[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10124]
[FR Doc No: 2021-03283]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3552-EM; Docket ID FEMA-2021-0001]

Tennessee; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of Tennessee (FEMA-3552-EM), dated January 5,
2021, and related determinations.

DATES: The declaration was issued January 5, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated January 5, 2021, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of Tennessee resulting from an explosion on December
25, 2020, are of sufficient severity and magnitude to warrant an
emergency declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (``the Stafford
Act''). Therefore, I declare that such an emergency exists in the
State of Tennessee.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs. In order to provide Federal assistance, you are
hereby authorized to allocate from funds available for these
purposes such amounts as you find necessary for Federal emergency
assistance and administrative expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended, Myra M.
Shird, of FEMA is appointed to act as the Federal Coordinating Officer
for this declared emergency.
    The following areas of the State of Tennessee have been designated
as adversely affected by this declared emergency:

    Emergency protective measures (Category B), limited to direct
federal assistance, under the Public Assistance program for Davidson
County.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03283 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Rules and Regulations]
[Pages 45654-45657]
[FR Doc No: 2022-16043]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2020-0437; FRL-8698-02-R6]

Air Plan Approval; Oklahoma; Volatile Organic Compound Emissions
in Nonattainment Areas and Former Nonattainment Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving revisions to the
State Implementation Plan (SIP) for Oklahoma submitted by the State of
Oklahoma designee with a letter dated May 7, 2020. The submittal covers
updates to the Oklahoma SIP, as contained in the State's 2019 annual
SIP update. Specifically, this action addresses revisions to Oklahoma
Administrative Code (OAC) Title 252 Chapter 100 Subchapter 39, Emission
of Volatile Organic Compounds (VOCs) in Nonattainment Areas and Former
Nonattainment Areas. There are two Oklahoma counties affected by this
action: Tulsa County and Oklahoma County.

DATES: This rule is effective on August 29, 2022.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2020-0437. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet. Publicly available docket
materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Clovis Steib, EPA Region 6 Office,
Infrastructure and Ozone Section,<PHONE_NUMBER>, [email protected].
Out of an abundance of caution for members of the public and our staff,
the EPA Region 6 office may be closed to the public to reduce the risk
of transmitting COVID-19. Please call or email the contact listed above
if you need alternative access to material indexed but not provided in
the docket.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our July
22, 2021, proposal (86 FR 38627). In that document we proposed to
approve revisions to the SIP for Oklahoma submitted by the State of
Oklahoma with a letter dated May 7, 2020. Specifically, the action
addressed revisions to OAC Title 252 Chapter 100 Subchapter 39,
Sections 4, 16, 40, and 41. The revisions corrected errors and made
these sections of the Oklahoma SIP consistent with EPA's rules. The two
areas in Oklahoma affected by this action are Tulsa County and Oklahoma
County.
    We received comments on our proposal from one commenter. Our
response to the comments follows.

II. Response to Comments

    Comment: One commenter stated that it is important for citizens to
stay informed and be kept up to date on Federal government revisions
and regulations, such as this proposed approval action on the Oklahoma
SIP.
    Response: Public comment is just one part of an extensive
rulemaking process. It is an invaluable gateway to plug in to the
regulatory process because it is required of all agencies, across
statutes, for any new regulation. Under the Administrative Procedures
Act (1946), Federal agencies like the EPA, are required to request
comments on new regulation proposals by all members of the public. We
thank the commenter for their interest and taking the time to submit
their response; as well as encouraging their fellow citizens to engage
in the public comment process. No changes to the proposal were made in
response to the comment.

III. Impact on Areas of Indian Country

    As stated in the proposed action, following the U.S. Supreme Court
decision in McGirt v. Oklahoma, 140 S.Ct. 2452 (2020), the Governor of
the State of Oklahoma requested approval under Section 10211(a) of the
Safe, Accountable, Flexible, Efficient Transportation Equity Act of
2005: A Legacy for Users, Public Law 109-59, 119 Stat. 1144, 1937
(August 10, 2005) (``SAFETEA''), to administer in certain areas of
Indian country (as defined at 18 U.S.C. 1151) the State's environmental
regulatory programs that were previously approved by the EPA outside of
Indian country.\1\ The State's request excluded certain areas of Indian
country further described below. In addition, the State only sought
approval to the extent that such approval is necessary for the State to
administer a program in light of Oklahoma Dept. of Environmental
Quality v. EPA, 740 F.3d 185 (D.C. Cir. 2014).\2\
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    \1\ A copy of the Governor's July 22, 2020, request can be found
in the docket for this rulemaking on the https://www.regulations.gov
website. See Docket ID No. EPA-R06-OAR-2020-0437.
    \2\ In ODEQ v. EPA, the D.C. Circuit held that under the CAA, a
state has the authority to implement a SIP in non-reservation areas
of Indian country in the state, where there has been no
demonstration of tribal jurisdiction. Under the D.C. Circuit's
decision, the CAA does not provide authority to states to implement
SIPs in Indian reservations. ODEQ did not, however, substantively
address the separate authority in Indian country provided
specifically to Oklahoma under SAFETEA. That separate authority was
not invoked until the State submitted its request under SAFETEA, and
was not approved until EPA's decision, described in this section, on
October 1, 2020.
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    On October 1, 2020, the EPA approved Oklahoma's SAFETEA request to
administer all of the State's EPA-approved environmental regulatory
programs, including the Oklahoma SIP, in the requested areas of Indian
country.\3\ As requested by Oklahoma, the EPA's approval under SAFETEA
does not include Indian country lands, including rights-of-way running
through the same, that: (1) qualify as Indian allotments, the Indian
titles to which have not been extinguished, under 18 U.S.C. 1151(c);
(2) are held in trust by the United States on behalf of an individual
Indian or Tribe; or (3) are owned in fee by a Tribe, if the Tribe (a)
acquired that fee title to such land, or an area that included such
land, in accordance with a treaty with the United States to which such
Tribe was a party, and (b) never allotted the land to a member or
citizen of the Tribe (collectively ``excluded Indian country lands'').
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    \3\ A copy of EPA's October 1, 2020, approval can be found in
the docket for this rulemaking on the https://www.regulations.gov
website. See Docket ID No. EPA-R06-OAR-2020-0437.
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    EPA's approval under SAFETEA expressly provided that to the extent
EPA's prior approvals of Oklahoma's environmental programs excluded

Indian country, any such exclusions are superseded for the geographic
areas of Indian country covered by the EPA's approval of Oklahoma's
SAFETEA request.\4\ The approval also provided that future revisions or
amendments to Oklahoma's approved environmental regulatory programs
would extend to the covered areas of Indian country (without any
further need for additional requests under SAFETEA).\5\
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    \4\ EPA's prior approvals relating to Oklahoma's SIP frequently
noted that the SIP was not approved to apply in areas of Indian
country (consistent with the D.C. Circuit's decision in ODEQ v. EPA)
located in the state. See, e.g., 85 FR 20178, 20180 (April 10,
2020). Such prior expressed limitations are superseded by the EPA's
approval of Oklahoma's SAFETEA request.
    \5\ On December 22, 2021, the EPA proposed to withdraw and
reconsider the October 1, 2020, SAFETEA approval. See https://www.epa.gov/ok/proposed-withdrawal-and-reconsideration-and-supporting-information. The EPA expects to have further discussions
with tribal governments and the State of Oklahoma as part of this
reconsideration. The EPA also notes that the October 1, 2020,
approval is the subject of a pending challenge in federal court.
Pawnee Nation of Oklahoma v. Regan, No. 20-9635 (10th Cir.). The EPA
may make further changes to the approval of Oklahoma's program to
reflect the outcome of the proposed withdrawal and reconsideration
of the October 1, 2020, SAFETEA approval.
---------------------------------------------------------------------------

    As explained above, the EPA is approving revisions to the SIP for
Oklahoma submitted by the State of Oklahoma with a letter dated May 7,
2020. Specifically, the action addressed revisions to OAC Title 252
Chapter 100 Subchapter 39, Sections 4, 16, 40, and 41. The revisions
corrected errors and made these sections of the Oklahoma SIP consistent
with EPA's rules. Consistent with the D.C. Circuit's decision in ODEQ
v. EPA and with EPA's October 1, 2020, SAFETEA approval, this portion
of the SIP applies in certain areas of Indian country. Under EPA's
October 1, 2020 SAFETEA approval, the SIP revisions approved in this
rulemaking action will apply to all Indian country within Tulsa and
Oklahoma Counties, other than the excluded Indian country lands, as
described above. Because--per the State's request under SAFETEA--EPA's
October 1, 2020 approval does not displace any SIP authority previously
exercised by the State under the CAA as interpreted in ODEQ v. EPA, the
approved SIP revisions for Oklahoma County and Tulsa County will also
apply to any Indian allotments or dependent Indian communities located
outside of an Indian reservation over which there has been no
demonstration of tribal authority.

