[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Proposed Rules]
[Pages 3059-3061]
[FR Doc No: 2016-00633]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-8466; Directorate Identifier 2015-NM-045-AD]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This
proposed AD was prompted by the need for more restrictive fuel
airworthiness limitations. This proposed AD would require revising the
maintenance program or inspection program, as applicable, to
incorporate certain fuel system airworthiness limitations. We are
proposing this AD to reduce the potential of ignition sources inside
fuel tanks, which, in combination with flammable fuel vapors, could
result in fuel tank explosions and consequent loss of the airplane.

DATES: We must receive comments on this proposed AD by March 7, 2016.

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 http://www.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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

    For service information identified in this proposed AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL
Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
8466; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-8466;
Directorate Identifier 2015-NM-045-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2015-0032, dated February 24, 2015 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Fokker Services
B.V. Model F.28 Mark 0070 and 0100 airplanes. The MCAI states:

    Fokker Services published issue 5 of Engineering Report SE-672,
containing Fuel Airworthiness Limitation Items (ALIs) and Critical
Design Configuration Control Limitations (CDCCLs). This report is
Part 3 of the Airworthiness Limitations Section (ALS Part 3) of the
Instructions for Continued Airworthiness, referred to in Section 06,
Appendix 1, of the Fokker 70/100 Maintenance Review Board (MRB)
document.
    The complete ALS currently consists of:
    Part 1--Report SE-473, Certification Maintenance Requirements
(CMRs), Part 2--Report SE-623, ALIs and Safe Life Items (SLIs), and
Part 3--Report SE-672, Fuel ALIs and CDCCLs.
    The instructions contained in those reports have been identified
as mandatory actions for continued airworthiness.
    For the reasons described above, this [EASA] AD requires
implementation of the maintenance actions as specified in ALS Part 3
of the Instructions for Continued Airworthiness, Fokker Services
Engineering Report SE-672 at issue 5.

    We have determined that the actions identified in this AD are
necessary to reduce the potential of structural failures or of ignition
sources inside fuel tanks, which, in combination with flammable fuel
vapors, could result in fuel tank explosions and consequent loss of the
airplane. You may examine the MCAI in the AD docket on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2015-8466.

Related Service Information Under 1 CFR Part 51

    Fokker Services B.V. has issued Fokker Services B.V. Engineering
Report SE-672, Fokker 70/100 Fuel ALI's and CDCCL's, Issue 5, released
December 11, 2014. The service information describes fuel airworthiness
limitation items and critical design configuration control limitations.
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 the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and/or CDCCLs.
Compliance with these actions and/or CDCCLs is required by 14 CFR
91.403(c). For airplanes that have been previously modified, altered,
or repaired in the areas addressed by this 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 according to paragraph
(i)(1) of this AD. The request should include a description of changes
to the required inspections that will ensure the continued operational
safety of the airplane.

Differences Between This Proposed AD and the MCAI or Service
Information

    The MCAI specifies that if there are findings from the ALS
inspection tasks, corrective actions must be accomplished in accordance
with Fokker Services maintenance documentation. However, this AD does
not include that requirement. Operators of U.S.-registered airplanes
are required by general airworthiness and operational regulations to
perform maintenance using methods that are acceptable to the FAA. We
consider those methods to be adequate to address any corrective actions
necessitated by the findings of ALS inspections required by this AD.

Costs of Compliance

    We estimate that this proposed AD affects 8 airplanes of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $680, or $85 per
product.

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.
    We are 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

    We 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will 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 (AD):

Fokker Services B.V.: Docket No. FAA-2015-8466; Directorate
Identifier 2015-NM-045-AD.

(a) Comments Due Date

    We must receive comments by March 7, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and
0100 airplanes, certificated in any category, all serial numbers.

(d) Subject

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

(e) Reason

    This AD was prompted by the need for more restrictive fuel
airworthiness limitations. We are issuing this AD to reduce the
potential of ignition sources inside fuel tanks, which, in
combination with flammable fuel vapors, could result in fuel tank
explosions and consequent loss of the airplane.

