to be obtained, soliciting, or requiring the disclosure to third
parties or the public of facts or opinions by or for an agency
regardless of form or format'' (44 U.S.C. 3502(3)(A)).
    OSHA's existing recordkeeping forms consist of the OSHA 300 Log,
the 300A Summary, and the 301 Incident Report. These forms are
contained in the Information Collection Request (ICR) titled 29 CFR
part 1904, Recording and Reporting Occupational Injuries and Illnesses,
which OMB approved under OMB Control Number 1218-0176 (expiration date
01/31/2018).
    In accordance with the PRA, OSHA solicited public comments on the
July 29, 2015 proposed rule. The proposed rule also invited the public
to submit comments to OMB and OSHA on the proposed collections of
information with regard to the following:
     Whether the proposed collections of information are
necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
cost) of the collections of information, including the validity of the
methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the compliance burden on employers, for
example, by using automated or other technological techniques for
collecting and transmitting information.
    Because the proposal simply reiterated and clarified employers'
existing obligations to record and maintain work-related injuries and
illnesses and did not add any new collection of information, the Agency
maintained the existing burden hour and cost estimates in the Recording
and Reporting Occupational Injuries and Illnesses Information
Collection Request. The Department also submitted this ICR to OMB for
review in accordance with 44 U.S.C. 3507(d) on July 29, 2015. On
October 7, 2015, OMB withheld approval of the revised ICR and issued a
Notice of Action (NOA) stating that prior to publication of the final
rule, the agency should provide a summary of any comments related to
the information collection and their response, including any changes
made to the ICR as a result of comments. In addition, the agency must
enter the correct burden estimates (see http://www.reginfo.gov/public/do/DownloadNOA?requestID=266192).
    The final rule adds no new compliance obligations. The rule simply
reiterates and clarifies employers' existing obligations to record
work-related injuries and illnesses; it does not require employers to
make records of any injuries or illnesses for which records were not
already required. Nor does the rule impose any new requirement that
employers reconsider or reassess records once they have been made;
employers remain subject to the existing requirement that they ensure
the accuracy and completeness of their 300 Logs. These revisions impose
no new cost burden because they do not require employers to do anything
new. The Department of Labor has submitted a final ICR to OMB
maintaining the existing burden hours and cost estimates. A copy of
this ICR is available at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201610-1218-003. OSHA will publish a separate notice
in the Federal Register that will announce OMB results of that review.
OSHA notes that a Federal agency cannot conduct or sponsor a collection
of information unless it is approved by OMB under the PRA, and the
collection of information notice displays a currently valid OMB control
number (44 U.S.C. 3507(a)(3)). Also, notwithstanding any other
provision of law, no employer shall be subject to penalty for failing
to comply with a collection of information if the collection of
information does not display a currently valid OMB control number (44
U.S.C. 3512).
    OSHA received comments relating to the estimated time necessary to
meet the paperwork requirements of the proposed changes published in
the July

29, 2015 proposed rule. A number of commenters stated their belief that
the rule will impose additional costs because it requires employers to
reassess, or ``think about,'' each record of a workplace injury or
illness repeatedly over the course of five full years. Ex. 0008, 0010,
0012, 0013, 0020, 0021, 0026, 0027. This concern is misplaced. An
employer's obligations remain the same as they are under the existing
rule: To record workplace injuries and illnesses within seven days of
when it learns of them and to maintain accurate records for five years.
The final rule does not contain any new requirement to review or
reassess existing records over the course of the maintenance period; it
simply makes clear that if an employer fails to record an injury or
illness within seven days of learning about it, it is not relieved of
the requirement to have and keep an accurate record of all recordable
injuries and illnesses for the duration of five years. Because the
final rule imposes no new requirement for review of records, there are
no additional costs involved for the time it would take to conduct such
review.
    OSHA estimates that it takes .38 of an hour to record an injury or
illness on all required OSHA forms, taking into account requirements
for providing access to records. The average hourly rate for an
Occupational Health and Safety Specialist (Standard Occupational
Classification code 29-9011) is estimated to be $48.78 (which includes
a 43% addition for benefits). This means that the total estimated cost
of preparing OSHA records is $18.54 per injury or illness. The American
Society of Safety Engineers and the National Association of
Manufacturers questioned these estimates of time and cost as too low.
Exs. 0019, 0026. OSHA stands by these estimates, however, as they have
been developed carefully through multiple notice and comment
rulemakings and Paperwork Reduction Act notices. Not all costs of
investigating an accident are attributable to OSHA's recordkeeping
requirements. Much of the same information has to be collected for
workers' compensation purposes. To avoid overlapping paperwork, OSHA
allows, and many employers take advantage of, the option to use
equivalent workers' compensation forms in place of OSHA's recordkeeping
forms. See 29 CFR 1904.29(a), (b)(4).
    As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the
following paragraphs provide information about this ICR.
    1. Title: 29 CFR part 1904 Recording and Reporting Occupational
Injuries and Illnesses.
    2. Number of respondents: Approximately 640,000 employers with
1,300,000 establishments are regularly required to maintain the forms.
    3. Frequency of responses: Annually.
    4. Number of responses: Approximately 1.99 million injury and
illness cases are recorded on the OSHA forms.
    5. Average time per response: Time required completing and
maintaining an entry (other than a needlestick) on the OSHA Form 300
ranges from 5 minutes to 30 minutes and averages 14 minutes. Time
required completing an entry on the OSHA 301 averages 22 minutes. OSHA
estimates 40% of recordable cases are recorded on form 301.
    6. Estimated total burden hours: The final rule adds no new
compliance obligations and does not require employers to make records
of any injuries or illnesses for which records are not currently
required to be made. The current total burden hours for the
recordkeeping (part 1904) ICR are 2,525,458.
    7. Estimated costs (capital-operation and maintenance): There are
no capital costs for the proposed information collection.

List of Subjects in 29 CFR Part 1904

    Health statistics, Occupational safety and health, Safety,
Reporting and recordkeeping requirements, State plans.

Authority and Signature

    This document was prepared under the direction of David Michaels,
Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor. It is issued pursuant to 29 U.S.C.
657, 673; 5 U.S.C. 553; and Secretary of Labor's Order No. 1-2012 (77
FR 3912, January 25, 2012).

David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

    Accordingly, the Occupational Safety and Health Administration
amends part 1904 of title 29 of the Code of Federal Regulations as
follows:

PART 1904--RECORDING AND REPORTING OCCUPATIONAL INJURIES AND
ILLNESSES

0
1. Revise the authority citation for part 1904 to read as follows:

    Authority:  29 U.S.C. 657, 658, 660, 666, 669, 673, Secretary of
Labor's Order No. 3-2000 (65 FR 50017), or 1-2012 (77 FR 3912), and
5 U.S.C. 553.

0
2. Revise Sec.  1904.0 to read as follows:

Sec.  1904.0   Purpose.

    The purpose of this rule (part 1904) is to require employers to
make and maintain accurate records of and report work-related
fatalities, injuries, and illnesses, and to make such records available
to the Government and to employees and their representatives so that
they can be used to secure safe and healthful working conditions. For
purposes of this part, accurate records are records of each and every
recordable injury and illness that are made and maintained in
accordance with the requirements of this part.

    Note to Sec.  1904.0: Recording or reporting a work-related
injury, illness, or fatality does not mean that the employer or
employee was at fault, that an OSHA rule has been violated, or that
the employee is eligible for workers' compensation or other
benefits.

Subpart C--Making and Maintaining Accurate Records, Recordkeeping
Forms, and Recording Criteria

0
3. Revise the heading of subpart C to read as set forth above.

0
4. In Sec.  1904.4, revise paragraph (a) introductory text and add a
note to Sec.  1904.4(a) to read as follows:

Sec.  1904.4   Recording criteria.

    (a) Basic requirement. Each employer required by this part to keep
records of fatalities, injuries, and illnesses must, in accordance with
the requirements of this part, make and maintain an accurate record of
each and every fatality, injury, and illness that:
* * * * *

    Note to Sec.  1904.4(a): This obligation to make and maintain an
accurate record of each and every recordable fatality, injury, and
illness continues throughout the entire record retention period
described in Sec.  1904.33.