IV. Environmental Justice Considerations

    Executive Order 12898 (Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
Feb. 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
The EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' \6\ The EPA further defines the term fair treatment to mean
that ``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.'' \7\ EPA is providing
additional analysis of environmental justice associated with this
action. We are doing so for the purpose of providing information to the
public, not as a basis of our final action.
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    \6\ See https://www.epa.gov/environmentaljustice/learn-about-environmental-justice.
    \7\ https://www.epa.gov/environmentaljustice/learn-about-environmental-justice.
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    EPA reviewed demographic data, which provides an assessment of
individual demographic groups of the populations living within the
affected Oklahoma and Tulsa counties area.\8\ The EPA then compared the
data to the national average for each of the demographic groups.\9\ The
results of the demographic analysis indicate that, for populations
within Tulsa and Oklahoma counties, the percent people of color
(persons who reported their race as a category other than white alone
(not Hispanic or Latino)) is slightly less than the national average
for Tulsa County; and slightly more than the national average for
Oklahoma County (38 and 44 percent, respectively versus 40 percent).
Within people of color, the percent of the population that is Black or
African American alone is below the national average for Tulsa County
and above the national average for Oklahoma County (10.8 and 15.8
percent, respectively versus 13.4 percent), and the percent of the
population that is American Indian/Alaska Native is higher than the
national average for both Tulsa and Oklahoma counties (6.9 and 4.4
percent, respectively versus 1.3 percent). The percent of the
population that is ``two or more races'' is higher than the national
average for both Tulsa and Oklahoma counties (6.2 and 5.4 percent,
respectively versus 2.8 percent). The percent of people living below
the poverty level in Tulsa and Oklahoma counties is higher than the
national average (12.8 and 15.2 percent, respectively versus 11.4
percent). The percent of people over 25 with a high school diploma in
Tulsa and Oklahoma counties is similar to the national average (89.9
and 88 percent, respectively versus 88.5 percent), as is the percent
with a ``bachelor's degree or higher'' (32 and 33.1 percent,
respectively versus 32.9 percent).
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    \8\ See the United States Census Bureau's QuickFacts on Oklahoma
at https://www.census.gov/quickfacts/fact/table/OK,US/PST045221.
    \9\ See the United States Census Bureau's QuickFacts on Oklahoma
at https://www.census.gov/quickfacts/fact/table/OK,US/PST045221.
---------------------------------------------------------------------------

    The SIP revisions do not appear to have a disproportionately high
or adverse human health or environmental effects on communities with EJ
concerns as the changes to the Oklahoma SIP will result in updates and
clarifications an also further restrict the use of cutback asphalt.
Since the use of cutback asphalt is prohibited for a longer period of
time each year communities throughout the affected counties will
realize benefits.

V. Final Action

    We are approving revisions to OAC 252:100-39, Emission of VOCs in
Nonattainment Areas and Former Nonattainment Areas, in Section 4
(Exemptions), Section 16 (Petroleum refinery process unit turnaround),
Section 40 (Cutback asphalt), and Section 41 (Storage, loading and
transport/delivery of VOCs) as submitted to us by a letter dated May 7,
2020 (Submittal). The submittal covers Oklahoma's 2019 regulatory
update. This action is being taken under section 110 of the Act.

VI. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, the EPA is finalizing the incorporation by reference the
revisions to the Oklahoma regulations, as described in the Final Action
section above. The EPA has made, and will continue to make, these
materials generally available through www.regulations.gov (please
contact the person identified in the FOR FURTHER

INFORMATION CONTACT section of this preamble for more information).
Therefore, these materials have been approved by EPA for inclusion in
the SIP, have been incorporated by reference by EPA into that plan, are
fully federally enforceable under sections 110 and 113 of the CAA as of
the effective date of the final rulemaking of EPA's approval, and will
be incorporated in the next update to the SIP compilation.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    This approval of revisions to the Oklahoma SIP will apply to
certain areas of Indian country in Tulsa and Oklahoma Counties, as
discussed in the preamble, and therefore has tribal implications as
specified in E.O. 13175 (65 FR 67249, November 9, 2000). However, this
action will neither impose substantial direct compliance costs on
federally recognized tribal governments, nor preempt tribal law. This
action will not impose substantial direct compliance costs on federally
recognized tribal governments because no actions will be required of
tribal governments. This action will also not preempt tribal law as no
Oklahoma tribe implements a regulatory program under the CAA, and thus
does not have applicable or related tribal laws. Consistent with the
EPA Policy on Consultation and Coordination with Indian Tribes (May 4,
2011), the EPA offered consultation to tribal governments that may be
affected by this action. EPA received no comments or requests for
consultation from tribal governments.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 27, 2022. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Volatile organic compounds.

    Dated: July 20, 2022.
Earthea Nance,
Regional Administrator, Region 6.

    For the reasons stated in the preamble, the Environmental
Protection Agency amends 40 CFR part 52 as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart LL--Oklahoma

0
2. In Sec.  52.1920 in paragraph (c) amend the table ``EPA APPROVED
OKLAHOMA REGULATIONS'' by revising the entries for ``252:100-39-4,''
``252:100-39-16,'' ``252:100-39-40,'' and ``252:100-39-41'' to read as
follows.
* * * * *
    (c) * * *

                                        EPA Approved Oklahoma Regulations
----------------------------------------------------------------------------------------------------------------
                                                      State
       State citation           Title/subject       effective    EPA approval date           Explanation
                                                      date
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                  OKLAHOMA ADMINISTRATIVE CODE, TITLE 252. DEPARTMENT OF ENVIRONMENTAL QUALITY
----------------------------------------------------------------------------------------------------------------
                                CHAPTER 100 (OAC 252:100). AIR POLLUTION CONTROL
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                       Subchapter 39. Emission of Organic Materials in Nonattainment Areas
----------------------------------------------------------------------------------------------------------------
                                           Part 1. General Provisions
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
252:100-39-4...............  Exemptions........       9/15/2019  7/29/2022,
                                                                  [Insert Federal
                                                                  Register
                                                                  citation].
----------------------------------------------------------------------------------------------------------------
                                      Part 3. Petroleum Refinery Operations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
252:100-39-16..............  Petroleum refinery       9/15/2019  7/29/2022,
                              process unit                        [Insert Federal
                              turnaround.                         Register
                                                                  citation].

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                                           Part 7. Specific Operations
----------------------------------------------------------------------------------------------------------------
252:100-39-40..............  Cutback asphalt          9/15/2019  7/29/2022,
                              (paving).                           [Insert Federal
                                                                  Register
                                                                  citation].
252:100-39-41..............  Storage, loading         9/15/2019  7/29/2022,
                              and transport/                      [Insert Federal
                              delivery of VOCs.                   Register
                                                                  citation].

                                                  * * * * * * *
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[FR Doc. 2022-16043 Filed 7-28-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Notices]
[Pages 49776-49777]
[FR Doc No: 2011-20367]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

The Development and Evaluation of Next-Generation Smallpox
Vaccines; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) Center for Biologics
Evaluation and Research (CBER) and the National Institutes of Health,
the National Institute of Allergy and Infectious Diseases are
announcing a public workshop entitled ``The Development and Evaluation
of Next-Generation Smallpox Vaccines.'' The purpose of the public
workshop is to identify and discuss the key issues related to the
development and evaluation of next-generation smallpox vaccines. The
public workshop will include presentations on the human response to
smallpox vaccines and development of animal models for demonstration of
effectiveness of next-generation smallpox vaccines.
    Date and Time: The public workshop will be held on September 16,
2011, from 8 a.m. to 5:30 p.m.
    Location: The public workshop will be held at the Hilton Washington
DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.
    Contact Person: Bernadette Williamson-Taylor, Center for Biologics
Evaluation and Research (HFM-43), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>,
Fax:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>(in the subject
line type ``Smallpox Workshop'').
    Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to the contact person by August 23, 2011. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Bernadette Williamson-Taylor (see Contact Person) at least 7
days in advance.

