[Federal Register Volume 84, Number 102 (Tuesday, May 28, 2019)]
[Notices]
[Pages 24591-24592]
[FR Doc No: 2019-11060]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0154]

Agency Information Collection Activities: Requests for Comments;
Clearance of New Approval of Information Collection: Airspace
Authorizations in Controlled Airspace Under 49 U.S.C. 44809(a)(5)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The Federal Register Notice with a 60-day comment period soliciting
comments on the following collection of information was published on
March 11, 2019 at Volume 84, pages 8778-79. The FAA received no
comments during the 60-day comment period. The FAA proposes collecting
information pursuant to new requirements under the U.S.C. that limited
recreational operations of unmanned aircraft must now apply for
airspace authorizations in controlled airspace. The FAA will use the
collected information to make determinations whether to authorize or
deny the requested operation of UAS in controlled airspace. The
proposed information collection is necessary to issue such
authorizations or denials consistent with the FAA's mandate to ensure
safe and efficient use of national airspace.

DATES: Written comments should be submitted by June 27, 2019.

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

FOR FURTHER INFORMATION CONTACT: Casey Nair, FAA's UAS Low Altitude
Authorization and Notification Capability (LAANC) Program Manager by
email at<EMAIL_ADDRESS>phone:<PHONE_NUMBER>

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: This is a new collection.
    Title: Airspace Authorizations in Controlled Airspace under 49
U.S.C. 44809(a)(5).
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: New information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on March 11, 2019 (84 FR 8778). There were no comments
made during the comment period. Congress recently enacted the FAA
Reauthorization Act of 2018 (the Act), which was signed into law by the
President on October 5, 2018. Included within the Act is 49 U.S.C.
44809(a), which established limited recreational operations of unmanned
aircraft. Limited recreational operations are those operations
otherwise excepted from FAA certification and operating authority by
adhering to all of the limitations listed in 49 U.S.C. 44809(a)(1) thru
(8). Among the listed limitations that must be met, 49 U.S.C.
44809(a)(5) requires that these operations receive an authorization
from the FAA prior to conducting any small UAS flight in Class B, Class
C, Class D, or within the lateral boundaries of the surface area of
Class E airspace designated for an airport. This is a new requirement.
Previously, only persons operating under part 107 have been required to
request these authorizations pursuant to OMB Control Number 2120-0768.
    In order to process airspace authorization requests, the FAA
requires the operator's name, the operator's contact information, and
information related to the date, place, and time of the requested small
UAS operation. This information is necessary for the FAA to meet its
statutory mandate of maintaining a safe and efficient national
airspace. See 49 U.S.C. 40103, 44701, and 44807. Similar to the
existing process for part 107 operations, the FAA proposes to use LAANC
and a web portal to process airspace authorization requests for limited
recreational operations.
    Respondents: Limited recreational operators of small unmanned
aircraft seeking to conduct flights within Class B, Class C, Class D,
or within the lateral boundaries of the surface area of Class E
airspace designated for an airport. The FAA estimates that between
2019-2021 that it will receive 1,019,964 requests for airspace
authorizations or 339,988 per year. This number is a decrease from the
1,165,387 or 388,462 annual that was estimated in the 60-Day Notice due
to the change in forecast of UAS growth that was published in the FAA
Aerospace Forecast for Fiscal Years 2019-2039.
    Frequency: The requested information will need to be provided each
time a limited recreational operator respondent requests an airspace
authorization to conduct a limited recreational operation of a small
UAS in controlled airspace.
    Estimated Average Burden per Response: 5 minutes per response for
members of the public using LAANC and 30 minutes per response for
members of the public using the web portal.
    Estimated Total Annual Burden: Because the FAA has not previously
collected airspace authorization requests from users under 49 U.S.C

Sec.  44809(a)(5), the FAA used historical data related to airspace
authorization requests submitted by part 107 operators. Under part 107,
the FAA has received .318 requests per UAS registered and 85.2% of
those requests were made through LAANC and 14.8% of the requests were
made through the web portal. Applying these ratios to 49 U.S.C. 44809
respondents, the FAA estimates that the annual burden hours on
respondents will be 49,299 hours (24,139 hours for 289,669 LAANC
respondents and 25,160 hours for 50,319 web portal respondents) for
airspace authorizations. To determine this calculation, the FAA
estimates that a respondent will require 5 minutes (or .08 hours) to
complete the authorization request form using LAANC and 30 minutes (or
.5 hours) using the web portal. The estimated annual burden hours
decreased from the 55,224 hours published in the 60-Day Notice to
49,299 due to the change in forecast of UAS growth that was published
in the FAA Aerospace Forecast for Fiscal Years 2019-2039.

    Issued in Washington, DC, on May 22, 2019.
Casey Nair,
UAS LAANC Program Manager.
[FR Doc. 2019-11060 Filed 5-24-19; 8:45 am]
 BILLING CODE 4910-13-P


Comment Info: =================

General Comment:I was a pack and a half day smoker for almost 20 years and vaping has saved my life and helped end a run of smoking-related disease in my family. With heavy restriction and regulation of these life-saving, world-changing products, millions more are going to die and continue polluting our planet. Please listen to the people and dont take away our right to better our lives.

 A 75 day comment period is insufficient time for the vaping industry and the wider vaping community to comment on the proposed deeming regulations. I would respectfully request that the period for comment be extended to 180 days.


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2007-0449; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Delaware;

Reasonably Available Control Technology Under the 8-Hour Ozone National
Ambient Air Quality Standard

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the State of Delaware.  This SIP revision pertains
to the requirements in meeting the reasonably available control
technology (RACT) under the 8-hour ozone national ambient air quality
standard (NAAQS).  These requirements are based on (1) certification
that previously adopted RACT controls in Delaware’s SIP that were
approved by EPA under the 1-hour ozone NAAQS are based on the currently
available technically and economically feasible controls, and that they
continue to represent RACT for the 8-hour implementation purposes; (2)
the adoption of new or more stringent regulations that represent RACT
control levels; and (3) a negative declaration that certain categories
of sources do not exist in Delaware.  This action is being taken under
the Clean Air Act (CAA).

