[Federal Register: September 15, 2010 (Volume 75, Number 178)]
[Rules and Regulations]
[Page 55965-55966]
[DOCID:fr15se10-7]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 232

[Release Nos. 33-9140; 34-62873; 39-2471; IC-29413]

Adoption of Updated EDGAR Filer Manual

AGENCY: Securities and Exchange Commission.

ACTION: Final rule.

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SUMMARY: The Securities and Exchange Commission (the Commission) is
adopting revisions to the Electronic Data Gathering, Analysis, and
Retrieval System (EDGAR) Filer Manual to reflect updates to the EDGAR
system. The revisions are being made primarily to support the
electronic filing of Form N-MFP (Monthly Schedule of Portfolio Holdings
of Money Market Funds) and any amendments to the form. The EDGAR system
is scheduled to be upgraded to support this functionality on August 30,
2010.
    The revisions to the Filer Manual reflect changes within Volume II
entitled EDGAR Filer Manual, Volume II: ``EDGAR Filing,'' Version 15
(August 2010). The updated manual will be incorporated by reference
into the Code of Federal Regulations.

DATES: Effective Date: September 15, 2010. The incorporation by
reference of the EDGAR Filer Manual is approved by the Director of the
Federal Register as of September 15, 2010.

FOR FURTHER INFORMATION CONTACT: In the Division of Investment
Management, for questions concerning Form N-MFP (Monthly Schedule of
Portfolio Holdings of Money Market Funds) contact Adam Glazer, Senior
Counsel, or C. Hunter Jones, Assistant Director of the Office of
Regulatory Policy, at<PHONE_NUMBER>, for questions concerning Series
and Class status, contact Ruth Armfield Sanders, Senior Special
Counsel, Office of Legal and Disclosure, at<PHONE_NUMBER>; in the
Office of Information Technology, contact Rick Heroux, at (202) 551-
8800.

SUPPLEMENTARY INFORMATION: We are adopting an updated EDGAR Filer
Manual, Volume II. The Filer Manual describes the technical formatting
requirements for the preparation and submission of electronic filings
through the EDGAR system.\1\ It also describes the requirements for
filing using EDGARLink \2\ and the Online Forms/XML Web site.
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    \1\ We originally adopted the Filer Manual on April 1, 1993,
with an effective date of April 26, 1993. Release No. 33-6986 (April
1, 1993) [58 FR 18638]. We implemented the most recent update to the
Filer Manual on April 08, 2010. See Release No. 33-9115 (April 1,
2010) [75 FR 17853].
    \2\ This is the filer assistance software we provide filers
filing on the EDGAR system.
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    The Filer Manual contains all the technical specifications for
filers to submit filings using the EDGAR system. Filers must comply
with the applicable provisions of the Filer Manual in order to assure
the timely acceptance and processing of filings made in electronic
format.\3\ Filers may consult the Filer Manual in conjunction with our
rules governing mandated electronic filing when preparing documents for
electronic submission.\4\
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    \3\ See Rule 301 of Regulation S-T (17 CFR 232.301).
    \4\ See Release No. 33-9115 (April 1, 2010) [75 FR 17853] in
which we implemented EDGAR Release 10.1. For a complete history of
Filer Manual rules, please see the cites therein.
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    In support of the adoption of new rule 30b1-7 under the Investment
Company Act of 1940 and new Form N-MFP, which were included in the

Commission's recent money market fund reform package,\5\ the EDGAR
system will be upgraded to Release 10.3 on August 30, 2010. EDGAR
Release 10.3 will deploy new submission types N-MFP and N-MFP/A to
facilitate the electronic filing of the new form. Filers must follow
the Form N-MFP XML Technical Specification, available at the
``Information for EDGAR Filers'' web page on the Commission's public
Web site (http://www.sec.gov/info/edgar.shtml), to construct their Form
N-MFP and Form N-MFP/A submissions via the EDGAR Filing Web site
(https://edgarfiling.sec.gov) or by clicking the ``Are you an EDGARLink
filer or would you like to create a new Asset-Backed Securities Issuing
Entity?'' link from the EDGAR Portal Web site (http://
www.portal.edgarfiling.sec.gov).
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    \5\ See Release No. IC-29132 [75 FR 10060].
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    Also being implemented in EDGAR Release 10.3, EDGAR will begin to
automatically change the status of a Series or Class to ``Inactive'' if
it has not been updated by filers or referenced in a filing in the past
375 calendar days.
    In addition, the EDGAR Filing Web site, EDGAR Filer Management Web
site and EDGAR OnlineForms Web site Login pages now will display a
message warning the filers that they are about to enter a federal
computer Web site.
    The filer manual is also being revised to address a change made
previously in EDGAR to disseminate the co-registrant information for
all investment company notices and orders issued in connection with
1940 Act applications. Prior to this change, only the primary
registrant information was disseminated.
    Along with adoption of the Filer Manual, we are amending Rule 301
of Regulation S-T to provide for the incorporation by reference into
the Code of Federal Regulations of today's revisions. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51.
    You may obtain paper copies of the updated Filer Manual at the
following address: Public Reference Room, U.S. Securities and Exchange
Commission, 100 F Street, NE., Room 1543, Washington, DC 20549, on
official business days between the hours of 10 a.m. and 3 p.m. We will
post electronic format copies on the Commission's Web site; the address
for the Filer Manual is http://www.sec.gov/info/edgar.shtml.
    Since the Filer Manual relates solely to agency procedures or
practice, publication for notice and comment is not required under the
Administrative Procedure Act (APA).\6\ It follows that the requirements
of the Regulatory Flexibility Act \7\ do not apply.
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    \6\ 5 U.S.C. 553(b).
    \7\ 5 U.S.C. 601-612.
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    The effective date for the updated Filer Manual and the rule
amendments is September 15, 2010. In accordance with the APA,\8\ we
find that there is good cause to establish an effective date less than
30 days after publication of these rules. The EDGAR system upgrade to
Release 10.3 is scheduled to become available on August 30, 2010. The
Commission believes that establishing an effective date less than 30
days after publication of these rules is necessary to coordinate the
effectiveness of the updated Filer Manual with the system upgrade.
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    \8\ 5 U.S.C. 553(d)(3).
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Statutory Basis

    We are adopting the amendments to Regulation S-T under Sections 6,
7, 8, 10, and 19(a) of the Securities Act of 1933,\9\ Sections 3, 12,
13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,\10\
Section 319 of the Trust Indenture Act of 1939,\11\ and Sections 8, 30,
31, and 38 of the Investment Company Act of 1940.\12\
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    \9\ 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a).
    \10\ 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll.
    \11\ 15 U.S.C. 77sss.
    \12\ 15 U.S.C. 80a-8, 80a-29, 80a-30, and 80a-37.
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List of Subjects in 17 CFR Part 232

    Incorporation by reference, Reporting and recordkeeping
requirements, Securities.

Text of the Amendment

0
In accordance with the foregoing, Title 17, Chapter II of the Code of
Federal Regulations is amended as follows:

PART 232--REGULATION S-T--GENERAL RULES AND REGULATIONS FOR
ELECTRONIC FILINGS

0
1. The authority citation for Part 232 continues to read in part as
follows:

    Authority:  15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77z-3,
77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c),
80a-8, 80a-29, 80a-30, 80a-37, and 7201 et seq.; and 18 U.S.C. 1350.
* * * * *

0
2. Section 232.301 is revised to read as follows:

Sec.  232.301  EDGAR Filer Manual.

