[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Proposed Rules]
[Pages 30812-30814]
[FR Doc No: 2017-13860]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2017-0265; FRL-9964-44-Region 9]

Approval and Promulgation of Air Quality State Implementation
Plans; California; Ambient Ozone Monitoring Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a portion of a state implementation plan (SIP) submission from
the State of California regarding Clean Air Act (CAA or ``Act'')
requirements for ambient ozone monitoring in the Bakersfield
Metropolitan Statistical Area (MSA) for the 1997 ozone and 2008 ozone
national ambient air quality standards (NAAQS or ``standards''). The
SIP submission is intended to revise a portion of the State's
``infrastructure'' SIP that, more broadly, provides for implementation,
maintenance, and enforcement of the standards. We are taking comments
on this proposal and plan to follow with a final action.

DATES: Any comments must arrive by August 2, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2017-0265 at http://www.regulations.gov, or via email to Rory Mays
at<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Rory Mays, Air Planning Office (AIR-
2), EPA Region IX,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we'', ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Background
II. Ozone Monitoring Evaluation and Proposed Action
III. Statutory and Executive Order Reviews

I. Background

    Section 110(a)(1) of the CAA requires states to submit SIPs meeting
the applicable requirements of section 110(a)(2) within three years
after promulgation of a new or revised NAAQS or within such shorter
period as the EPA may prescribe. Section 110(a)(2) requires states to
address structural SIP elements such as requirements for monitoring,
basic program requirements, and legal authority that are designed to
provide for implementation, maintenance, and enforcement of the NAAQS.
The SIP submission required by these provisions is referred to as the
infrastructure SIP. Section 110(a) imposes the obligation upon states
to make a SIP submission to the EPA for a new or revised NAAQS, but the
contents of individual state submissions may vary depending upon the
facts and circumstances. This proposed rule pertains to infrastructure
SIP requirements for ambient air quality monitoring.
    Each of the NAAQS revisions applicable to this proposed rule
triggered the requirement for states to submit infrastructure SIPs,
including provisions for ambient ozone monitoring. On July 18, 1997,
the EPA revised the form and levels of the primary and secondary ozone
standards to an 8-hour average of 0.08 parts per million (ppm).\1\ On
March 12, 2008, the EPA revised the levels of the primary and secondary
8-hour ozone standards to 0.075 ppm.\2\ The EPA has issued guidance on
infrastructure SIP requirements for the 2008 ozone and other NAAQS that
informs the states' development and the EPA's evaluation of ambient
ozone monitoring.\3\
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    \1\ 62 FR 38856 (July 18, 1997).
    \2\ 73 FR 16436 (March 27, 2008).
    \3\ Memorandum from Stephen D. Page, Director, Office of Air
Quality Planning and Standards, EPA, ``Guidance on Infrastructure
State Implementation Plan Elements under Clean Air Act Sections
110(a)(1) and 110(a)(2),'' September 13, 2013.
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    Section 110(a)(2)(B) of the CAA requires states to provide for the
establishment and operation of ambient air quality monitoring to (i)
monitor, compile, and analyze data, and (ii) make data available to the
EPA Administrator upon request. The EPA's implementing regulations for
ambient monitoring regulations for the various NAAQS are found in 40
CFR part 58. Among the requirements for ozone monitoring, 40 CFR part
58, Appendix D, 4.1(b) requires that ``within an [ozone] network, at
least one [ozone] site for each MSA, or [Combined Statistical Area
(CSA)] if multiple MSAs are

involved, must be designated to record the maximum concentration for
that particular metropolitan area'' and 40 CFR 58.14(b) requires that
``modifications to the [State and Local Air Monitoring Station (SLAMS)]
network for reasons other than those resulting from the periodic
network assessments . . . must be reviewed and approved by the Regional
Administrator.'' The San Joaquin Valley nonattainment area for the 1997
ozone and 2008 ozone NAAQS includes several MSAs and one CSA.
Generally, the highest ozone concentrations in the San Joaquin Valley
have occurred in the central and southern portions of the nonattainment
area, but in recent years, the highest ozone concentrations have
occurred in the central portion of the valley (i.e., within the Fresno
CSA, which includes all of Fresno and Madera counties).
    California made SIP submissions in 2007 and 2014 to, among other
things, address the requirements of section 110(a)(2)(B) and the EPA's
implementing regulations for the 1997 ozone and 2008 ozone NAAQS. The
EPA approved the submissions with respect to the ambient monitoring
requirements with one exception: \4\ we partially disapproved the
submissions for CAA section 110(a)(2)(B) with respect to the 1997 ozone
and 2008 ozone NAAQS for the Bakersfield MSA, which includes all of
Kern County. Our partial disapproval was based on the closure of the
MSA's maximum ozone concentration site located at Arvin-Bear Mountain
Blvd. (Air Quality System (AQS) ID: 06-029-5001),\5\ without EPA
approval of an alternative maximum ozone concentration site.
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    \4\ 81 FR 18766 at 18772 (April 1, 2016). See also, ``California
Infrastructure SIP, Overarching Technical Support Document,'' EPA,
Region IX, September 2014, pp. 11-15.
    \5\ The EPA's Air Quality System (AQS) contains ambient air
pollution data collected by federal, state, local, and tribal air
pollution control agencies from thousands of monitors. More
information is available at: https://www.epa.gov/aqs.
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    The EPA's partial disapproval for ambient ozone monitoring
established a deadline of May 2, 2018, for the EPA to promulgate a
federal implementation plan (FIP) or for the State of California to
submit, and the EPA to approve, an adequate SIP revision for this ozone
monitoring deficiency for the 1997 ozone NAAQS.\6\ With respect to the
2008 ozone NAAQS, the EPA's partial disapproval explained that a prior
FIP deadline of February 14, 2015, had been established by the EPA's
2013 finding that California and other states had failed to submit
infrastructure SIPs for that NAAQS.\7\ Regarding a lawsuit filed by the
Sierra Club, in May 2017 the U.S. District Court for the Northern
District of California entered a partial consent decree directing the
EPA to, among other things, sign a final rule approving a SIP revision,
promulgate a FIP, or a combination thereof for CAA section 110(a)(2)(B)
for the Bakersfield MSA for the 2008 ozone NAAQS by December 15,
2017.\8\ As discussed further in section II of this proposed rule, the
EPA proposes that California has submitted a SIP revision that
adequately resolves the underlying SIP deficiency with respect to
monitoring in the Bakersfield MSA for both the 1997 and 2008 ozone
NAAQS.
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    \6\ 81 FR 18766 at 18775 (April 1, 2016).
    \7\ 78 FR 2882 (January 15, 2013).
    \8\ Partial consent decree in Sierra Club v. EPA, Case No. 3:15-
cv-04328-JD (U.S. District Court for the Northern District of
California), filed May 23, 2017, pp. 4-6.
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II. Ozone Monitoring Evaluation and Proposed Action

