[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Rules and Regulations]
[Pages 48066-48068]
[FR Doc No: 2019-19737]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0719]
RIN 1625-AA00

Safety Zone; New Jersey Intracoastal Waterway, Atlantic City, NJ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain navigable waters of the New Jersey Intracoastal Waterway. The
safety zone is needed to protect participants of the 4th Annual Ironman
70.3 Atlantic City Triathlon on these navigable waters near Atlantic
City, NJ, during a swim event on September 15, 2019. This regulation
prohibits non-participant persons and vessels from entering, transiting
through, anchoring in, or remaining within the safety zone unless
authorized by the Captain of the Port (COTP) Delaware Bay or a
designated representative.

DATES: This rule is effective from 5:30 a.m. through 10:30 a.m. on
September 15, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0719 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this rule,
call or email Petty Officer Thomas Welker, U.S. Coast Guard Sector
Delaware Bay, Waterways Management Division; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    This swim event is listed in the table to 33 CFR 110.506, section
(a), row (2), but because this year's course location has expanded
beyond the previously published boundaries, we are issuing a new
temporary rule to ensure coverage over the event location.
Additionally, we are using ``Safety Zone'' authorities to issue this
rule instead of the ``Special Local Regulation'' authorities under
which we published the permanent rule for this event.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary

to the public interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard
finds that good cause exists for not publishing a notice of proposed
rulemaking (NPRM) with respect to this rule because it is impracticable
and contrary to the public interest to do so. There is insufficient
time to allow for a reasonable comment period prior to the date of the
event. We are taking immediate action to ensure the safety of
participants and the general public from hazards associated with non-
participant vessel movement near the swim event. It is impracticable
and contrary to the public interest to publish an NPRM because we must
establish this safety zone by September 15, 2019.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because the rule must be in effect by September 15, 2019, to mitigate
the potential safety hazards associated with the swim event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). DelMoSports, LLC notified the Coast
Guard that it will host the 4th Annual Ironman 70.3 Atlantic City
Triathlon on September 15, 2019. The event will include a 1.2-mile swim
with up to 2800 participants. The swim course is on the waters of the
New Jersey Intracoastal Waterway in Atlantic City, NJ. The Captain of
the Port Delaware Bay (COTP) has determined that potential hazards
associated with this swim event scheduled for September 15, 2019, will
be a safety concern for participants and for vessels operating within
the specified waters of the New Jersey Intracoastal Waterway. The
purpose of this rulemaking is to protect participants, spectators, and
transiting vessels on certain waters of the New Jersey Intracoastal
Waterway before, during, and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 5:30 a.m. until 10:30 a.m.
on September 15, 2019. The safety zone will cover navigable waters of
the New Jersey Intracoastal Waterway between the Albany Avenue (Highway
40) bridge in the southwest and New Jersey Intracoastal Waterway
Daybeacon 204 in the northeast. Paragraph (a) of the regulation text
below provides a detailed description of the location. The duration of
the zone is intended to ensure the safety of participants and vessels
on these navigable waters before, during, and after the swim event
scheduled from 5:30 a.m. to 10:30 a.m. on September 15, 2019. No person
or vessel will be permitted to enter, transit through, anchor in, or
remain within the safety zone without obtaining permission from the
COTP Delaware Bay or a designated representative. If the COTP Delaware
Bay or a designated representative grants authorization to enter,
transit through, anchor in, or remain within the safety zone, all
persons and vessels receiving such authorization must comply with the
instructions of the COTP Delaware Bay or a designated representative.
The Coast Guard will provide public notice of the safety zone by Local
Notice to Mariners and Broadcast Notice to Mariners.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    The impact of this rule is not significant for the following
reasons: (1) The enforcement period will last five hours when vessel
traffic is usually low; (2) although non-participant persons and
vessels may not enter, transit through, anchor in, or remain with the
safety zone without authorization from the COTP Delaware Bay or a
designated representative, surrounding channels within the New Jersey
Intracoastal Waterways will remain unaffected. Persons and vessels will
be able to operate in the surrounding area during the enforcement
period; (3) persons and vessels will still be able to enter, transit
through, anchor in, or remain within the regulated area if authorized
by the COTP Delaware Bay or a designated representative; and (4) the
Coast Guard will provide advance notification of the safety zone to the
local maritime community by Local Notice to Mariners, Broadcast Notice
to Mariners, and on-scene actual notice from designated
representatives.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A. above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting only 4 hours that
will prohibit entry within certain navigable waters during a swim
event. It is categorically excluded from further review under paragraph
L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning
Implementing Procedures 5090.1. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0719 to read as follows:

Sec.  165.T05-0719  Safety Zone; New Jersey Intracoastal Waterway,
Atlantic City, NJ.

    (a) Location. The following area is a safety zone: All navigable
waters of the New Jersey Intracoastal Waterway in Atlantic City, NJ,
within the polygon bounded by the following: Originating at the
southeast portion of the Albany Avenue Bridge where the bridge crosses
the shoreline at approximate position latitude 39[deg]21'12'' N,
longitude 074[deg]27'23'' W; thence northeasterly along the shoreline
to latitude 39[deg]21'43'' N, longitude 074[deg]26'41'' W; thence west
across the New Jersey Intracoastal Waterway to the shoreline at
latitude 39[deg]21'42'' N, longitude 074[deg]26'51'' W; thence west
along the shoreline to latitude 39[deg]21'41'' N, longitude
074[deg]26'55'' W; thence southwest across the mouth of Beach Thorofare
to the shoreline at latitude 39[deg]21'35'' N, longitude
074[deg]27'06'' W; thence southwest along the shoreline to the
northeast portion of the Albany Avenue Bridge where the bridge crosses
the shoreline at approximate position latitude 39[deg]21'16'' N,
longitude 074[deg]27'26'' W; thence south along the eastern, outermost
edge of the bridge to the point of origin.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard petty
officer, warrant or commissioned officer on board a Coast Guard vessel
or on board a federal, state, or local law enforcement vessel assisting
the Captain of the Port (COTP), Delaware Bay in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter or remain in the zone, contact the
COTP or the COTP's representative via VHF-FM channel 16 or 215-271-
4807. Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (3) This section applies to all vessels except those engaged in law
enforcement, aids to navigation servicing, and emergency response
operations.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the safety zone by Federal, State, and local
agencies.
    (e) Enforcement period. This zone will be enforced from
approximately (but no earlier than) 5:30 a.m. to approximately (but not
later than) 10:30 a.m. on September 15, 2019.

    Dated: September 6, 2019.
Jonathan D. Theel,
Captain, U.S. Coast Guard, Acting Captain of the Port Delaware Bay.
[FR Doc. 2019-19737 Filed 9-11-19; 8:45 am]
BILLING CODE 9110-04-P


PART A OF THE SUPPORTING STATEMENT

1.	Identification of the Information Collection

1(a)	Title and Number of the Information Collection.

	“Information Collection Request Survey for the Aerospace
Manufacturing and Rework Industry.”  This is a new information
collection request (ICR), and the EPA ICR number 2395.01.  The OMB
Control number is 2060-NEW.

1(b)	Short Characterization.

	This information collection survey for aerospace manufacturing and
rework facilities was prepared by EPA’s Sector Policies and Programs
Division (SPPD) in the Office of Air Quality Planning and Standards
(OAQPS), and they are the intended users of the collected data.
Respondents are owners or operators of aerospace manufacturing and
rework facilities.  Aerospace manufacturing and rework was listed as a
source category under the Clean Air Act (CAA) on July 16, 1992 (57 FR
31576).  The CAA requires that a risk and technology review (RTR) be
conducted for this source category by September 1, 2003.  This
information collection will provide SPPD with the data necessary to
conduct the RTR.

	This survey was developed specifically for aerospace manufacturing and
rework facilities.  This information collection has been tailored to the
processes at aerospace facilities and uses an electronic submission
approach that will be less burdensome for both the facilities that must
respond and for EPA personnel who must compile the responses.
Respondents are asked to complete simple forms from available
information and no request is made to create or develop emission
estimates from information in the literature.