    Filers must prepare electronic filings in the manner prescribed by
the EDGAR Filer Manual, promulgated by the Commission, which sets out
the technical formatting requirements for electronic submissions. The
requirements for becoming an EDGAR Filer and updating company data are
set forth in the updated EDGAR Filer Manual, Volume I: ``General
Information,'' Version 8 (October 2009). The requirements for filing on
EDGAR are set forth in the updated EDGAR Filer Manual, Volume II:
``EDGAR Filing,'' Version 15 (August 2010). Additional provisions
applicable to Form N-SAR filers are set forth in the EDGAR Filer
Manual, Volume III: ``N-SAR Supplement,'' Version 1 (September 2005).
All of these provisions have been incorporated by reference into the
Code of Federal Regulations, which action was approved by the Director
of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR
Part 51. You must comply with these requirements in order for documents
to be timely received and accepted. You can obtain paper copies of the
EDGAR Filer Manual from the following address: Public Reference Room,
U.S. Securities and Exchange Commission, 100 F Street, NE., Room 1543,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Electronic copies are available on the Commission's Web
site. The address for the Filer Manual is http://www.sec.gov/info/
edgar.shtml. You can also inspect the document at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/ibr_
locations.html.

    Dated: September 9, 2010.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2010-22983 Filed 9-14-10; 8:45 am]
BILLING CODE P


                       UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on August 16, 2002

   NOTICE OF ACTION TAKEN -- DOCKET OST-2000-7943

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of AMERICAN AIRLINES, INC AND TWA AIRLINES LLC  filed
8/01/02 to:

XX  Renew for two years exemption under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between a point or points in the United States and a point or points in
the Dominican Republic.

Applicant rep: Carl B. Nelson,<PHONE_NUMBER>    DOT Analyst:  Keith
Glatz,<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted

The above action was effective when taken:  August 16, 2002 through
August 16, 2004

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted to serve Santo Domingo and Puerto Plata is
consistent with the aviation agreement between the United States and the
Dominican Republic.  Authority to serve other points is consistent with
the overall state of aviation relations between the United States and
Dominican Republic.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our

action was consistent with Department policy; (2) grant of the exemption
authority was consistent with the public interest; and (3) grant of the
authority would not constitute a major regulatory action under the
Energy Policy and Conservation Act of 1975.  To the extent not granted,
we denied all requests in the referenced Docket.  We may amend, modify,
or revoke the authority granted in this Notice at any time without
hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

APPENDIX

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with the applicable requirements of the Federal Aviation
Administration Regulations and with all U.S. Government requirements
concerning security; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Proposed Rules]
[Pages 6443-6449]
[FR Doc No: 2022-01927]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 203

[Docket No. FDA-2020-N-1819]
RIN 0910-AH56

Certain Requirements Regarding Prescription Drug Marketing

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend certain prescription drug marketing regulations to
reflect changes to affected provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) resulting from enactment of the Drug Supply
Chain Security Act (DSCSA), Title II of the Drug Quality and Security
Act (DQSA). This action, if finalized, will remove or revise outdated
and conflicting regulatory requirements to align with changes to
affected provisions of the FD&C Act following enactment of the DSCSA.

DATES: Submit either electronic or written comments on the proposed
rule by April 5, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 5, 2022. Electronic
comments must be submitted on or before that date. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1819 for ``Certain Requirements Regarding Prescription Drug
Marketing.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly available at
https://www.regulations.gov, or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments

received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Aaron Weisbuch, Center for Drug
Evaluation and Research, Office of Compliance, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-3130, [email protected].
    With regard to biologics: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction
    B. Need for the Regulation
IV. Legal Authority
V. Description of the Proposed Rule
VI. Proposed Effective Dates
VII. Preliminary Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to amend part 203 (21 CFR part 203) to reflect
changes to affected provisions of the FD&C Act following enactment of
the DSCSA, Title II of the DQSA (Pub. L. 113-54). In this proposed
rulemaking, we are proposing to amend certain provisions of part 203 to
avoid potential confusion with the new standards and requirements for
wholesale distributors applicable under the FD&C Act (as amended by the
DSCSA), and to make certain related, conforming changes.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would: (1) Modify the ``scope'' and ``purpose''
sections of the regulations in part 203 to eliminate references to
wholesale distribution, (2) delete Subpart E--Wholesale Distribution in
its entirety, (3) delete from Sec.  203.3 the definitions for terms
that only appeared in subpart E, and (4) modify other provisions of
part 203 to eliminate references to wholesale distribution to conform
to the changes described above.

C. Legal Authority

    We are issuing this proposed rule under sections 503(c), 503(e),
582, 583 and 701(a) of the FD&C Act (21 U.S.C. 353(c), 353(e), 360eee-
1, 360eee-2, and 371(a)).

D. Costs and Benefits

    This proposed rule is a companion to the proposed rule ``National
Standards for the Licensure of Wholesale Drug Distributors and Third-
Party Logistics Providers'' (licensing standards proposed rule) which
implements the national licensing standards requirements of DSCSA. The
licensing standards proposed rule, which would amend part 205, is
published elsewhere in this issue of the Federal Register. We analyze
the effects of the two rules together; thus, we include the benefits
and costs of this proposed rule in the regulatory impact analysis of
the licensing standards proposed rule.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

------------------------------------------------------------------------
           Abbreviation/acronym                     What it means
------------------------------------------------------------------------
CFR.......................................  Code of Federal Regulations.
DSCSA.....................................  Drug Supply Chain Security
                                             Act.
DQSA......................................  Drug Quality and Security
                                             Act.
FDA or the Agency.........................  U.S. Food and Drug
                                             Administration.
FD&C Act..................................  Federal Food, Drug, and
                                             Cosmetic Act.
U.S.C.....................................  United States Code.
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III. Background

A. Introduction

    The DQSA was enacted on November 27, 2013. The DQSA contains two
titles: Title I, the Compounding Quality Act and Title II, the DSCSA.
The DSCSA amended Chapter V of the FD&C Act by adding Subchapter H
(Pharmaceutical Distribution Supply Chain), which includes new sections
581 through 585 (21 U.S.C. 360eee through 360eee-4), and by amending
section 503(e) of the FD&C Act. As amended, section 503(e) of the FD&C
Act, together with new section 583 of the FD&C Act, require the
Secretary of Health and Human Services (Secretary) \1\ to establish
national prescription drug wholesale distributor licensure standards.
In addition, section 582 of the FD&C Act establishes prescription drug
product tracing requirements for wholesale distributors and their
trading partners. FDA is proposing to revise the regulations in part
203 by removing or amending those sections of the regulations that have
been affected by the changes to the FD&C Act through the enactment of
the DSCSA.
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    \1\ This function has been delegated to FDA.
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B. Need for the Regulation

    This rulemaking, when finalized, would: (1) Remove existing
regulations regarding wholesale distribution of prescription drugs that
conflict with or were superseded by new requirements established under
the DSCSA; (2) modify other existing regulations for consistency with
the regulations on standards for licensure of wholesale distributors
that FDA is proposing pursuant to section 583 of the FD&C Act; and (3)
make certain related, conforming changes. This rulemaking is needed to
remove outdated regulations and to prevent confusion about requirements
for wholesale distributors under the FD&C Act.

