[Federal Register Volume 78, Number 31 (Thursday, February 14, 2013)]
[Rules and Regulations]
[Pages 10538-10546]
[FR Doc No: 2013-03456]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-OPP-2010-0785; FRL-9353-4]
RIN 2070-AJ76

Protections for Subjects in Human Research Involving Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing narrowly tailored amendments to the portions
of its rules for the protection of human subjects of research applying
to third parties who conduct or support research with pesticides
involving intentional exposure of human subjects and to persons who
submit the results of human research with pesticides to EPA. The
amendments broaden the applicability of the rules to cover human
testing with pesticides submitted to EPA under any regulatory statute
it administers. The amendments also disallow participation in third-
party pesticide studies by subjects who cannot consent for themselves.
Finally, the amendments identify specific considerations to be
addressed in EPA science and ethics reviews of proposed and completed
human research with pesticides, drawn from the recommendations of the
National Academy of Sciences (NAS). The amendments make no changes to
the current Federal Policy for the Protection of Human Subjects (the
``Common Rule''), which governs research with human subjects conducted
or supported by EPA and many other Federal departments and agencies.

DATES: This rule is effective April 15, 2013.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2010-0785, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in the EPA West
Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001.
The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
OPP Docket is<PHONE_NUMBER>. Please review the visitor instructions
and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Kelly Sherman, Immediate Office of the
Director (7501P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you conduct or
sponsor research that may be submitted to EPA and which involves
intentional exposure of human subjects. The following list of North
American Industrial Classification System (NAICS) codes is not intended
to be exhaustive, but rather provides a guide to help readers determine
whether this document might apply to them. Although EPA has in the past
received such third-party research from pesticide registrants, other
entities could submit such information to EPA.
     Pesticide and other Agricultural Chemical Manufacturing
(NAICS code 325320) who sponsor or conduct human research with
pesticides.
     Other entities (NAICS code 541710) that sponsor or conduct
human research with pesticides, and Institutional Review Boards (IRBs)
who review human research with pesticides to ensure it meets applicable
standards of ethical conduct. Under these new provisions, EPA must
consider the ethical aspects and scientific validity and reliability of
research in a manner that is consistent with the requirements of the
Common Rule as codified in 40 CFR part 26, subpart A. The ``Common
Rule'' is the name generally used to refer to the Federal Policy for
the Protection of Human Subjects, which governs research with human
subjects conducted or supported by EPA and many other Federal
departments and agencies. EPA's codification of the Common Rule appears
as subpart A in 40 CFR part 26.

B. What action is the agency taking?

    The amendments contained in this final rule change the 2006 rule,
published in the Federal Register issue of February 6, 2006 (71 FR
6138) (FRL-7759-8), subsequently amended in the Federal Register issue
of June 23, 2006 (71 FR 36171) (FRL-8071-6), and codified at 40 CFR
part 26, in the following substantive respects:
     By broadening the applicability of 40 CFR part 26,
subparts K, L, M, and Q, so these subparts would apply not only to
research submitted to or considered by EPA under the pesticide

laws, but also to research involving a ``pesticide'' (as defined in the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.
136(u)) which is submitted to or considered by EPA under any other
regulatory statute it administers.
     By incorporating the definition of ``pesticide'' from
FIFRA, as a substance or mixture of substances intended for pesticidal
effect.
     By deleting from 40 CFR part 26, subpart K, all references
to consent on behalf of a subject in research involving intentional
exposure to a pesticide by a subject's ``legally authorized
representative.''
     By incorporating into 40 CFR part 26, subparts P and Q,
factors to be considered by EPA and the Human Studies Review Board
(HSRB), in their review of proposed and completed human research,
derived from the recommendations by the National Research Council of
NAS in its 2004 Report entitled ``Intentional Human Dosing Studies for
EPA Regulatory Purposes: Scientific and Ethical Issues'' (hereafter,
2004 NAS Report) to EPA.

C. What is the agency's authority for taking this action?

    Sections 3(a) and 25(a) of FIFRA (7 U.S.C. 136a(a) and 136w(a)) and
section 408(e)(1)(C) of the Federal Food, Drug, and Cosmetic Act
(FFDCA) (21 U.S.C. 364a(e)(1)(C)), provide the legal authority for
these amendments to the 2006 rule on human research.

D. What are the incremental costs and benefits of this action?

    The incremental costs of these amendments both to industry and to
EPA are expected to be negligible. EPA has not, therefore, prepared a
new economic analysis for this rule. Because no research has been
identified that is outside the scope of the 2006 rule but that would be
within the scope of these amendments, EPA has no basis on which to
revise the cost estimates that were provided in the economic analysis
for the 2006 rule or those most recently provided in the 2008 renewal
of the Information Collection Request (ICR) for the existing regulation
at 40 CFR part 26. The estimates included in the ICR are summarized in
Unit VI.B. and a copy of the ICR is available in the docket.

II. Background

A. EPA's 2006 Rule

    As required by section 201 of the Department of the Interior,
Environment, and Related Agencies Appropriations Act, 2006 (2006
Appropriations Act), Public Law 109-54, 119 Stat. 531, EPA promulgated
a rule in 2006 establishing a set of protections for people
participating as subjects in third-party human research with pesticides
in 40 CFR part 26. (In this context ``third-party'' research is
research neither conducted (``first-party'') nor supported (``second-
party'') by EPA or another Common Rule Federal department or agency.)
The 2006 rule prohibits EPA from relying on third-party research on
pesticides involving intentional exposure of children or of pregnant or
nursing women, unless relying on the data is crucial to a decision that
would impose a more stringent regulatory restriction that would improve
protection of public health than could be justified without relying on
the data. It further forbids EPA itself to conduct or support any
research involving intentional exposure of pregnant or nursing women or
of children to any substance.

B. Petition for Review of the 2006 Rule and Settlement Agreement

    In early 2006, the Natural Resources Defense Council, Inc.;
Pesticide Action Network North American; Pineros y Campesinos Unido Del
Noroeste; Physicians for Social Responsibility-San Francisco; Farm
Labor Organizing Committee; ALF-CIO; and Migrant Clinicians Network
petitioned for review of the 2006 rule in the United States Court of
Appeals for the Second Circuit (Second Circuit Court of Appeals) (NRDC
v. EPA, No. 06-0820-ag (2d Cir.)). The Petitioners argued that the 2006
rule violated the 2006 Appropriations Act because it did not bar all
pesticide research with pregnant women and children, was inconsistent
with the 2004 NAS Report, and was inconsistent with the Nuremburg Code.
    After briefing and argument, but before a decision was rendered by
the Second Circuit Court of Appeals, EPA and Petitioners entered a
settlement agreement in which EPA agreed to conduct notice-and-comment
rulemaking on the issue of whether the 2006 rule should be amended. EPA
also agreed to propose, at a minimum, amendments to the 2006 rule that
were substantially consistent with language negotiated between the
parties and attached to the settlement agreement as Exhibit A. This
agreement, including Exhibit A, is available in the docket for this
action as described under ADDRESSES. The settlement agreement makes
clear that EPA retained full discretion concerning what amendments were
proposed, and what, if any, amendments are finalized.

