[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Proposed Rules]
[Pages 62760-62771]
[FR Doc No: 2018-26228]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

[EPA-HQ-ORD-2018-0280; FRL-9987-01-ORD]
RIN 2080-AA13

Protection of Human Research Subjects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On January 19, 2017, the Environmental Protection Agency
(EPA), acting in concert with other agencies, promulgated revisions to
the ``Common Rule,'' which is based on regulations for the protection
of human research subjects originally promulgated by the Department of
Health and Human Services (HHS) that were then revised and jointly
adopted by multiple departments and agencies that conduct or support
research involving human subjects. EPA's codification of these
revisions is in 40 CFR part 26, subpart A. These revisions will go into
effect on January 21, 2019. In addition to the core protections found
in the Common Rule, EPA has promulgated regulations that are specific
to research involving human subjects conducted or sponsored by EPA or
submitted to EPA for regulatory purposes. The revisions to the Common

Rule create a discrepancy within some of these EPA-specific
regulations. This proposed action is to harmonize the EPA-specific
regulations with revisions to the Common Rule in order to resolve those
discrepancies.

DATES: Comments must be received on or before February 4, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2018-0280, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Tom Sinks, Director, Office of Science
Advisor, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460 (Mail Code: 8105R); telephone number: 202-560-
3099; email address: [email protected].

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 particular interest to those who conduct human research
on substances regulated by EPA. 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 action is the agency taking?

    The Agency is proposing to amend subparts C, D, K, and M of its
regulations relating to human research. These changes are intended to
correct regulatory citation references in subparts C and D that have
been rendered ineffective by the revisions to the Common Rule, 82 FR
7149 (Jan. 19, 2017), codified by EPA at 40 CFR part 26, subpart A, and
to harmonize language in subpart K with those revisions, where
appropriate. Finally, there is a single typographical error in subpart
M that should be corrected while this action is being undertaken.
    Subparts C and D refer back to provisions in the Common Rule
codified at subpart A, and, in light of the revisions to the Common
Rule, several numerical citations (i.e., regulatory reference numbers)
in subparts C and D are no longer accurate and need to be updated.
    Subpart K, in establishing a process for review of third-party
research involving intentional exposure of human subjects, borrows
heavily from the provisions contained in the previous version of the
Common Rule. The proposed amendments would allow the Agency to align
subpart K with the revised Common Rule and maintain consistency of
Institutional Review Board (IRB) review between agency-conducted or
agency-sponsored human research and third-party human research.
    Failure to resolve these discrepancies will create confusion and,
more seriously, potential compliance and/or legal liabilities for
researchers, institutions, and sponsors who must follow EPA
regulations. In the absence of the proposed revisions to EPA-specific
subparts, there will effectively be two conflicting sets of regulations
to follow, once the Common Rule changes are reflected in subpart A and
compliance is required. These changes will reduce regulatory burdens
and potential confusion among the regulated community about which
standards to apply by enhancing consistency among those standards. In
addition, as discussed in the final rule amending the Common Rule, the
proposed amendments would enhance protections for human subjects and
improving consistency means that similar protections for human subjects
apply, regardless of who is conducting the study.

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

    The proposed rule described in this document is authorized under
provisions of the following statutes that EPA administers. The proposed
amendments to EPA's codification of the Common Rule and other
provisions regarding first- and second-party research are authorized
pursuant to 5 U.S.C. 301; the underlying Common Rule also cites to 42
U.S.C. 300v-1(b) as authority for the revisions to the Common Rule
provisions. The proposed amendments to regulations governing third-
party research involving intentional human exposure to pesticides or to
other substances where such research is used for purposes of pesticide
decision-making are authorized under the following statutory
provisions. Section 3(a) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizes EPA to regulate the distribution,
sale, or use of any unregistered pesticide in any State ``[t]o the
extent necessary to prevent unreasonable adverse effects on the
environment'' (defined at FIFRA section 2(bb), in pertinent part, as
``any unreasonable risk to man or the environment, taking into account
the economic, social, and environmental costs and benefits of the use
of any pesticide''). 7 U.S.C. 136a(a) and 136(bb). In addition, section
25(a) of FIFRA authorizes EPA to ``prescribe regulations to carry out
the provisions of [FIFRA].'' Id. at Sec.  136w(a). Section 408(e)(1)(C)
of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the
Administrator to issue a regulation establishing ``general procedures
and requirements to implement [Section 408].'' 21 U.S.C. 346a(e)(1)(C).
    EPA has also used the authority provided in section 201 of the
Department of the Interior, Environment, and Related Agencies
Appropriations Act, 2006, Public Law 109-54 (2006 Appropriations Act)
to promulgate the subparts B through Q of EPA's regulations at part 26.
    Public Law 109-54, 201, 119 Stat. 499, 531 (Aug. 2, 2005). In the
2006 Appropriations Act, Congress directed EPA to promulgate a rule on
``third-party intentional dosing human toxicity studies for pesticides
. . . '', prohibiting the use of pregnant women, infants or children as
subjects, consistent with the principles proposed in the 2004 report of
the National Academy of Sciences on intentional human dosing and the
principles of the Nuremberg Code, and establishing an independent Human
Subjects Review Board. Id.

II. Background

A. Common Rule

    In 1991, 15 federal departments and agencies, including EPA,
adopted a set of regulations intended to create a uniform body of
regulations across the federal government for the protection of human
subjects involved in research. See 56 FR 28003 (June 18, 1991).

Patterned after the regulations originally promulgated by HHS under 45
CFR part 46, this set of regulations was titled the ``Federal Policy
for the Protection of Human Subjects'' and is commonly referred to as
the ``Common Rule.'' The Common Rule regulations were subsequently
promulgated into each federal department's or agency's own set of
regulations and implemented, and are enforced at the individual
department or agency level. EPA codified the Common Rule provisions at
40 CFR part 26, subpart A.
    A number of changes in research involving human subjects have
occurred since the Common Rule was initially adopted in 1991. In 2011,
the Office of the Secretary of HHS, in coordination with the Executive
Office of the President's Office of Science and Technology Policy,
published an advance notice of proposed rulemaking, seeking comment on
areas where revisions to the Common Rule might be warranted. See 76 FR
44512 (Jul. 26, 2011). Then in 2015, HHS and the other Common Rule
agencies issued a notice of proposed rulemaking, proposing and seeking
comment on several potential regulatory revisions to the Common Rule.
See 80 FR 53931 (Sept. 8, 2015).
    On January 19, 2017, all Common Rule agencies and departments,
including EPA, adopted several revisions intended to ``modernize,
strengthen, and make [the Common Rule] more effective''. See 82 FR 7149
(Jan. 19, 2017). The preamble to the final rule noted that the
revisions are ``intended to better protect human subjects involved in
research, while facilitating valuable research and reducing burden,
delay, and ambiguity for investigators.'' Id. In brief, the January
2017 revisions established new requirements for the informed consent
process; allowed the use of broad consent (i.e., seeking prospective
consent to unspecified future research) from a subject for storage,
maintenance, and secondary research use of identifiable private
information and identifiable biospecimens; established new exempt
categories of research based on their risk profile; required the use of
a single IRB for U.S.-based cooperative research; and removed the
continuing review requirement for certain research, in addition to
making minor changes intended to improve the clarity and accuracy of
the rule. Id. at 7150. There are currently 20 Federal agencies and
departments that are signatories or have otherwise adopted the Common
Rule.
    The January 19, 2017 rule stated that its effective date and
compliance date would be January 19, 2018, with the exception of one
section (Sec.  _.114(b) (cooperative research)), which would have a
compliance date of January 20, 2020. Id. at 7274. The effective date
and January 19, 2018 compliance date were delayed until July 19, 2018,
through an interim final rule. See 83 FR 2885 (Jan. 22, 2018). Further
delay of the compliance date until January 21, 2019, was proposed in a
notice of proposed rulemaking, see 83 FR 17595 (Apr. 20, 2018), and
finalized on June 19, 2018. See 83 FR 28497.