* * * * *

0
5. Revise Sec.  1904.29(b)(3) to read as follows:

Sec.  1904.29   Forms.

* * * * *
    (b) * * *
    (3) How quickly must each injury or illness be recorded? You must
enter each and every recordable injury or illness on the OSHA 300 Log
and on a 301 Incident Report within seven (7) calendar days of
receiving information that the recordable injury or illness occurred. A
failure to record within seven days does not extinguish your continuing
obligation to make a record of the injury or illness and to maintain
accurate records of all recordable injuries and illnesses in accordance

with the requirements of this part. This obligation continues
throughout the entire record retention period described in Sec.
1904.33. See Sec. Sec.  1904.4(a); 1904.32(a)(1); 1904.33(b)(1); and
1904.40(a).
* * * * *

0
6. Revise the heading and paragraphs (a) and (b)(1) of Sec.  1904.32 to
read as follows:

Sec.  1904.32   Year-end review and annual summary.

    (a) Basic requirement. At the end of each calendar year, you must:
    (1) Review that year's OSHA 300 Log to verify that it contains
accurate entries for all recordable injuries and illnesses that
occurred during the year, and make any additions or corrections
necessary to ensure its accuracy;
    (2) Verify that each injury and illness recorded on the 300 Log,
including any injuries and illnesses added to the Log following your
year-end review pursuant to paragraph (a)(1) of this section, is
accurately recorded on a corresponding 301 Incident Report form;
    (3) After you have verified the accuracy of the Log, create an
annual summary of injuries and illnesses recorded on the Log;
    (4) Certify the summary; and
    (5) Post the summary.
    (b) * * *
    (1) How extensively do I have to review the OSHA 300 Log at the end
of the year? You must review the Log and its entries as extensively as
necessary to verify that all recordable injuries and illnesses that
occurred during the year are entered and that the Log and its entries
are accurate.
* * * * *

0
7. Revise the heading and paragraph (b) of Sec.  1904.33 to read as
follows:

Sec.  1904.33   Retention and maintenance of accurate records.

* * * * *
    (b) Implementation--(1) Other than the obligation identified in
Sec.  1904.32, do I have further recording duties with respect to the
OSHA 300 Logs and 301 Incident Reports during the five-year retention
period? You must make the following additions and corrections to the
OSHA Log and Incident Reports during the five-year retention period:
    (i) The OSHA Logs must contain entries for all recordable injuries
and illnesses that occurred during the calendar year to which each Log
relates. In addition, each and every recordable injury and illness must
be recorded on an Incident Report. This means that if a recordable case
occurred and you failed to record it on the Log for the year in which
the injury or illness occurred, and/or on an Incident Report, you are
under a continuing obligation to record the case on the Log and/or
Incident Report during the five-year retention period for that Log and/
or Incident Report;
    (ii) You must also make any additions and corrections to the OSHA
Log that are necessary to accurately reflect any changes that have
occurred with respect to previously recorded injuries and illnesses.
Thus, if the classification, description, or outcome of a previously
recorded case changes, you must remove or line out the original entry
and enter the new information; and
    (iii) You must have an Incident Report for each and every
recordable injury and illness; however, you are not required to make
additions or corrections to Incident Reports during the five-year
retention period.
    (2) Do I have to make additions or corrections to the annual
summary during the five-year retention period? You are not required to
make additions or corrections to the annual summaries during the five-
year retention period.

0
8. Revise Sec.  1904.34 to read as follows:

Sec.  1904.34   Change in business ownership.

    If your business changes ownership, you are responsible for
recording and reporting work-related injuries and illnesses only for
that period of the year during which you owned the establishment. You
must transfer the Part 1904 records to the new owner. The new owner
must save all records of the establishment kept by the prior owner, as
required by Sec.  1904.33, but need not update or correct the records
of the prior owner. The new owner is not responsible for recording and
reporting work-related injuries and illnesses that occurred before the
new owner took ownership of the establishment.

0
9. Revise paragraphs (b)(2) introductory text and (b)(2)(iii) of Sec.
1904.35 to read as follows:

Sec.  1904.35   Employee involvement.

* * * * *
    (b) * * *
    (2) Do I have to give my employees and their representatives access
to the OSHA injury and illness records? Yes, your employees, former
employees, their personal representatives, and their authorized
employee representatives have the right to access accurate OSHA injury
and illness records, with some limitations, as discussed below.
* * * * *
    (iii) If an employee or representative asks for access to the OSHA
300 Log, when do I have to provide it? When an employee, former
employee, personal representative, or authorized employee
representative asks for copies of your current or stored OSHA 300
Log(s) for an establishment the employee or former employee has worked
in, you must give the requester a copy of the relevant and accurate
OSHA 300 Log(s) by the end of the next business day.
* * * * *

Subpart E--Reporting Accurate Fatality, Injury, and Illness
Information to the Government

0
10. Revise the heading of subpart E to read as set forth above.

0
11. Revise the heading and paragraph (a) of Sec.  1904.40 to read as
follows:

Sec.  1904.40   Providing accurate records to government
representatives.

    (a) Basic requirement. When an authorized government representative
requests the records you keep under part 1904, you must provide
accurate records, or copies thereof, within four (4) business hours of
the request.
* * * * *
[FR Doc. 2016-30410 Filed 12-16-16; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Notices]
[Page 11898]
[DOCID:fr05mr08-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

February 19, 2008.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER08-400-002.
    Applicants: CalPeak Power-El Cajon, LLC.
    Description: CalPeak Power-El Cajon, LLC submits an amendment to
its 1/23/08 amended filing of Reliability Must-Run Service Agreement
between CalPeak El Cajon and the California Independent System Operator
Corporation.
    Filed Date: 02/13/2008.
    Accession Number: 20080215-0072.
    Comment Date: 5 p.m. Eastern Time on Wednesday, March 05, 2008.

    Docket Numbers: ER08-559-000.
    Applicants: Wisconsin Electric Power Company.
    Description: Wisconsin Electric Power Company submits a Notice of
Cancellation of Joint Operating Agreement with Edison Sault Electric
Company.
    Filed Date: 02/14/2008.
    Accession Number: 20080215-0031.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 06, 2008.

    Docket Numbers: ER08-561-000.
    Applicants: Benton County Wind Farm, LLC.
    Description: Benton County Wind Farm, LLC submits its proposed
market-based rate tariff entitled FERC Electric Tariff 1 for its
electric generating facility located in Benton County, Indiana.
    Filed Date: 02/12/2008.
    Accession Number: 20080215-0032.
    Comment Date: 5 p.m. Eastern Time on Tuesday, March 04, 2008.

    Docket Numbers: ER08-562-000.
    Applicants: Duke Energy Indiana, Inc
    Description: Duke Energy Indiana, Inc. submits a notice of
cancellation, cancelling the transmission system to transmission system
Interconnection Agreement with Hoosier Energy Rural Electric Coop, Inc.
    Filed Date: 02/14/2008.
    Accession Number: 20080215-0058.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 06, 2008.

    Docket Numbers: ER08-564-000.
    Applicants: Vision Power Systems, Inc.
    Description: Vision Power Systems Inc submits Petition for
Acceptance of Initial Tariff, Waivers and Blanket Authority.
    Filed Date: 02/14/2008.
    Accession Number: 20080215-0030.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 06, 2008.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:
    Docket Numbers: QM08-3-001.
    Applicants: Alliant Energy Corporate Services, Inc.
    Description: Additional Information and Clarification of Alliant
Energy Corporate Services, Inc.
    Filed Date: 02/14/2008.
    Accession Number: 20080214-5056.
    Comment Date: 5 p.m. Eastern Time on Thursday, March 13, 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 docket(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. E8-4201 Filed 3-4-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Page 37255]
[FR Doc No: 2015-16038]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2011-0928; FRL-9929-94-OEI]

Proposed Information Collection Request; Comment Request; Fuel
Use Requirements for Great Lake Steamships (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Fuel Use Requirements for Great
Lakes Steamships'' (EPA ICR No. 2458.02, OMB Control No. 2060-0679) to
the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
Before doing so, EPA is soliciting public comments on specific aspects
of the proposed information collection as described below. This is a
proposed extension of the ICR, which is currently approved through
August 31, 2015. 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: Comments must be submitted on or before August 31, 2015.

