P-20-0050 Sanitized Support Documents Index:
 P-20-0050 Sanitized Determination Document (linked)
 P-20-0050 Sanitized CHEM Report (attached)
 P-20-0050 Sanitized ECO Report (attached)
 P-20-0050 Sanitized ENG Report (attached)
 P-20-0050 Sanitized EXP Report (attached)
 P-20-0050 Sanitized Fate Report (attached)
 P-20-0050 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 88, Number 100 (Wednesday, May 24, 2023)]
[Rules and Regulations]
[Page 33550]
[FR Doc No: 2023-10602]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2022-N-2898]

Food Labeling, Infant Formula Requirements, Food Additives and
Generally Recognized as Safe Substances, New Dietary Ingredient
Notification; Technical Amendments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments; correction.

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

SUMMARY: The Food and Drug Administration is correcting a final rule
entitled ``Food Labeling, Infant Formula Requirements, Food Additives
and Generally Recognized as Safe Substances, New Dietary Ingredient
Notification; Technical Amendments'' that appeared in the Federal
Register of March 24, 2023. The final rule corrected typographical
errors, corrected errors in sample labels, restored inadvertent
omissions, and updated office and organization names, addresses, and
other references. The document was published with an incorrect
abbreviation to ``Potassium'' in the codified language. This document
corrects that error.

DATES: Effective May 24, 2023.

FOR FURTHER INFORMATION CONTACT: Mark Kantor, Office of Nutrition and
Food Labeling (HFS-830), Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-1450; or Alexandra Jurewitz, Office of Regulations and Policy
(HFS-024), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, March 24,
2023 (88 FR 17710 at 17718), an incorrect abbreviation to ``Potassium''
appeared in Sec.  101.9(j)(13)(ii)(B) of the codified language. This
document corrects that error.

List of Subjects in 21 CFR Part 101

    Food Labeling, Nutrition, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, FDA is correcting 21 CFR
part 101 with the following correcting amendment:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

Sec.  101.9  [Amended]

0
2. In Sec.  101.9, amend paragraph (j)(13)(ii)(B) by removing
``Potassium--Pot.'' and replacing it with ``Potassium--Potas.''.

    Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10602 Filed 5-23-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 129 (Thursday, July 5, 2012)]
[Notices]
[Page 39794]
[FR Doc No: 2012-16432]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Release From Federal Grant Assurance Obligations at
Fresno Yosemite International Airport, Fresno, CA

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of Request to Release Airport Land.

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

SUMMARY: The Federal Aviation Administration (FAA) proposes to rule and
invites public comment on the application for a release of
approximately 13.35 acres of airport property at the Fresno Yosemite
International Airport (FAT), Fresno, California from all conditions
contained in the Grant Assurances since the parcels of land is not
needed for airport purposes. The land is located approximately 5,000
feet from the end of runway 11L in the northwest corner of the airport
property. The property will be sold for its fair market value to the
Fresno Metropolitan Flood Control District and the proceeds deposited
in the airport account. The Fresno Metropolitan Flood Control District
will continue use of the property as storm water detention basin. The
detention basin usage will keep the property vacant and compatible with
the airport to ensure it does not interfere with the airport or its
operation, as well as continuing to serve the interest of civil
aviation.

DATES: Comments must be received on or before August 6, 2012.

FOR FURTHER INFORMATION CONTACT: Comments on the request may be mailed
or delivered to the FAA at the following address: Robert Lee, Airports
Compliance Specialist, Federal Aviation Administration, San Francisco
Airports District Office, Federal Register Comment, 1000 Marina
Boulevard, Suite 220, Brisbane, CA 94005. In addition, one copy of the
comment submitted to the FAA must be mailed or delivered to Mr. Russell
C. Widmar, Director of Aviation, 4995 E. Clinton Way, Fresno, CA 93727.

SUPPLEMENTARY INFORMATION: In accordance with the Wendell H. Ford
Aviation Investment and Reform Act for the 21st Century (AIR 21),
Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be
published in the Federal Register 30 days before the Secretary may
waive any condition imposed on a federally obligated airport by surplus
property conveyance deeds or grant agreements.
    The following is a brief overview of the request:
    The City of Fresno, California requested a release from grant
assurance obligations for approximately 13.35 acres of airport land to
allow for its sale. The property was originally acquired as separate
parcels with federal funding and airport generated funds. Approximately
2.23 acres were acquired under Airport Development Aid Program (ADAP)
grant No. 6-06-0087-02; 1.41 acres were acquired under Airport
Development Aid Program (ADAP) grant No. 6-06-0087-06; 3.05 acres were
acquired under Airport Improvement Program (AIP) grant No. 3-06-0087-16
for noise abatement; 4.02 acres acquired under AIP grant No. 3-06-0087-
19 for noise abatement; and 2.64 acres of the land was acquired from
the State of California with airport generated funds for a total of
13.35 acres of airport land to be released.
    Due to its location and condition, the property cannot be used for
airport purposes. The property previously contained homes that have
been removed and the land cleared. The land is presently kept vacant
and is unimproved and does not have any current or future income
generating potential. The planned land use is for a storm water
detention basin and will be kept vacant. The release will allow 13.35
acres to be sold to the Fresno Metropolitan Flood Control District. The
sale price will be based on an upward adjusted appraised fair market
value. The sale proceeds will be deposited in the airport account. The
Fresno Yosemite International Airport will be properly compensated,
thereby serving the interests of civil aviation.

    Issued in Brisbane, California, on June 20, 2012.
Michael A. Meyers,
Acting Assistant Manager, San Francisco Airports District Office,
Western-Pacific Region.
[FR Doc. 2012-16432 Filed 7-3-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 20, 2006 (Volume 71, Number 13)]
[Notices]
[Page 3289-3290]
[DOCID:fr20ja06-52]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0039, FRL-8023-4]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Reporting and Recordkeeping Requirements of the HCFC
Allowance System, EPA ICR Number 2014.03, OMB Control Number 2060-0498,
Correction

ACTION: Notice; correction.

