[Federal Register Volume 88, Number 131 (Tuesday, July 11, 2023)]
[Proposed Rules]
[Pages 44065-44068]
[FR Doc No: 2023-14611]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 88, No. 131 / Tuesday, July 11, 2023 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1403; Project Identifier MCAI-2023-00479-T]
RIN 2120-AA64

Airworthiness Directives; Dassault Aviation Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2020-03-19, which applies to certain Dassault Aviation Model MYSTERE-
FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. AD 2020-03-19 requires
revising the existing maintenance or inspection program, as applicable,
to incorporate new or more restrictive airworthiness limitations. Since
the FAA issued AD 2020-03-19, the FAA has determined that new or more
restrictive airworthiness limitations are necessary. This proposed AD
would continue to require the actions in AD 2020-03-19 and would
require revising the existing maintenance or inspection program, as
applicable, to incorporate additional new or more restrictive
airworthiness limitations, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is proposed for incorporation by
reference (IBR). The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 25,
2023.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to regulations.gov. Follow
the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-1403; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this NPRM, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
street address for Docket Operations is listed above.
    Material Incorporated by Reference:
     For EASA material that is proposed for IBR in this NPRM,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email [email protected]; website easa.europa.eu. You
may find this material on the EASA website at ad.easa.europa.eu. It is
also available at regulations.gov under Docket No. FAA-2023-1403.
     For Dassault service information identified in this NPRM,
contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box
2000, South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; website
dassaultfalcon.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aviation Safety
Engineer, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone:
206-231-3226; email: [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2023-1403; Project Identifier
MCAI-2023-00479-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
regulations.gov, including any personal information you provide. The
agency will also post a report summarizing each substantive verbal
contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to Tom
Rodriguez, Aviation Safety Engineer, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; email: [email protected].
Any commentary that the FAA receives that is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA issued AD 2020-03-19, Amendment 39-19843 (85 FR 11280,
February 27, 2020) (AD 2020-03-19), for certain Dassault Aviation Model
MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. AD 2020-03-19
was prompted by an MCAI originated by EASA, which is the Technical
Agent for the Member States of the European Union. EASA issued AD 2019-
0200R1, dated August 29, 2019 (EASA AD 2019-0200R1) (which corresponds
to FAA AD 2020-03-19), to correct an unsafe condition.

    AD 2020-03-19 requires revising the existing maintenance or
inspection program, as applicable, to incorporate new or more
restrictive airworthiness limitations. The FAA issued AD 2020-03-19 to
address fatigue cracking, damage, and corrosion in principal structural
elements, which could result in reduced structural integrity of the
airplane. AD 2020-03-19 specifies that accomplishing the actions
required by that AD terminates the requirements of paragraph (g)(1) of
AD 2010-26-05, Amendment 39-16544 (75 FR 79952, December 21, 2010) (AD
2010-26-05) only for Dassault Aviation Model MYSTERE-FALCON 20-C5, 20-
D5, 20-E5, and 20-F5 airplanes on which the Supplemental Structural
Inspection Program has not been embodied into the airplane's existing
maintenance or inspection program. This proposed AD would therefore
continue to allow that terminating action.

Actions Since AD 2020-03-19 Was Issued

    Since the FAA issued AD 2020-03-19, EASA superseded AD 2019-0200R1
and issued EASA AD 2023-0058, dated March 16, 2023 (EASA AD 2023-0058)
(referred to after this as the MCAI), for certain Dassault Aviation
MYSTERE-FALCON 20-( )5 series airplanes. The MCAI states that new or
more restrictive airworthiness limitations have been developed.
    The FAA is proposing this AD to address fatigue cracking, damage,
and corrosion in principal structural elements, which could result in
reduced structural integrity of the airplane. You may examine the MCAI
in the AD docket at regulations.gov under Docket No. FAA-2023-1403.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2023-0058. This service information
describes procedures for airworthiness limitations for safe life limits
and certification maintenance requirements.
    This proposed AD would also require Chapter 5-40-00, Airworthiness
Limitations, of the Dassault Falcon 20 Retrofit 731 Maintenance Manual,
Revision 13, dated January 1, 2019, which the Director of the Federal
Register approved for incorporation by reference as of April 2, 2020
(85 FR 11280, February 27, 2020).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES.

FAA's Determination

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI and
service information referenced above. The FAA is issuing this NPRM
after determining that the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements in This NPRM

    This proposed AD would retain all of the requirements of AD 2020-
03-19. This proposed AD would also require revising the existing
maintenance or inspection program, as applicable, to incorporate
additional new or more restrictive airworthiness limitations, which are
specified in EASA AD 2023-0058 already described, as proposed for
incorporation by reference. Any differences with EASA AD 2023-0058 are
identified as exceptions in the regulatory text of this AD.
    This proposed AD would require revisions to certain operator
maintenance documents to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance (AMOC) according to
paragraph (m)(1) of this proposed AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result, the
FAA proposes to incorporate EASA AD 2023-0058 by reference in the FAA
final rule. This proposed AD would, therefore, require compliance with
EASA AD 2023-0058 through that incorporation, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. Using common terms that are the same as the heading of a
particular section in EASA AD 2023-0058 does not mean that operators
need comply only with that section. For example, where the AD
requirement refers to ``all required actions and compliance times,''
compliance with this AD requirement is not limited to the section
titled ``Required Action(s) and Compliance Time(s)'' in EASA AD 2023-
0058. Service information required by EASA AD 2023-0058 for compliance
will be available at regulations.gov by searching for and locating
Docket No. FAA-2023-1403 after the FAA final rule is published.