C. Proposed Amendments to the 2006 EPA Rule

    Consistent with the settlement agreement, on January 18, 2011, EPA
Administrator Lisa Jackson signed a notice of proposed rulemaking for
proposed amendments to the 2006 rule. The proposed amendments were
substantially consistent with the regulatory language negotiated with
Petitioners. The notice of proposed rulemaking published in the Federal
Register issue of February 2, 2011 (76 FR 5735) (FRL-8862-7).

D. Retrospective Review of the Common Rule

    On July 26, 2011, after issuance of EPA's proposed rule, the
Department of Health and Human Services (HHS), in coordination with the
Office of Science and Technology Policy (OSTP), issued an advance
notice of proposed rulemaking concerning modernization of the Common
Rule which governs research with human subjects conducted or supported
by EPA and many other Federal departments and agencies (76 FR 44512,
July 26, 2011). HHS and OSTP sought comment on ``how to better protect
human subjects who are involved in research, while facilitating
valuable research and reducing burden, delay, and ambiguity for
investigators.'' Id. HHS and OSTP identified seven areas of concern
regarding the Common Rule. Most relevant to EPA's proposed amendments
to the 2006 rule, was a concern with ``the multiple, differing
regulatory requirements that can apply to a single research study * * *
.'' These requirements, according to HHS and OSTP, ``have been
criticized as complex, inconsistent, and lacking in clarity,'' and can
result in ``unwarranted variability across institutions and their
[Institutional Review Boards] in how the requirements are interpreted
and implemented'' (76 FR at 45514). HHS and OSTP stressed the
importance of clarifying and harmonizing human subject protections
across the Federal Government and sought comment on the means by which
this could be accomplished (76 FR at 44528).

III. The Final Rule

    EPA is finalizing the amendments to the 2006 rule as proposed. This
includes changes to the scope and consent provisions, and the
incorporation of selected individual recommendations from the 2004 NAS
Report as the specific ethical and scientific factors to be considered
by EPA and the HSRB in reviewing proposed and completed human research
(i.e., proposed

Sec. Sec.  26.1603 and 26.1703, see 76 FR 5745-5749).
    The amendments finalized in this rule are consistent with the
recommendations in the 2004 NAS Report and EPA practice under the 2006
rule. That practice has been modeled primarily on EPA's practice under
its Common Rule. Sections 26.109, 26.111, 26.116, and 26.117 of EPA's
Common Rule explicitly address most of the specific ethical
considerations included in the amendments to the 2006 rule, including
whether risks to subjects are minimized (compare Sec.  26.1603(c)(2)
with existing Sec.  26.111(a)(2)); whether risks are reasonable in
comparison to benefits (compare Sec.  26.1603(c)(3) with Sec.
26.111(a)(2)); whether subject selection would be equitable (compare
Sec.  26.1603(c)(4) with existing Sec.  26.111(a)(3)); whether consent
will be free and voluntary (compare Sec.  26.1603(c)(5) with existing
Sec. Sec.  26.116 and 26.117); whether an appropriately constituted
institutional review board (IRB) has reviewed the proposed research
(compare Sec.  26.1603(c)(6) with Sec.  26.109); and whether the
``special problems'' of research involving vulnerable populations are
taken into account (compare Sec.  26.1603(c)(7) and (8) with existing
Sec.  26.111(a)(3)). Other considerations are implicitly addressed.
    The Common Rule's requirement to ``minimize risks'' in Sec.
26.111(a)(1) necessitates consideration of whether adequate animal data
is available to assess potential risks to subjects (see Sec.
26.1603(c)(1)). It would involve consideration of whether medical care
is to be provided for injuries incurred in the proposed research (see
Sec.  26.1603(c)(10)). Section 26.111(b)'s requirement that additional
safeguards be in place to protect against undue influence of
``economically'' disadvantaged persons ensures that consideration of
whether any proposed payments are so high as to constitute undue
inducement or so low as to be attractive only to individuals who are
socioeconomically disadvantaged (see Sec.  26.1603(c)(9)). Although
scientific considerations are not addressed in similar detail in the
Common Rule requirements, nonetheless, the requirement to consider
scientific validity and reliability and the Common Rule's emphasis on
the need for ``sound research design'' in Sec.  26.111(a)(1) and the
need to take ``the importance of the knowledge that may reasonably be
expected to result'' from the study into account, mandate that EPA
focus on considerations addressing scientific validity such as those
included in Sec. Sec.  26.1603 and 26.1703. At a minimum, NAS
Recommendations 3-1, 4-1, 5-1, 5-2, 5-3, and 5-5 are critical to proper
consideration of the Common Rule's ethical requirements and its
requirement for ``sound research design.''

IV. Public Comments on the Proposed Amendments

    This unit discusses, in general terms, the public comments on the
proposed amendments and EPA's responses to those comments. EPA received
a total of 10 public comments on the proposed amendments during the 60-
day comment period. Comments were submitted by 4 individual citizens
and 6 different entities--the Agricultural Handler Exposure Task Force,
the American Chemistry Council (on behalf of the Antimicrobial Exposure
Assessment Task Force II), Beyond Pesticides, CropLife America, Natural
Resources Defense Council, and SC Johnson & Son, Inc. The docket (under
docket ID number EPA-HQ-OPP-2010-0785) includes all of the comments
submitted to EPA on the proposed amendments, as well as EPA's Response
to Comments document, which provides detailed responses to all comments
received.

A. Comments on Proposal To Expand Scope To Include Research Submitted
to EPA Under Any Regulatory Statute EPA Administers

    Two comments addressed the proposed changes to the scope of the
2006 rule. One commenter stated that the 2006 Appropriations Act did
not permit an expansion of scope beyond pesticide studies performed in
the FIFRA and FFDCA context, and another argued that the 2006
Appropriations Act required that the scope of the rule be further
expanded beyond studies submitted, or intended for submission, to EPA.
    After considering these comments, EPA has decided to finalize the
rule text relating to scope as it was proposed, i.e., expanding the
scope to cover research involving intentional exposure of human
subjects to pesticides where that research is submitted, or intended to
be submitted, to EPA under any regulatory statute that EPA administers.
As noted in EPA's Response to Comments document, EPA no longer regards
the 2006 Appropriations Act as authority for this rule. Therefore, EPA
believes it is unnecessary to address whether the 2006 Appropriation
Act either requires or does not allow EPA to establish a different
scope for this rule.
    Nevertheless, EPA regards FIFRA as providing adequate legal
authority for the scope of research covered by this final rule.
Sections 3(a) and 25(a) of FIFRA provide EPA with authority to regulate
pesticides, including research involving intentional exposure of a
human subject to a substance, when the substance is being tested as a
``pesticide.'' That includes research intended for submission to EPA,
whether under FIFRA, FFDCA, or any of EPA's other regulatory
authorities. EPA believes it makes sense to apply the same standards to
all human studies involving pesticides submitted to EPA. On the other
hand, EPA believes that it is not in the public interest to extend the
prohibition against research involving intentional exposure of children
or pregnant women to pesticides beyond the scope delineated in the
proposed rule because such a prohibition, if enforceable, could have
the unintended effect of prohibiting valuable research.