(f) Compliance

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

(g) Maintenance Program Revision

    (1) Within 12 months after the effective date of this AD, revise
the maintenance or inspection program, as applicable, to incorporate
the fuel airworthiness limitation items (ALIs) and critical design
configuration control limitations (CDCCLs) specified in Fokker
Services B.V. Engineering Report SE-672, Fokker 70/100 Fuel ALI's
and CDCCL's, Issue 5, released December 11, 2014.
    (2) The initial compliance times and repetitive intervals for
the actions are at the applicable times specified within Fokker
Services B.V. Engineering Report SE-672, Fokker 70/100 Fuel ALI's
and CDCCL's, Issue 5, released December 11, 2014. If any discrepancy
is found, repair using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency; or Fokker B.V. Service's
EASA Design Organization Approval (DOA). Repair any discrepancy
before further flight.

(h) No Alternative Inspections, Inspection Intervals, or CDCCLs

    After accomplishment of the actions specified in paragraph (g)
of this AD, no alternative inspections, inspection intervals, or
CDCCLs may be used unless the inspections, intervals, or CDCCLs are
approved as an AMOC in accordance with the procedures specified in
paragraph (i)(1) of this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Tom
Rodriguez, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>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. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Fokker Services B.V.'s EASA DOA. If approved by the DOA, the
approval must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to MCAI EASA Airworthiness Directive 2015-0032, dated
February 24, 2015, for related information. This MCAI may be found
in the AD docket on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-8466.
    (2) For service information identified in this AD, contact
Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130
EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31
(0)88-6280-111; email<EMAIL_ADDRESS>Internet http://www.myfokkerfleet.com. You may view this service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on January 5, 2016.
Victor Wicklund,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-00633 Filed 1-19-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Pages 14792-14793]
[FR Doc No: 2017-05631]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2017-0045]

Agency Information Collection Activities; Revision of an Approved
Information Collection: Request for Revocation of Authority Granted

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice; request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval and invites public comment. The FMCSA requests
approval to renew an ICR titled, ``Request for Revocation of Authority
Granted.''

DATES: We must receive your comments on or before May 22, 2017.

ADDRESSES: You may submit comments identified by Federal Docket
Management System (FDMS) Docket Number FMCSA-2017-0045. Using any of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001 between 9 a.m. and 5
p.m. e.t., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov, and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Tura Gatling, Office of Registration
Information and Licensing, Department of Transportation, OA, West
Building 6th Floor, 1200 New Jersey Avenue SE., Washington, DC 20590.
Telephone:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Background: The Federal Motor Carrier Safety Administration (FMCSA)
registers for-hire motor carriers of regulated commodities under 49
U.S.C. 13902, surface freight forwarders under 49 U.S.C. 13903, and
property brokers under 49 U.S.C. 13904. Each registration is effective
from the date specified under 49 U.S.C. 13905(c).
    Subsection (d) of 49 U.S.C. 13905 also provides that on application
of the registrant, the Secretary may amend or revoke a registration.
Form OCE-46 allows these transportation entities to apply voluntarily
for revocation of their registration (operating rights) or parts
thereof. If the transportation entity fails to maintain evidence of the
required level of insurance coverage on file with FMCSA, its
registration (operating authority) will be revoked involuntarily.
Although the effect of both types of revocation is the same, some
carriers prefer to request voluntary revocation. For various business
reasons, a carrier may request revocation of some part, but not all, of
its operating authority.
    This information collection supports the DOT Strategic Goal of
Safety by enabling motor carriers to voluntarily request revocation of
operating authority, or some part of that authority, by identifying
themselves to the FMCSA.
    A completed Form OCE-46 is filed with FMCSA by the registrant for
the purpose of requesting that all, or a part, of its registration be
revoked. The information contained on the form is used by the FMCSA in
making a determination on the revocation request. The use of Form OCE-
46 has proven to be an easy and effective means by which a registrant
can request revocation of its registration.
    Form OCE-46 is filed by registrants on a voluntary, and for the
most part, one-time basis. It calls for a very limited amount of
information to identify the registrant and the scope of its request.
Thus, the information collection itself