B. EPA's Human Studies Subparts

    In addition to the Common Rule (subpart A), EPA has adopted several
additional subparts to the rule at 40 CFR 26 that provide enhanced
protection for participants in human research conducted or supported by
EPA, or certain types of third party research. These EPA-specific
subparts were added in 2006 in response to a Congressional mandate. See
EPA, Protections for Subjects in Human Research, 71 FR 6138 (Feb. 6,
2006). Specifically, Congress prohibited EPA use of certain
appropriated funds until EPA issued a rule on the subject of EPA's
acceptance, consideration, or reliance on third-party intentional
dosing human toxicity studies for pesticides. Congress mandated three
requirements for EPA's rule: (1) Prohibit the use of pregnant women,
infants or children as subjects; (2) be consistent with the principles
proposed in the 2004 report of National Academy of Sciences
``Intentional Human Dosing Studies for EPA Regulatory Purposes:
Scientific and Ethical Issues'' and the principles of the Nuremberg
Code; and (3) establish an independent Human Subjects Review Board. See
Public Law 109-54.
    In accordance with that mandate, EPA created several regulatory
subparts in addition to subpart A. Subparts B through D govern research
conducted or sponsored by EPA involving pregnant or nursing women and
children. Specifically, subpart B categorically prohibits any EPA-
conducted or EPA-sponsored research involving intentional exposure to
any substance of human subjects who are children or pregnant or nursing
women; subparts C and D provide extra protections for pregnant women
and for children who are the subjects of observational research
conducted or supported by EPA.
    EPA also created several subparts, K through Q, governing third-
party pesticide research and EPA's reliance on research involving
intentional exposure of human subjects. EPA concluded that it was
appropriate to apply equivalent ethical standards to EPA-conducted and
EPA-sponsored research, as well as to third-party research and thus in
subpart K, extended the Common Rule provisions to third-party human
research involving intentional exposure of non-pregnant, non-nursing
adults relevant to pesticide regulatory decision-making. See 70 FR
53838, 53845 (Sept. 12, 2005). EPA copied the requirements from the
Common Rule into a new subpart K with a parallel numbering system to
the Common Rule, making minor modifications that reflected the more
limited set of human research subject to subpart K. For a discussion of
those minor modifications, see 71 FR at 6147. The other subparts
prohibited use of pregnant or nursing women or children as human
subjects in third-party research involving intentional exposure
(subpart L); established requirements for submission of information on
the ethical conduct of completed human research (subpart M);
established provisions to address noncompliance of an IRB or
institution (subpart O); established a Human Studies Review Board
(HSRB) and standards for EPA and HSRB review of proposed and completed
research involving intentional exposure (subpart P); and standards for
EPA reliance on such studies (subpart Q).
    Additional modifications to subparts K through Q were made in 2013.
Among those modifications were broadening its applicability to
decision-making outside the scope of the pesticide laws and eliminating
the option for a ``legally authorized representative'' to provide
informed consent for a human subject within the context of third-party
research involving intentional exposure to pesticides or submitted for
pesticide decision making. See 78 FR 10538, 10538-39 (Feb. 14, 2013).

III. Proposed Amendments and Request for Comment

    This section of the preamble provides a description of the proposed
changes to subparts C, D, K, and M. In sum, the rationale for revisions
to subparts C, D, and K is to ensure consistency with the revisions to
40 CFR part 26, subpart A, i.e., the Common Rule; the rationale for the
revision to subpart M is to correct a minor typographical error.

A. Harmonizing Subparts C and D With the Revised Common Rule

    Subpart C: Subpart C, which sets forth additional protections for
pregnant women and fetuses involved as subjects in observational
research conducted or supported by EPA, refers back to subpart A in
several provisions. First, the text at Sec.  [thinsp]26.301(b) provides
that the exemptions found in the Common Rule are applicable to the
observational

research studies covered by subpart C. The purpose of these exemptions
is to provide a mechanism to allow for the conduct of research that is
of such low risk that full IRB review and related processes are not
warranted and would only serve to inhibit research without adding
meaningful protections for human subjects. Recognizing this, the Common
Rule pre-emptively identifies several categories of research (including
much educational and social science research, simple surveys, and use
of existing data or records) that are exempt from the full set of
regulatory requirements that follow. In the revised Common Rule, the
exempt categories were revised and expanded and moved to a different
section number. Without a regulatory correction, EPA's regulations
would no longer reference the section describing exempt research. Thus,
a study involving an innocuous survey would no longer be eligible for
exemption, and EPA researchers or grantees for such studies would need
to comply with the full requirements of the Common Rule, in contrast to
other federal agencies and grantees, which would be able to proceed
with such research outside the scope of the Common Rule.
    The second change required to subpart C is found in Sec.
[thinsp]26.301(c), which refers back to the general provisions of the
Common Rule. The revised Common Rule contains several new provisions,
including a new reference to tribal laws in the preemption provision of
the Common Rule found at Sec.  26.101(f). EPA had initially added a
provision to its subpart clarifying that tribal laws are not preempted,
but this addition is no longer necessary, with updates to the Common
Rule. Specifically, the revised Common Rule provides that: ``This
policy does not affect any state or local laws or regulations
(including tribal law passed by the official governing body of an
American Indian or Alaska Native tribe).'' (Emphasis added). The
italicized language is new, and renders redundant and unnecessary EPA's
previous statement to the same effect. In addition, the Common Rule
contains new provisions on the effective and compliance dates of the
revised Common Rule and severability, that must also be included in
subpart C for consistency in implementation.
    Subpart D: Like subpart C, subpart D also incorporates by reference
the exemptions found in subpart A. Specifically, Sec.
[thinsp]26.401(b) lists the applicable exemptions in subpart A that are
also applicable to subpart D. Unlike subpart C, however, subpart D,
which provides additional protections for children involved as subjects
in observational research conducted or supported by EPA, provides that
the Common Rule exemption for research involving survey or interview
procedures or observations of public behavior does not apply to
research covered by subpart D, except in limited circumstances. Changes
to the relevant section numbers are needed to preserve access to the
exemptions incorporated by reference, as well as the provision limiting
the application in research involving children. In addition, changes
are needed to Sec.  [thinsp]26.401(a) and (c), respectively, to remove
the now- unnecessary clarification regarding preemption of tribal laws
and to include reference to the new general provisions in the Common
Rule, including the effective date information provision.
    In practice, failing to amend subparts C and D, especially with
respect to ensuring that the applicable exemptions in subpart A are
accurately incorporated by reference, would greatly complicate the
conduct of the above types of studies that have little to no risk,
without commensurate benefit for their subjects. It would also place
EPA at odds with the scientists and institutions conducting EPA-
sponsored research, and their IRBs that review the studies, all of whom
will be applying the new Common Rule.