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

SUMMARY: Through this action, EPA is correcting the Notice published in
the Federal Register on December 20, 2005 (70 FR 75458). Specifically,
EPA is clarifying that the OMB Control Number for this Information
Collection Activity is 2060-0498 and not 2060-0948. All other
components of the December 20, 2005 Notice remain the same.

FOR FURTHER INFORMATION CONTACT: Cindy Axinn Newberg, Stratospheric
Protection Division, Office of Atmospheric Programs, Office of Air and
Radiation, Mail Code 6205J, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-
343-9729 and e-mail address<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: Although the Notice was published in the
Federal Register on December 20, 2005 (70 FR 75458) with the correct
EPA ICR Number (2014.03), the OMB Control Number in the title and in
the Notice itself was incorrect. Therefore, EPA is clarifying that the
OMB Control Number is 2060-0498 and not 2060-0948.

Need for Correction

    As published, the Notice contains errors which may prove to be
misleading and need to be corrected.
    Agency Information Collection Activities: Proposed Collection;
Comment Request; Reporting and Recordkeeping Requirements of the HCFC
Allowance System, EPA ICR Number 2014.03, OMB Control Number 2060-0498,
Correction.

    Dated: January 12, 2006.
Drusilla Hufford,
Division Director, Stratospheric Protection Division.
[FR Doc. E6-635 Filed 1-19-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: December 29, 2009 (Volume 74, Number 248)]
[Notices]
[Page 68814-68815]
[DOCID:fr29de09-73]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP06-398-002]

MoBay Storage Hub, LLC; Notice of Application

December 22, 2009.
    Take notice that on December 10, 2009, MoBay Storage Hub, LLC
(MoBay), 5847 San Felipe, Suite 3050, Houston, Texas 77057, filed an
application in Docket No. CP06-398-002, pursuant to section 7(c) of the
Natural Gas Act (NGA), to amend its Certificate of Public Convenience
and Necessity issued by the Commission on December 20, 2006.
Specifically, MoBay requests authorization for the addition of nine new
injection/withdrawal wells;

two new caisson structures; and an increase in the certificated storage
capacity, all as more fully set forth in the application which is on
file with the Commission and open for public inspection. This filing
may also be viewed on the Commission's Web site at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number, excluding the
last three digits, in the docket number field to access the document.
For assistance, call<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to Jim
Goetz, MoBay Storage Hub, LLC, 5847 San Felipe, Suite 3050, Houston,
Texas 77057,<PHONE_NUMBER> (phone) or<PHONE_NUMBER> (fax).
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either complete
its environmental assessment (EA) and place it into the Commission's
public record (eLibrary) for this proceeding; or issue a Notice of
Schedule for Environmental Review. If a Notice of Schedule for
Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all Federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made in the proceeding with the Commission
and must mail a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Protests and interventions may be filed electronically via the
Internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-Filing'' link.
The Commission strongly encourages electronic filings.
    Comment Date: January 12, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-30813 Filed 12-28-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: November 13, 2008 (Volume 73, Number 220)]
[Notices]
[Page 67216-67217]
[DOCID:fr13no08-82]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 11a-3; SEC File No. 270-321; OMB Control No. 3235-0358.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission
(the ``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Section 11(a) of the Investment Company Act of 1940 (``Act'') (15
U.S.C. 80a-11(a)) provides that it is unlawful for a registered open-
end investment company (``fund'') or its underwriter to make an offer
to the fund's shareholders or the shareholders of any other fund to
exchange the fund's securities for securities of the same or another
fund on any basis other than the relative net asset values (``NAVs'')
of the respective securities to be exchanged, ``unless the terms of the
offer have first been submitted to and approved by the Commission or
are in accordance with such rules and regulations as the

Commission may have prescribed in respect of such offers.'' Section
11(a) was designed to prevent ``switching,'' the practice of inducing
shareholders of one fund to exchange their shares for the shares of
another fund for the purpose of exacting additional sales charges.
    Rule 11a-3 (17 CFR 270.11a-3) under the Act is an exemptive rule
that permits open-end investment companies (``funds''), other than
insurance company separate accounts, and funds' principal underwriters,
to make certain exchange offers to fund shareholders and shareholders
of other funds in the same group of investment companies. The rule
requires a fund, among other things, (i) to disclose in its prospectus
and advertising literature the amount of any administrative or
redemption fee imposed on an exchange transaction, (ii) if the fund
imposes an administrative fee on exchange transactions, other than a
nominal one, to maintain and preserve records with respect to the
actual costs incurred in connection with exchanges for at least six
years, and (iii) give the fund's shareholders a sixty-day notice of a
termination of an exchange offer or any material amendment to the terms
of an exchange offer (unless the only material effect of an amendment
is to reduce or eliminate an administrative fee, sales load or
redemption fee payable at the time of an exchange).
    The rule's requirements are designed to protect investors against
abuses associated with exchange offers, provide fund shareholders with
information necessary to evaluate exchange offers and certain material
changes in the terms of exchange offers, and enable the Commission
staff to monitor funds' use of administrative fees charged in
connection with exchange transactions.
    The staff estimates that there are approximately 1958 active open-
end investment companies registered with the Commission as of September
2008. The staff estimates that 25 percent (or 490) of these funds
impose a non-nominal administrative fee on exchange transactions. The
staff estimates that the recordkeeping requirement of the rule requires
approximately 1 hour annually of clerical time per fund, for a total of
490 hours for all funds.\1\
---------------------------------------------------------------------------

