[Federal Register: September 23, 2008 (Volume 73, Number 185)]
[Rules and Regulations]
[Page 54713-54717]
[DOCID:fr23se08-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 261

[EPA-R06-RCRA-2008-0455; SW-FRL-8713-3]

Hazardous Waste Management System; Identification and Listing of
Hazardous Waste; Final Rule

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is issuing a final
rule to add the name of Structural Metals, Inc, to the exclusion
granted to Conversion Systems Inc., (CSI) on June 13, 1995. As
described in the exclusion issued to CSI in paragraph (1)(B), the
Agency shall add the location of the treatment facility and the name of
the steel mill contracting CSI's services. This rule adds the location
of U.S. Ecology, Texas Ecology in Robstown, Texas as the treatment
facility and Structural Metals, Inc. as the steel mill contracting the
services of CSI. This rule also updates the 1995 exclusion to include
Paragraphs (6) and (7), the Delisting Reopener language and
Notification Requirements; and other updates regarding the disposal and
submission of Quality Assurance Plan prior to submission of data for a
new facility.

DATES: This rule is effective September 23, 2008.

ADDRESSES: The public docket for this direct final rule is located at
1445 Ross Avenue in the FOIA Review Room, identified by Docket ID No.
EPA-R06-RCRA-2008-0455. All documents in the electronic docket are
listed in the http://www.regulations.gov index. Although listed in the
index, some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the
Environmental Protection Agency, RCRA Branch, 1445 Ross Avenue, Dallas,
TX 75202. The hard copy RCRA regulatory docket for this direct final
rule, EPA-R06-RCRA-2008-0455, is available for viewing from 9 a.m. to 4
p.m., Monday through Friday, excluding Federal holidays. The public may
copy material from the regulatory docket at $0.15 per page. EPA
requests that you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The interested
persons wanting to examine these documents should make an appointment
with the office at least 24 hours in advance. The public may copy
material from any regulatory docket at no cost for the first 100 pages
and at a cost of $0.15 per page for additional copies.

FOR FURTHER INFORMATION CONTACT: For further technical information
concerning this document or for appointments to view the docket,
contact Michelle Peace, Environmental Protection Agency, Multimedia
Planning and Permitting Division, RCRA Branch, Mail Code: 6PD-C, 1445
Ross Avenue, Dallas, TX 75202, by calling<PHONE_NUMBER> or by e-mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 13, 1995 (60 FR 31107), EPA
finalized a conditional multiple site exclusion to Conversion Systems
Inc., in Horsham, Pennsylvania. In 1995, CSI petitioned EPA for a
multiple site exclusion for chemically stabilized electric arc furnace
dust (CSEAFD) resulting from the Super DetoxTM process as
modified by CSI. The original Super DetoxTM