has not been automated, although the information collected is
ultimately entered into an automated data base. Eighty five percent
(85%) of the Form OCE-46 filings are submitted electronically to FMCSA.
This ICR is being revised due to an anticipated increase in the
estimated number of annual filings from 3,000 to 3,501 and to account
for the cost of notarizing and mailing Form OCE-46.
    Title: Request for Revocation of Authority Granted.
    OMB Control Number: 2126-0018.
    Type of Request: Revision of a currently approved collection.
    Respondents: For-hire motor carriers of regulated commodities,
surface freight forwarders, and property brokers.
    Estimated Number of Respondents: 3,501.
    Estimated Time per Response: 0.25 hours.
    Expiration Date: July 31, 2017.
    Frequency of Response: On occasion.
    Estimated Total Annual Burden: 875 hours [3,501 responses x 0.25
hour = 875].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize or include your
comments in the request for OMB's clearance of this information
collection.

    Issued under the authority of 49 CFR 1.87 on: March 16, 2017.
Kelly Regal,
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2017-05631 Filed 3-21-17; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: October 13, 2009 (Volume 74, Number 196)]
[Rules and Regulations]
[Page 52395-52398]
[DOCID:fr13oc09-4]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0429; Directorate Identifier 2007-NM-059-AD;
Amendment 39-16038; AD 2009-21-01]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-300 and 737-400 Series
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 737-300 and 737-400 series airplanes. This AD requires
repetitive inspections to detect cracking of the aft fuselage skin, and
related investigative/corrective actions if necessary. This AD results
from reports of cracks in the aft fuselage skin on both sides of the
airplane. We are issuing this AD to detect and correct cracking in the
aft fuselage skin along the longitudinal edges of the bonded skin
doubler, which could result in reduced structural integrity of the
airplane.

DATES: This AD is effective November 17, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of November 17,
2009.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https:[sol][sol]www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6447; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 737-300 and 737-400 series airplanes. That NPRM
was published in the Federal Register on May 7, 2009 (74 FR 21278).
That NPRM proposed to require repetitive inspections to detect cracking
of the aft fuselage skin, and related investigative/corrective actions
if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the three commenters.

Support for the AD

    Boeing concurs with the content of the NPRM.

Request To Allow Use of Previous Service Information

    Southwest Airlines requests that skin panel replacements
accomplished in accordance with Part 3 of Boeing Service Bulletin 737-
53-1168, Revision 1, dated August 17, 1995; and Revision 2, dated
November 27, 1996; also be considered as terminating action for the
inspections specified in paragraph (g) of the NPRM. (We referred to
Boeing Service Bulletin 737-53-1168, Revision 3, dated November 28,
2006, as the appropriate source of service information for
accomplishing the actions specified in paragraph (g) of the NPRM for
Model 737-300 series airplanes.)
    We agree. We have reviewed the following service bulletins and have
determined that these documents are also acceptable for terminating the
inspections specified in paragraph (g) of this AD. Therefore, we have
revised paragraph (j) of this AD to include these additional documents.
Also, for easier

readability, we have added a table in paragraph (j) of this AD to
specify the acceptable service documents.

  Table--Acceptable Service Information for Optional Terminating Action
------------------------------------------------------------------------
            Model                               Document
------------------------------------------------------------------------
Model 737-300 series           Part 3 of the Accomplishment Instructions
 airplanes.                     of Boeing Service Bulletin 737-53-1168,
                                dated March 16, 1995.
                               Part 3 of the Accomplishment Instructions
                                of Boeing Service Bulletin 737-53-1168,
                                Revision 1, dated August 17, 1995.
                               Part 3 of the Accomplishment Instructions
                                of Boeing Service Bulletin 737-53-1168,
                                Revision 2, dated November 27, 1996.
Model 737-400 series           Part III of the Accomplishment
 airplanes.                     Instructions of Boeing Service Bulletin
                                737-53-1187, dated November 2, 1995.
                               Part III of the Accomplishment
                                Instructions of Boeing Service Bulletin
                                737-53-1187, Revision 1, dated January
                                16, 1997.
------------------------------------------------------------------------