SUPPLEMENTARY INFORMATION: Smallpox is a serious, highly contagious,
and sometimes fatal infectious disease. Although the World Health
Organization declared the disease eradicated in 1980, the threat of
smallpox as a biological weapon remains. Vaccination is the only
prevention for the disease and there are currently no FDA-approved
treatments.
    First-generation smallpox vaccines were prepared on the skin of
calves or other animals or in chicken eggs. Although these vaccines
were not evaluated for efficacy in well-controlled trials, they were
highly effective as evidenced by the successful global eradication of
smallpox. Manufacturing of these vaccines has ceased and they are no
longer licensed in the United States.
    In 2007, FDA licensed the first second-generation smallpox vaccine,
ACAM2000. This vaccine is based on a single plaque-purified vaccinia
virus derivative of Dryvax (a previously licensed first-generation
vaccine) and is aseptically propagated using cell culture technology
under modern manufacturing practices and standards. Both ACAM2000 and
Dryvax are derived from the New York City Board of Health strain and
produce a vesicular or pustular lesion (referred to as a ``vaccine
take'') that has been shown to correlate with protection. In clinical
trials, ACAM2000 elicited vaccinia-neutralizing antibodies and cell-
mediated immune responses, with both clinical and immunological
outcomes similar to Dryvax.
    Because ACAM2000 may cause serious adverse reactions, there is a
desire to develop safer vaccines should there be a need to vaccinate
the general population due to a threat of an attack with the smallpox
virus. Currently, the next-generation smallpox vaccines under
development do not produce the characteristic ``vaccine take.'' In
addition, it is not ethical or feasible to evaluate the effectiveness
of these vaccines in humans as the natural disease has been eradicated.
Therefore, the effectiveness of these next-generation smallpox vaccines
may be based on animal efficacy data, if scientifically appropriate,
and to comparative human immune response data. As for any biologic
product, licensure of new smallpox vaccines requires demonstration of
safety, purity, and potency.
    The public workshop will: (1) Discuss regulatory challenges and
approaches related to the licensure of next-generation smallpox
vaccines; (2) discuss the strengths and weaknesses of various animal
models relative to their ability to mimic human disease that can be
used to predict the effectiveness of

next-generation smallpox vaccines in humans; (3) discuss the most
appropriate methods to bridge immunogenicity of next-generation
smallpox vaccines to licensed smallpox vaccines in clinical trials; and
(4) discuss viable methods of extrapolating clinical efficacy of next-
generation smallpox vaccines from immunogenicity and efficacy data from
relevant animal models.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Division of Freedom of Information Office (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857, approximately 15 working days after the public
workshop at a cost of 10 cents per page. A transcript of the public
workshop will be available on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.

    Dated: August 4, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20367 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40694-40695]
[FR Doc No: 2016-14763]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC16-93-000.
    Applicants: Atlas Power Finance, LLC, Dynegy Inc., Energy Capital
Partners III, LLC, GDF Suez Energy North America, Inc.
    Description: Supplement to March 25, 2016 Joint Application for
Authorization under FPA Section 203 of Atlas Power Finance, et al.
    Filed Date: 6/15/16.
    Accession Number: 20160615-5149.
    Comments Due: 5 p.m. ET 6/29/16.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER16-1254-002.
    Applicants: MMP SCO, LLC.
    Description: Tariff Amendment: Second Amendment to Application for
Market-Based Rate Authorization to be effective 6/15/2016.
    Filed Date: 6/15/16.
    Accession Number: 20160615-5131.
    Comments Due: 5 p.m. ET 6/27/16.

    Docket Numbers: ER16-1882-000.
    Applicants: Boulder Solar Power, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Tariff to
be effective 7/1/2016.
    Filed Date: 6/3/16.
    Accession Number: 20160603-5296.
    Comments Due: 5 p.m. ET 6/24/16.

    Docket Numbers: ER16-1940-000.
    Applicants: Idaho Power Company.
    Description: Sec.  205(d) Rate Filing: SA 358--Construction
Agreement with PAC for Siphon Tap-Pingree Tap Line Rebuild to be
effective 6/1/2016.
    Filed Date: 6/16/16.
    Accession Number: 20160616-5000.
    Comments Due: 5 p.m. ET 7/7/16.

    Docket Numbers: ER16-1941-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: 2016 Revised Added
Facilities Rate under WDAT--Filing No. 14 to be effective 1/1/2016.
    Filed Date: 6/16/16.
    Accession Number: 20160616-5003.
    Comments Due: 5 p.m. ET 7/7/16.

    Docket Numbers: ER16-1942-000.
    Applicants: WM North Broward, Inc.
    Description: Notice of Cancellation market-based rate tariff of WM
North Broward, Inc.
    Filed Date: 6/16/16.
    Accession Number: 20160616-5042.
    Comments Due: 5 p.m. ET 7/7/16.

    Docket Numbers: ER16-1943-000.
    Applicants: Illinois Power Marketing Company.
    Description: Compliance filing: 2013 System Support Resource
Agreement Compliance Filing to be effective 1/1/2013.
    Filed Date: 6/16/16.
    Accession Number: 20160616-5053.
    Comments Due: 5 p.m. ET 7/7/16.

    Take notice that the Commission received the following electric
reliability filings:

    Docket Numbers: RR16-4-000.
    Applicants: North American Electric Reliability Corp.
    Description: North American Electric Reliability Corporation's
Revised Report of Comparisons of Budgeted to Actual

Costs for 2015 for NERC and the Regional Entities.
    Filed Date: 6/15/16.
    Accession Number: 20160615-5156.
    Comments Due: 5 p.m. ET 7/6/16.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 16, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-14763 Filed 6-21-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 197 (Thursday, October 11, 2018)]
[Notices]
[Pages 51464-51465]
[FR Doc No: 2018-22101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-N-0341; FDA-2012-N-0115; FDA-2018-N-1011; FDA-
2010-N-0110; FDA-2012-N-0547; FDA-2014-N-2347; FDA-2016-D-2285; FDA-
2016-D-1307; FDA-2016-D-4318; FDA-2016-N-0407; and FDA-2018-N-0270]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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

SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                number          expires
------------------------------------------------------------------------
New Animal Drugs for Investigational Use       0910-0117       8/31/2021
Guidance for Industry and FDA Staff,           0910-0594       8/31/2021
 Class II Special Controls: Automated
 Blood Cell Separator Device Operating
 by Centrifugal or Filtration Separation
 Principle..............................
Petition to Request an Exemption from          0910-0608       8/31/2021
 100 Percent Identity Testing of Dietary
 Ingredients: Current Good Manufacturing
 Practice in Manufacturing, Packaging,
 Labeling, or Holding Operations for
 Dietary Supplements....................
Prescription Drug Advertisements........       0910-0686       8/31/2021
Survey of the Occurrence of Foodborne          0910-0744       8/31/2021
 Illness Risk Factors in Selected Retail
 and Foodservice Facility Types.........
Permanent Discontinuation or                   0910-0759       8/31/2021
 Interruption in Manufacturing of
 Certain Drug and Biological Products...
Food and Cosmetic Export Certificate           0910-0793       8/31/2021
 Applications Process...................
Guidance for Industry: Medical Product         0910-0856       8/31/2021
 Communications That are Consistent With
 the Food and Drug Administration
 Required Labeling--Questions and
 Answers................................
Guidance for Industry: Drug and Device         0910-0857       8/31/2021
 Manufacturer Communications with
 Payors, Formulary Committees, and
 Similar Entities Questions and Answers.
Guidance for Industry: Compounding and         0910-0858       8/31/2021
 Repackaging of Radiopharmaceuticals by
 State-Licensed Nuclear Pharmacies,
 Federal Facilities, and Certain Other
 Entities...............................
Drug Supply Chain Security Act Pilot           0910-0859       8/31/2021
 Program................................
Survey on the Occurrence of Foodborne          0910-0799       9/30/2021
 Illness Risk Factors in Selected
 Institutional and Retail Food Stores
 and Facility Types (2015-2025).........
------------------------------------------------------------------------

    Dated: October 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22101 Filed 10-10-18; 8:45 am]
 BILLING CODE 4164-01-P


B. Spiked Blanks Table 38 summarizes the recovery data for target analytes spiked into aliquots of solvent that were taken through the GPC/ Florisil cleanup procedures and analyzed under the same HRGC/ MS conditions as required for the composite sample analysis. A comparison of the recoveries of the analytes from the spiked lipid samples and the spiked blanks is provided in Table 39. The method recoveries from the spiked blanks are greater than determined from the spiked lipid samples. As expected, these differences may be attributed to the effect of the sample matrix on method recovery.

