[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Proposed Rules]
[Pages 65340-65341]
[FR Doc No: 2012-26315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2009-F-0303]

Ajinomoto Co., Inc.; Filing of Food Additive Petition; Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is amending the filing
notice for a food additive petition filed by Ajinomoto Co., Inc., to
indicate that the petitioned additive, N-[N-[3-(3-hydroxy-4-
methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester,
monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20-
6), is for use as a non-nutritive sweetener and flavor enhancer in
foods generally, except meat and poultry. The previous filing notice
indicated that the proposed additive was for use as a non-nutritive
sweetener

in tabletop applications and powdered beverage mixes.

DATES: Submit either electronic or written comments on the petitioner's
environmental assessment by November 26, 2012.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of July 21, 2009 (74 FR 35871), FDA announced that a food
additive petition (FAP 9A4778) had been filed by Ajinomoto, Co., Inc.,
c/o Ajinomoto Corporate Services LLC, 1120 Connecticut Ave. NW., Suite
1010, Washington, DC 20036 (now c/o Ajinomoto North America, Inc., 400
Kelby St., Fort Lee, NJ 07024). In the notice of filing, FDA announced
that the petitioner proposed that the food additive regulations in part
172 Food Additives Permitted for Direct Addition to Food for Human
Consumption (21 CFR part 172) be amended to provide for the safe use of
N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-
phenylalanine 1-methyl ester, monohydrate (CAS Reg. No. 714229-20-6) as
a non-nutritive sweetener in tabletop applications and powdered
beverage mixes. The petition was filed under section 409 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 348).
    Subsequent to publication of the filing notice, Ajinomoto Co.,
Inc., amended its petition to provide for the safe use of N-[N-[3-(3-
hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-
methyl ester, monohydrate as a non-nutritive sweetener and flavor
enhancer in foods generally, except meat and poultry. Therefore, FDA is
amending the filing notice of July 21, 2009, to indicate that the
petitioner has proposed that the food additive regulations in part 172
be amended to provide for the use of N-[N-[3-(3-hydroxy-4-
methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1-methyl ester,
monohydrate (proposed additive name Advantame, CAS Reg. No. 714229-20-
6), as a non-nutritive sweetener and flavor enhancer in foods
generally, except meat and poultry.
    The potential environmental impact of this petition is being
reviewed. To encourage public participation consistent with regulation
issued under the National Environmental Policy Act (40 CFR 1501.4(b)),
the Agency is placing the environmental assessment submitted with the
petition that is the subject of this notice on public display at the
Division of Dockets Management (see DATES and ADDRESSES) for public
review and comment.
    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. FDA will also place on public display any
amendments to, or comments on, the petitioner's environmental
assessment without further announcement in the Federal Register. If,
based on its review, the Agency finds that an environmental impact
statement is not required, and this petition results in a regulation,
the notice of availability of the Agency's finding of no significant
impact and the evidence supporting that finding will be published with
the regulation in the Federal Register in accordance with 21 CFR
25.51(b).

    Dated: October 22, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2012-26315 Filed 10-25-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 50 (Wednesday, March 17, 2021)]
[Proposed Rules]
[Page 14558]
[FR Doc No: 2021-05405]

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DEPARTMENT OF LABOR

Employment and Training Administration

20 CFR Parts 641, 655, 658, 667, and 683

Office of Workers' Compensation Programs

20 CFR Part 726

Office of the Secretary of Labor

29 CFR Parts 7, 8, 22, 24, 26, 29, 37, 38, and 96

Office of Labor-Management Standards

29 CFR Parts 417 and 458

Wage and Hour Division

29 CFR Parts 500, 525, 530, and 580

Occupational Safety and Health Administration

29 CFR Parts 1978, 1979, 1980, 1981, 1982, 1983, 1984, 1985, 1986,
1987, and 1988

Office of Federal Contract Compliance Programs

41 CFR Part 60-30

RIN 1290-AA28

Rules of Practice and Procedure Concerning Filing and Service and
Amended Rules Concerning Filing and Service

AGENCY: Employment and Training Administration, Office of Workers'
Compensation Programs, Office of the Secretary, Office of Labor-
Management Standards, Wage and Hour Division, Occupational Safety and
Health Administration, Office of Federal Contract Compliance Programs.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Department of Labor is withdrawing the proposed rule that
accompanied its direct final rule (DFR) that requires electronic filing
(e-filing) and makes acceptance of electronic service (e-service)
automatic for attorneys and non-attorney representatives representing
parties in proceedings before the Administrative Review Board (Board),
unless the Board authorizes non-electronic filing and service for good
cause; establishes a new part containing rules of practice and
procedure for the Board; and amends existing regulations concerning
filing and service that apply where a governing statute or executive
order does not establish contrary rules of filing and service.

DATES: As of March 17, 2021, the proposed rule published January 11,
2021 (86 FR 1834), is withdrawn.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas Shepherd, Clerk of the
Appellate Boards, at<PHONE_NUMBER> or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the concurrent direct final rule (DFR)
published at 86 FR 1772, the Department stated that if a significant
adverse comment was submitted by February 10, 2021, the Department
would publish a timely withdrawal in the Federal Register informing the
public that the DFR will not take effect. The Department issued an
identical Notice of Proposed Rulemaking (NPRM) on the same day (86 FR
1834). The Department also issued a technical correction on February 9,
2021 (86 FR 8687). The Department received no comments on the
rulemaking. Accordingly, the Department is not proceeding with the
proposed rule and is withdrawing it from the rulemaking process. The
DFR became effective on February 25, 2021. Additionally, the Department
notes that it plans to hold listening sessions during the coming weeks
for users to provide feedback on the electronic filing and service
system. Information about those sessions will be announced at https://efile.dol.gov.

Milton A. Stewart,
Acting Secretary of Labor.
[FR Doc. 2021-05405 Filed 3-16-21; 8:45 am]
BILLING CODE 4510-HW-P


[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54724-54725]
[FR Doc No: 2013-21554]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Information Collection Activities: Submission for the Office of
Management and Budget (OMB) Review; Request for Comment

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice of the OMB review of information collection and
solicitation of public comment.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. chapter 35), this notice announces that the Information
Collection Request (ICR) abstracted below will be submitted to the
Office of Management and Budget (OMB) for review. The ICR describes the
nature of the information collection and its expected burden. A Federal
Register Notice with a 60-day comment period soliciting public comments
on the following information collection was published on May 8, 2013
(Federal Register/Vol. 78, No. 89/pp. 26848-26849).

DATES: Submit comments to the Office of Management and Budget (OMB) on
or before October 7, 2013.

