[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62401-62403]
[FR Doc No: 2022-22350]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC23-4-000.
    Applicants: Bitter Ridge Wind Farm, LLC, Persimmon Creek Wind Farm
1, LLC, BGTF Zeus Holdings LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Bitter Ridge Wind Farm, LLC, et al.
    Filed Date: 10/6/22.
    Accession Number: 20221006-5177.
    Comment Date: 5 p.m. ET 10/27/22.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-5-000.
    Applicants: RWE Renewables Americas, LLC.
    Description: Baron Winds LLC submits Notice of Self-Certification
of Exempt Wholesale Generator Status.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5005.
    Comment Date: 5 p.m. ET 10/28/22.

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL23-2-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Petition for Declaratory Order of Pacific Gas and
Electric Company.
    Filed Date: 10/3/22.
    Accession Number: 20221003-5359.
    Comment Date: 5 p.m. ET 11/2/22.

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

    Docket Numbers: ER20-1954-002.
    Applicants: ITC Great Plains, LLC, Southwest Power Pool, Inc.
    Description: Compliance filing: ITC Great Plains, LLC submits
tariff filing per 35: ITC Great Plains, LLC Second Revised Order No.
864 Compliance Filing to be effective 1/27/2020.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5091.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER22-469-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: 1148R21 American Electric Power
Service Corporation--Deficiency Response to be effective 12/1/2021.
    Filed Date: 10/5/22.
    Accession Number: 20221005-5133.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: ER22-643-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: 3881SO Southwestern Power Admin &
AEP OK--Deficiency Response to be effective 12/31/9998.
    Filed Date: 10/5/22.
    Accession Number: 20221005-5134.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: ER22-644-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: 3882SO Southwestern Power Admin&Publ
Ser--Deficiency Response to be effective 12/31/9998.
    Filed Date: 10/5/22.
    Accession Number: 20221005-5137.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: ER22-2660-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: SPS Amended Formula Rate Revisions
to Incorporate Changes Accepted in Er22-201 to be effective 5/19/2021.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5017.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER22-2690-001.
    Applicants: PPL Electric Utilities Corporation, PJM
Interconnection, L.L.C.
    Description: Tariff Amendment: PPL Services Corporation submits
tariff filing per 35.17(b): PJM TOs Response to Deficiency Letter in
ER22-2690 to be effective 10/19/2022.
    Filed Date: 10/5/22.
    Accession Number: 20221005-5140.
    Comment Date: 5 p.m. ET 10/26/22.

    Docket Numbers: ER23-32-000.
    Applicants: Duke Energy Florida, LLC.
    Description: Tariff Amendment: DEF-ECOGEN Notice of Cancellation of
LGIA SA No. 180 to be effective 12/6/2022.
    Filed Date: 10/6/22.
    Accession Number: 20221006-5135.
    Comment Date: 5 p.m. ET 10/27/22.

    Docket Numbers: ER23-33-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Rate Schedule
FERC No. 13 to be effective 10/3/2022.
    Filed Date: 10/6/22.
    Accession Number: 20221006-5138.
    Comment Date: 5 p.m. ET 10/27/22.

    Docket Numbers: ER23-34-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) Rate Filing: LS Power Grid California LLC
(Gates 500kV) IA (TO SA 447) to be effective 10/7/2022.
    Filed Date: 10/6/22.
    Accession Number: 20221006-5143.
    Comment Date: 5 p.m. ET 10/27/22.

    Docket Numbers: ER23-35-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA/CSA, Service
Agreement Nos. 6651/6652; Queue No. AG1-080 to be effective 9/7/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5011.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER23-36-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Cost Responsibility
Agreement, SA No. 6614; Non-Queue No. NQ-187 to be effective 9/12/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5014.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER23-37-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: Deseret TSOA Rev 9 to be
effective 12/7/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5034.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER23-38-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2022-10-07_SA 3142
Termination of ITC Midwest-EDF Renewables E&P (J495) to be effective
10/8/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5039.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER23-39-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2022-10-07_SA 3129
Termination of MidAmerican-Glaciers Edge Wind E&P (J506) to be
effective 10/8/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5041.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER23-40-000.
    Applicants: Midcontinent Independent System Operator, Inc., Otter
Tail Power Company.
    Description: Sec.  205(d) Rate Filing: Midcontinent Independent
System Operator, Inc. submits tariff filing per 35.13(a)(2)(iii: 2022-
10-07_SA 3913 3914 OTP-NSP FCA & FSA (Forman-Canby-Fergus MPFP) to be
effective 12/7/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5051.
    Comment Date: 5 p.m. ET 10/28/22.

    Docket Numbers: ER23-41-000.
    Applicants: Duke Energy Business Services LLC, PJM Interconnection,
L.L.C.
    Description: Tariff Amendment: Duke Energy Business Services LLC
submits tariff filing per 35.15: Notice of Termination of Amended and
Restated IA, PJM SA No. 3137 to be effective 12/7/2022.
    Filed Date: 10/7/22.
    Accession Number: 20221007-5059.
    Comment Date: 5 p.m. ET 10/28/22.

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

    Docket Numbers: RD22-5-000.
    Applicants: North American Electric Reliability Corporation.
    Description: Application of the North American Electric Reliability
Corporation for approval of FAC-001-4 and FAC-002-4.
    Filed Date: 6/14/22.
    Accession Number: 20220614-5204.
    Comment Date: 5 p.m. ET 10/28/22.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: October 7, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-22350 Filed 10-13-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Proposed Rules]
[Pages 16698-16704]
[FR Doc No: 2014-06614]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2013-N-0590]
RIN 0910-AG97

Implementation of the Food and Drug Administration Food Safety
Modernization Act Amendments to the Reportable Food Registry Provisions
of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance
notice of proposed rulemaking (ANPRM) to solicit comments, data, and
information to assist the Agency in implementing the FDA Food Safety
Modernization Act (FSMA), which added new provisions to the Reportable
Food Registry (RFR) requirements of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act). Under the new provisions, FDA may require
a responsible party to also submit to FDA ``consumer-oriented''
information regarding certain reportable foods, including information
necessary to enable a consumer to accurately identify whether the
consumer is in possession of a reportable food. FDA must prepare and
publish on FDA's Internet Web site a one-page summary of the consumer-
oriented information that can be easily printed by a grocery store for
the purposes of consumer notification. A grocery store that sold a
reportable food that is the subject of an FDA one-page summary, and
that is part of a chain of establishments with 15 or more physical
locations, is required to prominently display the FDA one-page summary,
or the information from the summary, within 24 hours after the one-page
summary is published on FDA's Web site, through a method identified by
FDA. FDA is seeking input on topics including consumer-oriented
information submissions, consumer notifications, posting consumer
notifications in grocery stores, and grocery stores subject to the new
requirements.