118 131 Table 36. Qualitative Summary of Toxaphene Identification in 45+ Age Category Sample no.

1 WN 45+ 2 WN 45+ I SA 45+ 3 SA 45+ 4 SA 45+ 1 ES 45+ 2 ES 45+ 1 ws 45+ 1 MO 45+ 1 MA 45+ 2 MA 45+ 1 PA 45+ 2 EN 45+ 3 EN 45+ Presence of toxaphenea + + ++ b ++ b + ++ b aIons monitored for HRGC/ MS analysis included m/ z 231, 233, 235, 269, 271, 273, 305, 307, and 309. bAdditional ions monitored for HRGC/ MS characterization . included m/ z 305, 307, 309, 327, 329, 331, 341, 343, and 345.

119 Table 37. Recovery Efficiency of SemivolatJle Organics from Spiked Human Adipose Tissues MRI sample number Average ' Standard Compound QC 223 QC 229 QC 234 QC 239 QC 240 Recovery Deviation 1.2 Dichlorobenzene 51 54 39 ND~ ND 48 8 2.4 Di chlorophenol 48 ND 82 63 103 74 24 1.2,4 Trichlorobenzene 56 40 57 ND ND 51 10 Naphthalene 127 140 97 ND ND 120 22 2.4,6 Tri chlorophenol 30 ND 41 30 45 37 8 Acenaphthylene 62 55 40 32 33 44 13 Dimethyl phthalate 39 88 53 48 54 56 19 Acenaphthene 67 53 40 34 32 46 16 Pentachlorobenzene 54 42 30 25 21 34 14 F1uorene 71 54 44 41 35 50 15 Diethyl phthalate 55 87 59 58 59 65 13 4 Chlorodiphenyl ether 61 50 38 31 26 41 14 4 Bromobiphenyl 68 61 47 45 37 52 13 0 BHC 103 100 83 66 62 83 19 Hexachlorobenzene 67 45 47 44 39 49 12 p BHC 97 ND 62 56 50 66 21 Phenanthrene 83 75 65 61 60 70 11 A BHC 58 53 74 61 66 62 8 Heptachlor 71 77 93 58 66 73 13 Di n butyl phthalate 110 126 55 46 86 85 34 Aldyin 80 87 71 67 66 * 74 9 4,4' Dibromobiphenyl 96 115 98 76 89 95 14 2,4,6 Tribromobiphenyl 70 79 70 55 58 66 10 Heptachlor epoxide 67 111 106 79 91 91 18 Fluoranthene 81 97 93 64 73 79 14 . e.'  ODE 65 63 61 42 50 56 10 Pyrene 68 96 94 58 69 78 16 Chrysene 66 70 67 45 55 61 10 y Chlordane 65 83 78 59 67 71 10 trans Nonachlor 78d 6: 90 6od 77 76d l2 214 220 217d 165 203d 204 23 136 75 41 42 ND 74 45 0 p'  DDD 63 77 69 42 56 61 13e e'  DDD 69 136 116 66 79 93 31 2,2', 4,4', 5 Pentachlorodiphenyl ether 58 102 85 51 69 73 21 ' DDT 54 136 116 66 79 90 35  tris( 1 dichloropropyl) phosphate 37 31 15 17 12 22 11 Butyl benzyl phthalate 74 55 27 26 22 41 23 2,2'. 4' ,5 Tetrabromobipheny1 64 128 116 58 68 87 33 E e ' DDT 63 126 126 43 62 84 39 Triphenyl phosphate 51 40 21 17 17 29 15 4 Chloro e terphenyl 33 70 57 27 38 49 25 2.5 Dichloro g terphenyl 45 91 77 32 45 58 25 Di_ n octy1 phthalate 143 55 46 29 43 63 46 Mirex 48 102 68 31 42 58 28 Tri nrto1y1 phosphate ND 32 23 15 18 22 7 2,4", 5 Tr ichloro g terphenyl 35 143 115 26 43 72 53 2.4.4" ,6 Tetrachloro~ terphenyl 48 160 114 32 39 80 57 d Naphthalene 59 54 38 18 26 39 17 4&~ 1,2,4,5 Tetrachlorobenzene 57 52 40 21 24 39 16 13C6 Hexachlombenzene 65 47 46 43 39 48 9 d,* Chrysene 40 51 47 21 24 37 11 aA bulk lipid sample was spiked with the following compounds at concentrations equivalent to 0.1 pg/ g. The ,, samples were taken through GPC and Florisil fractionation prior to HRGC/ MS analysis. Not determined. Not included in the average recovery calculation. : Not included in average. High recovery due to contribution from the adipose tissue matrix.

120 133 >

 m w e m . c  0 VI k L W rl > N 0 cu V W p:

U W 4 U N L W 0 L 0) V) n cr EW c arlE" CN . i  0,

W n n SW W WO N c " 0 . r B U 23 rn 0 N ai m I  w n cr m I I r n LV) wo cr en 121 01 r; 0, > 0 V L W En m L v > m al 5 e 0 c E2 0 122 ( n = 5) ( n = 6) Averaae .. Compound recovery RSD (%) recovery RSD (%)

1,2 Dichlbrobenzene 48 17 60 33 2,4 Dichlorophenol 74 32 62 20 1,2,4 Trichlorobenzene 51 20 61 14 Naphthalene 120 18 74 46 2,4,6 Trichlorophenol 37 22 65 23 Acenaphthylene 44 30 65 17 Dimethyl phthalate 56 34 55 22 . Acenaphthene 46 34 65 12 Pentachlorobenzene 34 30 61 18 F1uorene 50 20 65 15 Diethyl phthalate 65 34 49 13 4 Chlorodiphenyl ether 41 25 66 14 4 Bromobi phenyl wBHC Hexachlorobenzene f3 BHC Phenanthrene A BHC Heptachlor Di n butyl phthalate A1dFi n 4,4' Dibromobiphenyl 2,4,6 Tribromobiphenyl Heptachlor epoxide F1uoranthene  o, p' DDE Pyrene Chrysene w Chl ordane trans Nonachl or ~, p'  DDE Dieldrin o. D' DDD , J~

p, p'  DDD 2,2', 4,4'. 5 Pentachlorodi~ henvI 52 23 79 19 83 25 78 16 49 24 73 35 66 32 104 20 70 16 82 8 62 13 86 19 73 18 98 30 85 40 57 52 74 12 78 15 95 15 96 16 '

66 15 100 17 91 20 89 25 79 18 104 24 56 18 94 20 78 21 100 26 61 16 97 21 71 14 94 22 76 16 86 34 204 11 104 29 74 61 90 28 61 21 109 21 93 33 117 30 ." ether 73 29 108 28 . ~,~ DDT 90 39 102 22  tris( l, 3 Dichloropropyl) phosphate 22 50 29 21 Butvl benzvl Dhthalate 41 56 52 21 2,2i ,4' ,5? etrabromobiphenyl 87 38 120 18 g, p' DDT 84 41 110 17 Triphenyl phosphate 29 52 78 17 123 I3b Table 39 ( continued)

Compound 4 Chloro yterphenyl 2,5 Dichloro o terphenyl Di n octyl phxhalate Mi rex Tri m tolyl phosphate 2,4,' 5 Trichloro o terphenyl ' ,6 Tetrac hl dro o terpheny 1  Lipid samples Blanks .