IV. Legal Authority

    The Agency is proposing this rule under the authority to impose
requirements regarding prescription drug marketing and wholesale drug
distribution granted to it under various sections of the FD&C Act,
including sections 503(c), 503(e), 582, 583, and 701(a). Section 503(c)
describes certain restrictions on prescription drug marketing,
including relating to the sale of drug samples and of drugs that have
been purchased by hospitals or other healthcare entities. Section
503(e), together with section 583 of the FD&C Act, require the
Secretary to establish national prescription drug wholesale distributor
licensure standards, while section 582 describes requirements
applicable to wholesale distributors and other entities related to
product tracing. Section 701(a) provides general authority to issue
regulations for the efficient enforcement of the FD&C Act. By
clarifying provisions related to prescription drug marketing and by
removing provisions relating to wholesale distribution, this rule, when
finalized, is expected to aid in the efficient enforcement of the FD&C
Act.

V. Description of the Proposed Rule

    This proposed rule would make the deletions and changes to the
existing regulations in part 203 discussed below as well as technical
changes for clarity.

1. Scope and Purpose (Sec. Sec.  203.1 and 203.2)
    Existing Sec. Sec.  203.1 and 203.2 describe the scope and purpose
of the regulations in part 203, respectively. The proposed revisions
would narrow the scope and purpose descriptions in light of the
proposed elimination of requirements relating to wholesale distributors
from part 203. We plan to address the standards and requirements
related to wholesale distributor licensing elsewhere in our
regulations, in accordance with the applicable provisions of the FD&C
Act (as amended by the DSCSA).
2. Definitions (Sec.  203.3)
    Certain definitions that currently appear in this section would be
modified or eliminated.
    a. Authorized distributor of record. The amendments to section
503(e) effectuated by the DSCSA eliminated the definition of
``authorized distributors of record'' from section 503(e) of the FD&C
Act, which previously provided that the definition applied for the
purposes of section 503(d) and 503(e). However, the DSCSA added a
definition of the same term in section 503(d) of the FD&C Act, which
relates to drug sample distribution, in section 503(d)(4). The
``authorized distributor of record'' definition in Sec.  203.3 would be
revised to reflect the fact that, as used in the amended part 203, the
phrase would relate solely to distribution of drug samples. The revised
``authorized distributor of record'' definition would be found in the
new Sec.  203.3(a). In addition, as further discussed below, references
to distribution of products by authorized distributors of record would
be amended throughout the text of part 203, where appropriate, to
clarify that these references relate only to distribution of drug
samples.
    b. Emergency medical reasons. The proposed rule would amend the
definition of ``emergency medical reasons'' in the new Sec.  203.3(l).
Section 203.22, which sets forth exemptions from the sales restrictions
described in Sec.  203.20, generally provides an exemption from those
restrictions for sales, purchases, or trades of a drug for emergency
medical reasons (Sec.  203.22(d)). Section 203.3(m) currently states,
in part, that ``emergency medical reasons'' include, but are not
limited to, transfers of a prescription drug between healthcare
entities or from a healthcare entity to a retail pharmacy to alleviate
a temporary shortage of a prescription drug arising from delays in or
interruption of regular distribution schedules, as well as transfers of
prescription drugs by a retail pharmacy to another retail pharmacy to
alleviate a temporary shortage. As a result, under Sec.  203.22(d) such
transfers to alleviate temporary shortages are exempt from the sales
restrictions set forth in Sec.  203.20. Certain of those transfers may,
however, constitute ``wholesale distribution'' as defined in the DSCSA
(section 503(e)(4) of the FD&C Act) because, while the ``wholesale
distribution'' definition generally excludes distributions for
``emergency medical reasons,'' it states that a drug shortage not
caused by a public health emergency shall not constitute an emergency
medical reason. With certain exceptions, a person cannot simultaneously
be a healthcare entity and a wholesale distributor (see Sec.
203.3(p)). Because of this, FDA proposes to amend relevant language in
the ``emergency medical reasons'' definition to clarify the
relationship between it and the definition of ``wholesale
distribution'' in section 503(e)(4) of the FD&C Act. In particular, we
would add text to Sec.  203.3(l) to make clear that a transfer made to
alleviate a temporary shortage would generally be considered to be for
``emergency medical reasons'' for purposes of part 203 only where the
transfer was either to fulfill a specific patient need or where the
shortage was caused by a public health emergency (that is, where such
transfers would not constitute ``wholesale distribution'' as defined in
section 503(e)(4) of the FD&C Act). As explained in our companion
proposed rulemaking for part 205 (21 CFR part 205), the Agency
considers the transfer or sale of a drug from one dispenser to another
dispenser made to fulfill a specific patient need to be outside the
scope of the ``wholesale distribution'' definition in section 503(e)(4)
of the FD&C Act.
    c. Unauthorized distributor and wholesale distribution. The
definitions of ``unauthorized distributor'' and ``wholesale
distribution,'' currently codified in Sec.  203.3(bb) and (cc),
respectively, would be eliminated from part 203, because these terms
would no longer appear in part 203, as amended. The definition of the
term ``wholesale distributor'' would be modified to indicate that the
term would have the meaning set forth in section 581(29) of the FD&C
Act.
3. Exclusions (Sec.  203.22(h) and (i))
    Paragraphs (h) and (i) of Sec.  203.22, which set forth exemptions
from the sales restrictions in Sec.  203.20, would be modified to
eliminate the phrase indicating that the applicable requirements for a
wholesale distributor or retail pharmacy are contained in part 203,
because FDA is proposing to remove Sec.  203.50, as discussed in
section V.5.
4. Subpart D--Samples
    FDA would replace the term ``distributor'' where it appears in
subpart D with the phrase ``authorized distributor of record'' where
that phrase is not already used (Sec. Sec.  203.30, 203.31, 203.34,
203.36, and 203.37). As noted above, the DSCSA added a definition of
``authorized distributors of record'' in section 503(d) of the FD&C
Act, which relates to drug sample distribution.
5. Subpart E--Wholesale Distribution
    FDA proposes to remove Sec.  203.50 (Subpart E--Wholesale
Distribution) in its entirety. On July 14, 2011, FDA proposed to remove
Sec.  203.50(a) (76 FR 41434). Before that rulemaking was finalized,
the DSCSA was enacted. The DSCSA replaced section 503(e)(1)-(3) of the
FD&C Act and added additional and different requirements for wholesale
distributors. The DSCSA also added new requirements for wholesale
distributors, including phased-in prescription drug tracing
requirements in section 582(c) of the FD&C Act. FDA is withdrawing the
above referenced July 14, 2011, proposed rule in a document published
elsewhere in this issue of the Federal Register. In accordance with the
changes in statutory authorities, FDA proposes to remove Sec.  203.50
in its entirety. FDA is proposing new requirements for wholesale
distributors and wholesale distribution consistent with the relevant
provisions of the DSCSA in a separate proposed rulemaking for part 205,
also published in this issue of the Federal Register.

VI. Proposed Effective Date

    This regulation, if finalized as proposed, will be effective 30
calendar days after the date the final rule publishes in the Federal
Register.

VII. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health

and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the proposed rule imposes only minimal one-time costs
of less than $100 per entity to read and understand the rule on small
entities, we propose to certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    We include the costs to read and understand this proposed rule in
the regulatory impact analysis of the companion licensing standards
proposed rule. The full preliminary analysis of economic impacts of
both rules is available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm under
``National Standards for Licensing of Prescription Drug Wholesale
Distributor and Third Party Logistics Providers'' (Ref. 1).