    The California Air Resources Board (CARB) submitted the ``Staff
Report, [C]ARB Review of the San Joaquin Valley 2016 Plan for the 2008
8-Hour Ozone Standard'' (``2016 CARB Staff Report'') on August 24,
2016.\9\ We found this submission to be complete on December 19,
2016.\10\ We are proposing action only on the portions of the
submission that address ambient ozone monitoring in the Bakersfield MSA
pursuant to CAA section 110(a)(2)(B), and refer to those portions
herein as the ``2016 Bakersfield Ozone Monitoring SIP.'' \11\ We find
that this submission meets the procedural requirements for public
participation under CAA section 110(a)(2) and 40 CFR 51.102.
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    \9\ Letter from Richard W. Corey, Executive Officer, CARB to
Alexis Strauss, Acting Regional Administrator, Region IX, EPA,
August 24, 2016.
    \10\ Letter from Elizabeth Adams, Acting Director, Air Division,
Region IX, EPA to Richard W. Corey, Executive Officer, CARB,
December 19, 2016.
    \11\ 2016 CARB Staff Report, Section V.H (``Bakersfield Area
Monitor''), p. 23 and Section VII (``Staff Recommendation''), p. 24.
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    The 2016 Bakersfield Ozone Monitoring SIP notes that states must
meet federal monitoring regulations as part of the CAA infrastructure
requirements and refers to the EPA's disapproval of the State's
infrastructure SIP for ozone monitoring in the Bakersfield MSA.\12\
CARB states that it had operated an ozone monitor at the Arvin-Bear
Mountain Blvd. site for 20 years and that this site had recorded the
highest ozone concentrations in the Bakersfield MSA. Upon notification
in 2009 that the site lease would not be renewed, CARB established a
replacement site at Arvin's Di Giorgio elementary school (AQS ID: 06-
029-5002). This ozone monitor site relocation had not been approved by
the EPA at the time of the EPA's 2014 partial disapproval of
California's 2007 and 2014 infrastructure SIPs. CARB states that the
EPA has now approved the site relocation \13\ and includes a copy of
the letter as Appendix C to the 2016 CARB Staff Report.
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    \12\ Id.
    \13\ Letter from Meredith Kurpius, Manager, Air Quality Analysis
Office, Region IX, EPA to K. Magliano, Chief, Air Quality Planning
and Science Division, CARB, May 2, 2016.
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    We have reviewed the statements CARB made in its 2016 Bakersfield
Ozone Monitoring SIP, the EPA's 2016 approval letter, and CARB's 2016
site relocation request.\14\ Given the logistical constraints and
factors considered by CARB, the EPA concluded that the Arvin Di Giorgio
site provides the most similar concentrations from similar sources to
the Arvin-Bear Mountain Blvd. site and fulfilled the federal regulatory
requirement that such replacement site be nearby and have the same
scale of representation. In addition, we found that CARB's site
relocation, as approved by the EPA consistent with 40 CFR 58.14, met
the substantive requirements for site relocation under 40 CFR part 58
Appendix D, including the requirement under section 4.1(b) to designate
a site to record the maximum ozone concentration in the Bakersfield
MSA.
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    \14\ Letter from K. Magliano, Chief, Air Quality Planning and
Science Division, CARB to Meredith Kurpius, Manager, Air Quality
Analysis Office, Region IX, EPA, April 29, 2016. This site
relocation request noted that the Arvin-Bear Mountain Blvd. monitor
operated for the 21 years and that the highest ozone concentrations
in the Bakersfield MSA generally occurred at the Arvin-Bear Mountain
Blvd. site or the neighboring Edison site (AQS ID 060290007). The
ozone monitor at the Edison site continues to operate.
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    Since the underlying basis of the EPA's 2014 disapproval has been
adequately resolved (i.e., approved site relocation for the maximum
ozone concentration site in the Bakersfield MSA), we propose to approve
the 2016 Bakersfield Ozone Monitoring SIP for CAA section 110(a)(2)(B)
for the 1997 ozone and 2008 ozone NAAQS. We will accept comments from
the public on these proposals for the next 30 days. The deadline and
instructions for submission of comments are provided in the DATES and
ADDRESSES sections at the beginning of this preamble.
    In addition, the EPA previously approved an ozone emergency episode
plan from El Dorado County APCD as meeting the requirements of CAA
section 110(a)(2)(G) for the 1997 ozone and 2008 ozone NAAQS.\15\ That
action

resolved a separate, partial disapproval from the EPA's 2016 rulemaking
on California's 2007 and 2014 infrastructure SIPs. However, we
inadvertently did not remove certain paragraphs from the California SIP
that reflected the earlier disapproval. Thus, as an administrative
matter, we intend to use this rulemaking to remove the obsolete
paragraphs, specifically 40 CFR 52.223(i)(7) and 40 CFR 52.223(l)(7),
from the California SIP.
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    \15\ 81 FR 47300 (July 21, 2016).
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III. Statutory and Executive Order Reviews

    Under the Clean Air Act, 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 Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed 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 Clean Air Act; and
     does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

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

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

    Dated: June 21, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-13860 Filed 6-30-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: November 20, 2007 (Volume 72, Number 223)]
[Notices]
[Page 65318-65319]
[DOCID:fr20no07-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER07-1303-000; ER07-1303-001; ER07-1303-002]