	Information is requested from approximately 1,000 aerospace
manufacturing and rework facilities on general facility information,
coatings and spray booth information, other process information (e.g.,
storage tanks, composite processing, etc.), emission control devices in
place and their basic design and operating features, quantity of air
emissions, pollution prevention programs at each facility, and
information regarding startup and shutdown events.  This information is
necessary for EPA to adequately characterize residual risk at these
facilities, to characterize emissions and control measures for
operations not currently regulated, and to develop standards for new and
existing aerospace facilities under section 112 of the CAA, if
appropriate.  The information will be collected from the electronic
completion of simple forms, which will be compiled to develop a computer
database.  The completed forms and the computer database will become
part of the rulemaking docket.

	EPA estimates that there will be roughly 1,000 survey respondents and
that they will incur a total burden of 46,955 hours at an estimated cost
of $2,261,288 as a result of this one-time collection.  The cost to the
Agency is estimated to be approximately $47,633.

2.	Need For and Use of the Collection

2(a)	Need/Authority for the Collection.

	The EPA is charged under section 112 of the CAA with developing
national emission standards for 189 listed HAP.  The Aerospace
Manufacturing and Rework Facilities Maximum Achievable Control
Technology (Aerospace MACT) standard (40 CFR 63, subpart GG), is a
National Emission Standard for Hazardous Air Pollutants (NESHAP)
developed under the authority of section 112(d) of the CAA.  EPA is
required to review each MACT standard and to revise them “as necessary
(taking into account developments in practices, processes and control
technologies)” no less frequently than every eight years.  These
reviews are commonly referred to as “technology reviews.”  In
addition, EPA is required to assess the risk remaining (residual risk)
after each MACT standard and promulgate more stringent standards if they
are necessary to protect public health.  Under EPA’s RTR program, EPA
is addressing these two requirements concurrently.  EPA is updating the
information they currently possess and filling identified data gaps in
that information in order to provide a thorough basis for the RTR
efforts.  The data collection effort will gather additional information
to allow comprehensive and technically sound analyses that will form the
basis for future rulemaking decisions.  The information is being
collected under the authority of section 114 of the CAA.

2(b)	Practical Utility/Users of the Data.

	The SPPD of the OAQPS uses the information gathered through the survey
form to conduct the RTR, on which future rulemaking decisions will be
based.

 3.	Nonduplication, Consultations and Other Collection Criteria

3(a)	Nonduplication.

	To the best of EPA’s knowledge, the data to be collected through this
survey is not available elsewhere.  A search of EPA’s ongoing
information collections revealed no duplication of information gathering
efforts, and the information that will be requested is not available
through other sources.

	In 1994, EPA surveyed aerospace manufacturing and rework facilities to
gather information to develop MACT standards for the aerospace industry.
 That survey was sent to a small portion of the industry and did not ask
for information about certain aerospace manufacturing operations and
emission source types.  The current survey does not duplicate the
previous survey.  Furthermore, in response to changes in market
conditions and regulatory requirements (such as the OSHA hexavalent
chromium exposure limit), EPA expects that many aerospace facilities
have changed their coatings, enclosed their spray booth operations and
reduced HAP content in solvents since 1994.  To the extent that some of
the questions in this survey are similar to those in the previous
survey, many of the answers that facilities will provide may have
changed in the intervening years.  Because the current survey will
collect different and updated information as compared to the previous
survey, the data collected in 1994 does not fulfill EPA’s current
needs, and the current survey is not duplicative of the previous survey.

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

	Pursuant to the Paperwork Reduction Act  (PRA) (44 U.S. C 3501 et
seq.), the EPA notified the public through a Federal Register notice
(see XX FR XXXX, date) of the Agency’s intent to submit the Aerospace
Industry Survey ICR to OMB.  The notice included a description of the
entities to be affected by the proposed survey, a brief explanation of
the need for the survey, identification of the statutory authority under
which the survey will be issued, and an estimate of burden to be
incurred by survey respondents.  Through the notice, the Agency
requested comments and suggestions regarding the survey and the
reduction of data collection burden.  A summary of the comments EPA
received and EPA’s responses are included in Attachment 3.

3(c)	Consultations.

	Under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with
potential ICR respondents and data users about specific aspects of ICRs
before submitting an original or renewal ICR to OMB for review and
approval.  EPA sent out a letter providing potential respondents with a
list of the data elements that will be included in the survey and
requested feedback on these data elements via written communication or
by participation in a conference call with EPA.  This teleconference
meeting was held December 18, 2009, at the EPA facilities in Research
Triangle Park, NC.  The list of data elements is included as Attachment
2 to this supporting statement.  The letter was sent to relevant trade
organizations and to over 1,200 facilities believed to be aerospace
manufacturing or rework facilities.  No feedback, either written or at
the meeting, was provided by potential respondents directly relating to
the data elements of the survey.  Some facilities did respond to the
letter to inform EPA that they were not aerospace manufacturing and
rework facilities or were area sources.

3(d)	Effects of Less Frequent Collection.

	This survey is to be administered one time only.  If this survey is not
conducted, the specific data sought in this survey will not be available
for EPA’s use in decision making about the need for and scope of
potential residual risk rules for the aerospace industry.

3(e)	General Guidelines.

	This information collection complies with the guidelines in 5 CFR
1320.5(d)(2).

3(f)	Confidentiality.

	All information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in Title 40, Chapter 1, Part 2, Subpart
B—Confidentiality of Business Information (CBI) (See 40 CFR 2; 41 FR
36902, September 1, 1976; amended by 43 FR 39999, September 8, 1978; 43
FR 42251, September 28, 1978; 44 FR 17674, March 23, 1979.)

3(g)	Sensitive Questions.

	This section is not applicable because this survey does not involve
matters of a sensitive nature.

4.	The Respondents and the Information Requested

4(a)	Respondents/NAICS Codes.

	Respondents associated with this information collection are owners or
operators of existing aerospace manufacturing and rework facilities.
The North American Industrial Classification Codes (NAICS) associated
with this industry are presented in Table 1.

Table 1.  North American Industrial Classification Codes for the
Aerospace Manufacturing and Rework Industry

NAICS Code	Description

	336411	Aircraft Manufacturing

336412	Aircraft Engine and Engine Parts Manufacturing

336413	Other Aircraft Parts and Auxiliary Equipment Manufacturing

336414	Guided Missile and Space Vehicle Manufacturing

336415	Guided Missile and Space Vehicle Propulsion Units and Propulsion
Units Parts Manufacturing

336419	Other Guided Missile and Space Vehicle Parts and Auxiliary
Equipment Manufacturing

481111	Scheduled Passenger Air Transportation

481112	Scheduled Freight Air Transportation

481211	Nonscheduled Chartered Passenger Air Transportation

481212	Nonscheduled Chartered Freight Air Transportation

481219	Other Nonscheduled Air Transportation

Approximately 1,000 aerospace manufacturing and rework facilities have
been identified to receive this survey.  EPA projects a total of about
1,000 responses under this ICR.

4(b)	Information Requested.

	4(b)(i)	Data items, including recordkeeping requirements.  A copy of
the survey and instructions are provided as Attachment 1.  There are no
recordkeeping requirements associated with this request.  Information is
requested from each respondent on general facility information, coating
and spray booth information, other processes (e.g., storage tanks, metal
finishing, etc.), air emissions from these booths and other processes,
and identification of capture and control devices.

	Part I (Introduction) provides guidance to the respondent and
highlights that no additional monitoring or testing is required to
respond to the request.  The introduction lists an EPA contact for
questions and provides the name and address to which the completed
survey should be mailed.  Instructions are also provided for submitting
the completed form electronically.  Finally, an outline of the
questionnaire form is provided.

	Part II (Instructions) provides instructions on how to complete each
form in the questionnaire.  There are general instructions and
instructions specific to each form.

	Form A-1 (Parent Company Information) asks for information about the
parent company, and size of the parent company, in order for EPA to
conduct an appropriate economic analysis for this category and evaluate
potential small entity impacts.

	  Form A-2 (Facility Information) is where the respondent (facility
contact person), company and facility are identified.  EPA will use this
information to ensure that its facility list is current and accurate, a
necessary component of achieving to represent the universe of sources in
any analyses.  Coordinates are requested, along with a typical operating
schedule for the facility.  In addition, questions are asked about the
products produced at the facility and if the facility is a major source
of HAP emissions.

	Form B-1 (Spray Booth Information) requests data for each spray booth
at the facility, including the type of booth, the location coordinates
of each booth, and the dimensions of each booth.  Information is also
requested on the type of particulate filter system used in the booth.
Control device information should also be provided.