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30 that this action is of the
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

X. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XII. Reference

    The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

    1. Preliminary Regulatory Impact Analysis, Initial Regulatory
Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for
Certain Requirements Regarding Prescription Drug Marketing; Proposed
Rule, available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 203

    Labeling, Prescription drugs, Reporting and recordkeeping
requirements, Warehouses.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR part 203 be amended as follows:

PART 203--PRESCRIPTION DRUG MARKETING

0
1. The authority citation for part 203 continues to read as follows:

    Authority:  21 U.S.C. 331, 333, 351, 352, 353, 360, 371, 374,
381.

0
2. In part 203, remove the words ``the act'' wherever they appear and
add in their place ``the Federal Food, Drug, and Cosmetic Act''.
0
3. Revise Sec.  203.1 to read as follows:

Sec.  203.1  Scope.

    This part sets forth procedures and requirements pertaining to the
reimportation of prescription drugs, including both bulk drug
substances and finished dosage forms; the sale, purchase, or trade of
(or the offer to sell, purchase, or trade) prescription drugs,
including bulk drug substances, that were purchased by hospitals or
healthcare entities, or donated to charitable organizations; and the
distribution of prescription drug samples. For purposes of this part,
the term ``prescription drug'' has the meaning set forth in Sec.
203.3(x).
0
4. Revise Sec.  203.2 to read as follows:

Sec.  203.2  Purpose.

    The purpose of this part is to protect the public against drug
diversion and enhance the security of the drug supply chain by
establishing procedures and requirements relating to the reimportation
of prescription drugs, the distribution of prescription drug samples,
and the sale, purchase, or trade of prescription drugs purchased by
hospitals or healthcare entities or donated to charitable
organizations.
0
5. Revise Sec.  203.3 to read as follows:

Sec.  203.3   Definitions.

    (a) Authorized distributor of record means a distributor with whom
a manufacturer has established an ongoing relationship to distribute
such manufacturer's drug samples.
    (b) Blood means whole blood collected from a single donor and
processed either for transfusion or further manufacturing.
    (c) Blood component means that part of a single-donor unit of blood
separated by physical or mechanical means.
    (d) Bulk drug substance means any substance that is represented for
use in a drug and that, when used in the manufacturing, processing, or
packaging of a drug, becomes an active ingredient or a finished dosage
form of the drug, but the term does not include intermediates used in
the synthesis of such substances.
    (e) Charitable institution or charitable organization means a
nonprofit hospital, healthcare entity, organization, institution,
foundation, association, or corporation that has been granted an
exemption under section 501(c)(3) of the Internal Revenue Code of 1954,
as amended.

    (f) Common control means the power to direct or cause the direction
of the management and policies of a person or an organization, whether
by ownership of stock, voting rights, by contract, or otherwise.
    (g) Distribute means to sell, offer to sell, deliver, or offer to
deliver a drug to a recipient, except that the term ``distribute'' does
not include:
    (1) Delivering or offering to deliver a drug by a common carrier in
the usual course of business as a common carrier; or
    (2) Providing of a drug sample to a patient by:
    (i) A practitioner licensed to prescribe such drug;
    (ii) A healthcare professional acting at the direction and under
the supervision of such a practitioner; or
    (iii) The pharmacy of a hospital or of another healthcare entity
that is acting at the direction of such a practitioner and that
received such sample in accordance with the Federal Food, Drug, and
Cosmetic Act and the regulations in this part.
    (h) Drug sample means a unit of a prescription drug that is not
intended to be sold and is intended to promote the sale of the drug.
    (i) Drug coupon means a form that may be redeemed, at no cost or at
reduced cost, for a drug that is prescribed in accordance with section
503(b) of the Federal Food, Drug, and Cosmetic Act.
    (j) Electronic record means any combination of text, graphics,
data, audio, pictorial, or other information representation in digital
form that is created, modified, maintained, archived, retrieved, or
distributed by a computer system.
    (k) Electronic signature means any computer data compilation of any
symbol or series of symbols executed, adopted, or authorized by an
individual to be the legally binding equivalent of the individual's
handwritten signature.
    (l) Emergency medical reasons include, but are not limited to:
    (1) Transfers of a prescription drug between healthcare entities or
from a healthcare entity to a retail pharmacy to alleviate a temporary
shortage of a prescription drug arising from delays in or interruption
of regular distribution schedules, provided that such transfers are
made in order to fulfill a specific patient need or respond to a public
health emergency;
    (2) Sales to nearby emergency medical services, i.e., ambulance
companies, police, and fire-fighting organizations in the same State or
same marketing or service area, or nearby licensed practitioners, of
drugs for use in the treatment of acutely ill or injured persons;
    (3) Provision of minimal emergency supplies of drugs to nearby
nursing homes for use in emergencies or during hours of the day when
necessary drugs cannot be obtained; and
    (4) Transfers of prescription drugs by a retail pharmacy to another
retail pharmacy to alleviate a temporary shortage, provided that such
transfers are made in order to fulfill a specific patient need or
respond to a public health emergency but do not include regular and
systematic sales to licensed practitioners of prescription drugs that
will be used for routine office procedures.
    (m) FDA means the U.S. Food and Drug Administration.
    (n) Group purchasing organization means any entity established,
maintained, and operated for the purchase of prescription drugs for
distribution exclusively to its members with such membership consisting
solely of hospitals and healthcare entities bound by written contract
with the entity.
    (o) Handwritten signature means the scripted name or legal mark of
an individual handwritten by that individual and executed or adopted
with the present intention to authenticate a writing in a permanent
form. The act of signing with a writing or marking instrument such as a
pen or stylus is preserved. The scripted name or legal mark, while
conventionally applied to paper, may also be applied to other devices
that capture the name or mark.
    (p) Healthcare entity means any person that provides diagnostic,
medical, surgical, or dental treatment, or chronic or rehabilitative
care, but does not include any retail pharmacy or any wholesale
distributor. Except as provided in Sec.  203.22(h) and (i), a person
cannot simultaneously be a ``healthcare entity'' and a retail pharmacy
or wholesale distributor.
    (q) Licensed practitioner means any person licensed or authorized
by State law to prescribe drugs.
    (r) Manufacturer means any person who is a manufacturer as defined
by Sec.  201.1 of this chapter.
    (s) Nonprofit affiliate means any not-for-profit organization that
is either associated with or a subsidiary of a charitable organization
as defined in section 501(c)(3) of the Internal Revenue Code of 1954.
    (t) Ongoing relationship means an association that exists when a
manufacturer and a distributor enter into a written agreement under
which the distributor is authorized to distribute the manufacturer's
drug samples for a period of time or for a number of shipments. If the
distributor is not authorized to distribute a manufacturer's entire
drug sample line, the agreement must identify the specific drug samples
that the distributor is authorized to distribute.
    (u) PDA means the Prescription Drug Amendments of 1992.
    (v) PDMA means the Prescription Drug Marketing Act of 1987.
    (w) Person includes any individual, partnership, corporation, or
association.
    (x) Prescription drug means any drug (including any biological
product, except for blood and blood components intended for transfusion
or biological products that are also medical devices) required by
Federal law (including Federal regulation) to be dispensed only by a
prescription, including finished dosage forms and bulk drug substances
subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act.
    (y) Representative means an employee or agent of a drug
manufacturer or authorized distributor of record who promotes the sale
of prescription drugs to licensed practitioners and who may solicit or
receive written requests for the delivery of drug samples. A detailer
is a representative.
    (z) Sample unit means a packet, card, blister pack, bottle,
container, or other single package comprised of one or more dosage
units of a prescription drug sample, intended by the manufacturer or
authorized distributor of record to be provided by a licensed
practitioner to a patient in an unbroken or unopened condition.
    (aa) Wholesale distributor has the meaning set forth in section
581(29) of the Federal Food, Drug, and Cosmetic Act.
0
6. In Sec.  203.22, revise paragraphs (h) and (i) to read as follows:

Sec.  203.22  Exclusions.