Request To Publish Effectivity and Compliance Information

    The Aviation Group requests that paragraphs 1.E., ``Compliance,''
and 1.A., ``Effectivity,'' of Boeing Service Bulletin 737-53-1168,
Revision 3, dated November 28, 2006; and Boeing Service Bulletin 737-
53-1187, Revision 2, dated May 9, 2007; be added to the NPRM, either
within the body of the AD or as an incorporated attachment. The
commenter asserts that many owners, lessors, or their respective
representatives, are routinely denied access to the manufacturer's Web
site where the referenced service information is archived, making it
very difficult or impossible to evaluate and schedule compliance with
this AD.
    We do not agree to add the compliance and effectivity sections of
Boeing Service Bulletin 737-53-1168, Revision 3, dated November 28,
2006; and Boeing Service Bulletin 737-53-1187, Revision 2, dated May 9,
2007; to this AD. Due to the length and complexity of the applicability
and compliance times required in this AD, we referred directly to the
service information to ensure the accuracy of those sections in this
AD. We also gave notice for the compliance times in the ``Relevant
Service Information'' section of the NPRM. Operators should note that
type certificate holders are required under the Federal Aviation
Regulations to make available the service information necessary for
accomplishing AD requirements to affected operators. All service
information that we incorporate by reference in our AD is available to
those who operate the product that is the subject of the AD. The
necessary service information has also been incorporated by reference
in this AD; therefore, this information is also available for review at
the FAA or the Office of the Federal Register, as specified in the
Addresses section and paragraph (n) of this AD. We have made no change
to this AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We also determined that
these changes will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    We estimate that this AD affects about 516 airplanes of U.S.
registry. The following table provides the estimated costs for U.S.
operators to comply with this AD. The average labor rate is $80 per
work hour.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
                Action                          Work hours           Parts       Cost per product        registered                Fleet cost
                                                                                airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection to determine inspection      1........................        $0  $80.....................             516  $41,280.
 zones.
Repetitive inspections--Option 1......  64.......................         0  $5,120, per inspection               516  Up to $2,641,920.
                                                                              cycle.
Repetitive inspections--Option 2......  62.......................         0  $4,960, per inspection               516  Up to $2,559,360.
                                                                              cycle.
Internal inspection...................  5, per inspection zone (3         0  $1,200..................             516  $619,200.
                                         zones).
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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.
    We are 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 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 AD:

2009-21-01 Boeing: Amendment 39-16038. Docket No. FAA-2009-0429;
Directorate Identifier 2007-NM-059-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective November 17,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1) and (c)(2) of this AD, certificated in any category.
    (1) Boeing Model 737-300 series airplanes as identified in
Boeing Service Bulletin 737-53-1168, Revision 3, dated November 28,
2006.
    (2) Boeing Model 737-400 series airplanes as identified in
Boeing Service Bulletin 737-53-1187, Revision 2, dated May 9, 2007.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Unsafe Condition

    (e) This AD results from reports of cracks in the aft fuselage
skin on both sides of the airplane. We are issuing this AD to detect
and correct cracking in the aft fuselage skin along the longitudinal
edges of the bonded skin doubler, which could result in reduced
structural integrity of the airplane.