Airworthiness Limitation ADs Using the New Process

    The FAA's process of incorporating by reference MCAI ADs as the
primary source of information for compliance with corresponding FAA ADs
has been limited to certain MCAI ADs (primarily those with service
bulletins as the primary source of information for accomplishing the
actions required by the FAA AD). However, the FAA is now expanding the
process to include MCAI ADs that require a change to airworthiness
limitation documents, such as airworthiness limitation sections.
    For these ADs that incorporate by reference an MCAI AD that changes
airworthiness limitations, the FAA requirements are unchanged.
Operators must revise the existing maintenance or inspection program,
as applicable, to incorporate the information specified in the new
airworthiness limitation document. The airworthiness limitations must
be followed according to 14 CFR 91.403(c) and 91.409(e).
    The previous format of the airworthiness limitation ADs included a
paragraph that specified that no alternative actions (e.g.,
inspections) or intervals may be used unless the actions and intervals
are approved as an AMOC in accordance with the procedures specified in
the AMOCs paragraph under ``Additional AD Provisions.'' This new format
includes a ``New Provisions for Alternative Actions and Intervals''
paragraph that does not specifically refer to AMOCs, but operators may
still request an AMOC to use an alternative action or interval.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 56 airplanes of U.S. registry. The FAA estimates the following
costs to comply with this proposed AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2020-03-19 to be $7,650 (90 work-hours x $85 per work-
hour).

    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. Since operators incorporate maintenance or inspection
program changes for their affected fleet(s), the FAA has determined
that a per-operator estimate is more accurate than a per-airplane
estimate.
    The FAA estimates the total cost per operator for the new proposed
actions to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2020-03-19, Amendment 39-19843
(85 FR 11280, February 27, 2020); and
0
b. Adding the following new AD:

Dassault Aviation: Docket No. FAA-2023-1403; Project Identifier
MCAI-2023-00479-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 25, 2023.

(b) Affected ADs

    (1) This AD replaces AD 2020-03-19, Amendment 39-19843 (85 FR
11280, February 27, 2020) (AD 2020-03-19).
    (2) This AD affects AD 2010-26-05, Amendment 39-16544 (75 FR
79952, December 21, 2010) (AD 2010-26-05).

(c) Applicability

    This AD applies to Dassault Aviation Model MYSTERE-FALCON 20-C5,
20-D5, 20-E5, and 20-F5 airplanes, certificated in any category, as
identified in European Union Aviation Safety Agency (EASA) AD 2023-
0058, dated March 16, 2023 (EASA AD 2023-0058).

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Unsafe Condition

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking, damage, and corrosion
in principal structural elements. The unsafe condition, if not
addressed, could result in reduced structural integrity of the
airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Revision of the Existing Maintenance or Inspection
Program, With a New Terminating Action

    This paragraph restates the requirements of paragraph (g) of AD
2020-03-19, with a new terminating action. Within 90 days after
April 2, 2020 (the effective date of AD 2020-03-19), revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Chapter 5-40-00,
Airworthiness Limitations, of the Dassault Falcon 20 Retrofit 731
Maintenance Manual, Revision 13, dated January 1, 2019. The initial
compliance time for doing the tasks is at the time specified in
Chapter 5-40-00, Airworthiness Limitations, of the Dassault Falcon
20 Retrofit 731 Maintenance Manual, Revision 13, dated January 1,
2019, or within 90 days after April 2, 2020, whichever occurs later.
Accomplishing the revision of the existing maintenance or inspection
program required by paragraph (i) of this AD terminates the
requirements of this paragraph.

(h) Retained Restrictions on Alternative Actions, Intervals, With a New
Exception

    This paragraph restates the requirements of paragraph (h) of AD
2020-03-19, with a new exception. Except as required by paragraph
(i) of this AD, after the existing maintenance or inspection program
has been revised as required by paragraph (g) of this AD, no
alternative actions (e.g., inspections) or intervals are allowed
unless the actions or intervals are approved as an alternative
method of compliance (AMOC) in accordance with the procedures
specified in paragraph (m)(1) of this AD.

(i) New Revision of the Existing Maintenance or Inspection Program

    Except as specified in paragraph (j) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2023-0058. Accomplishing the revision of
the existing maintenance or inspection program required by this
paragraph terminates the requirements of paragraph (g) of this AD.

(j) Exceptions to EASA AD 2023-0058

    (1) This AD does not adopt the requirements specified in
paragraphs (1) and (2) of EASA AD 2023-0058.
    (2) Paragraph (3) of EASA AD 2023-0058 specifies revising ``the
approved AMP'' within 12 months after its effective date, but this
AD requires revising the existing maintenance or inspection program,
as applicable, within 90 days after the effective date of this AD.
    (3) The initial compliance time for doing the tasks specified in
paragraph (3) of EASA AD 2023-0058 is at the applicable
``limitations'' as incorporated by the requirements of paragraph (3)
of EASA AD 2023-0058, or within 90 days after the effective date of
this AD, whichever occurs later.
    (4) This AD does not adopt the provisions specified in
paragraphs (4) and (5) of EASA AD 2023-0058.
    (5) This AD does not adopt the ``Remarks'' section of EASA AD
2023-0058.

