22, 2000) (Fort James) (available on the Internet at:
http://www.epa.gov/region07/[fxsp0]programs/artd/[fxsp0]air/title5/

[fxsp0]petitiondb/[fxsp0]petitions/[fxsp0]fort--[fxsp0]james--
[fxsp0]decision1999.pdf).
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    Another commenter said that if EPA were to change the stringency of
monitoring without evaluating and revising the stringency of the
emission standards, this change could, by default, increase the
stringency of the underlying emissions standard. This is because the
stringency of an emissions standard is a function of an emission limit,
the method for measuring emissions, and the monitoring requirements
contained in the standard. Only by evaluating the monitoring in
conjunction with the underlying emissions limitations in the rule can
EPA assure that a control technology identified by the rule can meet a
standard. This is a particular issue under Sec.  70.6(c)(1) in which
there is no standard against which monitoring is to be judged and
little or no backstop against which a source can challenge the
imposition of overly stringent monitoring provisions in its permit.
Such an approach would effectively allow States to alter federally-
established emissions standards by changing the compliance method and
the manner in which compliance and violations of the Clean Air Act are
established, an authority Congress gave to EPA alone. Moreover,
additional monitoring could impose new substantive and potentially
costly requirements on sources ostensibly under the authority of Title
V. As stated in Sec.  70.1, Title V does not provide EPA or the States
with authority to create new substantive requirements which must be
established in the same context in order to assure that EPA and States
are not ``redefining'' compliance.
    Other commenters indicated that review and removal of these terms,
in some instances, will appreciably reduce the costs of the Title V
program, which the Title V Task Force recently observed cost many times
EPA's original cost estimates. Even with the administrative cost of
removing these terms, the commenters believed there will be a net
program benefit. One commenter asserted that EPA must state in the
final rulemaking that removal of new monitoring requirements including
recordkeeping and reporting that were added to permits pursuant to the
2002 and 1998 policies, which exceeded EPA's and the State authority in
the instance of the 1998 policy voided by the D.C. Circuit in
Appalachian Power, does not constitute ``backsliding.''
    Response: We disagree that all monitoring currently included in
individual permits that may be a result of an interpretation of Sec.
70.6(c)(1) or Sec.  71.6(c)(1) different than the proposed
interpretation must be removed. There are other authorities that allow
permitting authorities to revise monitoring that may or may not be
included in applicable rules. First, the gap-filling requirements of
the periodic monitoring provisions requires permitting authorities to
establish and include monitoring requirements in the permit where the
underlying requirement specifies no monitoring method, no frequency, or
only a one-time test. Second, some States have separate authority under
their existing State SIP regulations to revise existing monitoring
through the addition of permit conditions as necessary to assure
compliance with applicable requirements (e.g., State of Oregon Clean
Air Act Implementation Plan,