FOR FURTHER INFORMATION CONTACT: Randolph Atkins at the National
Highway Traffic Safety Administration, Office of Behavioral Safety
Research (NTI-131), W46-500, Department of Transportation, 1200 New
Jersey Avenue SE., Washington, DC 20590. Dr. Atkins' phone number is
202-366-5597 and his email address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2127-New.
    Title: Matching Countermeasures to Driver Types and Speeding
Behaviors.
    Form No.: NHTSA 1198.
    Type of Review: Regular.
    Respondents: The survey respondents will be a random sample of
drivers currently licensed and living in Idaho. The sample will be
stratified by age, gender, and numbers of citations for speeding in the
previous three years.
    Estimated Number of Respondents: An estimated sample size of 3200
drivers is projected for the survey mailing with a projected response
rate of 50% (1600 drivers).
    Estimated Time per Response: The average amount of time for each
respondent to complete the survey is estimated at 25 minutes. This
includes any time needed to retrieve information.
    Total Estimated Annual Burden Hours: 444.6 hours.
    Frequency of Collection: The survey will be administered a single
time.
    Abstract: In this study, NHTSA will be conducting a survey of a
random sample of licensed drivers in the State of Idaho, stratified by
age, gender and number of speeding convictions, in order to further
explore typologies of driver speeding types developed in our recent
Motivations for Speeding project and our 2011 National Survey of
Speeding Attitudes and Behavior with a focus on finding appropriate
countermeasures for various speeder types. This project will collect

information on the attitudes and experiences of the drivers surveyed
with regard to speeding countermeasures as well as actual driving
records and match countermeasures with driver types.
    One objective of this project is to further examine the driver
speeding typologies from the two previous studies. Each of the
typologies provides a different way of defining speeder types. The four
speeder types from the Motivations for Speeding project are based on
the actual driving behaviors of a small sample of volunteer drivers.
The three speeder types from the 2011 national phone survey are based
on self-reports from a nationally representative sample of drivers.
This project will compare these two ways of defining types of drivers
with regard to their speeding behavior using driver records and the
results of a mail survey of a representative sample of fully-licensed
drivers and examine the utility of each way of defining types of
speeders.
    A second objective of this project is the exploration of
appropriate speeding countermeasures for various driver speeding types
and roadways. This includes examining various countermeasures applied
to speeding, such as traditional law enforcement, in-vehicle
technologies, and driver education. This project will collect
information on the attitudes and experiences of the drivers surveyed
with regard to speeding countermeasures and match countermeasures with
driver types from the two speeding typologies. Based on the analysis of
this matching, recommendations for the most appropriate speeding
countermeasures for various driver types will be produced.
    The third objective of this project is to match actual driver
records with individual survey responses in order to compare patterns
of actual driving violations with speeding types and other responses,
and to validate self-report information found in the survey. The driver
records data will also be used to conduct a non-response bias analysis
for the survey.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th Street
NW., Washington, DC 20503, Attention: Desk Officer for Department of
Transportation, National Highway Traffic Safety Administration, or by
email at<EMAIL_ADDRESS>or fax:<PHONE_NUMBER>.
    Comments Are Invited On: whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department of Transportation, including whether the information
will have practical utility; the accuracy of the Department's estimate
of the burden of the proposed information collection; ways to enhance
the quality, utility and clarity of the information to be collected;
and ways to minimize the burden of the collection of information on
respondents, including the use of automated collection techniques or
other forms of information technology. A comment to OMB is most
effective if OMB receives it within 30 days of publication of this
notice.

    Authority:  44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC, on August 30, 2013.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2013-21554 Filed 9-4-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 186 (Wednesday, September 25, 2019)]
[Proposed Rules]
[Pages 50367-50369]
[FR Doc No: 2019-20319]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 191 and 194

[EPA-HQ-OAR-2019-0534; FRL-10000-12-OAR]

Review Process To Determine Whether the Waste Isolation Pilot
Plant Continues To Comply With the Disposal Regulations and Compliance
Criteria

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability; official opening of public comment
period.

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SUMMARY: The Environmental Protection Agency (EPA, or the Agency)
intends to evaluate whether the Waste Isolation Pilot Plant (WIPP)
continues to comply with the Agency's environmental radiation
protection standards for the disposal of radioactive waste. Pursuant to
the 1992 WIPP Land Withdrawal Act (LWA), as amended, the U.S.
Department of Energy (DOE, or the Department) must submit documentation
of continued compliance with the EPA's standards for disposal and other
statutory requirements every five years after the initial receipt of
transuranic waste at WIPP. The Agency requests public comment on all
aspects of the DOE's application.

DATES: The comment period opened on September 25, 2019, and will remain
open beyond the time when the EPA notifies the DOE that the
recertification application is complete, which will be specified in a
future Federal Register document. Announcements will be published in
the Federal Register to provide information on the Agency's
completeness determination and final recertification decision.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2019-0534, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Email<EMAIL_ADDRESS>Include Docket ID No. EPA-
HQ-OAR-2019-0534 in the subject line of the message.
     Mail: U.S. Environmental Protection Agency, Air and
Radiation Docket, EPA Docket Center, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460.
     Hand Delivery/Courier: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operations are 8:30 a.m.-4:30 p.m.,
Monday-Friday (except Federal Holidays).
    Instructions: All submissions received must include the Docket ID
No. for this notice of availability. Comments received may be posted
without change to https://www.regulations.gov/, including any personal
information provided. For detailed instructions and additional
information on submitting comments, see the SUPPLEMENTARY INFORMATION
section of this document.
    A copy of the DOE's 2019 Compliance Recertification Application
(CRA) is linked on the EPA's WIPP website (https://www.epa.gov/radiation/certification-and-recertification-wipp#2019).

FOR FURTHER INFORMATION CONTACT: Ray Lee, Office of Radiation and
Indoor Air, Radiation Protection Division, Center for Radiation
Information and Outreach, Mail Code 6608T, U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax

number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The DOE's 2019 CRA was received by the EPA
on March 19, 2019, and a copy is linked on the EPA's WIPP website in
ADDRESSES. The EPA will determine when the DOE has provided a complete
application; the Agency's completeness determination will be conveyed
to the DOE and published in the Federal Register. The EPA will evaluate
the ``complete'' application in determining whether the WIPP facility
continues to comply with the radiation protection standards for
disposal. The Agency requests public comment on all aspects of the
DOE's application.

I. Public Participation

Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2019-
0534, at https://www.regulations.gov (our preferred method), or the
other methods identified in the ADDRESSES section. Once submitted,
comments cannot be edited or removed from the docket. The EPA may
publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