	Form C-1 and C-2 (Coatings) are the same form except one requests the
information in English units and the other requests the information in
metric units.  Respondents do not have to fill out both forms, but can
fill out whichever one utilizes the data they have easily available.
Information is requested on the type of coating, including specialty
coatings and the HAP contained in each coating.  The forms also include
a section for the respondents to identify the spray booth that each
coating was applied in and the amount of coating that was applied.

	Form D-1 (Chemical Milling and Metal Finishing Operations) requests HAP
usage and emissions from chemical milling and metal finishing operations
at the facility.  Coordinates, dimensions and hours of operation are
requested for each tank.  Control device and work practice information
is also requested.

	Form E-1 (Blast Depainting/Cleaning Operations) is where the respondent
will report HAP emissions from blast depainting and cleaning operations
that use blasting methods.  In addition to emissions, coordinates,
dimensions and hours of operation are also requested.  Control device
and work practice information should also be recorded on this form.

	Form E-2 (Solvent Depainting Operations) is where the respondent will
report HAP emissions from depainting operations that use solvent
materials.  The same information is requested (e.g., emissions,
coordinates, control device) as in Form E-1.

	Form E-3 (Solvent Cleaning Operations) requests information on HAP
emissions from solvent cleaning operations such as hand-wipe cleaning of
aerospace components, cleaning of spray guns and cleaning of spray
booths.  In addition to HAP emissions, information is requested on
location coordinates, building dimensions, control devices and work
practices.

	Form E-4 (Solvent Cleaning Operations) requests information similar to
that requested on Form E-3, except that only cleaning operations subject
to the Halogenated Solvent Cleaning NESHAP (40 CFR 63, subpart T) should
be reported.  Even though halogenated solvent cleaning operations are
not subject to the aerospace NESHAP, the EPA is concerned that some
aerospace facilities may have mistakenly reported emissions from these
operations as emissions from operations subject to the aerospace NESHAP
in part reporting to state or local agencies.  In order to estimate the
residual risk accurately from each of these categories, the EPA is
attempting to first develop accurate emissions estimates.  The
respondents’ efforts to properly report halogenated solvent cleaning
operations on Form E-4 and not on Form E-3 will play an important role
in the EPA’s development of emissions estimates from these two
categories.

	Form F-1 and F-2 (Composite Processing Operations) are the same form
except one requests the information in English units and the other
requests the information in metric units.  Respondents do not have to
fill out both forms, but can fill out whichever one utilizes the data
they have easily available.  Information is requested on the type of
resins used in composite processing operations, the total volume of
resin used and information related to the spray booth used to apply the
resins.

	Form G-1 (Storage Tanks) is where the respondent will provide HAP
emissions from storage tanks used to store materials used in aerospace
manufacturing and rework operations.  The type of tank, the coordinates
of the tank, the dimensions of the tank, the HAP component of the
material in the tank and control device information are all requested.

	Form H-1 (Wastewater Treatment Operations) requests information on
wastewater treatment operations as they pertain to aerospace
manufacturing and rework operations.  The coordinates, dimensions, hours
of operation, HAP emissions and control device information are all
requested.

	Form I-1 (Startups and Shutdowns) provides examples of startup and
shutdown events that would be reported on this form.  Information on
this form is requested if it is readily available.  Additional testing
or data gathering is not required to complete this form for startup and
shutdown events.

	Forms J-1 to J-11 (Air Pollution Control Devices) provide a form for
each control device likely to be in use at aerospace manufacturing and
rework facilities.  If an air pollution control device is not in use at
the facility, the relevant form does not need to be filled out.  The
information requested for these forms should be readily available.  No
additional testing or data gathering is required in order to complete
these forms.

	Form K-1 (Air Pollution Control Device Costs) is where the respondent
will enter readily available information related to the cost of each air
pollution control device for which information was provided in Forms J-1
to J-11.

	4(b)(ii)	Respondent activities.  The survey will be sent to each
aerospace manufacturing and rework facility, who will be asked to
complete and return the survey instrument.  Completion of the survey
involves the following steps:

Reviewing instructions:  Respondents will need to read the instructions
for the survey;

Search data sources:  Respondents may need to consult records and review
facility information, in addition to gathering available data from
files, regarding coating usage, booth types, and other requested
information prior to completing the survey;

Complete and review the collection of information:  Respondents will
need to complete the survey and review their answers; and

Transmit or otherwise disclose the information:  Respondents will need
to return the completed survey to EPA.

The request does not require respondents to make measurements of
emissions or otherwise create information, and it relies on information
that should be readily available to the respondent.  Consequently, it is
consistent and compatible with existing reporting and recordkeeping
requirements because the survey asks only for this existing information.
 There is no need for respondents to develop or acquire technology or
systems to collect, process or disclose the information.

	Non-respondents will receive up to two reminder calls encouraging them
to participate.  If EPA decides to issue subpoenas because it does not
receive a sufficient response rate to accurately characterize the
industry, the initial non-respondents will need to review the subpoena,
as well as following the steps outlined above.

	This questionnaire asks for readily obtainable information, e.g.,
information known or easily accessible by technical, managerial or
supervisory employees of the facility who are responsible for
manufacturing, processing, technical services or marketing.  The
facility does not need to generate new information to complete the
survey.

	The collection will be a one-time event, and there will be no
requirement for respondents to maintain records to support their
responses.  However, EPA is suggesting that respondents keep a copy of
the completed questionnaire for their files in case the Agency contacts
them with any follow-up questions after reviewing their responses.

5.	The Information Collected – Agency Activities, Collection
Methodology and 	Information Management

5(a)	Agency Activities.

	Agency activities associated with the information collection include
preparing the questionnaire, answering respondent questions about the
questionnaire, reviewing data submissions, addressing requests for
confidentiality and compiling the data into a database.

5(b)	Collection Methodology and Management.

	Data collection will be accomplished using an electronic survey tool.
Recipients of the letter announcing the survey’s availability will be
directed to an EPA web page to download the files.  The respondent will
be asked to complete and return the survey within a three-month
timeframe.  Respondents will be encouraged to complete an electronic
copy of the survey and upload it to the EPA web page, which reduces
transcription errors when EPA processes the responses.  Non-respondents
will receive up to two reminder calls encouraging them to participate.
The web page will also have instructions on how to submit data that is
CBI.

	A written survey is being used because some of the information EPA is
requesting may require the respondent to consult records or other
documents at the facility, which would be difficult to do during a
telephone survey given the type of information requested and the number
of potential respondents.  In addition, the written survey method will
allow the respondent to complete the survey at his or her convenience.
Electronic transmission of the empty and completed survey forms will
lead to more efficient data collection, both in terms of reducing
mailing costs and paper usage and reducing transcription errors.  The
survey has been designed to be easily compiled into a database upon
receipt of the completed survey files.

	For this information collection, the submissions will be monitored for
completeness, and follow-up calls will be made to maximize the response
rate.  Confidential information will be maintained in secure locations
as required by procedures for handling CBI.  Confidential Business
Information will not be entered into the computer database.  Public
access to non-CBI information will be provided through the rulemaking
docket, which will contain the survey responses and a copy of the
resulting database.

5(c)	Small Entity Flexibility.

	EPA has identified a list of roughly 1,000 U.S. facilities with
aerospace manufacture or rework operations.  Some of these manufacturers
are small businesses as defined by the Small Business Administration’s
size standards.  EPA considered collecting data from only a sample of
manufacturers, but determined that a census (a survey administered to
the entire population of aerospace manufacturing and rework facilities,
including small businesses) is appropriate.  A census will more
accurately characterize the industry.  EPA needs to include small
businesses in the survey so that it can better estimate potential small
business impacts in the event the Agency ultimately decides to proceed
with a regulatory action.

	In developing the information request, SPPD considered whether a
separate request or no request for information should be made to small
facilities.  A major consideration was that the burden of responding to
the questionnaire is not excessive for small facilities.  Because they
have fewer and simpler processes, smaller facilities will require less
time to prepare a response than larger facilities.  The information
requested from the smaller facilities should be readily available and no
requests are made to perform measurements or create information.