(k) New Provisions for Alternative Actions and Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (i) of this AD, no alternative
actions (e.g., inspections) and intervals are allowed unless they
are approved as specified in the provisions of the

``Ref. Publications'' section of EASA AD 2023-0058.

(l) Terminating Action for Certain Actions in AD 2010-26-05

    Accomplishing the actions required by paragraph (g) or (i) of
this AD terminates all requirements of paragraph (g)(1) of AD 2010-
26-05 for Dassault Aviation Model MYSTERE-FALCON 20-C5, 20-D5, 20-
E5, and 20-F5 airplanes, except those on which the Dassault Aviation
MYSTERE-FALCON 20 Supplemental Structural Inspection Program has
been embodied, only.

(m) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Validation Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (n) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Dassault Aviation's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(n) Additional Information

    For more information about this AD, contact Tom Rodriguez,
Aviation Safety Engineer, 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; phone:<PHONE_NUMBER>; email: [email protected].

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
August 15, 2023.
    (i) European Union Aviation Safety Agency (EASA) AD 2023-0058,
dated March 16, 2023.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
April 2, 2020 (85 FR 11280, February 27, 2020).
    (i) Chapter 5-40-00, Airworthiness Limitations, of the Dassault
Falcon 20 Retrofit 731 Maintenance Manual, Revision 13, dated
January 1, 2019.
    (ii) [Reserved]
    (5) For EASA AD 2023-0058, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (6) For service information identified in this AD, contact
Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000,
South Hackensack, NJ 07606; telephone<PHONE_NUMBER>; website
dassaultfalcon.com.
    (7) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (8) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 6, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-14611 Filed 7-10-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 174 (Thursday, September 8, 2016)]
[Notices]
[Pages 62121-62122]
[FR Doc No: 2016-21531]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR16-68-000.
    Applicants: Southern California Gas Company.
    Description: Tariff filing per 284.123(b)(1) + (g): So Cal Gas--
Rate Change Filing to be effective 8/1/2016; Filing Type: 1300.
    Filed Date: 8/23/2016.
    Accession Number:<PHONE_NUMBER>08 http://elibrary.ferc.gov/idmws/doc_info.asp?accession_num=20160415-5222.
    Comments Due: 5 p.m. ET 9/13/16.
    284.123(g) Protests Due: 5 p.m. ET 10/24/16.

    Docket Numbers: RP16-1185-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Section 4(d) Rate Filing: Fuel Retention Rates--Winter
2016 to be effective 10/1/2016.
    Filed Date: 8/24/16.
    Accession Number: 20160824-5103.
    Comments Due: 5 p.m. ET 9/6/16.

    Docket Numbers: RP16-1186-000.
    Applicants: Empire Pipeline, Inc.
    Description: Section 4(d) Rate Filing: Tuscarora Lateral Project--
Petition to Amend to be effective 9/1/2016.
    Filed Date: 8/25/16.
    Accession Number: 20160825-5135.
    Comments Due: 5 p.m. ET 9/6/16.

    Docket Numbers: RP16-1187-000.
    Applicants: Mississippi Hub, LLC.
    Description: Section 4(d) Rate Filing: Mississippi Hub, LLC
Proposed Tariff Revisions to be effective 10/1/2016.
    Filed Date: 8/25/16.
    Accession Number: 20160825-5154.
    Comments Due: 5 p.m. ET 9/6/16.

    Docket Numbers: RP16-1188-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Section 4(d) Rate Filing: Neg Rate--ConEd Release to
Enhanced Energy 791998 to be effective 9/1/2016.
    Filed Date: 8/26/16.
    Accession Number: 20160826-5080.
    Comments Due: 5 p.m. ET 9/7/16.

    Docket Numbers: RP16-1189-000.
    Applicants: Northern Natural Gas Company.
    Description: Section 4(d) Rate Filing: 20160826 PRA Correction
Filing to be effective 11/1/2016.
    Filed Date: 8/26/16.
    Accession Number: 20160826-5111.
    Comments Due: 5 p.m. ET 9/7/16.

    Docket Numbers: RP16-1190-000.
    Applicants: Dominion Transmission, Inc.
    Description: Compliance filing DTI--August 26, 2016 Service
Agreement Termination Notice.
    Filed Date: 8/26/16.
    Accession Number: 20160826-5202.
    Comments Due: 5 p.m. ET 9/7/16.

    Docket Numbers: RP16-1191-000.
    Applicants: Transcontinental Gas Pipe Line Company.

    Description: Section 4(d) Rate Filing: 2016 ACA Tracker Filing--
GSS, LSS, SS-2 & S-2 to be effective 10/1/2016.
    Filed Date: 8/29/16.
    Accession Number: 20160829-5063.
    Comments Due: 5 p.m. ET 9/12/16.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP16-943-002.
    Applicants: Vector Pipeline L.P.
    Description: Compliance filing Negotiated Rate RP16-943 Supplement
to Compliance Filing to be effective 6/1/2016.
    Filed Date: 8/25/16.
    Accession Number: 20160825-5134.
    Comments Due: 5 p.m. ET 9/6/16.