B. Harmonizing Subpart K With the Revised Common Rule

    As noted above, when establishing new regulations for third-party
research in 2006, EPA determined that it was appropriate to extend the
Common Rule provisions to third-party research, so that equivalent
ethical standards were applied to both research conducted and supported
by EPA and by third parties. See 70 FR at 53845. At the same time, EPA
narrowed the extension of the Common Rule provisions by limiting the
scope of subpart K to third-party research involving intentional
exposure of human subjects to pesticides and intended to be submitted
to EPA under the pesticide laws and made minor modifications to those
provisions to reflect the narrower scope of studies in subpart K. See
id.
    With the adoption of revisions to the Common Rule, EPA believes
that many of the Common Rule revisions should again be extended to
subpart K for the same reasons that EPA adopted Common Rule provisions
for the original subpart K. The Common Rule amendments, as noted above,
are intended to accommodate changes in the field of human research and
to better protect human subjects, while facilitating research and
reducing burden and delay. Those revisions can similarly apply to
research subject to subpart K. EPA continues to believe that it is
appropriate for third-party research to be held to equivalent ethical
standards as research conducted or supported by EPA. In addition, EPA
recognizes the efficiencies in having equivalent or similar standards
for regulating the ethical conduct of research involving human
subjects, regardless of who conducts that research, and the confusion
that might arise if standards are different. Many investigators and
their IRBs will be following the revised Common Rule in non-EPA
research and in EPA-sponsored research. Increased variability in
standards will likely impose greater burden on the regulated community
to keep straight and apply the different standards for review of
research. Consistency in standards will result in greater clarity and
less regulatory burden as well as less potential for confusion and
misapplication of standards for the regulated community.
    Accordingly, EPA proposes to adopt the revisions finalized for the
Common Rule in January 19, 2017, with a few exceptions that are not
relevant or appropriate given the scope of subpart K. The same
considerations that informed the original drafting of subpart K and the
reasons for the 2013 revisions, as mentioned above, inform the
harmonization of subpart K with the applicable provisions of the
revised Common Rule. As with the original drafting of subpart K, there
are some elements of the broader Common Rule that are not applicable to
the particular subset of research subject to EPA's subpart K, and
inclusion of these provisions would be confusing and problematic. These
exceptions include definitions that did not apply to third-party
studies; categories of exempt research that are not relevant to third-
party studies; requirements for Federal Register notifications that
would be redundant with the HSRB process; references to research
involving pregnant women, fetuses or children that would not be allowed
under subpart L; and provisions for alteration or waiver of informed
consent. For various reasons, these provisions would generally not be
appropriate or permissible for intentional exposure studies, so those
provisions are not included in the proposed amendments to subpart K.
EPA already determined that waiver of informed consent and consent by
legally authorized representative are not appropriate for intentional
exposure studies, nor would such studies be eligible for exemption,

so these options are not offered under subpart K. See 71 FR at 6148; 76
FR at 5744-45.
    EPA is proposing to adopt the broad consent provisions, which were
newly added in the revised Common Rule, with a clarifying statement.
There was concern that the Common Rule reference to broad consent as an
``alternative'' to the informed consent requirements might lead to
mistaken use as a replacement for, rather than an adjunct to, full
informed consent. Because this would never be appropriate for an
intentional exposure study of the type regulated under this EPA-
specific subpart, a statement was added to clarify and confirm that the
option to obtain broad consent for the limited purposes of storage,
maintenance and secondary research use of identifiable private
information or identifiable biospecimens is not a replacement for
obtaining full informed consent for the primary research involving
intentional exposure of a human subject that is subject to subpart K.
    Another similarity with the Common Rule revisions is that EPA
intends that the proposed amendments to subpart K to apply
prospectively, i.e., to research subject to subpart K that is initiated
after the final rule goes into effect. As such, EPA proposes to replace
the date in section 26.1101(a) with the date the final rule becomes
effective. This revision would not eliminate the prior obligation any
third-party had to comply with subpart K if it was conducting or
sponsoring research involving intentional exposure to human subjects
covered by subpart K that was initiated prior to that date; such
research would have had to comply with the EPA regulations in effect at
the time the research was initiated. Clarity on this point is
significant because, in contrast to other Common Rule agencies, EPA's
regulations also require a retrospective analysis of completed research
involving intentional exposure to human subjects before EPA may rely on
any such research. Specifically, section 26.1705 of EPA's regulations
applies to research that was subject to EPA's rules ``at the time it
was conducted'' and requires that EPA determine, among other things,
that certain completed research involving intentional exposure of human
subjects was conducted in substantial compliance with ``[a]ll
applicable provisions of subparts A through L . . . .'' 40 CFR 26.1705.
It is important to be clear about the scope of research subject to this
retrospective review and to ensure that the research subject to the
retrospective review is evaluated under the appropriate standards. To
avoid the misinterpretation that subpart K no longer applies to
research initiated before the effective date of the final rule and to
avoid the retrospective application of newer regulatory requirements,
EPA is proposing to add a new paragraph (h) to Sec.  26.1101,
clarifying that research initiated before the effective date of the
final rule would be subject to the standards of EPA's regulations that
were in effect at the time the research was initiated.

C. Correcting Error in Subpart M

    The existing text at 40 CFR 26.1302 reads, ``[t]he definitions in
Sec.  26.102 apply to this subpart as well.'' EPA is proposing to amend
this text to reference the definitions in subpart K, which are found at
Sec.  26.1102, instead of the definitions in subpart A, found at Sec.
26.102. With the exception of subpart M, all EPA subparts from L to Q
refer to the definitions in subpart K, which include terms necessary
and relevant to these EPA-specific subparts. Subpart M was intended to
reference the same set of definitions. See 71 FR at 6147 (indicating
that definition in section 26.1102 was intended to apply to subpart M).
This was a typographical error at the time of original drafting, which
EPA is proposing to correct.

IV. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), EPA has submitted a draft
of the proposed rule to the FIFRA Scientific Advisory Panel (SAP), the
Secretary of Agriculture (USDA), and appropriate Congressional
Committees. The SAP waived its review on June 4, 2018. USDA responded
on July 3, 2018 and had no substantive comments on the proposal. Both
responses are in the docket for this rulemaking.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review. Any changes
made in response to OMB recommendations have been documented in the
docket for this rulemaking as required by the Executive Order.
    The incremental costs of these proposed amendments both to industry
and to EPA are expected to be negligible, including the costs to
industry related to informed consent documentation and the cost to EPA
of reviewing research submitted under the revised subpart K
requirements. Entities who would be impacted by the proposed amendments
have already been accounted for in previous economic analyses for the
revised Common Rule and the 2006 and 2013 EPA rulemakings concerning
human subjects research. EPA has not, therefore, prepared a new
economic analysis for this rulemaking. The cost estimates for complying
with the 2006 rule were incremental costs of $39,000 for industry and
$808,000 for EPA (71 FR at 6166), and the costs for the 2013 amendments
were estimated to be negligible (76 FR at 5751). The costs and benefits
associated with implementing these proposed amendments, particularly
those linked to IRBs, have already been captured by the economic
analysis for the Common Rule. The costs for this rule include costs for
some additional parties, i.e., third-party investigators, who may need
to spend some time familiarizing themselves with the new requirements,
but these costs will be negligible \1\ and outweighed by the benefits
to the regulated community of having consistent standards applied to
third-party studies. In addition to providing equally protective
ethical standards to the human subjects of third-party intentional
exposure research, the benefits of greater consistency will improve
efficiencies in the oversight and review of human research, improve
understanding of the standards that apply, and reduce the potential for
misapplication of standards. This proposal provides no basis on which
to revise the cost estimates that were provided in the economic
analysis for the 2006 rulemaking or those most recently provided in the
2013 renewal of the Information Collection Request (ICR) for the
existing regulation at 40 CFR part 26.
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    \1\ The revised Common Rule economic analysis, which included
more revisions than proposed in this document, estimated that
affected individuals would spend five hours to familiarize
themselves with the changes. See 82 FR at 7238.
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B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is not expected to be subject to Executive Order 13771
because this proposed rule is expected to result in no more than de
minimis costs.

C. Paperwork Reduction Act

    This action does not impose any new information collection burden
that would require additional review or approval by OMB under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. OMB previously
approved the information collection requirements contained in the
existing regulations at 40 CFR part 26 under OMB Control No. 2070-0169.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA.
    The Agency has not identified any small entities subject to the
requirements in this proposal, but it is possible that some small
pesticide registrants may initiate research subject to EPA's Human
Studies rule. The Agency has determined that impacted small entities,
if any, may experience an impact of 0.02% as indicated in the
``Economic Analysis of Final Rule: Protections for Human Research
Participants'' (Jan. 12, 2006). The Agency does not have any
information to support revising that analysis.