DATES: Submit either electronic or written comments by June 9, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0590 or Regulatory Information Number (RIN) number 0910-AG97, by any
of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0590 and RIN 0910-AG97 for this advance
notice of proposed rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets

Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ted Elkin, Center for Food Safety and
Applied Nutrition (HFS-008), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>; or April Hodges,
Center for Veterinary Medicine (HFV-230), Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Reportable Food Registry

    Section 1005 of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110-085) amended the FD&C Act by creating section
417 entitled ``Reportable Food Registry'' (21 U.S.C. 350(f)). Under
section 1005 of FDAAA, FDA established the RFR, an electronic portal
that is used to submit mandatory and voluntary reports to FDA regarding
``reportable foods.'' A ``reportable food'' is an article of food
(other than dietary supplements or infant formula) for which there is a
reasonable probability that the use of, or exposure to, such article of
food will cause serious adverse health consequences or death to humans
or animals (see section 201(ff) of the FD&C Act (21 U.S.C. 321(ff)) and
section 417(a)(2) of the FD&C Act). Subject to certain exceptions, a
``responsible party'' is required to submit a report to FDA through the
RFR, as soon as practicable, but in no case later than 24 hours after
determining that an article of food is a reportable food (see section
417(d) of the FD&C Act). Under section 417(a)(1) of the FD&C Act, a
``responsible party'' with respect to an article of food is defined as
``a person that submits the registration under section 415(a) [of the
FD&C Act (21 U.S.C. 350d)] for a food facility that is required to
register under section 415(a), at which such article of food is
manufactured, processed, packed, or held.'' The FD&C Act specifies that
the term ``person'' includes individuals, partnerships, corporations,
and associations (section 201(e) of the FD&C Act). A Federal, State, or
local public health official may submit a report about a reportable
food to FDA through the RFR (section 417(d)(3) of the FD&C Act).
    Several terms are used to describe the RFR system as a whole, as
well as its components. Reportable food reports are submitted through
the Department of Health and Human Services Safety Reporting Portal at
http://www.safetyreporting.hhs.gov/, which we refer to in this document
as ``the Safety Reporting Portal'' or ``SRP.'' The term ``Registry''
refers to the database maintained by FDA to catalogue reports that have
been submitted through the Safety Reporting Portal, and that Agency
review has determined to be reports for foods that meet the standard
for ``reportable foods.'' The terms ``Reportable Food Registry'' and
``RFR'' refer to the system as a whole. This terminology is consistent
with terms FDA uses in its annual reports on the RFR. (See ``The
Reportable Food Registry: A New Approach to Targeting Inspection
Resources and Identifying Patterns of Adulteration: First Annual
Report: September 8, 2009-September 7, 2010'' (January 2011); ``The
Reportable Food Registry: Targeting Inspection Resources and
Identifying Patterns of Adulteration: Second Annual Report: September
8, 2010-September 7, 2011'' (April 2012); and ``The Reportable Food
Registry: Targeting Inspection Resources and Identifying Patterns of
Adulteration: Third Annual Report: September 8, 2011-September 7,
2012'' (April 2013), available at http://www.fda.gov/ReportableFoodRegistry).
    The RFR reporting requirements cover reportable foods that are not
under the exclusive jurisdiction of the U.S. Department of Agriculture,
which include human food (except infant formula and dietary
supplements) and animal food/feed (including pet food) regulated by
FDA. (Other mandatory reporting systems exist for infant formula and
dietary supplements.\1\) Submissions through the Safety Reporting
Portal provide early warning to FDA about potential serious public
health risks related to reportable foods and increase the speed with
which the Agency and its partners at the State and local levels can
investigate and take appropriate action, including ensuring that
reportable foods are removed from commerce when necessary.
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    \1\ A manufacturer, packer, or distributor of a dietary
supplement whose name appears on the label of a dietary supplement
marketed in the United States must submit to FDA any report received
of a serious adverse event associated with such dietary supplement
when used in the United States, accompanied by a copy of the dietary
supplement's label, under section 761 of the FD&C Act (21 U.S.C.
379aa-1). Infant formula manufacturers must comply with notification
requirements for violative infant formula in 21 CFR 107.240.
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    FDA's RFR does not receive reportable food reports from consumers
through the Safety Reporting Portal. Instead, FDA has established other
reporting forms for receiving and responding to consumer emergencies,
complaints, questions, and concerns about FDA-regulated foods. (See,
e.g., ``Your Guide to Reporting Problems to FDA'' at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm).
    Reportable food reports submitted by responsible parties or public
health officials, such as Federal, State, or local public health
officials, are categorized and tracked by FDA. The initial report
concerning a reportable food that FDA generally receives from either a
responsible party or a public health official is designated as the
primary report for that reportable food. All other reports subsequently
received from a responsible party (i.e., either by an immediate
previous source (upstream) or an immediate subsequent recipient
(downstream)) of a reportable food for which a primary report has been
submitted are designated as subsequent reports. After consultation with
the responsible party that submitted an initial report, FDA may require
such responsible party to amend the initial report to include contact
information for certain parties directly linked in the supply chain
(section 417(d)(6)(A) of the FD&C Act). This type of report, which
corrects or adds to an initial report, is an amended report. The
responsible party may also provide corrections or add new information
to a report at any time voluntarily. FDA may also require a responsible
party that has submitted an initial report to notify the immediate
previous source (upstream) or the immediate subsequent recipient
(downstream) of the food for which the responsible party has submitted
an initial report, if FDA deems necessary (see section 417(d)(6)(B) of
the FD&C Act). If another responsible party, such as the immediate
previous source or immediate subsequent recipient of the food, receives
a notification regarding a food for which an initial report has been
submitted, FDA may require such responsible party to submit a report to
FDA regarding that reportable food (see section 417(d)(7) of the FD&C
Act). This type of report, as indicated previously, is a subsequent
report as it contains additional information regarding the reportable
food from a responsible party other than the responsible party that
submitted the initial report. If a responsible party receives a
notification with respect to a food and the responsible party has
already submitted an initial report or subsequent report to FDA with
respect to such food, the responsible party is required to amend such
report to include contact information for certain parties directly
linked in the supply chain and provide the unique report number(s)
issued through the Safety Reporting Portal for

report(s) (by which FDA is able to link reports about the reportable
food and identify the supply chain) for such reportable food (see
section 417(d)(8) of the FD&C Act).
    After reports are submitted to FDA through the Safety Reporting
Portal, FDA reviews and assesses the information for purposes of
identifying reportable foods, entering information into the Registry,
issuing an alert as FDA deems necessary, and exercising other existing
food safety authorities to protect the public health (see sections
417(b)(2) and (c) of the FD&C Act).
    Due to the potential for confusion, it is important to explain that
there are key differences between FDA's RFR and food recall programs.
Generally, FDA's food recall program has been the primary channel of
food product safety communication between FDA, consumers, and others in
the supply chain. The RFR is a separate program, and its general
purpose has been to provide a ``reliable mechanism to track patterns of
adulteration in food . . . [to] support efforts by the [FDA] to target
limited inspection resources to protect the public health'' (Pub. L.
110-085, section 1005(a)(4)). Where the food recall program would, in
part, gather and communicate information helpful to consumers who may
encounter a recalled food, such as safe product disposal instructions,
the RFR gathers information to identify and track a reportable food in
the supply chain. The FSMA amendments to section 417 of the FD&C Act
will give the RFR a greater role in informing the public in the event
of a potential public health emergency.