    \1\ This estimate is based on the following calculations: (1958
funds x 0.25% = 490 funds); (490 x 1 (clerical hour) = 490 clerical
hours).
---------------------------------------------------------------------------

    The staff estimates that 5 percent of these 1958 funds (or 98)
terminate an exchange offer or make a material change to the terms of
their exchange offer each year, requiring the fund to comply with the
notice requirement of the rule. The staff estimates that complying with
the notice requirement of the rule requires approximately 1 hour of
attorney time and 2 hours of clerical time per fund, for a total of
approximately 294 hours for all funds to comply with the notice
requirement.\2\ The recordkeeping and notice requirements together
therefore impose a total burden of 784 hours on all funds.\3\ The total
number of respondents is 588, each responding once a year.\4\ The
burdens associated with the disclosure requirement of the rule are
accounted for in the burdens associated with the Form N-1A registration
statement for funds.
---------------------------------------------------------------------------

    \2\ This estimate is based on the following calculations: (1958
(funds) x 0.05% = 98 funds); (98 x 1 (attorney hour) = 98 total
attorney hours); (98 (funds) x 2 (clerical hours) = 196 total
clerical hours); (98 (attorney hours) + 196 (clerical hours) = 294
total hours).
    \3\ This estimate is based on the following calculations: (294
(notice hours) + 490 (recordkeeping hours) = 784 total hours).
    \4\ This estimate is based on the following calculation: (490
funds responding to recordkeeping requirement + 98 funds responding
to notice requirement = 588 total respondents).
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms.An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid control number.
    Written comments are requested on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden(s)
of the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Lewis W. Walker, Acting
Director/CIO, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>
    Dated: November 5, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-26956 Filed 11-12-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32048-32049]
[FR Doc No: 2017-14520]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Opportunity for Public Comment on Disposal of 4.9 Acres
of Airport Land at Southbridge Municipal Airport in Southbridge, MA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comments.

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

SUMMARY: Notice is being given that the FAA is considering a request
from the Town of Southbridge, MA, to dispose of a 4.9 acre parcel of
airport land. The parcel, located on the southwest side of the airport,
is segregated by Barefoot Road and not contiguous with the main airport
parcel.
    The 4.9 acre parcel is located adjacent to the Town owned landfill
and is not suited for aeronautical use as a wetland and Barefoot Road
lie between the airport proper and the 4.9 acre parcel. The disposal of
this property will have

no effect on aviation land or future development opportunities for the
airport. An avigation easement will be placed on the land to protect
the airport's airspace.
    The property has a fair market value of $130,000. The Town
installed a new sewer line and pump station to serve the airport
terminal building and restaurant at a value of $844,000 and as such,
the in-kind services substantiates the fair market value of the land to
be transferred to the Town.

DATES: Comments must be received on or before August 10, 2017.

ADDRESSES: You may send comments using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, and follow the instructions on providing comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W 12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Interested persons may inspect the request and supporting documents
by contacting the FAA at the address listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Mr. Jorge E. Panteli, Compliance and
Land Use Specialist, Federal Aviation Administration New England Region
Airports Division, 1200 District Avenue, Burlington, Massachusetts
01803. Telephone:<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on June 5, 2017.
Mary T. Walsh,
Manager, ANE-600.
[FR Doc. 2017-14520 Filed 7-10-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Pages 13591-13592]
[FR Doc No: 2012-5477]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER12-1170-000]

Imperial Valley Solar Company (IVSC) 1, LLC; Supplemental Notice
That Initial Market-Based Rate Filing Includes Request for Blanket
Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Imperial Valley Solar Company (IVSC) 1, LLC's application for market-
based rate authority, with an accompanying rate tariff, noting that
such application includes a request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is March 21, 2012.
    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 Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding 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 email notification
when a document is added to a subscribed

docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 1, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-5477 Filed 3-6-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 11, 2007 (Volume 72, Number 111)]
[Notices]
[Page 32147-32148]
[DOCID:fr11jn07-84]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549

Extension:
    Form N-CSR, SEC File No. 270-512, OMB Control No. 3235-0570.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
(``OMB'') a request for extension of the previously approved collection
of information discussed below.
    The title for the collection of information is ``Form N-CSR (17 CFR
249.331 and 17 CFR 274.128) under the Securities Exchange Act of 1934
(15 U.S.C. 78a et seq.) (``Securities Exchange Act'') and under the
Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (``Investment
Company Act''), Certified Shareholder Report of Registered Management
Investment Companies.'' Form N-CSR is a combined reporting form used by
management investment companies to file certified shareholder reports
under the Investment Company Act and under the Securities Exhange Act.
Form N-CSR is to be used for reports under section 30(b)(2) of the
Investment Company Act and section 13(a) or 15(d) of the Securities
Exchange Act, filed pursuant to rule 30b2-1(a) under the Investment
Company Act (17 CFR 270.30b2-1(a)). Form N-CSR reports are to be filed
with the Commission not later than 10 days after the transmission to
stockholders of any report that is required to be transmitted to
stockholders under rule 30e-1 under the Investment Company Act (17 CFR
270.30e-1). The information provided on Form N-CSR may be used by the
Commission in its regulatory, disclosure review, inspection, and
policymaking roles. The information filed with the Commission also
permits the verification of compliance with

securities law requirements and assures the public availability and
dissemination of the information.
    The Commission estimates that there are 7,300 reports filed on Form
N-CSR annually and that the average number of portfolios referenced in
each filing is 2.5. The Commission further estimates that the hour
burden for preparing and filing a report on Form N-CSR is 7.57 hours
per portfolio. Given that filings on Form N-CSR are filed semi-
annually, filings on Form N-CSR require 15.14 hours per portfolio each
year. The total annual hour burden for Form N-CSR, therefore, is
estimated to be 138,153 hours.
    The information collection requirements imposed by Form N-CSR are
mandatory. Responses to the collection of information will not be kept
confidential. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a
currently valid control number.
    General comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312, or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: June 4, 2007.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-11159 Filed 6-8-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Notices]
[Pages 8728-8729]
[FR Doc No: 2011-3308]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13951-000]

