                           Notes from Meeting with
  American Health Care Association & National Center for Assisted Living

Attended by:
AHCA Staff:	Sandra Fitzler, Teresa Cagnolatti, Elise Smith

NCAL Staff:	Shelley Sabo, Karl Polzer

EPA Staff:	Charlotte Mooney, Jessica Young, Kristin Fitzgerald, and Lisa Lauer

Date:	March 23, 2011

EPA met with representatives from the American Health Care Association and the National Center for Assisted Living.   The AHCA and NCAL discussed the types of patients, operations, staffing, funding, and management of the different types of long term care facilities.


[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)]
[Notices]
[Pages 7381-7383]
[FR Doc No: 2019-03824]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3490]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exempt Infant Formula
Production: Current Good Manufacturing Practices, Quality Control
Procedures, Conduct of Audits, and Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April
3, 2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0811.
Also include the FDA docket number found

in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Exempt Infant Formula Production: Current Good Manufacturing Practices
(CGMPs), Quality Control Procedures, Conduct of Audits, and Records

OMB Control Number 0910-0811--Extension

    Section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 350a(h)(1)) exempts an infant formula that is
represented and labeled for use by an infant with an inborn error of
metabolism, low birth weight, or who otherwise has an unusual medical
or dietary problem from the requirements of section 412(a)-(c) of the
FD&C Act. These formulas are customarily referred to as ``exempt infant
formulas.'' Under part 106 (21 CFR part 106), we established
requirements for quality factors for infant formulas and CGMPs,
including quality control procedures. This collection of information
will help prevent the manufacture of adulterated infant formula, ensure
the safety of infant formula, and ensure that the nutrients in infant
formula are present in a form that is bioavailable.
    In the Federal Register of April 15, 2016 (81 FR 22174), we
published a notice of availability for the guidance document entitled
``Guidance for Industry: Exempt Infant Formula Production: Current Good
Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of
Audits, and Records and Reports.'' The guidance describes our current
thinking on the manufacturing of exempt infant formula in relation to
the requirements in part 106 for CGMPs, quality control procedures,
conduct of audits, and records and reports that apply to nonexempt
infant formulas. Persons with access to the internet may obtain the
guidance at https://www.fda.gov/FoodGuidances.
    Our estimate of the burden of the recordkeeping recommendations
includes the one-time burden of developing production and in-process
control systems and the annual burdens of developing and maintaining
aggregate production and control records, records pertaining to the
distribution of infant formula, and records pertaining to regularly
scheduled audits. Included in the burden estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    The guidance recommended, to the extent practicable, that
respondents include records required by part 106, subparts A, B, C, D,
and F for non-exempt infant formulas. Because the records and reporting
requirements related to part 106, subparts E and G are not generally
applicable to exempt infant formula manufacturers, FDA is not
recommending in the guidance that exempt infant formula manufacturers
follow these requirements. As such, the records and reporting
requirements in part 106, subparts E and G are not part of this
information collection.
    Description of Respondents: The respondent recordkeepers are
manufacturers of exempt infant formula.
    In the Federal Register of October 1, 2018 (83 FR 49393), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of the information collection as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeper         Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
First-Year Annual Burden:
    Production and In-Process Control System--              3               1               3  40.......................................             120
     106.6(c)(5) and 106.100(e)(1), and
     (e)(3).
    Controls to Prevent Adulteration due to                 3               1               3  6,400....................................          19,200
     Automatic (Mechanical or Electronic)
     Equipment--106.35(c) and 106.100(f)(5).
                                              ----------------------------------------------------------------------------------------------------------
        Total First Year Only Hourly           ..............  ..............  ..............  .........................................          19,320
         Recordkeeping Burden.
Recurring Annual Burden:
    Controls to Prevent Adulteration Caused                 4               1               4  1.5......................................               6
     by Facilities--Testing for Radiological
     Contaminants--106.20(f)(3).
    Controls to Prevent Adulteration Caused                 4               1               4  0.08 (5 minutes).........................            0.32
     by Facilities--Recordkeeping of Testing
     for Radiological Contaminants--
     106.20(f)(4) and 106.100(f)(1).
    Controls to Prevent Adulteration Caused                 3              52             156  0.08 (5 minutes).........................           12.48
     by Facilities--Testing for
     Bacteriological Contaminants--
     106.20(f)(3).
    Controls to Prevent Adulteration Caused                 3              52             156  0.08 (5 minutes).........................           12.48
     by Facilities--Recordkeeping of Testing
     for Bacteriological Contaminants--
     106.20(f)(4) and 106.100(f)(1).
    Controls to Prevent Adulteration by                     3              52             156  0.21 (13 minutes)........................           32.76
     Equipment or Utensils--106.30(d)(1) and
     106.100(f)(2).
    Controls to Prevent Adulteration by                     3              52             156  0.21 (13 minutes)........................           32.76
     Equipment or Utensils--106.30(e)(3)(iii)
     and 106.100(f)(3).
    Controls to Prevent Adulteration by                     3              52             156  0.19 (11 minutes)........................           29.64
     Equipment or Utensils--106.30(f)(2) and
     106.100(f)(4).

    Controls to Prevent Adulteration Due to                 3              52             156  520......................................          81,120
     Automatic (Mechanical or Electronic)
     Equipment--106.35(c) and 106.100(f)(5).
    Controls to Prevent Adulteration Due to                 3               2               6  640......................................           3,840
     Automatic (Mechanical or Electronic)
     Equipment--106.35(c) and 106.100(f)(5).
    Controls to Prevent Adulteration Caused                 3              52             156  0.17 (10 minutes)........................           26.52
     by Ingredients, Containers, and
     Closures--106.40(g) and 106.100(f)(6).
    Controls to Prevent Adulteration During                 3              52             156  0.23 (14 minutes)........................           35.88
     Manufacturing--106.50 and 106.100(e).
    Controls to Prevent Adulteration From                   3              52             156  0.25 (15 minutes)........................              39
     Microorganisms--106.55(d),
     106.100(e)(5)(ii), and 106.100(f)(7).
    Controls to Prevent Adulteration During                 1              12              12  0.25 (15 minutes)........................               3
     Packaging and Labeling of Infant
     Formula--106.60(c).
    General Quality Control Testing--                       2               1               2  2........................................               4
     106.91(b)(1)-(3).
    General Quality Control--106.91(b)(1),                  2              52             104  0.15 (9 minutes).........................            15.6
     106.91(d), and 106.100(e)(5)(i).
    General Quality Control--106.91(b)(2),                  2              52             104  0.15 (9 minutes).........................            15.6
     106.91(d), and 106.100(e)(5)(i).
    General Quality Control--106.91(b)(3),                  2              52             104  0.15 (9 minutes).........................            15.6
     106.91(d), and 106.100(e)(5)(i).
    Audit Plans and Procedures--106.94;                     3               1               3  8........................................              24
     Ongoing Review and Updating of Audits.
    Audit Plans and Procedures--106.94;                     3              52             156  4........................................             624
     Regular Audits.
                                              ----------------------------------------------------------------------------------------------------------
        Total Recurring Recordkeeping Burden.  ..............  ..............  ..............  .........................................       85,889.64
                                              ----------------------------------------------------------------------------------------------------------
        Total Recordkeeping Burden...........  ..............  ..............  ..............  .........................................      105,209.64
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection, we made a
correction since the last OMB approval. While the one-time estimated
recordkeeping burden remains as 19,320 hours, we increased the annual
estimated recurring recordkeeping burden to 85,889.64 hours due to a
calculation error (a 79,561.58 hour increase) for a total recordkeeping
burden of 105,209.64 hours.