B. Comments on Inclusion of NAS-Derived Considerations

    Two commenters questioned whether new regulatory text proposed at
Sec.  26.1603(b)(2)(ii) and (iii) would change the ways in which EPA
has been reviewing proposed studies to measure exposures experienced by
people who mix, load, or apply pesticides. As proposed, EPA would have
been required to consider whether the proposed research includes
representative study populations for the endpoint in question and has
adequate statistical power to detect appropriate effects. These
commenters expressed the same concern regarding the proposed regulatory
text at Sec.  26.1703(a)(2) and (3), which would require EPA to
consider these factors in determining whether to rely on the research.
As explained in more detail in EPA's Response to Comments document, EPA
does not believe that the adoption of the specific ethical and
scientific factors will impose any additional burden on sponsors of
exposure studies or on the types of exposure studies referenced by the
commenters.
    As explained previously, EPA has decided to finalize the proposed
text detailing specific scientific and ethical aspects of proposed and
completed research--including the text proposed at Sec.
26.1603(b)(2)(ii) and (iii) and at Sec.  26.1703(a)(2) and (3)--that
EPA and the HSRB must consider when reviewing such research. EPA also
notes that, under the 2006 rule as amended through this final rule, EPA
does not intend to change the way in which it reviews exposure research
with respect to the inclusion of representative populations or the
statistical power of the study, although EPA will consider whether
further guidance on this issue

is needed. In addition, EPA does not believe the codification of the
specific ethical and scientific factors derived from the 2004 NAS
Report represents a material change in the way a particular pesticide
study would have been reviewed. Thus, EPA believes that particular
pesticides studies that have been approved under the 2006 rule, would
also meet the standards reflected in this final rule.

C. Other Comments, Including Comments on Narrowing the Scope of the
2006 Rule To Include Only Intentional Dosing Studies

    The remainder of the public comments addressed issues beyond the
scope of the proposed amendments. These comments included arguments
that the burden of the requirements of the 2006 rule (as opposed to any
burden connected to this amendment) are unjustified, and assertions
that EPA's interpretation in the 2006 rule of the language ``research
involving intentional exposure of a human subject'' incorrectly
expanded the scope of the rule beyond that required in the 2006
Appropriations Act, which addressed only ``intentional dosing human
toxicity studies.'' The commenters are referring to Sec.  26.1101(a) of
the 2006 rule, which defines the scope of the rule as applying to ``all
research initiated after April 7, 2006 involving intentional exposure
of a human subject * * *.'' As EPA explained in the preamble to the
proposal for the 2006 rule, this scope was intended to capture ``all
intentional dosing human studies intended for submission to EPA under
the pesticide laws'', i.e., studies involving intentional dosing to
measure a toxic effect and studies involving intentional dosing to
measure other scientific endpoints, like exposure (Federal Register
issue of September 12, 2005 (70 FR at 53845) (FRL-7728-2)). Additional
discussion in the preambles to the proposal for the 2006 rule and 2006
rule further explains what studies EPA intended to be included within
the scope of the 2006 rule (70 FR at 53845-53847; 71 FR 6138, 6146,
6149-6150).
    Because these comments were directed at provisions in the 2006 rule
that EPA did not reopen for reconsideration as part of the proposed
amendments, these comments are beyond the scope of this final rule, and
no response to them is required to finalize this rule. Nonetheless, EPA
appreciates the concerns expressed by the commenters with regard to the
burdens imposed by the 2006 rule and recognizes that there may be value
in considering further amendments to the 2006 rule in a way that
reduces the burdens on investigators, e.g., by limiting the types of
research that are subject to particular requirements of the rule.

V. Conclusion

    EPA received relatively few comments on the proposed rule, and many
of the comments received did not address the amendments in the
proposal. For the reasons noted previously, the comments that did
address the proposal do not merit any change to the amendments as
proposed. Accordingly, EPA is finalizing the amendments as proposed for
the reasons stated herein and in the preamble to the proposed rule.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action,'' because the Office of
Management and Budget (OMB) determined that it would raise novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
Accordingly, EPA submitted this action to OMB for review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Any
changes made in response to OMB recommendations have been documented in
the docket for this rulemaking as required by the Executive Order.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
that would require additional review or approval by OMB. However, OMB
has previously approved the information collection requirements
contained in the existing regulations at 40 CFR part 26 under the
provisions of PRA (44 U.S.C. 3501 et seq.), and has assigned OMB
Control No. 2070-0169 (EPA ICR No. 2195). The OMB control numbers for
EPA's regulations in 40 CFR are listed in 40 CFR part 9.
    In its 2008 analysis supporting the most recent renewal of this
ICR, EPA estimated that respondents would submit to the Agency some 34
proposals for or reports of research involving intentional exposure of
human subjects each year. EPA estimated that preparation of information
required by the 2006 rule would require about 598 hours per study at a
cost of $45,927 per study, for a total estimated annual burden for
affected entities of 20,332 hours at an estimated cost of $1,561,518.
In addition, EPA estimated annual submission of 20 reports of research
requiring only documentation of ethical conduct at a cost of 12 hours/
$879 per report, or 240 hours/$17,580 per year. The total estimate of
the annual respondent burden and cost was the sum of these two
estimates, or 2,572 hours/$1,579,098.
    These paperwork burden and cost estimates include activities
related to initial rule familiarization, as well as activities that
researchers would have to perform even without the Agency's rulemaking
in this area, such as developing a protocol and maintaining records.
    The average annual burden on EPA for reviewing each of the 34 study
submissions was estimated to be 178 hours/$16,850 per study, or 6,052
hours/$572,900 per year. The average annual burden on EPA for reviewing
each of the 20 additional submissions was estimated to be 44 hours/
$3,158 per study, or 880 hours/$63,160 per year. The total estimate of
the annual burden on EPA was the sum of these two estimates, or 6,932
hours/$636,000 per year.
    In no year since promulgation of the 2006 rule have more than 7
protocols been submitted to EPA by industry; the average annual rate
has been just over 5 for the 5-year period of 2006-2010. Somewhat fewer
completed reports have been submitted during this period, so the
average of new protocols and finished studies has been about 11 per
year, less than a third of the projected 34 per year covered by the
ICR. There is no evidence to suggest an upward trend, and nothing in
these amendments is believed likely to lead to a significant change in
the rate of protocol and study submissions.
    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 (RFA)

    RFA (5 U.S.C. 601 et seq.), 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
(5 U.S.C. 551-553) 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 organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this rule on small
entities, small entity is defined as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201, which is based on
either the maximum number of employees or on the sales for small
businesses in each industry sector, as defined by a 6-digit NAICS code,
and for this rule is pesticide and other agricultural chemical
manufacturers (NAICS code 325320) who sponsor or conduct human research
with pesticides, or other entities (NAICS code 541710) that sponsor or
conduct human research with pesticides, and IRBs who review human
research with pesticides to ensure it meets applicable standards of
ethical conduct;
    2. A small governmental jurisdiction that is a government of a
city, county, town, school district, or special district with a
population of less than 50,000; or
    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. Because no
small entities have been identified that are directly regulated by
these amendments, EPA has not attempted to reduce the impact of this
final rule on small entities. Public comments were explicitly invited
on all aspects of the proposal and its impacts on small entities, but
no such comments were received.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of UMRA (2 U.S.C. 1531-1538) establishes requirements for
Federal agencies to assess the effects of their regulatory actions on
State, local, and tribal governments and the private sector. This rule
does not contain a Federal mandate that may result in expenditures of
$100 million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any 1 year. Thus, this rule is not
subject to the requirements of UMRA sections 202 or 205. This rule is
also not subject to the requirements of UMRA section 203, because it
contains no regulatory requirements that might significantly or
uniquely affect small governments. These amendments are unlikely to
affect State, local, and tribal governments at all, and are likely to
affect the private sector only trivially.