Bear Creek Hydro Associates, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

    On December 22, 2010, the Bear Creek Hydro Associates, LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the

feasibility of the Bear Creek Hydroelectric Project located on Bear
Creek, near Concrete, Washington. The sole purpose of a preliminary
permit, if issued, is to grant the permit holder priority to file a
license application during the permit term. A preliminary permit does
not authorize the permit holder to perform any land-disturbing
activities or otherwise enter upon lands or waters owned by others
without the owners' express permission.
    The proposed project would consist of upper and lower developments.
The applicant proposes to rehabilitate and refurbish facilities from an
existing project that has been decommissioned for about 30 years.
    The upper development includes the following existing facilities:
(1) A 100-foot-long diversion structure with a 30-foot-long, 6-foot-
high ungated overflow spillway section at an elevation of 987 feet msl;
(2) a 400-foot-long, 36-inch-diameter steel penstock; (3) an one-acre
reservoir with 2-acre-feet of storage; (4) a 40-foot by 16-foot
concrete powerhouse; (5) a 350-foot-long, 12.5 kilovolt (kV), 3-phased
transmission line; and (6) 1,850 feet of access roads. The existing
turbine would be used, but one new, 250-kilowatt (kW) generator would
be installed. The estimated annual power generation for the upper
development is 1.2 gigawatt-hours (GWh).
    The lower development includes the following existing facilities:
(1) A 235-foot-long diversion structure with an 82-foot-long, 24-foot-
high ungated overflow spillway section at an elevation of 912 feet msl;
(2) an 1.7-acre reservoir; and (3) a 28-foot by 82-foot concrete
powerhouse with three existing 200 kW Pelton turbines, totaling 600 kW.
The lower development would include the following new facilities: (1)
2,800 foot-long, 36-inch-diameter above-ground steel penstock; and (2)
a 3.5-mile-long, 12.5-kV transmission line. The estimated annual power
generation for the lower development is 11.7 GWh.
    Both developments would have a total installed capacity of 850 kW
and generate about 12.9 GWh of energy annually.
    Applicant Contact: Thomas M. McMaster, Bear Creek Hydro Associates,
LLC, 358 Shallow Shore Road, Bellingham, Washington 98229; phone: (360)
647-2196.
    FERC Contact: Patrick Murphy; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13951-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: February 8, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-3308 Filed 2-14-11; 8:45 am]
BILLING CODE 6717-01-P


""" Python script to construct Carrying Capacity Diagrams for the Scaled-RRF
    method for the 2015 Annual PM2.5 SIP update.

    This works for old 2008 Annual Averge worksheets only.

    Usage:  python "this file".py
"""

import sys
import win32com.client
import os
import glob
import shutil
import csv

#
def scale(ws2, OC_scale, EC_scale, OTR_scale, NOx_scale, NH4_scale, SOx_scale):
    index = [ 4, 5, 6, 7 ]
    for k in index:
        ws2.Range("I" + str(k)).Value = (1. - ws2.Range("B" + str(k)).Value) * NH4_scale
        ws2.Range("J" + str(k)).Value = (1. - ws2.Range("C" + str(k)).Value) * NOx_scale
        ws2.Range("K" + str(k)).Value = (1. - ws2.Range("D" + str(k)).Value) * SOx_scale
        ws2.Range("L" + str(k)).Value = (1. - ws2.Range("E" + str(k)).Value) * EC_scale
        ws2.Range("M" + str(k)).Value = (1. - ws2.Range("F" + str(k)).Value) * OC_scale
        ws2.Range("N" + str(k)).Value = (1. - ws2.Range("G" + str(k)).Value) * OTR_scale
# Substact from unity and copy back.
        ws2.Range("B" + str(k)).Value = 1. - ws2.Range("I" + str(k)).Value
        ws2.Range("C" + str(k)).Value = 1. - ws2.Range("J" + str(k)).Value
        ws2.Range("D" + str(k)).Value = 1. - ws2.Range("K" + str(k)).Value
        ws2.Range("E" + str(k)).Value = 1. - ws2.Range("L" + str(k)).Value
        ws2.Range("F" + str(k)).Value = 1. - ws2.Range("M" + str(k)).Value
        ws2.Range("G" + str(k)).Value = 1. - ws2.Range("N" + str(k)).Value
#
def pbw(ws):
    Row_List = [14, 15, 16, 17, 24, 25, 26, 27]
    mystring_1 = "temp 1.0 1.0 1 0 rh 0. ammonium 0. sulphate nitrate 0. 0. 0. 0. 3 3 3 3 3 \
30 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 3 9 3 10 3 \
11 3 12 3 13 3 14 3 15 3 16 3 17 3 18 3 19 3 20 3 \
21 3 22 3 23 3 24 3 25 3 26 3 27 3 28 3 29 3 30 3 "
# temp,rh are fixed.
    temp,rh = 294.15, 0.35
    mystring_2 = mystring_1.replace("temp", str(temp))
    mystring_3 = mystring_2.replace("rh", str(rh))
#
    Values = []
    pbw = []
#
    for i in Row_List:
        cellnum = "%s" % (i)
        nitrate = ws.Range("C" + cellnum).Value/62.0
        sulphate = ws.Range("D" + cellnum).Value/96.0
        ammonium = (nitrate + 2.0*sulphate)
        mystring_4 = mystring_3.replace("nitrate", str(nitrate))
        mystring_5 = mystring_4.replace("sulphate", str(sulphate))
        mystring_6 = mystring_5.replace("ammonium", str(ammonium))
        Values.append([mystring_6])
#
    shutil.copy('eaim.dat.tmp', 'eaim.dat')
    f = open("eaim.dat", 'a')
    f.write("\n".join((item[0] for item in Values)))
    f.write("\n")
    f.close()
#
    os.system("eaim.exe")
#
# Search the output for (PBW in grams) and save it to PBW.
    fout = open("eaim.rs1", 'r')
    for line in fout:
        if line.find("H2O(aq)") > -1:
            pbw.append(float(line.split()[2]))
    fout.close()
#
    k = 0
    for j in Row_List:
        cellnum = "%s" % (j)
        ws.Range("H" + cellnum).Value = pbw[k]
        k = k + 1

def main():

