[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)]
[Notices]
[Pages 42288-42289]
[FR Doc No: 2018-17872]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2006-0037; FRL-9982-33-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Exchange Network Grants Progress Reports
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), Exchange Network Grants Progress
Reports (EPA ICR No. 2207.07, OMB Control No. 2025-0006) to the Office
of Management and Budget (OMB) for review and approval in accordance
with the Paperwork Reduction Act. This is a proposed extension of the
ICR, which is currently approved through August 31, 2018. Public
comments were previously requested via the Federal Register on March 5,
2018 during a 60-day comment period. This notice allows for an
additional 30 days for public comments. A fuller description of the ICR
is given below, including its estimated burden and cost to the public.
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.

DATES: Additional comments may be submitted on or before September 20,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OEI-2006-0037, to (1) EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail
to: EPA Docket Center, Environmental Protection Agency, Mail Code
28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB
via email to [email protected]. Address comments to OMB Desk
Officer for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Edward Mixon, Information Exchange
Services Division, Office of Information Management (2823T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Under the U.S. EPA National Environmental Information
Exchange Network (NEIEN) Grant Program, EPA collects information from
the NEIEN grantees on assistance agreements that EPA has awarded.
Specifically, for each project, EPA proposes to have grantees submit
semi-annual reports on the progress and current status of each goal and
output, completion dates for outputs, and any problems encountered.
This information will help EPA ensure projects are on schedule to meet
their goals and produce high quality environmental results. New award
recipients will complete one Quality Assurance Reporting Form for each
award. This form provides a simple means for grant recipients to
describe how quality will

be addressed throughout their projects. Additionally, the Quality
Assurance Reporting Form is derived from guidelines provided in the
NEIEN 2018 Grant Solicitation Notice.
    Form Numbers: EPA Form 5300-26 (Semi-Annual Progress Report Form)
and EPA Form 5300-27 (Quality Assurance Reporting Form).
    Respondents/affected entities: State, tribal, and territorial
environmental government offices.
    Respondent's obligation to respond: Required to obtain or retain
benefits (2 CFR part 200 and 2 CFR part 1500).
    Estimated number of respondents: 172 (total).
    Frequency of response: Twice per year for the Semi-Annual Progress
Report Form; one time per grant for the Quality Assurance Reporting
Form.
    Total estimated burden: 280 hours (per year). Burden is defined at
5 CFR 1320.03(b)
    Total estimated cost: $16,187 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 60 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This is due to a slight decrease in the number of
grants (from 200 to 172) that are expected to be awarded annually
during the period of this ICR.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-17872 Filed 8-20-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 15, 2009 (Volume 74, Number 93)]
[Notices]
[Page 22990]
[DOCID:fr15my09-111]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59891; File No. SR-Phlx-2009-24]

Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Order
Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto,
Increasing Transaction Fees for Linkage Inbound Principal Orders and
Principal Acting as Agent Orders

May 8, 2009.

I. Introduction

    On March 24, 2009, the NASDAQ OMX PHLX, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change seeking to increase transaction fees applicable to
the execution of Principal Acting as Agent Orders (``P/A Orders'') \3\
and Principal Orders (``P Orders'') \4\ sent to the Exchange via the
Intermarket Options Linkage (``Linkage'') under the Plan for the
Purpose of Creating and Operating an Intermarket Option Linkage (the
``Plan'').\5\ On March 26, 2009, Phlx submitted Amendment No. 1 to the
proposed rule change. The proposed rule change was published for
comment in the Federal Register on April 8, 2009.\6\ The Commission
received no comments on the proposal. This order approves the proposed
rule change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ A P/A Order, is an order for the principal account of a
specialist (or equivalent entity on another Participant Exchange
that is authorized to represent Public Customer orders), reflecting
the terms of a related unexecuted Public Customer order for which
the specialist is acting as agent. See Exchange Rule 1083(k)(i).
    \4\ A P Order is an order for the principal account of an
Eligible Market Maker. See Exchange Rule 1083(k)(ii).
    \5\ See Securities Exchange Act Release Nos. 43086 (July 28,
2000), 65 FR 48023 (August 4, 2000) (order approving the Plan) and
43573 (November 16, 2000), 65 FR 70851 (November 28, 2000) (order
approving Phlx as a participant in the Plan).
    \6\ See Securities Exchange Act Release No. 59669 (April 1,
2009), 74 FR 16026.
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II. Description of the Proposal

    The Exchange proposes to amend the Equity Options Fees portion of
its fee schedule relating to transaction fees applicable to the
execution of P/A Orders and P Orders sent to the Linkage under the
Plan. Specifically, the Exchange proposes to increase its transaction
fees for P/A Orders from the current $0.15 per option contract to $0.30
per option contract, and for P Orders from the current $0.25 per option
contract to $0.45 per contract. This proposal is part of an existing
pilot program, which is scheduled to expire July 31, 2009.\7\
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act Release No. 58144 (July 11,
2008), 73 FR 41394 (July 18, 2008) (SR-Phlx-2008-49).
---------------------------------------------------------------------------

    The Exchange states that the purpose of the proposed rule change is
to raise revenue for the Exchange. The Exchange also represents that,
consistent with current practice, the Exchange: (i) Will charge the
clearing member organization of the sender of P Orders and P/A Orders;
and (ii) will not charge for the execution of Satisfaction Orders sent
through Linkage.
    The Exchange also proposes a technical amendment to the schedule of
Equity Option Fees by correcting a typographical error, changing the
word ``overlaying'' to read ``overlying.''

III. Discussion and Commission Findings

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange.\8\ In particular, the Commission finds that the proposal is
consistent with Section 6(b)(4) of the Act,\9\ which requires that an
exchange have rules that provide for the equitable allocation of
reasonable dues, fees, and other charges among its members and other
persons using its facilities. The Commission notes that the Options
Linkage fees are assessed pursuant to a pilot scheduled to end on July
31, 2009 and that the Commission is continuing to evaluate whether such
fees are appropriate.
---------------------------------------------------------------------------

    \8\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition, and capital formation. 15 U.S.C. 78c(f).
    \9\ 15 U.S.C. 78f(b)(4).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (SR-Phlx-2009-24), as amended,
is hereby approved.
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-11357 Filed 5-14-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 82, Number 132 (Wednesday, July 12, 2017)]
[Notices]
[Pages 32223-32224]
[FR Doc No: 2017-14046]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Air Traffic
Slots Management

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval of a new information collection.
The FAA collects information to allocate slots and maintain accurate
records of slot transfers at slot-controlled and schedule-facilitated
airports. The information is provided by air carriers and other
operators at all impacted airports.