Operating and Maintenance Requirements, as adopted under OAR 340-200-
0040; New Jersey Department Of Environmental Protection, New Jersey
Administrative Code Title 7, Chapter 27, Subchapter 22, 7:27-22.9
Compliance plans, (c)2.i.). When other authority to require monitoring
exists, such monitoring may be retained (or revised as appropriate) in
the permit but the permitting authority would revise the statement of
the origin of and authority for the monitoring to reflect the proper
legal authority, consistent with Sec. Sec.  70.6(a)(1)(i) and
71.6(a)(1)(i) at an appropriate time. Also, when such monitoring is
independently required solely by a State-only enforceable regulation,
the monitoring would remain, but the permit would be revised to
designate the monitoring as a non-federal requirement from a
enforcement perspective, consistent with Sec. Sec.  70.6(b)(2) and
71.6(b)(2).
    Any source may apply for a modification of its permit to remove
permit terms and conditions for monitoring included in the permit
pursuant to an inappropriate interpretation of Sec.  70.6(c)(1) or
Sec.  71.6(c)(1) (or an inappropriate interpretation of Sec.
70.6(a)(3)(i)(B), such as the one set forth in the periodic monitoring
guidance subsequently vacated by Appalachian Power Co. v. EPA, 208 F.3d
1015 (D.C. Cir. 2000)). A source may limit the scope of its permit
modification application to those monitoring conditions it believes are
affected by this rule. EPA encourages States to review such
applications carefully and expeditiously (without expanding the scope
of the modification). EPA believes that such modification is
appropriate and permitting authorities should remove permit terms and
conditions for monitoring where such monitoring was imposed pursuant to
Sec.  70.6(c)(1) and such monitoring is not justified under other legal
authority.
    Under the current parts 70 and 71 rules, changes such as removing
existing monitoring, recordkeeping, and reporting are generally
designated significant modifications. Further, any changes that would
result in less stringent monitoring in a permit would most typically be
treated as significant modifications by States. (See Sec.  70.7(e)(2)
and (e)(4).) Finally, in the event EPA is specifically required to
review monitoring in a permit, for example, in the context of permit
renewal or significant modification requests, we would have to ensure
that such change conforms to all sections of the parts 70 and 71 rules
and interpretations in effect at that time.
    In the specific cases of the Pacificorp and Fort James citizen
petitions, we noted in the preamble to the proposed interpretation that
we believe that the decisions had minimal effect on compliance for
these two facilities. In the former instance, while we acknowledge that
EPA would not have been authorized to require additional monitoring
under this interpretation of Sec. Sec.  70.6(c)(1) and 71.6(c)(1), we
required an already-required continuous opacity monitoring system
(COMS) to provide opacity data in lieu of quarterly Method 9 visible
opacity readings. We note that the owners or operators would have to
collect the COMS data in any case and report any excursions or excess
emissions as other information available as part of the semiannual
reporting requirement (Sec.  70.6(a)(3)(iii)(A)) and the annual
compliance certification. In the latter instance, we relied on the
authority under the periodic monitoring rule (Sec. Sec.  70.6(a)(3) and
71.6(a)(3)) to specify a frequency for an inspection in which there was
no frequency of monitoring specified in the standard. In neither case
did the decision change the stringency of the applicable requirement in
averaging time or the applicable emissions limit.
    We recognize and agree with the need to establish monitoring and
testing requirements consistent with the intended compliance
obligations. Part 64, for example, provides for such assessment and
associated flexibility in monitoring selection on a case-by-case basis
with a carefully constructed process that includes site-specific field
testing and documentation to verify that the monitoring data will
provide a reasonable assurance of compliance with the existing
applicable requirement. In the established EPA regulatory development
process (e.g., new and revised NSPS and NESHAP rules), we assess the
availability of data and monitoring technology for establishing ongoing
compliance obligations and evaluate cost and benefit implications and
the application of various monitoring technologies. We believe that
this approach is correct and consistent with the intent of the Act,
sections 504(b) and (c), in developing and implementing monitoring
requirements. On the other hand, the question of whether the stringency
of existing emissions limits were changed by earlier case-by-case
decisions about monitoring in preparing operating permits is not
relevant to the issue of the authority to require such monitoring and
not within the scope of this action.
    D. The authority for the permitting authorities to fill periodic
monitoring gaps should be reinstated.
    Several commenters observed that the rule eliminated the authority
of State and local agencies to include so-called ``gap-filling
monitoring'' in permits in situations in which applicable requirements
contain monitoring provisions, but such provisions are inadequate. The
commenters said that EPA should reconsider reinstating the ability of
the State and local agencies to include ``gap-filling monitoring'' in
Title V permits in the meantime.
    One commenter offered that finalization of that proposal will not
affect the authority and obligation of State and local permitting
authorities with approved part 70 operating permit programs to continue
to require such supplemental, enhanced monitoring. The commenter
asserted that the new interpretation that EPA proposes was not the
agency's interpretation when EPA acted on part 70 program approvals for
State and local permitting authorities. Nor is it the interpretation
that EPA has held over the course of implementing the part 70 permit
program since such initial approvals, as indicated in part by the
agency objection letters and orders responding to Title V petitions,
discussed above. Instead, the commenter contends, EPA's proposed new
interpretation is a direct contradiction and refutation of EPA's
longstanding interpretation, the opposite of that interpretation. The
commenter suggested that the provisions of the permit programs approved
prior to this latest interpretation will continue to govern permit
monitoring decisions despite the final dispensation of the proposal,
unless and until: (1) State, local and tribal permitting authorities
choose to undertake rulemaking to change their more rigorous permitting
authorities and practices, and weaken them by adopting EPA's new
interpretation as a matter of State or local law; (2) EPA receives
revised program submittals from State or local authorities, and issues
proposed federal rulemakings to revise the previously approved State or
local program for purposes of federal law, complete with notice and
comment and opportunity for public hearing; and (3) EPA finalizes the
proposed program revisions to codify the State or local's revised,
weaker practice as a matter of federal law.
    Another commenter said that by prohibiting States from enhancing
the monitoring established in existing rules and SIPs, EPA is not only
usurping States' authority to carry out their programs, but preventing
the opportunity for States to devise innovative and creative approaches
to compliance monitoring where