E. Executive Order 13132: Federalism

    This action does not have federalism implications because it will
not 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,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
It makes marginal changes in the scope of an existing rule applying to
sponsors and investigators conducting certain kinds of research
involving human subjects, and refines the standards for EPA oversight
of and reliance on such research. Thus, Executive Order 13132 does not
apply to this action.

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

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action will
not have substantial direct effects on Indian Tribes, will not
significantly or uniquely affect the communities of Indian tribal
governments, and does not involve or impose any requirements that
affect Indian Tribes. Thus, Executive Order 13175 does not apply to
this action.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
action is not subject to Executive Order 13045, because it does not
establish an environmental standard intended to mitigate health or
safety risks, nor is it an ``economically significant regulatory
action'' as defined in Executive Order 12866. The 2006 rule applies to
the conduct and review of research involving intentional exposure of
human subjects, and prohibits the conduct of or EPA reliance on any
such research involving subjects who are children, or pregnant or
nursing women. These provisions would not be affected by the
amendments.

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

    This action is not a ``significant regulatory action'' as defined
in Executive Order 13211 (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.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of NTTAA (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. NTTAA directs EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable voluntary consensus standards. This action does not involve
any 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 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations, because it does not
affect the level of protection provided to human health or the
environment. This rule does not entail special considerations of
environmental justice related issues. The strengthened protections for
human subjects participating in covered research established in the
2006 rule will not be altered by these amendments.

VII. Congressional Review Act

    The Congressional Review Act (5 U.S.C. 801 et seq.), 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 the Comptroller General of the United
States. EPA will submit a

report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the United States prior to publication of the rule in the Federal
Register. A major rule cannot take effect until 60 days after it is
published in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 26

    Environmental protection, Administrative practice and procedures,
Human research, Pesticides and pests.

    Dated: February 8, 2013.
Lisa P. Jackson,
Administrator.

    Therefore, 40 CFR chapter I is amended as follows:

PART 26--[AMENDED]

0
1. The authority citation for part 26 is revised to read as follows:

    Authority:  5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21
U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and
42 U.S.C. 300v-1(b).

0
2. In Sec.  26.1101:
0
a. Remove paragraphs (a), (c), and (g).
0
b. Redesignate paragraph (b) as (c), (f) as (g), (e) as (f), and (d) as
(e).
0
c. Add new paragraphs (a), (b), and (d).
    The amendments read as follows:

Sec.  26.1101  To what does this subpart apply?

    (a) Except as provided in paragraph (c) of this section, this
subpart applies to all research initiated on or after April 15, 2013
involving intentional exposure of a human subject to:
    (1) Any substance if, at any time prior to initiating such
research, any person who conducted or supported such research intended
either to submit results of the research to EPA for consideration in
connection with any action that may be performed by EPA under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C.
136-136y) or section 408 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) (21 U.S.C. 346a), or to hold the results of the research for
later inspection by EPA under FIFRA or section 408 of FFDCA; or
    (2) A pesticide if, at any time prior to initiating such research,
any person who conducted or supported such research intended either to
submit results of the research to EPA for consideration in connection
with any action that may be performed by EPA under any regulatory
statute administered by EPA other than those statutes designated in
paragraph (a)(1) of this section, or to hold the results of the
research for later inspection by EPA under any regulatory statute
administered by EPA other than those statutes designated in paragraph
(a)(1) of this section.
    (b) For purposes of determining a person's intent under paragraph
(a) of this section, EPA may consider any available and relevant
information. EPA must rebuttably presume the existence of intent if:
    (1) The person or the person's agent has submitted or made
available for inspection the results of such research to EPA; or
    (2) The person is a member of a class of people who, or whose
products or activities, are regulated by EPA and, at the time the
research was initiated, the results of such research would be relevant
to EPA's exercise of its regulatory authority with respect to that
class of people, products, or activities.
* * * * *
    (d) The EPA Administrator retains final judgment as to whether a
particular activity is covered by this subpart.
* * * * *

0
3. In Sec.  26.1102, revise paragraphs (a) and (c) and add new
paragraph (k) to read as follows:

Sec.  26.1102  Definitions.

    (a) Administrator means the Administrator of the Environmental
Protection Agency (EPA) and any other officer or employee of EPA to
whom authority has been delegated.
* * * * *
    (c) Pesticide means any substance or mixture of substances meeting
the definition in 7 U.S.C. 136(u) (Federal Insecticide, Fungicide, and
Rodenticide Act, section 2(u)).
* * * * *
    (k) Common Rule refers to the Federal Policy for the Protection of
Human Subjects that was established in 1991 by the Office of Science
and Technology Policy and codified in 1991 by EPA and 14 other Federal
departments and agencies (see the Federal Register issue of June 18,
1991 (56 FR 28003)) and subsequently codified by other Federal
departments and agencies. The Common Rule contains a widely accepted
set of standards for conducting ethical research with human subjects,
together with a set of procedures designed to ensure that the standards
are met. Once codified by a Federal department or agency, the
requirements of the Common Rule apply to research conducted or
sponsored by that Federal department or agency. EPA's codification of
the Common Rule appears in 40 CFR part 26, subpart A.

Sec.  26.1111  [Amended]

0
4. In Sec.  26.1111, remove from paragraph (a)(4) the phrase ``or the
subject's legally authorized representative.''

0
5. In Sec.  26.1116, revise the introductory text of the section to
read as follows:

Sec.  26.1116  General requirements for informed consent.

    No investigator may involve a human being as a subject in research
covered by this subpart unless the investigator has obtained the
legally effective informed consent of the subject. An investigator must
seek such consent only under circumstances that provide the prospective
subject sufficient opportunity to consider whether or not to
participate and that minimize the possibility of coercion or undue
influence. The information that is given to the subject must be in
language understandable to the subject. No informed consent, whether
oral or written, may include any exculpatory language through which the
subject is made to waive or appear to waive any of the subject's legal
rights, or releases or appears to release the investigator, the
sponsor, the institution or its agents from liability for negligence.
* * * * *

0
6. Revise Sec.  26.1117 to read as follows:

Sec.  26.1117  Documentation of informed consent.

    (a) Informed consent must be documented by the use of a written
consent form approved by the IRB and signed by the subject. A copy
shall be given to the subject.
    (b) The consent form may be either of the following:
    (1) A written consent document that embodies the elements of
informed consent required by Sec.  26.1116. This form may be read to
the subject, but in any event, the investigator must give the subject
adequate opportunity to read it before it is signed; or
    (2) A short form written consent document stating that the elements
of informed consent required by Sec.  26.1116 have been presented
orally to the subject. When this method is used, there must be a
witness to the oral presentation. Also, the IRB shall approve a written
summary of what is to be said to the subject. Only the short form
itself is to be signed by the subject. However, the witness must sign
both the short form and a copy of the summary, and the person actually
obtaining consent must sign a copy of the summary. A copy of the
summary must

be given to the subject, in addition to a copy of the short form.

