[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46957-46959]
[FR Doc No: 2018-20092]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2973]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Obtaining Information for Evaluating Nominated Bulk
Drug Substances for Use in Compounding Drug Products Under Section 503B
of the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on information collection associated with FDA
research in obtaining information from medical specialty groups and/or
medical experts regarding compounded drug products that contain certain
bulk drug substances to support establishment of a list of bulk drug
substances under section 503B of the Federal Food, Drug, and Cosmetic
Act (FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by November 16, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 16, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-2973 for ``Obtaining Information for Evaluating Nominated
Bulk Drug Substances for Use in Compounding Drug Products Under Section
503B of the Federal Food, Drug, and Cosmetic Act.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this

requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Clinical Use of Bulk Drug Substances Nominated for Use in Compounding
by Outsourcing Facilities

OMB Control Number 0910--NEW

    This information collection supports Agency-sponsored research.
Section 503B of the FD&C Act requires FDA to develop a list of bulk
drug substances that may be used in compounding under that section
(503B bulks list). Compounding includes the combining, admixing,
mixing, diluting, pooling, reconstituting, or otherwise altering of a
drug or bulk drug substance to create a drug. If certain conditions are
met, drug products compounded by entities known as outsourcing
facilities are exempt from the following requirements of the FD&C Act:
Requirements for FDA approval of drugs, labeling with adequate
directions for use, and drug supply chain security requirements.
Outsourcing facilities can only use a bulk drug substance to compound
drugs if: (1) The substance appears on a list developed by FDA of bulk
drug substances for which there is a clinical need (``bulks list'') or
(2) the substance is used to compound a drug on FDA's drug shortage
list at the time of compounding, distribution, and dispensing.
    Many bulk drug substances have been nominated by the public for use
in compounding by outsourcing facilities with adequate supporting
information for FDA to evaluate them. The substances were nominated to
treat a variety of conditions, ranging in degree of severity from
treatment of warts to treatment of cancer. To inform our evaluation of
bulk drug substances for inclusion on the 503B bulks list, we have
proposed a research study with the University of Maryland (UMD) Center
of Excellence in Regulatory Science and Innovation (CERSI) and the
Johns Hopkins University (JHU) CERSI. We intend to seek input from the
CERSI-UMD on the use of these bulk drug substances in clinical practice
by examining their current and historical use in compounding.
Information regarding the historical and current use of the substances
in compounding obtained by this research will help inform our
assessments as to the clinical need for outsourcing facilities to use
the substance in compounding.
    FDA's analysis concerning clinical need of nominated bulk drug
substances consists of two parts. The collaboration with CERSI-UMD and
CERSI-JHU pertains to part 2 of the analysis, which applies to bulk
drug substances that are not components of FDA-approved drug products,
as well as certain bulk drug substances that are components of FDA-
approved drug products and have successfully completed part 1. One of
the factors that FDA considers under part 2 is ``current and historical
use of the substance in compounded drug products, including information
about the medical condition(s) that the substance has been used to
treat and any references in peer-reviewed medical literature.''
    As needed, researchers will also engage outsourcing facilities that
have compounded using the bulk drug substance. Researchers may use
surveys, interviews, focus groups, and other information collect tools,
as appropriate, to obtain information concerning the use of compounded
product(s) from medical experts and outsourcing facilities. Within this
context, the following questions may be posed:
    1. What are the health conditions that the compounded drug is
currently and has been historically used to treat? What is the patient
population for which the compound drug has been used to treat?
    2. What are the characteristics of the compounded drugs using the
bulk drug substance (e.g., dosage form, strength, route of
administration)?
    3. Is the compounded drug considered standard therapy by healthcare
practitioners, and is it recommended in clinical practice guidelines?
If so, under what circumstances?
    4. Does an approved drug exist for the health condition that the
compounded drug product is used to treat? If so, what are the
circumstances under which a compounded drug product using the bulk drug
substance would be used in lieu of the approved drug product?
    5. What is the historical use of the compounded drug to treat the
health conditions identified, including the number of years during
which the compounded drug has been prescribed for each use, and any
change regarding its use over time?
    6. To what extent do practitioners prescribe the compounded drug to
treat each health condition identified? How many such prescriptions
and/or orders have been written in the past 5 years? Have there been
any notable changes in the number of prescriptions and/or orders
written over this time?
    7. How widespread is the use of the compounded drug product,
including use in other countries?
    8. Do practitioners order the compounded drug to maintain on hand
before a patient presents with a need for the drug (``office stock''),
or do practitioners typically write prescriptions for a patient after
the patient presents with a need for the compounded drug? If the
former, why (e.g., emergency situations, convenience)?
    9. What, if any, information exists regarding the effectiveness of
the compounded drug product in treating the specified health condition?
    We estimate the burden of the collection of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                       Information collection                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Focus groups and interviews........................................             150               10            1,500                2            3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate of the average burden per response on review
activities familiar to the Agency. Noting that 2 hours per response is
a significant amount of time, we are particularly interested in
feedback regarding this estimate, including comments regarding how an
alternative estimate might be derived.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20092 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Pages 51446-51448]
[FR Doc No: 2020-18239]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-1945]