	Many of the aerospace manufacturing and rework facilities meet the
definition of small business (e.g., companies with fewer than 1,000 or
1,500 employees total at all facilities for facilities in NAICS 2-digit
code 33, and companies with less than $7 million in annual average
receipts for facilities in NAICS 2-digit code 48), and information from
small entities is important to this regulatory development.  The
information collected from small entities will improve the analyses that
must be performed to assess the economic impact of a potential MACT
standard on them.  A Regulatory Flexibility Analysis must be performed
under the Regulatory Flexibility Act of 1980 if a proposed regulation
will have a significant economic impact on a substantial number of small
entities.  The information from small entities will also assist in
addressing the requirements of the Small Business Regulatory Enforcement
Fairness Act of 1996.

	Although many of these small businesses are not likely to be major
sources of HAP emissions, information on emissions and the level of
control performance achieved is needed from all facilities in the
industry to determine with reasonable accuracy the “average emission
limitation achieved” by the top-performing 12 percent of sources.  The
coverage of small facilities is especially important if any are in this
top 12 percent.

	In addition, the best controlled sources may include some of the
smaller facilities, which would affect the determination of MACT for new
aerospace facilities.  Information on smaller facilities will aid in
determining if a facility size cutoff is warranted, and if so, which of
the smaller facilities should be exempt from the MACT standard.  The
information on small facilities will also provide insight into pollution
prevention measures that might be applicable to larger facilities.  Even
if the smaller facilities are not major sources, the information from
their responses to the survey will be useful in determining if they are
significant area sources that may warrant regulation.

5(d)	Collection Schedule.

	The proposed mailing date for the survey is XXXX.  The respondents are
given three months to reply, with XXXX being the anticipated date when
all data is available for analysis by EPA.  The data will be used to
develop residual risk standards, if warranted, with proposal targeted
for August 2011 and promulgation in June 2010.

6.	Estimating the Burden and Cost of the Collection

6(a)	Estimating Respondent Burden.

	EPA will request that all U.S. aerospace manufacturing and rework
facilities complete the questionnaire forms.  Each section of the
questionnaire is expected to be completed by technical and clerical
staff and reviewed by managerial staff.  Respondent activities include
reading the cover letter and downloading the forms, reading the
instructions, gathering data, manipulating data for entry into the
forms, entering data into the forms and uploading the forms.  The
exhibit reflects the assumption that technical and clerical staff will
devote their time to reading instructions, gathering information,
completing the questionnaire forms and transmitting the information;
managerial staff will devote their time to reading instructions and
reviewing questionnaire responses.

	Table 2 presents the average number of hours required for each task for
respondents of three sizes:  small, medium and large.  Due to the wide
range in sizes of aerospace facilities, it was necessary to estimate the
burden for each size of facility.  Based on the industry’s facility
size breakdown contained in the proposal Background Information Document
for the Aerospace NESHAP, it is assumed that 84 percent of the
respondents are small facilities, 14 percent are medium facilities and
two percent are large facilities.  There are approximately 1,000
respondents expected to complete the questionnaire.

	A typical small-size facility respondent is estimated to need an
average of 30.75 hours to complete the questionnaire, while a typical
medium-size facility respondent is estimated to need an average of 86.74
hours to complete the questionnaire and a typical large-size facility
respondent is estimated to need an average of 142.75 hours to complete
the questionnaire.  These burden estimates include technical, management
and clerical hours.  Table 3 presents the burden estimate for small-size
facilities, while Table 4 presents the burden estimate for medium-size
facilities and Table 5 presents the burden estimate for large-size
facilities.  These unit burden estimates are average values.  As with
any average, some respondents will be above the average and others will
be below.

6(b)	Estimating Respondent Costs.

	The information collection activities and estimated costs for all
respondents are presented in Tables 3, 4  and 5.  The costs are based on
hourly rates estimated as follows:  technical at $49.80/hr, management
at $62.08/hr and clerical at $24.79/hr.  For a typical small-size
facility respondent, the costs are estimated as $1,703 (30.75 hours),
while for a typical medium-size facility respondent the costs are
estimated as $4,804 (86.75 hours), and for a typical large-size facility
the costs are estimated as $7,906 (142.75 hours).  There are no capital
or operation and maintenance costs.  A summary of the burden and costs
for all respondents is presented in Table 6.

6(c)	Estimating Agency Burden and Cost.

	The costs the federal government would incur would be for preparing the
questionnaire, answering respondent questions about the questionnaire,
reviewing data submissions, addressing requests for confidentiality and
compiling the data into a database.  The burden estimate is presented in
Table 7 at the end of this supporting statement.  Hourly labor rates
were taken from the Office of Personnel Management Salary Table 2010-GS
(effective January 2010) and are as follows:  technical (GS-12, Step 5)
at $32.73/hour, management (GS-15, Step 5) at $54.10/hr, and clerical
(GS-5, Step 5) at $14.90/hr.  The total costs for the Agency are
estimated as $47,633.

6(d)	Estimating the Respondent Universe and Total Burden and Costs.

	For small-size facilities, the total burden shown in Table 3 is
estimated as 1,291.5 management hours, 25,830 technical hours and 2,583
clerical hours at a cost of $1,430,543.  The total burden and costs are
based on 840 small-size aerospace facilities completing the survey.

	For medium-size facilities, the total burden shown in Table 4 is
estimated as 607.3 management hours, 12,145 technical hours and 1,214.5
clerical hours at a cost of $672,627.  The total burden and costs are
based on 140 medium-size aerospace facilities completing the survey.

	For large-size facilities, the total burden shown in Table 5 is
estimated as 142.8 management hours, 2,855 technical hours and 285.5
clerical hours at a cost of $158,118.  The total burden and costs are
based on 20 large-size aerospace facilities completing the survey.

6(e)	Bottom Line Burden Hours and Cost Tables.

	6(e)(i)	Respondent tally.  The total respondent burdens are given in
Table 6 and are estimated as 29,704.5 hours and $1,430,543 for
small-size respondents, 13,966.8 hours and $672,627 for medium-size
respondents and 3,283.3 hours and $158,118 for large-size respondents.
For all respondents, the total burden is estimated as 46,954.6 hours and
$2,261,288.

	6(e)(ii)	The Agency tally.  The total Agency burden is given in Table 7
and is estimated as 1,483.5 hours and $47,633.

	6(e)(iii)Variations in the annual bottom line.  This section does not
apply since no significant variation is anticipated.

6(f)	Reasons for Change in Burden.

	This section does not apply since this is a new collection.

6(g)	Burden Statement.

	The average respondent burden for each small-size facility is estimated
as 30.75 hours and a cost of $1,703.  The average respondent burden for
each medium-size facility is estimated as 86.75 hours and a cost of
$4,804.  The average respondent burden for each large-size facility is
estimated as 142.75 hours and a cost of 7,906.  This includes time to
read the cover letter and download the forms, read the instructions,
gather data, manipulate data for entry into forms, enter data into forms
and upload forms.  No capital costs or operation and maintenance costs
will be incurred.

	Burden means the total time, effort or financial resources expended by
persons to generate, maintain, retain or disclose or provide information
to or for a federal agency.  This includes the time needed to review
instructions; develop, acquire, install and utilize technology and
systems for the purposes of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.  An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.
The OMB control numbers for EPA’s regulations are listed in 40 CFR
part 9 and 48 CFR chapter 15.

	Send comments on the Agency’s need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, including through the use of automated
collection techniques to the Director, Office of Policy, Planning and
Evaluation (OPPE) Regulatory Information Division, U.S. Environmental
Protection Agency (2137), 401 M St., S.W., Washington, DC  20460; and to
the Office of Information and Regulatory Affairs, OMB, 725 17th Street,
NW, Washington, DC  20503, Attention:  Desk Officer for EPA.  Include
the EPA ICR number and OMB control number in any correspondence.

	PART B OF THE SUPPORTING STATEMENT

	This section is not applicable because statistical methods are not used
in the data collection associated with this information collection.