0
7. Revise the heading for subpart L to read as follows:

Subpart L--Prohibition of Third-Party Research Involving
Intentional Exposure to a Pesticide of Human Subjects Who Are
Children or Pregnant or Nursing Women

0
8. Revise Sec.  26.1201 to read as follows:

Sec.  26.1201   To what does this subpart apply?

    This subpart applies to any research subject to subpart K of this
part.

0
9. Revise Sec.  26.1301 to read as follows:

Sec.  26.1301  To what does this subpart apply?

    This subpart applies to any person who submits to EPA on or after
April 15, 2013 either of the following:
    (a) A report containing the results of any human research for
consideration in connection with an action that may be performed by EPA
under FIFRA (7 U.S.C. 136-136y) or section 408 of FFDCA (21 U.S.C.
346a).
    (b) A report containing the results of any human research on or
with a pesticide for consideration in connection with any action that
may be performed by EPA under any regulatory statute administered by
EPA.

Sec.  26.1302  [Amended]

0
10. In Sec.  26.1302, remove the word ``shall.''

Sec.  26.1502  [Amended]

0
11. In Sec.  26.1502:
0
a. Remove in the first sentence of paragraph (a), the period after the
phrase ``during an inspection'' and add in its place a comma.
0
b. Remove in the second sentence of paragraph (a), the phrase ``The
agency'' and add in its place ``EPA.''
0
c. Remove in the last sentence of the introductory text of paragraph
(b), the phrase ``the Agency'' and add in its place ``EPA.''

Sec.  26.1505  [Amended]

0
12. In Sec.  26.1505, remove from the last sentence, the citation
``Sec.  26.1502(c)'' and add in its place ``Sec.  26.1502(b)(4).''

Sec.  26.1507  [Amended]

0
13. In Sec.  26.1507, remove from the last sentence, the phrase ``The
Agency'' and add in its place ``EPA.''

Sec. Sec.  26.1601 through 26.1603  [Redesignated as Sec. Sec.  26.1603
through 26.1605]

0
14. Redesignate Sec. Sec.  26.1601 through 26.1603 as Sec. Sec.
26.1603 through 26.1605.

0
15. Add new Sec. Sec.  26.1601 and 26.1602 to subpart P to read as
follows:

Sec.  26.1601  To what does this subpart apply?

    This subpart applies to both of the following:
    (a) Reviews by EPA and by the Human Studies Review Board of
proposals to conduct new research subject to Sec.  26.1125.
    (b) Reviews by EPA on or after April 15, 2013 and, to the extent
required by Sec.  26.1604, by the Human Studies Review Board of reports
of completed research subject to Sec.  26.1701.

Sec.  26.1602   Definitions.

    The definitions in Sec.  26.1102 also apply to this subpart.

0
16. In newly redesignated Sec.  26.1603:
0
a. Remove paragraphs (a) and (e).
0
b. Redesignate paragraphs (b) through (d) as (e) through (g).
0
c. Add new paragraphs (a), (b), (c), (d), and (h).
    The amendments read as follows:

Sec.  26.1603  EPA review of proposed human research.

    (a) EPA must review all proposals for new human research submitted
under Sec.  26.1125 in a timely manner.
    (b) In reviewing proposals for new human research submitted under
Sec.  26.1125, the EPA Administrator must consider and make
determinations regarding the scientific validity and reliability of the
proposed research, including:
    (1) Whether the research would be likely to produce data that
address an important scientific or policy question that cannot be
resolved on the basis of animal data or human observational research.
    (2) Whether the proposed research is designed in accordance with
current scientific standards and practices to:
    (i) Address the research question.
    (ii) Include representative study populations for the endpoint in
question.
    (iii) Have adequate statistical power to detect appropriate
effects.
    (3) Whether the investigator proposes to conduct the research in
accordance with recognized good research practices, including, when
appropriate, good clinical practice guidelines and monitoring for the
safety of subjects.
    (c) In reviewing proposals for new research submitted under Sec.
26.1125, the EPA Administrator must consider and make determinations
regarding ethical aspects of the proposed research, including:
    (1) Whether adequate information is available from prior animal
studies or from other sources to assess the potential risks to subjects
in the proposed research.
    (2) Whether the research proposal adequately identifies anticipated
risks to human subjects and their likelihood of occurrence, minimizes
identified risks to human subjects, and identifies likely benefits of
the research and their distribution.
    (3) Whether the proposed research presents an acceptable balance of
risks and benefits. In making this determination for research intended
to reduce the interspecies uncertainty factor in a pesticide risk
assessment, the EPA Administrator will also consider the process laid
out and the attendant discussion for evaluating that type of study as
provided in Recommendation 4-1 of the 2004 Report from the National
Research Council of the National Academy of Sciences (NAS), entitled
``Intentional Human Dosing Studies for EPA Regulatory Purposes:
Scientific and Ethical Issues.''
    (4) Whether subject selection will be equitable.
    (5) Whether subjects' participation would follow free and fully
informed consent.
    (6) Whether an appropriately constituted IRB or its foreign
equivalent has approved the proposed research.
    (7) If any person from a vulnerable population may become a subject
in the proposed research, whether there is a convincing justification
for selection of such a person, and whether measures taken to protect
such human subjects are adequate.
    (8) If any person with a condition that would put them at increased
risk for adverse effects may become a subject in the proposed research,
whether there is a convincing justification for selection of such a
person, and whether measures taken to protect such human subjects are
adequate.
    (9) Whether any proposed payments to subjects are consistent with
the principles of justice and respect for persons, and whether they are
so high as to constitute undue inducement or so low as to be attractive
only to individuals who are socioeconomically disadvantaged.
    (10) Whether the sponsor or investigator would provide needed
medical care for injuries incurred in the proposed research, without
cost to the human subjects.
    (d) With respect to any research or any class of research subject
to this subpart, the EPA Administrator may recommend additional
conditions which, in the judgment of the EPA

Administrator, are necessary for the protection of human subjects.
* * * * *
    (h) EPA must provide the submitter of the proposal copies of the
EPA and Human Studies Review Board reviews.

0
17. In newly redesignated Sec.  26.1604, revise paragraph (a) to read
as follows:

Sec.  26.1604  EPA review of completed human research.

    (a) When considering, under any regulatory statute it administers,
data from completed research involving intentional exposure of humans
to a pesticide, EPA must thoroughly review the material submitted under
Sec.  26.1303, if any, and other available, relevant information and
document its conclusions regarding the scientific and ethical conduct
of the research.
* * * * *

0
18. Add Sec. Sec.  26.1606 and 26.1607 to subpart P to read as follows:

Sec.  26.1606  Human Studies Review Board review of proposed human
research.

    In commenting on proposals for new research submitted to it by EPA,
the Human Studies Review Board must consider the scientific merits and
ethical aspects of the proposed research, including all elements
required in Sec.  26.1603(b) and (c) and any additional conditions
recommended pursuant to Sec.  26.1603(d).

Sec.  26.1607  Human Studies Review Board review of completed human
research.

    In commenting on reports of completed research submitted to it by
EPA, the Human Studies Review Board must consider the scientific merits
and ethical aspects of the completed research, and must apply the
appropriate standards in subpart Q of this part.