B. FSMA Amendments to the Reportable Food Registry

    On January 4, 2011, FSMA (Pub. L. 111-353) was signed into law.
FSMA generally amended the FD&C Act to provide for a modernized,
prevention-based food safety system. FSMA amended section 417 of the
FD&C Act, which governs the RFR, in relevant part by adding paragraphs
(f), (g), and (h) (Pub. L. 111-353, 124 Stat. 3885, 3951-3953). Section
417(f), as amended by FSMA, provides that, within 18 months after the
date of enactment of FSMA, the Secretary of Health and Human Services
(the Secretary) (and by delegation, FDA) may require a responsible
party to submit to FDA ``consumer-oriented information'' regarding a
reportable food with the exception of fruits and vegetables that are
raw agricultural commodities. The consumer-oriented information must
include the following: (1) A description of the article of food; (2)
affected product identification codes, such as the Universal Product
Code (UPC), stock keeping unit (SKU), or lot or batch numbers
sufficient for the consumer to identify the article of food; (3)
contact information for the responsible party; and (4) any other
information FDA determines is necessary to enable a consumer to
accurately identify whether such consumer is in possession of the
reportable food (section 417(f)(4) of the FD&C Act). Section 417(g)(1)
of the FD&C Act, as amended by FSMA, requires FDA to prepare the
consumer-oriented information described in section 417(f) as a
standardized one-page summary, and publish the one-page summary on
FDA's Web site in a format that can be easily printed by a grocery
store for purposes of consumer notification.
    A grocery store that is part of a chain of establishments with 15
or more physical locations (``chain grocery store'') that sold a
reportable food that is the subject of a one-page summary published on
FDA's Web site must notify consumers by: (1) Prominently displaying the
one-page summary or information from such summary, through a method
described in section 417(h)(2) of the FD&C Act, no later than 24 hours
after the one-page summary is published on FDA's Web site, and (2)
maintain the display for 14 days (section 417(h)(1) of the FD&C Act).
The chain grocery store must also include in the consumer notification
the date and time that the one-page summary was posted on the FDA's Web
site (section 417(g)(2) of the FD&C Act).
    Section 417(h)(2) of the FD&C Act, as amended by FSMA, requires
that, within 1 year after the date of enactment of FSMA, FDA develop
and publish ``a list of acceptable conspicuous locations and manners''
from which a chain grocery store must select at least one method for
displaying a consumer notification about the reportable food. Section
417(h)(2) provides that the list of acceptable conspicuous locations
and manners must include the following:
     ``Posting the notification at or near the register;''
     ``Providing the location of the reportable food;''
     ``Providing targeted recall information given to customers
upon purchase of food;'' and
     ``Other such prominent and conspicuous locations and
manners utilized by grocery stores as of the date of the enactment of
[FSMA (i.e., as of January 4, 2011)] to provide notice of such recalls
to consumers as considered appropriate by the Secretary.''
    While sections 417(f) and 417(h)(2) of the FD&C Act include
statutory deadlines within 18 and 12 months of the enactment of FSMA,
respectively, FDA is issuing this ANPRM, rather than a notice of
proposed rulemaking, to solicit further input from the public regarding
issues related to the FSMA amendments to section 417 of the FD&C Act.
As discussed in the paragraphs that follow, FDA believes that the
information it obtains through this ANPRM will assist the Agency in
implementing and efficiently enforcing the FSMA amendments to section
417 of the FD&C Act.

II. June 6, 2011, Public Meeting and Request for Comments

    On May 26, 2011, FDA issued a Federal Register notice announcing a
public meeting scheduled for June 6, 2011, entitled ``FDA Food Safety
Modernization Act: Focus on Inspections and Compliance'' (FSMA public
meeting notice) and requesting comments (76 FR 30727). The purpose of
the public meeting was to provide interested persons an opportunity to
discuss implementation of inspections and compliance under FSMA, and to
give the public an opportunity to provide information and share views
to inform FDA's FSMA implementation strategies related to, among other
things, implementation of the new provisions in section 417 of the FD&C
Act. The FSMA public meeting notice presented the following questions
related to the FSMA amendments to section 417 of the FD&C Act:
     What information is necessary to enable a consumer to
accurately identify whether the consumer is in possession of a
reportable food?
     What methods could best be used by grocery stores to
inform consumers of information to enable them to identify whether they
possess a reportable food?
     Are there other approaches to getting key information in
the hands of consumers in real time that FDA should also consider
pursuing?
     Who should FDA consider to be a grocery store subject to
the consumer notification requirement in section 417(h) of the FD&C
Act?
     What methods are grocery stores currently using to provide
notice of food recalls to consumers?
    At the public meeting, FDA provided opportunities for individuals
to make presentations during an open public and Webcast comment
session. A transcript of FDA's remarks at the opening session, the open
public and Webcast comment session, and the listening session is
available on FDA's Web site at (http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm255954.htm). No public comments regarding
the FSMA amendments to

section 417 of the FD&C Act were received during the public meeting
sessions. Stakeholders were given other opportunities to express their
views during breakout sessions focused on specific topics, including a
session on section 417 of the FD&C Act. These sessions were not
recorded.
    In the FSMA public meeting notice, FDA also requested comments, and
noted that electronic or written comments could be submitted to the
Division of Dockets Management regardless of whether commenters
attended the public meeting. FDA opened Docket No. FDA-2011-N-0366 for
public comments. In response to this request, FDA received three
comments. The comments were from trade associations and a consumer
group. These comments are discussed in section III.