TABLE 2.  ESTIMATED RESPONDENT BURDEN FOR THE AEROSPACE ICR

Task	Technical Labor Hours by Facility Size

	Small	Medium	Large

Read cover letter/download forms	0.75	0.75	0.75

Read instructions	1.5	1.5	1.5

Gather data	20	60	100

Manipulate data for entry into forms	4	12	20

Enter data into forms	4	12	20

Upload forms	0.5	0.5	0.5

TOTAL TECHNICAL LABOR HOURS	  =SUM(ABOVE)  30.75 	  =SUM(ABOVE)  86.75
 =SUM(ABOVE)  142.75

TABLE 3.  ANNUAL RESPONDENT BURDEN AND COST FOR SMALL FACILITIES

Burden Item	(A)

Person hours per respondenta	(B)

Number of respondents	(C)

Technical person hours

(C = A x B)	(D)

Management person hours (0.05 x C)	(E)

Clerical person hours (0.1 x C)	(F)

Costb ($)

Read cover letter/download forms	0.75	840	630.0	31.5	63.0	34,891

Read instructions	1.5	840	1,260.0	63.0	126.0	69,783

Gather data	20	840	16,800.0	840.0	1,680.0	930,434

Manipulate data for entry into forms	4	840	3,360.0	168.0	336.0	186,087

Enter data into forms	4	840	3,360.0	168.0	336.0	186,087

Upload forms	0.5	840	420.0	21.0	42.0	23,260.86

TOTAL LABOR BURDEN AND COST	30.75	n/a	25,830.0	1,291.5	2,583.0	1,430,543

a See values in Table 1.

 b Costs were taken from the Bureau of Labor Statistics, National
Compensation Survey, Employer Costs for Employee Compensation
Supplementary Tables December 2007.  Supplementary Table 2 – Employer
costs per hour worked for employee compensation and costs as a percent
of total compensation:  Private industry workers in manufacturing
industries, by occupational group, establishment size and bargaining
status.  December 2007.  Available on-line at   HYPERLINK
"http://www.bls.gov/ect"  http://www.bls.gov/ect .  The cost for
technical person hours is $49.80/hour, taken from the total compensation
value for the “professional and related” occupational group.  The
cost for management person hours is $62.08/hr, taken from the total
compensation value for the “management, business and financial”
occupational group.  The cost for clerical person hours is $24.79/hr,
taken from the total compensation value for the “office and
administrative support” occupational group.

TABLE 4.  ANNUAL RESPONDENT BURDEN AND COST FOR MEDIUM FACILITIES

Burden Item	(A)

Person hours per respondenta	(B)

Number of respondents	(C)

Technical person hours

(C = A x B)	(D)

Management person hours (0.05 x C)	(E)

Clerical person hours (0.1 x C)	(F)

Costb ($)

Read cover letter/download forms	0.75	140	105.0	5.3	10.5	5,815

Read instructions	1.5	140	210.0	10.5	21.0	11,630

Gather data	60	140	8,400.0	420.0	840.0	465,217

Manipulate data for entry into forms	12	140	1,680.0	84.0	168.0	93,043

Enter data into forms	12	140	1,680.0	84.0	168.0	93,043

Upload forms	0.5	140	70.0	3.5	7.0	3,877

TOTAL LABOR BURDEN AND COST	86.75	n/a	12,145.0	607.3	1,214.5	672,627

a See values in Table 1.

b Costs were taken from the Bureau of Labor Statistics, National
Compensation Survey, Employer Costs for Employee Compensation
Supplementary Tables December 2007.  Supplementary Table 2 – Employer
costs per hour worked for employee compensation and costs as a percent
of total compensation:  Private industry workers in manufacturing
industries, by occupational group, establishment size and bargaining
status.  December 2007.  Available on-line at   HYPERLINK
"http://www.bls.gov/ect"  http://www.bls.gov/ect .  The cost for
technical person hours is $49.80/hour, taken from the total compensation
value for the “professional and related” occupational group.  The
cost for management person hours is $62.08/hr, taken from the total
compensation value for the “management, business and financial”
occupational group.  The cost for clerical person hours is $24.79/hr,
taken from the total compensation value for the “office and
administrative support” occupational group.

TABLE 5.  ANNUAL RESPONDENT BURDEN AND COST FOR LARGE FACILITIES

Burden Item	(A)

Person hours per respondenta	(B)

Number of respondents	(C)

Technical person hours

(C = A x B)	(D)

Management person hours (0.05 x C)	(E)

Clerical person hours (0.1 x C)	(F)

Costb ($)

Read cover letter/download forms	0.75	20	15.0	0.8	1.5	831

Read instructions	1.5	20	30.0	1.5	3.0	1,661

Gather data	100	20	2,000.0	100.0	200.0	110,766

Manipulate data for entry into forms	20	20	400.0	20.0	40.0	22,153

Enter data into forms	20	20	400.0	20.0	40.0	22,153

Upload forms	0.5	20	10.0	0.5	1.0	554

TOTAL LABOR BURDEN AND COST	142.75	n/a	2,855.0	142.8	285.5	158,118

a See values in Table 1.

b Costs were taken from the Bureau of Labor Statistics, National
Compensation Survey, Employer Costs for Employee Compensation
Supplementary Tables December 2007.  Supplementary Table 2 – Employer
costs per hour worked for employee compensation and costs as a percent
of total compensation:  Private industry workers in manufacturing
industries, by occupational group, establishment size and bargaining
status.  December 2007.  Available on-line at   HYPERLINK
"http://www.bls.gov/ect"  http://www.bls.gov/ect .  The cost for
technical person hours is $49.80/hour, taken from the total compensation
value for the “professional and related” occupational group.  The
cost for management person hours is $62.08/hr, taken from the total
compensation value for the “management, business and financial”
occupational group.  The cost for clerical person hours is $24.79/hr,
taken from the total compensation value for the “office and
administrative support” occupational group.

TABLE 6.  SUMMARY OF ESTIMATED RESPONDENT BURDEN FOR THE AEROSPACE ICR

	Value by Facility Size

	Small	Medium	Large

Total Number of Respondents	840	140	20

Total Labor Hours	29,704.5	13,966.8	3,283.3

Labor Hours Per Respondent	30.75	86.75	142.75

Total Labor Cost ($)	1,430,543	672,627	158,118

Labor Cost Per Respondent ($)	1,703	4,804	7,906

TABLE 7.  ANNUAL BURDEN AND COST FOR THE FEDERAL GOVERNMENT

Burden Item	(A)

EPA Hrs/Occurrence	(B)

Contractor Hrs/Occurrence	(C)

Number of Occurrences	(D)

Total EPA Hrs (AxC)	(E)

Total Contractor Hrs (BxC)	(F)

Total Hrs (D+E)c

Develop survey and industry mailing list	50.0	350.0	1	50.0	350.0	400.0

Distribute survey	40.0	0.0	1	40.0	0.0	40.0

Answer questionsa	0.1	0.25	200	20.0	50.0	70.0

Audit/review submissions	0.25	0.1	1000	250.0	100.0	350.0

Enter into database/QA check	0.0	0.3	1000	0.0	300.0	300.0

Analyze submissions and summarize results	0.0	80.0	1	0.0	80.0	80.0

Respond to requests for confidentialityb	0.3	0.2	100	30.0	20.0	50.0

TOTAL LABOR BURDEN AND COST	n/a	n/a	n/a	390.0	900.0	1,290.0

a It is assumed that questions will need to be answered for 20 percent
of the respondents.

b It is assumed that responses to requests for confidentiality will be
needed for 10 percent of the respondents.

c For the purposes of the cost calculations in this table, it is assumed
that EPA and Contractor hours for technical, management, and clerical
positions cost the same amount.

TABLE 7.  ANNUAL BURDEN AND COST FOR THE FEDERAL GOVERNMENT (cont.)

Burden Item	(G)

Technical person hours (=F) (GS12)	(H)

Management person hours (G x 0.05) (GS15)	(I)

Clerical person hours (G x 0.1) (GS5)	(J)

Costd ($)

Develop survey and industry mailing list	400.0	20.0	40.0	14,770.00

Distribute survey	40.0	2.0	4.0	1,477.00

Answer questionsa	70.0	3.5	7.0	2,584.75

Audit/review submissions	350.0	17.5	35.0	12,923.75

Enter into database/QA check	300.0	15.0	30.0	11,077.50

Analyze submissions and summarize results	80.0	4.0	8.0	2,954.00

Respond to requests for confidentialityb	50.0	2.5	5.0	1,846.25

TOTAL LABOR BURDEN AND COST	1,290.0	64.5	129.0	47,633.25

d Costs were taken from the U.S. Office of Personnel Management, Salary
Table 2010-GS, effective January 2010, available on-line at   HYPERLINK
"http://www.opm.gov/oca/10tables/html/gs_h.asp"
http://www.opm.gov/oca/10tables/html/gs_h.asp .  All hourly rates are
baseline values.  It was assumed that the technical person is a GS-12,
Step 5 employee with a rate of $32.73 per hour, that the management
person is a GS-15, Step 5 employee with a rate of $54.10 per hour, and
that the clerical person is a GS-5, Step 5 employee with a rate of
$14.90 per hour.