0
19. Revise the heading for subpart Q to read as follows:

Subpart Q--Standards for Assessing Whether To Rely on the Results
of Human Research in EPA Actions

0
20. Revise Sec. Sec.  26.1701 through 26.1705 to read as follows:
* * * * *
Sec.
26.1701 To what does this subpart apply?
26.1702 Definitions.
26.1703 Prohibitions applying to all research subject to this
subpart.
26.1704 Prohibition of reliance on unethical human research with
non-pregnant, non-nursing adults.
26.1705 Prohibition of reliance on unethical human research with
non-pregnant, non-nursing adults initiated after April 7, 2006.
* * * * *

Sec.  26.1701  To what does this subpart apply?

    (a) For decisions under FIFRA (7 U.S.C. 136-136y) or section 408 of
FFDCA (21 U.S.C. 346a), this subpart applies to research involving
intentional exposure of human subjects to any substance.
    (b) For decisions under any regulatory statute administered by EPA
other than those statutes designated in paragraph (a) of this section,
this subpart applies to research involving intentional exposure of
human subjects to a pesticide.

Sec.  26.1702  Definitions.

    The definitions in Sec.  26.1102 and Sec.  26.1202 also apply to
this subpart.

Sec.  26.1703  Prohibitions applying to all research subject to this
subpart.

    (a) Prohibition of reliance on scientifically invalid research. EPA
must not rely on data from research subject to this subpart unless EPA
determines that the data are relevant to a scientific or policy
question important for EPA decisionmaking, that the data were derived
in a manner that makes them scientifically valid and reliable, and that
it is appropriate to use the data for the purpose proposed by EPA. In
making such determinations, EPA must consider:
    (1) Whether the research was designed and conducted in accordance
with appropriate scientific standards and practices prevailing at the
time the research was conducted.
    (2) The extent to which the research subjects are representative of
the populations for the endpoint or endpoints in question.
    (3) The statistical power of the data to support the scientific
conclusion EPA intends to draw from the data.
    (4) In a study that reports only a No Observed Effect Level (NOEL)
or a No Observed Adverse Effect Level (NOAEL), whether a dose level in
the study gave rise to a biological effect, thereby demonstrating that
the study had adequate sensitivity to detect an effect of interest.
    (b) Prohibition of reliance on research subject to this subpart
involving intentional exposure of human subjects who are pregnant women
(and therefore their fetuses), nursing women, or children. Except as
provided in Sec.  26.1706, EPA must not rely on data from any research
subject to this subpart involving intentional exposure of any human
subject who is a pregnant woman (and therefore her fetus), a nursing
woman, or a child.

Sec.  26.1704  Prohibition of reliance on unethical human research with
non-pregnant, non-nursing adults.

    (a) This section applies to research subject to this subpart that
is not subject to Sec.  26.1705.
    (b) Except as provided in Sec.  26.1706, EPA must not rely on data
from any research subject to this section if there is clear and
convincing evidence that:
    (1) The conduct of the research was fundamentally unethical (e.g.,
the research was intended to seriously harm participants or failed to
obtain informed consent); or
    (2) The conduct of the research was deficient relative to the
ethical standards prevailing at the time the research was conducted in
a way that placed participants at increased risk of harm (based on
knowledge available at the time the study was conducted) or impaired
their informed consent.
    (c) The prohibition in this section is in addition to the
prohibitions in Sec.  26.1703.

Sec.  26.1705  Prohibition of reliance on unethical human research with
non-pregnant, non-nursing adults initiated after April 7, 2006.

    (a) This section applies to research subject to this subpart, that:
    (1) Was initiated after April 7, 2006.
    (2) Was subject, at the time it was conducted, either to subparts A
through L of this part, or to the codification of the Common Rule by
another Federal department or agency.
    (b) Except as provided in Sec.  26.1706, EPA must not rely on data
from any research subject to this section unless EPA determines that
the research was conducted in substantial compliance with either:
    (1) All applicable provisions of subparts A through L of this part,
or the codification of the Common Rule by another Federal department or
agency; or
    (2) If the research was conducted outside the United States, with
procedures at least as protective of subjects as those in subparts A
through L of this part, or the codification of the Common Rule by
another Federal department or agency.
    (c) Except as provided in Sec.  26.1706, EPA must not rely on data
from any research subject to this section unless EPA determines that
the research was conducted in substantial compliance with either:
    (1) A proposal that was found to be acceptable under Sec.
26.1603(c), and no amendments to or deviations from that proposal
placed participants at increased risk of harm (based on knowledge
available at the time the

study was conducted) or impaired their informed consent. If EPA
discovers that the submitter of the proposal materially misrepresented
or knowingly omitted information that would have altered the outcome of
EPA's evaluation of the proposal under Sec.  26.1603(c), EPA must not
rely on that data.
    (2) A proposal that would have been found to be acceptable under
Sec.  26.1603(c), if it had been subject to review under that section,
and no amendments to or deviations from that proposal placed
participants at increased risk of harm (based on knowledge available at
the time the study was conducted) or impaired their informed consent.
    (d) The prohibition in this section is in addition to the
prohibitions in Sec.  26.1703.

Sec.  26.1706  [Amended]

0
21. In Sec.  26.1706, remove in paragraph (d) the word ``publishes''
and add in its place the phrase ``has published.''

[FR Doc. 2013-03456 Filed 2-13-13; 8:45 am]
BILLING CODE 6560-50-P


SO2 National Ambient Air Quality Standards (NAAQS)
2018 SO2 NAAQS Review Data Files
AERMOD SO2 Air Modeling Input Data Files


[Federal Register: February 8, 2010 (Volume 75, Number 25)]
[Notices]
[Page 6199]
[DOCID:fr08fe10-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-32-000]

Central Minnesota Municipal Power Agency and Midwest Municipal
Transmission Group, Inc.; Notice of Filing

February 1, 2010.
    Take notice that on January 25, 2010, Central Minnesota Municipal
Power Agency and Midwest Municipal Transmission Group, Inc. (CMMPA/
MMTG) filed with the Federal Energy Regulatory Commission an amended
Petition for a Declaratory Order concerning formula rates and
incentives and request for expedited relief and waivers, requesting the
Commission's approval of incentive rates for their investments in the
CapX2020 Twin Cities to Brookings County (Brookings) transmission line
in South Dakota and Minnesota. The requested incentives are (a) 100
percent of their prudently incurred construction work-in-progress
(CWIP) in rate base; (b) recovery of 100 percent of their prudently
incurred costs of transmission facilities that are cancelled or
abandoned for reasons beyond their control; and (c) use of a
hypothetical capital structure of 55 percent equity-45 percent debt,
and appropriate waivers.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 16, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-2626 Filed 2-5-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Page 35691]
[FR Doc No: 2012-14469]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Update to Electronic Common Technical Document Module 1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

    The Food and Drug Administration (FDA) is announcing the following
meeting: Update to Electronic Common Technical Document Module 1. The
topic to be discussed is final documentation of the Electronic Common
Technical Document (eCTD) Module 1, which is used for electronic
submission of administrative and prescribing information by industry.
The purpose of the meeting is to provide clarification and answer
questions from industry and software vendors regarding the changes
being made to this module. Registration is required in advance and
participation will be limited.

DATES:  Date and Time: The meeting will be held on Tuesday, September
18, 2012, from 8 a.m. to 11:30 a.m.