* * * * *
    (h) The sale, purchase, or trade of, or the offer to sell,
purchase, or trade, by a registered blood establishment that qualifies
as a healthcare entity, any:
    (1) Drug indicated for a bleeding or clotting disorder, or anemia;
    (2) Blood collection container approved under section 505 of the
Federal Food, Drug, and Cosmetic Act; or
    (3) Drug that is a blood derivative (or a recombinant or synthetic
form of a blood derivative); as long as all of the healthcare services
that the establishment provides are related to its activities as a
registered blood establishment or the healthcare services consist of
collecting, processing, storing,

or administering human hematopoietic stem/progenitor cells or
performing diagnostic testing of specimens provided that these
specimens are tested together with specimens undergoing routine donor
testing. Blood establishments relying on the exclusion in this
paragraph (h)(3) must satisfy all other applicable requirements of the
Federal Food, Drug, and Cosmetic Act and the regulations in this part
promulgated thereunder.
    (i) The sale, purchase, or trade of, or the offer to sell,
purchase, or trade, by a comprehensive hemophilia diagnostic treatment
center that is receiving a grant under section 501(a)(2) of the Social
Security Act and that qualifies as a healthcare entity, any drug
indicated for a bleeding or clotting disorder, or anemia, or any drug
that is a blood derivative (or a recombinant or synthetic form of a
blood derivative). Comprehensive hemophilia diagnostic treatment
centers relying on the exclusion in this paragraph (i) must satisfy all
other applicable requirements of the Social Security Act and the
regulations in this part promulgated thereunder.
0
7. In Sec.  203.30, revise paragraphs (a)(4) and (c) to read as
follows:

Sec.  203.30  Sample distribution by mail or common carrier.

    (a) * * *
    (4) The receipt is returned to the manufacturer or authorized
distributor of record from which the drug sample was received.
* * * * *
    (c) Contents of the receipt to be completed upon delivery of a drug
sample. The receipt is to be on a form designated by the manufacturer
or authorized distributor of record, and is required to contain the
following:
    (1) If the drug sample is delivered to the licensed practitioner
who requested it, the receipt is required to contain the name, address,
professional title, and signature of the practitioner or the
practitioner's designee who acknowledges delivery of the drug sample;
the proprietary or established name and strength of the drug sample;
the quantity of the drug sample delivered; and the date of the
delivery.
    (2) If the drug sample is delivered to the pharmacy of a hospital
or other healthcare entity at the request of a licensed practitioner,
the receipt is required to contain the name and address of the
requesting licensed practitioner; the name and address of the hospital
or healthcare entity pharmacy designated to receive the drug sample;
the name, address, professional title, and signature of the person
acknowledging delivery of the drug sample; the proprietary or
established name and strength of the drug sample; the quantity of the
drug sample delivered; and the date of the delivery.
0
8. In Sec.  203.31, revise paragraphs (a)(4), (c), (d) introductory
text, (d)(2)(iii), and (e) to read as follows:

Sec.  203.31  Sample distribution by means other than mail or common
carrier (direct delivery by a representative or detailer).

    (a) * * *
    (4) The receipt is returned to the manufacturer or authorized
distributor of record; and
* * * * *
    (c) Contents of the receipt to be completed upon delivery of a drug
sample. The receipt is to be on a form designated by the manufacturer
or authorized distributor of record, and is required to contain the
following:
    (1) If the drug sample is received at the address of the licensed
practitioner who requested it, the receipt is required to contain the
name, address, professional title, and signature of the practitioner or
the practitioner's designee who acknowledges delivery of the drug
sample; the proprietary or established name and strength of the drug
sample; the quantity of the drug sample delivered; and the date of the
delivery.
    (2) If the drug sample is received by the pharmacy of a hospital or
other healthcare entity at the request of a licensed practitioner, the
receipt is required to contain the name and address of the requesting
licensed practitioner; the name and address of the hospital or
healthcare entity pharmacy designated to receive the drug sample; the
name, address, professional title, and signature of the person
acknowledging delivery of the drug sample; the proprietary or
established name and strength of the drug sample; the quantity of the
drug sample delivered; and the date of the delivery.
    (d) Inventory and reconciliation of drug samples of manufacturers'
and authorized distributors' representatives. Each drug manufacturer or
authorized distributor of record that distributes drug samples by means
of representatives shall conduct, at least annually, a complete and
accurate physical inventory of all drug samples. All drug samples in
the possession or control of each manufacturer's and authorized
distributor's representatives are required to be inventoried and the
results of the inventory are required to be recorded in an inventory
record, as specified in paragraph (d)(1) of this section. In addition,
manufacturers and authorized distributors of record shall reconcile the
results of the physical inventory with the most recently completed
prior physical inventory and create a report documenting the
reconciliation process, as specified in paragraph (d)(2) of this
section.
* * * * *
    (2) * * *
    (iii) A record of drug sample distributions since the most recently
completed inventory showing the name and address of each recipient of
each sample unit shipped, the date of the shipment, and the proprietary
or established name, dosage strength, and number of sample units
shipped. For the purposes of this paragraph (d)(2)(iii) and paragraph
(d)(2)(v) of this section, ``distributions'' includes distributions to
healthcare practitioners or designated hospital or healthcare entity
pharmacies, transfers or exchanges with other firm representatives,
returns to the manufacturer or authorized distributor of record,
destruction of drug samples by a sales representative, and other types
of drug sample dispositions. The specific type of distribution must be
specified in the record;
* * * * *
    (e) Lists of manufacturers' and authorized distributors'
representatives. Each drug manufacturer or authorized distributor of
record who distributes drug samples by means of representatives shall
maintain a list of the names and addresses of its representatives who
distribute drug samples and of the sites where drug samples are stored.
0
9. In Sec.  203.34, revise paragraph (b)(1) to read as follows:

Sec.  203.34  Policies and procedures; administrative systems.

* * * * *
    (b) * * *
    (1) Reconciling requests and receipts, identifying patterns of
nonresponse, and the manufacturer's or authorized distributor of
record's response when such patterns are found;
* * * * *
0
10. In Sec.  203.36, revise paragraph (a) to read as follows:

Sec.  203.36  Fulfillment houses, shipping and mailing services,
comarketing agreements, and third-party recordkeeping.

    (a) Responsibility for creating and maintaining forms, reports, and
records. Any manufacturer or authorized distributor of record that uses
a fulfillment house, shipping or mailing service, or other third party,
or engages in a comarketing agreement with another manufacturer or
authorized distributor of record to distribute drug samples or to meet
any of the

requirements of PDMA, PDA, or this part, remains responsible for
creating and maintaining all requests, receipts, forms, reports, and
records required under PDMA, PDA, and this part.
* * * * *
0
11. In Sec.  203.37, revise paragraph (e) to read as follows:

Sec.  203.37  Investigation and notification requirements.

* * * * *
    (e) Whom to notify at FDA. Notifications and reports concerning
samples of human prescription drugs or biological products that are
regulated by the Center for Drug Evaluation and Research shall be made
via email to [email protected]. Alternatively, reports and
correspondence concerning such samples may be made via regular mail to
the Office of Drug Security, Integrity, and Response, Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD
20993-0002, ATTN: PDMA Reports. Notifications and reports concerning
samples of human prescription biological products regulated by the
Center for Biologics Evaluation and Research shall be made to the Food
and Drug Administration, Center for Biologics Evaluation and Research,
Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112,
Silver Spring, MD 20993-0002.