    Dated: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03824 Filed 3-1-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Rules and Regulations]
[Pages 33791-33792]
[FR Doc No: 2017-15273]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0284; Airspace Docket No. 17-ACE-5]

Amendment of Class E Airspace; Orange City, IA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies Class E airspace extending up to 700 feet
above the surface at Orange City Municipal Airport, Orange City, IA.
Airspace reconfiguration is necessary due to the decommissioning of the
Orange City non directional radio beacon (NDB), and cancellation of the
NDB approach. This action enhances the safety and management of
standard instrument approach procedures for instrument flight rules
(IFR) operations at the airport.

DATES: Effective 0901 UTC, September 14, 2017. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html. FAA Order 7400.11, Airspace
Designations and Reporting Points, is published yearly and effective on
September 15.

FOR FURTHER INFORMATION CONTACT: Walter Tweedy (prepared by Ron

Laster), Federal Aviation Administration, Operations Support Group,
Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies Class E airspace extending up to and including 700 feet
above the surface area at Orange City Municipal Airport.

History

    The FAA published in the Federal Register (82 FR 19194, April 26,
2017) Docket No. FAA-2017-0284 a notice of proposed rulemaking (NPRM)
to modify Class E airspace extending upward from 700 feet above the
surface at Orange City Municipal Airport, Orange City, IA. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.11A, dated August 3, 2016, and effective
September 15, 2016, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designations listed in this document will be
published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace extending upward from 700 feet above
the surface within the 6.4-mile radius of Orange City Municipal
Airport, Orange City, IA, and within 2 miles each side of the 165[deg]
bearing from the airport extending from the 6.4-mile radius to 10.1
miles south of the airport. The segment each side of the 172[deg]
bearing from the Orange City NDB extending from the 6.4-mile radius to
7.4 miles south of the airport is removed due to the decommissioning of
the NDB, and cancellation of the NDB approach. The airport coordinates
are amended to be in concert with the FAA's aeronautical database. This
action enhances the safety and management of the standard instrument
approach procedures for IFR operations at the airport.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
 2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.11A, Airspace Designations and Reporting Points, dated August 3,
2016, and effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE IA E5 Orange City, IA [Amended]

Orange City Municipal Airport, IA
    (Lat. 42[deg]59'20'' N., long. 96[deg]03'45'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Orange City Municipal Airport and within
2 miles each side of the 165[deg] bearing from the airport extending
from the 6.4-mile radius to 10.1 miles south of the airport.

    Issued in Fort Worth, Texas, on July 12, 2017.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2017-15273 Filed 7-20-17; 8:45 am]
BILLING CODE 4910-13-P


8755 Federal Register / Vol. 68, No. 37 / Tuesday, February 25, 2003 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OEI   2002   0012, OEI   2002   0013, OEI   2002   0014; FRL   7454   2]

Agency Information Collection Activities; Submission of EPA ICR No. 1039.10 OMB Control No. 2030   0005, EPA ICR No. 1037.07, OMB Control No. 2030   0007, and EPA ICR No. 0246.08, OMB Control No. 2030   0016 to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following three continuing Information Collection Requests ( ICRs) have been forwarded to the Office of Management and Budget ( OMB) for review and approval: ( 1) Monthly Progress Reports, OMB Control No. 2030   0005, EPA ICR No. 1039.10, ( 2) Oral and Written Purchase Orders, OMB Control No. 2030   0007, EPA ICR No. 1037.07; and ( 3) Contractor Cumulative Claim and Reconciliation, OMB Control No. 2030   0016, EPA ICR No. 0246.08. The ICRs, which are abstracted below, describe the nature of the information collection and its estimated burden and cost. DATES: Additional comments may be submitted on or before March 27, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Brian K. Long, Policy, Training and Oversight Division, Office of Acquisition Management, Mail Code: 3802   R, 202   564   4737, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202   564   4737; fax number: 202   565   2552; e mail address: long. brian@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following individual continuing ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On 07/ 26/ 02 ( 67 FR 48891), EPA sought comments on the ICRs pursuant to 5 CFR 1320.8( d). EPA received no comments. EPA has established a public docket for these ICRs under Docket ID Nos. OEI   2002   0012 ( Monthly Progress Reports), OEI   2002   0013 ( Oral and Written Purchase Orders, and OEI   2002   0014 ( Contractor Cumulative Claim and Reconciliation, which are available for public viewing at the Office of Environmental Information ( OEI) Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the OEI Docket is ( 202) 566   1752. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e mail to oei. docket.@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: Monthly Progress Reports ( OMB Control No. 2030   0005, EPA ICR No. 1039.10). This is a request to renew an existing approved collection that is scheduled to expire on 02/ 28/ 03. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Agency contractors who have cost reimbursable, time and material, labor hour, or indefinite delivery/ indefinite quantity fixed rate contracts will report the technical and financial progress of the contract on a monthly basis. EPA will use this information to monitor the contractor's progress under the contract. Responses to the information collection are mandatory for contractors performing under a cost reimbursement contract, and are required to receive monthly reimbursement. Information submitted is protected from public release in accordance with the Agency's confidentiality regulations, 40 CFR 2.201. 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 OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average about 36 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Contractors holding cost reimbursable contracts with EPA. Estimated Number of Respondents: 324. Frequency of Response: Monthly. Estimated Total Annual Hour Burden: 140,940 hours. Estimated Total Annual Cost: $ 10,403,160, of which $ 39,000 is Operational and Maintenance.

VerDate Jan< 31> 2003 14: 36 Feb 24, 2003 Jkt 200001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25FEN1. SGM 25FEN1 8756 Federal Register / Vol. 68, No. 37 / Tuesday, February 25, 2003 / Notices Changes in the Estimates: There is a decrease of 36,105 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This is due to a reduction in the total number of active contracts and corresponding responses than previously reported. Title: Oral and Written Purchase Orders, ( OMB Control No. 2030   0007, EPA ICR No. 1037.07). This is a request to renew an existing approved collection that is scheduled to expire on 02/ 28/ 03. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: When EPA has a requirement for supplies or services and the value of same is under the simplified acquisition threshold, the Agency solicits verbal or written quotes from potential vendors. Vendor responses are voluntary and generally consist of item name, unit cost, delivery terms, company name, small business status, address, phone number, and point of contact. The Agency uses the collected information to make award decisions and obtain needed supplies and services. 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 OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 15 minutes per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Contractors who seek to provide supplies and services to the EPA under simplified acquisition procedures. Estimated Number of Respondents: 28,462. Frequency of Response: 1 per year. Estimated Total Annual Hour Burden: 7,116 hours. Estimated Total Annual Cost: $ 136,618. Changes in the Estimates: There is a decrease of 2,257 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is solely due to the drop in the number of purchase orders awarded over $ 25,000. In addition, the number of purchase orders awarded with a value less than $ 2,500 have decreased slightly due to the use of the Government wide commercial purchase cards. Title: Contractor Cumulative Claim and Reconciliation, ( OMB Control No. 2030   0016, EPA ICR No. 0246.08). This is a request to renew an existing approved collection that is scheduled to expire on 02/ 28/ 03. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: At the completion of a cost reimbursement contract, contractors will report final costs, incurred, including direct labor, materials, supplies, equipment, and other direct charges, subcontracting, consultant fees, indirect costs, and fixed fee. Contractors will report this information on EPA Form 1900   10. This form will be used to reconcile the contractor's costs. Establishment of the final costs and fixed fee is necessary to close out the contract, and is required to receive final payment. Information submitted is protected from public release in accordance with the Agency's confidentiality regulation, 40 CFR 2.201 et seq. 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 OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 40 minutes per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Contractors holding cost reimbursable contracts with the Agency. Estimated Number of Respondents: 247. Frequency of Response: Completion of contract. Estimated Total Annual Hour Burden: 163 hours. Estimated Total Annual Cost: $ 6,819 of which $ 2,470 is Operational and Maintenance. Changes in the Estimates: There is an increase of 98 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. The increase is solely due to the estimated number of information collected based on a large quantity of contracts closed out during FY 2002. EPA expects to continue to close out contracts at a high volume.