DATES: Written comments should be submitted by August 11, 2017.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Ronda Thompson,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-xxxx.
    Title: Air Traffic Slots Management.
    Form Numbers: No FAA forms associated with this collection.
    Type of Review: New information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published under 2120-0524 on October 13, 2016 (81 FR 70736). There
were no comments. The FAA has implemented several initiatives to
address congestion and delay issues within the National Airspace
System. The FAA has issued Orders limiting operations at John F.
Kennedy International Airport (JFK), Newark Liberty International
Airport (EWR), and LaGuardia Airport (LGA). These Orders resulted in
part from increasing congestion and delays at the airports requiring
the FAA to allocate arrival and departure slots at JFK, EWR, and LGA.
On April 6, 2016, the FAA announced a reduction in slot controls at EWR
and designation of EWR as a Level 2, schedule-facilitated airport under
the International Air Transport Association (IATA) Worldwide Slot
Guidelines (WSG) based on an updated demand and capacity analysis of
the airport. This change was effective from the Winter 2016 scheduling
season, which began on October 30, 2016. The FAA also has designated
O'Hare International Airport (ORD), San Francisco International Airport
(SFO), and Los Angeles International Airport (LAX) as Level 2 airports
under the IATA WSG. These Level 2 designations resulted in part from
increasing congestion and delays at the airports requiring FAA to
implement a voluntary process to manage operational growth at ORD and
SFO. The Level 2 designation was made at LAX due to a long-term
construction project expected to reduce runway capacity; therefore, the
designation is not expected to continue beyond the completion of the
planned construction at LAX. The information is reported to the FAA by
carriers holding a slot at JFK or LGA; by carriers operating at EWR,
LAX, ORD, or SFO; and by operators conducting unscheduled operations at
LGA. At JFK, carriers must notify the FAA of: (1) Requests for
confirmation of transferred slots; (2) requests for seasonal allocation
of historic and additional available slots; and (3) usage of slots on a
seasonal basis. At LGA, carriers must notify the FAA of: (1) Requests
for confirmation of transferred slots; (2) slots required to be
returned or slots voluntarily returned; (3) requests to be included in
a lottery for available slots; and (4) usage of slots on a bi-monthly
basis. At LGA, unscheduled operators must request and obtain a
reservation from the FAA prior to conducting an operation. At EWR, LAX,
ORD and SFO, carriers are asked to notify the FAA of their intended
operating schedules during peak hours on a semiannual basis. The FAA
estimates that all information from carriers is submitted
electronically from information stored in carrier scheduling databases,
and that nearly all requests for unscheduled operation reservations are
submitted electronically through either an internet or touch-tone
system interface.
    Respondents: 200 carriers at various airports; unknown number of
unscheduled operators at LaGuardia Airport.
    Frequency: Information is collected as needed; some reporting on
bimonthly or semiannual basis.
    Estimated Average Burden per Response: 2 minutes per unscheduled
operation reservation; 6 minutes per notice of slot transfer; 2 hour
per schedule submission or slot request; and 2 hours per slot usage
report.
    Estimated Total Annual Burden: 5,049.5 hours.

    Issued in Washington, DC, on June 28, 2017.
Ronda L Thompson,
FAA Information Collection Clearance Officer, Performance, Policy &
Records Management Branch, ASP-110.
[FR Doc. 2017-14046 Filed 7-11-17; 8:45 am]
 BILLING CODE 4910-13-P


Reader’s Guide for Flumetsulam

CRM: Melanie Biscoe

EPA/OPPTS/OPP/SRRD

Reader’s Guide to Flumetsulam Docket # EPA-HQ-OPP-2008-0625

Publication Date: September 17, 2008

	EPA has created this document to provide an organizational structure to
the Registration Review Flumetsulam Docket for Public Comments.  The
docket index groups related documents.  The first group contains the
Federal Register and Docket Organizational Documents, the second group
contains the Human Health Assessment, the third group contains the
Environmental Risk Assessment documents, and the fourth group contains
use/usage information and other information pertaining to the
flumetsulam registration review.   The Agency is providing the
“Reader’s Guide” to allow the reader to more easily access and
navigate the various items contained in the flumetsulam docket.

Federal Register and Docket Organizational Documents:

Docket Item 1.	Reader’s Guide to the Flumetsulam Docket # EPA-
HQ-OPP-2008-0625

Docket Item 2.	Flumetsulam Summary Document

Human Health Documents for Registration Review

Docket Item 3.	Flumetsulam.  Amended Human Health Assessment Scoping
Document in Support of Registration Review (August 12, 2008)

This document describes the scope of work necessary to support the
registration review.

Environmental Fate and Effects Documents for Registration Review

Docket Item 4.	Flumetsulam Registration Review: Ecological Risk
Assessment Problem Formulation	(June 3, 2008)

This document describes the ecological risk problem formulation.

Use and Usage Information for Registration Review

Docket Item 5.	Screening-Level Usage Analysis (SLUA) for Flumetsulam

			(November 19, 2007)

This document provides the available estimates of pesticide usage data
for propionic acid that is used on agricultural crops in the United
States.

Docket Item 6.	Flumetsulam Appendix A

			(November 19, 2007)

This table list the food/feed and non-food/non-feed uses eligible for
reregistration.


            Supporting Statement for a Request for OMB Review under
                          The Paperwork Reduction Act

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title and Number of the Information Collection

	Title:	Request for Contractor Access to TSCA Confidential Business Information

		EPA ICR No.:  1250.10	OMB Control No.:  2070-0075

	1(b)	Short Characterization

      The Environmental Protection Agency (EPA) procures contract support to facilitate the performance of certain duties.  EPA may require contractors to handle Toxic Substances Control Act (TSCA) Confidential Business Information (CBI).  Each contractor employee who will use TSCA CBI in the performance of his or her duties must be authorized for access to TSCA CBI through a multi-step process.  The TSCA CBI Protection Manual (EPA Publication 7700 A2, revised October 2003; see Attachment C) provides Federal and contractor employees with guidelines and operating procedures for handling TSCA CBI while performing their official duties, as well as the procedures to obtain authorization for access to TSCA CBI.