( n = 5) ( n = 6) Average recovery RSD (%) recovery RSD (%)

49 51 113 22 58 43 113 21 63 73 41 39 58 48 116 21 22 32 42 24 72 74 131 32 2,4,4 80 71 133 33 d  Naphthalene 39 44 69 30 * C6 1,2,4,5 Tetrachlorobenzene 39 41 63 22 f3C6 Hexachlorobenzene 48 19 74 36 d12 Chrysene 37 30 127 21 \

124 I37 C. Porcine Fat A porcine fat sample ( Adipose 121) provided by EPA EMSL/ LV was analyzed periodically as another means of determining the accuracy of the method for selected organochlorine pesticides. A primary difference in the porcine fat sample and the human adipose tissue samples was noted in the difference of the GPC profiles. The lipid peak from the porcine fat eluted from the GPC column at an earlier retention time and as a well defined Gaussian peak shape as compared to human adipose tissues. Typically, the lipid peak from the human adipose tissue was noted to. tai1 into the collection cycle of the GPC cleanup.

Table 40 summarizes the. results from the analysis of five aliquots of the reference material over the course of the analysis of the adipose tissue samples. Table 40 also reports the actual concentrations of porcine fat as reported by  PA EMSL/ LV and the accuracy of each of $ he measurements. Positive identification and quantitation of each of the spiked analytes was not possible due to the limitation encountered for the analysis of 1.13 g sample aliquots. Trace levels of trans nonachlor and p, p' DDT were detected in the sample extracts. The p, e' DDE residue was detected in all five of the analyses with an accuracy ranging from 76 to 210%. The levels of 2, p DDE were detected as positive quantifiable values. Responses to characteristic ions from the molecular clusters for hexachlorobenzene, fi BHC, heptachlor epoxide, mirex, and oxychlordane were observed. However, the intensities of the responses were less than the 2.5 times signal to noise as required for establishing the detection limit.

D. Replicate Analyses Replicate sample analyses were completed using a bulk homogenized:. lipid sample extracted from composited adipose tissue samples. The replicate analyses were achieved using either 1 or 4 9 aliquots of the homogenized lipid. The HRGC/ MS analysis resulted in the detection of several. ' organochlorine pesticides, PCBs, phthalate esters, and PAHs. The results of the replicate analysis & re presented in Table 41. The compounds that were detected . consistently in the 4 g samples included hexachlorobenzene, f3 BHC, heptachlor epoxide, trans nonachlor, p, p' DDE, p, e' DDT, diethyl phthalate, and di n octyl phthalate,

The results for e, p' DDE provide the most consistent data. The data point for sample QC 235 is considered an outlier by using a simple Q test. The reported concentration for the remaining 15 samples range from 1,600 to 3,000 ng/ g with an average of 2,260 ng/ g and precision of 20%. Since e, p' DDE is the analyte present at the highest concentration, it is expected that it would provide the best measure of method precision. The variability in the concentration of other analytes is in part due to the small sample sizes ( 1 to 4 g) in comparison to the 20 9 composite adipose samples. Responses for the characteristic ions for hexachlorobenzene, naphthalene, phenanthrene, and penta through heptachloro PCBs were observed in each of the replicate tissue samples. However, the responses for these components were below the estimated limit of detection and thus were considered as not detected in these analyses. Further studies based on this broad scan analysis approach should require the use of replicate samples of equivalent size to the composite samples.

125 13% r 01 0 N U 0 1T N iw N L u N  7 N N w.

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n n n . 0 0 0.0 0 00 00 00 N ZO e 0 ZO ZO ZON N ID m N cv N v CD U U U n n n n n 0 0' 0 00 0 00 0 PO nozl ZO ZO 0 ZO 0 ZO N N QI AI co N ? E U W N W U W al W c, c, m al m F  u W 7 m * r c, m fx m . t= c, 0 P 4 r p.  0 m z n .. .. a . c z cz .. U c, v L m c P 2, 0 c P =? N ew . c 0 w k c, OCz n n F 3 al 23 U I n n >, n 0 I  I  I . I=

ft ? la c, > r Em 0) cr 30I 4! 9 * l r 3 ZV m a PJ c) c3 cn ' a 128 IUI E. Method Blanks Method blanks were generated as composites during the GPC cleanup of the composited adipose tissue samples. At least one loop of the automated GPC unit was run as a blank for each day's operation. Enough methylene chloride was added to each composite blank to bring the total volume up to the equivalent of a GPC cleanup of a 20 g sample. These composite blanks were . taken through Florisil fractionation with the actual samples and analyzed by HRGC/ HRMS.

As discussed in the results section of this report, the blanks typically demonstrated background levels of phthalates and phosphate triesters. Blank values for these compounds were noted to fluctuate over a wide range. For example, blank values range from 0.079 to 1.5 pg for diethyl phthalate, 1.2 to 12 pg for di n butyl phthalate, and 2.9 to 20 pg for di n octyl phthalate Butyl benzyl phhalate ranged from not detected at 0.2 pg to 0.78. pg. The phthalate data were corrected for a specific blank taken through Florisil with a. set of samples. Hence, trends that may occur in these data might be associated with the bJank values. Ifthe detection level in a sample was less than the associated blank value, the blank value was reported as the estimated detection limit for that sample.

The phosphate triesters were detected in the method blanks less frequently than phthalate esters. The blank levels for triphenyl phosphate ranged from 2.4 to 26 pg, and the level of tributyl phosphate esters was'detected as 7 pg for a single method blank. The. values for the phosphate tri. esters reported are corrected for the observed background concentrations noted in the associated blanks. The criterion for the determination of the detection level of the phosphate triesters was handled as described for the phthalate esters.

F. Surrogate Compound Recovery '

The stable isotope labeled surrogate compounds representative of chlorobenzenes, PCBs, and PAHs were spiked into all composite samples, QC samples and method blanks prior to sample preparation to assess method performance on a per sample basis. The absolute recovery of each of the surrogates was measured versus the internal standard, anthracene d,,, which was added immediately prior to extract analysis by HRGC/ MS. The absolute recoveries of the surrogates from the composited samples and the associated QC samples are tabulated in Tables 42 and 43.

As noted in Table 42, the recoveries of 13C6 1,2,4,5 tetrachlorobenzene and 13C12 decachl orobiphenyl were determined by both HRGC/ MS and HRGC/ ECD. The recoveries for the HRGC/ ECD analyses were determined from the internal standards, dichloronaphthalene and octachloronaphthalene, which elute within the same retention windows as the two surrogate compounds ( Figure 21). The results from the HRGC/ ECD determination generally demonstrate higher recoveries than by the HRGC/ HS methods, especially the recovery of the 13C12 decachlorobiphenyl. The differences in the recoveries from the two methods may be attributed to selection of the internal quantitation standard matrix effects, or both. The sample extracts analyzed by HRGC/ ECD were diluted by a factor of 10 as compared to the extracts analyzed by HRGC/ MS.

129 UZ cyano rn" mmm prmw Oan NWN om0 mw  l lnmm I fr, ZN=: 4 WDmh r WN 000ma WCDO, has l wau mr w mwouwco "" 2 worn DO* or wmmpr wew PItN hnn WDmh VYY h* U *( om UY)*" mww mma Q) NO  l m5wIDDmO r CnO mmv, am* NNrn e .+ a d 01 0 m hl h I. rt hdQ) N mum Q h 0 3 t  r cr t 0 U v N rlUJ 0  PO* W ( u U . a ?.

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4 c, 3 t J , Cn n Un U in i Q 7 00 U X . r L cl i2 As noted in Figure 21, the 13Cl~ decachlorobiphenyland the octachloronaphthalene elute within a narrow retention window as compared to the retention window for anthracene dlo and the surrogate. These results suggest that additional internal standards are necessary to provide better quantitation in the broad scan analysis scheme. Estimates of the recoveries of the 13C, monochloroand 13C, 2 octachlorobipheny~ surrogates by HRGC/ ECD are difficult because of coelution of other compounds.

G. Internal Standard Response The response of the internal quantitation standard anthracene dIo was routinely monitored and recorded to determine if there were apparent problems resulting from instrument stability. Ifdrastic changes ( greater than 50% of standard) in the anthracene dlo response were noted, the HRGC/ MS analyst was required to reanalyze a calibration standard to determine ifthe response difference was due to instrument operation or sample extract matrix interferences.

A difference in the internal standard response was noted for the 6% and 15/ 50% Florisil fraction extracts. The differences were noted as significant changes in response when both the 6% and 15/ 50% extracts of a composite sample were analyzed within the same day. The internal standard response for the 15/ 50% was noted to range from 50 to 90% less than that observed for the calibration standards and 6% Florisil fractions. The difference in response is attributed to a sample matrix effect. Calibration standards and 6% Florisil extracts analyzed before and after the 15/ 50% Florisil extracts clearly demonstrated that the instrument stability was not responsible for the observed internal standard fluctuations.