something beyond existing requirements exists. A commenter indicated
that withdrawing the proposed interpretation and reinstating the States
authority to impose new monitoring are necessary to ensure the health
and safety of adjacent communities, to protect or further maintenance
of the National Ambient Air Quality Standards, and to ensure that
sources are required to correct compliance problems in a timely manner.
    Response: We reassert that the authority in Sec. Sec.
70.6(a)(3)(i)(B) and 71.6(a)(3)(i)(B) to fill gaps in existing
regulations with new periodic monitoring remains unaffected by this
proposed interpretation. We disagree with commenters that our
interpretation of Sec. Sec.  70.6(c)(1) and 71.6(c)(1) is inconsistent
with the plain language of the Act, as discussed in detail above.
Consistent with the broad authority the Act provides, we interpret
these regulatory sections, as the rules are written, as not providing
an authority to require permitting authorities to assess and revise
existing monitoring requirements independent of the periodic monitoring
requirements. In short, we have determined that other regulatory
avenues (e.g., revising existing EPA rules with inadequate monitoring,
expanding applicability of part 64, and providing guidance for
implementing the PM2.5 NAAQS) would be a more effective
policy approach. We also disagree with the commenter that previously
approved State and local permitting programs will have to be revised in
response to this action. State and local permitting authorities are
required to conduct approved title V permitting programs in accordance
with the requirements of 40 CFR part 70 and any agreement between the
permitting authority and EPA concerning operation of the program. As
evident by this action, we have determined that Sec. Sec.  70.6(c)(1)
and 71.6(c)(1) do not require or authorize State/local/Tribal
permitting authorities to review and revise existing monitoring
requirements in operating permits.
    E. Existing monitoring requirements in current rules are inadequate
and case-by-case review and revision are necessary.
    Several commenters suggested that while many rules include
comprehensive and modern monitoring requirements, others do not.
Commenters provided substantive and detailed comments and declarations
previously submitted (in response to the February 16, 2005, notice, 70
FR 7905) to the Agency to support their contention that many existing
federal regulatory monitoring requirements are insufficient to assure
compliance. Additionally, commenters noted that many sources are not
covered by updated NSPS or NESHAP rules that are intended to fill those
gaps. Where updated and complete monitoring requirements already exist
in federal or State rules, commenters believed that States are unlikely
to consider that more rigorous monitoring is necessary. But where
monitoring in existing rules is not sufficient, State permitting
authorities are much better suited than the EPA to understand
individual sources, their unique compliance histories and challenges,
and to fashion reasonable monitoring requirements that will assure the
public, the source, and the permitting authority of the source's
ongoing compliance. By prohibiting States from enhancing the monitoring
established in existing rules and SIPs, the commenter believed EPA is
not only usurping States' authority to carry out their programs, but
preventing the opportunity for States to devise innovative and creative
approaches to compliance monitoring where something beyond existing
requirements exists.
    Another commenter noted that, regardless of federal requirements on
gap filling, States independently have authority to gap-fill if they
include such provisions in their rules. The commenter said that EPA can
not attempt to limit State authority with this rulemaking. The
commenter cites EPA assertions that improvements to monitoring through
federal or State rulemakings (by amending the monitoring provisions of
applicable requirements themselves) will avoid time spent in case-by-
case sufficiency monitoring reviews in Operating Permits. The commenter
also agreed EPA should improve the monitoring, recordkeeping, and
reporting requirements in many of its rules; but disagree that this
should substitute for independent authority to add monitoring and
recordkeeping requirements on a case-by-case basis.
    Response: While we agree that there may be examples of inadequate
monitoring in existing rules, the proposed interpretation is about the
appropriate regulatory means to address those instances. The comments
providing examples of inadequate monitoring are not responsive to the
proposal. As noted above, with respect to the effect of this
interpretation on State authority to address inadequate monitoring, we
disagree that by finalizing this interpretation of the operating
permits regulations we have limited or usurped the authority State
agencies have to revise their own regulations or conduct case-by-case
monitoring reviews pursuant to State authority.
    As we have stated previously, the interpretation that part 70 is
not the appropriate vehicle for making changes to existing monitoring,
other than to apply periodic monitoring to fill gaps in regulations.
Further, the interpretation in no way prohibits the States from
developing regulations that include appropriate monitoring requirements
to assure compliance with State regulations such as SIPs. Likewise,
this interpretation does not prohibit a permitting authority from
implementing other State rule provisions including revising monitoring
in existing rules through the permitting process to assure compliance
with State regulations such as SIPs. We certainly encourage States to
act through regulatory development or other means to apply monitoring
as needed to assure ongoing compliance with State regulations. To the
extent that States have authority under State law to perform case-by-
case monitoring reviews and issue permits including additional
monitoring, such monitoring should be included on the ``State-only''
side of the permit. We agree that EPA regulations must include
monitoring sufficient to assure compliance and, as indicated above, we
believe that the most effective route to effect this policy is for us
to continue to improve such requirements by conducting additional
rulemakings.
    F. The Agency should provide further clarification or regulatory
action on the effect of monitoring policies on enforcement.
    One commenter requested some discussion from EPA concerning
existing permits which contain monitoring requirements created prior to
this interpretation of Sec. Sec.  70.6(c)(1) and 71.6(c)(1) and have
resulted in reported deviations from those permit conditions. Since EPA
interpretations are being reversed, the commenter asked whether
deviations from monitoring conditions set, without the legal standing
of established rulemaking processes following existing statutes and
regulations, would also be affected. Another commenter indicated that
reading Title V as imposing some new criterion for enforceability on
existing emissions standards beyond what Congress directed in section
114(a)(3) would be inconsistent with existing statutory requirements.
This commenter also cited examples for which use of a different test
method or procedure can lead to fundamental differences in results, due
to differences in analytical method, data reduction, or measurement
location. Even if the specified (or a