PS Energy Group, Inc.; Notice of Issuance of Order

November 13, 2007.
    PS Energy Group (PS Energy) filed an application for market-based
rate authority, with an accompanying rate schedule. The proposed
market-based rate schedule provides for the sale of energy and capacity
at market-based rates. PS Energy also requested waivers of various
Commission regulations. In particular, PS Energy requested that the
Commission grant blanket approval under 18 CFR Part 34 of all future

issuances of securities and assumptions of liability by PS Energy.
    On November 9, 2007, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development-West, granted the requests
for blanket approval under Part 34 (Director's Order). The Director's
Order also stated that the Commission would publish a separate notice
in the Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard concerning the
blanket approvals of issuances of securities or assumptions of
liability by PS Energy, should file a protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, D.C. 20426,
in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing protests is
December 10, 2007.
    Absent a request to be heard in opposition to such blanket
approvals by the deadline above, PS Energy is authorized to issue
securities and assume obligations or liabilities as a guarantor,
indorser, surety, or otherwise in respect of any security of another
person; provided that such issuance or assumption is for some lawful
object within the corporate purposes of PS Energy, compatible with the
public interest, and is reasonably necessary or appropriate for such
purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of PS Energy's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-22625 Filed 11-19-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62421-62426]
[FR Doc No: 2022-22305]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 individuals on its
advisory committee regardless of their gender identification, religious
affiliation, racial and ethnic identification, or disability status
and, therefore, encourages nominations of appropriately qualified
candidates from all 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
November 28, 2022, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by November 28, 2022. Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2023.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected] or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
    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, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. 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,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
5122, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[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
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             Contact person                      Committee/panel
------------------------------------------------------------------------
Rakesh Raghuwanshi, Office of the Chief  FDA Science Board Advisory
 Scientist, Food and Drug                 Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 1, Rm. 3309, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Prabhakara Atreya, Center for Biologics  Allergenic Products Advisory
 Evaluation and Research, Food and Drug   Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 71, Rm. 1226, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].

Moon Hee Choi, Center for Drugs          Anesthetic and Analgesic Drug
 Evaluation and Research, Food and Drug   Products Advisory Committee,
 Administration, 10903 New Hampshire      Non-Prescription Drugs
 Ave., Bldg. 31, Rm. 2434, Silver         Advisory Committee.
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
She-Chia Chen, Center for Drugs          Antimicrobial Drugs Advisory
 Evaluation and Research, Food and Drug   Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31 Rm. 2438, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Jessica Seo, Center for Drugs            Arthritis Advisory Committee,
 Evaluation and Research, Food and Drug   Peripheral and Central Nervous
 Administration, 10903 New Hampshire      System Drugs Advisory
 Ave., Bldg. 31, Rm. 2412, Silver         Committee.
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Yvette Staples, Center for Drugs         Cardiovascular and Renal Drugs
 Evaluation Research, Food and Drug       Advisory Committee, Medical
 Administration, 10903 New Hampshire      Imaging Drugs Advisory
 Ave., Bldg. 31, Rm. 2438, Silver         Committee.
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
LaToya Bonner, Center for Drugs          Endocrinologic and Metabolic
 Evaluation and Research, Food and Drug   Drugs Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2428, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Takyiah Stevenson, Center for Drugs      Pharmacy Compounding Advisory
 Evaluation Research, Food and Drug       Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2406, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Joyce Frimpong, Center for Drugs         Psychopharmacologic Drugs
 Evaluation and Research, Food and Drug   Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2462, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Candace Nalls, Center for Devices and    Anesthesiology and Respiratory
 Radiological Health, Food and Drug       Therapy Devices Panel;
 Administration, 10903 New Hampshire      Clinical Chemistry and
 Ave., Bldg. 66, Rm. 5211, Silver         Clinical Toxicology Devices
 Spring, MD 20993-0002,<PHONE_NUMBER>,     Panel; Ear, Nose and Throat
 [email protected].               Devices Panel;
                                          Gastroenterology-Urology
                                          Devices Panel; General and
                                          Plastic Surgery Devices Panel.
James Swink, Center for Devices and      Circulatory System Devices
 Radiological Health, Food and Drug       Panel; Microbiology Devices
 Administration, 10903 New Hampshire      Panel.
 Ave., Bldg. 66, Rm. 5211, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Akinola Awojope, Center for Devices and  Dental Products Panel;
 Radiological Health, Food and Drug       Obstetrics and Gynecology
 Administration, 10903 New Hampshire      Devices Panel; Orthopaedic and
 Ave., Bldg. 66, Rm. 5216, Silver         Rehabilitation Devices Panel.
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [email protected].
Jarrod Collier, Center for Devices and   General Hospital and Personal
 Radiological Health, Food and Drug       Use Devices Panel; Hematology
 Administration, 10903 New Hampshire      and Pathology Devices Panel;
 Ave., Bldg. 66, Rm. 5211, Silver         Molecular and Clinical
 Spring, MD 20993-0002,<PHONE_NUMBER>,     Genetics Panel; Ophthalmic
 [email protected].              Devices Panel; Radiological
                                          Devices Panel.
James Swink, Center for Devices and      National Mammography Quality
 Radiological Health, Food and Drug       Assurance Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5211, Silver
 Spring, MD 20993-0002,<PHONE_NUMBER>,
 [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 expertise
                 needed                            Type of vacancy                 Approximate date needed
----------------------------------------------------------------------------------------------------------------
FDA Science Board Advisory Committee--    1--Voting........................  Immediately.
 The Science Board provides advice to
 the Commissioner of Food and Drugs
 Administration (Commissioner) and other
 appropriate officials on specific
 complex scientific and technical issues
 important to FDA and its mission,
 including emerging issues within the
 scientific community. Additionally, the
 Science Board provides advice that
 supports the Agency in keeping pace
 with technical and scientific
 developments, including in regulatory
 science; and input into the Agency's
 research agenda, and on upgrading its
 scientific and research facilities and
 training opportunities. It also
 provides, where requested, expert
 review of Agency-sponsored intramural
 and extramural scientific research
 programs.
Allergenic Products Advisory Committee--  1--Voting........................  Immediately.
 Knowledgeable in the fields of allergy,
 immunology, pediatrics, internal
 medicine, biochemistry, and related
 specialties.