process was developed by Bethlehem Steel Corporation and used at its
Johnstown and Steelton, Pennsylvania facilities. Specifically, CSI was
granted the exclusion for CSEAFD generated at the existing Sterling,
Illinois facility at Northwestern Steel and future facilities to be
constructed. CSI initially planned to construct twelve other facilities
nationwide. The resulting CSEAFD is classified as K061 hazardous waste
by virtue of the derived from rule.
    On March 20, 2006, CSI submitted a K061 Delisting Initial
Verification Testing Report to EPA Region 6 in accordance with
paragraph 1(A) of the exclusion. It lists Structural Metals Inc, as the
new source and U.S. Ecology in Robstown, TX as the treatment location.
The data package included sampling results from four (4) representative
composite samples of the waste. This data was reviewed by EPA and also
evaluated using the Delisting Risk Assessment Software (DRAS) currently
used to evaluate new petitions. All constituent concentrations are
below the delisting levels published in the exclusion and meet the
current DRAS delisting exit levels.
    The Agency is also taking this time to update the 1995 CSI
exclusion to make the following corrections and additions to the
exclusion:
    (1) The address of the CSI facility has changed from Horsham, PA
and is now located in Willow Grove, PA;
    (2) Reports should be submitted to the appropriate Regional
Director or his/her designee and no longer the EPA Administrator;
    (3) New facilities added to this petition should submit and get EPA
approval of their Quality Assurance Project Plans for the verification
testing prior to requesting addition to the existing petition; and
    (4) Paragraphs (6) and (7) are added to the exclusion language.
    The purpose of paragraph (6), the Delisting Reopener Language, is
to require the facility to disclose new or different information
related to a condition at the facility or disposal of the waste, if it
is pertinent to the delisting. The petitioner must also use this
procedure, if the waste samples fail to meet the levels found in
paragraph (3). This provision will allow EPA to reevaluate the
exclusion, if a source provides new or additional information to EPA.
EPA will evaluate the information on which it based the decision to see
if it is still correct or if circumstances have changed so that the
information is no longer correct or would cause EPA to deny the
petition, if presented.
    This provision expressly requires the petitioner to report
differing site conditions or assumptions used in the petition.
Additionally, it requires the petitioner to report within 10 days of
discovery, instances where testing indicates that delisting levels were
not achieved and the waste was subsequently managed as non-hazardous
waste. If EPA discovers such information itself or from a third party,
it can act on it as appropriate. The language being proposed is similar
to those provisions found in RCRA regulations governing no-migration
petitions at Sec.  268.6.
    It is EPA's position that it has the authority under RCRA and the
Administrative Procedure Act (APA), 5 U.S.C. 551, et seq., to reopen a
delisting decision. EPA may reopen a delisting decision when it
receives new information that calls into question the assumptions
underlying the delisting.
    EPA believes a clear statement of its authority in delisting is
merited in light of EPA's experience. See the Federal Register notice
regarding Reynolds Metals Company at 62 FR 37694 (July 14, 1997) and 62
FR 63458 (December 1, 1997) where the delisted waste leached at greater
concentrations into the environment than the concentrations predicted
when conducting the TCLP, leading EPA to repeal the delisting. If an
immediate threat to human health and the environment presents itself,
EPA will continue to address these situations on a case-by-case basis.
Where necessary, EPA will make a good cause finding to justify
emergency rulemaking. See APA section 553 (b)(3)(B).
    EPA is also adding paragraph (7), Notification Requirements. The
treatment facility is required to notify State environmental agencies
at least 60 days before beginning the transport and disposal of
delisted wastes. This notification would be require for the state where
the treated waste is generated as well as states through which the
waste is transported and disposed.

Statutory and Executive Order Reviews

    Under Executive Order 12866, ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993), this rule is not of general applicability
and therefore is not a regulatory action subject to review by the
Office of Management and Budget (OMB). This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.) because it applies to a
particular facility only. Because this rule is of particular
applicability relating to a particular facility, it is not subject to
the regulatory flexibility provisions of the Regulatory Flexibility Act
(5 U.S.C. 601 et seq.), or to sections 202, 204, and 205 of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Because
this rule will affect only a particular facility, it will not
significantly or uniquely affect small governments, as specified in
section 203 of UMRA. Because this rule will affect only a particular
facility, this proposed rule 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, as specified in Executive Order 13132, ``Federalism,'' (64
FR 43255, August 10, 1999). Thus, Executive Order 13132 does not apply
to this rule. Similarly, because this rule will affect only a
particular facility, this proposed rule does not have tribal
implications, as specified in Executive Order 13175, ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000). Thus, Executive Order 13175 does not apply to this rule. This
rule also is not subject to Executive Order 13045, ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997), because it is not economically significant as
defined in Executive Order 12866, and because the Agency does not have
reason to believe the environmental health or safety risks addressed by
this action present a disproportionate risk to children. The basis for
this belief is that the Agency used the DRAS program, which considers
health and safety risks to infants and children, to calculate the
maximum allowable concentrations for this rule. This rule is not
subject to Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866. This rule does not involve technical
standards; thus, the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply. As required by section 3 of Executive Order 12988, ``Civil
Justice Reform,'' (61 FR 4729, February 7, 1996), in issuing this rule,
EPA has taken the necessary steps to eliminate drafting errors and
ambiguity, minimize potential litigation, and provide a clear legal
standard for

affected conduct. 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. Section 804 exempts from section 801 the
following types of rules: (1) Rules of particular applicability; (2)
rules relating to agency management or personnel; and (3) rules of
agency organization, procedure, or practice that do not substantially
affect the rights or obligations of non-agency parties 5 U.S.C. 804(3).
EPA is not required to submit a rule report regarding this action under
section 801 because this is a rule of particular applicability.

Lists of Subjects in 40 CFR Part 261

    Environmental protection, Hazardous waste, Recycling, Reporting and
recordkeeping requirements.