# Open each book, loop over the diagram(copy the appropriate sheet to a
# scratch sheet, scale RRFs, calculate PBW, copy the DV to another book,
# delete the sheet), and close the book.  Make sure the book does not need any
# intervension when you open the book or copy sheets.

# Initialize Excel application.

        xl = win32com.client.gencache.EnsureDispatch("Excel.Application")

# Visible make the workbook visible.  This allows updates and saves later.

        xl.Visible = 1

# win32.com looks for the file in "My Documents".  The following few lines
# tells win32.com where the file is.

        cwd = os.getcwd()
        print "%s" % cwd

# 2012 & 2020 emissions - With external adjustments - Baseline.
# From Steve Zelinka on Feb 13, 2015 (V1.01) + rules/incentives from Patricia
# on January 15, 2015.

        PM25_base = 65.956
        PM25_future = 60.181

# PM is now split in to EC, OC, and OTR (=PM-EC-OC).

        EC_base = 9.711
        EC_future = 6.498

        OC_base = 12.108
        OC_future = 11.013

        OTR_base = 44.137
        OTR_future = 43.306

        NOx_base = 332.191  # With Madera update
        NOx_future = 206.432

        SOx_base = 8.085
        SOx_future = 7.849

# 2014-2005 Baseline from the old Plan.

        PM25_2008_base = 86.0
        PM25_2008 = 22.7

        EC_2008_base = 11.4
        EC_2008 = 3.9

        OC_2008_base = 26.1
        OC_2008 = 7.5

        OTR_2008_base = 48.5
        OTR_2008 = 11.2

        NOx_2008_base = 575.4
        NOx_2008 = 284.2

        SOx_2008_base = 26.4
        SOx_2008 = 1.8

# SOx is not changed in the Carrying Capacity Diagram.  So, we can
# calculate that scaling factor here.

        SOx_scale = ((SOx_base - SOx_future)/SOx_base)*(SOx_2008_base/SOx_2008)
        print "SOx_scale %s" % SOx_scale

# Sheets in the Carrying Capacity Diagram.
        Scale_Sheets = ['BAC-CTRL_2013', \
                      'BEP-CTRL_2013', \
                      'FSF-CTRL_2013', 'MAD-CTRL_2013', 'MAD-CTRL_2014', \
                      'FSH-CTRL_2013', 'TRA-CTRL_2013', \
                      'CLO-CTRL_2013', \
                      'M14-CTRL_2013', 'MAN-CTRL_2013', 'TUR-CTRL_2013', \
                      'MRM-CTRL_2013', \
                      'MRC-CTRL_2013', \
                      'SOH-CTRL_2013', \
                      'VCS-CTRL_2013', 'HAN-CTRL_2013'  ]

# Design Values(DVs)are written into a csv file.
        dv_file = "CC_Diagrams_percent_2020.csv"
        dvWriter = csv.writer(open(dv_file, 'wb'), delimiter=',')
#
        files = glob.glob('4K-SENS_2013\*.xlsm')
        print "%s" % files
        for f in files:
            print "In the files loop"
            inname = f
            print "%s" % inname
# Open the workbooks and select the worksheets.
            wb = xl.Workbooks.Open(cwd + "/" + inname)
            number_sheets = wb.Sheets.Count
            print "Number of sheets %s" % number_sheets
            for ns in range(number_sheets):
                print "Sheet number %s" % ns
                wsname = wb.Sheets(ns+1).Name
                if wsname in Scale_Sheets:
                    print "In the worksheet %s" % wsname
                    dvWriter.writerow(wsname)
                    ws = wb.Sheets(ns+1)
                    for pm in range(30, 101, 5):
#                    for pm in range(100, 101, 5):
# DV array is used to write DVs into the csv file.
                        DV = []
# We are scaling from the 2013 future value.
#                       OC_scale = EC_scale = OTR_scale = \
#                       ((PM25_base - PM25_future * pm/100.)/PM25_base)*(PM25_2008_base/PM25_2008)
                        OC_scale = \
                        ((OC_base - OC_future * pm/100.)/OC_base)*(OC_2008_base/OC_2008)
                        EC_scale = \
                        ((EC_base - EC_future * pm/100.)/EC_base)*(EC_2008_base/EC_2008)
                        OTR_scale = \
                        ((OTR_base - OTR_future * pm/100.)/OTR_base)*(OTR_2008_base/OTR_2008)
                        print "OC_scale %s" % OC_scale
                        print "EC_scale %s" % EC_scale
                        print "OTR_scale %s" % OTR_scale
                        for nox in range(30, 101, 5):
#                        for nox in range(100, 101, 5):
                            NOx_scale = NH4_scale = \
                                ((NOx_base - NOx_future * nox/100.)/NOx_base)*(NOx_2008_base/NOx_2008)
                            print "NOx_scale %s" % NOx_scale
                            wb.Sheets(ns+1).Copy(After=wb.Sheets(number_sheets))
                            ws2 = wb.Sheets(number_sheets+1)
                            ws2.Name = wsname + "_CC"
# Scale the RRFs.  We could just pass two scaling factors, but we pass all
# just in case they were made different in the future.
                            scale(ws2, OC_scale, EC_scale, OTR_scale, NOx_scale, NH4_scale, \
                                  SOx_scale)
# Calculate particle bound water (PBW).
                            pbw(ws2)
# Write the future DV onto a different sheet.
                            DV_value = ws2.Range("O28").Value
                            DV.append(DV_value)
                            xl.DisplayAlerts=False
                            ws2.Delete()
                            xl.DisplayAlerts=True
                        dvWriter.writerow(DV)

            wb.Close(SaveChanges=1)
#
if __name__ == "__main__":
    sys.exit(main())