Anesthetic and Analgesic Drug Products    1--Voting........................  April 1, 2023.
 Advisory Committee--Knowledgeable in
 the fields of anesthesiology, surgery,
 epidemiology or statistics, and related
 specialties.
Non-Prescription Drugs Advisory           1--Voting........................  Immediately.
 Committee--Knowledgeable in the fields
 of internal medicine, family practice,
 clinical toxicology, clinical
 pharmacology, pharmacy, dentistry, and
 related specialties.
Antimicrobial Drugs Advisory Committee--  1--Voting........................  May 1, 2023.
 Knowledgeable in the fields of
 infectious disease, internal medicine,
 microbiology, pediatrics, epidemiology
 or statistics, and related specialties.
Arthritis Advisory Committee--            1--Voting........................  December 1, 2023.
 Knowledgeable in the fields of
 arthritis, rheumatology, orthopedics,
 epidemiology or statistics, analgesics,
 and related specialties.
Peripheral and Central Nervous Systems    1--Voting........................  February 1, 2023.
 Drugs Advisory Committee--Knowledgeable
 in the fields of neurology,
 neuropharmacology, neuropathology,
 otolaryngology, epidemiology or
 statistics, and related specialties.
Cardiovascular and Renal Drugs Advisory   1--Voting........................  July 1, 2023.
 Committee--Knowledgeable in the fields
 of cardiology, hypertension,
 arrhythmia, angina, congestive heart
 failure, diuresis, and biostatistics.
Medical Imaging Drugs Advisory            1--Voting........................  Immediately.
 Committee--Knowledgeable in the fields
 of nuclear medicine, radiology,
 epidemiology, statistics, and related
 specialties.
Endocrinologic and Metabolic Drugs        1--Voting........................  Immediately.
 Advisory Committee--Knowledgeable in
 the fields of endocrinology,
 metabolism, epidemiology or statistics,
 and related specialties.
Pharmacy Compounding Advisory Committee-- 1--Voting........................  October 1, 2023.
 Knowledgeable in the fields of
 pharmaceutical compounding,
 pharmaceutical manufacturing, pharmacy,
 medicine, and other related specialties.
Psychopharmacologic Drugs Advisory        1--Voting........................  Immediately.
 Committee--Knowledgeable in the fields
 of psychopharmacology, psychiatry,
 epidemiology or statistics, and related
 specialties.
Anesthesiology and Respiratory Therapy    1--Nonvoting.....................  Immediately.
 Devices Panel--Anesthesiologists,
 pulmonary medicine specialists, or
 other experts who have specialized
 interests in ventilator support,
 pharmacology, physiology, or the
 effects and complications of anesthesia.
Clinical Chemistry and Clinical           1--Nonvoting.....................  Immediately.
 Toxicology Devices Panel--Doctor of
 Medicine or Philosophy with experience
 in clinical chemistry (e.g., cardiac
 markers), clinical toxicology, clinical
 pathology, clinical laboratory
 medicine, and endocrinology.
Ear, Nose and Throat Devices Panel--      1--Nonvoting.....................  November 1, 2023.
 Otologists, neurotologists,
 audiologists.
Gastroenterology-Urology Devices Panel--  1--Nonvoting.....................  Immediately.
 Gastroenterologists, urologists, and
 nephrologists.
General and Plastic Surgery Devices       1--Nonvoting.....................  Immediately.
 Panel--Surgeons (general, plastic,
 reconstructive, pediatric, thoracic,
 abdominal, pelvic, and endoscopic);
 dermatologists; experts in
 biomaterials, lasers, wound healing,
 and quality of life; and
 biostatisticians.
Circulatory System Devices Panel--        1--Nonvoting.....................  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists, vascular and
 cardiothoracic surgeons, and
 cardiologists with special interest in
 congestive heart failure.
Microbiology Devices Panel--Clinicians    1--Nonvoting.....................  Immediately.
 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.
Dental Products Panel--Dentists,          1--Nonvoting.....................  Immediately.
 engineers and scientists who have
 expertise in the areas of dental
 implants, dental materials,
 periodontology, tissue engineering, and
 dental anatomy.
Obstetrics and Gynecology Devices Panel-- 1--Nonvoting.....................  Immediately.
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery, assisted
 reproductive technologies,
 contraception, postoperative adhesions,
 and cervical cancer and colposcopy;
 biostatisticians and engineers with
 experience in obstetrics/gynecology
 devices; urogynecologists; experts in
 breast care; experts in gynecology in
 the older patient; experts in
 diagnostic (optical) spectroscopy;
 experts in midwifery; labor and
 delivery nursing.
Orthopaedic and Rehabilitation Devices    1--Nonvoting.....................  Immediately.
 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.
General Hospital and Personal Use         1--Nonvoting.....................  Immediately.
 Devices Panel--Internists,
 pediatricians, neonatologists,
 endocrinologists, gerontologists,
 nurses, biomedical engineers, or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices Panel--  1--Nonvoting.....................  Immediately.
 Hematologists (benign and/or malignant
 hematology), hematopathologists
 (general and special hematology,
 coagulation and hemostasis, and
 hematological oncology), gynecologists
 with special interests in gynecological
 oncology, cytopathologists, and
 molecular pathologists with special
 interests in development of predictive
 biomarkers.
Molecular and Clinical Genetics Devices   1--Nonvoting.....................  Immediately.
 Panel--Experts in human genetics and in
 the clinical management of patients
 with genetic disorders, e.g.,
 pediatricians, obstetricians,
 neonatologists. The Agency is also
 interested in considering candidates
 with training in inborn errors of
 metabolism, biochemical and/or
 molecular genetics, population
 genetics, epidemiology, and related
 statistical training. Additionally,
 individuals with experience in genetic
 counseling, medical ethics, as well as
 ancillary fields of study will be
 considered.