DATES:  Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-

2007-0449 by one of the following methods:

A.    www.regulations.gov.  Follow the on-line instructions for
submitting comments.

B.    E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

C.    Mail:  EPA-R03-OAR-2007-0449, Cristina Fernandez, Chief, Air
Quality Planning

Branch, Mailcode 3AP21, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

D.    Hand Delivery:  At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket(s normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2007-0449.  EPA's policy is that all comments received will
be included in the public docket without change, and

may be made available online at www.regulations.gov, including any
personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.  Do not submit
information that you consider to be CBI or otherwise protected through
www.regulations.gov or e-mail.  The www.regulations.gov website is an
(anonymous access( system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment.  If you send an e-mail comment directly to EPA without going
through  www.regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the Internet.  If you submit an
electronic comment, EPA recommends that you include your name and other
contact information in the body of your comment and with any disk or
CD-ROM you submit.  If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.  Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or

in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.  Copies of the State submittal
are available at the Delaware Department of Natural Resources &
Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware
19901.

FOR FURTHER INFORMATION CONTACT:  Rose Quinto,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:  On October 2, 2006, the Delaware Department
of Natural Resources and Environmental Control (DNREC) submitted a
revision to its SIP that addresses the requirements of RACT under the
8-hour ozone NAAQS.  On October 5, 2006, DNREC submitted a supplement to
this SIP revision.

I.  Background

Ozone is formed in the atmosphere by photochemical reactions between
volatile organic compounds (VOC), oxides of nitrogen (NOx) and carbon
monoxide (CO) in the presence of sunlight.  In order to reduce ozone
concentrations in the ambient air, the CAA requires all nonattainment
areas to apply control on VOC/NOx emission sources to achieve emission
reductions.  Among effective control measures, RACT controls are a major
group for reducing VOC and NOx emissions from stationary sources.

RACT is defined as the lowest emission limitation that a particular
source is capable of meeting by the application of control technology
that is reasonably available considering technological and economic
feasibility (44 FR 53761 at 53762, September 17, 1979).   Section 182 of
the CAA sets forth two separate RACT requirements for ozone
nonattainment areas.  The first requirement, contained in section
182(a)(2)(A) of the CAA, and referred to as RACT fix-up requires the
correction of RACT rules for which EPA identified deficiencies before
the CAA was amended in 1990.  Delaware has no deficiencies to correct
under this section of the CAA.  The second requirement, set forth in
section 182(b)(2) of the CAA, applies to moderate (or worse) ozone
nonattainment area as well as to marginal and attainment areas in ozone
transport regions (OTRs) established pursuant to section 184 of the CAA,
and requires these areas to implement RACT controls on all major VOC and
NOx emission sources and on all sources and source categories covered by
a control technique guideline (CTG) issued by EPA.

Under the 1-hour ozone NAAQS, Kent and New Castle Counties in Delaware
were designated part of a severe ozone nonattainment area, and Sussex
County was designated as a marginal ozone nonattainment area located in
an OTR.  Therefore, all three counties were subject to RACT requirements
under the 1-hour ozone standard.  Since the early 1990’s, Delaware
implemented numerous RACT controls throughout the State to meet the CAA
RACT requirements.  These RACT controls were promulgated in the Delaware
Air Pollution Control Regulation No. 24 for VOC sources and Regulation
No. 12 for NOx sources.

Under the 8-hour ozone NAAQS, the entire State of Delaware (Kent, New
Castle and Sussex Counties) is a part of the Philadelphia moderate
nonattainment area, and is therefore subject to the CAA requirements.
Delaware is required to submit to EPA a SIP revision that addresses how
Delaware meets the RACT requirements under the 8-hour ozone standard.
The entire State of Delaware is also part of the OTR established under
section 184 of the CAA.

EPA requires under the 8-hour ozone NAAQS that states meet the CAA RACT
requirements, either through a certification that previously adopted
RACT controls in their SIP revisions approved by EPA under the 1-hour
ozone NAAQS represent adequate RACT control levels for 8-hour attainment
purposes, or through the adoption of new or more stringent regulations
that represent RACT control levels.  A certification must be accompanied
by appropriate supporting information such as consideration of
information received during the public comment period and consideration
of new data.  This information may supplement existing RACT guidance
documents that were developed for the 1-hour standard, such that the
State’s SIP accurately reflects RACTs for the 8-hour ozone standard
based on the current availability of technically and economically
feasible controls.  Adoption of new RACT regulations will occur when
states have new stationary sources not covered by existing RACT
regulations, or when new data or technical information indicates that a
previously adopted RACT measure does not represent a newly available
RACT control level.  Another 8-hour ozone NAAQS requirement for RACT is
to submit a negative declaration that there are no CTG or non-CTG major
sources of VOC and NOx emissions within Delaware.

II.  Summary of SIP Revision

Delaware’s SIP revision contains the requirements of RACT set forth by
the CAA under the 8-hour ozone NAAQS.  Delaware’s SIP revision
satisfies the 8-hour RACT requirements through (1) certification that
previously adopted RACT controls in Delaware’s SIP that were approved
by EPA under the 1-hour ozone NAAQS are based on the currently available
technically and economically feasible controls, and continues to
represent RACT for the 8-hour implementation purposes; (2) the adoption
of new or more stringent regulations that represent RACT control levels;
and (3) a negative declaration that certain CTG or non-CTG major sources
of VOC and NOx sources do not exist in Delaware.