Date: 	August 31, 2020
To: 	Docket
From: 	Korbin Smith, US EPA
Subject:	Identification of Major Sources for the NESHAP for Carbon Black Manufacturing (40 CFR Part 63, Subpart YY)

       Introduction
Section 112 of the Clean Air Act (CAA) outlines the statutory requirements for the EPA's stationary source air toxics program. Section 112 requires EPA to set maximum achievable control technology (MACT) standards for HAP-emitting processes in source categories listed for regulation of hazardous air pollutants (HAP). The MACT standard for the final promulgated rule for this category was developed under Section 112 of the CAA as Part 63, subpart YY; and was completed in July 2002 (67 FR 46258).
The Risk and Technology Review (RTR) is a combined effort to evaluate both risk and technology as required by the CAA after the application of the MACT standards. Section 112(f)(2) directs EPA to conduct risk assessments on each source category subject to MACT standards, and to determine if additional standards are needed to reduce residual risks. Section 112(d)(6) of the CAA requires EPA to review and revise MACT standards, as necessary, taking into account developments in practices, processes and control technologies. The Agency will conduct both these reviews during the RTR review.
The purpose of this memorandum is to describe the sources of data obtained for identifying major source carbon black production facilities with processes subject to 40 CFR 63 Subpart YY.
       Sources of Data
The main sources of data were the Office of Enforcement and Compliance (OECA), Enforcement and Compliance History Online (ECHO) website, and trade organization membership rosters.  Supplemental information was gathered from Title V permits, technical support documents, air emissions inventories, Toxics Release Inventory (TRI) reports, and contacts with relevant EPA Regions and state agencies.
 Office of Enforcement and Compliance
The EPA's Office of Enforcement and Compliance issued several consent decrees for carbon black production facilities from 2013-2017. As part of this effort a list of all major source facilities were identified and shared with OAQPS at the start of this rule making. The identified facilities are listed in table 1 below.

                  Table 1: Major Source Facilities from OECA
                                 Company Name
                                     City
                                     State
CABOT CORP -  PAMPA PLANT
PAMPA
TX
CABOT CORP - CANAL PLANT
FRANKLIN
LA
CABOT CORP - VILLE PLATTE PLANT
VILLE PLATTE
LA
COLUMBIAN CHEMICALS CO - NORTH BEND PLANT
CENTERVILLE/FRANKLIN
LA
COLUMBIAN CHEMICALS COMPANY - ULYSSES
ULYSSES
KS
CONTINENTAL CARBON COMPANY- PHENIX CITY
Phenix City
AL
CONTINENTAL CARBON SUNRAY PLANT
SUNRAY
TX
CONTINENTAL CARBON - PONCA CITY
PONCA CITY
OK
Orion Engineered Carbons LLC - Ivanhoe Carbon Black Plant
FRANKLIN
LA
ORION ENGINEERED CARBONS LLC- BELPRE PLANT
BELPRE
OH
ORION ENGINEERED CARBONS LLC- BORGER PLANT
BORGER
TX
ORION ENGINEERED CARBONS LLC-ORANGE PLANT
ORANGE
TX
SID RICHARDSON CARBON BIG SPRING FACILITY
BIG SPRING
TX
SID RICHARDSON CARBON BORGER PLANT
BORGER
TX
SID RICHARDSON CARBON CO - ADDIS PLANT
ADDIS
LA

 Trade Organization
The International Carbon Black Association (ICBA) represents all identified major sources subject the Carbon Black Manufacturing RTR. Members of ICBA include, Birla Carbon, Cabot Corporation, Cancarb Limited, Continental Carbon, Imerys, Orion Engineered Carbons, and Tokai Carbon CB. The ICBA confirmed the list of major sources provided by OECA, with the one change to ownership. Sid Richardson Carbon has sense been purchased by Tokai Carbon CB. The updated list with correct ownership can be found in table 2 below.
After review, all facilities listed in Table 1 were determined to be subject to subpart YY. All facilities listed in Table 2 became synthetic area source permits before the initial compliance date of July 11, 2005 and are not subject to subpart YY. The facilities in table 3 are not subject to the subpart.
                    Table 2: ICBA major source member list
                                 Company Name
                                     City
                                     State
CABOT CORP -  PAMPA PLANT
PAMPA
TX
CABOT CORP - CANAL PLANT
FRANKLIN
LA
CABOT CORP - VILLE PLATTE PLANT
VILLE PLATTE
LA
COLUMBIAN CHEMICALS CO - NORTH BEND PLANT
CENTERVILLE/FRANKLIN
LA
COLUMBIAN CHEMICALS COMPANY - ULYSSES
ULYSSES
KS
CONTINENTAL CARBON COMPANY- PHENIX CITY
Phenix City
AL
CONTINENTAL CARBON SUNRAY PLANT
SUNRAY
TX
CONTINENTAL CARBON - PONCA CITY
PONCA CITY
OK
Orion Engineered Carbons LLC - Ivanhoe Carbon Black Plant
FRANKLIN
LA
ORION ENGINEERED CARBONS LLC- BELPRE PLANT
BELPRE
OH
ORION ENGINEERED CARBONS LLC- BORGER PLANT
BORGER
TX
ORION ENGINEERED CARBONS LLC-ORANGE PLANT
ORANGE
TX
TOKAI CARBON CB BIG SPRING FACILITY
BIG SPRING
TX
TOKAI CARBON CB BORGER PLANT
BORGER
TX
TOKAI CARBON CB - ADDIS PLANT
ADDIS
LA