comparable) method is used, testing under conditions different from, or
conducted more frequently than, the testing considered in setting the
standard can reveal operating variability that was unknown or ignored
when the standard was set. In short, the commenter noted that changing
the method of measuring compliance with an emissions limitation can
affect the stringency of the limitation itself.
    The same commenter outlined how use of the specified method is also
often necessary to preserve assumptions regarding cost. Accordingly,
where emissions standards are subject to specific statutory criteria
and regulatory review requirements, any revision to those standards
must be accompanied by an evaluation of the revised standard, using
specified administrative procedures, to ensure its consistency with
statutory and regulatory review criteria. For example, when EPA or a
State identifies a control technology under the criteria for a
particular standard (e.g., identifies BDT for a particular NSPS), a
revision to that standard (including specification of a new compliance
method) is valid only if data show that the revised standard also can
be reliably and consistently achieved with the original control
technology. Even if achievability of the standard is not in question,
the commenter noted, substitution of one compliance method for another
is a substantive change that requires consideration of a number of
factors, including the cost of that change.
    Response: As noted above, the question of whether the stringency of
existing emissions limits were changed by earlier case-by-case
decisions about monitoring in preparing operating permits is not
relevant to the issue of the authority to require such monitoring and
not within the scope of this action. That is, whether Sec. Sec.
70.6(c)(1) and 71.6(c)(1) authorize permitting authorities to assess or
revise existing monitoring requirements different from assessment and
revision under other regulations has no bearing on a source's
compliance obligation under the applicable emissions limitation. The
proposed interpretation addresses only whether part 70 or 71 is a
proper vehicle for assessment and adjustment to existing monitoring
requirements beyond other requirements for assessing or revising
monitoring that may be required under Sec. Sec.  70.6(a)(3)(i) and
71.6(a)(3)(i) or other regulations.
    We disagree with commenters on the need to limit use of any data
collected with monitoring that might be a result of a misinterpretation
of the rule. To the extent that there are questions about whether data
from monitoring developed under a previous interpretation are relevant
to a compliance or enforcement decision, case-by-case review of any
actions based on specific permit conditions would be more effective and
appropriate. We believe that these situations will be very few in
number.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), we must
determine whether a regulatory action is ``significant'' and therefore
subject to Office of Management and Budget (OMB) review and the
requirements of the Executive Order. The Order defines a ``significant
regulatory action'' as one that is likely to result in a rule that may:
    1. Have an annual effect on the economy of $100 million or more,
adversely affecting in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety in State, local, or tribal governments or communities;
    2. Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    3. Materially alter the budgetary impact of entitlement, grants,
user fees, or loan programs of the rights and obligations of recipients
thereof; or
    4. Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    Under Executive Order 12866, it has been determined that this
interpretative rule is a ``significant regulatory action'' because it
raises important legal and policy issues. As such, we submitted this
rule to OMB for review. Changes made in response to OMB suggestions or
recommendations will be documented in the public record.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
This action merely states that notwithstanding the recitation in
Sec. Sec.  70.6(c)(1) and 71.6(c)(1) of monitoring as a permit element,
these provisions do not establish a separate regulatory standard or
basis for requiring or authorizing review and revision of existing
monitoring independent of any review and revision as may be required
under Sec. Sec.  70.6(a)(3) and 71.6(a)(3). The information collection
requirements in the existing regulations (parts 70 and 71) were
previously approved by OMB under the requirements of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. The existing ICR for part 70 is
assigned EPA ICR number 1587.06 and OMB control number 2060-0243; for
part 71, the EPA ICR number is 1713.05 and the OMB control number is
2060-0336. A copy of the OMB approved Information Collection Request
(ICR) may be obtained from Susan Auby, Collection Strategies Division;
U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave.,
NW., Washington, DC 20004 or by calling<PHONE_NUMBER>.
    Under the Paperwork Reduction Act, burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an Agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute, unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small not-for-profit enterprises, and small governmental jurisdictions.
    For purposes of assessing the impacts of this action on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration by category of business using the
North American Industrial Classification System (NAICS) and codified at
13 CFR 121.201; (2) a small governmental jurisdiction that is a
government of a city, country, town, school district, or special
district with a