VOC RACT Controls

Delaware Air Pollution Control Regulation No. 1124 (formerly Regulation
24) contains Delaware’s VOC RACT controls that were implemented and
approved in the Delaware SIP under the 1-hour ozone NAAQS.

Table 1 lists Delaware’s VOC RACT controls.

Table 1	Delaware’s VOC RACT Controls

Regulation

1124	Control of Volatile Organic Compound Emissions (Formerly Regulation
24)

	Title of Regulation	State Effective Date	Federal Register Date	Citation

Section 10	Aerospace Coatings	02/11/03	03/24/04	69 FR 13737

Section 11	Mobile Equipment Repair and Refinishing	11/11/01	11/22/02	67
FR 70315

Section 12	Surface Coating of Plastics Parts	11/29/94	01/26/96	61 FR
2419

Section 13	Automobile and Light-Duty Truck Coating Operations	01/11/93
05/03/95	60 FR 21707

Section 14	Can Coating	01/11/93	05/03/95	60 FR 21707

Section 15	Coil Coating	01/11/93	05/03/95	60 FR 21707

Section 16	Paper Coating	01/11/93	05/03/95	60 FR 21707

Section 17 	Fabric Coating	01/11/93	05/03/95	60 FR 21707

Section 18	Vinyl Coating	01/11/93	05/03/95	60 FR 21707

Section 19	Coating of Metal Furniture	01/11/93	05/03/95	60 FR 21707

Section 20	Coating of Large Appliances	01/11/93	05/03/95	60 FR 21707

Section 21	Coating of Magnet Wire	11/29/94	01/26/96	61 FR 2419

Section 22	Coating of Miscellaneous Metal Parts	01/11/93	05/03/95	60 FR
21707

Section 23	Coating of Flat Wood Paneling	01/11/93	05/03/95	60 FR 21707

Section 24	Bulk Gasoline Plants	01/11/93	05/03/95	60 FR 21707

Section 25	Bulk Gasoline Terminals	11/29/92	01/26/96	61 FR 2419

Section 26	Gasoline Dispensing Facility – Stage I Vapor Recovery
01/11/02	11/14/03	68 FR 64520

Section 27	Gasoline Tank Trucks	01/11/93	05/03/95	60 FR 21707

Section 28	Petroleum Refinery Sources	01/11/93	05/03/95	60 FR 21707

Section 29	Leaks from Petroleum Refinery Equipment	11/29/94	01/26/96	61
FR 2419

Section 30	Petroleum Liquid Storage in External Floating Roof Tanks
11/29/94	01/26/96	61 FR 2419

Section 31	Petroleum Liquid Storage in Fixed Roof Tanks	11/29/94
01/26/96	61 FR 2419

Section 32	Leaks from Natural Gas/Gasoline Processing Equipment	11/29/94
01/26/96	61 FR 2419

Section 33	Solvent Metal Cleaning and Drying	11/11/01	11/22/02	67 FR
70315

Section 34	Cutback and Emulsified Asphalt	01/11/93	05/03/95	60 FR 21707

Section 35	Manufacture of Synthesized Pharmaceutical Products	11/29/94
01/26/96	61 FR 2419

Section 36	Stage II Vapor Recovery	01/11/02	11/14/03	68 FR 64540

Section 37	Graphic Arts Systems	11/29/94	01/26/96	61 FR 2419

Section 38	Petroleum Solvent Dry Cleaners	01/11/93	05/03/95	60 FR 21707

Section 39 	Perchloroethylene Dry Cleaning	01/11/93	05/03/95	60 FR 21707

Section 40	Leaks from Synthetic Organic Chemical, Polymer, and Resin
Manufacturing Equipment	01/11/93	05/03/95	60 FR 21707

Section 41	Manufacture of High-Density Polyethylene, Polypropylene and
Polystyrene Resins	01/11/93	05/03/95	60 FR 21707

Section 42	Air Oxidation Processes in the Synthetic Organic Chemical
manufacturing Industry	01/11/93	05/03/95	60 FR 21707

Section 43	Bulk gasoline marine Tank Vessel Loading Facilities	11/29/94
01/26/96	61 FR 2419

Section 44 	Batch Processing Operations	11/29/94	01/26/96	61 FR 2419

Section 45	Industrial Cleaning Solvents	11/29/94	01/26/96	61 FR 2419

Section 47	Offset Lithographic Printing	11/29/94	01/26/96	61 FR 2419

Section 48	Reactor Processes and Distillation Operations in the
Synthetic Organic Chemical Manufacturing Industry	11/29/94	01/26/96	61
FR 2419

Section 49	Control of Volatile Organic Compound Emissions from Volatile
Organic Liquid Storage Vessels	11/29/94	01/26/96	61 FR 2419

Section 50	Other Facilities that Emit Volatile Organic Compounds (VOCs)
11/29/94	01/26/96	61 FR 2419

Delaware adopted a new VOC RACT control for lightering operations
(Section 46) and submitted it to EPA as a SIP revision.  EPA approved
this VOC RACT on September 13, 2007 (72 FR 52285) with an effective date
of October 15, 2007.

Delaware also submitted a negative declaration that the following VOC
CTG or non-CTG major sources do not exist in Delaware:  manufacture of
pneumatic rubber tires; wood furniture manufacturing operations; and
shipbuilding and ship repair operations (surface coating).

NOx RACT Controls

Delaware Air Pollution Control Regulation No. 12 contains Delaware’s
NOx RACT controls that were implemented and approved into the Delaware
SIP under the 1-hour ozone NAAQS.

Table 2 lists Delaware’s NOx RACT controls.