 Enforcement and Compliance History Online (ECHO)
                All Active Major Sources with NAICS Code: 325182
The ECHO website was searched for any active, major sources with the NAICS code 325182. The search returned 22 major source facilities, seven of which were previously unidentified and are shown in Table 3. There were no new facilities found subject to the rulemaking

                  Table 3: ECHO Results  -  MACT Subpart XXXX
Name
City
State
CABOT CORP FMO DIV
TUSCOLA
IL
DEGUSSA ENGINEERED CARBONS LP
BAYTOWN
TX
E I DUPONT DE NEMOURS CO - DELISLE PLANT
PASS CHRISTIAN
MS
HORSEHEAD CORP
ROCKWOOD
TN
NILOK CHEMICALS ARANSAS PASS CARBON BLACK PLANT
ROCKPORT
TX
SUN CHEMICAL BUSHY PARK FACILITY
GOOSE CREEK
SC
ZINC CORPORATION OF AMERICA
PALMERTON
PA

 CABOT CORP FMO DIV: manufactures fumed silica
 DEGUSSA ENGINEERED CARBONS LP: stopped manufacturing and is currently a distribution center
 E I DUPONT DE NEMOURS CO - DELISLE PLANT: manufactures titanium dioxide
 HORSEHEAD CORP: is a zinc recycling facility
 NILOK CHEMICALS ARANSAS PASS CARBON BLACK PLANT: closed in 2018
 SUN CHEMICAL BUSHY PARK FACILITY: manufactures pigments using aluminum
 ZINC CORPORATION OF AMERICA: manufactures zinc


MEMORANDUM

To:		Pulp and Paper Docket (EPA-HQ-OAR-2007-0544)

From:		John Bradfield, US EPA

Date:		December 6, 2011

Subject:	Review of Environmental Justice Impacts: Pulp and Paper

1.0	INTRODUCTION

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission by
identifying and addressing, as appropriate, disproportionately high and
adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low income
populations in the United States.

EPA defines “Environmental Justice” to include meaningful
involvement of all people regardless of race, color, national origin, or
income with respect to the development, implementation, and enforcement
of environmental laws, regulations, and polices.  To promote meaningful
involvement for the risk and technology review (RTR) of the NESHAP for
pulp and paper making (subpart S), EPA held public webinars ( HYPERLINK
"http://www.epa.gov/air/ej/announce.html"
www.epa.gov/air/ej/announce.html ) and hosted discussions during its
2011 Environmental Justice Conference. Stakeholder meetings were also
held with Sierra Club, Earth Justice, and with organizations that
participated in EPA Environmental Justice outreach efforts.  Further
stakeholder and public input is expected through public comment and
follow-up meetings with interested stakeholders.

DEMOGRAPHICS

EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority, low income, indigenous populations because it
increases the level of environmental protection for all affected
populations without having any disproportionately high and adverse human
health or environmental effects on any population, including any
minority, low income, or indigenous populations.

 These proposed standards may improve public health and welfare, now and
in the future, by reducing HAP emissions that may contribute to adverse
environmental and human health impacts. The reductions in HAP emissions
associated with the rule are expected to benefit all populations living
near the sources affected by this rule.

Additionally, the Agency has reviewed this rule to determine if there is
an overrepresentation of minority, low income, or indigenous populations
near the sources such that they may currently face disproportionate
risks from pollutants that could be mitigated by this rulemaking. This
analysis only gives some indication of the prevalence of sub-populations
that may be exposed to HAP pollution from the sources affected by this
rulemaking; it does not identify the demographic characteristics of the
most highly affected individuals or communities, nor does it quantify
the level of risk faced by those individuals or communities.

The demographic data in Table 2.1 shows that while most demographic
categories are below or within 10 percent of their corresponding
national averages, the African American population percentage within 3
miles of any source affected by this rulemaking exceeds the national
average by 3 percentage points (15 percent versus 12 percent), or +25
percent, and those age 65+ exceed the national average by 2 percentage
points (14 percent versus 12 percent) or +17 percent.

Table 2.1 Summary of Demographic Data Analysis

Demographic Summary	Near Source Total	% of Near Source Total	National
Total	% of National Total

Population	2,437,688

285,339,128

	White	1,929,157	79%	214,539,706	75%

African American	365,077	15%	35,043,873	12%

Native American	20,449	1%	2,489,515	1%

Other or Multiracial	123,005	5%	33,265,937	12%

Minority1	508,531	21%	70,799,422	25%

Hispanic or Latino2	78,804	3%	39,083,760	14%

Age 0-17	604,248	25%	77,245,364	27%

Age 65+	343,439	14%	35,491,274	12%

No High School Diploma	314,843	13%	36,660,464	13%

Below Poverty Line	353,183	14%	37,181,029	13%

Sources: The demographics are from the U.S. Census Bureau, 2000.
Information on the facilities is from U.S. EPA.

1The “Minorities” population is the overall population (in the first
row) minus white population (in the second row).

2The Census Bureau defines “Hispanic or Latino” as an ethnicity
rather than a racial category, Hispanics or Latinos may belong to any
race.

The analysis of demographic data used proximity-to-a-source as a
surrogate for exposure to identify those populations considered to be
living near affected sources, such that they have notable exposures to
emissions from these sources. The demographic data for this analysis
were extracted from the 2000 census data, which were provided to the EPA
by the United States Census Bureau. Distributions by race are based on
demographic information at the census block level, and all other
demographic groups are based on the extrapolation of census block group
level data to the census block level. The socio-demographic parameters
used in the analysis included the following categories: Racial (White,
African American, Native American, Other or Multiracial, and All Other
Races); Ethnicity (Hispanic); and Other (Number of people below the
poverty line, Number of people with ages between 0 and 18, Number of
people greater than or equal to 65, Number of people over age 25 without
a high school diploma).