Ophthalmic Devices Panel--Ophthalmists    1--Nonvoting.....................  Immediately.
 with expertise in corneal-external
 disease, vitreo-retinal surgery,
 glaucoma, ocular immunology, ocular
 pathology; optometrists; vision
 scientists; and ophthalmic
 professionals with expertise in
 clinical trial design, quality of life
 assessment, electrophysiology, low
 vision rehabilitation, and
 biostatistics.
Radiological Devices Panel--Physicians    1--Nonvoting.....................  Immediately.
 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.
National Mammography Quality Assurance    3--Voting........................  Immediately.
 Advisory Committee--Physician,
 practitioner, or other health
 professional whose clinical practice,
 research specialization, or
 professional expertise includes a
 significant focus on mammography.
----------------------------------------------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

    The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner of Food and Drugs (Commissioner) and other
appropriate officials on specific complex scientific and technical
issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice that supports the Agency in keeping pace with technical
and scientific developments, including in regulatory science, and input
into the Agency's research agenda and on upgrading its scientific and
research facilities and training opportunities. It also provides, where
requested, expert review of Agency-sponsored intramural and extramural
scientific research programs.

B. Allergenic Products Advisory Committee

    Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease and makes appropriate recommendations to the
Commissioner regarding the affirmation or revocation of biological
product licenses, on the safety, effectiveness, and labeling of the
products, on clinical and laboratory studies of such products, on
amendments or revisions to regulations governing the manufacture,
testing, and licensing of allergenic biological products, and on the
quality and relevance of FDA's research programs.

C. Anesthetic and Analgesic Drug Products 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.

D. Nonprescription Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases and advises the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee serves as a forum for the
exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.

E. Antimicrobial 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 infectious diseases and disorders.

F. Arthritis Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of arthritis, rheumatism, and related diseases.

G. Peripheral and Central Nervous System Drugs Advisory Committee

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

H. 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.

I. Medical Imaging Drugs 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.

J. Endocrinologic and Metabolic Drugs Advisory Committee

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

K. Pharmacy Compounding Advisory Committee

    Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.

L. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human

drug products for use in the practice of psychiatry and related fields.

M. Medical Devices Advisory Committee Panels

    The Medical Devices Advisory Committee has established certain
panels to 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: (1)
advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(6) advises on the necessity to ban a device; and (7) 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 on issues relating to the design of
clinical studies regarding the safety and effectiveness of marketed and
investigational devices.
    The Dental Products Panel reviews and evaluates data concerning the
safety and effectiveness of marketed and investigational products for
use in dentistry, endodontics or bone physiology relative to the oral
and maxillofacial area.
    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.

N. National Mammography Quality Assurance Advisory Committee

    Advises the Agency on the development of appropriate quality
standards and regulations for mammography facilities; standards and
regulations for bodies accrediting mammography facilities under this
program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; reporting new developments concerning
breast imaging that should be considered in the oversight of
mammography facilities. The Committee also advises on determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas;
determining whether there will be a sufficient number of medical
physicists after October 1, 1999; and determining the costs and
benefits of compliance with these requirements.

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 45 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
r[eacute]sum[eacute]. Ballots are to 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), 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 of 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.
After 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: October 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22305 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Notices]
[Page 40555-40556]
[DOCID:fr17jy06-110]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

    Extension:
    Rule 12d1-1; SEC File No. 270-526; OMB Control No. 3235-0584.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(the ``Commission'') is soliciting comments on the collections of
information summarized below. The Commission plans to submit these
existing collections of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Under current law, an investment company (``fund'') is limited in
the amount of securities the fund (``acquiring fund'') can acquire from
another fund (``acquired fund''). In general under the Investment
Company Act of 1940 (15 U.S.C. 80a) (the ``Investment Company Act'' or
``Act''), a registered fund (and companies it controls) cannot: (i)
Acquire more than three percent of another fund's securities; (ii)
invest more than five percent of its own assets in another fund; or
(iii) invest more than ten percent of its own assets in other funds in
the aggregate.\1\ In addition, a registered open-end fund, its
principal underwriter, and any registered broker or dealer cannot sell
that fund's shares to another fund if, as a result: (i) The acquiring
fund (and any companies it controls) owns more than three percent of
the acquired fund's stock; or (ii) all acquiring funds (and companies
they control) in the aggregate own more than ten percent of the
acquired fund's stock.\2\ Rule 12d1-1 under the Act (17 CFR 270.12d1-1)
provides an exemption from these limitations for ``cash sweep''
arrangements, in which a fund invests all or a portion of its available
cash in a money market fund rather than directly in short-term
instruments. An acquiring fund relying on the exemption may not pay a
sales load, distribution fee, or service fee on acquired fund shares,
or if it does, the acquiring fund's investment adviser must waive a
sufficient amount of its advisory fee to offset the cost of the loads
or distribution fees.\3\ The acquired fund may be a fund in the same
fund complex or in a different fund complex. In addition to providing
an exemption from section 12(d)(1) of the Act, the rule provides
exemptions from section 17(a) and Rule 17d-1, which restrict a fund's
ability to enter into transactions and joint arrangements with
affiliated persons.\4\ These provisions could otherwise prohibit an
acquiring fund from investing in a money market fund in the same fund
complex,\5\ or prohibit a fund that acquires five percent or more of
the securities of a money market fund in another fund complex from
making any additional investments in the money market fund.\6\
---------------------------------------------------------------------------

    \1\ See 15 U.S.C. 80a-12(d)(1)(A). If an acquiring fund is not
registered, these limitations apply only with respect to the
acquiring fund's acquisition of registered funds.
    \2\ See 15 U.S.C. 80a-12(d)(1)(B).
    \3\ See Rule 12d1-1(b)(1).
    \4\ See 15 U.S.C. 80a-17(a), 15 U.S.C. 80a-17(d); 17 CFR
270.17d-1.
    \5\ An affiliated person of a fund includes any person directly
or indirectly controlling, controlled by, or under common control
with such other person. See 15 U.S.C. 80a-2(a)(3)(C) (definition of
``affiliated person''). Most funds today are organized by an
investment adviser that advises or provides administrative services
to other funds in the same complex. Funds in a fund complex are
generally under common control of an investment adviser or other
person exercising a controlling influence over the management or
policies of the funds. See 15 U.S.C. 80a-2(a)(9). Not all advisers
control funds they advise. The determination of whether a fund is
under the control of its adviser, officers, or directors depends on
all the relevant facts and circumstances. See Investment Company
Mergers, Investment Company Act Release No. 25259 (Nov. 8, 2001) [66
FR 57602 (Nov. 15, 2001)], at n.11. To the extent that an acquiring
fund in a fund complex is under common control with a money market
fund in the same complex, the funds would rely on the Rule's
exemptions from section 17(a) and Rule 17d-1.
    \6\ See 15 U.S.C. 80a-2(a)(3)(A), (B).
---------------------------------------------------------------------------