ADDRESSES: Submit your comments, referencing the Docket ID Number
listed above online using www.regulations.gov (our preferred method) or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
    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: Alan Stout, Office of Transportation
and Air Quality, Environmental Protection Agency, 2565 Plymouth Road,
Ann Arbor, MI 48105; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
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.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: The U.S. Environmental Protection Agency (EPA) adopted
requirements for marine vessels operating in and around U.S.
territorial waters to use reduced-sulfur diesel fuel. This requirement
does not apply for steamships, but it would apply for steamships that
are converted to run on diesel engines. A regulatory provision allows
vessel owners to qualify for a waiver from the fuel-use requirements
for a defined period for such converted vessels. EPA uses the data to
oversee compliance with regulatory requirements, including
communicating with affected companies and answering questions from the
public or other industry participants regarding the waiver in question.
    Form Numbers: None.
    Estimated number of respondents: 2 (total).
    Frequency of response: Once
    Currently approved estimated burden: 14 hours (per year). Burden is
defined at 5 CFR 1320.03(b)
    Currently approved estimated cost: $988 (per year), includes no
annualized capital or operation & maintenance costs.
    Changes in Estimates: The final ICR will address all changes in the
estimates over the past three years.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-16038 Filed 6-29-15; 8:45 am]
 BILLING CODE 6560-50-P


\827\ Eversource Comments (2018 RM18-9) at 11.
    \828\ Dominion Comments (RM16-23) at 9.
    \829\ Duquesne Light Company Comments (2018 RM18-9) at 3-4.
    \830\ See, e.g., AWEA Comments (RM16-23) at 4; Delaware
Commission Comments (RM16-23) at 4; Fresh Energy/Sierra Club/Union
of Concerned Scientists Comments (RM16-23) at 1.
---------------------------------------------------------------------------

2. Commission Determination
    360. After consideration of the comments submitted, we find that it
is reasonable to provide RTOs/ISOs with additional time to submit their
proposed tariff revisions in response to the final rule, given that the
changes could require significant work on the part of RTOs/ISOs.
Consequently, after consideration of the comments submitted, we will
require each RTO/ISO to file the tariff changes needed to implement the
requirements of this final rule within 270 days of the publication date
of this final rule in the Federal Register. To the extent that an RTO/
ISO proposes to comply with any or all of the requirements in this
final rule using its currently effective requirements for distributed
energy resources, it must demonstrate on compliance that its existing
approach meets the requirements in this final rule.
    361. Based on comments submitted about the complexity of changes to
RTO/ISO market rules and systems, we will not require the
implementation of the tariff provisions within 12 months from the date
of the compliance filing, as proposed in the NOPR. Instead, we will
require each RTO/ISO to propose a reasonable implementation date,
together with adequate support explaining how the proposal is
appropriately tailored for its region and implements this final rule in
a timely manner. The Commission will establish on compliance the
effective date for each RTO's/ISO's compliance filing.

L. Issues Beyond the Scope of This Rulemaking

1. Comments
    362. Some commenters raise issues that were not addressed in the
NOPR. For instance, commenters raise issues regarding how the deduction
of behind-the-meter resources from reserve margin requirements affects
price formation; \831\ impacts of subsidizing resources on functioning
of RTO/ISO markets; \832\ capacity market mitigation policies for
distributed energy resources; \833\ impacts on system variability and
unpredictable operation due to RTO/ISO market participation of
distributed energy resources; \834\ impacts of distributed energy
resource aggregations on distribution system operations and
reliability, and necessary distribution system adjustments; \835\
reflecting distribution system benefits associated with distributed
energy resource aggregations into RTO/ISO market operation; \836\
distribution system configuration issues; \837\ need for modernizing
distribution system equipment, such as the deployment of distributed
energy resource management systems (DERMS); \838\ privacy and
cybersecurity concerns; \839\ data collection practices during
distributed energy resource registration focused on attributes
available for essential grid services, but not necessarily in support
of a market product; \840\ differing compensation for short-duration
resources to account for reduced run times in the capacity market;
\841\ and clarification that the term electric storage resource as
defined in Order No. 841 may include an aggregation of distributed
electric storage resources.\842\
---------------------------------------------------------------------------

    \831\ See, e.g., NRG Comments (RM16-23) at 6.
    \832\ See, e.g., PJM Market Monitor Comments (RM16-23) at 10.
    \833\ See, e.g., NRG Comments (RM16-23) at 6.
    \834\ See, e.g., Advanced Energy Economy Comments (2018 RM18-9)
at 24; NYISO Indicated Transmission Owners Comments (2018 RM18-9) at
20; Organization of MISO States Comments (2018 RM18-9) at 10.
    \835\ See, e.g., Advanced Energy Management Comments (2018 RM18-
9) at 24; Vice Chairman Place Comments (2018 RM18-9) at 2-3; EEI
Comments (2018 RM18-9) at 8-9, 19-21; Pacific Gas & Electric
Comments (2018 RM18-9) at 20-21, 24-25; PJM Comments (2018 RM18-9)
at 28; TAPS Comments (2018 RM18-9) at 7-11.
    \836\ See, e.g., Stem Comments (2018 RM18-9) at 11.
    \837\ See, e.g., NRECA Comments (2018 RM18-9) at 8.
    \838\ See, e.g., CAISO Comments (2018 RM18-9) at 7; EPSA
Comments (2018 RM18-9) at 9-13; Eversource Comments (2018 RM18-9) at
10-11.
    \839\ See, e.g., California Commission Comments (2018 RM18-9) at
18; NRECA Comments (2018 RM18-9) at 11.
    \840\ See, e.g., Union of Concerned Scientists Comments (RM16-
23) at 10-11 (citing J. Nelson, Ph.D. and L.M. Wisland, Achieving 50
Percent Renewable Electricity in California--The Role of Non-Fossil
Flexibility in a Cleaner Electricity Grid (2015), http://www.ucsusa.org/sites/default/files/attach/2015/08/Achieving-50-Percent-Renewable-Electricity-In-California.pdf).
    \841\ See, e.g., Advanced Energy Economy Comments (RM16-23) at
42-43.
    \842\ See, e.g., University of Delaware's EV R&D Group Comments
(2018 RM18-9) at 1.
---------------------------------------------------------------------------

2. Commission Determination
    363. The NOPR did not propose reforms related to these issues
raised by commenters. Therefore, these issues are outside the scope of
this proceeding and will not be addressed here.

V. Information Collection Statement

    364. The information collection (IC) contained in this final rule
is being submitted to the Office of Management and Budget (OMB) for
review under section 3507(d) of the Paperwork Reduction Act of
1995.\843\ OMB's regulations,\844\ in turn, require approval of certain
information collection requirements imposed by agency rules.
Respondents subject to the filing requirements of a rule will not be
penalized for failing to respond to the collection of information
unless the collection of information displays a valid OMB control
number.
---------------------------------------------------------------------------

    \843\ See 44 U.S.C. 3507(d).
    \844\ 5 CFR pt. 1320 (2020).
---------------------------------------------------------------------------

    365. The Commission has submitted this IC to OMB as a revision of
FERC-516H. OMB has assigned control number 1902-0303 to FERC-516H. The
Commission is not asking OMB to change the expiration date of control
number 1902-0303 (May 31, 2021).

A. Summary of This IC

    Title: FERC-516H (Electric Rate Schedules and Tariff Filings, in
Docket No. RM18-9-000).
    OMB Control No. 1902-0303.
    Type of Request: Revision of FERC-516H.
    Abstract: This final rule, at 18 CFR 35.28(g)(12), includes two IC
activities. Each RTO and ISO must have tariff provisions that allow DER
aggregations to participate directly in the organized wholesale
electric markets. In addition, each RTO and ISO must update the
economic dispatch software accordingly.
    Types of Respondent: RTOs and ISOs.
    Frequency of Collection: One time.
    Estimate of Annual Burden \845\: The Commission estimates the total
annual burden and cost \846\ for this IC in the following table:
---------------------------------------------------------------------------

    \845\ ``Burden'' is the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to Title 5 Code of Federal Regulations
1320.3.
    \846\ Commission staff believes that industry is similarly
situated in terms of cost for wages and benefits. Therefore, we are
using the FERC 2020 average cost (for wages plus benefits) for one
FERC full-time equivalent (FTE) of $172,329 ($83.00 per hour).
---------------------------------------------------------------------------

    In response to comments on the NOPR, we have increased the
estimated burden and cost for the requirements of the final rule from
those originally proposed in the NOPR. The estimated burden and cost
for the requirements contained in this final rule follow.