VI. REFERENCES .

Abbott PC, Collins GB, Goudling R, Hoodless RA. 1981. Organochlorine pesticide residues in human fat in the United Kingdom 1976 7. British Medical Journal 283: 1425 1428.

 . Albert L, Mendez F, Ipn C. 1980. 0rg. anochlorine pesticide residues in human adipose tissue in Mexico: results of a preliminary study in three Mexican cities. Archives of Environmental Health 35: 262 269.

Barquet A, Morgade C, Pfaffenberger CD. 1981. Determination of organochlorine pesticides and metabolites in drinking water, human blood serum, and adipose tissue. Journal of Toxicology and Environmental Health 7: 469 479.

Biros FJ, Enos HF. 1973. Oxychlordane residues in human adipose tissue. Bulletin of Environmental Contamination and Toxicology 10( 5): 257 260,

Biros FJ, Walker FJ.  1970. Pesticide residue analysis in human tissue by combined gas chromatography mass spectrometry. J Agr Food Chem 18( 3): 425 429.

134 Burns JE. 1974. Organochlorine pesticide and polychlorinated biphenyl residues in biopsied human adipose tissue  Texas 1969 72. Pesticides Monitoring Journal 7: l22 125.

Cramer PH, Miller HH, Going JE. 1981. Literature review summary of analytical methods for adipose tissue and blood. Interim Report. EPA Contract 68 01 5915, Task 24.

Dougherty RC, Whitaker MJ, Smith LM, Stalling DL, Kuehl DW. 1980. Negative chemical ionization studies of human and food chain contamination with xenobiotic chemicals. Environmental Health Perspectives 36: 103 118.

Erickson MD,. Stanley JS, Radolovich G, Turman K, Bauer K, Onstot 3, Rose D, Wickham M. 1982. Analytical methods for by product PCBs preliminary validation and interim methods. Washington, DC: Office of Toxic Substances, U. S. Environmental Protection Agency. EPA 500/ 5 82 006; NTIS No . PB83 127 696.

Eyster JT, Kimbrough RD. 1983. Partitioning of polybrominated biphenyls ( PBBs) in serum, adipose tissue, breast milk, placenta, cord blood, biliary fluid, and feces. Archives of Environmental Health 38( 1): 47 53.

Fukano S, Doguchi M. 1977. PCT, PCB, and pesticide residues in human fat and blood. Bulletin of Environmental Contamination and Toxicology 17( 5): 613.

Greer ES, Miller DJ, Bruscato FN, Hold RL. 1980. Investigation of pesticide residues in human adipose tissue in the northeast Louisiana area. J Agric Food Chem 28: 76 78.

Jansson B, Wideqvist U. 1983 Analysis of toxaphene ( PCC) and chlordane in biological samples by NCI mass spectrometry. Intern J Environ Anal Chem  13: 309 321.

Jensen GE, Clausen 3. 1979. Organochlorine compounds in adipose tissue of Greenlanders and Southern Danes. Journal of Toxicology and Environmental Health 5: 617 629.

Kuehl OW, Dougherty RC. 1980. Pentachlorophenol in the environment; evidence for its origin from commercial pentachlorophenol by negative chemical ionization mass spectrometry. Anal Chem 14: 447 449.

Kutz FW, Sovocool GW, Strassman S, Lewis RG. 1976 trans Nonachlor residues in human adipose tjssue. Bull Environ Cont Toxico i 4.

Kutz FW, Strassman SC, Sperling JF. 1979. Survey of selected organochlorine pesticides in the general population of the United States: fiscal years 19701975 Annals N Y Acad Sci 31: 60 68.

Kutz FW. Yobs AR. Strassman SC. 1976. Oraanochlo ine Desticide residues in human adipose tiisue. Bull SOC Pharmacof Environ Pathoi 4: 17 19.

135 t UGt t i Kutz FW, Yobs AR, Strassman SC, Viar JR Jr. 1977. Pesticides in people, effects of reducing DDT usage on total DDT storage in humans. Pest Mon 3 ll( 2): 61 63.

LeBel GL, Williams DT, 1983. Determination of organic phosphate triesters in hurnan. adipose tissue. J Assoc Off Anal Chem 66( 3): 691 698.

Lewis RG, Sovocool WG. 1982. Identification of polybrominated biphenyls in the adipose tissues of the general population of the United States. Journal of Analytical Toxicology 6: 196 198.

Lopez Avila V, Haile CL, Goddard PR, Malone LS, Northcutt RV, Rose OR, Robson RL. .1981. Development of methods for the analysis of extractable organic priority pollutants in municipal and industrial wastewater treatment sludges. In: Advances in the identification and analysis of organic pollutants in water. Keith LH, ed. Ann Arbor Sci.

Lucas RM, Pierson SA, Myers DL, Handy RW. 1981. National Human Adipose Tissue Survey Quality Assurance Program Plan. Preliminary draft. RTI/ 1864/ 21 11.

Mack GA, Stanley J. 1984. Preliminary strategy on the national human adipose tfssue : survey. Washington, DC: Office of Toxic Substances, Contracts 68 016721 ( Task 21) and 68 02 3938 ( Work Assignment 8).

MacLeod KE, Hanisch RC, Lewis RG. 1982. Evaluation of gel permeation chromatography for cleanup of human adipose tissue samples for GC/ MS analysis of pesticides and other chemicals. Journal of Analytical Toxicology 6~ 38 40.

Mes J, Campbell DS. 1976. Extraction efficiency of polychlorinated biphenyl, organochlorine, pesticides and phthalate esters from human adipose tissue. Bulletin of Environmental Contamination and Toxicology 16( 1): 53 60.

Mes J, Coffin DE, Campbell DS. 1974. Di n butyl and Di 2 ethylhexyl phthalate in human adipose tissue. Bull Environ Contam Toxicdl 12( 6): 721 725. . .

Mes 3, Davies DJ, Turton D. 1982. Polychlorinated biphenyl and other chlorinated hydrocarbon residues in adipose tissue of Canadians. Bull Environm Contam Toxicol 28: 97 104.

Mes J, Davies DJ, Turton D. 1985. Environmental contaminants in human fat: a comparison between accidental and nonaccidental causes of death. Ecotoxicology and Environmental Safety 10: 70 74.

Mori Y, Kikuta M, Okinaga E, 0kura. T. 1983. Levels of PCBs and organochlorine pesticides in human adipose tissue collected in ehime prefecture. Bull Environm Contam Toxico? 30: 74 73.

Norstrom RJ, Simon M, Mulvihill MJ. 1986. A gel permeation/ column chromatography cleanup method for determination of CDDs in animal tissue. Intern J Envi ron Anal Chem 23: 267 287.

136 Ribick MA, Dubay GR, Petty JD, Sta ling DL, Schmitt CJ. 1982. Toxaphene residues in fish: identification, quantification, and confirmation, at part per billion levels. Environ Sci T ch 16: 310 318.

Rogers WM. 1972. JAOAC 55: 22 38.

Sherma J, Beroza M. 1980, Analysis of Pesticide Residues in Human and Environmental Samples: A Compilation of Methods Sected for Use in Pesticide Monitoring Programs. EPA 600/ 8 80 038, Section 5, A,( l],( a) pp. 1 19.

Smith LM, Stalling DL, Johnson JL. 1984. Determination of part per trillion levels of polychlorinated dibenzofurans and dioxins in environmental samples. Anal Chem 56: 1830 1842.

Sovocool GW, Lewis RG. 1975. The identification of trace levels of organic pollutants in human tissues: compounds related to chlordate'heptachlorexposure In: Trace substances in environmental health. Hemphill DD, ed. pp. 265 286

Spearman R. 1982. Biochemistry of adipose tissue and its regulation. Physiology and Pathophysiology of the Skin 7: 2283 2325.

Stanley JS. 1985. MRf analytical method for the determination of semivolatile organic compounds in human adipose tissue. Interim Report, Revision No. 2 to Washington, DC: Office of Toxic Substances, U. S. Environmental Protection Agency. Contract 68 02 3938, Work Assignment No. 8.

Stanley JS. 1986a. Broad scan analysis of human adipose tissue: Volume I: '

Executive summary. EPA 560/ 5 86 035.