III. Issues and Requests for Data and Information

    As noted previously, FDA only received three comments regarding the
FSMA amendments to section 417 of the FD&C Act. While these comments
provided useful input, additional input from the public would assist
the Agency in implementing and efficiently enforcing the FSMA
amendments to section 417 of the FD&C Act. In addition to the issues
described in the FSMA public meeting notice, there are several other
issues related to the new requirements in section 417 for which FDA
believes further comment, data, and information would be helpful to the
Agency in implementing and enforcing the new requirements. As discussed
in the paragraphs that follow, FDA is soliciting input regarding what
information responsible parties should be required to provide to the
Agency in consumer-oriented information submissions for reportable
foods to enable consumers to accurately identify whether they possess
such foods, as specified in section 417(f)(4) of the FD&C Act (FDA
``may require a responsible party to submit to [FDA] consumer-oriented
information regarding a reportable food, which shall include . . . any
other information [FDA] determines is necessary to enable a consumer to
accurately identify whether such consumer is in possession of the
reportable food.''). FDA anticipates that additional input from the
public, including consumers and stakeholders, regarding what
information would allow consumers to determine whether they possess
reportable foods will be critical in FDA's implementation of section
417(f) of the FD&C Act.
    FDA is also soliciting input regarding manners and locations used
by grocery stores to provide food recall information to consumers, as
specified in section 417(h)(2) of the FD&C Act (FDA ``shall develop and
publish a list of acceptable conspicuous locations and manners, from
which grocery stores shall select at least one, for providing the
notification required in [section 417(h)(1) of the FD&C Act] . . .
[which] shall include . . . other such prominent and conspicuous
locations and manners utilized by grocery stores as of the date of the
enactment of [FSMA] to provide notice of such recalls to consumers . .
.''). There may be several manners and locations in which grocery
stores provide or have provided food recall information to consumers.
Further, grocery stores and consumers can provide more information to
FDA regarding these manners and locations, including the advantages and
disadvantages of particular approaches.
    In addition, FDA is soliciting information regarding potential
impacts to and costs incurred by chain grocery stores related to
posting consumer notifications, as required by section 417(h) of the
FD&C Act. Because grocery stores likely have experience with providing
notices to consumers, these stores likely have data and information
that could assist the Agency in estimating associated costs and burdens
related to compliance. Such information could also assist the Agency in
establishing requirements to efficiently enforce the FSMA amendments to
section 417 of the FD&C Act.
    FDA anticipates that information from stakeholders and the public
regarding these issues, along with the other issues described in the
paragraphs that follow, will significantly assist the Agency in
developing requirements to implement section 417 of FD&C Act and
efficiently enforce such requirements. For these reasons, FDA is
issuing this ANPRM to solicit additional comments, data, and other
information related to the FSMA amendments to section 417 of the FD&C
Act.

Issue 1: Consumer-Oriented Information Submissions and Consumer
Notifications

    Question 1a: What information should FDA require be included in
consumer-oriented information submissions and consumer notifications
for a reportable food to enable a consumer to accurately identify
whether he or she is in possession of the reportable food?
    Section 417(f) of the FD&C Act provides that the consumer-oriented
information submitted to FDA by a responsible party must include: (1) A
description of the article of food; (2) affected product identification
codes, such as UPC, SKU, or lot or batch numbers sufficient for the
consumer to identify the article of food; (3) contact information for
the responsible party; and (4) ``any other information the Secretary
determines is necessary to enable a consumer to accurately identify
whether such consumer is in possession of the reportable food.''
Section 417(g)(1) requires that FDA prepare the consumer-oriented
information as a standardized one-page summary and publish such one-
page summary on FDA's Web site in a format that can be easily printed
by grocery stores for the purposes of consumer notification. In
response to a similar question presented in the FSMA public meeting
notice, two commenters asserted that the consumer-oriented information
should include the reason for the recall of the reportable food, if
applicable. Another commenter recommended that the consumer-oriented
information include a picture of the product and product label, state
when the product was sold, and state what consumers should do with the
product.
    FDA is interested in additional data and information regarding what
information should be required in consumer-oriented information
submissions and consumer notifications for reportable foods to enable a
consumer to accurately identify whether such consumer is in possession
of the reportable food. FDA is also interested in data and information
regarding whether the one-page summary of consumer-oriented information
posted at FDA's Web site should contain other information, such as
advice to consumers on disposing of a reportable food product.
    Question 1b: Should FDA require responsible parties to submit
consumer-oriented information to FDA, as described in section 417(f) of
the FD&C Act, for reportable foods that are not available, or will not
be available, for sale to consumers in chain grocery stores or
otherwise available for sale to consumers at the retail food market?
    As noted previously, a ``responsible party'' generally is required
to submit a report to FDA through the Safety Reporting Portal, as soon
as practicable, but in no case later than 24 hours after determining
that an article of food is a reportable food (see section 417(d) of the
FD&C Act). In addition, section 417(f) of the FD&C Act provides that
FDA may require a responsible party to submit to FDA consumer-oriented
information regarding a reportable food (except for fruits and
vegetables that are raw agricultural commodities). It is

possible that there may be a reportable food, for which a responsible
party is required to submit a report to FDA through the Safety
Reporting Portal under section 417(d), that has not or will not reach
the retail food market, including chain grocery stores. For example,
many reportable food reports concern food ingredients and bulk
commercial products that are not sold at the retail level. One of the
purposes of the RFR is to identify makers of foods sold at retail who
have received an ingredient that is the subject of a reportable food
report to stop shipment of possibly contaminated foods before they are
sold at retail. Under section 417(f) of the FD&C Act, a responsible
party may also be required to submit to FDA consumer-oriented
information for such a reportable food. Section 417(h)(1) makes clear
that unless a chain grocery store sold a food that is the subject of a
one-page summary published by FDA, the grocery store is not required to
post a consumer notification described in section 417(g) about such
food. FDA is interested in comments or other information regarding
whether FDA should require responsible parties to submit the consumer-
oriented information described in section 417(f) for all reportable
foods, including those that have not been available, or will not be
available, for sale to consumers in chain grocery stores or otherwise
available for sale to consumers at the retail food market.
    Question 1c: FDA is interested in additional data and information
from industry and consumer groups regarding consumer preferences for
receiving information. For the one-page summaries of consumer-oriented
information prepared by FDA and published on FDA's Web site, what
structure and format would be the most useful to grocery stores and
consumers? To what extent, if any, should the consumer-oriented
information be provided in languages other than English?
    Question 1d: Should FDA revise and republish a one-page summary of
consumer-oriented information on FDA's Web site if the published
information no longer provides the information necessary to enable a
consumer to accurately identify whether such consumer is in possession
of the reportable food? For example, a recall expanding to include
additional lots, and corrections in amended industry reports could
create this scenario. If a one-page summary is revised and republished
on FDA's Web site, should this trigger additional posting obligations
for chain grocery stores?
    Question 1e: What mechanisms can be employed so that chain grocery
stores are aware that a one-page summary of consumer-oriented
information for a reportable food has been published on the Agency's
Web site, or that a previously published one-page summary has been
revised?