E. Unfunded Mandates Reform Act

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. 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.

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

    This action does not have tribal implications as specified in
Executive Order 13175. This action is not expected to 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.

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

    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern health or safety risks that the EPA has
reason to believe may disproportionately affect children, per the
definition of ``covered regulatory action'' in section 2-202 of the
Executive Order. This action is not subject to Executive Order 13045
because it does not concern an environmental health risk or safety
risk. This action is not subject to Executive Order 13045 because it
does not establish an environmental standard intended to mitigate
health or safety risks. EPA's regulations governing research involving
human subjects 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 remain in effect and
would not be affected by the proposed amendments.

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

    This action is not a ``significant energy action'' because it is
not likely to have any effect on the supply, distribution, or use of
energy.

J. National Technology Transfer and Advancement Act

    This action does not involve any technical standards.

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

    This action does not entail special considerations of environmental
justice-related issues as delineated by Executive Order 12898. The
strengthened protections for human subjects participating in covered
research established in the 2006 rule would not be altered by these
proposed amendments.

List of Subjects in 40 CFR Part 26

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

    Dated: November 16, 2018.
Andrew R. Wheeler,
Acting Administrator.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 26--[AMENDED]

0
1. The authority citation for part 26 continues 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. Amend Sec.  26.301 by revising paragraphs (b) and (c) to read as
follows:

Sec.  [thinsp]26.301  To what does this subpart apply?

* * * * *
    (b) The exemptions at Sec.  [thinsp]26.104(d) are applicable to
this subpart.
    (c) The provisions of Sec.  [thinsp]26.101(c) through (m) are
applicable to this subpart.

0
3. Amend Sec.  [thinsp]26.401 by revising paragraphs (a) and (b) to
read as follows:

Sec.  [thinsp]26.401   To what does this subpart apply?

    (a) This subpart applies to all observational research involving
children as subjects, conducted or supported by EPA. This includes
research conducted in EPA facilities by any person and research
conducted in any facility by EPA employees.
    (b) Exemptions at Sec.  [thinsp]26.104(d)(1) and (d)(3) through
(d)(8) are applicable to this subpart. The exemption at Sec.
[thinsp]26.104(d)(2) regarding educational tests is also applicable to
this subpart. However, the exemption at Sec.  [thinsp]26.104(d)(2) for
research involving survey or interview procedures or observations of
public behavior does not apply to research covered by this subpart,
except for research involving observation of public behavior when the
investigator(s) do not participate in the activities being observed.
* * * * *

Sec.  [thinsp]26.402   [Amended]

0
4. Amend Sec.  [thinsp]26.402 by removing paragraph (g).

0
5. Amend Sec.  [thinsp]26.406 by revising the last sentence of
paragraph (a) to read as follows:

Sec.  [thinsp]26.406  Requirements for permission by parents or
guardians and for assent by children.

    (a) * * * Even where the IRB determines that the subjects are
capable of assenting, the IRB may still waive the assent requirement
under circumstances in which consent may be waived in accord with Sec.
[thinsp]26.116(e).
* * * * *

0
6. Revise subpart K, consisting of Sec. Sec.  26.1101 through 26.1125,
to read as follows:

PART 26--PROTECTION OF HUMAN RESEARCH SUBJECTS

Subpart K--Basic Ethical Requirements for Third-Party Human
Research for Pesticides Involving Intentional Exposure of Non-
Pregnant, Non-Nursing Adults

Sec.
26.1101 To what does this subpart apply
26.1102 Definitions
26.1103-26.1106 [Reserved]
26.1107 IRB membership
26.1108 IRB functions and operations
26.1109 IRB review of research
26.1110 Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research.
26.1111 Criteria for IRB approval of research
26.1112 Review by institution
26.1113 Suspension or termination of IRB approval of research
26.1114 Cooperative research
26.1115 IRB records
26.1116 General requirements for informed consent
26.1117 Documentation of informed consent
26.1118-26.1122 [Reserved]
26.1123 Early termination of research
26.1124 [Reserved]
Sec.  26.1125 Prior submission of proposed human research for EPA
review

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 [effective date
for final rule] 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.
    (c) Unless otherwise required by the Administrator, research is
exempt from this subpart if it involves only the collection or study of
existing data, documents, records, pathological specimens, or
diagnostic specimens from previously conducted studies, and if these
sources are publicly available or if the information is recorded by the
investigator in such a manner that subjects cannot be identified,
directly or through identifiers linked to the subjects.
    (d) The EPA Administrator retains final judgment as to whether a
particular activity is covered by this subpart and this judgment shall
be exercised consistent with the ethical principles of the Belmont
Report.
    (e) Compliance with this subpart requires compliance with pertinent
Federal laws or regulations that provide additional protections for
human subjects.
    (f) This subpart does not affect any state or local laws or
regulations (including tribal law passed by the official governing body
of an American Indian or Alaska Native tribe) that may otherwise be
applicable and that provide additional protections for human subjects.
    (g) This subpart does not affect any foreign laws or regulations
that may otherwise be applicable and that provide additional
protections to human subjects of research.
    (h) Notwithstanding paragraph (a), nothing in this section alters
the previous obligation to comply with EPA regulations in this subpart
that governed research involving intentional exposure of human subjects
initiated prior to [effective date of final rule] and that were in
effect and applicable to such research at the time it was initiated.

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.
    (b) Common Rule refers to the Federal Policy for the Protection of
Human Subjects as established in 1991 and codified by EPA and 14 other
Federal departments and agencies (see the Federal Register issue of
June 18, 1991 (56 FR 28003)) and its subsequent revisions as adopted by
EPA and other federal departments and agencies (see the Federal
Register issue of January 19, 2017 (82 FR 7149)). 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 or adopted
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.
    (c) Federal department or agency refers to a federal department or
agency (the department or agency itself rather than its bureaus,
offices or divisions) that takes appropriate administrative action to
make the Common Rule applicable to the research involving human
subjects it conducts, supports, or otherwise regulates (e.g., the U.S.
Department of Health and Human Services, the U.S. Department of
Defense, or the Central Intelligence Agency).
    (d)(1) Human subject means a living individual about whom an
investigator (whether professional or student) conducting research:
    (i) Obtains information or biospecimens through intervention or
interaction with the individual, and uses, studies, or analyzes the
information or biospecimens, or
    (ii) Obtains, uses, studies, analyzes, or generates identifiable
private information or identifiable biospecimens.
    (2) Intervention includes both physical procedures by which
information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are
performed for research purposes.
    (3) Interaction includes communication or interpersonal contact
between investigator and subject.
    (4) Private information includes information about behavior that
occurs in a context in which an individual can reasonably expect that
no observation or

recording is taking place, and information which has been provided for
specific purposes by an individual and which the individual can
reasonably expect will not be made public (e.g., a medical record).
    (5) Identifiable private information is private information for
which the identity of the subject is or may readily be ascertained by
the investigator or associated with the information.
    (6) An identifiable biospecimen is a biospecimen for which the
identity of the subject is or may readily be ascertained by the
investigator or associated with the biospecimen.
    (e) Institution means any public or private entity or agency
(including federal, state, and other agencies).
    (f) IRB means an institutional review board established in accord
with and for the purposes expressed in this part.
    (g) IRB approval means the determination of the IRB that the
research has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other institutional
and federal requirements.
    (h) Minimal risk means that the probability and magnitude of harm
or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or
tests.
    (i) Person means any person, as that term is defined in FIFRA
section 2(s) (7 U.S.C. 136), except:
    (1) A federal agency that is subject to the provisions of the
Federal Policy for the Protection of Human Subjects of Research, and
    (2) A person when performing human research supported by a federal
agency covered by paragraph (i)(1) of this section.
    (j) 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) Research means a systematic investigation, including research,
development, testing and evaluation, designed to develop or contribute
to generalizable knowledge. Activities that meet this definition
constitute research for purposes of this subpart, whether or not they
are considered research for other purposes. For example, some
demonstration and service programs may include research activities.
    (l) Research involving intentional exposure of a human subject
means a study of a substance in which the exposure to the substance
experienced by a human subject participating in the study would not
have occurred but for the human subject's participation in the study.
    (m) Written, or in writing, for purposes of this subpart refers to
writing on a tangible medium (e.g., paper) or in an electronic format.