    Authority: Sec. 3001(f) RCRA, 42 U.S.C. 6921(f).

    Dated: August 29, 2008.
Bill Luthans,
Acting Director, Multimedia Planning and Permitting Division, EPA
Region 6.

0
For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is amended as follows:

PART 261--IDENTIFICATION AND LISTING OF HAZARDOUS WASTE

0
1. The authority citation for part 261 continues to read as follows:

    Authority: 42 U.S.C. 6905, 6912(a), 6921, 6922 and 6938.

0
2. Appendix IX to Part 261, Table 2--Wastes Excluded from Specific
Sources is amended by adding the following entry in alphabetical order
to ``Conversion Systems Inc.,'' to read as follows:

Appendix IX to Part 261--Wastes Excluded Under Sec. Sec.  260.20 and
260.22

* * * * *

                                 Table 2--Wastes Excluded From Specific Sources
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                Facility                            Address                        Waste description
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                                                  * * * * * * *
Conversion Systems, Inc.................  Willow Grove, PA...........  Chemically Stabilized Electric Arc
                                                                        Furnace Dust (CSEAFD) that is generated
                                                                        by Conversion Systems Inc. (CSI) using
                                                                        the Super Detox\TM\ process as modified
                                                                        by CSI to treat EAFD (EPA Hazardous
                                                                        Waste No. K061) at the following sites
                                                                        and that is disposed of in Subtitle C
                                                                        landfills:
                                                                       Northwestern Steel, Sterling, Illinois
                                                                        after June 13, 1995.
                                                                       Structural Metals, Inc. treated at U.S.
                                                                        Ecology, Robstown, Texas after September
                                                                        23, 2008.
                                                                       (1) Verification Testing Requirements:
                                                                        Sample collection and analyses,
                                                                        including quality control procedures
                                                                        must be performed using appropriate
                                                                        methods. As applicable to the method-
                                                                        defined parameters of concern, analyses
                                                                        requiring the use of SW-846 methods
                                                                        incorporated by reference in 40 CFR
                                                                        260.11 must be used without
                                                                        substitution. As applicable, the SW-846
                                                                        methods might include Methods 0010,
                                                                        0011, 0020, 0023A, 0030, 0031, 0040,
                                                                        0050, 0051, 0060, 0061, 1010A, 1020B,
                                                                        1110A, 1310B, 1311, 1312, 1320, 1330A,
                                                                        9010C, 9012B, 9040C, 9045D, 9060A, 9070A
                                                                        (uses EPA Method 1664, Rev. A), 9071B,
                                                                        and 9095B.
                                                                       (A) Initial Verification Testing: During
                                                                        the first 20 operating days of full
                                                                        scale operation of a newly constructed
                                                                        Super Detox\TM\ treatment facility, CSI
                                                                        must analyze a minimum of four (4)
                                                                        composite samples of CSEAFD
                                                                        representative of the full 20-day
                                                                        period. Composites must be comprised of
                                                                        representative samples collected from
                                                                        every batch generated. The CSEAFD
                                                                        samples must be analyzed for the
                                                                        constituents listed in Condition (3).
                                                                        CSI must report the operational and
                                                                        analytical test data, including quality
                                                                        control information, obtained during
                                                                        this initial period no later than 60
                                                                        days after the generation of the first
                                                                        batch of CSEAFD.
                                                                       (B) Addition of New Super Detox\TM\
                                                                        Treatment Facilities to Exclusion: If
                                                                        the Agency's review of the data obtained
                                                                        during initial verification testing
                                                                        indicates that the CSEAFD generated by a
                                                                        specific Super Detox\TM\ treatment
                                                                        facility consistently meets the
                                                                        delisting levels specified in Condition
                                                                        (3), the Agency will publish a notice
                                                                        adding to this exclusion the location of
                                                                        the new Super Detox\TM\ treatment
                                                                        facility and the name of the steel mill
                                                                        contracting CSI's services. If the
                                                                        Agency's review of the data obtained
                                                                        during initial verification testing
                                                                        indicates that the CSEAFD generated by a
                                                                        specific Super Detox\TM\ treatment
                                                                        facility fails to consistently meet the
                                                                        conditions of this exclusion, the Agency
                                                                        will not publish the notice adding the
                                                                        new facility.
                                                                       (C) Subsequent Verification Testing: For
                                                                        the Sterling, Illinois facility and any
                                                                        new facility subsequently added to CSI's
                                                                        conditional multiple-site exclusion, CSI
                                                                        must collect and analyze at least one
                                                                        composite sample of CSEAFD each month.
                                                                        The composite samples must be composed
                                                                        of representative samples collected from
                                                                        all batches treated in each month. The
                                                                        composite samples must be composed
                                                                        representative samples collected from
                                                                        all batches treated in each month. These
                                                                        monthly representative samples must be
                                                                        analyzed, prior to disposal of the
                                                                        CSEAFD, for the constituents listed in
                                                                        Condition (3). CSI may, at its
                                                                        discretion, analyze composite samples
                                                                        gathered more frequently to demonstrate
                                                                        that smaller batches of waste are non-
                                                                        hazardous.
                                                                       (2) Waste Holding and Handling: CSI must
                                                                        store as hazardous all CSEAFD generated
                                                                        until verification testing as specified
                                                                        in Conditions (1)(A) and (1)(C), as
                                                                        appropriate, is completed and valid
                                                                        analyses demonstrate that Condition (3)
                                                                        is satisfied. If the levels of
                                                                        constituents measured in the samples of
                                                                        CSEAFD do not exceed the levels set
                                                                        forth in Condition (3), then the CSEAFD
                                                                        is non-hazardous and may be managed and
                                                                        disposed of in Subtitle D landfills. If
                                                                        constituent levels in a sample exceed
                                                                        any of the delisting levels set in
                                                                        Condition (3), the CSEAFD generated
                                                                        during the time period corresponding to
                                                                        this sample must be retreated until it
                                                                        meets these levels, or managed and
                                                                        disposed of in accordance with Subtitle
                                                                        C of RCRA. CSEAFD generated by a new CSI
                                                                        treatment facility must be managed as a
                                                                        hazardous waste prior to the addition of
                                                                        the name and location of the facility to
                                                                        the exclusion. After addition of the new
                                                                        facility to the exclusion, CSEAFD
                                                                        generated during the verification
                                                                        testing in Condition (1)(A) is also non-
                                                                        hazardous, if the delisting levels in
                                                                        Condition (3) are satisfied.

