[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Rules and Regulations]
[Pages 27261-27264]
[FR Doc No: 2021-10590]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 86, No. 96 / Thursday, May 20, 2021 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0370; Project Identifier MCAI-2021-00477-T;
Amendment 39-21568; AD 2021-11-06]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A318, A319, A320, and A321 series airplanes. This AD
was prompted by the loss of a windshield in flight, and the consequent
rapid depressurization of the flight deck, which caused damage to
flight deck items and systems and subsequent thermal shock and
overheat, damage to windshield structural plies, and impaired
structural integrity of the windshield. This AD requires repetitive
inspections and electrical test measurements (EMTs) of affected
windshields, and corrective actions if necessary, as specified in a
European Union Aviation Safety Agency (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD becomes effective June 4, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 4,
2021.
    The FAA must receive comments on this AD by July 6, 2021.

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 https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2021-0370.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0370; 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 AD, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0111, dated April 22, 2021
(EASA AD 2021-0111) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus SAS Model A318, A319, and A321 series airplanes; and
Model A320-211, -212, -214, -215, -216, -231, -232, -233, -251N, -252N,
-253N, -271N, -272N, and -273N airplanes. Model 320-215 airplanes,
which are included in the applicability of EASA AD, are not
certificated by the FAA and are not included on the U.S. type
certificate data sheet; those airplanes are therefore not included in
applicability of this AD.
    This AD was prompted by the loss of the right windshield in flight
on a Model A319 series airplane. The consequent rapid depressurization
of the flight deck caused damage to flight deck items and systems and
led to a significant increase in flightcrew workload. Investigations
into the incident identified several contributing factors, including
manufacturing variability, fretting between windshield components,
water ingress, and corrosion of electrical braids. The subsequent
thermal shock and overheat damaged more than one of the windshield
structural plies and impaired the structural integrity of the
windshield. Failure of the windshield could result in injury to the
flightcrew and depressurization of the airplane, which could cause loss
of control of the airplane. See the MCAI for additional background
information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0111 specifies procedures for repetitive detailed
inspections of affected windshields for defects including delamination
or bubbles on the windshield and signs of water ingress and corrosion
damage of the windshield connector, EMTs (dielectric and insulation
tests) of the windshields for potential wiring insulation damage and
core degradation, and replacement of windshields that fail an
inspection or EMT. EASA AD 2021-0111 also specifies reporting
inspection and test results to Airbus. This material is reasonably
available because the interested parties have access to it through
their normal course of business or by the means identified in the
ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the

FAA's bilateral agreement with the State of Design Authority, the FAA
has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the FAA evaluated
all pertinent information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2021-0111 described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2021-0111
is incorporated by reference in this final rule. This AD, therefore,
requires compliance with EASA AD 2021-0111 in its entirety, through
that incorporation, except for any differences identified as exceptions
in the regulatory text of this AD. Using common terms that are the same
as the heading of a particular section in the EASA AD does not mean
that operators need comply only with that section. For example, where
the AD requirement refers to ``all required actions and compliance
times,'' compliance with this AD requirement is not limited to the
section titled ``Required Action(s) and Compliance Time(s)'' in the
EASA AD. Service information specified in EASA AD 2021-0111 that is
required for compliance with EASA AD 2021-0111 is available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0370.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because impaired structural integrity of the windshield could lead to
failure of the windshield, possibly resulting in injury to the
flightcrew and in-flight depressurization of the airplane, which would
require exceptional piloting skill to maintain control the airplane.
Accordingly, notice and opportunity for prior public comment are
impracticable and contrary to the public interest pursuant to 5 U.S.C.
553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0370; Project Identifier MCAI-
2021-00477-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, 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 final rule 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
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

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 AD 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 AD, 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 AD. Submissions containing CBI should be sent to Sanjay
Ralhan, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 1,728 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
                                                                   Cost per
                  Labor cost                      Parts cost        product          Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
3 work-hours x $85 per hour = $255............              $0            $255  Up to $440,640.
----------------------------------------------------------------------------------------------------------------
* The table does not include estimated costs for reporting.

    The FAA estimates that it takes about 1 work-hour per product to
comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, the FAA estimates the
cost of reporting the inspection results on U.S. operators to be
$146,880, or $85 per product.
    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
10 work-hours x $85 per hour = $850...         $12,990          $13,840
------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to
Information Collection Clearance Officer, Federal Aviation
Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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 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, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 airworthiness
directive:

2021-11-06 Airbus SAS: Amendment 39-21568; Docket No. FAA-2021-0370;
Project Identifier MCAI-2021-00477-T.

(a) Effective Date

    This airworthiness directive (AD) becomes effective June 4,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus SAS airplanes, certificated in any
category, identified in paragraphs (c)(1) through (4) of this AD.
    (1) All Model A318-111, A318-112, A318-121, and A318-122
airplanes.
    (2) All Model A319-111, A319-112, A319-113, A319-114, A319-115,
A319-131, A319-132, A319-133, A319-151N, A319-153N, and A319-171N
airplanes.
    (3) All Model A320-211, A320-212, A320-214, A320-216, A320-231,
A320-232, A320-233, A320-251N, A320-252N, A320-253N, A320-271N,
A320-272N, and A320-273N airplanes.
    (4) All Model A321-111, A321-112, A321-131, A321-211, A321-212,
A321-213, A321-231, A321-232, A321-251N, A321-252N, A321-253N, A321-
251NX, A321-252NX, A321-253NX, A321-271N, A321-272N, A321-271NX, and
A321-272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 56, Windows.