Stanley JS. 1986b. Broad scan analysis of human adipose tissue: Volume 11: Volatile organic compounds. EPA 560/ 5 86 036.

Stanley JS. 1986c. Broad scan analysis of human adipose tissue: Volume 111: Semivolatile organic compounds. EPA 560/ 5 86 037.

Stanley JS. 1986d. Broad scan analysis of human adipose tissue: Volume IV: Polychlorinated dibenzo 2 dioxins ( PCDDs) and polychlorinated dibenzofurans ( PCDFS). EPA 560/ 5 86 038,

Stanley JS, Stockton RA. 1986. Broad scan analysis of human adipose tissue: Volume V: Trace elements. EPA 560/ 5 86 039.

Tessari JD, Griffin L, Aaronson MJ. 1980. Comparison of two cleanup procedures ( Mills, Onley,, Gaither versus automated gel permeation) for residues of organochlorine pesticides and polychlorinated biphenyls in human adipose tissue Bull Environ Contam Toxicol 25: 59 64.

Watanabe I, Yakushiji T, Kunita N. 1980. Distribution differences between polychlorinated terphenyls. and polychlorinated biphenyls in human tissues. Bull Environm Contam Toxicol 25: 810 815.

137 Wolff MS, Anderson HA, Camper F, Nikaido MN, Daum SM, Haymes N, Selikoff 13. 1979. Analysis of adipose tissue and serum from PBB ( polybrominated biphenyl) exposed workers. Journal of Environmental Pathology and Toxicology 2: 1397 1411.

Wolff MS, Anderson HA, Rosenman KD, Selikoff IJ. 1979. Equilibrium of polybrominated biphenyl CPBB) residues in serum and fat of Michigan residents. Bull Envirdnm Contam Toxicol 21: 775 781.

Wolff MS, Anderson HA, Selikoff IJ. 1982. Human tissue burdens of halogenated aromatic chemicals in Michigan. JAMA 247( 15): 2112.

Wolff MS, Fischbein A, Thonton J, Rice C, Lilis R, Sefikoff IJ. 1982. Body burden of polychlorinated biphenyls among persons employed in capacitor manufacturing Int Arch Occup Environ Health 49: 199 208.

Wolff MS, Thornton 3, Fischbein A, Lilis R, Selikoff 13. 1982. Disposition of polychlorinated biphenyl congeners in occupationally exposed persons. Toxicology and Applied Pharmacology 62: 294 306.

Wright LH, Lewis RG, Crist HL, Sovocool GW, Simpson JM. 1978. The identification of polychlorinated terphenyls at trace levels in human adipose tissue by gas chromatography/ mass spectrometry. Journal of Analytical Toxicology 2: 76 79.

Yobs AR. .1971. The national human monitoring program for pesticides. Pestic Monitor J 5: 46.

Zell M, Ballschmiter K, 1980. Baseline studies of the global pollution 11. Global occurrence of hexachlorobenzene ( HCB) and polychlorocamphenes ( toxaphene ( PCC) in biological samples. Fresenius Z Anal Chem 300: 387 402.

, 138 I51 I I I 8 8 1 I I I I APPENDIX A NHATS FY82 COMPOSITE SAMPLE DATA REPORTED FOR ALL TARGET COMPOUNDS WITHIN A CENSUS DIVISION 139 Table A 1. Summary of the Total Mass of Selected Semivolatile Organic Compounds Determined in the Composited Human Adipose Tissues Representing the Mountain ( MO) Census Division Census division Compos ite no. Age group Wet tissue weight % lipid Compound Dichlorobenezene Trich! orobenzene Naphtha1ene Pentachlorobenzene Diethyl phthalate Tributyl phosphate Hexac h 1o robenzene f3 BHC Phenenthrene Di n butyl phthalate Hepzachlor epoxide Pyrene trans Nonachfor p, p' DDE Dieldrin p,~'  DDT Butylbenzyl phthalate Triphenyl phosphate Di  n octy1 phtha1ate Mi rex Tris ( 2 chloroethyl) phosphate Total PCB'S Tr ich1orobipheny1 Tetrachlorobiphenyl Pentachlorobiphenyl Hexachlorobiphenyl Heptachlorobipheny? Octachlorobiphenyl Nonachlorobiphenyl Decachlor0b ipheny1' Total pg/ composi te specimena MO  Mountain ( 1) ( 1) ( 1) 0 14 15 44 45+ 9.0 g 18.3 g 21.0 g 62.3 74.1 84.3 ND ( 0.20) ND ( 0.20) ND ( 0.20) NO ( 0.20) ND ( 0.20) ND'( 0.20) ND ( 0.20) ND ( 0: 20) ND ( 0.20) NO ( 0.20) ND ( 0.20) ND ( 0.20) b ND ( 0.50) 0. a7 b ND ( 1.0) ND ( 1.0) ND ( 0.20) 0.31 I 0.59 ND ( 0.20) 1.5 4.6 ND ( 0.20) ND ( 0.20) ND ( 0.20) b ND ( 2.4) ND ( 0.20) ND ( 0.20) ND ( 0.20) . 1.0 ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.40) ND ( 0.40) 2.8 5. I 8.1 24 ND ( 1.0) ND ( 1.0) NO ( 1.0) tr ' o. 2i 0.90 2.4 b 3.6 7.8 b tr 0.89 9.6 b ND ( 0.20) ND ( 12.2) ND ( 0.20) ND ( 0.20) ND ( 0.20) b ND ( 0.80) ND ( 0.80) NO ( 0.20) 1.2 11 NO ( 0.20) NO ( 0.20) ND ( 0.20) NO ( 0.20) ND ( 0.20) tr 0.44 ND ( 0.40) ND ( 0.40) tr 2.2 ND ( 0.40) tr 1.2 4.8 ND ( 0.40) ND ( 0.40) 3.3 NO ( 0.40) ND ( 0.40) ND ( 0.40) ND ( 0.40) ND ( 0.40) ND ( 0.40) ND ( 1.0) ND ( 1.0) ND ( 1.0)

aND = not detected. Value in parentheses is the estimated limit of detection ( LOD). tr trace. The compound is present at a level between LOD and LOQ. % ata n, ot summarized.

140 I I Table A 2. Summary of the Total Mass of Selected Semivolatile Organic Compounds Determined in the Composited Human Adipose Tissues Representing the New England ( NE) Census DivisionI I Census division Composite no. Age group Wet tissue weight % lipid I 1 Compound I Dichlorobenezene Trichlorobenzene Naphthalene Pentachlorobenzene Diethyl phthalate Tributyl phosphate Hexachlorobenzene 8 BHC Phenenthrene D i n bu ty1 phthalate Hephch7 or epoxide Pyrene trans Nonachlor I I I D p, p  DDE Dieldrin p, E'  DDT Butylbenzyl phthalate Triphenyl phosphate Di  n octy1 phthalate Mirex I I ,. Total pg/ composi te specimena NE  New England ( 1) ( 1) ( 1) 0 14 15 44 45+ 19.1 g 21.9 g 26.7 g 55.1 87.6 79.2 ND ( 0.20) ND ( 0.20) tr 0.77 ND ( 0.20) N5 ( 0.20) ND ( 0.20) ND ( 0.20) tr 0.60 ND ( 0.20) ND ( 0.20) ND ( a. 20) ND ( 0.20) tr 0.34 tr 0.32 tr 0.38 ND ( 1.0) NO ( 1.0) ND ( 1.0) ND ( 0.20) 24 \ tr 0.31 ND ( 0.20) 11 2.0 ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.20) tr 0.28 ND ( 0.20) 4.48 ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.40) 9.9 ND ( 0.40) 1.4 47 20 ND ( 1.0) ND ( 1.0) ND ( 1.0) ND ( 0.20) 6.8 7.1 ND ( 0 20) ND ( 0.20) ND ( 0.20) ND ( 0.40) ND ( 0.40) ND ( 0.40) tr 0.69 tr 0.24 ND ( 0.20) ND ( 0.20) tr 0.70 tr 0.60 Tris ( 2 chloroethyl) phosphate ND ( 0.80) ND ( 0.80) NO ( 0.80) Total PCB's ND ( 0.20) 2.0 3.4 Trichlorobiphenyl ND ( 0.20) ND ( 0 20) ND ( 0.20)

I Tetrachlorobiphenyl ND ( 0.20) tr 0.36 tr 0.23 Pentachlorobiphenyl ND ( 0.40) tr 0.46 tr 2.72 I Hexachlorobiphenyl ND ( 0.40) tr 1.2 ND ( 0.40) Heptachlorobiphenyl ND ( 0.40) ND ( 0.40) h# ( 0.40) Octach1 orobipheny7 ND ( 0.40) ND ( 0.40) tr 0.43 Nonachlorobiphenyl ND( 0.40) ND . ( 0.40) ND ( 0.40) Decachlorobiphenyl ND ( 1.0) ND ( 1.0) ND ( 1.0)

D D aND = not detected. Value in parentheses is the estimated limit of detection ( LOD). tr = trace. The compound is present at a level between LOD and 1OQ.