Compliance

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

Inspections, Related Investigative and Corrective Actions

    (g) At the applicable times specified in Tables 1 and 2 of
paragraph 1.E., ``Compliance,'' of Boeing Service Bulletin 737-53-
1168, Revision 3, dated November 28, 2006 (for Model 737-300 series
airplanes); or Table 1 of paragraph 1.E., of Boeing Service Bulletin
737-53-1187, Revision 2, dated May 9, 2007 (for Model 737-400 series
airplanes); except as provided by paragraph (k) of this AD: Do the
applicable inspections and related investigative actions to detect
cracks in the aft fuselage skin panels, by accomplishing all of the
applicable actions specified in the Accomplishment Instructions of
Boeing Service Bulletin 737-53-1168, Revision 3, dated November 28,
2006; or Boeing Service Bulletin 737-53-1187, Revision 2, dated May
9, 2007; as applicable; including Note (f) of Table 1 of paragraph
1.E. And, do the applicable corrective actions specified in the
Accomplishment Instructions of Boeing Service Bulletin 737-53-1168,
Revision 3, dated November 28, 2006; or Boeing Service Bulletin 737-
53-1187, Revision 2, dated May 9, 2007; as applicable; except as
provided by paragraphs (h), (i), and (l) of this AD. Repeat the
applicable inspections and related investigative actions thereafter
at the applicable intervals specified in Tables 1 and 2 of paragraph
1.E. of Boeing Service Bulletin 737-53-1168, Revision 3, dated
November 28, 2006; or Table 1 of paragraph 1.E. of Boeing Service
Bulletin 737-53-1187, Revision 2, dated May 9, 2007; as applicable.
    (h) If any crack is found during any inspection or corrective
action required by this AD, before further flight, repair in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 737-53-1168, Revision 3, dated November 28, 2006 (for Model
737-300 series airplanes); or Boeing Service Bulletin 737-53-1187,
Revision 2, dated May 9, 2007 (for Model 737-400 series airplanes);
except, where Boeing Service Bulletin 737-53-1168, Revision 3, dated
November 28, 2006; or Boeing Service Bulletin 737-53-1187, Revision
2, dated May 9, 2007; as applicable; specifies to contact Boeing,
before further flight, repair according to a method approved in
accordance with the procedures specified in paragraph (m) of this
AD.
    (i) If any cracking of a repaired area is found during any
inspection required by this AD, and Boeing Service Bulletin 737-53-
1168, Revision 3, dated November 28, 2006 (for Model 737-300 series
airplanes); or Boeing Service Bulletin 737-53-1187, Revision 2,
dated May 9, 2007 (for Model 737-400 series airplanes); specifies
contacting Boeing for appropriate action: Before further flight,
repair the cracking using a method approved in accordance with the
procedures specified in paragraph (m) of this AD.

Optional Terminating Action

    (j) Doing the skin panel replacement before the effective date
of this AD, in accordance with the service information specified in
Table 1 of this AD, as applicable, terminates the inspection
requirements of paragraph (g) of this AD for that skin panel only.
As of the effective date of this AD, doing the skin panel
replacement, in accordance with Boeing Service Bulletin 737-53-1168,
Revision 3, dated November 28, 2006; or Boeing Service Bulletin 737-
53-1187, Revision 2, dated May 9, 2007; as applicable; terminates
the inspection requirements of paragraph (g) of this AD for that
skin panel only.

 Table 1--Acceptable Service Information for Optional Terminating Action
------------------------------------------------------------------------
            Model                               Document
------------------------------------------------------------------------
Model 737-300 series           Part 3 of the Accomplishment Instructions
 airplanes.                     of Boeing Service Bulletin 737-53-1168,
                                dated March 16, 1995.
                               Part 3 of the Accomplishment Instructions
                                of Boeing Service Bulletin 737-53-1168,
                                Revision 1, dated August 17, 1995.
                               Part 3 of the Accomplishment Instructions
                                of Boeing Service Bulletin 737-53-1168,
                                Revision 2, dated November 27, 1996.
                               Part 3 of the Accomplishment Instructions
                                of Boeing Service Bulletin 737-53-1168,
                                Revision 3, dated November 28, 2006.
Model 737-400 series           Part III of the Accomplishment
 airplanes.                     Instructions of Boeing Service Bulletin
                                737-53-1187, dated November 2, 1995.
                               Part III of the Accomplishment
                                Instructions of Boeing Service Bulletin
                                737-53-1187, Revision 1, dated January
                                16, 1997.

                               Part III of the Accomplishment
                                Instructions of Boeing Service Bulletin
                                737-53-1187, Revision 2, dated May 9,
                                2007.
------------------------------------------------------------------------

Exception to Service Bulletins

    (k) Where Boeing Service Bulletin 737-53-1168, Revision 3, dated
November 28, 2006 (for Model 737-300 series airplanes); or Boeing
Service Bulletin 737-53-1187, Revision 2, dated May 9, 2007 (for
Model 737-400 series airplanes); specifies compliance times after
the release date of those service bulletins, this AD requires that
the specified actions be done within the specified compliance times
after the effective date of this AD.