Sec. Sec.  26.1103-26.1106  [Reserved]

Sec.  26.1107  IRB membership.

    (a) Each IRB shall have at least five members, with varying
backgrounds to promote complete and adequate review of research
activities that are presented for its approval. The IRB shall be
sufficiently qualified through the experience and expertise of its
members (professional competence), and the diversity of the members,
including consideration of race, gender, and cultural backgrounds and
sensitivity to such issues as community attitudes, to promote respect
for its advice and counsel in safeguarding the rights and welfare of
human subjects. The IRB shall be able to ascertain the acceptability of
proposed research in terms of institutional commitments (including
policies and resources) and regulations, applicable law, and standards
of professional conduct and practice. The IRB shall therefore include
persons knowledgeable in these areas. If an IRB regularly reviews
research that involves a category of subjects vulnerable to coercion or
undue influence, such as prisoners, individuals with impaired decision-
making capacity, or economically or educationally disadvantaged
persons, consideration shall be given to the inclusion of one or more
individuals who are knowledgeable about and experienced in working with
these categories of subjects.
    (b) Each IRB shall include at least one member whose primary
concerns are in scientific areas and at least one member whose primary
concerns are in nonscientific areas.
    (c) Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
    (d) No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the IRB.
    (e) An IRB may, in its discretion, invite individuals with
competence in special areas to assist in the review of issues that
require expertise beyond or in addition to that available on the IRB.
These individuals may not vote with the IRB.

Sec.  26.1108  IRB functions and operations.

    (a) In order to fulfill the requirements of this subpart each IRB
shall:
    (1) Have access to meeting space and sufficient staff to support
the IRB's review and recordkeeping duties;
    (2) Prepare and maintain a current list of the IRB members
identified by name; earned degrees; representative capacity;
indications of experience such as board certifications or licenses
sufficient to describe each member's chief anticipated contributions to
IRB deliberations; and any employment or other relationship between
each member and the institution, for example, full-time employee, part-
time employee, member of governing panel or board, stockholder, paid or
unpaid consultant;
    (3) Establish and follow written procedures for:
    (i) Conducting its initial and continuing review of research and
for reporting its findings and actions to the investigator and the
institution;
    (ii) Determining which projects require review more often than
annually and which projects need verification from sources other than
the investigator that no material changes have occurred since previous
IRB review;
    (iii) Ensuring prompt reporting to the IRB of proposed changes in
research activity, and for ensuring that investigators will conduct the
research activity in accordance with the terms of the IRB approval
until any proposed changes have been reviewed and approved by the IRB,
except when necessary to eliminate apparent immediate hazards to the
subject.
    (4) Establish and follow written procedures for ensuring prompt
reporting to the IRB, appropriate institutional officials, and the
Environmental Protection Agency of:
    (i) Any unanticipated problems involving risks to human subjects or
others or any instance of serious or continuing noncompliance with this
subpart or the requirements or determinations of the IRB; and
    (ii) Any suspension or termination of IRB approval.
    (b) Except when an expedited review procedure is used (see Sec.
26.1110), an IRB must review proposed research at convened meetings at
which a majority of the members of the IRB are present, including at
least one member whose primary concerns are in nonscientific areas. In
order for the research to be approved, it shall receive the approval of
a majority of those members present at the meeting.

Sec.  26.1109  IRB review of research.

    (a) An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this subpart.
    (b) An IRB shall require that information given to subjects as part
of informed consent is in accordance with Sec.  26.1116. The IRB may
require that information, in addition to that specifically mentioned in
Sec.  26.1116, be given to the subjects when, in the IRB's judgment,
the information would meaningfully add to the protection of the rights
and welfare of subjects.
    (c) An IRB shall require documentation of informed consent in
accordance with Sec.  26.1117
    (d) An IRB shall notify investigators and the institution in
writing of its decision to approve or disapprove the proposed research
activity, or of modifications required to secure IRB approval of the
research activity. If the IRB decides to disapprove a research
activity, it shall include in its written notification a statement of
the reasons for its decision and give the investigator an opportunity
to respond in person or in writing.
    (e) An IRB shall conduct continuing review of research requiring
review by the convened IRB at intervals appropriate to the degree of
risk, not less than once per year, except as described in paragraph (f)
of this section.
    (f)(1) Unless an IRB determines otherwise, continuing review of
research is not required in the following circumstances:
    (i) Research eligible for expedited review in accordance with Sec.
26.1110;
    (ii) Research that has progressed to the point that it involves
only one or both of the following, which are part of the IRB-approved
study:
    (A) Data analysis, including analysis of identifiable private
information or identifiable biospecimens, or
    (B) Accessing follow-up clinical data from procedures that subjects
would undergo as part of clinical care.
    (2) [Reserved.]
    (g) An IRB shall have authority to observe or have a third party
observe the consent process and the research.

Sec.  26.1110  Expedited review procedures for certain kinds of
research involving no more than minimal risk, and for minor changes in
approved research.

    (a) The Secretary of HHS, has established, and published as a
Notice in the Federal Register, a list of categories of research that
may be reviewed by the IRB through an expedited review procedure. The
Secretary will evaluate the list at least every 8 years and amend it,
as appropriate after consultation with other federal departments and
agencies and after publication in the Federal Register for public
comment. A copy of the list is available from the Office for Human
Research Protections, HHS, or any successor office.
    (b)(1) An IRB may use the expedited review procedure to review the
following:
    (i) Some or all of the research appearing on the list described in
paragraph (a) of this section, unless the reviewer finds that the study
involves more than minimal risk.
    (ii) Minor changes in previously approved research during the
period for which approval is authorized.
    (2) Under an expedited review procedure, the review may be carried
out by the IRB chairperson or by one or more experienced reviewers
designated by the chairperson from among members of the IRB. In
reviewing the research, the reviewers may exercise all of the
authorities of the IRB except that the reviewers may not disapprove the
research. A research activity may be disapproved only after review in
accordance with the non-expedited procedure set forth in Sec.
26.1108(b).
    (c) Each IRB that uses an expedited review procedure shall adopt a
method for keeping all members advised of research proposals that have
been approved under the procedure.
    (d) The Administrator may restrict, suspend, terminate, or choose
not to authorize an institution's or IRB's use of the expedited review
procedure for research covered by this subpart.

Sec.  26.1111  Criteria for IRB approval of research.

    (a) In order to approve research covered by this subpart the IRB
shall determine that all of the following requirements are satisfied:
    (1) Risks to subjects are minimized:
    (i) By using procedures that are consistent with sound research
design and that do not unnecessarily expose subjects to risk, and
    (ii) Whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment purposes.
    (2) Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of the knowledge that
may reasonably be expected to result. In evaluating risks and benefits,
the IRB should consider only those risks and benefits that may result
from the research (as distinguished from risks and benefits of
therapies subjects would receive even if not participating in the
research). The IRB should not consider possible long-range effects of
applying knowledge gained in the research (e.g., the possible effects
of the research on public policy) as among those research risks that
fall within the purview of its responsibility.
    (3) Selection of subjects is equitable. In making this assessment
the IRB should take into account the purposes of the research and the
setting in which the research will be conducted. The IRB should be
particularly cognizant of the special problems of research that
involves a category of subjects who are vulnerable to coercion or undue
influence, such as prisoners, individuals with impaired decision-making
capacity, or economically or educationally disadvantaged persons.
    (4) Informed consent will be sought from each prospective subject,
in accordance with, and to the extent required by Sec.  26.1116.
    (5) Informed consent will be appropriately documented in accordance
with Sec.  26.1117.
    (6) When appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of subjects.
    (7) When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
    (b) When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, such as prisoners, individuals with
impaired decision-making capacity, or economically or educationally
disadvantaged persons, additional safeguards have been included in the
study to protect the rights and welfare of these subjects.