Dated: February 4, 2003. Doreen Sterling, Acting Director, Collection Strategies Division. [ FR Doc. 03   4375 Filed 2   24   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ FRL   7454   6]

Gulf of Mexico Program Management Committee Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of meeting.

SUMMARY: Under the Federal Advisory Committee Act ( Pub. L. 92   463), EPA gives notice of a meeting of the Gulf of Mexico Program ( GMP) Management Committee ( MC). DATES: The meeting will be held on Wednesday, March 12, 2003, from 10 a. m. to 5: 30 p. m., and on Thursday, March 13, 2003, from 8: 30 a. m. to 1 p. m. ADDRESSES: The meeting will be held at the Double Tree Hotel, 300 Canal Street, New Orleans, Louisiana. ( 1   888   874   9074)

FOR FURTHER INFORMATION CONTACT: Gloria D. Car, Designated Federal VerDate Jan< 31> 2003 14: 36 Feb 24, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 25FEN1. SGM 25FEN1


[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Pages 38194-38196]
[FR Doc No: 2015-16306]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-1945-005; ER10-2042-017; ER10-2039-005; ER10-
1938-012; ER10-1934-011; ER10-1893-011; ER10-1871-005; ER13-1406-003;
ER10-1862-011.
    Applicants: Auburndale Peaker Energy Center, LLC, Calpine Energy
Services, L.P., Calpine Newark, LLC, Calpine Power America--CA, LLC,
CES Marketing IX, LLC, CES Marketing X, LLC, Morgan Energy Center, LLC,
Osprey Energy Center, LLC, Power Contract Financing, L.L.C.
    Description: Supplement to December 31, 2014 Updated Market Power
Analysis of the Calpine Southeast MBR Sellers.
    Filed Date: 6/25/15.
    Accession Number: 20150625-5130.
    Comments Due: 5 p.m. ET 7/16/15.

    Docket Numbers: ER10-2407-003; ER10-2425-004; ER10-2424-003; ER13-
1816-002.
    Applicants: Lost Lakes Wind Farm LLC, Pioneer Prairie Wind Farm I,
LLC, Rail Splitter Wind Farm, LLC, Sustaining Power Solutions LLC
    Description: Updated Market Power Analysis for Central Region of
Lost Lakes Wind Farm LLC, et al.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5087.
    Comments Due: 5 p.m. ET 8/25/15.

    Docket Numbers: ER11-47-006; ER12-1540-004; ER12-1541-004; ER12-
1542-004; ER12-1544-004; ER10-2981-006; ER14-2475-003; ER14-2476-003;
ER14-2477-003; ER14-594-006; ER11-46-009; ER10-2975-009; ER11-41-006;
ER12-2343-004; ER13-1896-009.
    Applicants: Appalachian Power Company, Indiana Michigan Power
Company, Kentucky Power Company, Kingsport Power Company, Wheeling
Power Company, AEP Texas Central Company, AEP Texas North Company,
Public Service Company of Oklahoma, Southwestern Electric Power
Company, Ohio Power Company, AEP Energy Partners, Inc., CSW Energy
Services, Inc., AEP Retail Energy Partners LLC, AEP Energy, Inc., AEP
Generation Resources Inc.
    Description: Updated Market Power Analysis in the Southwest Power
Pool balancing area authority of the AEP MBR affiliates.
    Filed Date: 6/26/15.

    Accession Number: 20150626-5039.
    Comments Due: 5 p.m. ET 8/25/15.

    Docket Numbers: ER14-2871-004; ER10-3243-006; ER10-3244-006; ER10-
3245-005; ER10-3249-005; ER10-3250-005; ER10-3251-004; ER14-2382-004;
ER15-621-003; ER11-2639-005; ER15-622-003; ER15-463-003; ER15-110-003;
ER13-1586-005; ER10-1992-011.
    Applicants: Cameron Ridge, LLC, Chandler Wind Partners, LLC, Coso
Geothermal Power Holdings, LLC, Foote Creek II, LLC, Foote Creek III,
LLC, Foote Creek IV, LLC, Oak Creek Wind Power, LLC, ON Wind Energy
LLC, Pacific Crest Power, LLC, Ridge Crest Wind Partners, LLC, Ridgetop
Energy, LLC, San Gorgonio West Winds II, LLC, Terra-Gen Energy
Services, LLC, TGP Energy Management, LLC, Victory Garden Phase IV,
LLC.
    Description: Notice of Non-Material Change in Status of Cameron
Ridge, LLC, et al.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5085.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1984-000.
    Applicants: Pacific Wind Lessee, LLC.
    Description: Section 205(d) Rate Filing: Revised Shared
Transmission Facilities Agreement and Request for Waiver to be
effective 6/26/2015.
    Filed Date: 6/25/15.
    Accession Number: 20150625-5088.
    Comments Due: 5 p.m. ET 7/16/15.

    Docket Numbers: ER15-1985-000.
    Applicants: AV Solar Ranch 1, LLC.
    Description: Section 205(d) Rate Filing: Exelon Tariff Changes to
be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5015.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1986-000.
    Applicants: Baltimore Gas and Electric Company.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5016.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1987-000.
    Applicants: Beebe Renewable Energy, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5017.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1988-000.
    Applicants: Calvert Cliffs Nuclear Power Plant, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5018.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1989-000.
    Applicants: CER Generation, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5019.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1990-000.
    Applicants: Commonwealth Edison Company.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5020.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1991-000.
    Applicants: Constellation Mystic Power, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5021.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1992-000.
    Applicants: Constellation Power Source Generation, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5022.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1993-000.
    Applicants: Cow Branch Wind Power, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5023.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1994-000.
    Applicants: CR Clearing, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5024.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1995-000.
    Applicants: Criterion Power Partners, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5025.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1996-000.
    Applicants: Exelon Framingham, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5026.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1997-000.
    Applicants: Exelon Wyman, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5027.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1998-000.
    Applicants: Harvest II Windfarm, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5028.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-1999-000.
    Applicants: Harvest Windfarm, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5029.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2000-000.
    Applicants: Michigan Wind 1, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5030.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2001-000.
    Applicants: Michigan Wind 2, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5031.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2002-000.
    Applicants: Nine Mile Point Nuclear Station, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5032.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2003-000.
    Applicants: PECO Energy Company.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5033.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2004-000.
    Applicants: Shooting Star Wind Project, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.

    Filed Date: 6/26/15.
    Accession Number: 20150626-5034.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2005-000.
    Applicants: Wildcat Wind, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5035.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2006-000.
    Applicants: Wind Capital Holdings, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5036.
    Comments Due: 5 p.m. ET 7/17/15.