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

    Dated: August 29, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-21531 Filed 9-7-16; 8:45 am]
 BILLING CODE 6717-01-P


From:
Allen Dittenhoefer<EMAIL_ADDRESS>Sent:
Wednesday, October 14, 2020 3:45 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Cc:
Knight, Jeffrey A<EMAIL_ADDRESS>Subject:
Pushing Capture Efficiencies

Dear Dr. Jones,

As a follow-up to our July 29, 2020 virtual meeting and our August 24, 2020 submittal, attached is a table summarizing the pushing capture efficiency estimates for the by-products recovery coke industry.  These estimates were based on: a) one or more years of battery-specific pushing opacity data and b) the theoretical relationship between plume opacity and pollutant concentration, as described in Item #3 of our August 24 submittal.  I have also attached the raw plant data files that support the pushing capture efficiency estimates.

As before, the table below identifies the plant codes for each by-product recovery plant.  Coke plant codes were used in the COETF's submission in order to maintain company proprietary information as confidential.  We also request that EPA treat these plant identifiers as confidential.

                                  Plant Code
                                  Plant Name
               Proprietary and Company Confidential Information
                      Subject to 40 CFR Part 2, Subpart B

Please let me and Jeff Knight know if EPA has any questions regarding this submission.

Allen C. Dittenhoefer, Ph.D.
Principal

Environmental Planning Specialists, Inc.
45 U.S. Highway 46 East
Suite 601
Pine Brook, NJ 07058
Direct:<PHONE_NUMBER> (Ext. 12705)
Mobile<PHONE_NUMBER>
<EMAIL_ADDRESS>www.envplanning.com

Proprietary and Company Confidential Information
Subject to 40 CFR Part 2, Subpart B

<< Pushing Capture Efficiencies Final 101420.pdf >>
<< Middletown PushOpacityTracking 2019 to August 2020.xls >>
<< ArcelorMittalMonessen_Pushing_Tracking_Nov 2018  9.29.20.xlsx >>
<< Pushing Capture BurnsHarbor 20190101 to 20200630 081120.xlsx >>
<< Clairton Batt 123 2019 Push Opacity 082720.xlsx >>
<< Clairton 2019 Push Opacity 13 14 15 Batteries 082820.xlsx >>
<< Clairton 2019 Push Opacity 19 20 Batteries 082820.xlsx >>
<< Clairton 2019 Push Opacity Battery B 082820.xlsm >>
<< Clairton 2019 Push Opacity Battery C 082820.xlsx >>
<< ABC Coke 2016 Push Method 9.xlsx >>
<< Mountain State Pushing Fugitives M9 2019 to present All Batteries.xlsx >>
<< Warren Push Data 2012-2019.xlsx >>


[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Proposed Rules]
[Pages 46121-46126]
[FR Doc No: 2018-19845]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. FDA-2017-N-6924]
RIN 0910-AH47

Repeal of Regulation Requiring an Approved New Drug Application
for Drugs Sterilized by Irradiation

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to repeal a regulation that requires an FDA-approved new drug
application (NDA) or abbreviated new drug application (ANDA) for any
drug product that is sterilized by irradiation (the irradiation
regulation). Repealing the irradiation regulation would mean that over-
the-counter (OTC) drug products that are generally recognized as safe
and effective, that are not misbranded, and that comply with all
applicable regulatory requirements can be marketed legally without an
NDA or ANDA, even if they are sterilized by irradiation. FDA is
proposing to take this action because the irradiation regulation is out
of date and unnecessary. The technology of controlled nuclear radiation
for sterilization of drugs is now well understood, and our regulations
require that OTC drugs be manufactured in compliance with current good
manufacturing practices (CGMPs). Appropriate and effective
sterilization of drugs, including by irradiation, is adequately
addressed by the CGMP requirements. This action is part of FDA's
implementation of Executive Orders (EOs) 13771 and 13777. Under these
EOs, FDA is comprehensively reviewing existing regulations to identify
opportunities for repeal, replacement, or modification that will result
in meaningful burden reduction while allowing the Agency to achieve our
public health mission and fulfill statutory obligations.

DATES: Submit either electronic or written comments on the proposed
rule by November 13, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 13, 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.