    The WIPP was authorized in 1980, under section 213 of the DOE
National Security and Military Applications of Nuclear Energy
Authorization Act of 1980 (Pub. L. 96-164, 93 Stat. 1259, 1265), ``for
the express purpose of providing a research and development facility to
demonstrate the safe disposal of radioactive wastes resulting from the
defense activities and programs of the United States.'' The WIPP is a
disposal system for transuranic (TRU) radioactive waste. Developed by
the DOE, the facility is located near Carlsbad in southeastern New
Mexico. TRU waste is emplaced 2,150 feet underground in an ancient
layer of salt that will eventually ``creep'' and encapsulate the waste
containers.
    The 1992 WIPP LWA (Pub. L. 102-579) \1\ limits radioactive waste
disposal in the WIPP to TRU radioactive wastes generated by defense-
related activities. TRU waste is defined as waste containing more than
100 nano-curies per gram of alpha-emitting radioactive isotopes, with
half-lives greater than twenty years and atomic numbers greater than
92. The Act further stipulates that radioactive waste shall not be TRU
waste if such waste also meets the definition of high-level radioactive
waste, has been specifically exempted from regulation with the
concurrence of the Administrator, or has been approved for an alternate
method of disposal by the Nuclear Regulatory Commission. The TRU
radioactive waste proposed for disposal in the WIPP consists of
materials such as rags, equipment, tools, protective gear and sludges
that have become contaminated during atomic energy defense activities.
The radioactive component of TRU waste consists of man-made elements
created during the process of nuclear fission, chiefly isotopes of
plutonium. Some TRU waste is contaminated with hazardous wastes
regulated under the Resource Conservation and Recovery Act (RCRA; 42
U.S.C. 6901-6992k). The waste proposed for disposal at the WIPP derives
from Federal facilities across the United States, including locations
in Colorado, Idaho, New Mexico, Nevada, Ohio, South Carolina, Tennessee
and Washington.
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    \1\ The 1992 WIPP Land Withdrawal Act was amended by the ``Waste
Isolation Pilot Plant Land Withdrawal Act Amendments,'' which were
part of the National Defense Authorization Act for Fiscal Year 1997
(Pub. L. 104-201).
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    The WIPP must meet the EPA's generic disposal standards at 40 CFR
part 191, subparts B and C, for high-level and TRU radioactive waste.
These standards limit releases of radioactive materials from disposal
systems for radioactive waste and require implementation of measures to
provide confidence for compliance with the radiation release limits.
Additionally, the regulations limit radiation doses to members of the
public and protect ground water resources by establishing maximum
concentrations for radionuclides in ground water. To help in
determining whether the WIPP facility meets these disposal standards,
the Agency issued the 1997 WIPP Compliance Criteria (40 CFR part 194),
which provides guidance for interpretation and implementation of the
disposal standards specifically for the WIPP site. The Compliance
Criteria--along with its accompanying preamble and supporting
documents--describe what information the DOE must provide and how the
EPA evaluates WIPP's performance and provides ongoing independent
oversight. The Agency implements its environmental radiation protection
standards, 40 CFR part 191, by applying the WIPP Compliance Criteria,
40 CFR part 194, to the disposal of TRU radioactive waste at the WIPP.
For more information about 40 CFR part 191, refer to Federal Register
documents published in 1985 (50 FR 38066, Sep. 19, 1985) and 1993 (58
FR 66398, Dec. 20, 1993). For more information about 40 CFR part 194,
refer to Federal Register documents published in 1996 (61 FR 5224, Feb.
9, 1996) and 1995 (60 FR 5766, Jan. 30, 1995).
    Using the process outlined in the WIPP Compliance Criteria, the EPA
determined on May 18, 1998 (63 FR 27354), that the DOE had demonstrated
that the WIPP complied with the Agency's radioactive waste disposal
regulations at subparts B and C of 40 CFR part 191. The EPA's
certification determination permitted the WIPP to begin accepting TRU
waste for disposal, provided that other applicable conditions and
environmental regulations were met.
    Since the 1998 certification decision, the EPA has conducted
ongoing independent technical review and inspections of all WIPP
activities related to compliance with the Agency's disposal
regulations. The initial certification decision identified the starting
(baseline) conditions for the WIPP site and established the waste and
facility characteristics necessary to ensure proper disposal in
accordance with the regulations. At that time, the EPA and the DOE
understood that future information and knowledge gained from the actual
operations of the WIPP would result in changes to best practices and
procedures for the facility.
    In recognition of this, section 8(f) of the amended WIPP LWA
requires the EPA to evaluate all changes in conditions or activities at
the WIPP every five years to determine if the facility continues to
comply with the Agency's disposal regulations. This determination is
not subject to standard rulemaking procedures or judicial review, as
stated in the aforementioned section of the WIPP LWA.
    The first recertification process began with the DOE's submittal of
the initial CRA, which was received by the Agency on March 26, 2004.
The EPA deemed the CRA-2004 to be complete on

September 29, 2005, and published its first WIPP recertification
decision on March 29, 2006 (71 FR 18010).
    The EPA received the DOE's second CRA on March 24, 2009. The Agency
deemed the CRA-2009 to be complete on June 29, 2010, and published the
second WIPP recertification decision on November 18, 2010 (75 FR
70584).
    The EPA received the Department's third CRA on March 26, 2014. The
Agency deemed the CRA-2014 to be complete on March 10, 2017, and
published the third WIPP recertification decision on July 10, 2017 (82
FR 33106).
    The EPA received the Department's fourth CRA on March 19, 2019.
After the EPA has determined that the application is complete, the
Agency will review the CRA-2019 to ensure that all of the changes made
at the WIPP since the third recertification process have been
accurately reflected and that the facility will continue to safely
contain TRU radioactive waste. An approved CRA-2019 (along with any
supplemental completeness information submitted by the DOE) would serve
as the baseline for the next recertification that will occur starting
in 2024.
    With today's notice, the Agency solicits public comment on the
DOE's documentation of whether the WIPP facility continues to comply
with the disposal regulations. An electronic copy of the application is
available for review and linked on the EPA's WIPP website (https://www.epa.gov/radiation/certification-and-recertification-wipp#2019).
Additional background information related to the Agency's
recertification activities is available in the public dockets and on
this website. The EPA will evaluate DOE's complete application and make
a determination whether the WIPP continues to comply with the radiation
protection standards for disposal. The EPA will consider public comment
and other information relevant to the WIPP's compliance. The Agency is
most interested in public comment on issues where changes to the
disposal system have occurred that may potentially impact the WIPP's
ability to remain in compliance with requirements in the EPA's disposal
regulations, as well as any areas where the public believes that
changes have occurred that have not been identified by the DOE.
    The EPA's first step in the recertification process is a
``completeness'' determination of DOE's application. The EPA will make
this completeness determination as a first step in its more extensive
technical review of the application. This determination is based on a
number of the Agency's WIPP-specific guidances, most notably, the
``Compliance Application Guidance'' (CAG; EPA Pub. 402-R-95-014) and
``Guidance to the U.S. Department of Energy on Preparation for
Recertification of the Waste Isolation Pilot Plant with 40 CFR parts
191 and 194'' (Docket A-98-49, Item II-B3-14; December 12, 2000). Both
guidance documents include guidelines regarding: (1) Content of
certification/recertification applications; (2) documentation and
format requirements; (3) time frame and evaluation process; and (4)
change reporting and modification. The Agency developed these guidance
documents to assist the DOE with the preparation of any compliance
application for the WIPP. It is the EPA's intent that these guidance
documents give the DOE and the public a general understanding of the
information that is expected to be included in a ``complete''
application of compliance. However, the DOE does not have to resubmit
information already supplied to the EPA in prior recertification
applications. The focus of each recertification is on any changes to
the disposal system since the previous recertification decision. The
EPA may request additional information as necessary from the DOE to
ensure the completeness of the CRA.
    Once the 2019 recertification application is deemed complete, the
EPA will provide the DOE with written notification of its completeness
determination and publish a Federal Register document announcing this
determination. All correspondence between the EPA and the DOE regarding
the completeness of the CRA-2019, and any additional information sent
by the DOE, such as the supplementary results and calculations planned
for submittal in December 2019, will be placed in the public docket
(via www.regulations.gov) and linked on the Agency's WIPP website
(https://www.epa.gov/radiation/certification-and-recertification-wipp#2019).
    The EPA will make a final decision as to whether the WIPP continues
to meet the disposal regulations after each of the aforementioned steps
(i.e., technical analysis of the application, issuance of a notice on
the CRA-2019's completeness in the Federal Register, and analyses of
public comment) have been completed. As required by the LWA, the Agency
will make a final recertification decision within six months of issuing
its completeness determination.