      Specifically, for purposes of this information collection, contractor personnel must submit to EPA the EPA form titled "TSCA CBI Access Request, Agreement, and Approval" (EPA Form 7740-6) (Attachment B).  The Information Management Division (IMD), Office of Pollution Prevention and Toxics (OPPT), uses EPA Form 7740-6 to collect information about contractor personnel so that the Agency can evaluate their suitability for access to TSCA CBI.  EPA stores the information on the OPPT Confidential Business Information Tracking System (CBITS).

2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	This information collection request is necessary to protect information under provisions of TSCA section 14 (Attachment A).  It is necessary for EPA to provide guidance to its employees, other Federal agencies and contractors on the proper handling of CBI submitted to EPA under TSCA.

	This information collection activity is necessary to protect confidential information submitted to the Agency as mandated by TSCA section 14 and is consistent with 5 CFR 1320.6.  The consequences of not collecting these data could be monumental to private industry.  Under TSCA, industry is required to submit data that may be deemed to be confidential, such as formulas and financial information related to chemicals companies plan to produce.  EPA is obligated to protect these data as outlined by TSCA section 14.  In addition, the Agency could possibly harm businesses if these data were released to competitors.

	The information collected by this request will be used to evaluate contractor personnel who will be authorized for access to TSCA CBI.  Therefore the collection of information is necessary to provide the protection mandated by TSCA.

	2(b)	Use/Users of the Data

	The information will be maintained within OPPT in paper copy files and in an automated security access tracking system (CBITS, AXCON module) with access limited to the OPPT TSCA Security Officer and Document Control Officers (DCOs) in OPPT, other parts of EPA, in Regional Offices and at contractor firms.

	The information will also be used to generate a monthly TSCA Authorized Access List for distribution to DCOs for verification of Federal and contractor employees authorized access to TSCA CBI.  The information provided by contractor employees will not be released to sources who do not have a valid "need to know."  Information submitted by one contractor will not be shared with another EPA contractor.  If this information is not collected by the Agency, EPA will not be able to evaluate the suitability of its contractor employees for TSCA CBI access.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Non-Duplication

	No other Federal agency or department could provide the information necessary for EPA to authorize contractor personnel for access to TSCA CBI.  The data being collected are not available from any other sources and can only be collected from individuals themselves.

	3(b)	Public Notice Required Prior to ICR Submission to OMB

	 Prior to submission to OMB, this ICR will be made available to the public for comment through a Federal Register notice.  The public will have 60 days to provide comments.  Any comments received will be given consideration when completing the supporting statement that is submitted to OMB.

	3(c)	Consultations

	Under 5 CFR 1320.8(d)(1) OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval.  In accordance with this regulation, EPA will pursue additional consultations with interested parties during the development of the renewal of this collection.
      3(d)	Effects of Less Frequent Collection

	This is a one-time information collection, if the clearance is renewed annually.  When a clearance lapses, then a repeat of the initial collection is required.

	3(e)	General Guidelines

	This information collection complies with the general guidelines found at 5 CFR 1320.5.

	3(f)	Confidentiality

	The information collected is stored at EPA Headquarters in paper files and in a secured local area network, the Confidential Business Information Tracking System (CBITS) AXCON module.  Any hard-copy information that is discarded from the system is shredded.  The EPA form used to collect these data contains a Privacy Act statement that complies with the Privacy Act and OMB Circular 108.

	3(g)	Sensitive Questions

	There are no sensitive questions contained in this information collection.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents and NAICS Codes

	Respondents affected by this activity are found mainly under NAICS codes 514 (Information Services) and 561 (Administrative and Support Services).

	4(b)	Information Requested

	(i)	Data Items

	To complete the form, the contractor employee must: describe why access to TSCA CBI is necessary for the successful performance of his or her duties under the contract; identify, by section of TSCA, the types of CBI to which access is needed; and provide personal identification information.  Justification statements are provided on the form and the employee only has to designate which statement (A, B, C, D or Other) is applicable.

	In addition, the contractor must appoint an employee to serve as a liaison (DCO) between EPA and the contractor to handle issues relating to employee access to TSCA CBI.  Contractor responsibilities for maintaining the access list are explained under Chapter 2.D.l.f of the TSCA Confidential Business Information Security Manual.  Contractor DCOs must ensure that contractor employees read the security manual and attend a security briefing.  The DCO is responsible for conducting a review, on a monthly basis, of the TSCA CBI Authorized Access List to determine whether any names should be added to or deleted from the list or whether any employee's access authority should be broadened or narrowed.  Any changes to the list require approval by the EPA Project Officer and the OPPT DCO.

	(ii)	Respondent Activities

	The process that contractor employees must go through in order to be authorized access to TSCA CBI entails the following:

	(1)	Read EPA Form 7740-6.
      (2)	Gather required information and complete the form.
	(3)	Submit the form to the contractor DCO for processing, compilation and review.
      (4)	The contractor DCO files an in-house reference copy of the form.
      (5)	The contractor DCO forwards the form to the EPA Project Officer (or Delivery Order Project Officer) for signature and to forward on to the OPPT DCO for further review and processing.
      (6)	The contractor employee views the TSCA CBI security video.

5.	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities -- Inventory

	The contractor DCO forwards the EPA Form 7740-6 submitted by a contractor employee to the EPA Project Officer.  The Project Officer then signs the form (Section V) and forwards the form to the OPPT DCO.  OPPT DCO staff review the form for completeness.  The form is processed by the DCO staff and appropriate authorizing signatures are obtained; the OPPT DCO is the final approval authority.  The information on the form is then entered into the CBITS AXCON module.

	The information is retained within OPPT in paper copy files.  The information is entered into CBITS with access limited to the OPPT Security Staff and other Agency and Regional Office DCOs.  Current plus one year of contractor information is maintained in the paper files.  Paper files are destroyed by shredding after a contractor employee has relinquished his/her access.

	5(b)	Collection Methodology and Management

	Once processed within OPPT, each EPA Form 7740-6 is reviewed by an EPA Project Officer and the OPPT DCO, and the data are entered into CBITS.  The monthly TSCA CBI Access List, which acts as a quality check on data entry accuracy, is produced, published and distributed to TSCA DCOs.  There is no public access to the TSCA CBI Authorized Access List, nor to any of the information stored in the CBITS AXCON module.