                                                                       (3) Delisting Levels: All leachable
                                                                        constituents for those metals must not
                                                                        exceed the following levels (ppm):
                                                                        Antimony-0.06; Arsenic-0.50; Barium-7.6;
                                                                        Beryllium-0.010; Cadmium-0.050; Chromium-
                                                                        0.33; Lead-0.15; Mercury-0.009; Nickel-
                                                                        1.00; Selenium-0.16; Silver-0.30;
                                                                        Thallium-0.020; Vanadium-2.0; Zinc-70.
                                                                        Metal concentrations must be measured in
                                                                        the waste leachate by the method
                                                                        specified in 40 CFR 261.24.
                                                                       (4) Changes in Operating Conditions:
                                                                        After initiating subsequent testing
                                                                        described in Condition (1)(C), if CSI
                                                                        significantly changes the stabilization
                                                                        process established under Condition (1)
                                                                        (e.g., use of new stabilization
                                                                        reagents), CSI must notify the Agency in
                                                                        writing. After written approval by EPA,
                                                                        CSI may handle CSEAFD generated from the
                                                                        new process as non-hazardous, if the
                                                                        wastes meet the delisting levels set in
                                                                        Condition (3).
                                                                       (5) Data Submittals: CSI must submit the
                                                                        information described below. If CSI
                                                                        fails to submit the required data within
                                                                        the specified time or maintain the
                                                                        required records on-site for the
                                                                        specified time, EPA, at its discretion,
                                                                        will consider this sufficient basis to
                                                                        reopen the exclusion as described in
                                                                        paragraph (6). CSI must:
                                                                       (A) At least one month prior to operation
                                                                        of a new Super Detox\TM\ treatment
                                                                        facility, CSI must notify, in writing,
                                                                        the EPA Regional Administrator or his
                                                                        designee, when the new Super Detox\TM\
                                                                        treatment facility is scheduled to be on-
                                                                        line. The data obtained through
                                                                        paragraph 1(A) must be submitted to the
                                                                        Regional Administrator or his designee
                                                                        within the time period specified. All
                                                                        supporting data can be submitted on CD-
                                                                        ROM or some comparable electronic media.
                                                                       (B) CSI shall submit and receive EPA
                                                                        approval of the Quality Assurance
                                                                        Project Plan for data collection for
                                                                        each new facility added to this
                                                                        exclusion prior to conducting sampling
                                                                        events in paragraph 1(A).
                                                                       (C) Compile records of analytical data
                                                                        from paragraph (3), summarized, and
                                                                        maintained on-site for a minimum of five
                                                                        years.
                                                                       (D) Furnish these records and data when
                                                                        either EPA or the State agency requests
                                                                        them for inspection.
                                                                       (E) Send along with all data a signed
                                                                        copy of the following certification
                                                                        statement, to attest to the truth and
                                                                        accuracy of the data submitted. ``Under
                                                                        civil and criminal penalty of law for
                                                                        the making or submission of false or
                                                                        fraudulent statements or representations
                                                                        (pursuant to the applicable provisions
                                                                        of the Federal Code, which include, but
                                                                        may not be limited to, 18 U.S.C. 1001
                                                                        and 42 U.S.C. 6928), I certify that the
                                                                        information contained in or accompanying
                                                                        this document is true, accurate and
                                                                        complete.
                                                                       As to the (those) identified section(s)
                                                                        of this document for which I cannot
                                                                        personally verify its (their) truth and
                                                                        accuracy, I certify as the company
                                                                        official having supervisory
                                                                        responsibility for the persons who,
                                                                        acting under my direct instructions,
                                                                        made the verification that this
                                                                        information is true, accurate and
                                                                        complete. If any of this information is
                                                                        determined by EPA in its sole discretion
                                                                        to be false, inaccurate or incomplete,
                                                                        and upon conveyance of this fact to the
                                                                        company, I recognize and agree that this
                                                                        exclusion of waste will be void as if it
                                                                        never had effect or to the extent
                                                                        directed by EPA and that the company