List of Subjects in 40 CFR Parts 191 and 194

    Environmental protection, Radiation protection, Transuranic
radioactive waste, Waste isolation pilot plant, Waste treatment and
disposal.

    Dated: September 12, 2019.
Jonathan D. Edwards,
Director, Office of Radiation and Indoor Air.
[FR Doc. 2019-20319 Filed 9-24-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)]
[Notices]
[Pages 7043-7046]
[FR Doc No: 2018-03236]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0481]

Submission of Content Necessary for Bioresearch Monitoring
Inspection Planning for the Center of Drug Evaluation and Research;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Standardized Format for Electronic Submission of NDA and BLA Content
for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER
Submissions'' along with the Bioresearch Monitoring Technical
Conformance Guide Containing Technical Specifications (BIMO Technical
Conformance Guide). The draft guidance and BIMO Technical Conformance
Guide describe and provide specifications for the electronic submission
of certain data and information in standardized formats. This
information is used by the Center for Drug Evaluation and Research
(CDER) in the planning of, and by FDA's Office of Regulatory Affairs
(ORA) in the conduct of, bioresearch monitoring (BIMO) inspections. The
draft guidance addresses major (i.e., pivotal) studies used to support
safety and efficacy claims in new drug applications (NDAs) and
biologics license applications (BLAs) regulated by CDER, as well as
certain supplemental applications containing new clinical study
reports. This draft guidance, when finalized, is intended to assist
applicants in the submission of electronic data and information in
standardized formats, and supersedes the previously issued draft
guidance entitled ``Providing Submissions in Electronic Format--Summary
Level Clinical Site Data for CDER's Inspection Planning'' (December
2012) (Summary Level Clinical Site Draft Guidance).

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 17, 2018.

ADDRESSES: 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-D-0481 for ``Standardized Format for Electronic Submission of
New Drug Application and Certain Biologics License Application Content
for the Planning of Bioresearch Monitoring Inspections for Submissions
to the Center for Drug Evaluation and Research; Draft Guidance for
Industry; Bioresearch Monitoring Technical Conformance Guide Containing
Technical Specifications; Availability.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states,
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments, and you must identify this information as
``confidential.'' Any information marked ``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.
    Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jean Mulinde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of: (1) A draft guidance for
industry entitled ``Standardized Format for Electronic Submission of
NDA and BLA Content for the Planning of Bioresearch Monitoring
Inspections (BIMO) for CDER Submissions'' and (2) the BIMO Technical
Conformance Guide. This draft guidance and the BIMO Technical
Conformance Guide describe and provide specifications for the
electronic submission of data and information in standardized formats,
for submitting information used by CDER in the planning of, and by ORA
in the conduct

of, BIMO inspections. The draft guidance and the technical conformance
guide address major (i.e., pivotal) studies used to support safety and
efficacy claims in NDAs, BLAs, and NDA and BLA supplemental
applications containing new clinical study reports that are regulated
by CDER.
    To meet its review performance goals in accordance with CDER good
review management principles and practices for products covered by the
Prescription Drug User Fee Act, CDER generally initiates inspection
planning early in the application review process (i.e., during the
filing determination and review planning phase). CDER's inspection
planning includes the selection of clinical investigator sites and
other regulated entities for on-site inspections, and the preparation
of assignment memos and background packages that CDER provides to FDA's
ORA, which performs FDA's BIMO inspections. CDER uses the data and
information described in this guidance to plan BIMO inspections,
including: (1) To facilitate the timely identification of sites for
inspection and (2) to ensure the availability of information needed to
conduct BIMO inspections by ORA investigators.
    This draft guidance and the associated technical conformance guide
supersede the previously issued Summary Level Clinical Site Draft
Guidance that published in the Federal Register on December 19, 2012
(77 FR 75174). FDA carefully considered all of the comments received to
the docket for the Summary Level Clinical Site Draft Guidance in
developing this guidance. This draft guidance includes clarifications,
additional detail on some topics, revised nomenclature for some data
variables, and descriptions of additional data and information in
standardized formats that are submitted in NDAs and BLAs to CDER, to
facilitate the planning of routine BIMO inspections.
    In section 745A(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379k-1(a)), Congress granted explicit authorization to FDA to
specify, in guidance, the electronic format for submissions under
section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or
(j)) and submissions under section 351(a) or (k) of the Public Health
Service Act (42 U.S.C. 262(a) or (k)). Accordingly, to the extent that
this guidance, when finalized, provides such requirements, as indicated
by the use of the words must or required, this guidance will not be
subject to the usual restrictions in FDA's good guidance practice (GGP)
regulations, such as the requirement that guidances not establish
legally enforceable responsibilities (see 21 CFR 10.115(d); see also
the guidance for industry ``Providing Regulatory Submissions in
Electronic Format--Submissions Under Section 745A(a) of the Federal
Food, Drug, and Cosmetic Act,'' available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    To comply with GGP regulations and make sure that regulated
entities and the public understand that guidance documents are
nonbinding, FDA guidances ordinarily contain standard language
explaining that guidance documents should be viewed only as
recommendations unless specific regulatory or statutory requirements
are cited. FDA is not including this standard language in this draft
guidance document because it is not an accurate description of this
guidance. Insofar as this guidance specifies the format for electronic
submissions pursuant to section 745A(a) of the FD&C Act, when
finalized, it will have binding effect.
    The draft guidance and the BIMO Technical Conformance Guide, when
finalized, will represent the current thinking of FDA on standardized
format for electronic submission of NDA and BLA content for the
planning of BIMO inspections for CDER Submissions.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance and the associated technical conformance guide, FDA
invites comments on the following topics: (1) Whether the proposed
information collected is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimated burden of the proposed
information collected, including the validity of the methodology and
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information collected; and (4) ways to minimize the burden of
information collected on the respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    The draft guidance and the Bioresearch Monitoring Technical
Conformance Guide provide the electronic format and specifications for
submission of data and information used by CDER in the planning of, and
by ORA in the conduct of, BIMO inspections. Data and information
described in the draft guidance comprises information required in parts
312, 314, or 601 (21 CFR parts 312, 314, or 601), including case
histories (Sec.  312.62(b)), information regarding foreign clinical
studies not conducted under an investigational new drug application
(IND) (Sec.  312.120), and the clinical data section (Sec.
314.50(d)(5)) and case report forms and tabulations (Sec.  314.50(f)),
or in part 601 (Sec.  601.2 Applications for biologics licenses;
procedures for filing) in an NDA, BLA, or supplement. The draft
guidance and the associated technical conformance guide describe the
electronic format of clinical study-level information, subject-level
data line listings by clinical site, and the summary-level clinical
site dataset that are submitted from all major (i.e., pivotal) studies
used to support safety and efficacy claims in NDAs, BLAs, and NDA and
BLA supplemental applications containing new clinical study reports.
The variables described in the format are elements currently used in
other submissions; some of the variable names described in the summary-
level clinical site dataset are new. The financial disclosure
information is currently reported in Module 1 (region specific
information) of the electronic common technical document, but is new as
a variable in the summary-level clinical site dataset. In addition,
identifying that a study has been conducted under an IND is new as a
request in a dataset. Initial preparation of some of the clinical
study-level information, the subject-level data line listings by
clinical site, and the summary-level clinical site dataset and the
development of new standard operating procedures (SOPs) would require
added time. Once SOPs have been established, generation of the clinical
study-level information, subject-level data line listings by clinical
site, and the summary-level clinical site dataset should not involve
significant