Subpart E [Removed and Reserved]

0
12. Remove and reserve subpart E, consisting of Sec.  203.50.

    Dated: January 24, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-01927 Filed 2-3-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 180 (Friday, September 16, 2011)]
[Notices]
[Pages 57769-57770]
[FR Doc No: 2011-23731]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9258; 34-65322; File No. 265-27]

Advisory Committee on Small and Emerging Companies

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Federal Advisory Committee Establishment.

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

SUMMARY: The Securities and Exchange Commission intends to establish
the Securities and Exchange Commission Advisory Committee on Small and
Emerging Companies.

ADDRESSES: Written comments may be submitted by the following methods:

Electronic Comments

     Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
     Send an e-mail message to<EMAIL_ADDRESS>including
File No. X-XXX on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. 265-27. To help us process and
review your comments more efficiently, please use only one method. The
Commission will post all comments on the Commission's Internet Web site
(http://www.sec.gov/rules/other.shtml). Comments also will be available
for Web site viewing and printing in the Commission's Public Reference
Room, 100 F Street, NE., Washington, DC 20549, on official business
days between the hours of 10 a.m. and 3 p.m. All comments received will
be posted without change; we do not edit personal identifying
information from your submissions. You should submit only information
that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Johanna V. Losert, Special Counsel, or
Gerald J. Laporte, Office Chief, Office of

Small Business Policy, Securities and Exchange Commission, 100 F
Street, NE., Washington DC 20549-3628,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with the requirements of the
Federal Advisory Committee Act, 5 U.S.C.--App., the Commission is
publishing this notice that the Chairman of the Commission, with the
concurrence of the other Commissioners, intends to establish the
Securities and Exchange Commission Advisory Committee on Small and
Emerging Companies (the ``Committee''). The Committee's objective is to
provide the Commission with advice on its rules, regulations, and
policies, with regard to its mission of protecting investors,
maintaining fair, orderly, and efficient markets, and facilitating
capital formation, as they relate to the following:
    (1) Capital raising by emerging privately-held small businesses
(``emerging companies'') and publicly traded companies with less than
$250 million in public market capitalization (``smaller public
companies'') through securities offerings, including private and
limited offerings and initial and other public offerings;
    (2) Trading in the securities of emerging companies and smaller
public companies; and
    (3) Public reporting and corporate governance requirements of
emerging companies and smaller public companies.
    Up to 20 voting members will be appointed to the Committee who can
effectively represent those directly affected by, interested in, and/or
qualified to provide advice to the Commission on its rules,
regulations, and policies as set forth above. The Committee's
membership will be balanced fairly in terms of points of view
represented and functions to be performed. Non-voting observers for the
committee from the North American Securities Administrators Association
and the Small Business Administration may also be named.
    The Committee may be established 15 days after publication of this
notice in the Federal Register by filing a charter for the Committee
with the Committee on Banking, Housing, and Urban Affairs of the United
States Senate and the Committee on Financial Services of the United
States House of Representatives. A copy of the charter as so filed also
will be filed with the Chairman of the Commission, furnished to the
Library of Congress, and posted on the Commission's Web site at http://www.sec.gov. An undated copy of the charter is now available at http://www.faca.gov.
    The Committee will operate for two years from the date it is
established or such earlier date as determined by the Commission
unless, before the expiration of that time period, its charter is re-
established or renewed in accordance with the Federal Advisory
Committee Act.
    The Committee will meet at such intervals as are necessary to carry
out its functions. The charter contemplates that the full Committee
will meet three times annually. Meetings of subgroups or subcommittees
of the full Committee may occur more frequently.
    The charter will provide that the duties of the Committee are to be
solely advisory. The Commission alone will make any determinations of
action to be taken and policy to be expressed with respect to matters
within the Commission's authority as to which the Committee provides
advice or makes recommendations. The Chairman of the Commission affirms
that the establishment of the Committee is necessary and in the public
interest.

    By the Commission.

    Dated: September 12, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-23731 Filed 9-15-11; 8:45 am]
BILLING CODE 8011-01-P


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

EPA Registration Division contact: [ToJohn Bazuinny Kish,
703-3058-73819443]

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format  in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[Arysta LifeScience North
America, LLC],” with the information specific to your action.

I. [Arysta LifeScience North America, LLC]

[8F7437Insert petition number]

Summary of Petitions

	EPA has received a pesticide petition ([8F7437insert petition number])
from [(15401 Weston Parkway, Suite 150, Cary, North Carolina 27513)]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

Options (pick one)

 by establishing a tolerance for residues of

[Ffluoxastrobin,
(1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dih
ydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its Z isomer,
(1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl](5,6-dih
ydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime] in or on the raw
agricultural commodities [corn, field grain at 0.02 ppm; corn, field,
aspirated grain fractions at 0.50 ppm; corn, field, forage at 3.0 ppm;
corn, field, fodder/stover at 4.5 ppm; soybean, seed at 0.05 ppm;
soybean, aspirated grain fractions at 0.40 ppm; soybean, forage at 9.0
ppm, soybean, hay at 1.2 ppm; soybean, hulls at 0.40 ppm].  EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition.  Additional data
may be needed before EPA rules on the petition.

A. Residue Chemistry

. [The metabolism of fluoxastrobin in plants is adequately understood.
Studies have been conducted to delineate the metabolism of radiolabeled
fluoxastrobin in peanut, tomato, spring wheat, and various
representative rotational crops, all showing similar results. The
residue of concern is parent fluoxastrobin (sum of E and Z isomers).]

. [Adequate analytical methodology using HPLC/MS/MS detection is
available for enforcement purposes.]

. [Magnitude of residue and processing trials were conducted on corn,
field and soybean.  Therefore, the data support the proposed
tolerances.]

B. Toxicological Profile

.  [Oral and dermal LD50 values were >2000 mg/kg bw.  Inhalation LC50
values were >4998 mg/m3 air.  Fluoxastrobin technical was not irritating
to rabbit skin, was moderately irritating to eyes in rabbits and was
non-sensitizing dermally in the Magnusson/Kligman maximization test in
guinea pigs.  Acute toxicity studies for fluoxastrobin technical support
an overall toxicity Category III.]

.  [Several genotoxicity tests were conducted to test for
point-mutagenic activity, chromosome aberration in vitro and in vivo,
and for DNA repair.  All tests conducted were negative, indicating no
evidence of mutagenic or genotoxic potential.]

.  [An oral developmental toxicity study in rat did not reveal any
evidence of teratogenic potential.  The maternal NOAEL was 300 mg/kg and
the developmental NOAEL was 1000 mg/kg bw/day.  An oral developmental
toxicity study in rabbits demonstrated a maternal NOAEL of 25 mg/kg
bw/day, a developmental NOAEL of 100 mg/kg bw/day and did not reveal any
teratogenic potential.  A two-generation study in rats, with a parental
toxicity NOAEL of 73.7 mg/kg bw/day for males and 86.7 mg/kg bw/day for
females, did not reveal evidence of a primary reproductive toxicity
potential.  The reproductive NOAEL was 763.6 mg/kg bw/day for males and
806.5 mg/kg bw/day in females.]