                                    Additions to FERC-516H, as Implemented in the Final Rule in Docket No. RM18-9-000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    A                           B            C            D                     E                            F                    G
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Avg. number
                                                             of         Total
            Types of response               Number of    responses    number of    Average burden (hours) and    Total annual burden hours     Cost per
                                           respondents      per       responses         cost per response          and total annual cost      respondent
                                                         respondent
                                                                       (col. B x                                (col. D x..................    (col. F /
                                                                         col. C)                                col. E)....................      col. B)
--------------------------------------------------------------------------------------------------------------------------------------------------------
One-Time Tariff Filing Due to RM18-9                 6            1            6  1,529 hrs; $126,907.........  9,174 hrs; $761,442........     $126,907
 Final Rule.
Software Update..........................            6            1            6  1,500 hrs; $124,500.........  9,000 hrs; $747,000........      124,500
                                          --------------------------------------------------------------------------------------------------------------
    Total Burden.........................  ...........  ...........  ...........  3029 hrs; $251,407..........  18,174 hrs; $1,508,442.....      251,407
--------------------------------------------------------------------------------------------------------------------------------------------------------

B. Discussion

    366. The Commission implements this final rule and FERC-516H to
remove barriers to the participation of distributed energy resource
aggregations in the capacity, energy, and ancillary service markets
operated by RTOs and ISOs. This IC in this final rule conforms to the
Commission's need for efficient information collection, communication,
and management within the energy industry.
    367. In this final rule, we are requiring each RTO/ISO to propose
revisions to its tariff that (1) allow distributed energy resource
aggregations to participate directly in RTO/ISO markets and establish
distributed energy resource aggregators as a type of market
participant; (2) allow distributed energy resource aggregators to
register distributed energy resource aggregations under one or more
participation models that accommodate the physical and operational
characteristics of the distributed energy resource aggregations; (3)
establish a minimum size requirement for distributed energy resource
aggregations that does not exceed 100 kW; (4) address locational
requirements for distributed energy resource aggregations; (5) address
distribution factors and bidding parameters for distributed energy
resource aggregations; (6) address information and data requirements
for distributed energy resource aggregations; (7) address metering and
telemetry requirements for distributed energy resource aggregations;
(8) address coordination between the RTO/ISO, the distributed energy
resource aggregator, the distribution utility, and the relevant
electric retail regulatory authorities; (9) address modification to the
list of resources in a distributed energy resource aggregation; and
(10) address market participation agreements for distributed energy
resource aggregators.
    368. Interested persons may obtain information on the reporting
requirements by contacting Ellen Brown, Office of the Executive
Director, Email<EMAIL_ADDRESS>Phone:<PHONE_NUMBER>.

VI. Environmental Analysis

    369. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\847\ We
conclude that neither an Environmental Assessment nor an Environmental
Impact Statement is required for this final rule under Sec.
380.4(a)(15) of the Commission's regulations, which provides a
categorical exemption for approval of actions under sections 205 and
206 of the FPA relating to the filing of schedules containing all rates
and charges for the transmission or sale of electric energy subject to
the Commission's jurisdiction, plus the classification, practices,
contracts, and regulations that affect rates, charges, classifications,
and services.\848\
---------------------------------------------------------------------------

    \847\ Regulations Implementing the Nat'l Envt'l Policy Act of
1969, Order No. 486, 52 FR 47,897 (Dec. 17, 1987), FERC Stats. &
Regs., ] 30,783 (1987) (cross-referenced at 41 FERC ] 61,284).
    \848\ 18 CFR 380.4(a)(15) (2020).
---------------------------------------------------------------------------

VII. Regulatory Flexibility Act Certification

    370. The Regulatory Flexibility Act of 1980 (RFA) \849\ generally
requires a description and analysis of rules that will have a
significant economic impact on a substantial number of small entities.
The RFA mandates consideration of regulatory alternatives that
accomplish the stated objectives of a rule and that minimize any
significant economic impact on a substantial number of small entities.
The SBA Office of Size Standards develops the numerical definition of a
small business.\850\ The small business size standards are provided in
13 CFR 121.201.
---------------------------------------------------------------------------

    \849\ 5 U.S.C. 601-12.
    \850\ 13 CFR 121.101 (2020).
---------------------------------------------------------------------------

    371. Under the SBA classification, the six RTOs/ISOs would be
considered electric bulk power transmission and control, for which the
small business size threshold is 500 or fewer employees.\851\ Because
each RTO/ISO has more than 500 employees, none are considered small
entities.
---------------------------------------------------------------------------

    \851\ 13 CFR 121.201 (Sector 22, Utilities).
---------------------------------------------------------------------------

    372. Furthermore, because of their pivotal roles in wholesale
electric power markets in their regions, none of the RTOs/ISOs meet the
last criterion of the two-part RFA definition of a small entity: ``not
dominant in its field of operation.'' \852\
---------------------------------------------------------------------------

    \852\ The RFA definition of ``small entity'' refers to the
definition provided in the Small Business Act, which defines a
``small business concern'' as a business that is independently owned
and operated and that is not dominant in its field of operation. The
SBA's regulations at 13 CFR 121.201 define the threshold for a small
Electric Bulk Power Transmission and Control entity (NAICS code
221121) to be 500 employees. See 5 U.S.C. 601(3) (citing to section
3 of the Small Business Act, 15 U.S.C. 632).
---------------------------------------------------------------------------

    373. The estimated cost related to this final rule includes: (a)
Preparing and making a one-time tariff filing ($126,907 per entity, as
detailed in the Information Collection section above), and (b) updating
the economic dispatch software. We estimate the one-time software work
will take 1,500 hours with an approximate cost of $124,500 per entity.
Therefore, the total estimated one-time cost for the tariff filing and
software work is $251,407 per entity (or $126,907 + $124,500); the
total estimated one-time industry cost is $1,508,442.
    374. As a result, we certify that the reforms required by this
final rule would not have a significant economic impact on a
substantial number of small entities, and therefore no regulatory
flexibility analysis is required.

VIII. Document Availability

    375. 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://www.ferc.gov). At this time,
the Commission has suspended access to the Commission's Public
Reference Room due to the President's March 13, 2020 proclamation
declaring a National Emergency concerning the Novel Coronavirus Disease
(COVID-19).
    376. From FERC's Home Page on the internet, this information is
available on eLibrary. The full text of this document is available on
eLibrary in PDF and Microsoft Word format for viewing, printing, and/or
downloading. To access this document in eLibrary, type the docket
number excluding the last three digits of this document in the docket
number field.
    377. User assistance is available for eLibrary and the FERC's
website during normal business hours from FERC Online Support at (202)
502-6652 (toll free at 1-866-208-3676) or email at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. Email the Public Reference Room at
<EMAIL_ADDRESS>
IX. Effective Date and Congressional Notification

    378. These regulations are effective December 21, 2020. The
Commission has determined, with the concurrence of the Administrator of
the Office of Information and Regulatory Affairs of OMB, that this rule
is not a ``major rule'' as defined in section 351 of the Small Business
Regulatory Enforcement Fairness Act of 1996.

List of Subjects in 18 CFR Part 35

    Electric power rates, Electric utilities.

    By the Commission. Commissioner Danly is dissenting with a
separate statement attached.

    Issued: September 17, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.

    In consideration of the foregoing, the Commission amends part 35,
chapter I, title 18, Code of Federal Regulations, as follows:

PART 35--FILING OF RATE SCHEDULES AND TARIFFS

0
1. The authority citation for part 35 continues to read as follows:

    Authority:  16 U.S.C. 791a-825r, 2601-2645; 31 U.S.C. 9701; 42
U.S.C. 7101-7352.