                                                                        will be liable for any actions taken in
                                                                        contravention of the company's RCRA and
                                                                        CERCLA obligations premised upon the
                                                                        company's reliance on the void
                                                                        exclusion.''
                                                                       (6) Reopener: (A) If, anytime after
                                                                        disposal of the delisted waste CSI, the
                                                                        treatment facility, or the steel mill
                                                                        possess or is otherwise made aware of
                                                                        any data (including but not limited to
                                                                        leachate data or ground water monitoring
                                                                        data) relevant to the delisted waste
                                                                        indicating that any constituent
                                                                        identified for the delisting
                                                                        verification testing is at a level
                                                                        higher than the delisting level allowed
                                                                        by EPA in granting the petition, then
                                                                        the facility must report the data, in
                                                                        writing, to EPA within 10 days of first
                                                                        possessing or being made aware of that
                                                                        data.
                                                                       (B) If subsequent verification testing of
                                                                        the waste as required by paragraph 1(C)
                                                                        does not meet the delisting requirements
                                                                        in paragraph 3 and the waste is
                                                                        subsequently managed as non-hazardous
                                                                        waste, CSI must report the data, in
                                                                        writing, to EPA within 10 days of first
                                                                        possessing or being made aware of that
                                                                        data.
                                                                       (C) If CSI fails to submit the
                                                                        information described in paragraphs (5),
                                                                        (6)(A) or (6)(B) or if any other
                                                                        information is received from any source,
                                                                        EPA will make a preliminary
                                                                        determination as to whether the reported
                                                                        information requires action to protect
                                                                        human health and/or the environment.
                                                                        Further action may include suspending,
                                                                        or revoking the exclusion, or other
                                                                        appropriate response necessary to
                                                                        protect human health and the
                                                                        environment.
                                                                       (D) If EPA determines that the reported
                                                                        information requires action, EPA will
                                                                        notify the facility in writing of the
                                                                        actions it believes are necessary to
                                                                        protect human health and the
                                                                        environment. The notice shall include a
                                                                        statement of the proposed action and a
                                                                        statement providing the facility with an
                                                                        opportunity to present information
                                                                        explaining why the proposed EPA action
                                                                        is not necessary. The facility shall
                                                                        have 10 days from the date of EPA's
                                                                        notice to present such information.
                                                                       (E) Following the receipt of information
                                                                        from the facility described in paragraph
                                                                        (6)(D) or (if no information is
                                                                        presented under paragraph (6)(D)) the
                                                                        initial receipt of information described
                                                                        in paragraphs (5), (6)(A) or (6)(B), EPA
                                                                        will issue a final written determination
                                                                        describing the actions that are
                                                                        necessary to protect human health and/or
                                                                        the environment. Any required action
                                                                        described in EPA's determination shall
                                                                        become effective immediately, unless EPA
                                                                        provides otherwise.
                                                                       (7) Notification Requirements: CSI or the
                                                                        treatment facility must do the following
                                                                        before transporting the delisted waste.
                                                                        Failure to provide this notification
                                                                        will result in a violation of the
                                                                        delisting petition and a possible
                                                                        revocation of the decision.
                                                                       (A) Provide a one-time written
                                                                        notification to any state Regulatory
                                                                        Agency to which or through which it will
                                                                        transport the delisted waste described
                                                                        above for disposal, 60 days before
                                                                        beginning such activities.
                                                                       (B) Update the one-time written
                                                                        notification if it ships the delisted
                                                                        waste into a different disposal
                                                                        facility.
                                                                       (C) Failure to provide this notification
                                                                        will result in a violation of the
                                                                        delisting exclusion and a possible
                                                                        revocation of the decision.