    Docket Numbers: ER15-2007-000.
    Applicants: R.E. Ginna Nuclear Power Plant, LLC.
    Description: Section 205(d) Rate Filing: Exelon MBR Tariff Changes
to be effective 6/29/2015.
    Filed Date: 6/26/15.
    Accession Number: 20150626-5076.
    Comments Due: 5 p.m. ET 7/17/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 26, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-16306 Filed 7-1-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Notices]
[Page 26710]
[FR Doc No: 2019-12041]

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

SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 6h-1; SEC File No. 270-497; OMB Control No. 3235-0555

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (``PRA'') (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 approval of extension of
the previously approved collection of information provided for in Rule
6h-1 (17 CFR 240.6h-1) under the Securities Exchange Act of 1934, as
amended (``Act'') (15 U.S.C. 78a et seq.).
    Section 6(h) of the Act (15 U.S.C. 78f(h)) requires national
securities exchanges and national securities associations that trade
security futures products to establish listing standards that, among
other things, require that: (i) Trading in such products not be readily
susceptible to price manipulation; and (ii) the market on which the
security futures product trades has in place procedures to coordinate
trading halts with the listing market for the security or securities
underlying the security futures product. Rule 6h-1 implements these
statutory requirements and requires that (1) the final settlement price
for each cash-settled security futures product fairly reflect the
opening price of the underlying security or securities, and (2) the
exchanges and associations trading security futures products halt
trading in any security futures product for as long as trading in the
underlying security, or trading in 50% or more of the underlying
securities, is halted on the listing market.
    It is estimated that approximately 1 respondent, consisting of a
designated contract market not already registered as a national
securities exchange under Section 6(g) of the Exchange Act that seeks
to list or trade security futures products, will incur an average
burden of 10 hours per year to comply with this rule, for a total
burden of 10 hours. At an average internal cost per hour of
approximately $401, the resultant total internal cost of compliance for
the respondents is $4,010 per year (1 respondent x 10 hours/respondent
x $401/hour).
    Compliance with Rule 6h-1 is mandatory. Any listing standards
established pursuant to Rule 6h-1 would be filed with the Commission as
proposed rule changes pursuant to Section 19(b) of the Act and would be
published in the Federal Register.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Comments should
be directed to: (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 by sending an email to:
<EMAIL_ADDRESS>and (ii) Charles Riddle, Acting Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Candace Kenner, 100 F Street NE, Washington, DC 20549, or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: June 4, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-12041 Filed 6-6-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35062-35064]
[FR Doc No: 2017-15862]

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

17 CFR Part 232

[Release Nos. 33-10385; 34-81080; 39-2517; IC-32724]

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 and related rules to reflect
updates to the EDGAR system. The updates are being made primarily to
reflect amendments made to several forms under the Securities Act of
1933 (``Securities Act'') and the Securities Exchange Act of 1934
(``Exchange Act'') to effectuate inflation adjustments and other
technical amendments required under Titles I and III of the Jumpstart
Our Business Startups (``JOBS'') Act; support recent updates to Form C
and Form D; includes instructions for hyperlinking to exhibits included
with certain Securities Act and Exchange Act forms and makes certain
corrective changes to previously revised sections. The revised EDGAR
Filer Manual also announces updates to the technical specifications for
the ABS-EE schema and terminates support for US-GAAP-2015, EXCH-2015,
CURRENCY-2014, and COUNTRY-2013 taxonomies. The EDGAR system is
scheduled to be upgraded on July 17, 2017.

DATES: Effective July 28, 2017. The incorporation by reference of the
EDGAR Filer Manual is approved by the Director of the Federal Register
as of July 28, 2017.

FOR FURTHER INFORMATION CONTACT: In the Division of Corporation
Finance, for questions concerning Forms ABS-EE, ABS-15G, C, D, S-1, S-
3, S-4, S-8, S-11, F-1, F-3, F-4, 8-K, 10, 10-D, 10-K, 10-Q, 20-F, and
40-F, contact Heather Mackintosh at<PHONE_NUMBER>; in the Division of
Trading and Markets, for questions concerning Forms 17-H and X-17A-5,
contact Kathy Bateman at<PHONE_NUMBER>; in the Office of Investment
Management, for questions concerning Forms 1-E, 2-E, N-1A, N-23C-2, N-
23C3, 40-APP, and 40-17G, contact Heather Fernandez at<PHONE_NUMBER>;
and in the Division of Economic and Risk Analysis, for questions
concerning taxonomies and eXtensible Business Reporting Language
(XBRL), contact Brian Hankin at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: We are adopting an updated EDGAR Filer
Manual, Volume I and 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 Online and the Online Forms/XML
Web site.
---------------------------------------------------------------------------

    \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 March 13, 2017. See Release No. 33-10324 (March 31,
2017) [82 FR 15993].
---------------------------------------------------------------------------

    The revisions to the Filer Manual reflect changes within Volume I
entitled EDGAR Filer Manual, Volume I: ``General Information,'' Version
28 (July 2017) and Volume II entitled EDGAR Filer Manual, Volume II:
``EDGAR Filing,'' Version 42 (July 2017). The updated manual will be
incorporated by reference into the Code of Federal Regulations.
    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.\2\ Filers may consult the Filer Manual in conjunction with our
rules governing mandated electronic filing when preparing documents for
electronic submission.\3\
---------------------------------------------------------------------------

    \2\ See Rule 301 of Regulation S-T (17 CFR 232.301).
    \3\ See Release No. 33-10324 in which we implemented revisions
to reflect EDGAR Release 17.1. For additional history of EDGAR Filer
Manual revisions, please see the citations therein.
---------------------------------------------------------------------------

    The EDGAR system will be upgraded to Release 17.2 on July 17, 2017
and will introduce the following changes:
    Effective September 1, 2017, large accelerated and accelerated
filers filing Forms S-1, S-3, S-4, S-8, S-11, F-1, F-3, F-4, F-10, SF-
1, and SF-3 under the Securities Act and Forms 10, 10-K, 10-Q, 8-K, 20-
F, and 10-D under the Exchange Act will be required to submit these
forms in HTML and include a hyperlink to each exhibit listed in the
exhibit index of these filings, including exhibits that are
incorporated by reference.\4\ Instructions for hyperlinking to an
exhibit submitted with a previous submission, or an exhibit that is
being filed concurrently with the submission, have been included in
Chapter 5 of Volume II of the EDGAR Filer Manual. Instructions for
using HTML Styles to indicate the location of the Exhibit Links and the
Summary Section have also been included in Chapter 5 of Volume II of
the EDGAR Filer Manual.
---------------------------------------------------------------------------

    \4\ Non-accelerated filers and smaller reporting companies that
submit filings in ASCII will not need to comply with these
requirements until September 1, 2018. The compliance date for any
Form 10-D filing that will require a hyperlink to an exhibit filed
with Form ABS-EE will be delayed until SEC staff completes
programming changes to EDGAR. These changes will allow Form 10-D
filers to include the Form 10-D and Form ABS-EE in a single
submission so that the required exhibit hyperlinks can be created at
the time the Form 10-D is filed. The Commission will publish a
notice in the Federal Register and on the Commission Web site
announcing the compliance date for those Form 10-D filings.
---------------------------------------------------------------------------