0
2. Amend Sec.  35.28 by adding paragraphs (b)(10) and (11) and (g)(12)
as follows.

Sec.  35.28   Non-discriminatory open access transmission tariff.

* * * * *
    (b) * * *
    (10) Distributed energy resource as used in this section means any
resource located on the distribution system, any subsystem thereof or
behind a customer meter.
    (11) Distributed energy resource aggregator as used in this section
means the entity that aggregates one or more distributed energy
resources for purposes of participation in the capacity, energy and/or
ancillary service markets of the regional transmission organizations
and/or independent system operators.
* * * * *
    (g) * * *
    (12) Distributed energy resource aggregators. (i) Each independent
system operator and regional transmission organization must have tariff
provisions that allow distributed energy resource aggregations to
participate directly in the organized wholesale electric markets. Each
regional transmission organization and independent system operator must
establish distributed energy resource aggregators as a type of market
participant. Additionally, each regional transmission organization and
independent system operator must allow distributed energy resource
aggregators to register distributed energy resource aggregations under
one or more participation models in the regional transmission
operator's or the independent system operator's tariff that accommodate
the physical and operational characteristics of the distributed energy
resource aggregation.
    (ii) Each regional transmission organization and independent system
operator, to accommodate the participation of distributed energy
resource aggregations, must establish market rules that address:
    (A) Eligibility to participate in the independent system operator
or regional transmission organization markets through a distributed
energy resource aggregation;
    (B) Locational requirements for distributed energy resource
aggregations;
    (C) Distribution factors and bidding parameters for distributed
energy resource aggregations;
    (D) Information and data requirements for distributed energy
resource aggregations;
    (E) Modification to the list of resources in a distributed energy
resource aggregation;
    (F) Metering and telemetry system requirements for distributed
energy resource aggregations;
    (G) Coordination between the regional transmission organization or
independent system operator, the distributed energy resource
aggregator, the distribution utility, and the relevant electric retail
regulatory authorities; and
    (H) Market participation agreements for distributed energy resource
aggregators.
    (iii) Each regional transmission organization and independent
system operator must establish a minimum size requirement for
distributed energy resource aggregations that does not exceed 100 kW.
    (iv) Each regional transmission organization and independent system
operator must accept bids from a distributed energy resource aggregator
if its aggregation includes distributed energy resources that are
customers of utilities that distributed more than 4 million megawatt-
hours in the previous fiscal year. An independent system operator or
regional transmission organization must not accept bids from a
distributed energy resource aggregator if its aggregation includes
distributed energy resources that are customers of utilities that
distributed 4 million megawatt-hours or less in the previous fiscal
year, unless the relevant electric retail regulatory authority permits
such customers to be bid into RTO/ISO markets by a distributed energy
resource aggregator.

    Note: The following appendix will not appear in the Code of
Federal Regulations.

Appendix A: Abbreviated Names of Commenters

    The following table contains the abbreviated names of all
commenters in this docket.

------------------------------------------------------------------------
         Abbreviation                    Commenter (full name)
------------------------------------------------------------------------
Advanced Energy Buyers.......  Advanced Energy Buyers.
Advanced Energy Economy......  Advanced Energy Economy.

Advanced Energy Management...  Advanced Energy Management Alliance.
Advanced Microgrid Solutions.  Advanced Microgrid Solutions, Inc.
Advanced Rail Energy Storage.  Advanced Rail Energy Storage, LLC.
AES Companies................  AES Companies.
Alevo........................  Alevo USA Inc.
Altametric...................  Altametric LLC.
Amanda Drabek................  Amanda Drabek, Pantsuit Nation of East
                                Texas.
American Petroleum Institute.  American Petroleum Institute.
Vice Chairman Place..........  Vice Chairman Andrew Place of the
                                Pennsylvania Public Utilities
                                Commission.
APPA.........................  American Public Power Association.
APPA/NRECA...................  American Public Power Association and
                                National Rural Electric Cooperative
                                Association.
Arkansas Commission..........  Arkansas Public Service Commission.
Avangrid.....................  AVANGRID, Inc.
AWEA.........................  American Wind Energy Association.
Beacon Power.................  Beacon Power, LLC.
Benjamin Kingston............  Benjamin D. Kingston.
Bonneville...................  Bonneville Power Administration.
Brookfield Renewable.........  Brookfield Renewable.
CAISO........................  California Independent System Operator
                                Corporation.
California Commission........  Public Utilities Commission of the State
                                of California.
California Energy Storage      California Energy Storage Alliance.
 Alliance.
California Municipals........  California Municipal Utilities
                                Association.
Calpine......................  Calpine.
Center for Biological          Center for Biological Diversity.
 Diversity.
City of New York.............  City of New York.
Connecticut Department of      Connecticut Department of Energy and
 Energy.                        Environmental Protection.
Connecticut State Entities...  Bureau of Energy and Technology Policy of
                                the Connecticut Department of Energy and
                                Environmental Protection and the
                                Connecticut Public Utilities Regulatory
                                Authority.
Delaware Commission..........  Delaware Public Service Commission.
DER/Storage Developers.......  DER and Storage Developers.
Direct Energy................  Direct Energy.
Dominion.....................  Dominion Resources Services, Inc.
DTE Electric/Consumers Energy  DTE Electric Company and Consumers Energy
                                Company.
Duke Energy..................  Duke Energy Corporation.
E4TheFuture..................  E4TheFuture.
Eagle Crest..................  Eagle Crest Energy Company.
EEI..........................  Edison Electric Institute.
Efficient Holdings...........  Efficient Holdings, LLC.
ELCON........................  Electricity Consumers Resource Council.
Energy Storage Association...  Energy Storage Association.
EPRI.........................  Electric Power Research Institute.
EPSA.........................  Electric Power Supply Association.
EPSA/PJM Power Providers.....  Electric Power Supply Association and PJM
                                Power Providers Group.
Eversource...................  Eversource Energy Service Company.
Exelon.......................  Exelon Corporation.
FirstEnergy..................  FirstEnergy.
FirstLight...................  FirstLight Power Resources, Inc.
Fluidic......................  Fluidic Energy.
Fresh Energy/Sierra Club/      Fresh Energy, the Sierra Club, and the
 Union of Concerned             Union of Concerned Scientists.
 Scientists.
Genbright....................  Genbright LLC.
Global Cold Chain Alliance...  Global Cold Chain Alliance.
GridWise.....................  GridWise Alliance.
Guannan He...................  Guannan He.
Harvard Environmental Policy   Harvard Environmental Policy Initiative.
 Initiative.
Icetec.......................  Icetec.
Imperial Irrigation District.  Imperial Irrigation District.
Independent Energy Producers   Independent Energy Producers Association.
 Association.
Indiana Commission...........  Indiana Utility Regulatory Commission.
Institute for Policy           Institute for Policy Integrity.
 Integrity.
IPKeys/Motorola..............  IPKeys Technologies and Motorola
                                Solutions.
IRC..........................  ISO-RTO Council.
ISO-NE.......................  ISO New England Inc.
Kansas Commission............  Kansas Corporation Commission.
Kathy Seal...................  Kathy Seal.
Leadership Group.............  Leadership Group.
Liza White...................  Liza C. White.
Lorenzo Kristov..............  Lorenzo Kristov.
Lyla Fadali..................  Lyla Fadali.
Magnum.......................  Magnum CAES, LLC.
Maryland and New Jersey        Maryland Public Service Commission and
 Commissions.                   New Jersey Board of Public Utilities.
Massachusetts Commission.....  Massachusetts Department of Public
                                Utilities.
Massachusetts State Entities.  Massachusetts Department of Public
                                Utilities and Massachusetts Department
                                of Energy Resources.