population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of this final rule on small
entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The
originally promulgated part 70 and part 71 rules included the text of
Sec. Sec.  70.6(c)(1) and 71.6(c)(1), and this interpretation does not
revise that text. Moreover, any burdens associated with the
interpretation of Sec. Sec.  70.6(c)(1) and 71.6(c)(1) as described in
this action are less than those associated with any interpretation
under the rule and that we may have previously enunciated.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
must prepare a written statement, including a cost-benefit analysis,
for proposed and final rules with ``federal mandates'' that may result
in expenditures to State, local, and tribal governments, in the
aggregate, or to the private sector, of $100 million or more in any one
year. Before promulgating a rule for which a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least-costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply where they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least-
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, EPA must have developed under section 203 of the UMRA a
small government agency plan. The plan must provide for notifying
potentially affected small governments, enabling officials of affected
small governments to have meaningful and timely input in the
development of our regulatory proposals with significant federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
    This action contains no new federal mandates (under the regulatory
provisions of title II of the UMRA) for State, local, or tribal
governments or the private sector. This action imposes no new
enforceable duty on any State, local or tribal governments or the
private sector. Rather, EPA merely states that Sec. Sec.  70.6(c)(1)
and 71.6(c)(1) do not establish a separate regulatory standard or basis
for requiring or authorizing review and revision of existing
monitoring, independent of any review and revision as may be required
under the periodic monitoring rules, Sec. Sec.  70.6(a)(3) and
71.6(a)(3). Therefore, this action is not subject to the requirements
of sections 202 and 205 of the UMRA.
    In addition, EPA has determined that this action contains no new
regulatory requirements that might significantly or uniquely affect
small governments. With this action, EPA sets out the correct
interpretation of Sec. Sec.  70.6(c)(1) and 71.6(c)(1), which is that
they do not require or authorize title V permitting authorities--
including any small governments that may be such permitting
authorities--to conduct reviews of and revise existing monitoring
through case-by-case monitoring reviews of individual permits under
Sec. Sec.  70.6(c)(1) and 71.6(c)(1). Therefore, this action is not
subject to the requirements of section 203 of the UMRA.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This action does not have any new federalism implications. The
action will not have new substantial direct effects on the States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132. This
interpretation will not impose any new requirements. Accordingly, it
will not alter the overall relationship or distribution of powers
between governments for the part 70 and part 71 operating permits
programs. Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments'' (65 FR 67249, November 6, 2000), requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.''
    This action does not have new tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
This action does not significantly or uniquely affect the communities
of Indian tribal governments. As discussed above, this action imposes
no new requirements that would impose compliance burdens beyond those
that would already apply. Accordingly, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    This action is not subject to Executive Order 13045 because it is
not