Issue 2: Grocery Stores

    Question 2a: What types of retail establishments should FDA
consider to be ``grocery stores'' within the meaning of section 417(h)
of the FD&C Act? Section 417(h)(1) provides in relevant part that if a
chain grocery store sold a reportable food that is the subject of a
one-page consumer-oriented information summary published on FDA's Web
site, the chain grocery store must prominently display the one-page
summary or information from the one-page summary within 24 hours after
the one-page summary is published on FDA's Web site and maintain such
display for 14 days. The FD&C Act does not define the term ``grocery
store.'' FDA requests comment on what types of retail establishments
should be subject to the consumer notification requirements of section
417(h). Please provide an explanation for your response and any
supporting data.
    Comments that FDA received in response to the FSMA public meeting
notice supported a broad definition of the term ``grocery store'' to
encompass all retail establishments in which the sale of groceries is a
primary business activity, including supermarkets, warehouse stores,
wholesale club stores, convenience stores, and other stores that are
part of a chain. One commenter noted that consumers may buy groceries
online from both grocery store chains and other online retailers, and
stated that these retailers should also be required to provide the
consumer notifications described in section 417(h) of the FD&C Act. Two
commenters recommended that, in developing a definition of the term
``grocery store'' for purposes of implementing section 417(h), FDA
consider the definition of ``retail food establishment,'' which
includes grocery stores, in FDA's regulations for registration of food
facilities at 21 CFR 1.227(b)(11).

Issue 3: Posting Consumer Notifications

    Question 3a: How can a chain grocery store prominently display or
provide a consumer notification via a conspicuous location or manner as
described in section 417(h)(2) of the FD&C Act? Section 417(h)(1) of
the FD&C Act provides in relevant part that if a chain grocery store
sold a reportable food that is the subject of a one-page consumer-
oriented information summary published on FDA's Web site, the chain
grocery store must ``prominently display such summary or the
information from such summary via at least one of the methods
identified in [section 417(h)(2)].'' Section 417(h)(2) provides in
relevant part that FDA shall develop and publish ``a list of acceptable
conspicuous locations and manners, from which grocery stores shall
select at least one, for providing [consumer notifications].'' Further,
section 417(h)(2) provides that such list must include: (1) Posting the
notification at or near the register; (2) providing the location of the
reportable food; (3) providing targeted recall information given to
customers upon purchase of a food; and (4) other such prominent and
conspicuous locations and manners utilized by grocery stores as of the
date of enactment of FSMA (i.e., January 4, 2011) to provide notice of
such recalls to consumers as considered appropriate by FDA.
    Question 3b: How can a chain grocery store prominently display or
provide a consumer notification ``at or near the register'' as
described in section 417(h)(2)(A) of the FD&C Act?
    Question 3c: How can a chain grocery store prominently display or
provide a consumer notification in a way that provides ``the location
of the reportable food,'' as described in section 417(h)(2)(B) of the
FD&C Act?
    Question 3d: How can a chain grocery store prominently display or
provide a consumer notification in a way that provides ``targeted
recall information given to customers upon purchase of a food,'' as
described in section 417(h)(2)(C) of the FD&C Act?
    Question 3e: Section 417(h)(2) of the FD&C Act requires FDA to
develop and publish a ``list of acceptable conspicuous locations and
manners'' for chain grocery stores to post the consumer notifications
described in section 417(g), and describes certain locations and
manners. Section 417(h)(2)(D) provides in relevant part that such a
list must include ``other such prominent and conspicuous locations and
manners utilized by grocery stores as of the date of enactment of
[FSMA] to provide notice of . . . recalls to consumers as considered
appropriate by [FDA]''. What methods, manners, and/or locations, if
any, have grocery stores or other retail food establishments used to
effectively notify consumers about food recalls?
    One comment that FDA received in response to the FSMA public
meeting notice stated that FDA regulations implementing the consumer
notification requirements of section 417 of the FD&C

Act or related guidance should provide retailers with the flexibility
to choose among different approaches to notifying consumers about food
recall information. The commenter stated that the regulations should
``afford the opportunity for new ideas and modes of notification and
not be so prescriptive as to limit innovation.'' Section 417(h)(2)(D)
of the FD&C Act specifies that the other manners and locations that
must be included on the list developed and published by FDA (as
considered appropriate by FDA) are those used by grocery stores as of
the date of enactment of FSMA to provide notice of food recalls that
are ``conspicuous'' and ``prominent.'' In light of this requirement,
FDA is particularly interested in data and information on the most
innovative and effective approaches used by grocery stores or other
retail food establishments to notify consumers about food recalls in
manners and locations that are conspicuous and prominent.
    One commenter recommended that, where purchases of food have
occurred over the Internet, electronically contacting consumers is
effective because the retailer knows exactly what the consumer
purchased and has reliable contact information for the consumer. The
commenters noted that these consumers may never see a posting in a
physical store. Two commenters recommended the use of loyalty cards as
a tool to notify customers. One of these commenters cited a report by a
retailer that noted that the retailer was able to electronically notify
90 percent of purchasers (17 of 19) of a recalled food item.
    One commenter stated that retailers currently notify consumers of
food recalls by: (1) Posting information at or near the register; (2)
posting information at the area where the food is displayed; (3)
loyalty card or membership notifications by email, phone, or mail; (4)
providing printout information to consumers at checkout; (5) Web site
posting; (6) posting information at kiosks in the store; and (7)
posting information on a bulletin board or similar information area.
The comment suggested that FDA allow retailers to choose one or more
manners of notification, or use different manners for different
recalls. The commenter identified factors that may be relevant to the
manner used, including the size of recall; whether the product was
distributed nationally or more narrowly; the type of product; the
target customers; the shelf life of the product, and the product's use
as an ingredient in other foods.
    Question 3f: What factors could influence a chain grocery store's
decision about whether to display a one-page summary of consumer-
oriented information regarding a reportable food as published on FDA's
Web site, or instead to display the information from the FDA summary?
    Section 417(h)(1) of the FD&C Act requires in relevant part that
chain grocery stores prominently display, in the prescribed timeframe,
either the consumer-oriented information one-page summary published on
FDA's Web site ``or the information from such summary.''
    Question 3g: Could compliance with the consumer notification
requirements of section 417(h) of the FD&C Act by chain grocery stores
affect the voluntary or mandatory display of other information
regarding a food recall by retail establishments?
    One commenter stated that food retailers receive product recall
notifications primarily from their suppliers or manufacturers, usually
before the information is provided by FDA or through the RFR. The
commenter stated that in addition to removing the product from sale,
food retailers take action to notify consumers. The commenter argued
that if FDA links notifying consumers about recalls to the RFR one-page
summaries prepared by FDA and published on FDA's Web site, it could
result in a delay compared to current practices for notifying consumers
about recalls, or could result in duplicative notices. The commenter
recommended that food retailers who notify consumers about food recalls
before FDA information is available not be required to provide any
subsequent notifications, unless information about the recall has
changed.
    FDA is interested in receiving further comment on the issues raised
in these comments. We note that nothing in the new requirements in
section 417 of the FD&C Act precludes a chain grocery store from
posting its own notice regarding a food recall before FDA publishes on
its Web site a one-page summary of consumer-oriented information
regarding a reportable food. However, regardless of the actions a
responsible party or grocery store may take prior to FDA's publication
of a one-page summary, the consumer notification requirements of
section 417(h) would still apply. Accordingly, if a chain grocery store
sold a reportable food that is the subject of a one-page summary, the
grocery store would still be required to prominently display the one-
page summary or the information from the summary within 24 hours after
the summary is published on FDA's Web site and must maintain the
display for 14 days.
    Question 3h: What, if any, impact will the consumer notification
requirements in section 417(h) have on grocery store operations? For
example, how might the requirements affect resources if resources are
spent monitoring FDA's Web site for new consumer notifications to be
posted, or resources are spent posting such notifications or the
information from such notifications?
    Question 3i: What are the estimated costs to chain grocery stores,
per store and per reportable food, associated with displaying consumer
notifications as required by section 417(h)?
    Question 3j: How much time (hours per reportable food) is currently
used by grocery store and other retail food establishment employees
(including managers) to notify consumers about reportable foods? What
is the estimated change, if any, in the time spent on notifying
consumers about reportable foods as a result of the consumer
notification requirements in section 417(h) of the FD&C Act?
    Question 3k: Should chain grocery stores be permitted to use
multiple manners and locations, as identified by FDA, to post consumer
notifications consecutively for a total of 14 days?
    Section 417(h)(1) of the FD&C Act provides in relevant part that a
chain grocery store that sold a reportable food that is the subject of
a one-page summary published on FDA's Web site must prominently display
such summary or the information from such summary, and maintain such
display for 14 days. One commenter suggested that the 14-day time
period should begin when the retailer first notifies consumers about a
recall. Further, the commenter stated that for other methods of
informing consumers about food recalls a 14-day duration might not be
practicable (e.g., repeated phone calls to the same consumer for 14
days). The commenter also stated that the 14-day time period should
include all notification manners used by the grocery store. The
commenter noted, as an example, that a grocery could post a sign for 2
days notifying consumers about a recall for a food product whose shelf
life is long past, and then the grocery store could post the
information for the next 12 days on the retailer's Web site. Because of
the statutory terms in section 417(h) of the FD&C Act regarding a chain
grocery store ``prominently display[ing]'' an FDA one-page summary or
information from such summary and ``maintain[ing] the display for 14
days,'' it seems unlikely that the telephone calls described in the
comment would satisfy section 417(h).