Massachusetts Municipal        Massachusetts Municipal Wholesale
 Electric.                      Electric Company.
Matthew d'Alessio............  Matthew d'Alessio.
Mensah.......................  AF Mensah Inc.
Microgrid Resources Coalition  Microgrid Resources Coalition.
Microsoft....................  Microsoft Corporation.
Minnesota Energy Storage       Minnesota Energy Storage Alliance.
 Alliance.
MISO.........................  Midcontinent Independent System Operator,
                                Inc.
MISO Transmission Owners.....  MISO Transmission Owners.
Mosaic Power.................  Mosaic Power, LLC.
NARUC........................  National Association of Regulatory
                                Utility Commissioners.
National Hydropower            National Hydropower Association.
 Association.
NEPOOL.......................  New England Power Pool.
NERC.........................  North American Electric Reliability
                                Corporation.
NESCOE.......................  New England States Committee on
                                Electricity.
New Jersey Board.............  New Jersey Board of Public Utilities.
New York Commission..........  New York Public Service Commission.
New York State Entities......  New York Public Service Commission and
                                New York State Energy Research and
                                Development Authority.
New York Utility Intervention  Utility Intervention Unit of the New York
 Unit.                          State Department of State.
NextEra......................  NextEra Energy Resources, LLC.
NRECA........................  National Rural Electric Cooperative
                                Association.
NRG..........................  NRG Energy, Inc.
NYISO........................  New York Independent System Operator,
                                Inc.
NYISO Indicated Transmission   Central Hudson Gas & Electric
 Owners.                        Corporation, Consolidated Edison Company
                                of New York, Inc., National Grid, New
                                York Power Authority, Orange and
                                Rockland Utilities, Inc., and Power.
NYPA.........................  New York Power Authority.
Ohio Commission..............  Public Utilities Commission of Ohio.
Open Access Technology.......  Open Access Technology International,
                                Inc.
OpenADR......................  OpenADR Alliance.
Organization of MISO States..  Organization of MISO States.
Pacific Gas & Electric.......  Pacific Gas and Electric Company.
PJM..........................  PJM Interconnection, L.L.C.
PJM Market Monitor...........  Monitoring Analytics, LLC.
PJM Utilities Coalition......  American Electric Power Service
                                Corporation, East Kentucky Power
                                Cooperative, Inc., and FirstEnergy
                                Service Company, on behalf of its
                                affiliates.
Power Applications...........  Power Applications and Research Systems,
                                Inc.
Protect Sudbury..............  Protect Sudbury.
Public Interest Organizations  Clean Wisconsin, Environmental Defense
                                Fund, Environmental Law & Policy Center,
                                Fresh Energy, GridLab, Natural Resources
                                Defense Council, Northwest Energy
                                Coalition, Sierra Club, Southern
                                Environmental Law Center, Union of
                                Concerned Scientists, Vote Solar,
                                Western Grid Group.
R Street Institute...........  R Street Institute.
RES Americas.................  Renewable Energy Systems Americas Inc.
Research Scientists..........  Drs. Audun Botterud, Apurba Sakti, and
                                Francis O'Sullivan.
Robert Borlick...............  Robert L. Borlick.
San Diego Gas & Electric.....  San Diego Gas & Electric.
San Diego Water..............  San Diego County Water Authority.
Schulte Associates...........  Schulte Associates LLC.
SEIA.........................  Solar Energy Industries Association.
Silicon Valley Leadership      Silicon Valley Leadership Group.
 Group.
Six Cities...................  Cities of Anaheim, Azusa, Banning,
                                Colton, Pasadena, and Riverside,
                                California.
SoCal Edison.................  Southern California Edison Company.
Southern Companies...........  Southern Company Services, Inc.
SPP..........................  Southwest Power Pool, Inc.
Starwood Energy..............  Starwood Energy Group Global, L.L.C.
Stem.........................  Stem, Inc.
Sunrun.......................  Sunrun Inc.
TAPS.........................  Transmission Access Policy Study Group.
TechNet......................  TechNet.
TeMix........................  TeMix Inc.
Tesla........................  Tesla, Inc.
Tesla/SolarCity..............  Tesla, Inc. and SolarCity Corporation.
Trans Bay....................  Trans Bay Cable LLC.
Union of Concerned Scientists  Union of Concerned Scientists.
University of Delaware's EV    EV R&D Group, University of Delaware.
 R&D Group.
UofD/Mensah..................  EV R&D Group, University of Delaware and
                                AF Mensah Inc.
Viking Cold Solutions........  Viking Cold Solutions.
Xcel Energy Services.........  Xcel Energy Services Inc.
------------------------------------------------------------------------

     United States of America--Federal Energy Regulatory Commission
------------------------------------------------------------------------
                                                       Docket No.
------------------------------------------------------------------------
Participation of Distributed Energy Resource    RM18-9-000.
 Aggregations in Markets Operated by Regional
 Transmission Organizations and Independent
 System Operators.
------------------------------------------------------------------------

(Issued September 17, 2020)
DANLY, Commissioner, dissenting:

    1. The Commission today approves a rule requiring Regional
Transmission Organizations (RTO) and Independent System Operators (ISO)
to revise their tariffs to accommodate distributed energy resource
(DER) aggregators. I dissent because, regardless of the benefits
promised by DERs, the Commission goes too far in declaring the extent
of its own jurisdiction and because the Commission should not encourage
resource development by fiat.
    2. The Federal Power Act (FPA) delineates the respective roles of
the Commission and the States, assigning powers in accordance with each
sovereigns' core interests.\853\ The federal government is tasked with
ensuring just and reasonable wholesale rates, prohibiting state action
that would either encumber interstate commerce or harm other states.
The States retain authority over the most local of concerns: Choice of
generation, siting of transmission lines, and the entirety of retail
sales and distribution. Each sovereign has a sphere of authority, and
in each sphere, the relevant sovereign's powers are supreme.
---------------------------------------------------------------------------

    \853\ See 16 U.S.C. 824 (2018).
---------------------------------------------------------------------------

    3. Respect for the States' role in our federal system and under the
FPA would counsel against even modest, non-essential declarations of
our authority, if done at the States' expense. Why, when issuing a
directive to the RTOs and ISOs (undoubtedly Commission-jurisdictional
entities), must we also declare that ``retail regulatory authorit[ies]
cannot broadly prohibit the participation in RTO/ISO markets of all
distributed energy resources or of all distributed energy resource
aggregators''? \854\ Perhaps the States should not or cannot prohibit
such participation.\855\ But it is not for us to make sweeping
declarations regarding the States' jurisdiction over distributed
generation. Rather, the Commission's jurisdiction over wholesale rates
would ideally be vindicated, were it to collide with a state
prohibition, through a challenge to a specific enactment or regulation
by making arguments ``armed with principles of federal preemption and
the Supremacy Clause.'' \856\
---------------------------------------------------------------------------

    \854\ Final Rule, Order No. 2222, 172 FERC ] 61,247, at P 58
(2020).
    \855\ I acknowledge the legal authority upon which the majority
bases its exercise of jurisdiction. Compare FERC v. Elec. Power
Supply Ass'n, 136 S. Ct. 760 (2016), with Nat'l Ass'n of Regulatory
Util. Comm'rs v. FERC, 964 F.3d 1177 (D.C. Cir. 2020). The concern I
express is prudential, not legal.
    \856\ Midwest ISO Transmission Owners v. FERC, 373 F.3d 1361,
1372 (D.C. Cir. 2004).
---------------------------------------------------------------------------

    4. Apart from the Commission's injudicious jurisdictional
declarations, today's order stands as an imprudent exercise of the
Commission's power. Why promulgate a rule at all? Reluctance to govern
by fiat is counseled particularly in a case like this in which the
generation resources the majority seeks to promote, by their very
nature, inevitably will affect the distribution system, responsibility
for which is assigned, with no ambiguity, to the States. We should
allow the RTOs and ISOs (or the States or the utilities) to develop
their own DER programs in the first instance. If the promises of DERs
are what they purport to be, the markets will encourage their
development. And if those programs result in wholesale sales in
interstate commerce, then the question of the Commission's jurisdiction
will be ripe. Commission directives are unnecessary to encourage the
development of economically-viable resources. I have greater faith in
the power of market forces and in the discernment of the utilities and
the States.
    For these reasons, I respectfully dissent.

James P. Danly,

Commissioner.