additional work. The applicant would likely perform more quality
assurance, which may add time to preparation and review of the
submission.
    Based on CDER's data on the number of NDAs, BLAs, and NDA and BLA
supplemental applications containing new clinical study reports that
would be covered by the draft guidance, we estimate that each year
approximately 75 applicants will submit for 125 original NDA or BLA
applications and 152 supplemental applications containing new clinical
study reports. We estimate that the submission of the clinical study-
level information, subject-level data line listings by clinical site,
and the summary-level clinical site dataset for each application would
take approximately 40 hours to prepare. Initial preparation of the
clinical study-level information, subject-level data line listings by
clinical site, and the summary-level clinical site dataset could
involve the development of new SOPs for some applicants. We estimate
that 75 applicants would take approximately 20 hours to develop and
subsequently 2 hours annually to maintain and update the SOP(s). The
clinical study-level information, subject-level data line listings by
clinical site, and the summary-level clinical site dataset submitted
with each application would likely involve additional quality assurance
procedures, which would add approximately 2 hours for each submission.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in part 312 have been approved under OMB control number 0910-0014; the
collections of information in part 314 have been approved under OMB
control number 0910-0001; the collections of information in part 601
have been approved under OMB control number 0910-0338.
    FDA estimates the burden of this collection of information as
follows:

                                                         Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Number of       Number of responses
                           Activity                             respondents (i.e.,     per respondent          Total         Hours per      Total hours
                                                                    applicants)     (i.e., applications)     responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submissions (clinical study-level information, subject-level                    75                   3.7             277              40          11,080
 data line listings by clinical site, and the summary-level
 clinical site dataset).......................................
Quality Assurance.............................................                  75                   3.7             277               2             554
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ..................  ....................  ..............  ..............          11,634
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

                                   Table 2--Estimated Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of      records per    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeper                    recordkeeper
----------------------------------------------------------------------------------------------------------------
Develop Initial SOP(s)..........              75               1              75              20           1,500
Maintain and Update SOP(s)......              75               1              75               2             150
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,650
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03236 Filed 2-15-18; 8:45 am]
BILLING CODE 4164-01-P


 [Federal Register: October 23, 2009 (Volume 74, Number 204)] [ Notices]                [Page 54826-54827] [DOCID:fr23oc09-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0486]

  Agency Information Collection Activities; Proposed Collection;

Comment Request; Guidance for Industry, FDA, and Foreign Governments:

Fiscal Year 2010 Medical Device User Fee Small Business Qualification

and Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an

opportunity for public comment on the proposed collection of certain

information by the agency. Under the Paperwork Reduction Act of 1995

(the PRA), Federal agencies are required to publish notice in the

Federal Register concerning each proposed collection of information,

including each proposed extension of an existing collection of

information, and to allow 60 days for public comment in response to the

notice. This notice solicits comments on FDA Forms 3602 and FDA Form

3602A which will allow domestic and foreign applicants to certify that

they qualify as a ``small business'' and pay certain medical device

user fees at reduced rates.

DATES:  Submit written or electronic comments on the collection of

information by December 22, 2009.

ADDRESSES: Submit electronic comments on the collection of information

to: http://www.regulations.gov. Submit written comments on the

collection of information to the Division of Dockets Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with the docket

number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of

Information Management (HFA-710), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

agencies must obtain approval from the Office of Management and Budget

(OMB) for each collection of information they conduct or sponsor.

``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests or requirements that members of

the public submit reports, keep records, or provide information to a

third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))

requires Federal agencies to provide a 60-day notice in the Federal

Register concerning each proposed collection of information, including

each proposed extension of an existing collection of information,

before submitting the collection to OMB for approval. To comply with

this requirement, FDA is publishing notice of the proposed collection

of information set forth in this document.

    With respect to the following collection of information, FDA

invites comments on these topics: (1) Whether the proposed collection

of information is necessary for the proper performance of FDA's

functions, including whether the information will have

practicalutility; (2) the accuracy of FDA's estimate of the burden of

the proposed collection of information, including the validity of the

methodology and assumptions used; (3) ways to enhance the quality,

utility, and clarity of the information to be collected; and (4) ways

to minimize the burden of the collection of information on respondents,

including through the use of automated collection techniques, when

appropriate, and other forms of information technology.

Guidance for Industry, FDA, and Foreign Governments: FY 2010 Medical

Device User Fee Small Business Qualification and Certification FD&C Act

Section 738 (OMB Control Number 0910-0508)--Extension

    Section 101 of the Medical Device User Fee and Modernization Act

(MDUFMA) amends the Federal Food, Drug, and Cosmetic Act (the act) to

provide for user fees for certain medical device applications. FDA

published a Federal Register notice on August 3, 2009 (74 FR 38444),

announcing fees for fiscal year (FY) 2010. To avoid harming small

businesses, MDUFMA provides for reduced or waived fees for applicants

who qualify as a ``small business.'' This means there are two levels of

fees, a standard fee, and a reduced or waived small business fee.

FDA From 3602-- For Domestic Small Business Applicants

    For FY 2010, you can qualify for a small business fee discount

under MDUFMA if you reported gross receipts or sales of no more than

$100 million on your Federal income tax return for the most recent tax

year. If you have any affiliates, partners, or parent firms, you must

add their gross receipts or sales to yours and the total must be no

more than $100 million. If your gross receipts or sales are no more

than $30 million, including all of your affiliates, partners, and

parent firms, you will also qualify for a waiver of the fee for your

first (ever) premarket application, (product development protocol,

biologics licensing application, or Premarket Report). An applicant

must pay the full standard fee unless it provides evidence

demonstrating to FDA that it meets the ``small business'' criteria. The

evidence required by MDUFMA is a copy of the most recent Federal income

tax return of the applicant, and any affiliate, partner, or parent

firm. FDA will review these

materials and decide whether an applicant is a ``small business''

within the meaning of MDUFMA.