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-2017-N-6924 for ``Repeal of Regulation Requiring an Approved New
Drug Application for Drugs Sterilized by Irradiation.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sudha Shukla, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5198, Silver Spring, MD 20993-0002, 301-
796-3345.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Background and Discussion
    A. The History of the Irradiation Regulation
    B. Sterilization by Irradiation
    C. The OTC Drug Monograph System and Current Good Manufacturing
Practices
    D. Conclusion
III. Legal Authority
IV. Proposed Effective Date
V. Economic Analysis of Impacts
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. References

I. Executive Summary

    This proposed rule would repeal the irradiation regulation, which
provides that any drug sterilized by irradiation is a new drug. This
action, if finalized, would mean that OTC drugs marketed pursuant to
the OTC Drug Review that are generally recognized as safe and
effective, that are not misbranded, and that comply with all applicable
regulatory requirements can be marketed legally without an FDA-approved
NDA or ANDA, even if the drugs are sterilized by irradiation. FDA is
taking this action because the Agency no longer concludes that drugs
sterilized by irradiation are necessarily new drugs. The technology of
controlled nuclear radiation for sterilization of drugs is now well
understood. In addition, drugs that are marketed pursuant to the OTC
Drug Review must be manufactured in compliance with CGMPs. Appropriate
and effective sterilization of drugs, including by irradiation, is
adequately addressed by the CGMP requirements. Repealing the
irradiation regulation would eliminate a requirement that is no longer
necessary, and will not diminish public health protections.
    The estimated one-time costs of this rule range from $120 to $150.
Avoiding the unnecessary preparation and review of a premarket drug
application will generate an estimated one-time cost savings that range
from about $395,000 to $2,076,000. Over 10 years with a 7 percent
discount rate, the annualized net cost savings range from $0.05 million
to $0.28 million, with a primary estimate of $0.06 million; with a 3
percent discount rate, the annualized net cost savings range from $0.04
million to $0.24 million, with a primary estimate of $0.05 million.
Over an infinite horizon, we assume that one sponsor will benefit from
this deregulatory action every 10 years; the present value of the net
cost savings over the infinite horizon range from $0.83 million to
$4.37 million with a 7 percent discount rate and from $1.58 million to
$8.30 million with a 3 percent discount rate.

II. Background and Discussion

    On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform
Agenda'' (https://www.gpo.gov/fdsys/pkg/FR-2017-03-01/pdf/2017-04107.pdf) was issued. One of the provisions in the E.O. requires
Agencies to evaluate existing regulations and make recommendations to
the Agency head regarding their repeal, replacement, or modification,
consistent with applicable law. As part of this initiative, FDA is
proposing to repeal the irradiation regulation as specified in this
rule.
    In addition, in a citizen petition dated August 14, 2014, Richard
O. Wood of The Wood Burditt Group LLC requested that the irradiation
regulation be revoked. FDA has responded to Mr. Wood's citizen
petition. A copy of the response is available at: https://www.regulations.gov under Docket No. FDA-2014-P-1784.

A. The History of the Irradiation Regulation

    In the November 29, 1955, issue of the Federal Register, FDA issued
a statement of interpretation relating to the sterilization of drugs by
irradiation (20 FR 8747 to 8748).\1\ In the statement, FDA explained
that there was an interest in the utilization of newly developed
sources of radiation for the sterilization of drugs. The Agency went on
to state that it was necessary in the interest of protecting the public
health to establish by adequate investigations that the irradiation
treatment does not cause the drug to become unsafe or otherwise
unsuitable for use. For this reason, all drug products sterilized by
irradiation would be regarded as new drugs within the meaning of
section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act),
which would mean that an effective new drug application would be
required for such products.
---------------------------------------------------------------------------

    \1\ Available at: https://www.loc.gov/item/fr020231/. A month
later, this provision was included at Sec.  3.45 in the
republication of chapter 21 of the Code of Federal Regulations in
the Federal Register. See 20 FR 9525 at 9554 (December 20, 1955),
available at: http://cdn.loc.gov/service/ll/fedreg/fr020/fr020246/fr020246.pdf. In 1975, FDA republished and re-codified the rule at
21 CFR 200.30. See 40 FR 13996 at 13997 (March 27, 1975), available
at: https://www.loc.gov/item/fr040060/.
---------------------------------------------------------------------------

    In 1996, FDA proposed to revise the statement and consolidate it
with similar provisions into a single list of drugs that have been
determined by previous rulemaking procedures to be new drugs within the
meaning of section 201(p) of the FD&C Act (61 FR 29502 at 29503 to
29504 (June 11, 1996)). The Agency proposed to remove any existing
background information describing the Agency's basis for determination
of new drug status from the regulatory text.
    In 1997, FDA finalized these provisions, now located in 21 CFR
310.502, entitled ``Certain drugs accorded new drug status through
rulemaking procedures.'' (62 FR 12084 at 12084 (March 14, 1997).)
Paragraph 310.502(a) sets forth a list of drugs that have been
determined by rulemaking procedures to be ``new drugs'' within the
meaning of section 201(p) of the FD&C Act. Included on the list is
sterilization of drugs by irradiation (Sec.  310.502(a)(11) (21 CFR
310.502(a)(11)). Because this regulation reflects an FDA determination
that the drugs on the list are ``new drugs,'' an NDA or ANDA must be
submitted and approved by FDA before they can be marketed legally. For
a non-prescription drug that could otherwise be legally marketed
without an approved NDA or ANDA in effect pursuant to the OTC Drug
Review, the effect of Sec.  310.502(a)(11) is that, if the drug is
sterilized by irradiation, an approved NDA or ANDA is necessary.