    The rule also permits a registered fund to rely on the exemption to
invest in an unregistered money market fund that limits its investments
to those in which a registered money market fund may invest under Rule
2a 7 under the Act (17 CFR 270.2a 7), and undertakes to comply with all
the other provisions of Rule 2a 7. In addition the acquiring fund must
reasonably believe that the unregistered money market fund (i) Operates
in compliance with Rule 2a 7, (ii) complies with sections 17(a), (d),
(e), 18, and 22(e) of the Act \7\ as if it were a registered open-end
fund, (iii) has adopted procedures designed to ensure that it complies
with these statutory provisions, (iv) maintains the records required by
Rules 31a 1(b)(2)(ii), 31a 1(b)(2)(iv), and 31a-1(b)(9); \8\ and (v)
preserves permanently, the first two

years in an easily accessible place, all books and records required to
be made under these rules.
---------------------------------------------------------------------------

    \7\ See 15 U.S.C. 80a-17(a), 15 U.S.C. 80a-17(d), 15 U.S.C. 80a-
17(e), 15 U.S.C. 80a-18, 15 U.S.C. 80a-22(e).
    \8\ See 17 CFR 270.31a-1(b)(2)(ii), 17 CFR 270.31a-1(b)(2)(iv),
17 CFR 270.31a-1(b)(9).
---------------------------------------------------------------------------

    Rule 2a-7 contains certain collection of information requirements.
An unregistered money market fund that complies with Rule 2a 7 would be
subject to these collection of information requirements. In addition,
the recordkeeping requirements under Rule 31 with which the acquiring
fund reasonably believes the unregistered money market fund complies
are collections of information for the unregistered money market fund.
By allowing funds to invest in registered and unregistered money market
funds, Rule 12d1-1 is intended to provide funds greater options for
cash management. In order for a registered fund to rely on the
exemption to invest in an unregistered money market fund, the
unregistered money market fund must comply with certain collection of
information requirements for registered money market funds. These
requirements are intended to ensure that the unregistered money market
fund has established procedures for collecting the information
necessary to make adequate credit reviews of securities in its
portfolio, as well as other recordkeeping requirements that will assist
the acquiring fund in overseeing the unregistered money market fund
(and Commission staff in its examination of the unregistered money
market fund's adviser).
    Commission staff estimates that registered funds currently invest
in 40 unregistered money market funds in excess of the statutory limits
under an exemptive order issued by the Commission, and will invest in
approximately 6 new unregistered money market funds each year.\9\ Staff
estimates that each of these unregistered money market funds spends
1220 hours to perform the record of credit risk analysis and other
determinations annually, and in the first year after the rule's
adoption, each will spend 21 hours to implement the board
procedures.\10\ Finally, Commission staff estimates that 10
unregistered money market funds spends 4.5 hours to review and amend
procedures annually. The estimated total of annual responses under Rule
12d1-1 is 57,131.\11\
---------------------------------------------------------------------------

    \9\ This estimate is based on the number of applications filed
with the Commission in 2005. This estimate may be understated
because applicants generally do not identify the name or number of
unregistered money market funds in which registered funds intend to
invest, and each application also applies to unregistered money
market funds to be organized in the future.
    \10\ The Commission adopted Rule 12d1-1 on June 20, 2006. See
Fund of Funds Investments, Investment Company Act Release No. 27399
(June 20, 2006).
    \11\ This estimate is based on the following calculation: (40 x
1220) + (6 x 1220) + (40 x 21) + (6 x 21) + (10 x 4.5) = 57,131.
---------------------------------------------------------------------------

    Commission staff estimates that in addition to the costs described
in section 12, unregistered money market funds will incur costs to
preserve records, as required under Rule 2a-7. These costs will vary
significantly for individual funds, depending on the amount of assets
under fund management and whether the fund preserves its records in a
storage facility in hard copy or has developed and maintains a computer
system to create and preserve compliance records. In its Rule 2a-7
submission, Commission staff estimated that the amount an individual
money market fund may spend ranged from $100 per year to $300,000. We
have no reason to believe the range would be different for unregistered
money market funds. As noted before, we have no information on the
amount of assets managed by unregistered money market funds.
Accordingly, Commission staff has estimated that an unregistered money
market fund in which registered funds would invest in reliance on Rule
12d1-1 would have, on average, $376.4 million in assets under
management.\12\ Based on a cost of $0.0000005 per dollar of assets
under management for medium-sized funds, the staff estimates compliance
with Rule 2a-7 would cost these types of unregistered money market
funds $8,000 annually.\13\ Commission staff estimates that unregistered
money market funds will not incur any capital costs to create computer
programs for maintaining and preserving compliance records for Rule 2a-
7.\14\
---------------------------------------------------------------------------

    \12\ This estimate is based on the average of assets under
management of medium-sized registered money market funds ($50
million to $999 million).
    \13\ This estimate was based on the following calculation: 46
unregistered money market funds x $357.7 million in assets under
management x $0.0000005 = $8,227. The estimate of cost per dollar of
assets is the same as that used for medium-sized funds in the Rule
2a-7 submission.
    \14\ This estimate is based on information Commission staff
obtained in its survey for the Rule 2a-7 submission. Of the funds
surveyed, no medium-sized funds incurred this type of capital cost.
The funds either maintained record systems using a program the fund
would be likely to have in the ordinary course of business (such as
Excel) or the records were maintained by the fund's custodian.
---------------------------------------------------------------------------