FDA Form 3602A-- For Foreign Small Business Applicants

    The 2007 Amendments provide an alternative way for a foreign

business to qualify as a small business eligible to pay a

significantly-lower fee when a medical device user fee must be paid.

    Before passage of the 2007 Amendments, the only way a business

could qualify as a small business was to submit a Federal (U.S.) income

tax return showing its gross receipts or sales that did not exceed a

statutory threshold, currently, $100 million. If a business could not

provide a Federal income tax return, it did not qualify as a small

business and had to pay the standard (full) fee. Because many foreign

businesses have not, and cannot, file a Federal (U.S.) income tax

return, this requirement has effectively prevented those businesses

from qualifying for the small business fee rates. Thus, foreign

governments, including the European Union, have objected.

    In lieu of a Federal income tax return, the 2007 Amendments will

allow a foreign business to qualify as a small business by submitting a

certification from its national taxing authority, the foreign

equivalent of our Internal Revenue Service. This certification,

referred to as a ``National Taxing Authority Certification,'' must:

     Be in English;

     Be from the national taxing authority of the country in

which the business is headquartered;

     Provide the business' gross receipts or sales for the most

recent year, in both the local currency and in U.S. dollars, and the

exchange rate used in converting local currency to U.S. dollars;

     Provide the dates during which the reported receipts or

sales were collected; and

     Bear the official seal of the national taxing authority.

    Both FDA Forms 3602 and 3602A are available in the guidance

document, ``Guidance for Industry, FDA and Foreign Governments: FY 2010

MDUFMA Small Business Qualification and Certification'' , available on

the Internet at http://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/Overview/

MedicalDeviceUserFeeandModernizationActMDUFMA/UCM179257.pdf. This

guidance describes the criteria FDA will use to decide whether an

entity qualifies as a MDUFMA small business and will help prospective

applicants understand what they need to do to meet the small business

criteria for FY 2010.

    FDA estimates the burden of this collection of information as

follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\

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

                                                        Number of         Annual Frequency        Total Annual          Hours per

                  FDA  Form No.                        Respondents          per Response            Responses            Response         Total  Hours

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

3602                                                             3,000                     1                 3,000                  1              3,000

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

3602A                                                              340                     1                   340                  1                340

Sections I and II

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

3602A                                                               33                     7                   231                  1                231

Section III

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

TOTALS                                                                                3,571

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

\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The FDA Form 3602 burden is based on the number of applications

received in the last 3 years. FDA believes most entities that submit

FDA Form 3602A will not have any affiliates, and very few will have

more than three or four affiliates. Based on our experience with FDA

Form 3602A, FDA believes each business will require 1 hour to complete

Sections I and II. FDA does not have any data on the time that will be

required to complete Section III, the National Taxing Authority

Certification, since there is a different tax verification process by

each country's National Taxing Authority.

    The information collection for FDA Form 3602 is currently approved

under OMB control number 0910-0508. The information collection for FDA

Form 3602A is currently approved under OMB control number 0910-0613.

With this request for approval, FDA is requesting to consolidate OMB

approvals 0910-0508 and 0910-0613 into one information collection using

the OMB control number 0910-0508.

    Dated: October 16, 2009.

David Horowitz,

Assistant Commissioner for Policy.

[FR Doc. E9-25538 Filed 10-22-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19469-19470]
[FR Doc No: 2020-07198]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

March 31, 2020.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP18-922-005.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing TPC RP18-922 Stipulation and
Agreement Compliance Filing to be effective 1/1/2019.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5141.
    Comments Due: 5 p.m. ET 4/8/20.

    Docket Numbers: RP20-688-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Amended
Macquarie 510932 to be effective 4/1/2020.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5026.
    Comments Due: 5 p.m. ET 4/8/20.

    Docket Numbers: RP20-689-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Update Filing
(Conoco Apr 20) to be effective 4/1/2020.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5040.
    Comments Due: 5 p.m. ET 4/8/20.

    Docket Numbers: RP20-690-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Compressor Usage Surcharge
2020 to be effective 5/1/2020.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5043.
    Comments Due: 5 p.m. ET 4/8/20.

    Docket Numbers: RP20-691-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Annual Gas Compressor Fuel Report of Kern River Gas
Transmission Company under RP20-691.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5117.
    Comments Due: 5 p.m. ET 4/8/20.

    Docket Numbers: RP20-692-000.
    Applicants: Pine Needle LNG Company, LLC.
    Description: Sec.  4(d) Rate Filing: Tariff Clean-Up to be
effective 4/27/2020.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5132.
    Comments Due: 5 p.m. ET 4/8/20.

    Docket Numbers: RP20-693-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.

    Description: Sec.  4(d) Rate Filing: Tariff Clean Up Filing to be
effective 4/27/2020.
    Filed Date: 3/27/20.
    Accession Number: 20200327-5299.
    Comments Due: 5 p.m. ET 4/8/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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 comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    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: March 31, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-07198 Filed 4-6-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Page 41278]
[FR Doc No: 2011-17636]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2011-0112]

Cargo Security Risk Reduction; Public Listening Sessions

AGENCY: Coast Guard, DHS.

ACTION: Notice of meetings.

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

SUMMARY: The Coast Guard's Office of Port and Facility Activities (CG-
544) is sponsoring information and listening sessions in St. Louis, MO
and Houston, TX to discuss the progress and development of a CDC
Security National Strategy to reduce risks associated with the
transport, transfer, and storage of Certain Dangerous Cargo (CDC) in
bulk within the U.S. Marine Transportation System. These sessions will
be open to the public.

DATES: The first session will be held in St. Louis, MO on Tuesday,
August 2, 2011, from 8 a.m. to 1 p.m. The second session will be held
in Houston, TX on Thursday, August 18, 2011, from 8 a.m. to 1 p.m.

ADDRESSES: The St. Louis, MO session will be held at the Hilton St.
Louis at the Ballpark, One South Broadway, St. Louis, MO 63102. The
Houston, TX session will be held at the Hobby Airport Hilton, 8181
Airport Blvd., Houston, TX 77051.
    This meeting is open to the public. Please note that the session
may adjourn early if all business, concerns, and questions are
addressed. Seating may be limited, but session organizers will make
every effort to suitably accommodate all participants. For information
on facilities or services for individuals with disabilities, or to
request special assistance at either or both sessions, please contact
LTJG William Gasperetti or LTJG Bradley Bergan, using the contact
information listed in this notice.
    Written comments will be received for a short period of time after
the public meetings from interested stakeholders.