FDA is interested in further comment and information regarding manners
and locations for posting consumer notifications for the 14-day time
period specified in section 417(h).

Issue 4: Other Issues

    Question 4a: As noted previously, the term ``reportable food'' does
not include dietary supplements or infant formula (see sections 201(ff)
and 417(a)(2) of the FD&C Act). Further, as discussed previously,
section 417(f) of the FD&C Act, as amended by FSMA, provides that FDA
may require a responsible party to submit to FDA ``consumer-oriented
information'' regarding a reportable food with the exception of fruits
and vegetables that are raw agricultural commodities. Based on these
exceptions and exclusions, responsible parties may not submit to FDA
consumer-oriented information, under section 417(f) of the FD&C Act,
for dietary supplements, infant formula, and fruits and vegetables that
are raw agricultural commodities. There may be potential public health
impacts if consumer notifications for reportable foods do not include
information on dietary supplements, infant formula, and fruits and
vegetables that are raw agricultural commodities, particularly if the
public believes that such consumer notifications are meant to encompass
all food products regulated by FDA. FDA seeks comments or other
information on whether consumer notifications posted by chain grocery
stores, as specified by section 417(h) of the FD&C Act, should include
information advising consumers that such notifications do not cover
certain foods, such as a statement asserting that the consumer
notifications do not include reportable food or recall information for
dietary supplements, infant formula, and fruits and vegetables that are
raw agricultural commodities, and consumers should consult FDA's Web
site for any relevant information for these products.
    Question 4b: There may be a situation where FDA is aware of a class
1 recall for a reportable food for which a responsible party would be
required to submit to FDA consumer-oriented information for such
reportable food under section 417(f) of the FD&C Act, but the
responsible party failed to submit such information to FDA. In such
situations, should FDA prepare and publish a one-page summary of
consumer-oriented information, if known, for such reportable food, and
require chain grocery stores that sold the reportable food to post such
summary or the information from such summary, as specified in section
417(h) of the FD&C Act?

IV. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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.
    Please note that this is not related to the request in the Federal
Register of May 25, 2010 (75 FR 29350) (Docket No. FDA-2009-D-0260),
for comments regarding the finalization of the current RFR, 2d Edition,
draft guidance.

    Dated: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06614 Filed 3-25-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 10, 2010 (Volume 75, Number 89)]
[Rules and Regulations]
[Page 25759-25760]
[DOCID:fr10my10-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30724; Amdt. No. 3373]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective May 10, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of May 10, 2010.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For Examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Programs Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory

evaluation as the anticipated impact is so minimal. For the same
reason, the FAA certifies that this amendment will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on April 30, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal regulations, Part 97, 14 CFR part 97, is amended by amending
Standard Instrument Approach Procedures, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
  AIRAC date      State          City              Airport          FDC No.      FDC date          Subject
----------------------------------------------------------------------------------------------------------------
3-Jun-10......  MI         Jackson........  Jackson County--           0/1674      4/19/10  ILS Rwy 24, Amdt 14.
                                             Reynolds Field.
3-Jun-10......  FL         Destin.........  Destin-Fort Walton         0/2702      3/30/10  Takeoff Minimums and
                                             Beach.                                          Obstacle DP, Orig.
3-Jun-10......  GA         Cornelia.......  Habersham County....       0/2958      3/31/10  NDB Rwy 6, Amdt 1C.
3-Jun-10......  MI         Kalamazoo......  Kalamazoo/Battle           0/3828      4/16/10  ILS OR LOC Rwy 35,
                                             Creek Intl.                                     Amdt 22A.
3-Jun-10......  PA         Zelienople.....  Zelienople Muni.....       0/4396      4/19/10  RNAV (GPS) Rwy 35,
                                                                                Orig.
3-Jun-10......  MI         Lansing........  Capital City........       0/4539      4/19/10  ILS OR LOC Rwy 10R,
                                                                                Amdt 9C.
3-Jun-10......  AL         Prattville.....  Prattville-Grouby          0/5483      4/15/10  RNAV (GPS) Rwy 9,
                                             Field.                                          Amdt 1.
3-Jun-10......  MI         Kalamazoo......  Kalamazoo/Battle           0/5675      4/19/10  NDB Rwy 35, Amdt 19.
                                             Creek Intl.
3-Jun-10......  MI         Kalamazoo......  Kalamazoo/Battle           0/5676      4/19/10  VOR Rwy 35, Amdt 17.
                                             Creek Intl.
3-Jun-10......  PA         York...........  York................       0/5817      4/19/10  NDB Rwy 17, Amdt 6A.
3-Jun-10......  AL         Bay Minette....  Bay Minette Muni....       0/6318      4/20/10  RNAV (GPS) Rwy 26,
                                                                                Orig.
3-Jun-10......  PA         Pittsburgh.....  Pittsburgh                 0/9365      4/20/10  ILS OR LOC Rwy 32,
                                             International.                                  Amdt 12A.
3-Jun-10......  PA         Pittsburgh.....  Pittsburgh                 0/9371      4/20/10  ILS OR LOC Rwy 10R,
                                             International.                                  Amdt 10C; ILS Rwy
                                                                                10R (CAT II), Amdt
                                                                                10C; ILS Rwy 10R
                                                                                (CAT III), Amdt
                                                                                10C.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-10699 Filed 5-7-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Proposed Rules]
[Pages 27996-27998]
[FR Doc No: 2019-12539]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2019-0289; FRL-9994-78-Region 7]