Table 2	Delaware’s NOx RACT Controls

Regulation 12	Control of Nitrogen Oxide Emissions

Source Group	State Effective Date	Federal Register Date	Citation

Fuel burning equipment with an input capacity of 100 mmBTU/hour or
greater	11/24/93	06/14/01	66 FR 32231

Fuel burning equipment with an input capacity of 50 mmBTU/hour or
greater and less than 100 mmBTU/hour	11/24/93	06/14/01	66 FR 32231

Fuel burning equipment with an input capacity of less than 50 mmBTU/hour
11/24/93	06/14/01	66 FR 32231

Alternative requirement for fuel burning equipment - Seasonal fuel
switching (April 1 through October 31) to a low NOx emitting fuel
11/24/93	06/14/01	66 FR 32231

Gas turbines	11/24/93	06/14/01	66 FR 32231

Stationary internal combustion engines	11/24/93	06/14/01	66 FR 32231

Fuel burning equipment used exclusively for providing residential
comfort heating and hot water	11/24/93	06/14/01	66 FR 32231

Incinerator or thermal/catalytic oxidizer constructed before November
15, 1992, and used primarily for the control of air pollution	11/24/93
06/14/01	66 FR 32231

Fuel burning equipment with rated heat capacity of less than 15
mmBTU/hour	11/24/93	06/14/01	66 FR 32231

Stationary internal combustion engine with a rated capacity of less
than450 hp of output power	11/24/93	06/14/01	66 FR 32231

Any source operating during the month of November to the end of March
and operating with a capacity factor of five percent or less from April
1 to October 31	11/24/93	06/14/01	66 FR 32231

Any fuel burning equipment, gas turbine, or internal combustion engine
with an annual capacity factor of less than five percent	11/24/93
06/14/01	66 FR 32231

Case-by-case RACT determination	11/24/93	06/14/01	66 FR 32231

Delaware submitted a negative declaration that the following CTG or
non-CTG major sources of NOx emissions do not exist in Delaware:  cement
kilns and stationary internal combustion engines.

III.  Proposed Action

EPA is proposing to approve the Delaware SIP revision that addresses the
requirements of RACT under the 8-hour ozone NAAQS.  Delaware submitted
this SIP revision on October 2, 2006 and a supplement submittal on
October 5, 2006.  This SIP revision is based on a combination of (1)
certification that previously adopted RACT controls in Delaware’s SIP
that were approved by EPA under the 1-hour ozone NAAQS are based on the
currently available technically and economically feasible controls, and
that they continue to represent RACT for the 8-hour implementation
purposes; (2) the adoption of new or more stringent regulations that
represent RACT control levels; and (3) the negative declaration that
there are no CTG or non-CTG major sources of VOC and NOx emissions
within Delaware.  EPA is soliciting public comments on the issues
discussed in this document.  These comments will be considered before
taking final action.

IV.  Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law.  For that reason, this proposed action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
CAA; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this proposed rule, pertaining to the Delaware RACT under
the 8-hour ozone NAAQS, does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state, and
EPA notes that it will not impose substantial direct costs on tribal
governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

Authority: 42 U.S.C. 7401 et seq.

                              /s/

May 21, 2008
____________________________

Dated:                             		   		Donald S. Welsh,

Regional Administrator,

Region III.

 PAGE

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 PAGE  13


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on December 23, 2003

   NOTICE OF ACTION TAKEN -- DOCKET OST-2001-10493

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of      Delta Air Lines, Inc.         filed   7/28/03 to:

XX  Renew for two years exemption under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between the United States and Brazzaville, Republic of Congo, via Paris,
France, and to integrate this authority with its existing exemption and
certificate authority.  Delta provides service to these points on a
code-share basis with Air France.

Applicant rep:    Robert E. Cohn<PHONE_NUMBER>      DOT Analyst:
Sylvia Moore<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:  December 23, 2003, through
December 23, 2005, or until 90 days after final Department action on
Delta’s corresponding certificate application in Docket OST-99-6246,
whichever  occurs earlier.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The exemption authority granted is consistent with the overall state
of aviation relations between the United States and the Republic of
Congo and with the aviation agreement between the United States and
France.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX  Holder’s
Certificates of Public Convenience and Necessity

	    XX  Standard Exemption Conditions (attached)

                  XX  Statement of Authorization approving Delta/Air
France code-share operations  	    	           dated August 6, 1998, and
conditions therein

________________________

Conditions:  The route integration authority granted is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, (a) nothing in award of
the route integration authority requested should be construed as
conferring upon Delta rights (including fifth-freedom intermediate
and/or beyond rights) to serve markets where U.S. carrier entry is
limited unless Delta notifies the Department of its intent to serve such
a market and unless and until the Department has completed any necessary
carrier selection procedures to determine which carrier(s) should be
authorized to exercise such rights; and (b) should there

(See Reverse Side)

2

be a request by any carrier to use the limited-entry route rights that
are included in Delta’s authority by virtue of the route integration
exemption granted here, but that are not then being used by Delta, the
holding of such authority by route integration will not be considered as
providing any preference for Delta in a competitive carrier selection
proceeding to determine which carrier(s) should be entitled to use the
authority at issue.

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the exemption authority was consistent with the
public interest; and (3) grant of the authority would not constitute a
major regulatory action under the Energy Policy and Conservation Act of
1975.  To the extent not granted, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											8/2003


 	United States

Environmental Protection Agency	Office of Chemical Safety

and Pollution Prevention

(7101)	EPA 730-C-11-003

June 19, 2012

Product Performance

Test Guidelines

OCSPP 810.2600:

	Disinfectants and Sanitizers for Use in Water – Efficacy Data
Recommendations

NOTICE

This guideline is one of a series of test guidelines established by the
United States Environmental Protection Agency’s Office of Chemical
Safety and Pollution Prevention (OCSPP) for use in testing pesticides
and chemical substances to develop data for submission to the Agency
under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601, et seq.),
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C.
136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic
Act (FFDCA) (21 U.S.C. 346a).  Prior to April 22, 2010, OCSPP was known
as the Office of Prevention, Pesticides and Toxic Substances (OPPTS).
To distinguish these guidelines from guidelines issued by other
organizations, the numbering convention adopted in 1994 specifically
included OPPTS as part of the guideline’s number.  Any test guidelines
developed after April 22, 2010 will use the new acronym (OCSPP) in their
title.