``economically significant'' as defined under Executive Order 12866 and
because it is not expected to have a disproportionate effect on
children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not a ``significant energy action,'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001), because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy. This
action merely finalizes that these provisions in parts 70 and 71 do not
establish a separate regulatory standard or basis for requiring or
authorizing review and revision of existing monitoring independent of
any review and revision of monitoring as may be required under
Sec. Sec.  70.6(a)(3) and 71.6(a)(3). Further, we have concluded that
this action is not likely to have any adverse energy effects.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note),
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    The NTTAA does not apply to this action because it does not involve
technical standards. Therefore, EPA did not consider the use of any
voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898, ''Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (February
11, 1994), is designed to address the environmental and human health
conditions of minority and low-income populations. EPA is committed to
addressing environmental justice concerns and has assumed a leadership
role in environmental justice initiatives to enhance environmental
quality for all citizens of the United States. The Agency's goals are
to ensure that no segment of the population, regardless of race, color,
national origin, income, or net worth bears disproportionately high and
adverse human health and environmental impacts as a result of EPA's
policies, programs, and activities. Our goal is to ensure that all
citizens live in clean and sustainable communities. This action merely
finalizes an interpretation of an existing rule and includes no changes
that are expected to significantly or disproportionately impact
environmental justice communities.

K. Congressional Review Act

    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 the
final rule amendments and other required information to the United
States Senate, the United States House of Representatives, and the
Comptroller General of the United States prior to publication of the
final 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). The final
rule will be effective on January 16, 2007.

    Dated: December 11, 2006.
Stephen L. Johnson,
Administrator.
 [FR Doc. E6-21427 Filed 12-14-06; 8:45 am]

BILLING CODE 6560-50-P


Statement of the Air and Radiation Management Administration

Maryland Department of the Environment

	For the Public Hearing Concerning the

Baltimore Nonattainment Area 8-Hour Ozone State Implementation Plan and
Base Year Inventory

Held on May 22, 2007

Good evening. My name is James Wilkinson.  I am a Planner in the Air
Quality Planning Division, Air Quality Planning Program of the Air &
Radiation Management Administration, Maryland Department of Environment.

This public hearing is related to the air quality plan titled the
Baltimore Nonattainment Area 8-Hour Ozone State Implementation Plan and
Base Year Inventory.

This public hearing is being held pursuant to federal law found at 42 U.
S. C. § 7410(a) and 40 CFR Parts 51.102 and 251. It is also being held
in conformance with the State Administrative Procedure Act, under the
State Government Article, beginning at Section 10-101.

Notice of this public hearing appeared in the:

Baltimore Sun on April 23, 2007

The Examiner Newspaper on April 21, 2007

Maryland Department of the Environment website starting on March 15,
2007

Copies of these notices will be submitted with the formal SIP submission
package to the USEPA.

Access to the proposed document was made available via the website of
the Maryland Department of the Environment.  Hard copies were also
available at the Maryland Department of the Environment.

The purpose of this hearing is to provide the public with an opportunity
to formally comment on the proposed document.

Summary of Proposed State Implementation Plan

High levels of ozone are a health problem. When it is breathed into the
lungs, ozone reacts with lung tissue. It can harm breathing passages,
decrease the lungs’ working ability and cause coughing and chest
pains; eye and throat irritation; breathing difficulties even for
healthy individuals, but especially for those with respiratory problems
such as allergies, asthma, bronchitis and emphysema; and greater
susceptibility to respiratory infection.

In 1997 EPA issued a revised ozone health standard based on an 8-hour
measurement to protect against longer exposure periods. Since the late
1980’s more than 3,000 published health studies indicated that health
effects occur at levels lower than the previous standard and that
exposure times longer than one hour are of concern.

EPA designated the Baltimore region as a moderate nonattainment area for
the 8-hour ozone standard in April 2004. The region has a deadline of
June 15, 2010, to meet the 8-hour ozone standard.  The geographic scope
of the region includes the following Maryland counties and
jurisdictions: Anne Arundel, Baltimore, Baltimore City, Carroll,
Harford, and Howard.