No Reporting Required

    (l) Although Boeing Service Bulletin 737-53-1168, Revision 3,
dated November 28, 2006 (for Model 737-300 series airplanes); and
Boeing Service Bulletin 737-53-1187, Revision 2, dated May 9, 2007
(for Model 737-400 series airplanes); specify to submit information
to the manufacturer, this AD does not include such a requirement.

Alternative Methods of Compliance (AMOCs)

    (m)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6447; fax<PHONE_NUMBER>. Or, e-mail information to 9-ANM-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (n) You must use Boeing Service Bulletin 737-53-1168, Revision
3, dated November 28, 2006; or Boeing Service Bulletin 737-53-1187,
Revision 2, dated May 9, 2007; as applicable; to do the actions
required by this AD, unless the AD specifies otherwise. If you do
the optional terminating action specified in this AD, you must use
the service information specified in Table 2 of this AD, as
applicable, to do the optional terminating action, unless the AD
specifies otherwise.

                          Table 2--Service Information for Optional Terminating Action
----------------------------------------------------------------------------------------------------------------
        Boeing Service Bulletin--                   Revision--                           Dated--
----------------------------------------------------------------------------------------------------------------
737-53-1168..............................  Original....................  March 16, 1995.
737-53-1168..............................  1...........................  August 17, 1995.
737-53-1168..............................  2...........................  November 27, 1996.
737-53-1168..............................  3...........................  November 28, 2006.
737-53-1187..............................  Original....................  November 2, 1995.
737-53-1187..............................  1...........................  January 16, 1997.
737-53-1187..............................  2...........................  May 9, 2007.
----------------------------------------------------------------------------------------------------------------

     (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the 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, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on September 25, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-23877 Filed 10-9-09; 8:45 am]

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[Federal Register Volume 85, Number 112 (Wednesday, June 10, 2020)]
[Proposed Rules]
[Page 35404]
[FR Doc No: 2020-12581]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2020-0081]
RIN 1625-AA08

Special Local Regulation; Choptank River, Hambrooks Bay,
Cambridge, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking; withdrawal.

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

SUMMARY: The Coast Guard is withdrawing its proposed rule concerning
temporary special local regulations for certain waters of the Choptank
River that was to have been in effect on July 25, 2020 and July 26,
2020 to provide for the safety of life on these navigable waters
located at Cambridge, MD during a high-speed power boat racing event.
The proposed rule is being withdrawn because it is no longer necessary.
The event sponsor has cancelled the boat race.

DATES: The Coast Guard is withdrawing the proposed rule published May
6, 2020 (85 FR 26903) as of June 10, 2020.

ADDRESSES: To view the docket for this withdrawn rulemaking, go to
https://www.regulations.gov, type USCG-2020-0081 in the ``SEARCH'' box
and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice, call or email MST3 Courtney Perry, Sector Maryland-National
Capital Region Waterways Management Division, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On May 6, 2020, we published a notice of proposed rulemaking
entitled ``Special Local Regulation; Choptank River, Hambrooks Bay,
Cambridge, MD'' in the Federal Register (85 FR 26903). The rulemaking
concerned was proposing to establish temporary special local
regulations for certain waters of the Choptank River in Cambridge, MD
on July 25, 2020 and July 26, 2020. This action was necessary to
provide for the safety of life on these waters during a high-speed
power boat racing event. This rulemaking would have prohibited persons
and vessels from entering the regulated area unless authorized by the
Captain of the Port Maryland-National Capital Region or a designated
representative.

Withdrawal

    The proposed rule is being withdrawn due to a regulated area no
longer being necessary following a cancellation of the high-speed power
boat racing event by the event sponsor.

Authority

    We are issuing this notice of withdrawal under the authority of 46
U.S.C. 70034.