	 The OCSPP test guidelines serve as a compendium of accepted scientific
methodologies and protocols that are intended to provide data to inform
regulatory decisions under TSCA, FIFRA and/or FFDCA.  This document
provides guidance for conducting the test, and is also used by EPA, the
public and the companies that are subject to data submission
requirements under TSCA, FIFRA and/or the FFDCA.  As a guidance
document, these guidelines are not binding on either EPA or any outside
parties, and the EPA may depart from the guidelines where circumstances
warrant and without prior notice.  At places in this guidance, the
Agency uses the word “should.”  In this guidance, the use of
“should” with regard to an action means that the action is
recommended rather than mandatory.  The procedures contained in this
guideline are strongly recommended for generating the data that are the
subject of the guideline, but EPA recognizes that departures may be
appropriate in specific situations. You may propose alternatives to the
recommendations described in these guidelines, and the Agency will
assess them for appropriateness on a case-by-case basis.

	For additional information about these test guidelines and to access
these guidelines electronically, please go to http://www.epa.gov/ocspp
and select “Test Methods & Guidelines” on the left side navigation
menu.  You may also access the guidelines in   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  grouped by
Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through
EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

OCSPP 810.2600:  Disinfectants and sanitizers for treating water –
efficacy data recommendations.

	(a)	Scope.—

	(1) Applicability.  This guideline describes test methods that EPA
believes will generally satisfy testing requirements of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et
seq.) and the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C.
346a).  It addresses testing to demonstrate the effectiveness of
antimicrobial pesticides bearing label claims for the disinfection or
sanitization of water.

(2) Background.  The source materials used in developing this OCSPP test
guideline are OPP guidelines 91-8 Products for treating water systems
and 91-30 Acceptable methods (Pesticide Assessment Guidelines,
Subdivision G, Product Performance, EPA report 540/9-82-026, October
1982).

	   (b) Purpose.  This guideline addresses efficacy testing for
antimicrobial pesticides intended to be used in water systems, namely
drinking water and swimming pools, as disinfectants or sanitizers.

	  (c) General considerations. –(1)  This guideline recommends methods
for use in tests to be conducted to address the data requirements for
pesticide registration.  Good Laboratory Practice Standards (GLP) as
defined in 40 CFR Part 160 apply to studies of disinfectants for water.
According to 40 CFR §160.17: “EPA may refuse to consider reliable for
purposes of supporting an application for a research or marketing permit
any data from a study which was not conducted in accordance with this
part.” 40 CFR §160.12(b) requires with any submitted research data
“[a] A statement that the study was conducted in accordance with this
part; [b] A statement describing in detail all differences between the
practices used in the study and those required by this part; or [c] A
statement that the person was not a sponsor of the study, did not
conduct the study, and does not know whether the study was conducted in
accordance with this part.” Note:  The Association of Official
Analytical Chemists (AOAC) recommended tests are designed to be
conducted as written. For deviations (e.g., cultures grown with shaking
instead of static, dilution of culture prior to drying on carriers)
proposed to be used in the conduct of these tests, obtain written
approval from the Agency and document such deviations in the study
reports submitted to the Agency. The Agency may consult with the AOAC
prior to accepting modifications to their standardized methods. Refer to
OCSPP Test Guideline 810.2000 for general testing recommendations prior
to initiating tests.

		(d)  Drinking water for humans—(1) Public water systems. Applicants
should contact EPA’s Antimicrobials Division prior to conducting
studies to support label claims for disinfection of public water
systems. Evidence should be submitted that the chemical intended for use
as a drinking water disinfectant is in compliance with the EPA’s
Office of Drinking Water’s regulations.

		(2)  Emergency water supplies. This section addresses efficacy testing
for additives such as solutions, powders, or tablets intended for
emergency disinfection of small quantities of drinking water of
questionable potability (e.g., water obtained from lakes, streams, etc),
by the general public, in the absence of bacteriological monitoring
facilities.

	(i) Test procedure.  The Agency recommends the use of The Guide
Standard and Protocol for Testing Microbiological Water Purifiers (Ref.
1).  Three samples of product, representing three different batches, one
of which should be at least 60 days old, should be tested in triplicate.
 The test organisms should be Raoultella terrigena – American Type
Culture Collection (ATCC) 33257 (R. terrigena) (formerly designated as
Klebsiella terrigena), Polio 1 (LSa) (ATCC VR-59), or Chat (ATCC
VR-1562) Rotavirus (Wa or SA-11) (ATCC VR-2018 or VR-1565),
Cryptosporidium parvum (C. parvum) and Giardia intestinalis (G.
intestinalis) (formerly Giardia lamblia). Giardia muris may be tested in
place of Giardia intestinalis.

	(ii) Evaluation of success—(A)  Bacteria. A 6-log10 (99.9999 percent)
reduction of an influent challenge of 1 x107 organisms per 100 mL of the
bacterial challenge organism R. terrigena should be demonstrated by the
testing.

(B)  Viruses.  A 4-log10 (99.99 percent) reduction of a mixed influent
challenge of 1 x 107 organisms per liter of each of the following
viruses: Poliovirus (LSa) and Rotavirus (Wa) should be demonstrated by
the testing. Virus types should be mixed in roughly equal 1 x 107/L
concentrations and a joint 4-log10 reduction should be demonstrated. MS2
coliphage virus may also be used as a surrogate for Poliovirus and
Rotavirus.