[A subchronic toxicity feeding study with rats over 90 days demonstrated
a NOAEL of 7.3 and 18.3 mg/kg bw/day for males and females,
respectively, based on reduced body weights and alterations in several
urinary tract related clinical chemistry parameters, at the higher dose
levels.  In a subchronic feeding study in mice over 14 weeks a NOAEL was
not established based on decreased alanine aminotransferase (ALAT) and
increased absolute and relative liver weights at the low dose level
(21.7 and 35.3 mg/kg bw/day for males and females, respectively).  A
14-week feeding study in dogs demonstrated a NOAEL of 3.0 mg/kg bw/day
based on decreased body weights and food consumption, and liver effects
(enzyme induction, increased liver weights and cytoplasmic change) and
thyroid effects (decreased T3).]

.  [A 24-month chronic/oncogenicity feeding study in rats demonstrated a
NOAEL of 53.0 and 35.2 mg/kg bw/day for males and females, respectively.
 An oncogenicity study in the mouse revealed a NOAEL of 18.5 and 29.5
mg/kg bw/day for males and females, respectively based on liver effects.
 There was no indication in the rat or mouse for an oncogenic effect of
fluoxastrobin.  A one-year feeding study with dogs demonstrated a NOAEL
of 1.7 and 1.5 mg/kg bw/day for males and females, respectively based on
decreased body weights and slight  liver effects (increased alkaline
phosphatase (Aph) and liver weights).]

. [Metabolism and pharmacokinetic studies in the rats, lactating goats
and laying hens demonstrate that fluoxastrobin residues are rapidly
absorbed, metabolized and eliminated.  There was no evidence of
accumulation of residues in any tissues or organs.  The metabolic
pattern was always complex and numerous metabolites were identified.
The main metabolic reactions, however, are very comparable for all
tested animal species and most metabolites were present at low levels.
As per the meat and milk tolerances established in 40 CFR 180.609, the
tolerance expression includes fluoxastrobin (sum of E and Z isomers) and
it’s phenoxy-hydroxypyrimidine metabolite.]

. [The residues of concern are fluoxastrobin and its
phenoxy-hydroxypyrimidine metabolite.  This metabolite was investigated
for acute oral toxicity and point mutagenic activity in a bacterial
reverse mutation assay.  The phenoxy-hydroxypyrimidine metabolite did
not show mutagenic activity in the reverse mutation assay and the oral
LD50 was >300<500 mg/kg body weight.]

.  [There is no evidence to suggest that fluoxastrobin has any primary
endocrine disruptive potential.  Reproductive and developmental findings
provided no evidence of an enhanced sensitivity of the young.]

C. Aggregate Exposure

.

.  [A chronic dietary analysis was conducted to estimate exposure to
potential fluoxastrobin residues in/on corn, field and soybean in
addition to all proposed and currently registered crops.  Acute analyses
were not conducted since, as per EPA’s 1/24/05 human health risk
assessment, there was no indication of an adverse effect attributable to
a single dose and therefore an acute reference dose (aRfD) was not
established. Tier I analysis was conducted for the chronic scenario
using the DEEM-FCID( (Exponent, Inc.) software.  Chronic dietary
exposure estimates from potential residues of fluoxastrobin for the US
Population was 16.7% of the chronic RfD.  The sub-population with the
highest exposure was Children 1-2 with 38.0% of the chronic RfD used.
Tier I assessments use tolerance residue values and 100% crop treated.
These can be considered very conservative estimates of exposure.]

. [EPA has previously demonstrated (as per EPA’s 1/24/05 human health
risk assessment) that the use on turf is associated with the highest
potential impacts to surface water using PRZM/EXAMS, with the average
concentration in surface water of 28 ppb.  Groundwater concentrations
have been estimated to be <1 ppb.  Since the application rate on turf (4
applications at 0.55 lb ai/A with 14-day RTI) is higher than that on
corn, field and soybean (2 applications at 0.18 lb ai/A with 7- and
14-day RTI, respectively), there is no need to evaluate potential
drinking water impacts for the proposed use on corn, field and soybean.
Therefore, the worst-case assumption is 28 ppb fluoxastrobin in drinking
water.]

. [Residential Post-application Exposures: The proposed use on corn,
field and soybean will not result in residential post-application
exposures; therefore residential post-application exposures are
associated only with adults and children who may contact treated turf.
In EPA’s 2005 assessment, MOEs for residential post-application
exposures were found to be greater than 100 for all scenarios.]

[Aggregate Exposures: Short-term and intermediate-term aggregate
exposures were calculated.  Dietary exposures include the addition of
the corn, field and soybean uses to all proposed and registered crops
and impacts to drinking water.  Short-term aggregate calculations
include only oral exposures because there is no short-term dermal
endpoint.  The intermediate-term aggregate calculations include both
dermal and oral exposures.  Aggregate MOEs are greater than 100 for
adults and children for both short- and intermediate-term exposure
durations.

Aggregate exposures are not calculated for the long-term (i.e., chronic)
because only dietary exposures factor into the long-term scenario.
Therefore, the chronic dietary exposures are the same as the long-term
exposures.]

D. Cumulative Effects

[Fluoxastrobin is a novel strobilurin analog.  Arysta LifeScience North
America, LLC will submit information, if necessary, for EPA to consider
concerning potential cumulative effects of fluoxastrobin consistent with
the schedule established by EPA at 62 Federal Register 42020 (Aug. 4,
1997) and other EPA publications pursuant to the Food Quality Protection
Act. ]

E. Safety Determination

. [Using the conservative assumptions described above, based on the
completeness and reliability of the toxicity data, it is concluded that
dietary exposure (food and water) from the proposed and registered uses
of fluoxastrobin will utilize at most 16.7% of the reference dose for
the US Population, and is likely to be much less as more realistic data
and models are developed.  EPA generally has no concern for exposures
below 100% of the RfD because the RfD represents the level at or below
which daily dietary (food plus water) exposure over a lifetime will not
pose appreciable risks to human health.  In addition, aggregate (food
and water dietary plus residential) MOEs are greater than 100 for adults
for both short- and intermediate-term exposure durations. Finally, all
handler exposure scenarios also have MOE greater than 100. Therefore,
there is a reasonable certainty that no harm will occur to the US
Population from aggregate exposure to fluoxastrobin.]

.  [Consideration of the toxicology database as described above leads to
no additional concerns for infants and children.  Therefore the FQPA
safety factor can be established at 1X.  Using the conservative exposure
assumptions described in the exposure section above, the margins of
exposure that will result for short- and intermediate-term aggregate
exposure (food plus water plus residential) to residues of fluoxastrobin
are greater than 100 for children. This value is based on a worst-case
aggregate exposure calculation of a child 1-6 who has a background
dietary exposure to potential residues and plays on a maximally treated
lawn.  Therefore, there is a reasonable certainty that no harm will
occur to infants and children from aggregate exposure to residues of
fluoxastrobin.]

F. International Tolerances

	[Codex maximum residue levels (MRLs) are not yet established for
fluoxastrobin.]