	CBITS is housed on a secured Local Area Network with OPPT internal access only.  The system is available to CBI-cleared users exclusively.

      5(c)	Small Entity Flexibility

	All contractors regardless of company size are treated in the same manner.  The collection process is simple and straightforward and can be completed quickly.

	5(d)	Collection Schedule

	The information is collected once per each individual contractor employee requesting access authorization to TSCA CBI, provided there is no lapse in clearance and the individual does not relinquish his or her TSCA CBI access authorization.

6.	Estimating the Burden and Cost of the Collection

	6(a)	Estimating Respondent Burden

	Eligible contractors were directly contacted in the development of earlier versions of this ICR to determine the amount of time that would be required by them to complete the tasks outlined in section 3 of this ICR.  Because the requirements for this ICR have not changed from the time the earlier estimates were made, the same estimates are used in this analysis.  Currently 20 companies are under contract to EPA and have a need to clear employees for access to TSCA CBI.  Those firms have a total of 303 such employees cleared for access for an average of about 15 CBI cleared employees per firm.

	The per-employee burdens are given in table 6.1 and the total annual respondent burden is shown in table 6.2.  In previous ICRs, the breakdown of employees among managerial, technical and clerical employees was approximately 33%, 58% and 9% respectively.  This same breakdown was used in this analysis resulting in an estimate of 100 managerial, 176 technical, and 27 clerical employees.  The total annual burden for all firms is estimated to be 483 hours.

Table 6.1:  EMPLOYEE BURDEN ESTIMATES

                             Collection Activities
                           Per Employee Burden Hours

                                  Management
                                   Technical
                                   Clerical
1.Contractor employee can either view the TSCA CBI security video; complete the TSCA CBI On-line Briefing via the EPA Intranet; or use the supplied CD-ROM for those the cannot access the intranet
                                                                         0.5000

                                                                         0.5000

                                                                         0.5000

2. Read EPA Form 7740-6
                                                                         0.1630
                                                                         0.1630
                                                                         0.1630
3. Gather required information and complete form.
                                                                         0.2240
                                                                         0.1975
                                                                         0.5280
4. Contractor Document Control Officer processes, compiles and reviews form.
                                                                         0.0961
                                                                         0.0367
                                                                         1.5480
5. Store, file, or maintain copy of form for in-house reference.
                                                                         0.1089
                                                                         0.0086
                                                                         3.0190
6. Complete written form, obtain signatures, forward to EPA Information Management Division
                                                                         0.2275
                                                                         0.0558
                                                                          0.971

       Table 6.2: TOTAL ANNUAL RESPONDENT (CONTRACTOR) BURDEN ESTIMATES

                             Collection Activities
                            Burden Hours (per year)
                                  Total Hours

                                  Management
                                   Technical
                                   Clerical

1.Contractor employee can either view the TSCA CBI security video; complete the TSCA CBI On-line Briefing via the EPA Intranet; or use the supplied CD-ROM for those the cannot access the intranet.
                                                                           50.0
                                                                           88.0
                                                                           13.5
                                                                          151.5
2. Read EPA Form 7740-6
                                                                           16.3
                                                                           28.7
                                                                            4.4
                                                                           49.4
3. Gather required information and complete form.
                                                                           22.4
                                                                           34.8
                                                                           14.3
                                                                           71.4
4. Contractor Document Control Officer processes, compiles and reviews form.
                                                                            9.6
                                                                            6.5
                                                                           41.8
                                                                           57.9
5. Store, file, or maintain copy of form for in-house reference.
                                                                           10.9
                                                                            1.5
                                                                           81.5
                                                                           93.9
6. Complete written form, obtain signatures, forward to EPA Information Management Division.
                                                                           22.7
                                                                            9.8
                                                                           26.2
                                                                           58.8
Totals
                                                                          132.0
                                                                          169.3
                                                                          181.7
                                                                          482.9

      6(b)	Estimating Respondent Costs

	Respondent hourly costs in this ICR have been updated using the data sources that have been used for this purpose in the past. The underlying data come from the Bureau of Labor Statistics' Employer Costs for Employee Compensation Supplementary Tables: December 2006  -  December 2012, US Bureau of Labor Statistics, March 12, 2013 (BLS 2013, accessed March 28, 2013). Total hourly cost estimates include wages, fringe benefits, and overhead.   The wage and fringe benefit numbers are from the BLS data, and the overhead allowance is calculated at 17% of the hourly wage.

Category
                                  Hourly wage
                                Fringe benefits
                                   Overhead
                               Total hourly cost
Managerial
                                    $43.95
                                    $21.46
                                     $7.47
                                    $72.88
Technical
                                    $38.53
                                    $19.31
                                     $6.55
                                    $64.39
Clerical
                                    $17.64
                                     $8.87
                                     $3.00
                                    $29.51

	Estimated total annual costs to the respondents are equal to $25,875 and are presented in table 6.3.  There are no capital costs for the contractors associated with this collection.

           Table 6.3: ANNUAL RESPONDENT (CONTRACTOR) COST ESTIMATES

Labor category
                                  Hourly cost
                             Number of clearances
                                  Labor hours
                               Labor Cost Total
Managerial
                                    $72.88
                                      100
                                     132.0
                                     $9,617
Technical
                                    $64.39
                                      176
                                     169.2
                                    $10,897
Clerical
                                    $29.51
                                       27
                                     181.7
                                   $  5,361
Totals
                                     482.9
                                    $25,875

	6(c) 	Estimating Agency Burden and Cost

	The costs and burdens to the Federal Government are presented in the table 6.4.  The Office of Pollution Prevention and Toxics bases its burden hour estimates on prior experience in gathering and processing information associated with other information collections.  Hourly wages for clerical support are based upon the salary for a GS-7, step1 ($20.22).  Hourly costs for managerial and technical support are based upon the salary for GS-15, step 1 ($59.30) and GS-12, step 1 ($35.88), respectively.  The hourly rates were taken from the U.S. Office of Personnel Management's 2013 General Schedule for workers with the Washington DC locality payment (Table 2013-DCB).  These hourly estimates were then multiplied by 1.6 to account for benefits (EPA Instructions for Preparing Information Collection Requests, 1992).  The hourly cost estimates adjusted for benefits are $94.88 for managers, $57.41 for technical workers, and $32.35 for clerical workers. Also included is an estimated $6,500 cost for equipment.  The total cost to the Agency to maintain the collection system is $58,830 per annum and the total Agency burden is estimated at 1172 hours.