    Submission form types D and D/A will be updated to remove the
reference to ``Rule 505'' in Item 6: Federal Exemption(s) and
Exclusion(s) Claimed. The ``Terms of Submission'' in the Signature and
Submission screen will be updated to replace the references to
``relying on Regulation D'' and ``Rule 505(b)(2)(iii)'' with ``relying
on Rule 504 or Rule 506'' and ``Rule 504(b)(3),'' respectively. The
Total Offering Amount in ``Item 13: Offering and Sales Amounts'' will
increase from a maximum of $1,000,000 to $5,000,000 if any ``Rule 504''
item is selected on submission form types D and D/A. Corresponding
changes will be made to Chapter 8 and Appendix A of the EDGAR Filer
Manual.
    In Release No. 33-10332 (March 31, 2017) [82 FR 17545], the
Commission adopted rule changes to effectuate inflation adjustments and
other technical amendments required under Titles I and III of the JOBS
Act. The technical changes included revisions to Commission forms so
that registrants can designate whether they are an Emerging Growth
Company (EGC) and inform the Commission as to whether they have elected
not to use the extended transition period for EGCs to comply with any
new or revised financial accounting standards. The following EDGARLink
Online submission form types will be revised to reflect the two fields:
S-1, S-1/A, S-3, S-3/A, S-4, S-4/A, S-8, S-11, S-11/A, F-1, F-1/A, F-3,
F-3/A, F-4, F-4/A, 10-12B, 10-12B/A, 10-12G, 10-12G/A, 8-K, 8-K/A, 8-
K12B, 8-K12B/A, 8-K12G3, 8-K12G3/A, 8-K15D5, 8-K15D5/A, 10-Q, 10-Q/A,
10-QT, 10-QT/A, 10-K, 10-K/A, 10-KT, 10-KT/A, 20-F, 20-F/A, 20FR12B,
20FR12B/A, 20FR12G, 20FR12G/A, 40-F, 40-F/A, 40FR12B, 40FR12B/A,
40FR12G, and 40FR12G/A. Corresponding changes will be made to Chapter 7
of the EDGAR Filer Manual. In addition, submission form types C and C/A
will be updated to increase the maximum limit of the ``Target Offering
Amount'' and ``Maximum Offering Amount'' fields to $1,070,000.
Corresponding changes will be made to Chapter 8 of the EDGAR Filer
Manual.
    EDGAR will be updated so that broker-dealers filing submission form
type 17HACON must indicate whether or not the submission is for is for
a full year. Submission form type 17HACON will require broker-dealers
to attach an ``ORGCHART'' document to confidential annual 17-H reports
on submission form type 17HACON even if the field ``No material changes
have occurred since last filed'' is selected. Corresponding changes
will be made to Chapter 8 of Volume II of the EDGAR File Manual.
    An Instructions menu icon will be added to the filer interface in
the top-right corner for submission form types X-17A-5 and X-17A-5/A,
which provides instructions on how to file broker-dealer annual reports
through EDGAR. Corresponding changes will be made to Chapter 8 of
Volume II of the EDGAR Filer Manual.
    Filers will no longer have to submit form type N-1A using ``dummy''
Series and Classes (Contracts) and will instead be able to register via
submission form type N-1A using their existing Series and Classes
(Contracts). Corresponding Changes will be made to Chapter 7 of Volume
II of the EDGAR Filer Manual.
    Clarifying changes to Chapter 8 of Volume II of the EDGAR Filer
Manual will be added to specify that, when Transfer Agent form
submissions created using the filer interface, filers are limited to a
maximum of 100 document attachments. Also, the revision clarifies that
the maximum size of a Transfer Agent submission, including all attached
documents, may not exceed 200 MB.
    Chapter 5, Section <IP_ADDRESS> will be revised to remove duplicate HTML
tags. Chapter 6, section 6.12.7 will be revised to clarify that start/
end labels should not be used on duration-type facts. Chapters 5 and 6
will be revised to include clarifying changes instructions for data
tagging and labeling.
    The ABS-EE schema will be updated with the following changes:

    [cir] RMBS, 1(m)(21)(xi)
postModificationARMPaymentRecastFrequency will be changed from
decimal format to integer format, with a maximum length of eight
digits.
    [cir] The maximum integer length will increase from two digits
to eight digits for the following Asset Class Items:
    [ssquf] Item 1(c)(29)(iv),
initialFixedRatePeriodHybridARMNumber;
    [ssquf] Item 1(c)(29)(xxi), HELOCDrawNumber;
    [ssquf] Item 1(m)(21)(iv), postModificationInterestResetNumber;
    [ssquf] Item 1(m)(21)(xx),
postModificationARMInterestRateTeaserNumber;
    [ssquf] Item 1(m)(21)(xxi),
postModificationARMPaymentTeaserNumber;
    [ssquf] Item 1(m)(22)(i),
postModificationInterestOnlyTermNumber;
    [ssquf] Item 3(c)(9), originalInterestOnlyTermNumber;
    [ssquf] Item 3(c)(12), gracePeriodNumber;
    [ssquf] Item 3(j)(2), paymentExtendedNumber;
    [ssquf] Item 4(c)(8), gracePeriod; and
    [ssquf] Item 4(j)(2), leaseExtended.

    For more information, see the updated EDGAR ABS XML Technical
Specification document available on the SEC's Public Web site (https://www.sec.gov/info/edgar/tech-specs).

    EDGAR will no longer provide support for the US-GAAP-2015, EXCH-
2015, CURRENCY-2014, and COUNTRY-2013 taxonomies. Please see https://www.sec.gov/info/edgar/edgartaxonomies.shtml for a complete list of
supported standard taxonomies.
    Along with the 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 these 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.
    The updated EDGAR Filer Manual will be available for Web site
viewing and printing; the address for the Filer Manual is https://www.sec.gov/info/edgar/edmanuals.htm. You may also 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.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m.
    Since the Filer Manual and the corresponding rule changes relate
solely to agency procedures or practice, publication for notice and
comment is not required under the Administrative Procedure Act
(``APA'').\5\ It follows that the requirements of the Regulatory
Flexibility Act \6\ do not apply.
---------------------------------------------------------------------------

    \5\ 5 U.S.C. 553(b)(A).
    \6\ 5 U.S.C. 601-612.
---------------------------------------------------------------------------

    The effective date for the updated Filer Manual and the rule
amendments is July 28, 2017. In accordance with the APA,\7\ 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 17.2 is scheduled to become available on July 17, 2017. 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 these system upgrades.
---------------------------------------------------------------------------

    \7\ 5 U.S.C. 553(d)(3).
---------------------------------------------------------------------------

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,\8\ Sections 3, 12,
13, 14, 15, 23, and 35A of the Securities Exchange Act of 1934,\9\
Section 319 of the Trust Indenture Act of 1939,\10\ and Sections 8, 30,
31, and 38 of the Investment Company Act of 1940.\11\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a).
    \9\ 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll.
    \10\ 15 U.S.C. 77sss.
    \11\ 15 U.S.C. 80a-8, 80a-29, 80a-30, and 80a-37.
---------------------------------------------------------------------------

List of Subjects in 17 CFR Part 232

    Incorporation by reference, Reporting and recordkeeping
requirements, Securities.

Text of the Amendment

    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. 77c, 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,
unless otherwise noted.
* * * * *

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 28 (July 2017). The requirements for filing on
EDGAR are set forth in the updated EDGAR Filer Manual, Volume II:
``EDGAR Filing,'' Version 42 (July 2017). 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. The EDGAR Filer Manual is available for Web site viewing and
printing; the address for the Filer Manual is https://www.sec.gov/info/edgar/edmanuals.htm. 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., Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. 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: July 6, 2017.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2017-15862 Filed 7-27-17; 8:45 am]
BILLING CODE 8011-01-P


1 EPA Registration Division contact: Bipin Gandhi ( 703 308 8380)

ExxonMobil Chemical Company [ 4E6935]

EPA has received a pesticide petition [ 4E6935] from ExxonMobil Chemical Company ( ExxonMobil), division of Exxon Mobil Corporation, 13501 Katy Freeway, Houston, TX 77079 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 to establish an exemption from the requirement of a tolerance for C9 Rich Aromatic Hydrocarbon Fluid, ( Aromatic 100 Fluid), in or on the raw agricultural commodities. 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 1. Plant metabolism. Due to the inherent physicochemical properties ( volatility) of C9 Rich Aromatic Hydrocarbon Fluid, there is little likelihood of C9 Rich Aromatic Hydrocarbon Fluid remaining intact in any crop matrix.