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[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]
[Page 43961-43963]
[DOCID:fr27jy10-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

July 19, 2010.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG10-52-000.
    Applicants: RRI Energy West, Inc.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of RRI Energy West, Inc.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5047.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

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

    Docket Numbers: ER96-1361-017; ER07-903-006; ER00-1770-023; ER99-
2781-015; ER04-472-012; ER08-1336-004; ER01-202-012; ER98-3096-019;
ER98-4138-013; ER04-472-013.
    Applicants: Atlantic City Electric Company; Bethlehem Renewable
Energy, LLC; Conectiv Energy Supply, Inc.; Delmarva Power & Light
Company; Eastern Landfill Gas, LLC; Energy Systems North East LLC;
Potomac Power Resources, Inc.; Pepco Energy Services, Inc.; Potomac
Electric Power Company; Fauquier Landfull Gas, LLC.
    Description: Notification of Change in Status of Pepco Holdings
Inc.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5040.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Docket Numbers: ER01-390-009; ER99-3450-011; ER99-2769-012; ER00-
2706-009; ER01-2760-008; ER10-566-003; ER08-1255-005; ER98-4515-011;
ER09-1364-003; ER01-138-008; ER06-744-006; ER01-1418-012; ER02-1238-
012; ER03-28-006; ER03-398-013; ER09-1488-002; ER02-1884-011.
    Applicants: Chandler Wind Partners, LLC, Foote Creek II, LLC, Foote
Creek IV, LLC, Ridge Crest Wind Partners, LLC, Oak Creek Wind Power,
LLC, Delta Person Limited Partnership, Waterside Power LLC, Michigan
Power Limited Partnership, Sabine Cogen LP, Foote Creek III, LLC,
Effingham County Power, LLC, MPC Generating, LLC, Walton County Power,
LLC, Washington County Power, LLC, Black Bear Hydro Partners, LLC, Coso
Geothermal Power Holdings, LLC, Cadillac Renewable Energy LLC.
    Description: Notice of Non-Material Change in Status of Chandler
Wind Partners, LLC, et. al. under ER01-390, et al.
    Filed Date: 07/12/2010.
    Accession Number: 20100712-5166.
    Comment Date: 5 p.m. Eastern Time on Monday, August 02, 2010.

    Docket Numbers: ER10-941-003.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits certain revisions
to the protocols attached to the Seams Agreement with Entergy Services,
Inc.
    Filed Date: 07/15/2010.
    Accession Number: 20100716-0202.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 05, 2010.

    Docket Numbers: ER10-1339-001.
    Applicants: Southern Indiana Gas and Electric Company.
    Description: Southern Indiana Gas and Electric Company, Inc.
submits tariff filing per 35: Southern Indiana Gas & Electric Company
Ancillary Services Tariff to be effective 7/16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5041.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1472-001.
    Applicants: Choice Energy, LLC.
    Description: Choice Energy, LLC submits their Application for Order
Accepting Rates for Filing and Granting Waivers and Blanket Approvals.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-0181.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1785-000.
    Applicants: UBS AG.
    Description: UBS AG submits tariff filing per 35.12: UBS AG
Electric Rate Schedule Baseline to be effective 7/15/2010.
    Filed Date: 07/15/2010.
    Accession Number: 20100715-5074.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 05, 2010.

    Docket Numbers: ER10-1786-000.
    Applicants: Credit Suisse Energy, LLC.
    Description: Credit Suisse Energy, LLC submits tariff filing per
35.12: Credit Suisse Energy LLC Electric Rate Schedule to be effective
7/15/2010.
    Filed Date: 07/15/2010.
    Accession Number: 20100715-5075.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 05, 2010.

    Docket Numbers: ER10-1787-000.
    Applicants: PSEG Energy Resources & Trade LLC.
    Description: PSEG Energy Resources & Trade LLC submits tariff
filing per 35: Compliance filing of PSEG ER&T Reactive Supply & Voltage
Control Service Tariff to be effective 7/15/2010.
    Filed Date: 07/15/2010.
    Accession Number: 20100715-5108.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 05, 2010.

    Docket Numbers: ER10-1788-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii): Revision to Trinity Public Utilities District
Interconnection Agreement to be effective 9/14/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5000.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1789-000.
    Applicants: PSEG Energy Resources & Trade LLC.
    Description: PSEG Energy Resources & Trade LLC submits tariff
filing per 35: PSEG Energy Resources & Trade LLC Market-Based Rate
Tariff Volume No. 1 to be effective 7/16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5036.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1790-000.
    Applicants: BP Energy Company.
    Description: BP Energy Company submits tariff filing per 35.12:
Baseline MBR Tariff Filing of BP Energy Company to be effective 8/1/
2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5051.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1791-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
et al submits the proposed revisions to their ISO Open Access
Transmission, Energy and Operating Reserve Markets Tariff.
    Filed Date: 07/15/2010.
    Accession Number: 20100716-0206.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 05, 2010.

    Docket Numbers: ER10-1792-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits an executed interim
interconnection service agreement with Blackstone Wind Farm III LLC et
al.
    Filed Date: 07/15/2010.
    Accession Number: 20100716-0203.
    Comment Date: 5 p.m. Eastern Time on Thursday, August 05, 2010.

    Docket Numbers: ER10-1793-000.
    Applicants: PSEG Power Connecticut LLC.
    Description: PSEG Power Connecticut LLC submits tariff filing per
35: Compliance Filing re PSEG Power Connecticut LLC Market-Based Rate
Tariff to be effective 7/16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5091.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1794-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.12: 2010--7--16--WestConnect--Baseline to be effective 7/
16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5095.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1795-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Golden Spread Electric Cooperative, Inc. submits
tariff filing per 35: 2010 Annual Update to be effective 7/16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5101.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1796-000.
    Applicants: Southwestern Public Service Company.
    Description: Southwestern Public Service Company submits tariff
filing per 35.12: 20100716--Baseline Filing to be effective 7/16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5120.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1797-000.
    Applicants: Northern States Power Company, a Minnesota Corporation.
    Description: Northern States Power Company, a Minnesota corporation
submits tariff filing per 35.12: 20100716--Baseline Filing to be
effective 7/16/2010.
    Filed Date: 07/16/2010.
    Accession Number: 20100716-5137.
    Comment Date: 5 p.m. Eastern Time on Friday, August 06, 2010.

    Docket Numbers: ER10-1798-000.
    Applicants: Northern States Power Company, a Wisconsin Corporation.
    Description: Northern States Power Company, a Wisconsin corporation
submits tariff filing per 35.12: 20100716--Baseline Filing to be
effective 7/16/2010.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5000.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Docket Numbers: ER10-1799-000.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.12: 20100719--Baseline Filing to be effective 7/16/2010.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5039.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Docket Numbers: ER10-1800-000.
    Applicants: Indianapolis Power & Light Company.
    Description: Indianapolis Power & Light Company submits tariff
filing per 35.12: IPL Market Based Rate Tariff to be effective 7/20/
2010.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5042.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Docket Numbers: ER10-1801-000.
    Applicants: The Connecticut Light and Power Company.
    Description: The Connecticut Light and Power Company submits tariff
filing per 35.12: CL&P Baseline Filing of Market-Based Tariff Under
Order No. 714 to be effective 7/19/2010.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5069.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Docket Numbers: ER10-1802-000.
    Applicants: Dominion Energy Manchester Street, Inc.
    Description: Dominion Energy Manchester Street, Inc. submits tariff
filing per 35.12: Baseline to be effective 7/19/2010.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5070.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Docket Numbers: ER10-1805-000.
    Applicants: Public Service Company of New Hampshire.
    Description: Public Service Company of New Hampshire submits tariff
filing per 35.12: PSNH Baseline Filing of

Market-Based Tariff Under Order No. 714 to be effective 7/19/2010.
    Filed Date: 07/19/2010.
    Accession Number: 20100719-5083.
    Comment Date: 5 p.m. Eastern Time on Monday, August 09, 2010.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St, NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-18310 Filed 7-26-10; 8:45 am]
BILLING CODE 6717-01-P