                Table 6.4:  ANNUAL AGENCY BURDEN/COST ESTIMATES

                             Collection Activities
                            Burden Hours (per year)
                                  Total Hours
                                  Total Cost

                             Management @ $94.88
                                  Technical
                                   @ $57.41
                                   Clerical
                                   @ $32.35

1.  Read EPA Form 7740-6
                                                                           35.5
                                                                           40.0
                                                                           18.5
                                                                           94.0
                                                                         $6,263
2.  Gather required information and complete form.
                                                                           16.5
                                                                           44.5
                                                                          122.0
                                                                          162.5
                                                                         $8,067
3. EPA Document Control Officer processes, compiles and reviews form.
                                                                           19.0
                                                                           44.5
                                                                          175.0
                                                                          238.5
                                                                        $10,019
4. Complete written form and obtain appropriate signatures.
                                                                           18.0
                                                                           12.5
                                                                           47.0
                                                                           77.5
                                                                         $3,946
5. Store, file or maintain copy of form for in-house reference.
                                                                            5.0
                                                                           30.5
                                                                          160.5
                                                                          196.0
                                                                         $7,418
6. DCO forwards form to Information Management Division
                                                                            2.5
                                                                            0.0
                                                                           50.5
                                                                           53.0
                                                                         $1,871
7. Systems operations
                                                                            5.0
                                                                          150.0
                                                                          175.0
                                                                          330.0
                                            $14,747 (labor), $6,500 (equipment)
Totals
                                                                          101.5
                                                                          322.0
                                                                          748.5
                                                                        1,172.0
                                                                        $58,830

	6(d) 	Total Burden Estimates

	Table 6.5 displays the annual burdens and costs borne by respondents and EPA, respectively, associated with preparing, filing and reviewing a reporting form resulting from this information collection.

                   Table 6.5.  TOTAL COST AND BURDEN SUMMARY

                              Annual Burden Hours
                                 Annual Costs
Industry
                                      482.9
                                    $25,875
Agency
                                    1,172.0
                                    $58,830

	6(e) 	Reasons for Change in Burden

The estimated annual burden to contractors has decreased by 118 hours (from 601 hours to 483 hours) in total estimated respondent burden compared with that identified in the information collection most recently approved by OMB.  This reflects a decrease in the number of contractor employees that needed clearance.  This decrease represents an adjustment. Also, the costs to the industry respondents decreased by $4,378, again reflecting the decline in the number of employees needing clearance.

      6(f) 	Burden Statement

	The annual public burden for this collection of information is estimated to average 1.6 hours per response.  Burden is defined in 5 CFR 1320.3(b).  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 number for this information collection appears on page 1 of this document.  The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ- OPPT-2013-0459, which is available for online viewing at www.regulations.gov, or in-person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC).  The EPA/DC Public Reading Room is located in the EPA West Building, Room 3334, 1301 Constitution Ave., N.W., Washington, DC.  The EPA/DC 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 EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone number for the Pollution Prevention and Toxics Docket is<PHONE_NUMBER>.

      You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Submit your comments, referencing Docket ID No. EPA-HQ- OPPT-2013-0459 and OMB Control No. 2070-0075, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., N.W., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, DC 20503.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA-HQ-OPPT-2013-0459.  These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement.

Attachment A:
Section 14 of the Toxic Substances Control Act (15 U.S.C. 2613)  -  Disclosure of data. Available electronically at: http://www.access.gpo.gov/uscode/title15/chapter53_subchapteri_.html

Attachment B:
EPA Form EPA Form 7740-6 - TSCA CBI Access Request, Agreement, and Approval. Available electronically at: http://www.epa.gov/oppt/itc/pubs/tscacbitesting/appendix_a.pdf

Attachment C:
TSCA Confidential Business Information Security Manual. Available electronically at: http://www.epa.gov/oppt/pubs/tsca-cbi-protection-manual.pdf


[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Notices]
[Pages 27143-27144]
[FR Doc No: 2022-09773]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-201-000]

Texas Eastern Transmission, LP; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on April 22, 2022 Texas Eastern Transmission, LP
filed a prior notice request for authorization, in accordance with 18
CFR 157.205 and 157.208 of the Federal Energy Regulatory Commission's
(Commission) regulations and Texas Eastern's blanket certificate issued
in Docket Nos. CP82-535-000 to offset and replace a portion of 24-inch
diameter pipeline in Westmoreland County and Indiana County
Pennsylvania, at a crossing of the Conemaugh River; Texas Eastern
estimates that the cost of the project will be about $15 million.
    Specifically, Texas Eastern proposes to install a total of
approximately 2,660 feet of 24-inch diameter pipeline at a crossing of
the Conemaugh River. The replacement project includes approximately
2,260 feet of new pipeline that will be installed via horizontal
direction drill, most of which will be placed adjacent to the existing
Line 12 pipeline river crossing, and approximately 398 feet of pipeline
to be installed via open-cut-trench method. The replacement project
also includes the discontinued use of approximately 1,674 feet of the
existing 24-inch Line 12 pipeline facilities, approximately 1,280 feet
of which will be capped, grouted, and remain in place and an additional
394 feet on the west side of the river that will be removed, all as
more fully set forth in the application which is on file with the
Commission and open for public inspection.
    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 protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Estela D. Lozano Director, Regulatory,-Texas Eastern Transmission, LP
P.O. Box 1642 Houston, Texas 77251-1642 Phone:<PHONE_NUMBER>
Facsimile:<PHONE_NUMBER> Email: [email protected].
    Pursuant to Section 157.9 of the Commission's Rules of Practice and
Procedure,\1\ within 90 days of this Notice the Commission staff will
either: Complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
---------------------------------------------------------------------------

    \1\ 18 CFR (Code of Federal Regulations) 157.9.
---------------------------------------------------------------------------

Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on July 1, 2022. How
to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is July 1, 2022. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is July 1, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before July 1, 2022. The filing of a comment alone will not serve
to make the filer a party to the proceeding. To become a party, you
must intervene in the proceeding.