    The collections of information required for unregistered money
market funds by Rule 12d1-1 are necessary in order for acquiring funds
to be able to obtain the benefits described above. Notices to the
Commission will not be kept confidential. 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 control number.
    Written comments are invited on: (a) Whether the proposed
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 of 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 60
days of this publication.
    Please direct your written comments to R. Corey Booth, Director/
Chief Information Officer, Securities and Exchange Commission, C/O
Shirley Martinson, 6432 General Green Way, Alexandria, Virginia 22312
or send an e-mail to<EMAIL_ADDRESS>
     Dated: June 23, 2006.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. E6-11229 Filed 7-14-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16679-16680]
[FR Doc No: 2013-06142]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0206]

Center for Drug Evaluation and Research Medical Policy Council;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket, request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to receive suggestions, recommendations, and
comments for topics from interested parties, including academic
institutions, regulated industry, patient representatives, and other
interested organizations, on medical policy issues that may be
considered by the CDER Medical Policy Council (Council) in FDA's Center
for Drug Evaluation and Research (CDER). These comments will help the
Agency identify and address medical policy issues that need
clarification through guidance, notice and comment procedures, or other
means.

DATES: Submit either electronic or written comments by July 16, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
301), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sandra J. Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-1042, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In January 2012, CDER established the Council to ensure better
coordination of medical policy development and implementation within
CDER and consistent, predictable communication of medical policy
decisions to the public through guidance, notice and comment
procedures, or other means.
    Chaired by CDER's Associate Director for Medical Policy, the
Council provides a senior-level forum through which medical policy
issues can be raised, considered, developed, and implemented. Council
members include the following senior clinical leaders: The Center
Director, the Deputy Center Director for Clinical Science, the Director
of the Office of New Drugs, and the Director of the Office of
Surveillance and Epidemiology. Experts from within CDER and other FDA
offices provide expertise as needed for specific policy topics under
consideration. By establishing this docket, FDA encourages the public
to recommend specific topics for consideration by the Council. The
Agency believes that this process will also ensure additional
transparency in CDER's approach to medical policy development and
implementation.

II. Range of Medical Policy Issues To Be Considered

    FDA envisions a variety of topics that may be relevant for
consideration by the Council. Specific topics could address issues
related to the following: (1) Clinical evidence of effectiveness or
safety, (2) clinical study/trial design, (3) professional and patient
labeling, (4) prescription drug promotion, (5) human subjects
protection, (6) bioresearch monitoring, (7) good clinical practice, (8)
counter-terrorism drug development (such as in the application of the
Animal Rule, 21 CFR 314.600), and (9) postmarketing surveillance. To be
considered by the Council, a medical policy issue typically would meet
one or more of the following criteria:
     A novel medical policy issue requiring senior management
input;
     An issue on which CDER seems to have taken inconsistent
positions;
     An existing medical policy position that should be
reconsidered in light of scientific or regulatory advances;
     A complex safety management issue requiring senior
management input;
     A medical policy that may be triggered by a specific
product, but that will be applicable to other products; or
     Strategies for implementation of a new policy.

III. Establishment of a Docket and Request for Comments

    FDA is requesting public suggestions, recommendations, and comments
for topics (including scientific, clinical, regulatory, or other
topics) on existing or novel medical policy issues that may warrant
consideration by the Council. Comments should describe the following:
(1) The medical policy issue recommended for discussion, (2) the
rationale for doing so (e.g., clarifying previous advice or precedents,
reconciling apparently differing perspectives within CDER or between
CDER and regulated industry), (3) recommendations on how the medical
policy issue could be addressed or implemented; and (4) existing policy
documents (e.g., final guidance) relevant to the medical policy issue.
Note that policy issues concerning any draft guidance should be
submitted to the docket for that draft guidance.
    The Agency will carefully consider all comments submitted. FDA
generally will not respond directly to the person or organization
submitting the

comment. In general, medical policy decisions reached by the Council
are communicated and implemented in accordance with FDA's good guidance
practices regulation (21 CFR 10.115) or notice and comment procedures.

IV. Request for Comments

    Interested persons may submit either written comments regarding
this notice to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06142 Filed 3-15-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3428-3430]
[FR Doc No: 2019-02003]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR19-30-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: COH Rates effective
1-31-2019.
    Filed Date: 1/30/19.
    Accession Number:<PHONE_NUMBER>64.
    Comments/Protests Due: 5 p.m. ET 2/20/19.

    Docket Number: PR19-32-000.
    Applicants: Southern California Gas Company.
    Description: Tariff filing per 284.123(b),(e)+(g): Offshore
Delivery Service Rate Revision--January 2019 to be effective 1/1/2019.
    Filed Date: 1/30/19.
    Accession Number:<PHONE_NUMBER>18.
    Comments Due: 5 p.m. ET 2/20/19.
    284.123(g) Protests Due: 5 p.m. ET 4/1/19.

    Docket Number: PR19-33-000.
    Applicants: NorthWestern Corporation.
    Description: Tariff filing per 284.123(b),(e)/: Revised Rate
Schedules for Transportation and Storage (Tax Tracker and TCJA) to be
effective 1/1/2019.
    Filed Date: 1/31/19.
    Accession Number:<PHONE_NUMBER>96.
    Comments/Protests Due: 5 p.m. ET 2/21/19.

    Docket Numbers: RP19-608-000.

    Applicants: Kinder Morgan Illinois Pipeline LLC.
    Description: Penalty Revenue Crediting Report of Kinder Morgan
Illinois Pipeline LLC.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5229.
    Comments Due: 5 p.m. ET 2/11/19.

    Docket Numbers: RP19-609-000.
    Applicants: Kinder Morgan Louisiana Pipeline LLC.
    Description: Penalty Revenue Crediting Report of Kinder Morgan
Louisiana Pipeline LLC.
    Filed Date: 1/30/19.
    Accession Number: 20190130-5230.
    Comments Due: 5 p.m. ET 2/11/19.