Location:  The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, Great Room 1503, Silver
Spring, MD 20993. The following link contains public meeting attendee
information as well as frequently asked questions and answers regarding
public meetings at White Oak: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

Contact: Julie Quinonez, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1135,
Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) to Julie Quinonez (see
Contact). Registrations will be accepted in the order that they are
received with a limit of 350.

SUPPLEMENTARY INFORMATION: The eCTD is an International Conference on
Harmonization (ICH) standard based on specifications developed by ICH
and its member parties. The Center for Drug Evaluation and Research
(CDER) and the Center for Biologics Evaluation and Research (CBER) have
been receiving submissions in the eCTD format since 2003, and the eCTD
has been the standard for electronic submissions to CDER and CBER since
January 1, 2008. In fact, the majority of new electronic submissions
are now received in eCTD format. Since adoption of the eCTD standard,
it has become necessary to update the administrative portion of the
eCTD Module 1 to reflect regulatory changes; to provide clarification
of business rules for submission, processing, and review; to refine the
characterization of promotional labeling and advertising material; and
to facilitate automated processing of submissions. In the process of
considering these changes, FDA has previously made available for
comment versions of documents that support making regulatory
submissions in electronic format using the (eCTD) specifications. These
draft documents represented FDA's major updates to Module 1 of the eCTD
based on previous comments. FDA will make available revised versions of
these documents in preparation for this meeting. These documents will
be posted at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm.
    If you need special accommodations due to a disability, please
contact Julie Quinonez (see Contact) at least 7 days in advance.

    Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14469 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: January 17, 2007 (Volume 72, Number 10)]
[Notices]
[Page 1993-1995]
[DOCID:fr17ja07-42]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0349; FRL-8105-7]

Experimental Use Permit; Receipt of Application

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces receipt of an application 264-EUP-140
from Bayer CropScience LP (BCS) requesting an experimental use permit
(EUP) for the Bacillus thuringiensis Cry1Ab protein and the genetic
material necessary for its production in Events T303-3 and T304-40
cotton plants. The Agency has determined that the application may be of
regional and national significance. Therefore, in accordance with 40
CFR 172.11(a), the Agency is soliciting comments on this application.

DATES: Comments must be received on or before February 16, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0349, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The

Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0349. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
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 in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Sharlene R. Matten, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who are interested in
agricultural biotechnology or may be required to conduct testing of
pesticidal substances under the Federal Food, Drug, and Cosmetic Act
(FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Since other entities may also be interested, the Agency has
not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

    BCS has requested an extension of EUP 264-EUP-140 granted by EPA on
February 7, 2006 (71 FR 41020, July 19, 2006) (FRL-8060-6). This EUP
will expire January 31, 2007. BCS is proposing to test 84 acres of the
plant-incorporated protectant Bacillus thuringiensis Cry1Ab protein (a
total of 0.91g to 7.31g or 0.002 to 0.016 pounds of Cry1Ab protein) and
the genetic material necessary for its production in Events T303-3 and
T304-40 cotton plants in an experimental program of 285 total acres
from February 1, 2007 to January 31, 2008. The Cry1Ab protein is
effective in controlling lepidopteran larvae such as bollworm
(Helicoverpa zea) and tobacco budworm (Heliothis virescens) larvae,
which are common pests of cotton. In total, the proposed program will
be carried out in Arizona, California, Georgia, Louisiana, Mississippi,
North Carolina, South Carolina, and Texas. The planned experimental
program includes the following: Insect efficacy trials, agronomic
performance evaluation, breeding, herbicide efficacy evaluations, and
dissemination studies, as well as the production of sample material for
regulatory feeding and analytical studies. In addition to these
experimental plans, seed may be produced for future plantings of
experimental field trials.

III. What Action is the Agency Taking?

    Following the review of the BCS application and any comments and
data received in response to this notice, EPA will decide whether to
issue or deny the EUP request for this EUP program, and if issued, the
conditions under which it is to be conducted. Any issuance of an EUP
will be announced in the Federal Register.

IV. What is the Agency's Authority for Taking this Action?

    The specific legal authority for EPA to take this action is under
FIFRA section 5.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: January 4, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

[FR Doc. E7-550 Filed 1-16-07; 8:45 am]

BILLING CODE 6560-50-S


June 7, 2010

MEMORANDUM

SUBJECT:	Inadvertent Error in the Preamble to the Proposed National
Emission Standards for Hazardous Air Pollutants for Area Sources:
Industrial, Commercial, and Institutional Boilers

FROM:	Mary K. Johnson

Project Lead

Office of Air and Radiation

TO:		Docket ID No.  EPA-HQ-OAR-2006-0790

We have identified an inadvertent error in the burden estimates for the
proposed National Emission Standards for Hazardous Air Pollutants for
Area Sources:  Industrial, Commercial, and Institutional Boilers, which
was signed on April 29, 1010.  Specifically, the burden estimates
included in the Paperwork Reduction Act section of the preamble (75 Fed.
Reg. 31896) were preliminary estimates, and the preamble does not
reflect the updated burden estimates.  The current burden estimates
associated with the information collection activities of the proposed
rule are set forth in the Supporting Statement (see docket item
EPA-HQ-OAR-2006-0790-0031).

The attached redline/strike-out version of the affected preamble section
(i.e., page 31918) identifies the errors and shows the corrected
estimates.

cc:  Robert J. Wayland

Attachment

The annual monitoring, reporting, and recordkeeping burden for this
collection (averaged over the first 3 years after the effective date of
the standards) is estimated to be $523 551 million.  This includes 3.6
million labor hours per year at a cost of $336 million and total
non-labor capital costs of $186 215 million per year.  This estimate
includes initial and annual performance tests, conducting and
documenting an energy assessment, conducting and documenting a tune-up,
semiannual excess emission reports, maintenance inspections, developing
a monitoring plan, notifications, and recordkeeping.  Monitoring,
testing, tune-up and energy assessment costs were also included in the
cost estimates presented in the control costs impacts estimates in
section VI.B of this preamble.  The total burden for the Federal
government (averaged over the first 3 years after the effective date of
the standard) is estimated to be 767,403 hours per year at a total labor
cost of $37.6 million per year.


Placeholder: confidential business information item

CBI Memo from ICF International on 10-25-2013

For more information please contact David Donaldson by phone at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>


[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Pages 76707-76709]
[FR Doc No: 2011-31514]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-6-000]

El Paso Natural Gas Company: Notice of Intent To Prepare an
Environmental Assessment for the Proposed Willcox Lateral 2013
Expansion Project and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Willcox Lateral 2013 Expansion
Project (Project) involving modification, construction, and operation
of certain meter, compressor and lateral facilities by El Paso Natural
Gas Company (EPNG) in Cochise County, Arizona. The

Commission will use this EA in its decision-making process to determine
whether the Project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the Project. Your input will help the Commission staff
determine what issues need to be evaluated in the EA. Please note that
the scoping period will close on January 2, 2012.
    You may submit comments in written form. Further details on how to
submit written comments are in the Public Participation section of this
notice.
    This notice is being sent to the Commission's current environmental
mailing list for this Project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    EPNG provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility on My Land? What Do I
Need To Know?'' This fact sheet addresses a number of typically-asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (http://www.ferc.gov).