How to File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-201-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
---------------------------------------------------------------------------

    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project. The eFiling feature includes
a document-less intervention option; for more information, visit
https://www.ferc.gov/docs-filing/efiling/document-less-intervention.pdf.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP22-201-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: Estela D.
Lozano Director, Regulatory, Texas Eastern Transmission, LP P.O. Box
1642 Houston, Texas 77251-1642 Phone:<PHONE_NUMBER> Facsimile: (713)
627-5947 Email: [email protected].
    Any subsequent submissions by an intervenor must be served on the
applicant and all other parties to the proceeding. Contact information
for parties can be downloaded from the service list at the eService
link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: May 2, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-09773 Filed 5-5-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 14, 2008 (Volume 73, Number 221)]
[Notices]
[Page 67495-67498]
[DOCID:fr14no08-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 5, 2008.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC09-13-000.
    Applicants: Reliant Energy, Inc., FR Reliant Holding LP.
    Description: Joint application of Reliant Energy, Inc. and FR
Reliant Holdings LP for authorization for the indirect disposition of
jurisdictional facilities.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0098.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: EC09-15-000.
    Applicants: Fox Energy Company LLC, Fox Energy OP, L.P., Fox River
Power, LLC.
    Description: Application for Authorization of Disposition of
Jurisdictional Facilities and Requests for Expedited Consideration and
Confidential Treatment of Fox Energy Company LLC, et al.
    Filed Date: 11/04/2008.
    Accession Number: 20081104-5092.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 25, 2008.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER99-3502-008.
    Applicants: Berkshire Power Company, LLC.
    Description: Berkshire Power Company, LLC submits modifications to
Compliance Filing under ER99-3502.
    Filed Date: 10/31/2008.
    Accession Number: 20081105-0080.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER08-100-005; ER07-265-005; ER07-1215-006.
    Applicants: Sempra Energy Trading LLC; Sempra Energy Solutions LLC;
The Royal Bank of Scotland plc.
    Description: Notice of Change in Status Sempra Energy Trading LLC,
et al. under ER08-100, et al.
    Filed Date: 11/03/2008.
    Accession Number: 20081103-5151.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: ER09-47-001.
    Applicants: Alberta Power, LLC.
    Description: Alberta Power, LLC submits an amended Petition for
Acceptance of Initial Tariff (FERC Electric Tariff, Original Volume 1)
and Waivers under ER09-47.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0031.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-138-000.
    Applicants: FPL Energy Oliver Wind I, LLC.
    Description: FPL Energy Oliver Wind I, LLC submits request for
authorization to sell energy and capacity at market based rates and
request for expedited action under ER09-138.
    Filed Date: 10/28/2008.
    Accession Number: 20081030-0119.
    Comment Date: 5 p.m. Eastern Time on Tuesday, November 18, 2008.

    Docket Numbers: ER09-173-000.
    Applicants: Canandaigua Power Partners II, LLC.
    Description: Cananadaigua Power Partners II, LLC's application for
order accepting initial Market-Based Rate Tariff, Waiving Regulations,
and granting blanket approvals under ER09-173.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0099.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-188-000.
    Applicants: California Independent System Operator C.
    Description: California Independent System Operator Corp submits an
executed Amended and Restated Metered Subsystem Agreement under ER09-
188.
    Filed Date: 10/31/2008.
    Accession Number: 20081103-0163.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-190-000.
    Applicants: Dynegy Oakland, LLC.
    Description: Dynegy Oakland, LLC submits Appendix A et al.,
revisions to certain Must-Run Rate Schedules of its Reliability Must
Run Agreement with the California Independent System Operator
Corporation under ER09-190.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0131.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-191-000.
    Applicants: Dynegy South Bay, LLC.
    Description: Dynegy South Bay, LLC submits Appendix A et al.,
revisions to certain Must-Run Rate Schedules of its Reliability Must
Run Agreement with the California Independent System Operator
Corporation under ER09-191.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0132.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-192-000.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc submits Informational Filing of
Contract with its Independent Market Monitoring Unit, Potomac
Economics, Ltd under ER09-192.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0133.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-194-000.
    Applicants: Mirant Potrero, LLC.
    Description: Mirant Potrero, LLC submits revisions to its Must-Run
Service Agreement with the California Independent System Operator
Corporation under ER09-194.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0135.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-195-000.
    Applicants: Xcel Energy Services, Inc.
    Description: Public Service Company of Colorado submits Fourth
Revised Sheet 7 et al. effective under ER09-195.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0136.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-196-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company's CD'S containing a
Notice of Cancellation a revised rate sheet to the Firm Transmission
Service Agreement between SCE and the Imperial Irrigation District
under ER09-196.
    Filed Date: 10/31/2008.
    Accession Number: 20081031-4011.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-197-000.
    Applicants: ISO New England, Inc.
    Description: ISO New England, Inc. submits administrative costs for
calendar year 2009 under ER09-197.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0143.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-198-001.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff sheets supplementing its 10/31/08 filing, request for shortened
notice and comments periods, and request for expedited commission
action etc. under ER09-198.
    Filed Date: 11/04/2008.
    Accession Number: 20081105-0103.
    Comment Date: 5 p.m. Eastern Time on Monday, November 10, 2008.