    Docket Numbers: RP19-427-001.
    Applicants: Honeoye Storage Corporation.
    Description: Compliance filing 20190131 157 Tariff In Compliance
with Order Approving Settlement to be effective 1/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5285.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-610-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Superseding Non-conforming
Agmts Filing--Coastal Bend to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5037.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-611-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 1-31-19 to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5040.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-612-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated & Non-Conforming
Svc Agmts--ESU to be effective 3/18/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5041.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-613-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Cherokee
AGL--Replacement Shippers--Feb 2019 to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5079.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-614-000.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Sec.  4(d) Rate Filing: Conforming and Nonconforming
Negotiated Rate Service Agreements to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5082.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-615-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Agreement
Update (Conoco Feb 19) to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5083.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-616-000.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Sec.  4(d) Rate Filing: Tariff Revisions Applicable to
Rate Schedule FT-2 to be effective 3/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5084.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-617-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Coastal Bend Agmt releases eff 2-1-2019) to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5085.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-618-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Atlanta Gas 8438 to various shippers eff 2-1-2019) to be effective 2/
1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5086.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-619-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmt
(Petrohawk 41455 to BP 50582) to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5088.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-620-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Cap Rel Neg Rate Agmts
(Gulfport 34939, 35446 to Eco-Energy 37770, 37771) to be effective 2/1/
2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5089.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-621-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20190131 Negotiated Rate to be
effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5094.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-622-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20190131 Remove Gulf Coast to
be effective 3/2/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5095.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-623-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates for releases
to UGI contracts eff 2-1-19 to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5128.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-624-000.
    Applicants: Alliance Pipeline L.P.
    Description: Sec.  4(d) Rate Filing: Contract Adjustments for 2-1-
2019 to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5144.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-625-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: Sec.  4(d) Rate Filing: Negotiated Rates--Chevron
911109 releases eff 2-1-19 to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5187.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-626-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Columbia to
Alpha Gas 960135 to be effective 2/1/2019.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5191.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-627-000.
    Applicants: Great Lakes Gas Transmission Limited Partnership.
    Description: Compliance filing Semi-Annual Transporter's Use Report
to be effective N/A.
    Filed Date: 1/31/19.
    Accession Number: 20190131-5194.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-628-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Neg Rate 2019-01-31 E2W (7) to
be effective 2/1/2019.

    Filed Date: 1/31/19.
    Accession Number: 20190131-5228.
    Comments Due: 5 p.m. ET 2/12/19.

    Docket Numbers: RP19-629-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing--
February 2019--Newfield 1011022 to be effective 2/1/2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5002.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-630-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Capacity Release
Agreements--2/1/2019 to be effective 2/1/2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5007.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-631-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt and
Cap Rel Neg Rate Agmt (Aethon37657 to Scona50621) to be effective 2/1/
2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5027.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-632-000.
    Applicants: Midwestern Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreement--Exelon & Duke Energy Indiana to be effective 1/31/2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5070.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-633-000.
    Applicants: Cheniere Corpus Christi Pipeline, LP.
    Description: Sec.  4(d) Rate Filing: Electric Power Costs to be
effective 3/1/2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5072.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-634-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20190201 Annual PRA to be
effective 4/1/2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5095.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-635-000.
    Applicants: Cheniere Corpus Christi Pipeline, LP.
    Description: Sec.  4(d) Rate Filing: 311(a)(1) Transportation to be
effective 3/1/2019.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5207.
    Comments Due: 5 p.m. ET 2/13/19.

    Docket Numbers: RP19-636-000.
    Applicants: Black Marlin Pipeline Company.
    Description: Petition for Waiver from Implementing NAESB version
3.1 standards of Black Marlin Pipeline Company.
    Filed Date: 2/1/19.
    Accession Number: 20190201-5225.
    Comments Due: 5 p.m. ET 2/13/19.

    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: February 4, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-02003 Filed 2-11-19; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Dear Director Zeller.

I am writing as a concerned citizen regarding this proposed rule by asking that the comment period be extended for an additional 105 days. I need to provide a more detailed account of my personal history (in 2008 I was diagnosed with COPD and how today, that diagnosis is no longer true.) I'll need a chance to get my medical records together to prove this so that to you its more than an anecdote.

Additionally, I just heard about this. I don't know how much time is left, but more time would be much appreciated.

Thank you, Paul McCoy


[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Pages 30928-30929]
[FR Doc No: 2013-12230]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: General and Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 26, 2013, from 8
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom 2, Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel phone number is<PHONE_NUMBER>.
    Contact Person: Avena Russell, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1535, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
301-796-3805, or FDA Advisory Committee Information Line, 1-800-741-
8138<PHONE_NUMBER> in the Washington, DC area). A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm
and scroll down to the appropriate advisory committee meeting link, or
call the advisory committee information line to learn about possible
modifications before coming to the meeting.
    Agenda: On June 26, 2013, the committee will discuss and make
recommendations regarding the possible reclassification of blood lancet
devices. The committee will discuss whether new scientific data are
sufficient to support the reasonable assurance of safety and
effectiveness to develop special controls that support regulation of
blood lancets from class I to class II and class III. The four subsets
of blood lancets have been identified with the following indications
for use:
     Blood lancet with an integral sharps injury prevention
feature is for single use only, disposable blood lancet with a blade
attached to a solid base which includes an integral sharps injury
prevention feature that allows the device to be used once and then
renders it inoperable and incapable of further use and which is used to
puncture the skin to obtain a drop of blood for diagnostic purposes;
     Blood lancet without an integral sharps injury prevention
feature is for single use only, disposable blood lancet with a blade
attached to a solid base which is used to puncture the skin to obtain a
drop of blood for diagnostic purposes;
     Blood lancet for single patient use only is a multiple use
capable blood lancet with a single use blade inserted into a solid,
reusable base which is used only for a single patient to puncture the
skin to obtain a drop of blood for diagnostic purposes; and
     Multiple use blood lancet for multiple patient use is a
multiple use capable blood lancet with a single use blade inserted into
a solid, reusable base which is used for multiple patients to puncture
the skin to obtain a drop of blood for diagnostic purposes.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before June
7, 2013. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral

presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before June 6, 2013. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by June 10,
2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Committee Management Staff, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>at least 7 days in advance of the
meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: May 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-12230 Filed 5-22-13; 8:45 am]
BILLING CODE 4160-01-P