FOR FURTHER INFORMATION CONTACT: To submit questions and comments or to
RSVP for the sessions, send e-mails to<EMAIL_ADDRESS>Comments,
questions and responses may be posted for public viewing on the Office
of Port and Facility Activities (CG-544) Web site at http://www.uscg.mil/hq/cg5/cg544/cdc.asp or the Federal Docket Management
System at http://www.Regulations.gov. For logistical issues, please
contact either LTJG William Gasperetti, Domestic Ports Division (CG-
5441) at<PHONE_NUMBER> or via e-mail at<EMAIL_ADDRESS>or
LTJG Bradley Bergan, Domestic Ports Division (CG-5441) at<PHONE_NUMBER>
or via e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    In September 2009, the Coast Guard held a Cargo Security Symposium
in Reston, Virginia, to inform and guide the development of a national
strategy for reducing the maritime security risks present in the bulk
transportation and transfer of CDCs within ports and waterways of the
United States. Because CDCs have chemical properties that, if released,
could result in substantial death and injury in high density population
areas and significant damage to critical infrastructure and key
resources (CIKR), it is important for the Coast Guard, in concert with
stakeholders, to implement a holistic strategy to mitigate CDC
transport, transfer, and storage security risks. These security risks
can be reduced through sound risk management and shared responsibility
between public and private sector stakeholders, across the Security
Spectrum.\1\
---------------------------------------------------------------------------

    \1\ The Security Spectrum generally consists of Awareness,
Prevention/Protection, Response, and Recovery.
---------------------------------------------------------------------------

    Following the 2009 Cargo Security Symposium, a National Cargo
Security Risk Reduction Workgroup for CDCs was chartered by the Coast
Guard to discuss CDC security topics that could inform the development
of a CDC Security National Strategy. The results of the workgroup's
discussions have led to the development of components that will
comprise a working draft of the CDC Security National Strategy. The
working draft will be further informed by a required CDC Security
National Study, called for by section 812 of the Coast Guard
Authorization Act of 2010 and input received at the public listening
sessions described in this notice.

Agenda of Public Meeting

    The Coast Guard is holding listening sessions to discuss the
working draft of the CDC Security National Strategy and further its
development. Primarily, we are soliciting stakeholder input on the
goals and how best to implement those goals under a ``shared
responsibility'' paradigm. The agenda for the two sessions will
principally consist of a presentation and discussion of certain
elements of the working draft of the CDC Security National Strategy and
future strategy implementation considerations. Included in the CDC
Security National Strategy, and to be discussed, are the following
goals:
     Provide to internal and external stakeholders real-time
national, regional, and local awareness of the risk of intentional
attacks on the CDC Marine Transportation System.
     Consistently assess vulnerability to threats of
intentional attacks on the CDC Marine Transportation System and
mitigate the vulnerability to an acceptable level.
     Dynamically assess the potential consequences of
intentional attacks on the CDC Marine Transportation System and capably
mitigate, through coordinated response, the impact of a successful
attack.
     Lead the development of national, regional, and local
resiliency/recovery capability from successful attacks on the CDC
Marine Transportation System.
    This notice is issued under the authority of 5 U.S.C. 552(a).

    Dated: July 7, 2011.
K.C. Kiefer,
Captain, U.S. Coast Guard, Chief, Office of Port and Facility
Activities (CG-544).
[FR Doc. 2011-17636 Filed 7-12-11; 8:45 am]
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[Federal Register Volume 88, Number 195 (Wednesday, October 11, 2023)]
[Proposed Rules]
[Pages 70409-70412]
[FR Doc No: 2023-22373]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-1991; Project Identifier AD-2023-00700-E]
RIN 2120-AA64

Airworthiness Directives; CFM International, S.A. Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain CFM International, S.A. (CFM) Model LEAP-1A23, LEAP-1A24,
LEAP-1A24E1, LEAP-1A26, LEAP-1A26CJ, LEAP-1A26E1, LEAP-1A29, LEAP-
1A29CJ, LEAP-1A30, LEAP-1A32, LEAP-1A33, LEAP-1A33B2, and LEAP-1A35A
engines. This proposed AD was prompted by a report of multiple aborted
takeoffs and air turn-backs (ATBs) caused by high-pressure compressor
(HPC) stall, which was induced by high levels of non-synchronous
vibration (NSV). Additional manufacturer investigation revealed that
wear on the No. 3 bearing spring finger housing can lead to high levels
of NSV. This proposed AD would require initial and repetitive
calculations of the levels of NSV, inspection of the stage 2 high-
pressure turbine (HPT) nozzle assembly honeycomb and HPT stator
stationary seal honeycomb and, depending on the results of the
calculations and inspections, replacement of certain parts. This
proposed AD would also require replacement of the No. 3 bearing spring
finger housing. 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 November
27, 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 by
searching for and locating Docket No. FAA-2023-1991; 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, any comments
received, and other information. The street address for Docket
Operations is listed above.
    Material Incorporated by Reference:
     For service information identified in this NPRM, contact
CFM International, S.A., GE Aviation Fleet Support, 1 Neumann Way, M/D
Room 285, Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email:
[email protected].
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mehdi Lamnyi, Aviation Safety
Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198; phone:
(781) 238-7743; 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-2023-1991; Project Identifier
AD-2023-00700-E'' 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 Mehdi Lamnyi, Aviation
Safety Engineer, FAA, 2200 South 216th Street, Des Moines, WA 98198.
Any commentary that the FAA receives which is not specifically
designated as CBI will be placed in the public docket for this
rulemaking.

Background

    The FAA was notified by the engine manufacturer of three aborted
takeoffs and two ATBs caused by HPC stall. Additional manufacturer
investigation revealed that wear on the No. 3 bearing spring finger
housing can lead to high levels of NSV, which could induce HPC stall.
As a result of its investigation, the manufacturer published service
information that specifies procedures for addressing this situation.
This condition, if not addressed, could result in engine power loss at
a critical phase of flight such as takeoff or climb, loss of engine
thrust control, reduced controllability of the airplane, and loss of
the airplane.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed CFM Service Bulletin (SB) LEAP-1A-72-00-0504-01A-
930A-D, Issue 001, dated June 14, 2023. This service information
identifies affected No. 3 bearing spring finger housings and specifies
procedures for monitoring NSV during engine operation. This service
information also specifies procedures for replacing the No. 3 bearing
spring finger housings, inspecting the stage 2 HPT nozzle assembly
honeycomb and HPT stator stationary seal honeycomb, and replacing the
stage 2 HPT nozzle assembly honeycomb and HPT stator stationary seal.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in ADDRESSES.

Proposed AD Requirements in This NPRM

    This proposed AD would require repetitive calculations of the
levels of NSV and, depending on the results of the calculations,
replacement of the No. 3 bearing spring finger housing. This proposed
AD would require, following the removal and replacement of the No. 3
bearing spring finger housing, inspection of the stage 2 HPT nozzle
assembly honeycomb and HPT stator stationary seal honeycomb for rubs
and, depending on findings, replacement of the stage 2 HPT nozzle
assembly honeycomb and HPT stator stationary seal. This proposed AD
would also require replacement of the No. 3 bearing spring finger
housing, regardless of calculated level of NSV, at a certain time.