B. Sterilization by Irradiation

    Since the paragraph now reflected at Sec.  310.502(a)(11) was
published in 1955, the technology of controlled nuclear radiation for
sterilization of drugs has become well understood. Gamma ray
irradiation has been recognized as a method of sterilizing drug
products for half a century (Refs. 1 and 2). Electron beam and x-ray
irradiation are also recognized methods for sterilizing drugs (Ref. 1).
    Information and data on whether a particular drug can safely and
effectively be sterilized by irradiation are available in the
scientific literature (Ref. 1). The United States Pharmacopeial
Convention (USP) has provided guidance on irradiation sterilization of
drug products since 1965 (Refs. 1 and 3). This includes chapter <1229>
on ``Sterilization of Compendial Articles,'' which sets forth
principles that may be applied to the sterilization of compendial and
non-compendial drug products, and chapter <1229.10> on ``Radiation
Sterilization,'' which sets forth guidelines on validation of
sterilization by irradiation (Refs. 3 and 4). The American National
Standards Institute, the Association for the Advancement of Medical
Instrumentation, ASTM International, and the International Organization
for Standardization (ISO) have also published standards on the
irradiation of medical products, including drugs (Ref. 1). ISO standard
11137, which sets forth several methods that can be used to determine
the appropriate radiation dose for health care products, was first
published in 1984 \2\ (Ref. 1).
---------------------------------------------------------------------------

    \2\ ISO 11137-1 specifies standards for the development,
validation, and routine control of a radiation sterilization process
for medical devices, while ISO 11137-2 specifies dose establishment
and dose audit methods and defines product family approaches for
dose establishment and dose audits. Additional target sterilization
doses are covered in ISO Technical Information Report (TIR) 13004.
Neither ISO 11137-2 nor TIR 13004 is explicitly limited to medical
devices. In addition, both ISO 11137-2 and ISO TIR 13004 reference
ISO 11137-1 as ``indispensable for the application of this
document.'' This implies that the concepts in ISO 11137-1 may be
applied to sterilization of drug products.
---------------------------------------------------------------------------

    USP chapter <1229.10> states that the methods set forth in ISO
11137 typically guide the choice of radiation dose (Ref. 3). Relevant
factors include a drug's pre-sterilization level of microbial
contamination (sometimes referred to as its bioburden) and the desired
sterility assurance level (Ref. 1). Once the dose is selected, USP
General Chapter <1229.10> states that all materials exposed to
radiation, especially the drug product and its primary container,
should be evaluated for immediate and long-term effects, and
``[p]roduct stability, safety, and functionality should be confirmed
over the product's intended use period'' (Ref. 3). Among the advantages
of sterilizing drug products by irradiation is that due to radiation's
high penetrability, drug products can be irradiated after they are
placed in their final containers (Ref. 1). Known as terminal
sterilization, this provides a greater degree of sterilization
assurance than aseptic processing and, where feasible, its use is
preferable to relying solely on aseptic processing to ensure sterility
(Ref. 5). Other advantages to irradiation sterilization of drugs
include low chemical reactivity; the very low rise in temperature
associated with radiation, which allows for its use on heat-sensitive
products; that irradiation sterilization has fewer process variables
than other methods, which translates into fewer sterility rejections;
and that radiation does not leave behind any sterilant residuals (Refs.
1 and 6).

C. The OTC Drug Monograph System and Current Good Manufacturing
Practices

    The OTC Drug Review was established to evaluate the safety and
effectiveness of OTC drug products marketed in the United States before
May 11, 1972. As set forth in 21 CFR 330.10, it is a multiphase public
rulemaking process (each phase requiring a Federal Register
publication) resulting in the establishment of monographs for OTC
therapeutic drug classes. OTC drug monographs, which can be found in
Title 21, chapter I, subchapter D of the Code of Federal Regulations,
cover acceptable ingredients, doses, formulations, other conditions,
and labeling for certain OTC drugs. A company can legally make and
market an OTC product that meets each of the conditions contained in an
applicable monograph and, in addition, each of the general conditions
set forth in Sec.  330.1. Among the general conditions that apply to
all drug products marketed under the OTC Drug Review is the requirement
set forth in Sec.  330.1(a) that they be manufactured in compliance
with current good manufacturing practices, as established by parts 210
and 211 of this chapter. The CGMP requirements in parts 210 and 211

encompass sterilization, including by irradiation.\3\
---------------------------------------------------------------------------

    \3\ We note that sterilization is not generally a condition
specifically covered by OTC monographs. Currently, the monograph for
ophthalmic drug products at 21 CFR part 349 is the only monograph
that incorporates a sterility condition. There are, however, OTC
products covered by a monograph or tentative final monograph that
are not required to be sterile, but which manufacturers may choose
to sterilize. These may include consumer and healthcare antiseptics,
such as consumer hand washes, body washes, and hand rubs, first aid
antiseptics, health care personnel hand washes and hand rubs,
surgical hand scrubs and rubs, and patient preoperative skin
preparations. In 2013, FDA asked manufacturers to voluntarily revise
the product labels for topical antiseptics to indicate whether the
product is manufactured as a sterile or nonsterile product (Ref. 7).
---------------------------------------------------------------------------