		(C)  Cysts (Protozoan).  A 3-log10 (99.9 percent) reduction of an
influent challenge of 1 x 106 organisms per liter of C. parvum and G.
intestinalis (or G. muris if tested) or a 3-log10 reduction of an
influent challenge of 1 x 107 particles or spheres of 4 to 6 um diameter
(as an option for units or components based on occlusion filtration,
where disinfection or other active processes are not involved) should be
demonstrated by the testing.

		(3) Water purifier units.  This section addresses efficacy testing for
products bearing label claims for microbiological water purification
(removal of pathogenic microorganisms).  This section does not apply to
products only used to treat water in order to achieve specific chemical
removal from water or other non-microbiological claims.  National
Sanitation Foundation (NSF) Standard 42 (Aesthetic Effects) provides
partial guidance for chemical removal.

		(i)  Test procedure.  The Agency recommends the use of The Guide
Standard and Protocol for Testing Microbiological Water Purifiers (Ref.
1).  This is a general guide and in some cases may present only the
minimum features and framework for the testing of microbiological water
purifiers. Users of the Guide Standard and Protocol should include
pre-testing of their units in a testing rig, including the sampling
techniques to be used. In some cases, it may be appropriate to alter
and/or add to the guide in order to meet specific operational problems,
to use an alternative organism or laboratory procedure, or to respond to
innovative treatment units. However, these alterations and/or additions
should not decrease the level of testing or alter the intent of the
protocol and should be submitted to the Antimicrobials Division for
approval prior to initiation of testing.

		(ii)  Evaluation of microbiological water purifier success—(A)
Bacteria.  A 6-log10 (99.9999 percent) reduction of an influent
challenge of 1 x 107 organisms per 100 mL of the bacterial challenge
organism Raoultella terrigena (ATCC) 33257) should be demonstrated by
the testing.

	(B)  Viruses.  A 4-log10 (99.99 percent) reduction of a mixed influent
challenge of 1 x 107 organisms per liter of each of the following
viruses: Poliovirus (LSa) (ATCC-VR-59) or Chat (ATCC 1562 and Rotavirus
(Wa) (ATCC-VR-2018) or SA11 (ATCC 1565) should be demonstrated by the
testing. Virus types should be mixed in roughly equal 1 x 107/L
concentrations and a joint 4-log10 reduction should be demonstrated. MS2
coliphage virus may also be used as a surrogate for Poliovirus and
Rotavirus.

	(C)   Cysts (Protozoan).  A 3-log10 (99.9 percent) reduction of an
influent challenge of 1 x 106 organisms per liter of Cryptosporidium
parvum and Giardia intestinalis (formerly Giardia lamblia) or Giardia
muris (if tested) or a 3-log10 reduction of an influent challenge of 1 x
107 particles or spheres of 4 to 6 um diameter (as an option for units
or components based on occlusion filtration, where disinfection or other
active processes are not involved) should be demonstrated by the
testing. Note: When using spheres as surrogates for oocysts, the charge
of the surrogate particle, the shape of the particle, the size range of
the particle, as well as the actual method of sample collection, are
critical to the accurate and conservative evaluation of the reduction
efficiency of size occlusion technologies.

	(D) Other Optional Protocols. The Agency will consider protocols
developed by the National Sanitation Foundation (NSF) International to
support microbiological water purifier label claims. Specifically, NSF
53, NSF 55, NSF 58 and NSF 62 may be used where appropriate. NSF
protocols P231 and P248 may also be used to generate data to support
label claims as microbiological water purifiers. A pre-registration
consultation is recommended prior to the use of any of these NSF
standards to ensure the data will support the label claims.

	(e)  Swimming pool, spa, and hot tub water. This section addresses
efficacy testing for disinfectants bearing label claims for use in
swimming pools, spas, and hot tubs. Numerous factors influence the
concentrations necessary for disinfection of swimming pool water in
practical applications: the number of swimmers/bathers in the pool;
frequency of use; frequency with which water is changed; general weather
conditions; and types and degree of organic contamination of the water
by the swimmers/bathers themselves (e.g., suntan lotion and oils) and by
various debris.  Therefore, a two-phased study, consisting of a
laboratory test and confirmatory field test, is recommended.

(1)  Test procedure - Laboratory test.  The Agency recommends the use of
the AOAC International Disinfectants (Water) for Swimming Pools (Ref.
2).  The test organisms should be Escherichia coli (E.coli) (ATCC 11229)
and Enterococcus faecium (E. faecium) (ATCC 6569) (formerly designated
as Streptococcus faecalis).

(i)  Evaluation of success.  The lowest concentration of the test
substance providing results equivalent to those of the sodium
hypochlorite reference standard is the lowest concentration of the
product that should be considered effective.

	(2)  Test procedure - Field test. The Agency recommends efficacy data
to be derived from in-use tests under an experimental use permit (EUP)
in at least two swimming pools, using the following components.

	(i)  Bacteriologic monitoring.  Bacteriologic monitoring of swimming
pool water following treatment with disinfectant product during the
field test should be conducted in the following manner: Water samples
for bacteriologic monitoring should be taken on opposite sides of the
pool in the shallow area and as remote as possible from the inlets,
preferably at the midpoint between the inlets.  A minimum of 144 samples
(72 samples per pool) should be collected during the test period.
Samples should be taken just below the surface of the water and
preferably at such times when the number of persons using the pool
during the preceding hour has been at least equal to 50 percent of the
maximum bather load of the pool and the number of persons in the pool
water at the time the samples are collected is at least 25 percent of
the maximum bather load (as defined in Suggested Ordinance and
Regulations Covering Public Swimming Pools, APHA Joint Committee on
Swimming Pools and Bathing Places) of the pool (Ref. 3).  Pertinent
chemical characteristics (e.g., pH, nitrogenous substances, metals, and
water hardness) of the pool water at the sampling site should be
determined at the time of sampling. (Ref. 4)

	(ii)  Field test.  Field tests should be conducted for an entire
swimming season (4 to 12 months).  Reports should include (but are not
limited to) the following information.