    Docket Numbers: ER09-201-000.
    Applicants: Gilroy Energy Center, LLC.
    Description: Gilroy Energy Center, LLC submits Exhibit C, annual
revisions to certain Rate Schedules of its Reliability Must-Run
Agreement with California Independent System Operator Corporation under
ER09-201.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0137.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-202-000.
    Applicants: Los Medanos Energy Center, LLC.
    Description: Los Medanos Energy Center, LLC submits Exhibit C,
annual revisions to certain Rate Schedules of its Reliability Must-Run
Agreement with California Independent System Operator Corporation under
ER09-202.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0138.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-203-000.
    Applicants: New England Power Pool.
    Description: The New England Power Pool submits transmittal letter
along with the counterpart signature page of the NEPOOL Agreement,
dated as of 9/1/71 as amended executed by the GenPower Trading, LLC et
al. under ER09-203.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0139.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-204-000.
    Applicants: Virginia Electric & Power Company.
    Description: Dominion Virginia Power submits revised tariff sheets
in Schedule 12-Appendix to the open-access transmission tariff
administered by PJM Interconnection, LLC under ER09-204.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0140.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-205-000.
    Applicants: National Grid Generation LLC.
    Description: National Grid Generation LLC submits Original Sheet 86
et al. to FERC Electric Rate Schedule No. 1, to be effective 1/1/09
under ER09-205.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0045.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-206-000.
    Applicants: Pasco Cogen, Ltd.
    Description: Application of Pasco Cogen, Ltd. for market-based rate
authority, expeditted action, associated waivers, blanket approvals
etc. under ER09-206.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0044.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-207-000.
    Applicants: NSTAR Electric Company.
    Description: NSTAR Electric Co. submits a Transfer Agreement with
H.Q. Energy Services (US) Inc. under ER09-207.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0043.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-208-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits an executed Service
Agreement for Network Intergration Transmission Service under ER09-208.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0042.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-209-000.
    Applicants: ISO New England Inc. and New England Power.
    Description: ISO New England Inc et al. submits Second Revised
Sheet 7317R et al. to FERC Electric Tariff No. 1, to be effective 12/
31/08 under ER09-209.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0041.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-210-000.
    Applicants: CalPeak Power--El Cajon, LLC.
    Description: CalPeak Power LLC (CalPeak Entities) submits
modifications to certain schedules contained in the Reliability Must-
Run Service Agreement between each of the CalPeak Entities and the
California Independent System Operator Corporation under ER09-210.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0040.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-211-000.
    Applicants: Calpeak Power-Border, LLC.
    Description: CalPeak Power LLC (CalPeak Entities) submits
modifications to certain schedules contained in the Reliability Must-
Run Service Agreement between each of the CalPeak Entities and the
California Independent System Operator Corporation under ER09-210.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0040.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-212-000.
    Applicants: CalPeak Power--Enterprise, LLC.
    Description: CalPeak Power LLC (CalPeak Entities) submits
modifications to certain schedules contained in the Reliability Must-
Run Service Agreement between each of the CalPeak Entities and the
California Independent System Operator Corporation under ER09-210.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0040.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-213-000.
    Applicants: California Independent System Operator Corp.
    Description: California Independent System Operator Corp submits an
amendment to the CAISO Market Redesign and Technology Upgrade Tariff
under ER09-213.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0039.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-215-000.
    Applicants: Pittsfield Generating Company, L.P.
    Description: Pittsfield Generating Co, LP submits First Revised
Sheet 1 et al. to FERC Electric Tariff, Original Volume No. 1, to be
effective 1/1/09 under ER09-215.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0038.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-216-000.
    Applicants: Oklahoma Gas and Electric Company.
    Description: Oklahoma Gas and Electric Co. submits an amendment to
the 8/4/00 Interconnection Agreement with ONEOK Power Marketing Co.
under ER09-216.
    Filed Date: 10/31/2008
    Accession Number: 20081104-0037.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-217-000.
    Applicants: Arizona Public Service Company.
    Description: Arizona Public Service Co. submits a substitute non-
confirming service agreement for retail network integration
transmission service etc under ER09-217.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0036.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-218-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Co. First Revised Sheet 2
et al. to FERC Electric Tariff, First Revised Volume No. 5, to be
effective 1/3/09 under ER09-218.
    Filed Date: 11/03/2008.
    Accession Number: 20081104-0035.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: ER09-219-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits Sixth Revised
Service Agreement No. 208 Intergration Service Agreement etc under
ER09-219 et al.
    Filed Date: 11/03/2008.
    Accession Number: 20081104-0027.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: ER09-220-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits Sixth Revised
Service Agreement No. 208 Intergration Service Agreement etc under
ER09-219 et al.
    Filed Date: 11/03/2008.
    Accession Number: 20081104-0027.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: ER09-221-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits Sixth Revised
Service Agreement No. 208 Intergration Service Agreement etc under
ER09-219 et al.
    Filed Date: 11/03/2008.
    Accession Number: 20081104-0027.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: ER09-222-000.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Co. submits a Network Integration
Transmission Service Agreement and Network Operating Agreement with
Interstate Power and Light Co. under ER09-222.
    Filed Date: 11/03/2008.
    Accession Number: 20081104-0033.
    Comment Date: 5 p.m. Eastern Time on Monday, November 24, 2008.

    Docket Numbers: ER09-223-000.
    Applicants: Virginia Electric and Power Company.

    Description: Virginia Electric and Power Co. submits an executed
Mutual Operating Agreement with Northern Virginia Electric Cooperative
under ER09-223.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0034.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-224-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits revised pages to
its Open Access Transmission Tariff intended to implement a rate update
for Westar Energy, Inc etc. under ER09-224.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0032.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: ER09-225-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits Rate Schedule No.
335, the Requirements Power Purchase Agreement with Haywood Electric
Membership Corp dated as of 10/10/08 under ER09-225.
    Filed Date: 10/31/2008.
    Accession Number: 20081104-0046.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-82-002.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits Attachment C
Compliance Filing under OA07-82.
    Filed Date: 11/05/2008.
    Accession Number: 20081105-5070.
    Comment Date: 5 p.m. Eastern Time on Wednesday, November 26, 2008.

    Docket Numbers: OA08-62-003.
    Applicants: California Independent System Operator C.
    Description: The California Independent System Operator Corporation
submits the Commission's 6/19/08 Order on Compliance under OA08-62.
    Filed Date: 10/31/2008
    Accession Number: 20081104-0026.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

    Docket Numbers: OA09-10-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits their Notification
Filing pursuant to PJM Open Access Transmission Tariff and FERC's 6/25/
08 Order under OA09-10.
    Filed Date: 10/30/2008.
    Accession Number: 20081103-0199.
    Comment Date: 5 p.m. Eastern Time on Thursday, November 20, 2008.

    Docket Numbers: OA09-11-000.
    Applicants: Black Hills Power, Inc., et al.
    Description: Black Hills Power, Inc et al. submits a revised
version of Attachment K to the OATT in compliance with FERC's Order 890
under OA09-11.
    Filed Date: 10/31/2008.
    Accession Number: 20081103-0162.
    Comment Date: 5 p.m. Eastern Time on Friday, November 21, 2008.