(e) Reason

    This AD was prompted by the loss of a windshield in flight, and
the consequent rapid depressurization of the flight deck, which
caused damage to flight deck items and systems and subsequent
thermal shock and overheat, damage to windshield structural plies,
and impaired structural integrity of the windshield. The FAA is
issuing this AD to prevent failure of the windshield, which could
result in injury to the flightcrew and in-flight depressurization of
the airplane, and would require exceptional piloting skill to
maintain control the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0111, dated April 22, 2021 (EASA AD 2021-0111).

(h) Exceptions to EASA AD 2021-0111

    (1) Where EASA AD 2021-0111 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2021-0111 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (j) of this
AD. 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
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified 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 procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Related Information

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0111,
dated April 22, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0111, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>Internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0370.
    (5) You may view this material 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_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 12, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-10590 Filed 5-17-21; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Notices]
[Pages 37646-37648]
[FR Doc No: 2019-16361]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-2330]

Pathology Peer Review in Nonclinical Toxicology Studies:
Questions and Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Pathology
Peer Review in Nonclinical Toxicology Studies: Questions and Answers.''
This draft guidance represents FDA's current thinking on the management
and conduct of pathology peer review performed during good laboratory
practice (GLP)-

compliant toxicology studies. When pathology peer review occurs as part
of a nonclinical laboratory study conducted in compliance with GLP
regulations, it should be well-documented. However, documentation
practices during pathology peer review have not been clearly defined
and vary among nonclinical testing facilities. This question-and-answer
(Q&A) draft guidance is intended to clarify FDA's recommendations
concerning the management, conduct, and documentation of pathology peer
review.

DATES: Submit either electronic or written comments on the draft
guidance by September 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-2330 for ``Pathology Peer Review in Nonclinical Toxicology
Studies: Questions and Answers.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the 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 or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, 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. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Tahseen Mirza, Center for Drug
Evaluation and Research, Office of Study Integrity and Surveillance,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm.
5330, Silver Spring, MD 20993,<PHONE_NUMBER>; or Stephen Ripley, Office
of the Center Director, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>; or Judy Davis, Office of
Device Evaluation, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1216,
Silver Spring, MD 20993,<PHONE_NUMBER>; or Hilary Hoffman, Center for
Veterinary Medicine, Office of New Animal Drug Evaluation, Food and
Drug Administration, 7500 Standish Place, Rm. 389, Rockville, MD,
20855,<PHONE_NUMBER>; or Yuquang Wang, Center for Food Safety and
Nutrition, Office of the Center Director, Food and Drug Administration,
5001 Campus Drive, Rm. 4A035, College Park, MD, 20740,<PHONE_NUMBER>; or
Kimberly Benson, Center for Tobacco Products, Office of Science, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G335,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pathology Peer Review in Nonclinical Toxicology Studies:
Questions and Answers.'' This draft guidance represents FDA's current
thinking on the management and conduct of pathology peer review
performed during GLP-compliant toxicology studies.
    The histopathological assessment of tissue samples is one of the
key activities performed during GLP-compliant toxicology studies.
Commonly, histopathological assessment includes an initial read of

tissue slides by the study pathologist and a subsequent review
(referred to as pathology peer review) by a second pathologist.
Pathology peer review may be particularly useful in situations where
unique or unexpected findings are noted or when the reviewing
pathologist has a particular expertise with a class of compounds. When
pathology peer review occurs as part of a nonclinical laboratory study
conducted in compliance with 21 CFR part 58 (GLP regulations), it
should be well-documented in the study records. However, documentation
practices during pathology peer review have not been clearly defined
and vary among nonclinical testing facilities.
    The GLP regulations include general requirements for histopathology
evaluation (for example, it requires that standard operating procedures
be established to cover histopathology), and pathology peer review can
be valuable to the histopathology evaluation during a GLP study even
though it is not specifically addressed in the GLP regulations. This
Q&A draft guidance is intended to clarify FDA's recommendations
concerning the management and conduct of pathology peer review when
performed during GLP-compliant toxicology studies.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Pathology
Peer Review in Nonclinical Toxicology Studies: Questions and Answers.''
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. This
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
following collections of information regarding GLP-compliant toxicology
studies have been approved under OMB control number 0910-0119:
     Sec.  58.29 related to personnel who conduct nonclinical
laboratory studies;
     Sec.  58.35 for preparing quality control units;
     Sec.  58.81 for preparing and maintaining standard
operating procedures for testing facilities; pathology peer review
should be planned, conducted, documented, and reported in accordance
with established procedure;
     Sec.  Sec.  58.120, 58.185, and 58.190 for preparing a
final report for each study, including a protocol and any changes to
the protocol and for maintaining documentation, protocols, and final
reports generated from nonclinical laboratory studies.

III. Electronic Access

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

    Dated: July 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16361 Filed 7-31-19; 8:45 am]
 BILLING CODE 4164-01-P