	(A)  The daily swimmer/bather load.

	(B)  The design of the pool, the recirculation and filter system, and
water capacity.

	(C)  The amount and identification of all chemicals added daily to the
swimming pool water (including the time, site, and method).

	(D)  The range of chemical characteristics of the swimming pool water
such as:  pH, nitrogenous substances, metals, and hardness.

	(E) The physical characteristics of the swimming pool water, including
temperature and clarity, determined at least daily.

	(F)  Meteorological data, including air temperature, rainfall, and
number of hours of sunlight (determined daily) for outdoor pools.

	(G)  Bacteriologic monitoring, conducted daily, in accordance with the
suggested Ordinance and Regulations Covering Public Swimming Pools of
the American Public Health Association. (Ref. 3)

	(H) The concentration of the antimicrobial agent in the swimming pool
monitored daily at the same time intervals that the bacteriological
assay samples are obtained.

	(I) The method that the product user will employ for monitoring the
level (concentration in ppm) of antimicrobial agent contained in the
pool water.

	(iii)  Evaluation of field testing success.  The product, when used as
recommended in swimming pool water, should demonstrate that not more
than 15 percent of the samples collected fail to meet the following
bacterial indices (Ref. 3):

(A) The standard plate count at 35°C not to exceed 200 colonies/1.0 mL.

(B) The most probable number of coliform bacteria to be less than 2.2
organisms/100.0 mL.  When the membrane filter test is used, no more than
1.0 coliform organism/50 mL.

		(C)  The most probable number of enterococcal organisms to be less
than 2.2 organisms/100 mL.  When the membrane filter test is used, no
more than 1.0 enterococcal organism/50 mL.

	(3) Optional Test Method. The Agency recommends use of NSF/ANSI
Standard 50. The test organisms should be Enterococcus faecium (ATCC
6569 and Pseudomonas aeruginosa (ATCC 27313).

	(i)  Evaluation of success. The product, when used as directed in
swimming pool water should demonstrate a 3-log kill of the two target
microorganisms, Enterococcus faecium and Pseudomonas aeruginosa.

		(f) Data collection and reporting—(1) General.  To assist in the
proper review and evaluation of product performance, complete
descriptions of the test employed and the results obtained should be
submitted to the Agency.  All test reports should include, at the least,
the following information:

		(i) Study title;

		(ii)  Product Identity;

		(iii)  Guideline number/Data Requirement;

		(iv)  Identification of the testing laboratory or organization;

		(v)  Location where the test was performed;

		(vi)  Name(s) of the person(s) responsible for the test;

		(vii)  Statement of Confidentiality Claims;

		(viii)  Statement of 40 CFR Part 160 Good Laboratory Practice
compliance and Quality Assurance Statement;

		(ix)  Purpose of the study;

		(x)  Date and time of the start and end of the test;

		(xi)  Test employed and any modifications (e.g., organic soil, hard
water, etc), when using standard tests (e.g., AOAC, ASTM, etc) all
deviations to the test methods should be reported;

		(xii)  Test microorganisms employed, including identification of the
specific strain (ATCC or other);

		(xiii)  Description of the test substance, including the percent of
active ingredient;

		(xiv)  Concentration or dilution of the product tested and how
prepared;

		(xv)  Number of samples, batches and replicates tested;

		(xvi)  Manufacture date of each product batch;

		(xvii)  Identification of all material or procedural options employed,
where such choice is provided for or recommended in the test method
selected (e.g., growth media, drying time for inoculated carriers,
neutralization confirmation and/or subculture media, secondary
subculturing);

		(xviii)  Test exposure conditions (e.g., contact time, temperature,
and relative humidity);

		(xix)  Complete reports of results obtained for each replication;

		(xx)  Any control data essential to establish the validity of the
test;

		(xxi)  Carrier counts;

		(xxii)  Statistical treatment of the data;

		(xxiii)  Conclusions;

		(xxiv)  References;

		(xxv)  Appendices, including study protocol and all raw data reports
associated with the conduct of the study;

The applicant is encouraged to use the EPA’s standard efficacy report
format, which may be found at  HYPERLINK
"http://www.epa.gov/oppad001/efficacystudystandards.htm"
http://www.epa.gov/oppad001/efficacystudystandards.htm .

		(2)  Data for modifications of recommended methods.  When recommended
methods are modified for testing conducted to support specific claims
and/or use patterns for a product, the protocol, identifying and
describing each modification, should be provided with the study report.
The applicant is encouraged to submit the proposed modification to the
Agency for review and evaluation prior to initiation of the test.

		(3)  Data for other methods.  When recommended methods, or
modifications thereto, are not employed to develop efficacy data (such
as actual in-use or many kinds of simulated-use testing), complete
testing protocols should be submitted with the test reports.  All
materials and procedures employed in testing should be described in a
manner consistent with original research reports published in technical
or scientific journals.  Where references to published reports or papers
are made, copies or reprints of such references should be provided with
the test reports.  The applicant should submit the proposed testing
protocols for in-use or simulated-use studies (with a proposed label to
show the claims to be supported by the protocol) to the Agency for
review and evaluation prior to initiation of the test.

		(g)  References.  The references in this paragraph may be consulted
for additional background information.

			(1)	Guide Standard and Protocol for Testing Microbiological Water
Purifiers.  United States Environmental Protection Agency, Registration
Division, Office of Pesticide Programs and Criteria and Standards
Division, Office of Drinking Water, April 1987.

			(2) Official Methods of Analysis of the Association of Official
Analytical Chemists, Use-Dilution Methods, Chapter 6, Disinfectants;
Current Edition.  Association of Official Analytical Chemists (AOAC),
2200 Wilson Boulevard Arlington, VA 22201.