Sec.  26.1112  Review by institution.

    Research covered by this subpart that has been approved by an IRB
may be subject to further appropriate review and approval or
disapproval by officials of the institution. However, those officials
may not approve the research if it has not been approved by an IRB.

Sec.  26.1113  Suspension or termination of IRB approval of research.

    An IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
requirements or that has been associated with unexpected serious harm
to subjects. Any suspension or termination of approval shall include a
statement of the reasons for the IRB's action and shall be reported
promptly to the investigator, appropriate institutional officials, and
the Administrator of EPA.

Sec.  26.1114  Cooperative research.

    In complying with this subpart, sponsors, investigators, or
institutions involved in multi-institutional studies may use joint
review, reliance upon the review of another qualified IRB, or similar
arrangements aimed at avoidance of duplication of effort.

Sec.  26.1115  IRB records.

    (a) An institution, or when appropriate an IRB, shall prepare and
maintain adequate documentation of IRB activities, including the
following:
    (1) Copies of all research proposals reviewed, scientific
evaluations, if any, that accompany the proposals, approved sample
consent documents, progress reports submitted by investigators, and
reports of injuries to subjects.
    (2) Minutes of IRB meetings, which shall be in sufficient detail to
show attendance at the meetings; actions taken by the IRB; the vote on
these actions including the number of members voting for, against, and
abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the discussion of controverted
issues and their resolution.
    (3) Records of continuing review activities, including the
rationale for conducting continuing review of research that otherwise
would not require continuing review as described in Sec.
26.1109(f)(1).
    (4) Copies of all correspondence between the IRB and the
investigators.
    (5) A list of IRB members in the same detail as described in Sec.
26.1108(a)(2).
    (6) Written procedures for the IRB in the same detail as described
in Sec.  26.1108(a)(3) and (4).
    (7) Statements of significant new findings provided to subjects, as
required by Sec.  26.1116(c)(5).
    (8) The rationale for an expedited reviewer's determination under
Sec.  26.1110(b)(1)(i) that research appearing on the expedited review
list described in Sec.  26.1110(a) is more than minimal risk.
    (9) Documentation specifying the responsibilities that an
institution and an organization operating an IRB each will undertake to
ensure compliance with the requirements of this subpart.
    (b) The records required by this subpart shall be retained for at
least 3 years, and records relating to research which is conducted
shall be retained for at least 3 years after completion of the
research. The institution or IRB may maintain the records in printed
form or electronically. All records shall be accessible for inspection
and copying by authorized representatives of EPA at reasonable times
and in a reasonable manner.

Sec.  26.1116  General requirements for informed consent.

    (a) General. General requirements for informed consent, whether
written or oral, are set forth in this paragraph and apply to consent
obtained in accordance with the requirements set forth in paragraphs
(b) and (c) of this section. Except as provided elsewhere in this
subpart:
    (1) Before involving a human subject in research covered by this
subpart, an investigator shall obtain the legally effective informed
consent of the subject.
    (2) An investigator shall seek informed consent only under
circumstances that provide the prospective subject sufficient
opportunity to discuss and consider whether or not to participate and
that minimize the possibility of coercion or undue influence.
    (3) The information that is given to the subject shall be in
language understandable to the subject.
    (4) The prospective subject must be provided with the information
that a reasonable person would want to have in order to make an
informed decision about whether to participate, and an opportunity to
discuss that information.
    (5)(i) Informed consent must begin with a concise and focused
presentation of the key information that is most likely to assist a
prospective subject in understanding the reasons why one might or might
not want to participate in the research. This part of the informed
consent must be organized and presented in a way that facilitates
comprehension.
    (ii) Informed consent as a whole must present information in
sufficient detail relating to the research, and must be organized and
presented in a way that does not merely provide lists of isolated
facts, but rather facilitates the prospective subject's understanding
of the reasons why one might or might not want to participate.
    (6) No informed consent 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.
    (b) Basic elements of informed consent. In seeking informed consent
the following information shall be provided to each subject:
    (1) A statement that the study involves research, an explanation of
the purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures that are experimental;
    (2) A description of any reasonably foreseeable risks or
discomforts to the subject;
    (3) A description of any benefits to the subject or to others that
may reasonably be expected from the research;
    (4) A disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the subject;
    (5) A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained;
    (6) For research involving more than minimal risk, an explanation
as to whether any compensation and an explanation as to whether any
medical treatments are available if injury occurs and, if so, what they
consist of, or where further information may be obtained;
    (7) An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom to
contact in the event of a research- related injury to the subject;
    (8) A statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
the subject is otherwise entitled; and
    (9) One of the following statements about any research that
involves the collection of identifiable private information or
identifiable biospecimens:
    (i) A statement that identifiers might be removed from the
identifiable private information or identifiable biospecimens and that,
after such removal, the information or biospecimens could be used for
future research studies or distributed to another investigator for
future research studies without additional informed consent from the
subject, if this might be a possibility; or
    (ii) A statement that the subject's information or biospecimens
collected as part of the research, even if identifiers are removed,
will not be used or distributed for future research studies.
    (c) Additional elements of informed consent. One or more of the
following elements of information, when appropriate, shall also be
provided to each subject:
    (1) A statement that the particular treatment or procedure may
involve