B. Toxicological Profile 2 1. Acute toxicity. C9 Rich Aromatic Hydrocarbon Fluid has a low order of acute toxicity based on studies conducted in rats via oral and inhalation exposure, and in rabbits via dermal exposure. The oral LD50 of 1,2,4 trimethylbenzene, a structurally similar analog, was 3.4 and 6.0 g/ kg in rats ( US EPA 1976). A four hour acute inhalation study of C9 Rich Aromatic Hydrocarbon Fluid ( Aromatic 100 Fluid) showed no mortality at the maximum attainable vapor concentration ( 6193 mg/ m3 or 1192 ppm) ( EMBSI 1996). Some animals exhibited decreased motor activity during exposure, but all animals appeared normal following removal from the chamber and no clinical signs were observed during the 14 day postexposure observation period. There were no abnormalities observed following gross post mortem examination. Based on this study, inhalation exposure to C9 Rich Aromatic Hydrocarbon Fluid up to the maximum attainable vapor concentrations does not result in mortality or gross systemic toxicity. The acute dermal study of C9 Rich Aromatic Hydrocarbon Fluid in rabbits exceeds 3.1 g/ kg. All animals survived to study termination and clinical signs of skin irritation were minimal, indicating that the dermal LD50 exceeds 3.1 g/ kg ( EMBSI 1984). These data demonstrate that C9 Rich Aromatic Hydrocarbon Fluid has low acute toxicity by all routes of exposure. C9 Rich Aromatic Hydrocarbon Fluid is a moderate skin irritant in rabbits. Also, an eye irritation study in rabbits showed that C9 Rich Aromatic Hydrocarbon Fluid is a mild to moderate eye irritant.

2. Genotoxicity. Aromatic fluids containing primarily C9 Aromatic Hydrocarbon Material ( C9AHM) have been tested in several mutagencity assays, all showing no evidence of mutagenic activity. C9AHM showed no evidence of causing mutagenic effects when tested for mutagenic activity in the following in vitro tests: bacterial reverse mutation assay; CHO gene mutation assay; CHO sister chromatid exchange assay; and CHO/ HGPRT forward mutation suspension assay ( Schreiner et al 1989). In addition, C9AHM was tested in an in vivo bone marrow chromosomal 3 aberration test ( Schreiner et al. 1989). There was no indication of mutagenic activity in any of the assays, providing evidence that C9 Rich Aromatic Hydrocarbon Fluid is not mutagenic.

3. Reproductive and developmental toxicity. C9 Rich Aromatic Hydrocarbon Fluid showed no evidence of causing developmental toxicity and is unlikely to be a selective developmental toxicant. Based on the data from C9AHM, C9 Rich Aromatic Hydrocarbon Fluid is unlikely to be a reproductive toxicant. C9AHM has been tested for both reproductive and developmental toxicity. In a mouse inhalation developmental toxicity test, there was evidence of developmental delays at maternally toxic levels, but there was no evidence of selective developmental toxicity ( McKee et al. 1990). Pregnant mice were exposed to 100, 500, or 1500 ppm for 6 hr/ day from days 6 15 of gestation. Exposure to 1500 ppm produced severe maternal toxicity and fetal effects including mortality, reduced body weight, delayed ossification and an increased incidence of cleft palate. Exposure to 500 ppm resulted in a significant reduction in fetal weight gain, but no other evidence of developmental effects, nor any adverse effects in the maternal animals. The lowest dose level ( 100 ppm) did not cause any developmental toxicity. C9AHM was evaluated in a three generation reproduction study by inhalation in rats at 0, 100, 500, or 1500 ppm ( McKee et al. 1990). 1 The only adverse reproductive effect among parental animals was reduced fertility in high dose F1 males. However, comparable effects were not seen in FO or F2 males, or among females of any generation. The 500 ppm dose level was identified as the NOAEL with respect to reproductive effects across all three generations; further analysis of the data, however, support the conclusion that even the 1500 ppm dose level displayed a lack of adverse reproductive effects. Exposure at the mid and high dose 1 Actual exposures were 0, 103, 495 and 1480 ppm. 4 levels resulted in reduced parental weight gain in both the F0 and F1 generations, resulting in a NOAEL for parental systemic toxicity of 100 ppm. For F2 rats, this effect was seen at 100 ppm as well. Thus, there was no consistent evidence of reproductive toxicity even at exposure levels that resulted in significantly reduced parental weight gain. Based on these data, the NOAEL for reproductive effects is either 500 or 1500 ppm. The NOAEL for parental system toxicity is 100 ppm in the F0 and F1 generations, and the LOAEL is 100 ppm in the F2 generation. The NOAEL for offspring toxicity is 500 ppm in the F1 and F2 generations, and 100 ppm in the F3 generation.

4. Subchronic toxicity. The available data show that C9 Rich Aromatic Hydrocarbon Fluid has low order of subchronic toxicity by the inhalation and oral routes of exposure. In one study, rats were exposed via inhalation to a 50/ 50 mixture of C9 Rich Aromatic Hydrocarbon Fluid at 450, 900, and 1800 mg/ m3 for 6 hours/ day, 5 days/ week for twelve months ( Clark et al. 1989). Transient changes in hematologic and plasma clinical chemical parameters and increased liver and kidney weights were observed at the highest dose only. No corresponding histopathological differences or evidence of exposure related kidney dysfunction were observed, leading the study researchers to conclude that the observed effects were physiological adaptive responses and not biologically significant. The study NOAEL was greater than 1800 mg/ m3. In a 90 day oral gavage subchronic toxicity study on a structurally related analog, 1,3,5 trimethylbenzene, ( IIT Research Institute 1995), Sprague Dawley rats were dosed at levels of 0, 50, 200 and 600 mg/ kg/ day. A satellite groups received 600 mg/ kg/ day and was held for a 28 day recovery period. There were no treatment related deaths during the study. There was a statistically significant decrease in body weight gain in the high dose males at the end of Week 5; although weight gain in the high dose males was still decreased compared to controls at the end of the treatment period, cumulative body weight gain was not significantly 5 different in treatment versus control animals. In addition, cumulative body weight gain in the recovery animals at the end of the 28 day recovery period was similar to control animals. The only significant changes observed were increased phosphorous levels and alterations in liver and kidney weights in high dose animals. At the end of the 28 day recovery period, these effects were no longer observed, indicating that these effects are reversible. These effects were considered an adaptive response and therefore not an adverse effect from exposure to the test material. Based on the results of this study, the NOAEL was 600 mg/ kg/ day. The neurotoxicity of C9 Rich Aromatic Hydrocarbon Fluid was assessed as part of a neurobehavioral testing program on aliphatic, cycloaliphatic and aromatic hydrocarbon solvents. This study suggests that C9 Rich Aromatic Hydrocarbon Fluid can cause slight, transient central nervous system depression   with related, minor neurobehavioral effects which are known to occur under conditions of very high exposures to hydrocarbon solvents  but that C9 Rich Aromatic Hydrocarbon Fluid is not expected to cause any nervous system damage. This test program was jointly sponsored by the Dutch government and the CEFIC Hydrocarbon Solvent Producers Association ( Nessel et al. 2000; TNO Nutrition and Food Research Institute 2001). The purpose of this testing program was to develop data on the neurobehavioral effects of hydrocarbon solvent constituents on the central nervous system. Most representative for purposes of evaluating the toxicity of C9 Rich Aromatic Hydrocarbon Fluid was the test on C10 C11 Aromatics. Male rats were exposed by inhalation, 8 hours per day for 3 consecutive days to 0, 35, 110 or 365 ppm ( 0, 0.2, 0.6 and 2.0 g/ m3). Animals were tested for effects on motor activity, functional observation measures ( FOB), and learned performance of a visual discrimination task. No remarkable clinical signs were observed during the testing period. Some low to moderate gait abnormalities were observed during the 3 day exposure period in rats exposed at the maximum concentration level. In the learned performance test, the high dose rats had increased latencies to make a 6 correct choice and latencies to obtain water reinforcement, as well as increases in the variability of the speed of responding. A small, but statistically significant, decrease in the number of collected reinforcements also was observed in the high dose group. Effects of exposure were most clearly observed after the first eight hour exposure period. The LOAEL for this test was 365 ppm ( 2.0 g/ m3), and the NOAEL was 110 ppm ( 0.6 g/ m3).