			(3)	Suggested Ordinance and Regulations Covering Public Swimming
Pools.  Joint Committee on swimming Pools of the American Public Health
Association, in Cooperation with the United States Public Health
Service, 1964. The American Public Health Association, New York, NY.

			(4)	Standard Methods for the Examination of Water and Wastewater,
Current Edition, Standard Methods Online:
http://www.standardmethods.org.

 PAGE   1

Page   PAGE  7

Page   PAGE  1


[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Notices]
[Pages 35007-35009]
[FR Doc No: 2018-15782]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2733]

Pharmacy Compounding Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Pharmacy Compounding Advisory
Committee (PCAC). The general function of the committee is to provide
advice on scientific, technical, and medical issues concerning drug
compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act),
and, as required, any other product for which FDA has regulatory
responsibility, and to make appropriate recommendations to the Agency.
The meeting will be open to the public. FDA is establishing a docket
for public comment on this document.

DATES: The meeting will be held on September 12, 2018, from 8 a.m. to
4:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-2733. The docket will close on
September 11, 2018. Submit either electronic or written comments on
this public meeting by September 11, 2018. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 11, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
    Comments received on or before August 28, 2018, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact

information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): 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-2733 for ``Pharmacy Compounding Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA 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 be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Background: Section 503A of the FD&C Act (21 U.S.C. 353a) describes
the conditions that must be satisfied for human drug products
compounded by a licensed pharmacist in a State licensed pharmacy or a
Federal facility, or a licensed physician, to be exempt from the
following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21
U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice);
(2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of
drugs with adequate directions for use); and (3) section 505 (21 U.S.C.
355) (concerning the approval of human drug products under new drug
applications or abbreviated new drug applications).
    One of the conditions that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
product must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list developed by the Secretary through
regulations issued by the Secretary (the ``503A Bulks List'') (see
section 503A(b)(1)(A)(i) of the FD&C Act).
    Agenda: The committee will receive information on the following two
issues to follow up on discussions from previous PCAC meetings:
Balancing the criteria for the 503A bulk drug substance evaluation and
compounding as it relates to dietary supplements. In addition, the
committee will discuss six bulk drug substances nominated for inclusion
on the 503A Bulks List. FDA will discuss the following nominated bulk
drug substances: Alpha lipoic acid, coenzyme Q10, creatine monohydrate,
pyridoxal 5 phosphate, choline chloride, and quercetin. The chart below
identifies the use(s) FDA reviewed for each of the six bulk drug
substances being discussed at this advisory committee meeting. The
nominators of these substances will be invited to make a short
presentation supporting the nomination.

------------------------------------------------------------------------
             Drug                            Uses reviewed
------------------------------------------------------------------------
Alpha lipoic acid............  Diabetic neuropathy and associated pain,
                                acute liver toxicity from Amanita spp.
                                mushroom poisoning and other toxins,
                                hepatitis C, cancer, cirrhosis,
                                fibromyalgia, and muscle pain.
Coenzyme Q10.................  Mitochondrial disorders.
Creatine monohydrate.........  Mitochondrial disorders.
Pyridoxal 5 phosphate........  Epilepsy and seizure disorders.
Choline chloride.............  Hepatic steatosis, non-alcoholic fatty
                                liver disease, fetal alcohol spectrum
                                disorder, and atherosclerosis.

Quercetin....................  Asthma, allergy, cancer prevention and
                                treatment, and hypertension.
------------------------------------------------------------------------

    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before August 28, 2018, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 9:40 a.m., 10:45 a.m. and 10:55 a.m., 11:50
a.m. and 12 noon, 1:50 p.m. and 2 p.m., 3:05 p.m. and 3:15 p.m., and
4:10 p.m. and 4:20 p.m. Those individuals interested in making formal
oral presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before August 20, 2018. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by August
21, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jay Fajiculay (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: July 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15782 Filed 7-23-18; 8:45 am]
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[Federal Register: February 28, 2008 (Volume 73, Number 40)]
[Notices]
[Page 10764]
[DOCID:fr28fe08-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-516-002]

PJM Interconnection, L.L.C.; Notice of Filing

February 22, 2008.
    Take notice that on February 7, 2008, PJM Interconnection, L.L.C.
submitted revisions to the Reliability Pricing Model of its Open Access
Transmission Tariff filed on January 31, 2008.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 28, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-3758 Filed 2-27-08; 8:45 am]

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[Federal Register: April 13, 2006 (Volume 71, Number 71)]
[Proposed Rules]
[Page 19155]
[DOCID:fr13ap06-33]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2005-TN-0008-200534(b); FRL-8157-7]

Approval and Promulgation of Implementation Plans; Tennessee:
Revisions to Volatile Organic Compound Definition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Tennessee State
Implementation Plan (SIP), submitted by the Tennessee Department of
Environment and Conservation on September 7, 1998. This revision adds
16 compounds to the list of compounds excluded from the definition of
``Volatile Organic Compounds.'' In the Final Rules Section of this
Federal Register, EPA is approving the State's SIP revision as a direct
final rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no significant, material, and adverse comments are received in
response to this rule, no further activity is contemplated. If EPA
receives adverse comments, the direct final rule will be withdrawn and
all public comments received will be addressed in a subsequent final
rule based on this proposed rule. EPA will not institute a second
comment period on this document. Any parties interested in commenting
on this document should do so at this time.

DATES: Written comments must be received on or before May 15, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2005-TN-0008, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2005-TN-0008,'' Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: James Hou, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division 12th floor, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: James Hou, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-8965. Mr. Hou can also be reached via electronic mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: For additional information see the direct
final rule which is published in the Rules Section of this Federal
Register.

    Dated: March 31, 2006.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 06-3489 Filed 4-12-06; 8:45 am]

BILLING CODE 6560-50-P