                                                  * * * * * * *
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[FR Doc. E8-22170 Filed 9-22-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Page 69432]
[FR Doc No: 2010-28480]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL11-3-000]

Ross Bachofer v. Calpine Corporation; Notice of Complaint

November 4, 2010.
    Take notice that on October 26, 2010, pursuant to sections 206 of
the Rules and Practice and Procedure, 18 CFR 385.206 and section 206 of
the Federal Power Act, 16 U.S.C. 2824c, Ross Bachofer (Complainant)
filed a complaint against Calpine Corporation (Respondent), alleging
that damages to the Complainant's property are due to flooding caused
by the Respondent.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 24, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-28480 Filed 11-10-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Pages 1738-1739]
[FR Doc No: 2022-00408]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-33-000]

Notice of Request Under Blanket Authorization and Establishing
Intervention and Protest Deadline; Northern Natural Gas Company

    Take notice that on December 27, 2021, Northern Natural Gas Company
(Northern), 1111 South 103rd Street, Omaha, Nebraska 68124, filed in
the above referenced docket, a prior notice request pursuant to
sections 157.205, 157.213(b) and 157.216(b) of the Commission's
regulations under the Natural Gas Act (NGA) and Northern's blanket
certificate issued in Docket No. CP82-401-000, for authorization to
replace an injection and withdrawal well at its Redfield Storage Field,
located in Dallas County, Iowa. Northern purposes to (1) install and
operate an injection and withdrawal well; (2) install a natural gas
pipeline lateral; (3) install a water production line; and (4) abandon
an existing injection and withdrawal well. Northern estimates that the
cost of the Project is approximately $3.8 million. Northern states that
the replacement injection and withdrawal well will have no impact on
the Redfield storage field's certificated physical parameters,
including total gas storage inventory, reservoir pressure, reservoir
and buffer boundaries and certificated capacity. In addition, Northern
states that there will be no impact to service of Northern's customers
as a result of the proposed Project, all as more fully set forth in the
application, which is on file with the Commission and open to public
inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions regarding this prior notice request should be
directed to Michael T. Loeffler, Senior Director, Certificates and
External Affairs for Northern, 1111 South 103rd Street, Omaha, NE
68124, at<PHONE_NUMBER>, or by email to [email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on March 7, 2022. How
to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is March 7, 2022. A protest may also serve
as a motion to intervene so long as the

protestor states it also seeks to be an intervenor.
---------------------------------------------------------------------------

    \3\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is March 7, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before March 7, 2022. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-33-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \6\
---------------------------------------------------------------------------

    \6\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below.\7\ Your submission must reference the Project docket
number CP22-33-000. Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
---------------------------------------------------------------------------

    \7\ Hand-delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.
---------------------------------------------------------------------------