5. Chronic toxicity. C9 Rich Aromatic Hydrocarbon Fluid has not been tested specifically for carcinogenicity because data on its structure and metabolism, subchronic health effects, and genotoxicity indicate that C9 Rich Aromatic Hydrocarbon Fluid is not likely to have carcinogenic properties. C9 Rich Aromatic Hydrocarbon Fluid does not belong to a class of chemicals known to react with DNA, nor is it metabolized to materials that are likely to react with DNA. The data available for C9 Rich Aromatic Hydrocarbon Fluid indicate that this compound is not genotoxic and also does not produce significant cumulative toxicity. Therefore, C9 Rich Aromatic Hydrocarbon Fluid is unlikely to be carcinogenic either by genetic or epigenetic mechanisms and is unlikely to be either an inducer or promoter of carcinogenicity. In addition, when C9AHM was evaluated as part of a TSCA Section 4 Test Rule, EPA concluded based on the negative mutagenicity studies and other available data that no further mutagenicity or carcinogenicity testing of these compounds was required.

6. Animal metabolism. Due to the complex, multi constituent nature of these types of aromatic hydrocarbon solvents, absorption, metabolism, distribution and excretion studies are not conducted specifically on C9 Rich Aromatic Hydrocarbon Fluid. However, sufficient data on other aromatic solvents   such as alkylbenzenes and alkylnaphthalenes   exist to describe the absorption, distribution, 7 metabolism and excretion of C9 Rich Aromatic Hydrocarbon Fluid ( Hissink, et al. 1999; Snyder 1987; Patty's Toxicology 2001; European Union, 1999). Typically, aromatic hydrocarbons are well absorbed, widely distributed between tissues, extensively metabolized and rapidly excreted. Heavy aromatic hydrocarbon solvents are generally wellabsorbed by most routes of exposure. They are rapidly absorbed into the blood from oral, dermal or inhalation routes of exposure, although the efficiency of dermal absorption varies depending on the molecular weight and structure of the compounds. Following absorption, heavy aromatic hydrocarbon solvents distribute throughout the body and are extensively metabolized and eliminated. Typically, these solvents will be found at higher levels in the organs of metabolism and excretion, although they can distribute to other tissues as well, particularly those with high lipid content. The most common metabolic pathway for heavy aromatic hydrocarbon solvents is oxidation followed by conjugation. Cytochrome P450 catalyzes the oxidation of the solvents to alcohol or acidic forms. For compounds with side chains   including many constituents of C9 Rich Aromatic Hydrocarbon Fluid   side chain oxidation is the first step in metabolism. Glucuronidation and sulfation are both common Phase II reactions in the metabolism of heavy aromatic hydrocarbon solvents, and these reactions typically occur in the liver. Other conjugation reactions also may occur. This conjugation typically serves to detoxify the heavy aromatic hydrocarbon solvent metabolites, and the conjugates often can be found excreted in the urine. Heavy aromatic hydrocarbon solvents are rapidly excreted. Both rodents and humans show similar clearance kinetics of hydrocarbons from blood. Typically, they are excreted as various metabolites in the urine, although some parent compound may still be present. Urine is the primary route of excretion for hydrophilic conjugates from both oral and inhalation exposure to heavy aromatic hydrocarbon solvents, although a much smaller fraction of metabolite excretion can also occur through the feces. Some lower molecular weight components of heavy aromatic hydrocarbon solvents   including a few of the constituents in C9 Rich Aromatic Hydrocarbon Fluid   may also be 8 excreted through the lung. In radiotracer experiments, most heavy aromatic hydrocarbon solvents are almost completely eliminated from the body within 48 hours, although small amounts may reside in organs with high lipid content for slightly longer periods of time.

7. Metabolite toxicology. There are no known metabolites of toxicological concern.

8. Endocrine disruption. There are no significant findings in other relevant toxicity tests, i. e., developmental toxicity, which would suggest that C9 Rich Aromatic Hydrocarbon Fluid produces effects characteristic of the disruption of endocrine function. In addition, the absence of any endocrine related structural alerts suggest that C9 Rich Aromatic Hydrocarbon Fluid is not likely to have endocrine disrupting properties.

C. Aggregate Exposure 1. Dietary exposure. For Tier 1 " generic inert" acute and chronic estimates, a conservative approach was taken which did not account for considerations of inert ingredient specific weight fractions and effective application rates, or for evaporative loss, an important physical property of the C9 Rich Aromatic Hydrocarbon Fluid. In addition, actual application rates are lower than the tolerance based residue data used in the Tier 1 assessment. Therefore, Tier 1 estimates on C9 Rich Aromatic Hydrocarbon Fluid represent a conservative assessment. Physicochemical properties of C9 Rich Aromatic Hydrocarbon Fluid, e. g., volatility, which directly impacts bioavailability, were considered in assessing potential dietary exposure. Evaporative loss experiments were conducted using ASTM Method D3539 ( Section 16.2) on structurally related analogs to show that there was significant potential for evaporative 9 loss from treated agricultural surfaces. These studies showed that the evaporative loss rate for C9 Rich Aromatic Hydrocarbon Fluid was rapid and far exceeded the realistic application rate. These data represent a conservative evaporative loss rate estimates since environmental conditions, e. g., air movement and variable temperature, were not taken into consideration. To further explore the potential for evaporative loss and the impact on dietary exposure to C9 Rich Aromatic Hydrocarbon Fluid, a refined Tier 2 and 3 dietary exposure analysis was developed based on selection of publicly available surrogate food residue data for volatile pesticide active ingredients. These volatile active ingredients, which have vapor pressures less than that of C9 Rich Aromatic Hydrocarbon Fluid and associated " relative diffusion" or loss to air that are generally much lower than those for C9 Rich Aromatic Hydrocarbon Fluid, have extensive food residue data reported in the USDA Pesticide Data Program ( PDP). The extensive, multiyear PDP data for these two volatile surrogates were all below the detection limit therefore, these data clearly demonstrate the low potential for food residues associated with relatively volatile chemicals used on a variety of fruits and vegetables. For the health benchmark, a review of the dataset suggested that the most sensitive acute endpoint is the reduced weight gain for both maternal animals and offspring in the developmental study, with a NOAEL of 100 ppm for offspring and 500 ppm for maternal animals. Because the majority of exposure to C9 Rich Aromatic Hydrocarbon Fluid as a pesticide inert will occur through the oral route, these inhalation NOAELs wer converted to oral NOAELs of 182 mg/ kg/ day ( offspring) and 909 mg/ kg/ day ( maternal animals). Consistent with EPA practice, a 100 fold safety factor ( or Margin of Exposure, MOE) was applied to these NOAELs to determine the level at which adverse effects would not be anticipated. For the chronic endpoint, a NOAEL of 600 mg/ kg/ day was applied based on the subchronic toxicity study on 1,3,5 trimethylbenzene, which showed reversible increased phosphorous levels and alterations in liver and kidney weights. In addition the NOAEL in the 12 month inhalation study in rats on C9 Rich Aromatic Hydrocarbon Fluid showed 10 NOAEL of 1,800 mg/ m3, equivalent to 169 mg/ kg/ day. To ensure a highly conservative risk assessment, an additional 10 fold safety factor was applied to the usual 100 fold safety factor, resulting in a chronic safety factor of 1000. No additional database uncertainty factors were warranted since C9 Rich Aromatic Hydrocarbon Fluid has been assessed for all major toxicological endpoints.