 PAGE

 PAGE   1


[Federal Register: December 5, 2007 (Volume 72, Number 233)]
[Notices]
[Page 68578-68580]
[DOCID:fr05de07-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PL07-2-000]

Composition of Proxy Groups for Determining Gas and Oil Pipeline
Return on Equity; Notice of Technical Conference and Request for
Additional Comments

Issued November 15, 2007.
    Before Commissioners: Joseph T. Kelliher, Chairman; Suedeen G.
Kelly, Marc Spitzer, Philip D. Moeller, and Jon Wellinghoff.
    1. On July 19, 2007, the Commission issued a proposed policy
statement, concerning the composition of the proxy groups used to
determine gas and oil pipelines' return on equity (ROE) under the
Discounted Cash Flow (DCF) method.\1\ Initial and reply comments were
due on August 30 and September 19, 2007 respectively. In this notice,
the Commission is requesting additional

comments on or before December 14, 2007, solely on the issue of master
limited partnership growth rates. The Commission is also establishing a
technical conference for further consideration of that one issue. The
technical conference will be held on January 8, 2008. The technical
conference will be organized around panels whose members will be
selected from among the parties who file comments. However, all parties
and the public are invited to attend. Additional comments on the growth
rate issue discussed at the technical conference will be due on January
25, 2008.
---------------------------------------------------------------------------

    \1\ Composition of Proxy Groups for Determining Gas and Oil
Pipeline Return on Equity, 120 FERC ] 61,068 (2007).
---------------------------------------------------------------------------

I. Background

    2. The Commission uses a DCF financial model to develop a range of
returns earned on investments in companies with corresponding risks for
determining the ROE for natural gas and oil pipelines. In the proposed
policy statement, the Commission proposed to modify its current policy
regarding the composition of the proxy group used in its DCF analysis
to allow master limited partnerships (MLPs) to be included in the proxy
group. The proposed policy statement found that cost of service
ratemaking requires that firms in the proxy group be of comparable risk
to the firm whose ROE is being determined in a particular rate
proceeding. The proposed policy statement found that expanding the
proxy group to include MLPs whose business is more narrowly focused on
pipeline activities would help provide a more representative proxy
group. The Commission proposed to cap the cash distribution used to
determine an MLP's return under the DCF method at the MLP's reported
earnings. The Commission found that this was necessary to exclude that
portion of an MLP's distributions constituting return of equity. The
Commission also proposed to require a showing that the MLP has had
stable earnings over a multi-year period, so as to justify a finding
that it will be able to maintain the current level of cash
distributions in future years. The proposed policy statement found that
these requirements should render the MLP's cash distribution comparable
to a corporation's dividend for purposes of the DCF analysis. Under the
proposed policy, the Commission would leave to individual cases the
determination of which specific MLPs and corporations should be
included in the proxy group.
    3. Interested parties filed some twenty-two initial comments and
fourteen reply comments, which focused on three issues: (1) Whether
MLPs should be included in the gas pipeline proxy group at all; (2)
whether the proposed cap on the MLP cash distributions used in the DCF
analysis is necessary or adequate; and (3) whether the short and long
term growth component of the DCF model should be modified given the
financial practices of MLPs. Other points include the potential
distorting effects of MLP tax treatment, the payouts by MLPs, the
general partner's incentive distributions, and the relative returns to
the limited and general partners. One party requested a technical
conference to discuss the issues.
    4. Based on its review of the comments to date, the Commission
believes that there is adequate material in the record to address most
issues without additional comments or addressing them at the technical
conference. These include: (1) Whether the Commission should permit
MLPs to be included in the proxy group for both gas and oil pipelines;
(2) the proposed earnings cap on the MLPs' distributions; and (3)
whether the Commission should explore other means of determining the
equity cost of capital at this time.
    5. However, the Commission concludes that the current record is
inadequate for deciding how an MLP's growth should be projected for
purposes of the DCF analysis. Currently, the Commission projects growth
in dividends based on an average of short- and long-term growth
projections, with two-thirds weight given to the short-term growth
forecast and one-third weight given to the long-term growth forecast.
The Commission uses the five-year growth forecasts published by the
Institutional Brokers Estimate System (IBES) for the short-term growth
forecast; long-term growth is based on forecasts of the growth of the
economy as a whole, as reflected in Gross Domestic Product (GDP). The
commenters generally agree that MLPs will have lower growth potential
than corporations, because of their distributions in excess of
earnings. However, the existing record is insufficient for the
Commission to determine (1) whether its current method of projecting
growth adequately reflects the lower growth potential of MLPs,
particularly over the long term,\2\ and (2) if not, what alternative
method should be used to project the growth of MLPs.
---------------------------------------------------------------------------

    \2\ See MLPs: Safe to Come Back into the Water, Wachovia Capital
Markets, LLC, Equity Research Department, at 9-10 (August 20, 2007),
attached to the initial comments of Enbridge Energy Partners, L.P.
and cited to in the reply comments of NYPSC at 5, using a projected
MLP long term annual growth rate of 2.5 percent. Currently, GDP is
projected to grow at a rate of approximately 4.5 percent.
---------------------------------------------------------------------------

    6. Therefore, the Commission has determined that the current record
must be supplemented before the Commission can resolve the issue of how
to project MLP growth rates, if the Commission ultimately decides to
permit the use of MLPs in the proxy group. In addition, the Commission
recognizes that the various components of the DCF model interact with
one another, with the result that the appropriate growth projection for
MLPs necessarily depends to some extent on whether the Commission caps
the distributions used to determine an MLP's dividend yield. Parties
should focus their comments and discussion at the technical conference
on the issue of the appropriate MLP growth projection and, in
particular, the appropriate growth projection if the Commission, as
recommended by certain parties, does not cap the distributions used to
determine dividend yield. In order to adequately consider the issue of
whether to cap such distributions, the Commission needs a more complete
record on the issue of growth projections.

II. Request for Comments and Notice of Technical Conference

    7. The Commission requests that the parties submit additional
comments on the issue of the appropriate growth component to be used in
the Commission's DCF model in the context discussed above, when
determining the equity cost of capital for an MLP. The comments must be
filed on or before December 14, 2007.
    8. The Commission is also establishing a staff led technical
conference to discuss the MLP growth issue to be held on Tuesday,
January 8, 2008. This conference is intended to be a working session
focused solely on the appropriate growth component to be used in the
Commission's DCF model when determining the equity cost of capital for
an MLP. It is, therefore, not appropriate to discuss at this technical
conference how the other components of the DCF model should be applied
in determining the equity cost of capital of an MLP. The conference
will be organized into a limited number of panel discussions.
    9. Parties interested in serving on a panel should so indicate in
their comments. To ensure that all points of view are represented and
to help the conference move expeditiously, the Commission encourages
parties sharing the same position to coordinate their efforts and
designate one speaker to represent their shared position.

    10. The Commission emphasizes that industry growth rates are a
highly technical, if critical issue. For this reason the Commission
strongly urges any party filing comments, or participating in a panel,
to provide technical analyses and utilize a speaker at the conference
who can respond to technical questions from the staff. The list of
prospective panel members will be announced in a later notice.
    11. All parties, whether or not selected to participate in a panel,
may file post-conference comments on or before January 25, 2008. The
post-conference comments should address only the MLP growth projection
issue discussed at the conference. For more information about the
conference or participation in panels, please contact John Robinson by
e-mail at<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER>.

III. Procedure for Comments

    12. The comments requested by this notice must refer to Docket No.
PL07-2-000, and must include the commentor's name, the organization it
represents, if applicable, and its address. To facilitate the
Commission's review of the comments, commentors are requested to
provide an executive summary of their position. Additional issues the
commentors wish to raise should be identified separately. The
commentors should double space their comments.
    13. Comments may be filed on paper or electronically via the
eFiling link on the Commission's Web site at http://www.ferc.gov. The

Commission accepts most standard word processing formats and commentors
may attach additional files with supporting information in certain
other file formats. Commentors filing electronically do not need to
make a paper filing. Commentors that are not able to file comments
electronically must send an original and 14 copies of their comments
to: Federal Energy Regulatory Commission, Office of the Secretary, 888
First Street, NE., Washington, DC 20426.
    14. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commentors are not required to
serve copies of their comments on other commentors.