In determining the aggregate demographic makeup of the communities near
affected sources, the EPA focused on those census blocks within 3 miles
of affected sources and determined the demographic composition (e.g.,
race, income, etc.) of these census blocks and compared them to the
corresponding compositions nationally. The radius of 3 miles (or
approximately 5 km) is consistent with other demographic analyses
focused on areas around potential sources, however, not necessarily
associated with the distance which health risks are seen.      To the
extent that any minority, low income, or indigenous subpopulation is
disproportionately impacted by the emissions as a result of the
proximity of their homes to these sources, that subpopulation also
stands to see increased environmental and health benefit from the
emission reductions called for by this rule.

 U.S. GAO (Government Accountability Office). Demographics of People
Living Near Waste Facilities. Washington DC: Government Printing Office;
1995.

 Mohai P, Saha R. “Reassessing Racial and Socio-economic Disparities
in Environmental Justice Research”. Demography. 2006;43(2): 383–399.

 Mennis J. “Using Geographic Information Systems to Create and Analyze
Statistical Surfaces of Populations and Risk for Environmental Justice
Analysis”. Social Science Quarterly, 2002;83(1):281-297.

 Bullard RD, Mohai P, Wright B, Saha R, et al. Toxic Waste and Race at
Twenty 1987-2007. United Church of Christ. March, 2007.

 PAGE   1


American Lung Association Environmental Defense December 2, 2003 The Honorable Michael Leavitt Administrator U. S. Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N. W., 1101A Washington, D. C. 20460 Dear Administrator Leavitt:

The American Lung Association and Environmental Defense respectfully request that the U. S. Environmental Protection Agency issue 8 hour ozone nonattainment designations that are based on protective, comprehensive boundaries. In 1997, EPA strengthened the ozone national ambient air quality standard to improve protection of children and other vulnerable populations against decreased lung function, respiratory ailments, and hospital admissions and emergency room visits for asthma attacks and other respiratory disease.

The ozone health standard was subject to a multiyear legal challenge by industry and, ultimately, was affirmed by a unanimous Supreme Court in 2001. The designation of air quality areas under the federal Clean Air Act is the first pivotal step in carrying out this more protective air quality standard for ozone. Simply put, the nation cannot effectively address the pressing public health impacts of ozone without protective air quality management boundaries.

Our organizations have conducted a detailed examination of state recommended ozone nonattainment designations. The results of our analyses are enclosed. In short, a number of the recommendations omit areas containing significant population where, in all likelihood, numerous people are exposed to ozone air pollution that violates the health based standard. Moreover, several recommendations omit surrounding areas with air pollution sources that contribute to violations of the 8 hour ozone standard.

These omissions and other deficiencies in the state recommendations contravene the Clean Air Act, EPA's long standing boundary policy, sound science, and basic common sense. We are deeply concerned that the failure to provide protective nonattainment designations for the health based 8 hour ozone standard will postpone critical air pollution reductions, delay timely attainment of the standard, and prolong the exposure of children and other vulnerable populations to unhealthy levels of ozone air pollution. Sound science and decades of ozone air quality planning and management experience demonstrate that comprehensive boundaries are a necessary predicate   indeed a bedrock foundation   to address the far reaching sources and scope of harmful ozone air pollution. With your steadfast leadership, we can put the nation on the path to realize the public health protections that the ozone standard was designed to achieve.

Sincerely,

John Kirkwood Fred Krupp President and CEO President American Lung Association Environmental Defense Enclosures


[Federal Register Volume 81, Number 232 (Friday, December 2, 2016)]
[Notices]
[Pages 87043-87044]
[FR Doc No: 2016-28971]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3969]

Physiologically Based Pharmacokinetic Analyses--Format and
Content; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Physiologically Based Pharmacokinetic Analyses--Format and Content.''
This guidance recommends to drug sponsors the format and content for
submitting physiologically based pharmacokinetic (PBPK) analyses to FDA
to enable efficient and consistent review.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 31, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-3969 for ``Physiologically Based Pharmacokinetic Analyses--
Format and Content; Draft Guidance for Industry; Availability.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ping Zhao, Office of Clinical
Pharmacology, Office of Translational Sciences, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3182, Silver Spring, MD 20993-0002, 301-
796-3774.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Physiologically Based Pharmacokinetic Analyses--Format and
Content.'' A PBPK analysis uses models and simulations that combine
physiology, population, and drug characteristics to describe the
pharmacokinetics and/or pharmacodynamics of that particular drug in
humans. Throughout a drug's life cycle, PBPK analyses can be used to
support decisions on whether, when, and how to conduct certain clinical
pharmacology studies, inform dosing recommendations, and enable
prescription drug labeling. Currently, the format and content of PBPK
analyses that are submitted to FDA vary significantly across drug
developers. Standardizing the content and format of the PBPK analyses
can facilitate FDA's efficient assessment, consistent application, and
timely decision making during regulatory review. This guidance
recommends including the following five sections in a PBPK study
report: (1) Executive Summary, (2) Materials and Methods, (3) Results,
(4) Discussion, and (5) Appendices. This guidance does not address
methodological considerations and best practices for the conduct of
PBPK modeling and simulation, or the appropriateness of PBPK analyses
for a particular drug.
    This draft guidance is being issued consistent with FDA's good
guidance

practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the format and
content of PBPK analyses. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR 314.50(d) has been approved under
OMB control number 0910-0001.

    Dated: November 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28971 Filed 12-1-16; 8:45 am]
 BILLING CODE 4164-01-P