i. Food. A conservative tiered dietary exposure assessment was conducted. Exposure values were expressed in terms of margin of exposure ( MOE) which was calculated by dividing the NOAEL by the exposure for each population subgroup. The acute MOEs focused on the lowest NOAELs developmental/ maternal toxicity, and therefore, are based on upper percentile ( 99.9th) exposures for the subpopulations of females in reproductive age, i. e., 13 to 49 years, and children 1 to 2 years ( the highest exposed subgroup). Tier I screening level analysis for a generic inert, adjusted for evaporative loss, resulted in acceptable acute and chronic MOEs. When a conservative evaporative loss rate of 98% is adopted, while retaining all other conservative assumptions in the exposure assessment, the MOE far exceeded the acceptable level of 100. Chronic dietary MOEs, even with no consideration for evaporative loss, far exceeded the acceptable MOE of 1000. In sum, these data support a conclusion that any dietary exposures to C9 Rich Aromatic Hydrocarbon Fluid satisfy the statute's " reasonable certainty of no harm" standard, based on worst case exposure assumptions about how C9 Rich Aromatic Hydrocarbon Fluid is used and conservative health benchmarks.

ii. Drinking water. An exposure assessment for drinking water is not necessary due to the volatile nature of this product, lack of water solubility, and the proposed use patterns.

2. Non dietary exposure. C9 Rich Aromatic Hydrocarbon Fluid is 11 not typically suitable for indoor use in consumer products due to its inherent characteristic odor which cannot be masked by fragrances. Three outdoor residential application scenarios with the greatest potential for human exposure were modeled to determine whether these uses also satisfy the statue's " reasonable certainty of no harm" standard. Maximum weight percentages of C9 Rich Aromatic Hydrocarbon Fluid in residential use products were assumed based on federal and state Volatile Organic Compound ( VOC) limits for consumer product formulations. OPP recommended values for applicator dermal and inhalation unit exposure values, specific to method of application, were used for estimating potential exposures during application. And based on a weight of empirical evidence, an upper bound dermal absorption value was assumed for C9 Rich Aromatic Hydrocarbon Fluid. Chronic residential exposures were not considered plausible given the seasonal and intermittent application events , and the rapid evaporative loss of the relatively volatile C9 Rich Aromatic Hydrocarbon Fluid. Based on the health benchmarks and foregoing exposure analysis described for the dietary exposure, non dietary exposure showed that in all cases, the calculated MOEs were met even using the most conservative Tier 1 exposure assessment, with maximum possible concentrations of C9 Rich Aromatic Hydrocarbon Fluid allowable in the product formulation and with no evaporative loss. No further analysis was warranted. Thus, the results of this conservative risk assessments support the conclusion that typical residential exposures to C9 Rich Aromatic Hydrocarbon Fluid satisfy the statute's " reasonable certainty of no harm" standard, based on worst case exposure assumptions about how C9 Rich Aromatic Hydrocarbon Fluid is used.

D. Cumulative Effects There are currently no available data or other reliable information to indicate that any toxic effects produced by C9 Rich Aromatic Hydrocarbon Fluid would be cumulative with those of other chemical 12 compounds.

E. Safety Determination 1. U. S. population. Based on the inherent characteristic odor property, low toxicity, high volatility resulting in rapid evaporative loss, lack of water solubility, and the conservatism applied in the dietary and non dietary ( residential) risk assessments, C9 Rich Aromatic Hydrocarbon Fluid meets the statute's " reasonable certainty of no harm" standard and a tolerance exemption should be granted.

2. Infants and children. The potential aggregate exposure of C9 Rich Aromatic Hydrocarbon Fluid from dietary and non dietary exposure routes to infants and children and based on this risk assessment, concluded that aggregate exposure is not expected to exceed the acceptable MOEs, even when infants and children are considered.

F. International Tolerances There are no known international tolerances for residues of C9 Rich Aromatic Hydrocarbon Fluid in food or animal feed.


[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Notices]
[Pages 57647-57648]
[FR Doc No: 2017-26235]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation.

ACTION: Notice and request for comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted

below has been forwarded to the Office of Management and Budget (OMB)
for review and comment. The ICR describes the nature of the information
collections and their expected burden. The Federal Register Notice with
a 60-day comment period was published on September 8, 2017 (82 FR
42570). The agency received no comments.

DATES: Comments must be submitted on or before January 5, 2018.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725-17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication.

FOR FURTHER INFORMATION CONTACT: Wayne McKenzie at the National Highway
Traffic Safety Administration, Office of Crash Avoidance Standards,
1200 New Jersey Avenue SE., West Building, Room W43-462, Washington, DC
20590. Mr. McKenzie's telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: 49 CFR Part 564--Replaceable Light Source Dimensional
Information Collection.
    OMB Number: 2127-0563.
    Type of Request: Request for public comment on a previously
approved collection of information.
    Abstract: The information to be collected is in response to 49 CFR
part 564, ``Replaceable Light Source Dimensional Information.'' Persons
desiring to use newly designed replaceable headlamp light sources are
required to submit interchangeability and performance specifications to
the agency. After a short agency review to assure completeness, the
information is placed in a public docket for use by any person who
would like to manufacture headlamp light sources for highway motor
vehicles. In Federal Motor Vehicle Safety Standard No. 108, Lamps,
reflective devices and associated equipment, ``Part 564 submissions''
are referenced as being the source of information regarding the
performance and interchangeability information for legal headlamp light
sources, whether original equipment or replacement equipment. The
submitted information about headlamp light sources becomes the basis
for certification of compliance with safety standards.
    NHTSA anticipates approximately 7 bulb manufacturers will be
affected by these reporting requirements. NHTSA does not believe that
any of these manufacturers are a small business (i.e., one that employs
less than 500 persons) since each manufacturer employs more than 500
persons.
    Affected Public: Businesses or other profit organizations.
    Estimated Total Annual Burden: NHTSA estimates that the
manufacturers will incur a total annual reporting hour of 28 hours.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

    Authority: Paperwork Reduction Act of 1995, 44 U.S.C. Chapter
35; delegation of authority at 49 CFR 1.95.

Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2017-26235 Filed 12-5-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1494-1495]
[FR Doc No: 2021-00128]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-772-000]

Resi Station, 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
Resi Station, 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 January 24, 2021.
    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 may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: January 4, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-00128 Filed 1-7-21; 8:45 am]
BILLING CODE 6717-01-P