IV. Document Availability

    15. 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) and

in the Commission's Public Reference Room during normal business hours
(8:30 a.m. to 5 p.m. Eastern time) at 888 First Street, NE., Room 2A,
Washington DC 20426.
    16. From the Commission's Home Page on the Internet, this
information is available in the Commission's document management
system, 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) in the docket number field.
    17. User assistance is available for eLibrary and the Commission's
Web site during normal business hours. For assistance, please contact
the Commission's Online Support at 1-866-208-3676 (toll free) or 202-
502-6652 (e-mail at<EMAIL_ADDRESS>or the Public Reference
Room at<PHONE_NUMBER>, TTY<PHONE_NUMBER> (e-mail at
public.referenceroom@ferc.gov).

    By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E7-23552 Filed 12-4-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Rules and Regulations]
[Pages 81438-81439]
[FR Doc No: 2010-32575]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0770; Airspace Docket No. 10-AGL-11]

Amendment of Class E Airspace; Columbus, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace for the Columbus, OH,
area, to accommodate Area Navigation (RNAV) Standard Instrument
Approach Procedures (SIAP) at Port Columbus International Airport,
Columbus, OH. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, March 10, 2011. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On October 21, 2010, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace for Columbus,
OH, creating additional controlled airspace at Port Columbus
International Airport (75 FR 64966) Docket No. FAA-2010-0770.
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and
effective

September 15, 2010, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designations listed in this document will be
published subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace extending upward from 700 feet
above the surface to accommodate SIAPs at Port Columbus International
Airport, Columbus, OH. This action is necessary for the safety and
management of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Port Columbus International
Airport, Columbus, OH.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface

AGL OH E5 Columbus, OH (Amended)

Columbus, Port Columbus International Airport, OH
    (Lat. 39[deg]59'53'' N., long. 82[deg]53'31'' W.)
Columbus, Rickenbacker International Airport, OH
    (Lat. 39[deg]48'50'' N., long. 82[deg]55'40'' W.)
Columbus, Ohio State University Airport, OH
    (Lat. 40[deg]04'47'' N., long. 83[deg]04'23'' W.)
Columbus, Bolton Field Airport, OH
    (Lat. 39[deg]54'04'' N., long. 83[deg]08'13'' W.)
Columbus, Darby Dan Airport, OH
    (Lat. 39[deg]56'31'' N., long. 83[deg]12'18'' W.)
Lancaster, Fairfield County Airport, OH
    (Lat. 39[deg]45'20'' N., long. 82[deg]39'26'' W.)
Don Scott NDB
    (Lat. 40[deg]04'49'' N., long. 83[deg]04'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Port Columbus International Airport, and
within 3.3 miles either side of the 094[deg] bearing from Port
Columbus International Airport extending from the 7-mile radius to
12.1 miles east of the airport, and within a 7-mile radius of
Rickenbacker International Airport, and within 4 miles either side
of the 045[deg] bearing from Rickenbacker International Airport
extending from the 7-mile radius area to 12.5 miles northeast of the
airport, and within a 6.5-mile radius of the Ohio State University
Airport, and within 3 miles either side of the 091[deg] bearing from
the Don Scott NDB extending from the 6.5-mile radius area to 9.8
miles east of the NDB, and within a 7.4-mile radius of Bolton Field
Airport, and within a 6.4-mile radius of Fairfield County Airport,
and within a 6.5-mile radius of Darby Dan Airport, excluding that
airspace within the London, OH, Class E airspace area.

    Issued in Fort Worth, Texas, on December 15, 2010.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-32575 Filed 12-27-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64080-64083]
[FR Doc No: 2019-25140]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4626]

List of Bulk Drug Substances for Compounding Office Stock Drugs
for Use in Nonfood-Producing Animals or Antidotes for Food-Producing
Animals; Request for Nominations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for nominations.

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

SUMMARY: FDA is establishing a public docket for interested parties to
nominate bulk drug substances or renominate bulk drug substances that
were previously nominated without adequate supporting information, for
inclusion on a list of bulk drug substances for compounding certain
animal drugs without a patient specific prescription (i.e., office
stock) for use in nonfood-producing animals or as antidotes for food-
producing animals, as described in the draft guidance for industry
#256, ``Compounding Animal Drugs from Bulk Drug Substances,'' when that
guidance is finalized. Individuals may also comment on bulk drug
substances that have been reviewed by FDA and added to this list, or
nominations that are currently under FDA review.

DATES: You may submit either electronic or written nominations and
comments at any time.

ADDRESSES: You may submit nominations and comments by any of the
following methods.

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 in the following ways:
     Mail/Hand Delivery/Courier (for 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-2018-N-4626 for ``List of Bulk Drug Substances for Compounding
Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes
for Food-Producing Animals.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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
nominations and 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: Eric Nelson, Division of Compliance
(HFV-230), Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Except with respect to the limited exemption provided by the
Federal Food, Drug, and Cosmetic Act (FD&C Act) described in the
following paragraph, statutory provisions applicable to manufactured
animal drugs under the FD&C Act also apply to animal drugs compounded
from bulk drug substances.
    Sections 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4)
and (5)) provide a limited exemption from certain requirements for
compounded animal drugs made from already FDA-approved animal or human
drugs. Such use is considered an extralabel use. The FD&C Act provides
that a compounded drug is exempt from the approval requirements in
section 512(a) of the FD&C Act and requirements for adequate directions
for use in section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) if
it meets the conditions set out in the statute and the extralabel use
regulations at 21 CFR part 530.
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of draft guidance for industry #256 entitled
``Compounding Animal Drugs from Bulk Drug Substances'' (GFI #256).\1\
The draft guidance describes circumstances under which FDA, based on
our current understanding of the risks of animal drugs compounded from
bulk drug substances, does not intend to take action against
pharmacists in either State-licensed pharmacies or Federal facilities,
or veterinarians, who compound animal drugs from bulk drug substances.
If the draft guidance is finalized, FDA would not intend to take action
under sections 512(a), 501(a)(5), 502(f), and 501(a)(2)(B) of the FD&C
Act so long as such compounding is done under the approach described in
draft GFI #256.
---------------------------------------------------------------------------

    \1\ Draft GFI #256 can be found at https://www.fda.gov/animal-veterinary/guidance-industry/guidance-number.
---------------------------------------------------------------------------

II. Nominating Bulk Drug Substances

    In a Federal Register notice published on May 19, 2015 (80 FR
28622), FDA invited all interested parties to nominate bulk drug
substances for inclusion on a list of bulk drug substances that could
be used by outsourcing facilities registered under the FD&C Act to
compound animal drugs under the conditions described in draft GFI #230,
``Compounding Animal