[FR Doc. 2020-20973 Filed 10-20-20; 8:45 am]
BILLING CODE 6717-01-P


APPENDIX 2 Survey Sample Size and Expected Response Rate 1 Survey Sample Size and Expected Response Rate Required Number of Completed Forms The required number of completed survey forms ( n) is derived from the level of precision required for the estimates and the desired level of confidence. A typical estimated quantity is the percentage ( P) of the population which has a particular characteristic. The uncertainty in this estimate is denoted by

P, the half width of the confidence interval for P. When estimating a fixed percentage P, the uncertainty at the specified level of confidence is determined by the number of completed questionnaire forms obtained in the survey. Conversely, for a fixed level of confidence, the required number of completed forms may be estimated by specifying a desired value for the half width of the confidence interval

P.

Table 1 shows the required sample sizes for two levels of confidence, 90 and 95% ( Levy and Lemeshow). If the desired

P is fixed at 2 percentage points, there is a different sample size required for each value of P, ranging from n = 502 at P = 5% to n = 2,641 at P = 50% for a 95%

confidence interval. Since many characteristics are being estimated in the survey, the safest approach is to use the highest number of required survey forms. This occurs when P = 50%. If n = 2,641 forms are completed, then characteristics which occur in less than half of the population will have a

P less than 2 percentage points. ( Note, however, that a

P of 2 percentage points may be a very large relative error for small values of P; i. e., if P = 2% and

P = 2%, then the relative error is 100%). 2 Table 1 a. Number of responses ( n) required for a 95% confidence interval of P ±

P.

P 1% 2% 3% 4% 5% 6% 7%

_______________________________________________________________ P = 5% 2,007 502 223 125 80 56 41 10% 3,803 951 423 238 152 106 78 15% 5,388 1,347 599 337 216 150 110 20% 6,761 1,690 751 423 270 188 138 25% 7,923 1,981 880 495 317 220 162 30% 8,874 2,219 986 555 355 247 181 35% 9,614 2,403 1,068 601 385 267 196 40% 10,142 2,535 1,127 634 406 282 207 45% 10,459 2,615 1,162 654 418 291 213 50% 10,564 2,641 1,174 660 423 293 216 b. Number of responses ( n) required for a 90% confidence interval of P ±

P.

P 1% 2% 3% 4% 5% 6% 7%

_______________________________________________________________ P = 5% 1,414 353 157 88 57 39 29 10% 2,679 670 298 167 107 74 55 15% 3,795 949 422 237 152 105 77 20% 4,763 1,191 529 298 191 132 97 25% 5,581 1,395 620 349 223 155 114 30% 6,251 1,563 695 391 250 174 128 35% 6,772 1,693 752 423 271 188 138 40% 7,144 1,786 794 446 286 198 146 45% 7,367 1,842 819 460 295 205 150 50% 7,442 1,860 827 465 298 207 152 3 Required Number of Telephone Contact Attempts Given an estimate of n, the required number of completed surveys, the number of telephone contact attempts ( N) that will be required is dependent on several additional factors that can only be estimated imprecisely. These factors include:

r1  the Phase 1 response rate for agreeing to complete the initial screening, expressed as a percentage of initial telephone contacts;

e1  the eligibility rate, which is the percentage of Phase 1 respondents who complete the screening that are eligible to complete the survey;

r2  the Phase 1 response rate for agreeing to be called back to complete the survey, expressed as a percentage of the eligible Phase 1 respondents; and r3  the Phase 2 response rate for completing the entire survey form, expressed as a percentage of the eligible Phase 1 respondents who agree to be called back to complete the survey.

Of the four factors above, the eligibility rate ( e1) will have the greatest impact on the required number of telephone contacts. The large impact of this factor is due to the relatively low rate of incidence ( approximately 10 percent) of asthma in the general population. The survey design has no effect on this factor.

The remaining factors are three different types of response rates. Each of these three factors may be influenced by the survey design. Due to the salesman's " foot in the door" effect ( Hornik, et al.), it is expected that r3 > r2 > r1. The foot in the door effect states that compliance with a small initial request significantly enhances the likelihood of compliance with a subsequent " target" request. Hence, the smallest response with the largest negative effect is expected to be r1, the response rate for completing the screening. The reasons for nonresponse in Phase 1 include no answer after repeated tries or an outright refusal to participate after initial contact is made.

In their 1988 analysis of survey results for Canadian smokers, Bull, et al., report telephone response rates by the cumulative number of call attempts made:

1 39% 4 2 67%

3 82%

4 88%

5 92%

6 96%

The dramatic increase in response that occurs with an increase in calling effort is confirmed in other U. S. studies. However, the very high level of response seen in Canada does not appear to be reflective of current conditions in the United States.

In the early 1990' s, Mishra, et al. report completion rates for telephone surveys with a minimum of four call attempts in Orange County, CA, that range from 46 percent to 59 percent, with a midpoint of 52.5 percent. The authors note that ownership of telephone answering machines was over 70 percent during this time period. Kristal, et al. report similar results in their telephone health survey in the State of Washington. This study was conducted in two stages: the first stage included up to 11 initial call attempts including callbacks; and the second stage included an additional 11 initial call attempts. Response rates in the first stage were 65 percent for women and 53 percent for men, with an average of approximately 59 percent. Only a few percentage points of improvement were reported to result from the second stage effort.

In summary, the early Canadian response rate appears to be significantly higher than those reported in later U. S. studies. The Canadian study represents a perhaps unobtainable goal for U. S. telephone surveys. Surveys taken in the Pacific coast area of the United States five years later show a marked decrease in response rates, despite a relatively high number of call attempts.

The average of the two midpoints for these studies is approximately 56 percent. This effect is partially due to the increased reliance on telephone answering machines in the United States in the 1990' s. The results also imply that residents along the Pacific coast simply were not home as often as Canadian residents in the late 1980' s. However, the lower response may also be due to the larger numbers of two income and single occupant residences on the Pacific coast. The currently planned survey will use random digit dialing with a minimum of seven call attempts for initial contact. The response rate for completing the screening is estimated to be r1 = 60%

( 0.60), reflecting approximately the Washington State study midpoint. This estimate may be compared to the midpoint for the Orange County study, augmented by eight percent given the increase in the number of contact attempts from four to seven. This increase is the same as that obtained in the Canadian study when contact attempts increase from four to six. 5 Successful completion of the screening phase will identify the actual number of eligible respondents. At this time, EPA estimates that approximately 10 percent of U. S. households have asthmatics ( Mannino). Hence, the eligibility rate is estimated to be e1 = 0.10.

Respondents determined to be eligible in the first phase will be asked to participate in the main portion of the survey. Not all eligible households will agree to participate. However, households are more likely to agree to participate once the screening is completed. Hornik, et al. report that having a " foot in the door" increased response rates from 48 percent to 59 percent in Israel,

amounting to a relative increase in response of approximately 23 percent. Hence, the estimated response rate for eligible respondents agreeing to participate in the second phase of the survey is r2 = 0.74.

In Phase 2, eligible respondents who have completed the screening and have agreed to participate in the full survey effort will be contacted to complete the full survey. At this stage,

the primary obstacle will be reaching the respondent when they are at home and at a convenient time. Information about the best time for future contacts will be obtained when respondents agree to participate in the full survey. This will reduce the chance that a respondent who has agreed to participate cannot be contacted. However, it is likely that passive refusals and terminations will be encountered at this phase. Passive refusal occurs when a respondent who has agreed to participate requests that the interviewer " call back later." After several attempts,

with the same result, it becomes obvious that the respondent does not really intend to participate but has not given a direct refusal. Passive refusals may also occur when telephone answering machines are used to " screen" calls. Terminations occur when the respondent refuses to complete the entire interview. Longer interviews such as the currently planned survey incur the risk of higher termination rates.

A passive refusal rate of 9.6 percent for high effort surveys is reported in Mishra, et al.

Termination rates of approximately five percent are indicated in Hornik, et al. Hence, the estimate for the phase 2 response rate is r3 = 0.85.

The total number of required telephone contacts is estimated as:

N = n / ( e1 r1 r2 r3 ). 6 Using the hypothetical goal of n = 2,641 completed forms as derived above, the required number of initial telephone contact attempts is estimated to be:

N = n / ( 0.10)( 0.60)( 0.74)( 0.85) = 2,641 / 0.03774 = 69,979.

If other precision goals are desired, the required number of completed forms shown in the bottom row of Table 1a or 1b should be divided by 0.03774 to estimate the required number of contact attempts.