    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail at: 1111 South 103rd Street, Omaha, NE 68124, or by
email to (with a link to the document) at: [email protected]. Any
subsequent submissions by an intervenor must be served on the applicant
and all other parties to the proceeding. Contact information for
parties can be downloaded from the service list at the eService link on
FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: January 6, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-00408 Filed 1-11-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15578-15581]
[FR Doc No: 2018-07426]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1095]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any consumer organizations interested in participating in the
selection of voting and/or nonvoting consumer representatives to serve
on its advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by May 11,
2018, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by May 11, 2018. Nominations will be accepted for current
vacancies and for those that will or may occur through July 31, 2018.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
[email protected], by mail or delivery service to Advisory
Committee Oversight and Management Staff, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by Fax: 301-847-
8640.
    Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm; by mail or delivery service to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, Silver Spring, MD 20993-0002; or by Fax:<PHONE_NUMBER>. Additional
information about becoming a member of an FDA advisory committee can
also be obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].
    For questions relating to specific advisory committees or panels,
contact the appropriate contact person listed in table 1.

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
                Contact person                      Committee/panel
------------------------------------------------------------------------
Moon Hee V. Choi, Center for Drug Evaluation   Anesthetic and Analgesic
 and Research, Food and Drug Administration,    Drug Products Advisory
 10903 New Hampshire Ave., Bldg. 31, Rm.        Committee.
 2434, Silver Spring, MD 20993-0002, 301-796-
 2894, email: [email protected].
Lauren Tesh, Center for Drug Evaluation and    Antimicrobial Advisory
 Research, Food and Drug Administration,        Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2426, Silver Spring, MD 20993-0002, 301-796-
 2721, email: [email protected].
Kalyani Bhatt, Center for Drug Evaluation and  Bone, Reproductive and
 Research, Food and Drug Administration,        Urological Drugs
 10903 New Hampshire Ave., Bldg. 31, Rm.        Advisory Committee.
 2438, Silver Spring, MD 20993-0002, 301-796-
 9005, email: [email protected].
Jennifer Shepherd, Center for Drug Evaluation  Cardiovascular and Renal
 and Research, Food and Drug Administration,    Drugs Advisory
 10903 New Hampshire Ave., Bldg. 31, Rm.        Committee, Medical
 2434, Silver Spring, MD 20993-0002, 301-796-   Imaging Advisory
 4043, email: [email protected].    Committee.
Cindy Chee, Center for Drug Evaluation and     Pulmonary-Allergy Drugs
 Research, Food and Drug Administration,        Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20993-0002, 301-796-
 0889, email: [email protected].
Patricio Garcia, Center for Devices and        Clinical Chemistry and
 Radiological Health, Food and Drug             Clinical Toxicology
 Administration, 10903 New Hampshire Ave.,      Devices Panel,
 Bldg. 66, Rm. G610, Silver Spring, MD 20993-   Gastroenterology and
 0002,<PHONE_NUMBER>, email:                     Urology Devices Panel.
 [email protected].
Evella Washington, Center for Devices and      Ear, Nose and Throat
 Radiological Health, Food and Drug             Devices Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. G640, Silver Spring, MD 20993-
 0002,<PHONE_NUMBER>, email:
 [email protected].
Joan Adams-White, Center for Devices and       Medical Devices Dispute
 Radiological Health, Food and Drug             Resolution Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm., 5572, Silver Spring, MD 20993-
 0002,<PHONE_NUMBER>, email: [email protected].
Aden Asefa, Center for Devices and             Microbiology Devices
 Radiological Health, Food and Drug             Panel, Radiology Devices
 Administration, 10903 New Hampshire Ave.,      Panel.
 Bldg. 66, Rm. G642, Silver Spring, MD 20993-
 0002,<PHONE_NUMBER>, email:
 [email protected].
Sara Anderson, Center for Devices and          Orthopaedic and
 Radiological Health, Food and Drug             Rehabilitation Devices
 Administration, 10903 New Hampshire Ave.,      Panel, Radiological
 Bldg. 66, Rm. G616 Silver Spring, MD 20993-    Devices Panel.
 0002,<PHONE_NUMBER>, email:
 [email protected].
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:

    Table 2--Committee Descriptions, Type of Consumer Representative
                  Vacancy, and Approximate Date Needed
------------------------------------------------------------------------
   Committee/panel/areas of                           Approximate date
       expertise needed          Type of vacancy           needed
------------------------------------------------------------------------
Anesthetic and Analgesic Drug   1--Voting........  Immediately.
 Products Advisory Committee--
 Knowledgeable in the fields
 of anesthesiology, surgery,
 epidemiology or statistics,
 and related specialties.
Antimicrobial Advisory          1--Voting........  Immediately.
 Committee--Knowledgeable in
 the fields of infectious
 disease, internal medicine,
 microbiology, pediatrics,
 epidemiology or statistics,
 and related specialties.
Bone, Reproductive and          1--Voting........  Immediately.
 Urological Drugs Advisory
 Committee--Knowledgeable in
 the fields of obstetrics,
 gynecology, endocrinology,
 pediatrics, epidemiology or
 statistics and related
 specialties.
Cardiovascular and Renal Drugs  1--Voting........  July 1, 2018.
 Advisory Committee--
 Knowledgeable in the fields
 of cardiology, hypertension,
 arrhythmia, angina,
 congestive heart failure,
 diuresis, and biostatistics.
Medical Imaging Advisory        1--Voting........  Immediately.
 Committee--Knowledgeable in
 the fields of nuclear
 medicine, radiology,
 epidemiology, statistics and
 related specialties.
Pulmonary- Allergy Drugs        1--Voting........  Immediately.
 Advisory Committee--
 Knowledgeable in the fields
 of pulmonary medicine,
 allergy, clinical immunology,
 and epidemiology or
 statistics.
Clinical Chemistry and          1--Non-Voting....  Immediately.
 Clinical Toxicology Devices
 Panel--Doctors of medicine or
 philosophy with experience in
 clinical chemistry (e.g.,
 cardiac markers), clinical
 toxicology, clinical
 pathology, clinical
 laboratory medicine, and
 endocrinology.
Gastroenterology and Urology    1--Non-Voting....  Immediately.
 Devices Panel--
 Gastroenterologists,
 urologists and nephrologists.
Radiology Devices Panel--       1--Non-Voting....  Immediately.
 Physicians with experience in
 general radiology,
 mammography, ultrasound,
 magnetic resonance, computed
 tomography, other
 radiological subspecialties
 and radiation oncology;
 scientists with experience in
 diagnostic devices, radiation
 physics, statistical
 analysis, digital imaging and
 image analysis.
Ear, Nose and Throat Devices    1--Non-Voting....  Immediately.
 Panel--Experts in Otologists,
 neurologists, audiologists.

Medical Devices Dispute         1--Non-Voting....  Immediately.
 Resolution--Experts with
 broad, cross-cutting
 scientific, clinical,
 analytical or mediation
 skills.
Microbiology Devices Panel--    1--Non-Voting....  Immediately.
 Clinicians with an expertise
 in infectious disease, e.g.,
 pulmonary disease
 specialists, sexually
 transmitted disease
 specialists, pediatric
 infectious disease
 specialists, experts in
 tropical medicine and
 emerging infectious diseases,
 mycologists; clinical
 microbiologists and
 virologists; clinical
 virology and microbiology
 laboratory directors, with
 expertise in clinical
 diagnosis and in vitro
 diagnostic assays, e.g.,
 hepatologists; molecular
 biologists.
Orthopaedic and Rehabilitation  1--Non-Voting....  Immediately.
 Devices Panel--Orthopedic
 surgeons (joint spine,
 trauma, and pediatric);
 rheumatologists; engineers
 (biomedical, biomaterials,
 and biomechanical); experts
 in rehabilitation medicine,
 sports medicine, and
 connective tissue
 engineering; and
 biostatisticians.
------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. Anesthetic and Analgesic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.

B. Antimicrobial Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.

C. Bone, Reproductive & Urologic Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of
obstetrics, gynecology, and related specialties.

D. Cardiovascular and Renal Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.

E. Medical Imaging Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.

F. Pulmonary-Allergy Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of pulmonary disease and diseases with allergic
and/or immunologic mechanisms.

G. Certain Panels of the Medical Devices Advisory Committee

    Review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
may also make appropriate recommendations to the Commissioner of Food
and Drugs on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer

health branches of Federal, State, and local governments also may
participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots must be filled out and returned to FDA within 30 days.
The nominee receiving the highest number of votes ordinarily will be
selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES section of this document), and a list
of consumer or community-based organizations for which the candidate
can demonstrate active participation.
    Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07426 Filed 4-10-18; 8:45 am]
 BILLING CODE 4164-01-P