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

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-27021 Filed 11-13-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 143 (Wednesday, July 27, 2022)]
[Notices]
[Pages 45110-45111]
[FR Doc No: 2022-16076]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3132]

General Clinical Pharmacology Considerations for Neonatal Studies
for Drugs and Biological Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``General
Clinical Pharmacology Considerations for Neonatal Studies for Drugs and
Biological Products.'' This guidance is intended to assist sponsors of
investigational new drug applications (INDs) and applicants of new drug
applications (NDAs), biologics license applications (BLAs), and
supplements to such applications who are planning to conduct clinical
studies in neonatal populations. This guidance finalizes the draft
guidance of the same title issued on August 1, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on July 27, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked, and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3132 for ``General Clinical Pharmacology Considerations for
Neonatal Studies for Drugs and Biological Products.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002 or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Elimika Pfuma Fletcher, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2162, Silver Spring, MD 20993, 301-796-
3473, [email protected] or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
``General Clinical Pharmacology Considerations for Neonatal Studies for
Drugs and Biological Products.'' This guidance is intended to assist
sponsors of INDs and applicants of NDAs, BLAs, and supplements to such
applications who are planning to conduct clinical studies in neonatal
populations.
    In 2012, the Best Pharmaceuticals for Children Act (Pub. L. 107-
109) (BPCA)

and the Pediatric Research Equity Act (Pub. L. 108-155) were made
permanent under Title V of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144) (FDASIA). FDASIA requires that all
BPCA requests for pediatric drug studies include a rationale for not
including neonatal studies if none are requested.
    Given that most drugs used in neonatal intensive care units (NICUs)
are used in an off-label capacity, it is important that drug
information be obtained in neonates to address gaps in neonatal
labeling. In addition, therapies need to be developed for conditions
unique to neonates. New approaches to the study of drugs in neonates
should consider the diversity of the patient population and underlying
conditions that are cared for in NICUs. Therefore, this guidance
addresses subgroup classifications of neonates; general
pharmacokinetic, pharmacodynamic, and pharmacogenomic considerations
for clinical pharmacology studies in neonates; and clinical
pharmacology considerations for planned studies in neonates.
    This guidance finalizes the draft guidance entitled ``General
Clinical Pharmacology Considerations for Neonatal Studies for Drugs and
Biological Products'' issued on August 1, 2019 (84 FR 37653). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include the
addition of a section addressing immunogenicity, additional text
regarding consideration of the total volume administered to neonates,
and additional clarity regarding the use of microsampling methodology.
In addition, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``General Clinical Pharmacology
Considerations for Neonatal Studies for Drugs and Biological
Products.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it
refers to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information related to institutional review boards in 21 CFR part 56
have been approved under OMB control number 0910-0130. The collections
of information in 21 CFR part 314 for the submission of new drug
applications have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR part 601 for the submission of
biologics license applications have been approved under OMB control
number 0910-0338. The collections of information 21 CFR part 312 for
the submission of investigational new drug applications have been
approved under OMB control number 0910-0014. The collections of
information in Sec. Sec.  312.47 and 312.82 for requesting meetings
with FDA about drug development programs have been approved under OMB
control number 0910-0429. The collections of information for the
submission of prescription drug labeling in 21 CFR 201.56 and 21 CFR
201.57 have been approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.regulations.gov, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: July 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16076 Filed 7-26-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15219-15220]
[FR Doc No: 2018-07206]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2017-0286]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 40 individuals from the
prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs)
against persons with insulin-treated diabetes mellitus (ITDM) from
operating a commercial motor vehicle (CMV) in interstate commerce. The
exemptions enable these individuals with ITDM to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on February 16, 2018. The
exemptions expire on February 16, 2020.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter

provides, to http://www.regulations.gov, as described in the system of
records notice (DOT/ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.

II. Background

    On January 16, 2018, FMCSA published a notice announcing receipt of
applications from 40 individuals requesting an exemption from diabetes
requirement in 49 CFR 391.41(b)(3) and requested comments from the
public (83 FR 2283). The public comment period ended on February 15,
2018, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    The Agency's decision regarding these exemption applications is
based on the program eligibility criteria and an individualized
assessment of information submitted by each applicant. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the January 16, 2018, Federal
Register notice (83 FR 2283) and will not be repeated in this notice.
    These 40 applicants have had ITDM over a range of one to 24 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (two
or more) severe hypoglycemic episodes in the past five years. In each
case, an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must submit a quarterly monitoring checklist completed by
the treating endocrinologist as well as an annual checklist with a
comprehensive medical evaluation; (2) each driver must report within
two business days of occurrence, all episodes of severe hypoglycemia,
significant complications, or inability to manage diabetes; also, any
involvement in an accident or any other adverse event in a CMV or
personal vehicle, whether or not it is related to an episode of
hypoglycemia; (3) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the Medical Examiner at
the time of the annual medical examination; and (4) each driver must
provide a copy of the annual medical certification to the employer for
retention in the driver's qualification file, or keeping a copy in his/
her driver's qualification file if he/she is self-employed. The driver
must also have a copy of the exemption when driving, for presentation
to a duly authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 40 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above:

Kyle A. Bernard (PA)
Zachary R. Brigham (SC)
Kenneth D. Chitwood (PA)
Tony M. Damesworth (TN)
Walter Dudiak (PA)
Mark T. Feldmann (KY)
John H. Fritz (IN)
Scott T. Fry (CO)
Richard E. Henderson (AZ)
Leah M. Hennes (MN)
Gerard M. Hubert (MA)
Gregory L. Humphrey (IL)
Parkinson B. James (NY)
John M. Jessup (MI)
Kevin A. Kirker (WI)
Ryan A. Knutson (SD)
Benjamin T. Lamoreaux (FL)
Joseph W. Latawiec (MN)
Tommy Leyva (CA)
Melvin Lumpkins, III (LA)
Craig E. Lynn (GA)
Charles E. Madenford, III (PA)
David R. Meddows (IL)
Kevin L. Miller (PA)
Charles A. Moerer (IN)
Cirilo M. Nunez (NJ)
LaVonda B. Pearson (NC)
Andrea N. Pressley (NJ)
Darby J. Russo (LA)
Gary S. Schreiner (FL)
Nicholas A. Scialanca (PA)
Robert C. Scott (WI)
Thermond D. Smith (IL)
Edward D. Smith (NE)
Jeffrey W. Stamper (MO)
Wayne R. Steffler (NY)
Thomas J. Stylc (PA)
Todd A. Vanwinkle (NE)
Jacob W. Williams (PA)
Kevin A. Wiswell (ME)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315.

    Issued on: April 2, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-07206 Filed 4-6-18; 8:45 am]
 BILLING CODE 4910-EX-P