Drugs from Bulk Drug Substances'' (announced in the same issue of the
Federal Register (80 FR 28624)) (the 2015 request for nominations
notice).
    Although that draft guidance was subsequently withdrawn in November
2017, FDA received over 30 comments containing nominations for multiple
bulk drug substances in response to the 2015 request for nominations
notice. FDA's approach for evaluating whether to include a bulk drug
substance on the list described in the 2015 request for nominations
notice is substantially the same as the approach below for including a
bulk drug substance on the list of bulk drug substances for compounding
certain animal drugs without a patient specific prescription (i.e.,
office stock) for use in nonfood-producing animals or antidotes for
food-producing animals in accordance with FDA's draft guidance for
industry #256 (the List). As a result, CVM intends to include on the
List the eight bulk drug substances that FDA previously determined met
the approach set out in the now withdrawn 2015 draft guidance. To the
extent these substances and conditions of use meet the approach of the
final guidance, FDA intends to include them on the List when the draft
guidance is finalized.
     Apomorphine hydrochloride--Indication: For the induction
of emesis in dogs. Dosage form: 6.25 mg subconjunctival tablets, 3.125-
6.25 milligrams/milliliters (mg/ml) subconjunctival solution, and 2.5
mg/ml injectable solution.
     Cisapride--Indication: For the management of
gastrointestinal motility disorders in cats. Dosage form: 2.5 & 5 mg
oral tablets, 2.5 & 5 mg oral capsules, 5-10 mg/ml oral suspension.
     Dipyrone--Indication: For the treatment of severe, acute
fever in dogs suffering from Shar-Pei Fever. Dosage form: 250 mg/ml and
500 mg/ml injectable solution.
     Guaifenesin--Indication: For muscle relaxation in the
horse during anesthetic induction and/or surgery. Dosage form: 50 g
soluble powder to be reconstituted into a solution for IV infusion with
the addition of 500 ml (10%) or 1000 ml (5%) sterile diluent.
     Miconazole nitrate--Indication: For the treatment of
fungal keratitis in horses. Dosage form: 1% or 2% miconazole nitrate
ophthalmic solution or ophthalmic ointment.
     Potassium bromide--Indication: For initiation of treatment
for seizures in dogs. Dosage form: 250 mg/ml oral solution.
     Tacrolimus--Indication: For treatment of dogs with
keratoconjunctivitis sicca that is non-responsive to cyclosporine.
Dosage form: 0.01-0.03% tacrolimus ophthalmic drops.
     Metronidazole benzoate--Indication: For the treatment of
feline inflammatory bowel disease in cats. Dosage form: 80 mg/ml oral
suspension.
    The docket used to collect the previous nominations is now closed
for comment. However, FDA is establishing a new public docket so that
interested parties can nominate bulk drug substances, re-nominate bulk
drug substances with adequate supporting information that were
previously nominated without adequate supporting information, or
comment on the eight previously nominated bulk drug substances that FDA
intends to add to the List when the draft guidance is finalized. This
docket will remain open indefinitely so that individuals may nominate
and comment on bulk drug substances at any time.

When will FDA include a bulk drug substance on the list of bulk drug
substances for compounding office stock drugs for use in nonfood-
producing animals or antidotes for food-producing animals?

    FDA intends to include a bulk drug substance on the List when:
    1. There is no marketed FDA-approved, conditionally approved, or
indexed animal drug that can be used as labeled to treat the condition;
    2. There is no marketed FDA-approved animal or human drug that
could be used in an extralabel manner under section 512(a)(4) or (a)(5)
of the FD&C Act and part 530 to treat the condition;
    3. The drug cannot be compounded from a legally marketed FDA-
approved, conditionally approved, or indexed animal or human drug;
    4. Immediate treatment with the compounded drug is necessary to
avoid animal suffering or death; and
    5. FDA has not identified a significant safety concern specific to
the use of the bulk drug substance to compound animal drugs (under the
listed conditions and limitations).
    For bulk drug substances for compounding drugs intended for use as
antidotes in food-producing animals in addition to the above:
    6. There is sufficient scientific information for the veterinarian
to determine appropriate withdrawal, withholding, or discard time(s)
for meat, milk, eggs, or any food which might be derived from the
treated animal(s).

How do I submit a nomination for the list?

    You may submit nominations and comments to the docket through
https://www.regulations.gov. The information to support nominations can
be uploaded as attachments to your comment. The docket number is FDA-
2018-N-4626.
    You may submit written submissions to the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All submissions must include the Docket No. FDA-
2018-N-4626 for ``List of Bulk Drug Substances for Compounding Office
Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-
Producing Animals.''

What information should I submit with the nomination?

    You may nominate specific bulk drug substances for inclusion on the
List. Each bulk drug substance should be submitted to the docket as its
own, separate nomination. Submissions to the docket containing more
than one bulk drug substance will not be considered an adequate
nomination and will not be reviewed. In addition, nominations will only
be evaluated if they are for specific substances that meet the
definition of a bulk drug substance.\2\ Nominated substances that do
not meet this definition will not be evaluated for inclusion on the
List.
---------------------------------------------------------------------------

    \2\ FDA regulations define ``bulk drug substance'' and ``active
pharmaceutical ingredient'' as ``any substance that is intended for
incorporation into a finished drug product and is intended to
furnish pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or
to affect the structure or any function of the body.'' The terms do
not include intermediates used in the synthesis of the substance. 21
CFR 207.1. ``Active ingredient'' is defined as ``any component that
is intended to furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention
of disease, or to affect the structure or any function of the body
of man or other animals. The term includes those components that may
undergo chemical change in the manufacture of the drug product and
be present in the drug product in a modified form intended to
furnish the specified activity or effect.'' 21 CFR 210.3(b)(7). Any
component other than an active ingredient is an ``inactive
ingredient'' (21 CFR 210.3(b)(8)). Inactive ingredients used in
compounded drug products commonly include flavorings, dyes,
diluents, or other excipients. In addition, for purposes of
evaluating nominations, FDA considers bulk chemicals used to make
antidotes intended to treat toxicoses in animals to be bulk drug
substances.
---------------------------------------------------------------------------

    For FDA to evaluate a bulk drug substance for inclusion on the
List, you should submit the following information about the bulk drug
substance and the compounded animal drug in the nomination:
    1. Confirmation That the Nominated Substance is a Bulk Drug
Substance: A

statement that the nominated substance meets the definition of bulk
drug substance.
    2. Description of the Bulk Drug Substance:
    (a) Chemical name(s);
    (b) common name(s);
    (c) chemical grade (e.g., USP-NF, ACS, etc.);
    (d) description of the strength, stability, purity; and
    (e) how the bulk drug substance is supplied (e.g., powder, liquid).
    3. Description of the Animal Drugs That Will be Compounded With the
Bulk Drug Substance:
    (a) dosage form(s) into which the bulk drug substance will be
compounded (e.g., capsule, tablet, suspension);
    (b) strength(s) of the compounded drug(s); and
    (c) intended route(s) of administration of the compounded drug(s).
    4. Information Requested for FDA to Evaluate Bulk Drug Substances
for Inclusion on the List:
    (a) the species and condition(s) that the drug to be compounded
with the nominated bulk drug substance is intended to treat;
    (b) a bibliography of scientific literature containing safety and
effectiveness data for the drug compounded using the nominated
substance;
    (c) a list of animal drugs, if any, that are FDA-approved,
conditionally approved, or indexed for the condition(s) in the species
that the drug compounded with the nominated substance is intended to
address;
    (d) if there are marketed FDA-approved, conditionally approved, or
indexed drugs that address the same condition(s) in the same species,
an explanation, supported by relevant scientific literature or other
evidence, of why a compounded drug is necessary (e.g., why the FDA-
approved, conditionally approved, or indexed drug is not suitable for a
particular animal population);
    (e) confirmation, using supporting evidence, that there are no
marketed FDA-approved animal or human drugs that could be prescribed in
an extralabel manner under section 512(a)(4) and (a)(5) of the FD&C Act
and 21 CFR part 530 to treat the condition(s) in the species that the
drug compounded with the nominated substance is intended to address;
    (f) If the bulk drug substance is an active ingredient in a
marketed FDA-approved, conditionally approved, or indexed animal or
human drug, an explanation, supported by appropriate scientific data or
information, of why the animal drug cannot be compounded from the
marketed FDA-approved, conditionally approved, or indexed animal or
human drug.
    (g) An explanation, supported by relevant scientific literature or
other evidence, of why the animal drug to be compounded with the
nominated bulk drug substance must be available to the veterinarian for
immediate treatment to avoid animal suffering or death. Nominations
should include specific information documenting that animal suffering
or death will result if treatment is delayed until a compounded animal
drug can be obtained pursuant to a prescription for an individually
identified animal; and
    (h) A description of any human user or animal safety concerns
associated with use of the nominated bulk drug substance or finished
compounded drug for the condition(s) in the species that the compounded
drug is intended to address. If there are concerns, an explanation,
supported by scientific literature or other evidence, of why the
concerns should not preclude inclusion of that bulk drug substance on
the List.
    (i) For compounded drugs intended for use as antidotes to treat
toxicoses in food-producing animals, relevant scientific literature or
other evidence that demonstrates that the prescribing veterinarian has
a basis for determining appropriate withdrawal, withholding, or discard
time(s) for meat, milk, eggs, or any food which might be derived from
the treated animal(s).

    Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25140 Filed 11-19-19; 8:45 am]
 BILLING CODE 4164-01-P


Placeholder for document 147; this document is titled " Response to Section 114 Request for Information Concerning Albemarle Corporation's Inventories of Methyl Bromide as of December 31, 2002, dated January 16, 2003" and contains Confidential Business Information.

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