risks to the subject (or to the embryo or fetus, if the subject may
become pregnant) that are currently unforeseeable;
    (2) Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard to
the subject's consent;
    (3) Any additional costs to the subject that may result from
participation in the research;
    (4) The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by the
subject;
    (5) A statement that significant new findings developed during the
course of the research that may relate to the subject's willingness to
continue participation will be provided to the subject;
    (6) The approximate number of subjects involved in the study;
    (7) A statement that the subject's biospecimens (even if
identifiers are removed) may be used for commercial profit and whether
the subject will or will not share in this commercial profit;
    (8) A statement regarding whether clinically relevant research
results, including individual research results, will be disclosed to
subjects, and if so, under what conditions; and
    (9) For research involving biospecimens, whether the research will
(if known) or might include whole genome sequencing (i.e., sequencing
of a human germline or somatic specimen with the intent to generate the
genome or exome sequence of that specimen).
    (d) Elements of broad consent for the storage, maintenance, and
secondary research use of identifiable private information or
identifiable biospecimens. Broad consent for the storage, maintenance,
and secondary research use of identifiable private information or
identifiable biospecimens (collected for either research studies other
than the proposed research or non-research purposes) is permitted as an
alternative to the informed consent requirements in paragraphs (b) and
(c) of this section. Broad consent is only permitted for the purposes
mentioned and may not be substituted for the elements of informed
consent in paragraphs (b) and (c) of this section, as required for the
intentional exposure research subject to this subpart. If the subject
is asked to provide broad consent, in addition to providing the
informed consent required in paragraph (b) and (c), the following shall
be provided to each subject:
    (1) The information required in paragraphs (b)(2), (b)(3), (b)(5),
and (b)(8) and, when appropriate, (c)(7) and (9) of this section;
    (2) A general description of the types of research that may be
conducted with the identifiable private information or identifiable
biospecimens. This description must include sufficient information such
that a reasonable person would expect that the broad consent would
permit the types of research conducted;
    (3) A description of the identifiable private information or
identifiable biospecimens that might be used in research, whether
sharing of identifiable private information or identifiable
biospecimens might occur, and the types of institutions or researchers
that might conduct research with the identifiable private information
or identifiable biospecimens;
    (4) A description of the period of time that the identifiable
private information or identifiable biospecimens may be stored and
maintained (which period of time could be indefinite), and a
description of the period of time that the identifiable private
information or identifiable biospecimens may be used for research
purposes (which period of time could be indefinite);
    (5) Unless the subject will be provided details about specific
research studies, a statement that they will not be informed of the
details of any specific research studies that might be conducted using
the subject's identifiable private information or identifiable
biospecimens, including the purposes of the research, and that they
might have chosen not to consent to some of those specific research
studies;
    (6) Unless it is known that clinically relevant research results,
including individual research results, will be disclosed to the subject
in all circumstances, a statement that such results may not be
disclosed to the subject; and
    (7) An explanation of whom to contact for answers to questions
about the subject's rights and about storage and use of the subject's
identifiable private information or identifiable biospecimens, and whom
to contact in the event of a research-related harm.
    (e) Screening, recruiting, or determining eligibility. An IRB may
approve a research proposal in which an investigator will obtain
information or biospecimens for the purpose of screening, recruiting,
or determining the eligibility of prospective subjects without the
informed consent of the prospective subject, if either of the following
conditions are met:
    (1) The investigator will obtain information through oral or
written communication with the prospective subject, or
    (2) The investigator will obtain identifiable private information
or identifiable biospecimens by accessing records or stored
identifiable biospecimens.
    (f) Preemption. The informed consent requirements in this subpart
are not intended to preempt any applicable Federal, state, or local
laws (including tribal laws passed by the official governing body of an
American Indian or Alaska Native tribe) that require additional
information to be disclosed in order for informed consent to be legally
effective.
    (g) Emergency medical care. Nothing in this subpart is intended to
limit the authority of a physician to provide emergency medical care,
to the extent the physician is permitted to do so under applicable
Federal, state, or local law (including tribal law passed by the
official governing body of an American Indian or Alaska Native tribe).
    (h) Additional information for subjects when research involves a
pesticide. If the research involves intentional exposure of subjects to
a pesticide, the subjects of the research must be informed of the
identity of the pesticide and the nature of its pesticidal function.

Sec.  26.1117  Documentation of informed consent.

    (a) Informed consent shall be documented by the use of a written
consent form approved by the IRB and signed (including in an electronic
format) by the subject. A written copy shall be given to the subject.
    (b) The informed consent form may be either of the following:
    (1) A written informed consent form that meets the requirements of
Sec.  26.1116. The investigator shall give the subject adequate
opportunity to read the informed consent form before it is signed;
alternatively, this form may be read to the subject.
    (2) A short form written informed consent form stating that the
elements of informed consent required by Sec.  26.1116 have been
presented orally to the subject, and that the key information required
by Sec.  26.1116(a)(5)(i) was presented first to the subject, before
other information, if any, was provided. The IRB shall approve a
written summary of what is to be said to the subject. When this method
is used, there shall be a witness to the oral presentation. Only the
short form itself is to be signed by the subject. However, the witness
shall sign both the short form and a copy of the summary, and the
person actually obtaining consent

shall 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.

Sec. Sec.  26.1118-26.1122  [Reserved]

Sec.  26.1123  Early termination of research.

    The Administrator may require that any project covered by this
subpart be terminated or suspended when the Administrator finds that an
IRB, investigator, sponsor, or institution has materially failed to
comply with the terms of this subpart.

Sec.  26.1124  [Reserved]

Sec.  26.1125   Prior submission of proposed human research for EPA
review.

    Any person or institution who intends to conduct or sponsor human
research covered by Sec.  26.1101(a) shall, after receiving approval
from all appropriate IRBs, submit to EPA prior to initiating such
research all information relevant to the proposed research specified by
Sec.  26.1115(a), and the following additional information, to the
extent not already included:
    (a) A discussion of:
    (1) The potential risks to human subjects;
    (2) The measures proposed to minimize risks to the human subjects;
    (3) The nature and magnitude of all expected benefits of such
research, and to whom they would accrue;
    (4) Alternative means of obtaining information comparable to what
would be collected through the proposed research; and
    (5) The balance of risks and benefits of the proposed research.
    (b) All information for subjects and written informed consent
agreements as originally provided to the IRB, and as approved by the
IRB.
    (c) Information about how subjects will be recruited, including any
advertisements proposed to be used.
    (d) A description of the circumstances and methods proposed for
presenting information to potential human subjects for the purpose of
obtaining their informed consent.
    (e) All correspondence between the IRB and the investigators or
sponsors.
    (f) Official notification to the sponsor or investigator, in
accordance with the requirements of this subpart, that research
involving human subjects has been reviewed and approved by an IRB.

0
7. Revise Sec.  26.1302 to read as follows:

Sec.  [thinsp]26.1302  Definitions.

    The definitions in Sec.  26.1102 apply to this subpart as well.

[FR Doc. 2018-26228 Filed 12-4-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 18, 2009 (Volume 74, Number 158)]
[Notices]
[Page 41734]
[DOCID:fr18au09-63]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Development of Antiviral Products for Treatment of Smallpox and
Related Poxvirus Infections; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
workshop regarding scientific issues in clinical development of
antiviral drug products for treatment of smallpox and related poxvirus
infections. This public workshop is intended to provide information for
and gain perspective from health care providers, academia, and industry
on various aspects of antiviral product development for smallpox and
related poxvirus infections, including the status of clinical
understanding of smallpox from pre-eradication experience, current
epidemiology of naturally occurring poxvirus infections, potential
effect of antiviral treatment for smallpox and related poxvirus
infections, and issues pertaining to animal models for smallpox and
related poxvirus infections. The input from this public workshop will
help in developing topics for further discussion.
    Dates and Times: The public workshop will be held on September 1,
2009, from 8:30 a.m. to 5:30 p.m. and on September 2, 2009, from 8 a.m.
to 4 p.m.
    Location: The public workshop will be held at the Crowne Plaza
Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910.
    Contact Person: Chris Moser or Lori Benner, Center for Drug
Evaluation and Research, Food and Drug Administration, Office of
Antimicrobial Products, New Hampshire Ave., Bldg. 22, rm. 6209, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    Registration: To register electronically, e-mail registration
information (including name, title, firm name, address, telephone, and
fax number) to<EMAIL_ADDRESS>by August 24, 2009. Persons
without access to the Internet can call<PHONE_NUMBER> to register.
Registration is free for the public workshop, but interested parties
are encouraged to register early because spaced is limited. Seating
will be available on a first-come, first-served basis. Persons needing
a sign language interpreter or other special accommodations should
notify Christine Moser or Lori Benner (see Contact Person) at least 7
days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding antiviral drug development for smallpox and related poxvirus
infections. This public workshop will focus on scientific
considerations in the clinical development of products for treatment of
smallpox and related poxvirus infections. This public workshop is
intended to provide information regarding historical perspectives on
smallpox and current perspectives on related poxvirus infections in
humans. The workshop will explore approaches to assessing the potential
effect of antiviral treatment for smallpox and related poxvirus
infections. Issues pertaining to animal models for smallpox and related
poxvirus infection and their relationship to disease in humans will be
discussed at the workshop. In addition, the workshop will include
perspectives of public health organizations on possible uses of an
antiviral product for poxvirus infections.
    The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the public workshop, at a cost of
10 cents per page. Transcripts will also be available on the Internet
at http://www.fda.gov/Drugs/NewsEvents/ucm169065.htm approximately 45
days after the workshop.

    Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19781 Filed 8-17-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 143 (Monday, July 27, 2015)]
[Notices]
[Page 44370]
[FR Doc No: 2015-18273]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2015-0010; OMB No. 1660-0070]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; National Fire Department Census

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed extension, without change, of a currently
approved collection. In accordance with the Paperwork Reduction Act of
1995, this notice seeks comments concerning the use of a form to
collect data for the development and continuation of the National Fire
Department Census.

DATES: Comments must be submitted on or before August 26, 2015.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, 500 C Street SW., Washington, DC 20472-
3100, or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on May 6, 2015 at 80 FR
26071 with a 60 day public comment period. No comments were received.
The purpose of this notice is to notify the public that FEMA will
submit the information collection abstracted below to the Office of
Management and Budget for review and clearance.

Collection of Information

    Title: National Fire Department Census.
    Type of information collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0070.
    Form Titles and Numbers: FEMA Form 070-0-0-1, National Fire
Department Census.
    Abstract: This collection seeks to identify fire departments in the
United States to compile and update a database related to their
demographics, capabilities, and activities. The database is used to
guide programmatic decisions and provide information to the public and
the fire service.
    Affected Public: State, Local, or Tribal Government.
    Estimated Number of Respondents: 8,280.
    Estimated Total Annual Burden Hours: 2,093 hours.
    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $10,072. The estimated annual cost to respondents
operations and maintenance costs for technical services is $0. There
are no annual start-up or capital costs. The cost to the Federal
government is $88,866.

    Dated: July 16, 2015.
Janice Waller,
Acting, Director, Records Management Division, Mission Support Bureau,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2015-18273 Filed 7-24-15; 8:45 am]
BILLING CODE 9111-45-P


[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22319-22320]
[FR Doc No: 2016-08761]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0043]

TUV SUD America Inc.: Grant of Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces its final decision to expand
the scope of recognition for TUV SUD America Inc. as a Nationally
Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
April 15, 2016.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; telephone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's Web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of TUV SUD America Inc. (TUVAM) as an NRTL. TUVAM's
expansion covers the addition of one test standard to its scope of
recognition.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an

acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that require
testing and certification of the products.
    The Agency processes applications by an NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding and, in the second
notice, the Agency provides its final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational Web page
for each NRTL that details its scope of recognition. These pages are
available from the Agency's Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    TUVAM submitted an application, dated August 10, 2015 (OSHA-2007-
0043-0018) to expand its recognition to include one additional test
standard. OSHA staff performed a comparability analysis and reviewed
other pertinent information. OSHA did not perform any on-site reviews
in relation to this application.
    OSHA published the preliminary notice announcing TUVAM's expansion
application in the Federal Register on January 22, 2016 (81 FR 3833).
The Agency requested comments by February 8, 2016, but it received no
comments in response to this notice. OSHA now is proceeding with this
final notice to grant expansion of TUVAM's scope of recognition.
    To obtain or review copies of all public documents pertaining to
TUVAM's application, go to www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC
20210. Docket No. OSHA-2007-0043 contains all materials in the record
concerning TUVAM's recognition.

II. Final Decision and Order

    OSHA staff examined TUVAM's expansion application, its capability
to meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that
TUVAM meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the limitation and conditions listed below.
OSHA, therefore, is proceeding with this final notice to grant TUVAM's
scope of recognition. OSHA limits the expansion of TUVAM's recognition
to testing and certification of products for demonstration of
conformance to the test standard listed in Table 1 below.

 Table 1--Appropriate Test Standard for Inclusion in TUVAM's NRTL Scope
                             of Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
UL 62368-1........................  Audio/Video, information and
                                     communication technology equipment--
                                     Part 1: Safety Requirements.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, an
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standard listed above as an American National Standard. However,
for convenience, we may use the designation of the standards-developing
organization for the standard as opposed to the ANSI designation. Under
the NRTL Program's policy (see OSHA Instruction CPL 1-0.3, Appendix C,
paragraph XIV), any NRTL recognized for a particular test standard may
use either the proprietary version of the test standard or the ANSI
version of that standard. Contact ANSI to determine whether a test
standard is currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
TUVAM must abide by the following conditions of the recognition:
    1. TUVAM must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as an NRTL, and provide details of the
change(s);
    2. TUVAM must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. TUVAM must continue to meet the requirements for recognition,
including all previously published conditions on TUVAM's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of TUVAM, subject to the limitation and conditions
specified above.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on April 12, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-08761 Filed 4-14-16; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Proposed Rules]
[Page 23866]
[FR Doc No: 2013-09428]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0678; Directorate Identifier 2010-NM-020-AD]
RIN 2120-AA64

Airworthiness Directives; the Boeing Company

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Proposed rule; withdrawal.

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

SUMMARY: The FAA withdraws a notice of proposed rulemaking (NPRM) that
proposed a new airworthiness directive (AD) for certain The Boeing
Company Model 777-200 and -300 series airplanes. The proposed AD would
have required installing new operational software in the cabin
management system, and loading new software into the mass memory card.
Since the proposed AD was issued, we have received new data that
indicates the unsafe condition would not be adequately addressed by the
proposed action. Subsequently, we are considering issuing new
rulemaking that positively addresses the unsafe condition identified in
the NPRM and eliminates the need for the actions proposed in the NPRM.
Accordingly, the proposed AD is withdrawn.

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

FOR FURTHER INFORMATION CONTACT: Ray Mei, Aerospace Engineer, Systems
and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6467; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We proposed to amend part 39 of the Federal Aviation Regulations
(14 CFR part 39) with a notice of proposed rulemaking (NPRM) for a new
AD for certain Model 777-200 and -300 series airplanes. That NPRM
published in the Federal Register on July 7, 2010 (75 FR 38945). The
NPRM would have required installing new operational software in the
cabin management system, and loading new software into the mass memory
card. The NPRM resulted from an in-flight entertainment (IFE) systems
review. The proposed actions were intended to ensure that the
flightcrew is able to turn off electrical power to the IFE system and
other non-essential electrical systems through a switch in the flight
compartment in the event of smoke or flames. In the event of smoke or
flames in the airplane flight deck or passenger cabin, the flightcrew's
inability to turn off electrical power to the IFE system and other non-
essential electrical systems could result in the inability to control
smoke or flames in the airplane flight deck or passenger cabin during a
non-normal or emergency situation.

Actions Since NPRM (75 FR 38945, July 7, 2010) Was Issued

    Since we issued the NPRM (75 FR 38945, July 7, 2010), we have
received new data that the actions that indicates the unsafe condition
would not be adequately addressed by the proposed action. Subsequently,
we are considering issuing new rulemaking that positively addresses the
unsafe condition identified in the NPRM and eliminates the need for the
actions proposed in the NPRM.

FAA's Conclusions

    Upon further consideration, we have determined that the unsafe
condition still exists, however, we intend to address it with new AD
rulemaking. Accordingly, the NPRM (75 FR 38945, July 7, 2010) is
withdrawn.
    Withdrawal of the NPRM (75 FR 38945, July 7, 2010) does not
preclude the FAA from issuing another related action or commit the FAA
to any course of action in the future.

Regulatory Impact

    Since this action only withdraws an NPRM (75 FR 38945, July 7,
2010), it is neither a proposed nor a final rule and therefore is not
covered under Executive Order 12866, the Regulatory Flexibility Act, or
DOT Regulatory Policies and Procedures (44 FR 11034, February 26,
1979).

List of Subjects in 14 CFR Part 39

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

The Withdrawal

    Accordingly, we withdraw the NPRM, Docket No. FAA-2010-0678,
Directorate Identifier 2010-NM-020-AD, which published in the Federal
Register on July 7, 2010 (75 FR 38945).

    Issued in Renton, Washington, on February 1, 2013.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-09428 Filed 4-22-13; 8:45 am]
BILLING CODE 4910-13-P