    Dated: June 5, 2020.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Sector Maryland-National
Capital Region.
[FR Doc. 2020-12581 Filed 6-9-20; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26056-26058]
[FR Doc No: 2021-09964]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4524]

S11 Nonclinical Safety Testing in Support of Development of
Pediatric Pharmaceuticals; International Council for Harmonisation;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``S11
Nonclinical Safety Testing in Support of Development of Pediatric
Pharmaceuticals.'' The guidance was prepared under the auspices of the
International Council for Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH), formerly the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use. The guidance recommends
international standards for the nonclinical safety studies recommended
to support the development of pediatric medicines. The guidance
provides a weight of evidence approach to determine when nonclinical
toxicity studies may be recommended in juvenile animals. If such
studies are recommended, the guidance provides appropriate study
designs. The guidance is intended to promote harmonization of
recommendations for such studies and should facilitate the timely
conduct of pediatric clinical trials and reduce the use of animals in
accordance with the 3R (replace/reduce/refine) principles. Tissue
engineered products, gene and cellular therapies, and vaccines are
excluded from the scope of this guidance. The guidance replaces the
draft guidance issued on February 1, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on May 12, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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-4524 for ``S11 Nonclinical Safety Testing in Support of
Development of Pediatric Pharmaceuticals.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this 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; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Karen Davis Bruno, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6428, Silver Spring, MD 20993-0002, 301-
796-1199; or, Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``S11 Nonclinical Safety Testing in Support of Development of
Pediatric Pharmaceuticals.'' The guidance was prepared under the
auspices of ICH. ICH has the mission of achieving greater regulatory
harmonization worldwide to ensure that safe, effective, high-quality
medicines are developed, registered, and maintained in the most
resource-efficient manner. By harmonizing the regulatory requirements
in regions around the world, ICH guidelines have substantially reduced
duplicative clinical studies, prevented unnecessary animal studies,
standardized the reporting of important safety information,
standardized marketing application submissions, and made many other
improvements in the quality of global drug development and
manufacturing and the products available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. In the Federal Register of February 1, 2019 (84 FR 1161),
FDA published a notice announcing the availability of a draft guidance
entitled ``S11 Nonclinical Safety Testing in Support of Development of
Pediatric Medicines.'' The notice gave interested persons an
opportunity to submit comments by April 2, 2019. After consideration of
the comments received and revisions to the guideline, a final draft of
the guideline was submitted to the ICH Assembly and endorsed by the
regulatory agencies in April 2020.
    This guidance finalizes the draft guidance issued on February 1,
2019. The guidance describes a weight of evidence approach to determine
when nonclinical toxicity studies may be recommended in juvenile
animals to support development of medicines to be used in pediatric
patients. If such studies are recommended, the guidance also provides
appropriate study designs. The guidance describes study designs as
consisting of a core set of endpoints that can be supplemented by
additional endpoints depending on the concerns identified in the weight
of evidence approach. The guidance also provides guidance on potential
approaches for the nonclinical support of drugs that will be developed
only for use in pediatric patients or that will be first tested in
pediatric patients. The guidance is intended to promote harmonization
of recommendations for such studies and should facilitate the timely
conduct of pediatric clinical trials and reduce the use of animals in
accordance with the 3R (replace/reduce/refine) principles.
    The draft guidance was revised based on comments received. The
revisions include refinement of the weight of evidence approach and in
descriptions of the core and additional endpoints that can be
incorporated into juvenile animal studies. The final guidance also
includes a new section on data interpretation. The appendices on age-
dependent development of organ systems by species and preweaning litter
allocation in the rodent were also updated. Additionally, the title of
the guidance was updated from ``Nonclinical Safety Testing in Support
of Development of Pediatric Medicines'' to ``Nonclinical Safety Testing
in Support of Development of Pediatric Pharmaceuticals.''

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``S11 Nonclinical Safety Testing in Support
of Development of Pediatric Pharmaceuticals.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312, pertaining to the submission of
nonclinical and preclinical data, including a pediatric clinical
development plan, have been approved under OMB control number 0910-
0014; the collections of information in 21 CFR part 58 pertaining to
good laboratory practice for nonclinical laboratory studies have been
approved under OMB control number 0910-0119; and the collections of
information in FDA's guidance for industry on ``Expedited Programs for
Serious Conditions--Drugs and Biologics'' has been approved under OMB
control number 0910-0765.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

    Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09964 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P