I Table A 3. Summary of the Total Mass of Selected Semivolatile Organic Compounds Determined in the Composited Human Adipose Tissues Representing the Pacific ( PA) Census Division Census division Composite no. Age group Wet tissue weight % lipid Compound Dichlorobenezene Trichlorobenzene Naphtha1ene Pentachlorobenzene Diethyl phthalate Tributyl phosphate Hexachlorobenzene p BHC Phenenthrene Oi n butyl phthalate HepEach? or epoxide Pyrene. trans Nonachlor p, e  ODE Dieldrin p, p  DDT Butylbenzyl phthalate Triphenyl phosphate 0i n octy1 p htha1ate Mi rex Tris ( 2 chloroethyl) phosphate Total PCB s Trichlorobiphenyl Tetrachlorobiphenyl Pentachlorobiphenyl Hexachlorobiphenyl Heptachlorobiphenyt Octachlorobiphenyl Nonachlorobiphenyl Decachlorobiphenyl Total pg/ composi te specimena PA  Pacific ( 1) ( 1) 0 14 45+ 19.7 g 22.0 g 62.9 19.2 ND ( 0.20) 1 ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.20) tr 0.20 ND ( 0.20) ND ( 0.20) ND ( 0.45) ND ( 0.49) ND ( 1.0) ND ( 1.0) tr 0.37 1.7 tr 0.48 b ND ( 0.20) ND ( 0.20) ND ( 0.76) ND ( 2.6) ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.40) ND ( 0.40) 3.2 ND ( 0.20) ND ( 1.0) ND ( 1.0) tr 0.27 ND ( 0.20) ND ( 0.20) 1.7 ND ( 0.40) ND ( 0.40) ND ( 2.3) 16 ND ( 0.20) ND ( 0.20) ND ( 0.80) NO ( 0.80) ND ( 0.20) 6.7 ND ( 0.20) ND ( 0.20) ND ( 0.20) ND ( 0.20) NO ( 0.40) tr 0.71 NO ( 0.40) tr 0.44 ND ( 0.40) 2. a NO ( 0.40) 2.2 ND ( 0.40) tr 0.56 ND ( 1.0) ND ( 1.0)

aND = not detected. Value in parentheses is the estimated limit of detection ( LOD). tr = trace. The compound is present at a level between LOD and LOQ, bData not summarized.

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m n I v 148


[Federal Register Volume 82, Number 246 (Tuesday, December 26, 2017)]
[Notices]
[Page 61056]
[FR Doc No: 2017-27740]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form TCR and Form WB-APP-Implementing the Whistleblower
Provisions of Section 21 F of the Securities Exchange Act of 1934;
SEC File No. 270-625, OMB Control No. 3235-0686

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and
Exchange Commission (``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit an extension for this current collection of information to the
Office of Management and Budget for approval.
    In Release No. 34-64545,\1\ the Commission adopted rules
(``Rules'') and forms to implement Section 21F of the Securities
Exchange Act of 1934 entitled ``Securities Whistleblower Incentives and
Protection,'' which was created by Section 922 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act (``Dodd-Frank Act'').\2\ The
Rules describe the whistleblower program that the Commission has
established pursuant to the Dodd-Frank Act which requires the
Commission to pay an award, subject to certain limitations and
conditions, to whistleblowers who voluntarily provide the Commission
with original information about a violation of the federal securities
laws that leads to the successful enforcement of a covered judicial or
administrative action, or of a related action. The Rules define certain
terms critical to the operation of the whistleblower program, outline
the procedures for applying for awards and the Commission's procedures
for making decisions on claims, and generally explain the scope of the
whistleblower program to the public and to potential whistleblowers.
---------------------------------------------------------------------------

    \1\ Implementation of the Whistleblower Provisions of Section
21F of the Securities Exchange Act of 1934, Release No. 34-64545;
File No. S7-33-10 (adopted May 25, 2011).
    \2\ Public Law 111-203, Sec.  922(a), 124 Stat 1841 (2010).
---------------------------------------------------------------------------

    Form TCR is a form submitted by whistleblowers who wish to provide
information to the Commission and its staff regarding potential
violations of the securities laws. Form TCR is required for submission
of information under the Rules. The Commission estimates that it takes
a whistleblower, on average, one and one-half hours to complete Form
TCR. Based on the receipt of an average of approximately 700 annual
Form TCR submissions for the past three fiscal years, the Commission
estimates that the annual reporting burden of Form TCR is 1,050 hours.
    Form WB-APP is a form that is submitted by whistleblowers filing a
claim for a whistleblower award. Form WB-APP is required for
application for an award under the Rules. The Commission estimates that
it takes a whistleblower, on average, one hour to complete Form WB-APP.
The completion time depends largely on the complexity of the alleged
violation and the amount of information the whistleblower possesses in
support of his or her application for an award. Based on the receipt of
an average of approximately 110 \3\ annual Form WB-APP submissions for
the past six fiscal years, the Commission estimates that the annual
reporting burden of Form WB-APP is 110 hours.
---------------------------------------------------------------------------

    \3\ This figure does not include Form WB-APP submissions which
were facially deficient, subsequently withdrawn, or submitted by
individuals who have been barred by the Commission from
participation in the whistleblower program.
---------------------------------------------------------------------------

    Estimated annual reporting burden = 1,160 hours.
    Written comments are invited on: (a) Whether this collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information will have practical
utility; (b) the accuracy of the agency's estimate of the burden
imposed by the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 30
days of this publication. Please direct your written comments to Pamela
Dyson, Director/Chief Information Officer, Securities and Exchange
Commission, c/o Remi Pavlik-Simon, 100 F St. NE, Washington, DC 20549;
or send an email to: [email protected].

    Dated: December 20, 2017.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-27740 Filed 12-22-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52439-52440]
[FR Doc No: 2016-18711]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0566]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey of Alumni
Commissioner's Fellowship Program Fellows

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget

(OMB) for review and clearance under the Paperwork Reduction Act of
1995.

DATES: Fax written comments on the collection of information by
September 7, 2016.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the title Outcomes Evaluation Survey
for Graduates of the FDA Commissioner's Fellowship Program. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Survey of Alumni Commissioner's Fellowship Program Fellows--OMB Control
Number 0910-NEW

    FDA is requesting approval from the Office of Management and Budget
to gather information from Alumni Commissioner's Fellowship Program
(CFP) Fellows. The information from Alumni CFP Fellows will allow FDA's
Office of the Commissioner (OC) to easily and efficiently elicit and
review program feedback. The online survey will assist the Agency in
promoting and protecting the public health by encouraging outside
persons to share their experience with the FDA while a Commissioner's
Fellow. The process will reduce the time and cost of submitting written
documentation to the Agency and lessen the likelihood of surveys being
misrouted within the Agency mail system. The information gathered by
the survey will be used to gain insights into, and to document, impacts
that the CFP has had and is having on former CFP fellows and
contributions and impacts that the former fellows are making in their
current work. The surveys include questions to assess the following
measures: Post-fellowship employment (e.g., employment type); number of
awards; number of contributions while a CFP fellow (e.g., number of
publications, guidances authored or co-authored); and contributions in
their field (e.g., list of publications).
    In the Federal Register of February 24, 2016 (81 FR 9202), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fellowship Program Survey...................              35               1              35  0.50 (30 minutes).........................            17.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating maintenance costs associated with this collection of information.

    FDA based these estimates on the number of fellows that have
graduated and left the Agency over the past 5 years.

    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18711 Filed 8-5-16; 8:45 am]
BILLING CODE 4164-01-P