    In 1955, when the determination with respect to drugs sterilized by
irradiation (now reflected in Sec.  310.502(a)(11)) was made, neither
the OTC drug monograph system nor the CGMP requirements existed. The
authorizing legislation that the CGMP regulations implement, section
501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), was enacted in
1962 (Drug Amendments of 1962, October 10, 1962, Pub. L. 87-781, Title
I, sec. 101), and the first CGMP regulations followed in 1963 (Part
133--Drugs; Current Good Manufacturing Practice in Manufacture,
Processing, Packing, or Holding, 28 FR 6385 (June 20, 1963) available
at: https://www.loc.gov/item/fr028120/). The regulations creating
procedures for establishing OTC drug monographs were issued in 1972 (37
FR 9464 (May 11, 1972)) available at: https://www.loc.gov/item/fr037092/). Because of these subsequent statutes and regulations, Sec.
310.502(a)(11) can be revoked and manufacturers will still be obligated
to ensure that, if they use radiation: (1) The drug products that they
purport to be sterile are in fact sterile and (2) their use of
radiation does not have a detrimental effect on their drug products'
identity, strength, quality, purity, or stability.
    CGMP regulations require manufacturers to take steps to ensure that
sterile drug products are free of objectionable microorganisms. (See,
e.g., 21 CFR 211.28(a), 211.42(b) and (c), 211.67(a), 211.84(c),
211.110(a), 211.113(b), 211.165(b), 211.167(a).) The CGMP regulations
also include provisions that ensure that irradiation or any other
sterilization processes do not have a detrimental effect on a drug
product's identity, strength, quality, purity, or stability. (See,
e.g., 21 CFR 211.22, 211.25(b), 211.68, 211.100, 211.160(b), 211.165,
211.166.)
    Numerous records relating to the manufacture of the drug product
must be maintained and made available for inspection (21 CFR part 211,
subpart J). FDA conducts inspections at manufacturing facilities,
including irradiation facilities, to ensure that the CGMP regulations
are followed. Inspection findings are reviewed and, when appropriate,
action may be recommended against manufacturers observed to be out of
compliance.
    Choosing the sterilization process that is suitable for a
particular drug product is the responsibility of the manufacturer and
is an important part of pharmaceutical development. To guide them in
choosing an appropriate method of sterilization and otherwise complying
with the CGMP requirements, manufacturers can turn to voluntary
consensus standards that are widely-known by industry and recognized by
FDA for the development, validation, and routine control of the
sterilization of drugs by irradiation. As noted previously in this
document, ISO publishes standards that address the different doses of
radiation that are appropriate depending on the type and amount of
microbiological contamination and the necessary degree of sterility
assurance (Ref. 3). These include the following:
     ISO 11137-1:2006: Sterilization of health care products--
Radiation--Part 1: Requirements for development, validation and routine
control of a sterilization process for medical devices;
     ISO 11137-2:2013: Sterilization of health care products--
Radiation--Part 2: Establishing the sterilization dose;
     ISO 11137-3:2006: Sterilization of health care products--
Radiation--Part 3: Guidance on dosimetric aspects; and
     ISO/TS 13004:2013: Sterilization of health care products--
Substantiation of selected sterilization dose: Method VDmaxSD.
     The USP also provides guidance on irradiation
sterilization, including in chapter <1229.10>, which specifically
addresses the topic (Ref. 3).

D. Conclusion

    We propose the repeal of Sec.  310.502(a)(11) because the Agency no
longer concludes that drugs sterilized by irradiation are necessarily
new drugs. The technology of controlled nuclear radiation for
sterilization of drugs is now well understood and sterilization is a
manufacturing process that is adequately addressed by the regulations
governing the OTC drug monograph system and CGMPs.

III. Legal Authority

    FDA is issuing this proposed rule under the drugs and general
administrative provisions of the FD&C Act (sections 201, 301, 501, 502,
503, 505, 510, 701, 702, and 704 (21 U.S.C. 321, 331, 351, 352, 353,
355, 360, 371, 372, and 374)) and under section 361 of the Public
Health Service Act (PHS Act) (42 U.S.C. 264). The FD&C Act gives us the
authority to issue and enforce regulations designed to help ensure that
drug products are safe, effective, and manufactured according to
current good manufacturing practices, while section 361 of the PHS Act
gives us the authority to issue and enforce regulations designed to
prevent the introduction, transmission, or spread of communicable
diseases.

IV. Proposed Effective Date

    Any final rule that results from this proposed rule will be
effective 30 days after the date of the final rule's publication in the
Federal Register.

V. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). EOs
12866 and 13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
proposed rule is not a significant regulatory action as defined by E.O.
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because few entities will be affected and the net effect will
be cost savings to affected firms, we propose to certify that the
proposed rule, if finalized, will not have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after

adjustment for inflation is $150 million, using the most current (2017)
Implicit Price Deflator for the Gross Domestic Product. This proposed
rule would not result in an expenditure in any year that meets or
exceeds this amount.
    Table 1 summarizes our estimate of the annualized costs and
benefits of the proposed rule.