Interim Action

    The FAA considers that this proposed AD would be an interim action.
The design approval holder is currently developing a modification to
address this issue. The FAA may consider additional rulemaking on this
subject.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 48 engines installed on airplanes of U.S. registry. The FAA
estimates that 33 engines installed on airplanes of U.S. registry would
require replacement of the No. 3 bearing spring finger housing.
    The FAA estimates the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Calculate NSV data....................  1 work-hour x $85 per                 $0             $85          $4,080
                                         hour = $85.
Replace No. 3 bearing spring finger     17 work-hours x $85 per           64,590          66,035       2,179,155
 housing.                                hour = $1,445.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacement and inspection that would be required based on the results
of the proposed calculation. The agency has no way of determining the
number of aircraft that might need these replacements and inspections:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Inspect stage 2 HPT nozzle assembly honeycomb   4 work-hours x $85 per hour =                 $0            $340
 and HPT stator stationary seal honeycomb.       $340.
Replace stage 2 HPT nozzle assembly honeycomb.  8 work-hours x $85 per hour =             58,536          59,216
                                                 $680.
Replace HPT stator stationary seal............  8 work-hours x $85 per hour =              6,855           7,535
                                                 $680.
----------------------------------------------------------------------------------------------------------------

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 adding the following new airworthiness
directive:

CFM International, S.A.: Docket No. FAA-2023-1991; Project
Identifier AD-2023-00700-E.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by November 27, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to CFM International, S.A. (CFM) Model LEAP-
1A23, LEAP-1A24, LEAP-1A24E1, LEAP-1A26, LEAP-1A26CJ, LEAP-1A26E1,
LEAP-1A29, LEAP-1A29CJ, LEAP-1A30, LEAP-1A32, LEAP-1A33, LEAP-
1A33B2, and LEAP-1A35A engines with an installed No. 3 bearing
spring finger housing having part number (P/N) 2629M62G01 and a
serial number identified in Table 1 or Table 2 of CFM Service
Bulletin (SB) LEAP-1A-72-00-0504-01A-930A-D, Issue 001, dated June
14, 2023 (CFM SB LEAP-1A-72-00-0504-01A-930A-D).

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by a report of multiple aborted takeoffs
and air turn-backs caused by high-pressure compressor (HPC) stall,
which was induced by high levels of non-synchronous vibration (NSV),
and an additional manufacturer investigation that revealed wear on
the No. 3 bearing spring finger housing. The FAA is issuing this AD
to prevent HPC stall. The unsafe condition, if not addressed, could
result in engine power loss at a critical phase of flight such as
takeoff or climb, loss of engine thrust control, reduced
controllability of the airplane, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    (1) Within 125 flight cycles (FCs) after the effective date of
this AD and thereafter at intervals not to exceed 125 FCs, calculate
the NSV data in accordance with the Accomplishment Instructions,
paragraphs 5.A.(1) and 5.A.(3), or 5.B.(1) and 5.B.(3) of CFM SB
LEAP-1A-72-00-0504-01A-930A-D.
    (2) If, during any calculation required by paragraph (g)(1) of
this AD, the NSV data exceeds the limits specified in the
Accomplishment Instructions, paragraph 5.A.(4)(a)1 or 5.B.(4)(a)1 of
CFM SB LEAP-1A-72-00-0504-01A-930A-D, discontinue the calculations
required by paragraph (g)(1) of this AD and within 150 FCs of
performing the calculation:
    (i) Remove from service the No. 3 bearing spring finger housing
having P/N 2629M62G01 and a serial number identified in Table 1 or
Table 2 of CFM SB LEAP-1A-72-00-0504-01A-930A-D and replace with a
part eligible for installation.
    (ii) Inspect the stage 2 high-pressure turbine (HPT) nozzle
assembly honeycomb for rubs in accordance with the Accomplishment
Instructions, paragraphs 5.A.(4)(a)3b1) or 5.B.(4)(a)3b1) of CFM SB
LEAP-1A-72-00-0504-01A-930A-D.
    (iii) Inspect the HPT stator stationary seal honeycomb for rubs
in accordance with the Accomplishment Instructions, paragraphs
5.A.(4)(a)3b2) or 5.B.(4)(a)3b2) of CFM SB LEAP-1A-72-00-0504-01A-
930A-D.
    (3) If, during the inspection required by paragraph (g)(2)(ii)
of this AD, the stage 2 HPT nozzle assembly honeycomb fails to meet
the serviceability criteria referenced in the Accomplishment
Instructions, paragraphs 5.A.(4)(a)3b1) or 5.B.(4)(a)3b1) of CFM SB
LEAP-1A-72-00-0504-01A-930A-D, before further flight, replace the
stage 2 HPT nozzle assembly honeycomb.
    (4) If, during the inspection required by paragraph (g)(2)(iii)
of this AD, the HPT stator stationary seal honeycomb fails to meet
the serviceability criteria referenced in the Accomplishment
Instructions, paragraphs 5.A.(4)(a)3b2) or 5.B.(4)(a)3b2) of CFM SB
LEAP-1A-72-00-0504-01A-930A-D, before further flight, replace the
HPT stator stationary seal.
    (5) At the next piece-part exposure after the effective date of
this AD, but before exceeding 9,900 cycles since new, replace the
No. 3 bearing spring finger housing having P/N 2629M62G01 and a
serial number identified in Table 1 of CFM SB LEAP-1A-72-00-0504-
01A-930A-D with a part eligible for installation.

(h) Terminating Action

    Replacement of the No. 3 bearing spring finger housing having P/
N 2629M62G01 and a serial number identified in Table 1 or Table 2 of
CFM SB LEAP-1A-72-00-0504-01A-930A-D with a part eligible for
installation, as specified in paragraphs (g)(2)(i) and (g)(5) of
this AD, constitutes terminating action for the calculations
required by paragraph (g)(1) of this AD.

(i) Definition

    For the purpose of this AD, a ``part eligible for installation''
is a No. 3 bearing spring finger housing that does not have P/N
2629M62G01 and a serial number identified in Table 1 or Table 2 of
CFM SB LEAP-1A-72-00-0504-01A-930A-D.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, AIR-520, Continued Operational Safety 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 local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the branch office, send it to
the attention of the person identified in paragraph (k) of this AD
and email it to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) For service information that contains steps that are labeled
as Required for Compliance (RC), the following provisions apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, that are required by
paragraph (g) of this AD must be done to comply with this AD. An
AMOC is required for any deviations to RC steps required by
paragraph (g) of this AD, including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    For more information about this AD, contact Mehdi Lamnyi,
Aviation Safety Engineer, FAA, 2200 South 216th Street, Des Moines,
WA 98198; phone:<PHONE_NUMBER>; email: [email protected].

(l) 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 the AD specifies otherwise.
    (i) CFM International, S.A. Service Bulletin LEAP-1A-72-00-0504-
01A-930A-D, Issue 001, dated June 14, 2023.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact CFM
International, S.A., GE Aviation Fleet Support, 1 Neumann Way, M/D
Room 285, Cincinnati, OH 45215; phone:<PHONE_NUMBER>; email:
[email protected].
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) 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 October 3, 2023.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2023-22373 Filed 10-10-23; 8:45 am]
BILLING CODE 4910-13-P