Summary of the Proposed Project

    The Project involves the modification of EPNG's existing pipeline
system and installation of new facilities including:
     A new 400-foot long, 16-inch diameter lateral pipeline to
connect the Douglas Meter Station to EPNG's existing Line No. 2164;
     The replacement of compressor modules and station yard
piping at the existing Willcox Compressor Station;
     Expansion of the existing Douglas Meter Station by
installing updated flow control and pressure regulation equipment; and
     The replacement of the existing two 8-inch orifice meters
with two 8-inch ultrasonic meters to increase the capacity at the El
Fresnal meter Station.
    The general location of the Project facilities is shown in Appendix
1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice are not printed in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at http://www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call 9<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the Project would disturb about 27 acres. Most of
the construction would be temporary. Less than one acre of new
permanent easement would be required for this project.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. The NEPA also requires
us \2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \2\ ``We'', ``us'', and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed Project under these
general headings:
     Geology and soils;
     Land use and recreation;
     Water resources, fisheries, and wetlands;
     Cultural resources;
     Vegetation and wildlife;
     Air quality and noise; and
     Public safety.
    We will also evaluate reasonable alternatives to the proposed
Project or portions of the Project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary (FERC's records
information system, see the Additional Information section of this
Notice). To ensure we have the opportunity to consider and address your
comments, please carefully follow the instructions in the Public
Participation section. Depending on the comments received during the
scoping process, we may also publish and distribute the EA to the
public for an allotted comment period. Comments on the EA will be
considered before we make our recommendations to the Commission.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect the environmental issues of this
project to formally cooperate with us in the preparation of the EA.\3\
Agencies that would like to request cooperating agency status should
follow the instructions for filing comments provided under the Public
Participation section of this notice.
---------------------------------------------------------------------------

    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Arizona State Historic Preservation Office (SHPO), and to
solicit their views and those of other government agencies, interested
Indian Tribes, and the public on the Project's potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the Project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this Project will document our
findings on the impacts on historic properties and summarize the status
on consultations under section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to

avoid or lessen environmental impacts. The more specific your comments,
the more useful they will be. To ensure that your comments are timely
and properly recorded, please send in your comments so that they will
be received in Washington, DC on or before January 2, 2012.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the Project docket number (CP12-6-000) with your submission.
The Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You may file your comments electronically by using the eComment
feature, which is located on the Commission's Web site at (http://www.ferc.gov) under the link to Documents and Filings. This is an
method for interested persons to submit brief, text-only comments on a
project;
    (2) You may file your comments electronically by using the eFiling
feature, which is located on the Commission's Web site at (http://www.ferc.gov) under the link to Documents and Filings. With eFiling you
can provide comments in a variety of formats by attaching them as a
file with your submission. New eFiling users must first create an
account by clicking on ``eRegister''. You must select the type of
filing you are making. If you are filing a comment on a particular
project, please select ``Comment on a Filing''; or
    (3) You may file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Indian Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for Project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed Project.
    If we publish and distribute the EA, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (Appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits, in the Docket Number field i.e., CP12-
6-000). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx along with other related information

    Dated: December 2, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-31514 Filed 12-7-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39802-39804]
[FR Doc No: 2018-17123]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83781; File No. SR-FINRA-2018-027]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend FINRA Rule 9000 Series (Code of
Procedure) To Reflect an Internal Reorganization of FINRA's Enforcement
Operations

August 6, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934

(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 3, 2018, Financial Industry Regulatory Authority, Inc.
(``FINRA'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    FINRA is proposing to make technical and other non-substantive
changes to FINRA Rule 9000 Series (Code of Procedure) (``the Code'') to
reflect an internal reorganization of FINRA's enforcement operations to
create a single Department of Enforcement.
    The text of the proposed rule change is available on FINRA's
website at http://www.finra.org, at the principal office of FINRA and
at the Commission's Public Reference Room.

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

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    In March 2017, FINRA launched FINRA360, a comprehensive self-
evaluation and organizational improvement initiative to ensure that
FINRA is operating as an optimally effective self-regulatory
organization, working to protect investors and promote market integrity
in a manner that supports strong and vibrant capital markets. In
connection with this ongoing initiative, FINRA has sought feedback from
its members, as well as investors, investor advocates, regulators,
trade associations and FINRA employees. FINRA has analyzed the feedback
received from these stakeholders and as a result has made significant
changes across the organization.\3\
---------------------------------------------------------------------------

    \3\ See FINRA, Progress Report on FINRA360 (April 2018), https://www.finra.org/sites/default/files/FINRA360ProgressReport_April2018.pdf.
---------------------------------------------------------------------------

    Until last summer, FINRA had two distinct enforcement teams. One
enforcement group that was historically part of the Department of
Market Regulation handled disciplinary actions related to trading-based
matters found through Market Regulation's surveillance and examination
programs; and a separate enforcement group handled cases referred from
other regulatory oversight divisions including Member Regulation,
Corporate Financing, the Office of Fraud Detection and Market
Intelligence, and Advertising Regulation. As part of FINRA360,
stakeholders raised concerns that these dual programs sometimes
resulted in duplication of effort and inconsistency of results. As a
result, in July 2017, FINRA announced its plan to consolidate its
existing enforcement functions into a unified Department of
Enforcement. On July 26, 2018, FINRA announced that it had completed
the final phase of this consolidation.\4\ The unified structure is
intended to improve FINRA's ability to streamline investigations, share
information, enhance consistency and maximize resources to protect
investors and the markets.
---------------------------------------------------------------------------

    \4\ See News Release, FINRA, FINRA Announces Enforcement
Structure, Senior Leadership (July 26, 2018), http://www.finra.org/newsroom/2018/finra-announces-enforcement-structure-senior-leadership-team.
---------------------------------------------------------------------------

    The proposed rule change would make technical and other non-
substantive changes to the Code to reflect the single Department of
Enforcement. The proposed changes would therefore remove references to
the Market Regulation department, its head and employees from the Code
where those references reflect the previously separate Market
Regulation enforcement function.
    FINRA has filed the proposed rule change for immediate
effectiveness and has requested that the SEC waive the requirement that
the proposed rule change not become operative for 30 days after the
date of the filing, so FINRA can implement the proposed rule change
immediately.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\5\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change will
provide clarity to members and the public by reflecting throughout the
Code the now unified FINRA Department of Enforcement.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. The proposed rule change brings
clarity and consistency to FINRA rules without adding any burden on
firms.

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

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \6\ and Rule 19b-
4(f)(6) thereunder.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires FINRA to give the Commission written notice of its intent
to file the proposed rule change, along with a brief description and
text of the proposed rule change, at least five business days prior
to the date of filing of the proposed rule change, or such shorter
time as designated by the Commission. FINRA has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \8\ normally
does not become operative for 30 days after the date of its filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\9\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. FINRA has requested
that the Commission waive the 30-day operative delay so that the
internal reorganization of FINRA's enforcement operations can
immediately be reflected in the Code. Because waiver of the operative
delay would increase transparency and accuracy of the Code, the
Commission

believes that waiver of the operative delay is consistent with the
protection of investors and the public interest. Accordingly, the
Commission hereby waives the operative delay and designates the
proposal as operative upon filing.\10\
---------------------------------------------------------------------------

    \8\ Id.
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-FINRA-2018-027 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2018-027. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of FINRA. All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FINRA-2018-027 and should be submitted
on or before August 31, 2018.
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-17123 Filed 8-9-18; 8:45 am]
 BILLING CODE 8011-01-P