Air Plan Approval; Missouri; Revision to Sulfur Dioxide Control
Requirements for Lake Road Generating Facility

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing
approval of a State Implementation Plan (SIP) revision submitted by the
State of Missouri on November 2, 2018. The revision replaces a Consent
Decree in Missouri's SIP with an Administrative Order on Consent (AOC)
between the Missouri Department of Natural Resources (MoDNR) and Kansas
City Power and Light (KCPL). The EPA is also proposing to approve an
amendment to the AOC. This action strengthens Missouri's SIP by
replacing an outdated Consent Decree with an AOC and its Amendment that
reflect current operating conditions at the facility, and does not
result in an increase in sulfur dioxide (SO2) emissions from
the Lake Road Generating Facility.

DATES: Comments must be received on or before July 17, 2019.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-R07-
OAR-2019-0289 to https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received will be posted without
change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions on sending comments and
additional information on the rulemaking process, see the ``Written
Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.

FOR FURTHER INFORMATION CONTACT: Jonathan Meyer, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number (913) 551-
7140; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to the EPA.

Table of Contents

I. Written Comments
II. What is being addressed in this document?
    A. 1997 Violation of the 1971 SO2 National Ambient
Air Quality Standards (NAAQS)
    B. Designation of Buchanan County for the 2010 SO2
NAAQS
    C. 2015 Administrative Order on Consent and 2018 Amendment
III. Have the requirements for approval of a SIP revision been met?
IV. What action is EPA taking?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews

I. Written Comments

    Submit your comments, identified by Docket ID No. EPA-R07-OAR-2019-
0289 at https://www.regulations.gov. Once submitted, comments cannot be
edited or removed from Regulations.gov. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. What is being addressed in this document?

    The EPA is proposing to approve a SIP revision submitted by the
State of Missouri on November 2, 2018. The revision consists of an AOC
between the MoDNR and KCPL that limits emissions SO2 from
KCPL's Lake Road Generating facility in St. Joseph, Missouri, and an
Amendment to the AOC. The AOC and its Amendment replace a Consent
Decree in Missouri's SIP and strengthens SO2 control
requirements for KCPL's Lake Road Generating facility. This action
strengthens Missouri's SIP by replacing an outdated Consent Decree with
an AOC and its Amendment that reflect current operating conditions at
the facility and does not result in an increase in SO2
emissions from the Lake Road Generating Facility.

A. 1997 Violation of the 1971 SO2 National Ambient Air
Quality Standards (NAAQS)

    In 1997, a monitor in St. Joseph (Buchanan County), Missouri
measured a violation of the 1971 24-hour SO2 NAAQS. At the
time of the 1997 violation, Buchanan County was designated as ``Better
than National Standards'' (equivalent to ``attainment'') for the 1971
24-hour SO2 NAAQS. To address the violation, the State of
Missouri and the St. Joseph Light and Power (SJLP) Company entered into
a Consent Decree that required SO2 control measures at the
SJLP Lake Road power generating facility, hereinafter referred to as
the ``2000 \1\ Consent Decree''. The 2000 Consent Decree was submitted
by the State of Missouri in order to maintain attainment of the 1971
24-hour SO2 NAAQS and was not submitted because of a SIP
call. On November 15, 2001, the EPA approved the 2000 Consent Decree as
a revision to Missouri's SIP. (66 FR 57389, November 15, 2001).
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    \1\ The EPA is referring to the Consent Decree as the ``2000
Consent Decree'' to be consistent with the State's November 2, 2018,
SIP revision submittal. The 2000 Consent Decree was entered by the
Circuit Court of Buchanan County, Missouri, on May 25, 2001.
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B. Designation of Buchanan County for the 2010 SO2 NAAQS

    On June 22, 2010, the EPA established a new 1-hour SO2
standard (``the 2010 SO2 NAAQS'') and revoked the existing
24-hour and annual primary SO2 standards. (75 FR 35520, June
22, 2010, at 75 FR 35592). The EPA directed States to continue
implementing any attainment and maintenance requirements of the 1971
24-hour SO2 NAAQS until the requirements were subsumed by
any new planning and control requirements associated with the 2010
SO2 NAAQS. (75 FR 35520, June 22, 2010, at 75 FR 35580).
Accordingly, areas designated as nonattainment for the 2010
SO2 NAAQS or areas that do not meet the requirements of a
SIP call for the 1971 SO2 NAAQS remain subject to the 1971
SO2 NAAQS until the area submits, and EPA approves, an
attainment plan for the 2010 SO2 NAAQS. See 40 CFR 50.4(e).
However, the EPA also stated that any existing SIP provisions under
Clean Air Act (CAA) sections 110, 191 and 192 for the 1971 24-hour
SO2 NAAQS remain in effect. (75 FR 35520, June 22, 2010, at
75 FR 35581).
    On January 9, 2018, Buchanan County was designated as Attainment/
Unclassifiable for the 2010 SO2 NAAQS (83 FR 1098, January
9, 2018) and

therefore the State of Missouri was not required to submit a SIP
providing for attainment of the SO2 NAAQS under sections 191
and 192 of the CAA. However, because the 2000 Consent Decree was
approved pursuant to section 110 of the CAA, the provisions of the
Consent Decree remain in effect notwithstanding EPA's revocation of the
1971 24-hour SO2 NAAQS and designation of Buchanan County as
Attainment/Unclassifiable for the 2010 SO2 NAAQS.