This document, the Baltimore Nonattainment Area 8-Hour Ozone State
Implementation Plan and Base Year Inventory, is a plan to improve air
quality in the Baltimore nonattainment area to meet the National Ambient
Air Quality Standard (NAAQS) for the 8-hour ozone standard. The Plan
consists of a Reasonable Further Progress Plan; an attainment plan; an
analysis of reasonably available control measures; an attainment
demonstration; contingency plans, and mobile emissions budgets. The plan
also presents a Base-Year Emissions Inventory for 2002 and projected
emissions inventories used to predict attainment.

Based upon all of the components prepared for this SIP document
including the significant technical analysis and air quality modeling
performed for the region there is a dramatic weight of evidence
available that shows the region will meet the 8-hour ozone standard
during the 2009 ozone season.

CONSIDERATION OF COMMENTS

The Department will consider all pertinent comments, and revise the
proposed plan if necessary, before making a final decision to adopt the
plan and submit it to the U.S. Environmental Protection Agency for
approval as a Maryland State Implementation Plan (SIP).  Written
comments may be presented at this hearing or mailed to Brian Hug, MDE
ARMA, 1800 Washington Boulevard, Baltimore MD 21230 postmarked no later
than May 22, 2007.

 PAGE

 PAGE   1


[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Pages 18371-18373]
[FR Doc No: 2022-06661]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0280]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Financial Disclosure
by Clinical Investigators

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by April 29, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0396. Also include the FDA docket
number found in brackets in the heading of this document.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Financial Disclosure by Clinical Investigators

OMB Control Number 0910-0396--Extension

    Respondents to this collection are sponsors of marketing
applications that contain clinical data from studies covered by the
regulations. These sponsors represent pharmaceutical, biologic, and
medical device firms. Respondents are also clinical investigators who
provide financial information to the sponsors of marketing
applications.
    In the Federal Register of December 2, 2021 (86 FR 68500), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
    Table 1 shows information that is the basis of the estimated number
of respondents in tables 2 through 4.

 Table 1--Estimated Number of Applications, Clinical Trials, and Investigators Subject to the Regulation by Type
                                               of Application \1\
----------------------------------------------------------------------------------------------------------------
                                   Total number      Number of
        Application type                of         applications      Number of trials            Number of
                                   applications      affected                                  investigators
----------------------------------------------------------------------------------------------------------------
Drugs:
    New drug application (NDA),               55              55  3 to 10...............  3 to 100.
     new molecular entity (NME).
    NDA non-NME.................              78              37  3 to 10...............  3 to 100.
    NDA efficacy supplement.....             196             119  1 to 3................  10 to 30.
    Abbreviated new drug                     821               1  1.1...................  2.
     application (ANDA).
    ANDA supplement.............          10,894               1  1.....................  2.
CBER Biologics:
    Biologics license                         10              10  3 to 10...............  3 to 100.
     application (BLA).
    BLA efficacy supplement.....              30              30  1 to 3................  10 to 30.
CDER Biologics:

    BLAs........................              25              25  3 to 10...............  3 to 100.
    BLA efficacy supplements....             102              65  1 to 3................  10 to 30.
Medical Devices:
    Premarket approval (PMA)....              39              39  1 to 31...............  10 to 20.
    PMA supplement..............              29              29  1 to 3................  3 to 10.
    Reclassification devices....               0               0  0.....................  0.
    510(k)......................           3,947             247  1.....................  3 to 10.
    De Novo requests............              63              57  1 to 3................  10 to 20.
----------------------------------------------------------------------------------------------------------------
\1\ Source: Agency estimates.

    FDA estimates the burden of this collection of information as
follows:

Reporting Burden

    Under Sec.  54.4(a) (21 CFR 54.4(a)), applicants submitting an
application that relies on clinical studies must submit a complete list
of clinical investigators who participated in a covered clinical study,
and must either certify to the absence of certain financial
arrangements with clinical investigators (Form FDA 3454) or, under
Sec.  54.4(a)(3), disclose to FDA the nature of those arrangements and
the steps taken by the applicant or sponsor to minimize the potential
for bias (Form FDA 3455).
    FDA estimates that almost all applicants submit a certification
statement under Sec.  54.4(a)(1) and (2). Preparation of the statement
using Form FDA 3454 should require no more than 1 hour per study. The
number of respondents is based on the estimated number of affected
applications.
    When certification is not possible and disclosure is made using
Form FDA 3455, the applicant must describe, under Sec.  54.4(a)(3), the
financial arrangements or interests and the steps that were taken to
minimize the potential for bias in the affected study. As the applicant
would be fully aware of those arrangements and the steps taken to
address them, describing them will be straightforward. The Agency
estimates that it will take about 5 hours to prepare this narrative.
Based on our experience with this collection, FDA estimates that
approximately 10 percent of the respondents with affected applications
will submit disclosure statements.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Certification--54.4(a)(1) and                715               1             715               1             715
 (2)--Form FDA 3454.............
Disclosure--54.4(a)(3)--Form FDA              72               1              72               5             360
 3455...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,075
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

Recordkeeping Burden

    Under Sec.  54.6 (21 CFR 54.6), the sponsors of covered studies
must maintain complete records of compensation agreements with any
compensation paid to nonemployee clinical investigators, including
information showing any financial interests held by the clinical
investigator, for 2 years after the date of approval of the
applications. Sponsors of covered studies maintain many records
regarding clinical investigators, including protocol agreements and
investigator r[eacute]sum[eacute]s or curriculum vitae. FDA estimates
than an average of 15 minutes will be required for each recordkeeper to
add this record to the clinical investigators' file.

                                                   Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                           21 CFR section                               Number of       records per      Total annual         per        Total hours \2\
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping--54.6................................................             715                1              715             0.25              179
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

Third-Party Disclosure Burden

    Under Sec.  54.4(b), clinical investigators supply to the sponsor
of a covered study financial information sufficient to allow the
sponsor to submit complete and accurate certification or disclosure
statements. Clinical investigators are accustomed to supplying such
information when applying for research grants. Also, most people know
the financial holdings of their immediate family, and records of such
interests are generally accessible because they are needed for
preparing tax records. For these reasons, FDA estimates that the

time required for this task may range from 5 to 15 minutes; we used the
median, 10 minutes, for the average burden per disclosure (see table
1).

                                                Table 4--Estimated Annual Third-Party Disclosure Burden1
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           21 CFR section                               Number of     disclosures per    Total annual    Average burden  Total hours \2\
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
54.4(b)--Clinical Investigators....................................          13,082                1           13,082             0.17            2,224
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    The burden for this information collection request has changed
since the last OMB approval. Our estimated burden for the information
collection reflects a 298 hour increase. We have adjusted our estimated
burden for the information collection to reflect the number of
submissions we received in the last few years. Additionally, for
products regulated by the Center for Devices and Radiological Health,
we now include De Novo requests as a type of application that may rely
on clinical studies. Upon review, we have corrected an inadvertent
omission regarding the number of BLAs and BLA efficacy supplements
received by our Center for Drug Evaluation and Research and used, in
part, as a basis for calculating the cumulative burden estimate. We
have corrected that error here, as reflected in table 1.

    Dated: March 24, 2022.
Andi Lipstein Fristedt,
Deputy Commissioner for Policy, Legislation, and International Affairs,
U.S. Food and Drug Administration.
[FR Doc. 2022-06661 Filed 3-29-22; 8:45 am]
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[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40316-40317]
[FR Doc No: 2016-14551]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2335]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XOFIGO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XOFIGO and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
22, 2016. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 19, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2014-E-2335 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; XOFIGO.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product XOFIGO
(radium 223 dichloride). XOFIGO is indicated for treatment of patients
with castration-resistant prostate cancer, symptomatic bone metastases
and no known visceral metastatic disease. Subsequent to this approval,
the USPTO received a patent term restoration application for XOFIGO
(U.S. Patent No. 6,635,234) from Algeta ASA, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated March 19, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of XOFIGO represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
XOFIGO is 1,945 days. Of this time, 1,792 days occurred during the
testing phase of the regulatory review period, while 153 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 19, 2008. Algeta ASA claims that February 21, 2008,
is the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was January 19, 2008, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
14, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for XOFIGO (NDA 203971) was initially submitted on
December 14, 2012.
    3. The date the application was approved: May 15, 2013. FDA has
verified the applicant's claim that NDA 203971 was approved on May 15,
2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,032 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Submit petitions electronically to http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14551 Filed 6-20-16; 8:45 am]
 BILLING CODE 4164-01-P