                                       Table 1--Summary of Benefits, Costs and Distributional Effects of the Rule
                                                                       [$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                            ------------------------------------
                Category                   Primary       Low        High                               Period                     Notes
                                          estimate    estimate    estimate      Year      Discount     covered
                                                                               dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized, Monetized $millions/          $0.06       $0.05       $0.28        2016           7          10  Benefits are cost savings.
     year.
                                               0.05        0.04        0.24        2016           3          10  Benefits are cost savings.
    Annualized Quantified..............  ..........  ..........  ..........        2016           7          10
                                         ..........  ..........  ..........        2016           3          10  .......................................
                                        ----------------------------------------------------------------------------------------------------------------
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year        0.00        0.00        0.00        2016           7          10  Costs total less than $100.
                                               0.00        0.00        0.00        2016           3          10  Costs total less than $100.
    Annualized Quantified..............  ..........  ..........  ..........        2016           7          10
                                         ..........  ..........  ..........        2016           3          10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualitative
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized               0.14        0.14        0.14        2016           7          10  User Fee.
     $millions/year.
                                               0.12        0.12        0.12        2016           3          10  User Fee.
                                        ----------------------------------------------------------------------------------------------------------------
                                         From:
                                         To:
                                        ----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized           ..........  ..........  ..........        2016           7          10
     $millions/year.
                                         ..........  ..........  ..........        2016           3          10
                                        ----------------------------------------------------------------------------------------------------------------
                                         From:
                                         To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
--------------------------------------------------------------------------------------------------------------------------------------------------------
    State, Local or Tribal Government: None.............................................................................................................
    Small Business: None................................................................................................................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Because the proposed rule will repeal an outdated regulation and
generate net cost savings, we consider this action a deregulatory
action under E.O. 13771. Table 2 presents a summary of the E.O. 13771
impacts of the proposed rule over an infinite horizon. For this
estimate, we assume that one sponsor will benefit from this
deregulatory action every 10 years.

                                                               Table 2--E.O. 13771 Summary
                                                 [In $ millions 2016 dollars, over an infinite horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $0.00           $0.00           $0.00           $0.00           $0.00           $0.00
Present Value of Cost Savings...........................            0.97            0.83            4.37            1.84            1.58            8.30
Present Value of Net Costs..............................          (0.97)          (0.83)          (4.37)          (1.84)          (1.58)          (8.30)
Annualized Costs........................................           $0.00           $0.00           $0.00           $0.00           $0.00           $0.00
Annualized Cost Savings.................................           $0.07           $0.06           $0.31           $0.06           $0.05           $0.25
Annualized Net Costs....................................          (0.07)          (0.06)          (0.31)          (0.06)          (0.05)          (0.25)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the proposed rule. The full analysis of
economic impacts is available in the docket for this proposed rule
(Ref. 8) and at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VI. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.31(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VII. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information resulting from compliance with
CGMPs have been

approved under OMB control number 0910-0139.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13132. We have determined that this
proposed rule does not contain policies that have substantial direct
effects 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the E.O. and, consequently, a
federalism summary impact statement is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in E.O. 13175. We have tentatively determined that
the rule does not contain policies that would 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.
The Agency solicits comments from tribal officials on any potential
impact on Indian Tribes from this proposed action.

X. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.

1. Jacobs, G., ``Validation of the Radiation Sterilization of
Pharmaceuticals.'' In: J. Agalloco and F. J. Carleton (eds.),
Validation of Pharmaceutical Processes (3rd Ed.) Informa USA, New
York, 2007.
2. Microbiology Sub-Committee, Radiation Sterilization Task Force,
Parenteral Drug Association, Technical Report No. 11,
``Sterilization of Parenterals by Gamma Radiation,'' Journal of
Parenteral Science and Technology, 42 (3S), 1988, available at:
https://store.pda.org/ProductCatalog/Product.aspx?ID=1170.
3. United States Pharmacopeial Convention (USP 40), Radiation
Sterilization <1229.10>, 2017.
4. United States Pharmacopeial Convention (USP 40), Sterilization of
Compendial Articles <1229>, 2017.
5. FDA Guidance for Industry on ``Sterile Drug Products Produced by
Aseptic Processing--Current Good Manufacturing Practice,'' September
2004; available at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070342.pdf.
6. United States Pharmacopeial Convention (USP 40), Sterilization
and Sterility Assurance of Compendial Articles <1211>, 2017.
7. FDA Drug Safety Communication, ``FDA Requests Label Changes and
Single-Use Packaging for Some Over-the-Counter Topical Antiseptic
Products to Decrease Risk of Infection,'' November 13, 2013;
available at https://www.fda.gov/Drugs/DrugSafety/ucm374711.htm.
8. FDA Preliminary Regulatory Impact Analysis, Repeal of Regulation
Requiring an Approved New Drug Application for Drugs Sterilized by
Irradiation; https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 310 be
amended as follows:

PART 310--NEW DRUGS

0
1. The authority citation for part 310 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-1; 42 U.S.C.
216, 241, 242(a), 262.

0
2. In Sec.  310.502, revise paragraph (a) introductory text and remove
and reserve paragraph (a)(11) to read as follows:

Sec.  310.502  Certain drugs accorded new drug status through
rulemaking procedures.

    (a) The drugs listed in this paragraph have been determined by
rulemaking procedures to be new drugs within the meaning of section
201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new
drug application under section 505 of the Federal Food, Drug, and
Cosmetic Act and part 314 of this chapter is required for marketing the
following drugs:
* * * * *
    (11) [Reserved]
* * * * *

    Dated: September 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-19845 Filed 9-11-18; 8:45 am]
 BILLING CODE 4164-01-P