C. 2015 Administrative Order on Consent and 2018 Amendment

    KCPL acquired SJLP's Lake Road facility in 2008. On March 30, 2015,
KCPL notified the MoDNR of its intent to cease the combustion of coal
in Boiler No. 6 at the facility by April 16, 2016, to comply with the
Mercury Air Toxics Standards rule, 40 CFR part 63, subpart UUUUU. KCPL
also requested to use natural gas instead of coal as the primary fuel
and to designate No. 2 fuel oil the secondary fuel of Boiler No. 6.
    Because the 2000 Consent Decree stipulated the type of fuel to be
used in each combustion unit, including Boiler No. 6, MoDNR and KCPL
entered into an AOC on March 30, 2016, (hereinafter referred to as the
``2015 \2\ AOC'') that included the substantive requirements from the
2000 Consent Decree and revised the fuel requirements for Boiler No. 6.
The 2015 AOC did not revise the SO2 allowable emission rate
of 1,400 pounds SO2 per hour (lbs SO2/hr)
established in the 2000 Consent Decree for Boiler No. 6; therefore, the
EPA's proposed approval of this SIP revision will not result in an
increase in allowable SO2 emissions.
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    \2\ The EPA is referring to the Administrative Order on Consent
as the ``2015 AOC'' to be consistent with the State's November 2,
2018 SIP revision submittal. The 2015 AOC was signed by the parties
in 2016.
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    On June 13, 2018, the MoDNR and KCPL revised the 2015 AOC to
require low sulfur coal as the primary fuel in Boiler No. 5, rather
than a blend of high and medium sulfur coal as required by the 2000
Consent Decree and the 2015 AOC. The 2018 AOC Amendment did not revise
the SO2 allowable emission rate of 453.26 lbs
SO2/hr established in the 2000 Consent Decree for Boiler No.
5; therefore, the EPA's proposed approval of this SIP revision will not
result in an increase in allowable SO2 emissions.
    Section 110(l) of the CAA prohibits the EPA from approving a SIP
revision that interferes with any applicable requirement concerning
attainment and reasonable further progress or any other applicable
requirement of the CAA. The MoDNR anticipates that the 2015 AOC and
2018 AOC Amendment will result in decreased SO2 emissions
that will further assist with maintenance and attainment of both the
1971 and 2010 SO2 NAAQS.
    While the 2015 AOC and 2018 AOC Amendment do not reduce allowable
emissions from the Lake Road Facility, the use of low sulfur coal as a
primary fuel for Boiler No. 5 and natural gas as a primary fuel for
Boiler No. 6 will result in a reduction in actual SO2
emissions. The MoDNR included an analysis of SO2 emissions
from the Lake Road facility between 2002 through 2017 and found that
SO2 emissions have decreased by 89 percent from 2002 through
2017, attributable to the 2000 Consent Decree, and more recently, to
the 2015 AOC. As such, the MoDNR has demonstrated, and the EPA proposes
to conclude, that the SIP revision is in accordance with the
requirements of section 110(l) of the CAA.
    A comparison of the requirements of the 2000 Consent Decree, the
2015 AOC and the 2018 Amendment can be found in the Technical Support
Document that is included in the docket.

III. Have the requirements for approval of a SIP revision been met?

    The State submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice on this SIP revision from July 30, 2018,
to September 6, 2018, and received zero comments. In addition, the
revision meets the substantive SIP requirements of the CAA, including
section 110 and implementing regulations.

IV. What action is EPA taking?

    We are proposing to approve replacing the May 25, 2001, St. Joseph
Light and Power Consent Decree with the 2015 AOC and 2018 Amendment
between MoDNR and KCPL. We are processing this as a proposed action
because we are soliciting comments on this proposed action. Final
rulemaking will occur after consideration of any comments.

V. Incorporation by Reference

    In this document, the EPA is proposing to include regulatory text
in an EPA final rule that includes incorporation by reference. In
accordance with requirements of 1 CFR 51.5, the EPA is proposing to
incorporate by reference the Missouri Regulations described in the
proposed amendments to 40 CFR part 52 set forth below. The EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 7 Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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 the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using

practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where 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, Carbon monoxide,
Hydrocarbons, Incorporation by reference, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides.

    Dated: June 10, 2019.
James Gulliford,
Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA proposes to amend
40 CFR part 52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart--AA Missouri

0
2. In Sec.  52.1320, the table in paragraph (d) is amended by:
0
a. Revising entry ``(17)'' and;
0
b. Adding entries ``(32)'' and ``(33)'' to the end of the table.
    The revision and additions read as follows:

Sec.  52.1320  Identification of plan.

* * * * *
    (d) * * *

                            EPA--Approved Missouri Source-Specific Permits and Orders
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                                                             State
          Name of source            Order/ permit No.   effective date   EPA approval date       Explanation
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                                                  * * * * * * *
(17) St. Joseph Light & Power SO2  Consent Decree.....       5/21/2001  11/15/2001, 66 FR    Replaced on [Date
                                                                         57389 and [Date of   of publication of
                                                                         publication of the   the final rule in
                                                                         final rule in the    the Federal
                                                                         Federal Register],   Register] with
                                                                         [Federal Register    (32) and (33).
                                                                         citation of the
                                                                         final rule].

                                                  * * * * * * *
(32) Kansas City Power and Light-- Administrative            9/27/2018  [Date of             ...................
 Lake Road Facility.                Order on Consent                     publication of the
                                    No. APCP-2015-118.                   final rule in the
                                                                         Federal Register],
                                                                         [Federal Register
                                                                         citation of the
                                                                         final rule].
(33) Kansas City Power and Light-- Amendment #1 to           9/27/2018  [Date of             ...................
 Lake Road Facility.                Administrative                       publication of the
                                    Order on Consent                     final rule in the
                                    No. APCP-2015-118.                   Federal Register],
                                                                         [Federal Register
                                                                         citation of the
                                                                         final rule].
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[FR Doc. 2019-12539 Filed 6-14-19; 8:45 am]
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[Federal Register: September 23, 2010 (Volume 75, Number 184)]
[Notices]
[Page 57968]
[DOCID:fr23se10-74]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    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: Gastroenterology and Urology 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 December 2 and 3, 2010,
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620
Perry Pkwy., Gaithersburg, MD.
    Contact Person: Margaret McCabe-Janicki, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-
796-7029, or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area), code<PHONE_NUMBER>. Please call
the Information Line for up-to-date information on this meeting. 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 and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On December 2, 2010, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application (PMA) for SOLESTA, sponsored by Oceana
Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal
incontinence in patients who have failed conservative therapy. On
December 3, 2010, the committee will discuss, make recommendations, and
vote on information related to the PMA for the LAP-BAND Adjustable
Gastric Banding System, sponsored by Allergan. The sponsor is
requesting an expanded Indication for Use for their LAP-BAND Adjustable
Gastric Banding System to include weight reduction in patients with a
Body Mass Index (BMI) of at least 35 kg/m\2\ or a BMI of at least 30
kg/m\2\ with one or more comorbid conditions.
    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 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
November 18, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on December 2 and 3, 2010.
Those desiring to make 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 November 10, 2010.
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 November 11, 2010.
    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,
Conference Management Staff,<PHONE_NUMBER>, 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: September 17, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-23842 Filed 9-22-10; 8:45 am]
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