For example, EPA has set a goal of three percentage points at the 90% confidence interval for each of its sample subsets ( i. e., children with asthma and low income adults with asthma). For a goal of three percentage points, the sample size required at P = 50% is n = 827. To achieve this goal for low income populations, EPA intends to over sample in communities known to have a high percentage of low income households. However, as information identifying the nation's population of child asthmatics does not exist, EPA must increase the size of its overall sample to achieve its goal for children. EPA estimates that one in four individuals who suffer from asthma are children ( Mannino). Therefore, in order to achieve a precision rate of +/ 3 percent at the 90% confidence interval the total number of required initial telephone contact attempts is estimated as N = n / ( 0.25)( 0.10)( 0.60)( 0.74)( 0.85) = 827/ 0.009435 = 87,652.

Note: Appendix 4 provides a bibliography of cited references.


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4479-4482]
[FR Doc No: 2019-02479]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0482]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reporting Associated With New Animal Drug Applications
and Veterinary Master Files

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
associated with new animal drug applications.

DATES: Submit either electronic or written comments on the collection
of information by April 16, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 16, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service

acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-0482 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Reporting Associated with New
Animal Drug Applications and Veterinary Master Files.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Reporting Associated With New Animal Drug Applications (NADA) and
Veterinary Master Files--21 CFR 514.1, 514.4, 514.5, 514.6, 514.8,
514.11, and 558.5

OMB Control Number 0910-0032--Extension

    Under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal
drug application (NADA) seeking our approval to legally market a new
animal drug. Section 512(b)(1) sets forth the information required to
be submitted in a NADA. Sections 514.1, 514.4, 514.6, 514.8, and 514.11
of our regulations (21 CFR 514.1, 514.4, 514.6, 514.8, and 514.11)
further specify the information that the NADA must contain. The
application must include safety and effectiveness data, proposed
labeling, product manufacturing information, and where necessary,
complete information on food safety (including microbial food safety)
and any methods used to determine residues of drug chemicals in edible
tissue from food producing animals. FDA Guidance #152 outlines a risk
assessment approach for evaluating the microbial food safety of
antimicrobial new animal drugs. We request that applicants utilize Form
FDA 356V, as appropriate, to ensure efficient and accurate processing
of information to support new animal drug approval.
    Under section 512(b)(3) of the FD&C Act, any person intending to
file a NADA or supplemental NADA or a

request for an investigational exemption under section 512(j) of the
FD&C Act is entitled to one or more conferences with us prior to making
a submission. Section 514.5 of our regulations (21 CFR 514.5) describes
the procedures for requesting, conducting, and documenting
presubmission conferences. We have found that these meetings have
increased the efficiency of the drug development and drug review
processes. We encourage sponsors to submit data for review at the most
appropriate and productive times in the drug development process.
Rather than submitting all data for review as part of a complete
application, we have found that the submission of data supporting
discrete technical sections during the investigational phase of the new
animal drug is the most appropriate and productive. This ``phased
review'' of data submissions has created efficiencies for both us and
the animal pharmaceutical industry.
    Additionally, we have found that various uses of veterinary master
files have increased the efficiency of the drug development and drug
review processes for both us and the animal pharmaceutical industry. A
veterinary master file is a repository for submission to FDA's Center
for Veterinary Medicine of confidential detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more veterinary drugs. The
benefits of veterinary master files include confidential exchange of
information with FDA, a process for reporting information outside of a
NADA or an investigational new animal drug (INAD) file, as well as an
opportunity for increased communication with FDA during early stages of
product development. Respondents may choose to use veterinary master
files to provide and organize confidential detailed information to the
Agency. A holder of a veterinary master file may also authorize other
parties to reference information in the veterinary master file without
disclosing information in the file to those parties. Veterinary master
files can be used as repositories for information that can be
referenced in multiple submissions to the Agency, thus minimizing
paperwork burden. Veterinary master files are already used by the
animal pharmaceutical industry in support of information being
submitted for NADAs, abbreviated new animal drug applications (ANADAs),
INAD files, and generic investigational new animal drug (JINAD) files.
In previous information collection requests, we have included the time
necessary to compile and submit such information to veterinary master
files within the burden estimates provided for applications and amended
applications (for NADAs and INAD files) and abbreviated applications
and amended abbreviated applications (for ANADAs and JINAD files),
respectively. We are now combining the time necessary to compile and
submit such information to veterinary master files within the burden
estimates provided in this collection of information.
    We are also developing new approaches to permit more complex uses
of veterinary master files to facilitate the development of animal drug
products. We expect respondents will want to use veterinary master
files to submit information to us for review and consultation during
all phases of animal drug product development (including product
development that precedes the establishment of an INAD file or the
submission of a NADA). This information could include information about
processes, facilities, or articles used in the manufacturing,
processing, packaging, and storing of veterinary drugs and drug
substances. Information submitted to FDA through a veterinary master
file could also include drug characterization, methods, protocols, or
other relevant information. In this request for OMB review, we seek
approval of an increased use of veterinary master files by respondents
to submit additional information to us for review and consultation
during all phases of animal drug product development (including product
development that precedes the establishment of an INAD file or the
submission of a NADA). To account for an expected increase in reporting
burden hours associated with the increased use of veterinary master
files by respondents, we are separately estimating in table 1, row 10,
the burden of the use of veterinary master files during all phases of
product development (including product development that precedes the
establishment of an INAD file or the submission of a NADA).
    Finally, Sec.  558.5(i) of our regulations (21 CFR 558.5(i))
describes the procedure for requesting a waiver of the labeling
requirements of Sec.  558.5(h) in the event that there is evidence to
indicate that it is unlikely a new animal drug would be used in the
manufacture of a liquid medicated feed.
    The reporting associated with NADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(1) of the FD&C Act. We use the information collected to
review the data, labeling, and manufacturing controls and procedures to
evaluate the safety and effectiveness of the proposed new animal drug.
    Description of Respondents: Respondents include persons developing,
manufacturing, and/or researching new animal drugs.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
514.1 and 514.6; applications                182            0.05               9             212           1,908
 and amended applications.......
514.1(b)(8) and 514.8(c)(1); \2\             182            0.10              18              90           1,620
 evidence to establish safety
 and effectiveness..............
514.5(b), (d), (f); requesting               182            0.49              89              50           4,450
 presubmission conferences......
514.8(b); manufacturing changes              182            1.40             255              35           8,925
 to an approved application.....
514.8(c)(1); labeling and other              182            0.05               9              71             639
 changes to an approved
 application....................
514.8(c)(2) and (3); labeling                182            0.43              78              20           1,560
 and other changes to an
 approved application...........
514.11; submission of data,                  182            0.09              16               1              16
 studies, and other information.
558.5(i); requirements for                   182            0.01               2               5              10
 liquid medicated feed..........
Form FDA 356V...................             182            2.92             531               5           2,655

Use of veterinary master files                15               1              15              20             300
 during all phases of product
 development (including product
 development that precedes the
 establishment of an INAD file
 or the submission of a NADA)...
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           1,022  ..............          22,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
  antimicrobial concerns as part of the overall preapproval safety evaluation.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our previous
estimates. However, as discussed, we have separately estimated the
burden of the ``Use of veterinary master files during all phases of
product development (including product development that precedes the
establishment of an INAD file or the submission of an NADA)'' in table
1, row 10. We base our estimate of the total annual responses for the
use of veterinary master files on such uses initiated during calendar
year 2018. We base our estimate of the hours per response upon our
experience with the respondents' use of veterinary master files. We
estimate that the time it takes to compile information and submit it to
a veterinary master file will vary from 1 to 50 hours, depending on the
complexity of the information; therefore, we are estimating on average
the burden per response to be 20 hours. Accordingly, we report an
additional 300 burden hours and 15 total annual responses in row 10. We
are also correcting several rounding errors that were made in our last
request for OMB approval. Correcting these rounding errors reduces our
previously reported total burden hours and total responses. Thus, our
estimated burden for the information collection reflects a net overall
increase of 124 hours and a corresponding increase of 14 responses.

    Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02479 Filed 2-14-19; 8:45 am]
 BILLING CODE 4164-01-P