Determination of Regulatory Review Period for Purposes of Patent
Extension; OXERVATE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for OXERVATE and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by October 19, 2020.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by February 16, 2021. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 19, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 19, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-E-1945 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; OXERVATE.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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 Sec.  10.20 (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>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product OXERVATE
(cenegermin-bkbj). OXERVATE is indicated for the treatment of
neurotrophic keratitis. Subsequent to this approval, the USPTO received
a patent term restoration application for OXERVATE (U.S. Patent No.
8,501,439) from Dompe Farmaceutici S.p.A., and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated June 21, 2019, FDA advised the
USPTO that this human biological product had undergone a regulatory
review period and that the approval of OXERVATE represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
OXERVATE is 1,484 days. Of this time, 1,240 days occurred during the
testing phase of the regulatory review period, while 244 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 1,
2014. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on August 1,
2014.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): December 22, 2017. FDA has verified the
applicant's claim that the biologics license application (BLA) for
OXERVATE (BLA 761094) was initially submitted on December 22, 2017.
    3. The date the application was approved: August 22, 2018. FDA has
verified the applicant's claim that BLA 761094 was approved on August
22, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 863 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th

Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format
specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18239 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Rules and Regulations]
[Pages 70711-70714]
[FR Doc No: 2022-20914]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0460; Project Identifier AD-2021-00824-R;
Amendment 39-22198; AD 2022-20-14]
RIN 2120-AA64

Airworthiness Directives; Bell Textron Inc., Helicopters and
Various Restricted Category Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
Bell Textron Inc., Model 204B, 205A, 205A-1, 205B, 210, 212, 412,
412CF, and 412EP helicopters and various restricted category
helicopters. This AD was prompted by reports of cracks found on the
main transmission support case. This AD requires repetitive inspections
of the main transmission housing assembly for cracks, pitting, and
corrosion and depending on the results, corrective action. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective December 27, 2022.

ADDRESSES:

Examining the AD Docket

    You may examine the AD docket at regulations.gov by searching for
and locating Docket No. FAA-2022-0460; 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 final rule, any comments
received, and other information. The address for Docket Operations is
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: Hye Yoon Jang, Aerospace Engineer,
Delegation Oversight Section, DSCO Branch, Compliance & Airworthiness
Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone
(817) 222-5190; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to Bell Textron Inc.,
Model 204B, 205A, 205A-1, 205B, 210, 212, 412, 412CF, and 412EP
helicopters and restricted category Model HH-1K, SW205A-1, TH-1F, TH-
1L, UH-1A, UH-1B, UH-1E, UH-1F, UH-1H, UH-1L, and UH-1P helicopters.
    The NPRM published in the Federal Register on April 14, 2022 (87 FR
22146). The NPRM was prompted by reports of main transmission support
cases found cracked at one of the lateral mounts. In the NPRM, the FAA
proposed to require, within 3,000 hours time-in-service (TIS)
accumulated by the main transmission after the effective date of the
AD, and thereafter at intervals not to exceed 3,000 hours TIS
accumulated by the main transmission, removing certain screws and
washers and visually inspecting the upper and lower transmission
support case lateral mount screws for corrosion and thread damage,
washers for corrosion and pitting, bushings for corrosion and pitting,
and lateral mount surfaces for corrosion and mechanical damage such as
any crack or pitting. If there is any corrosion, thread damage, or
mechanical damage, the NPRM proposed to require removing the affected
parts from service before further flight.
    The NPRM also proposed to require repetitive fluorescent penetrant
inspections (FPIs) of all surfaces of the main transmission support
case lateral mounts for a crack. For helicopters with a main
transmission that has accumulated 6,000 or more total hours TIS, the
initial FPI would be required before further flight after the effective
date of the AD. For helicopters with a main transmission that has
accumulated less than 6,000 total hours TIS, the initial FPI would be
required before the main transmission accumulates 6,000 total hours
TIS. For all helicopters, following the initial FPI, the NPRM proposed
to require performing an FPI at intervals not to exceed 6,000 hours TIS
accumulated by the main transmission. If there is any crack, the NPRM
proposed to require removing the main transmission support case from
service before further flight. The FAA is issuing this AD to address
the unsafe condition on these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from one commenter, Bell Textron Inc. The
following presents the comments received on the NPRM and the FAA's
response to each comment.

Comment Regarding the Unsafe Condition and Compliance With Service
Information

    Bell Textron Inc., commented that stress corrosion cracking of the
support case that originates from a threaded hole used to secure the
washer to the case lateral mount is not considered a safety of flight
issue as changes to its maintenance manual and Component Repair and
Overhaul (CR&O) manual address the issue. Bell Textron Inc., stated
that it has revised its manuals to include a requirement to remove the
washers at the scheduled 3000-hour Special Inspection for a detailed
visual inspection and an FPI at the scheduled 6000-hour Overhaul to
detect corrosion originating from a threaded hole under the washer that
could result in cracking. Bell Textron Inc., also stated that its CR&O
manual now specifies an improved washer installation procedure to
minimize the risk of corrosion, as well as damage limits for the
affected area.
    The FAA acknowledges this comment; however, not all operators are
required to accomplish a manufacturer's maintenance procedures. In
order for procedures in service information, including procedures in
manuals, to become mandatory when the FAA has determined the procedures
are necessary to correct an identified unsafe condition, the FAA must
issue an AD.

Request for Changes to the Required Actions

    Request: Regarding the outcome of the visual inspections, Bell
Textron Inc., recommended that rather than mandating the removal of
parts that have any damage from service, which could ground several
helicopters, the required actions of the proposed AD be revised to
refer to the applicable CR&O manual for damage limits and repair
procedure instead.
    FAA Response: The FAA partially agrees. The FAA has revised the
required actions in this final rule by specifying certain threshold
limits and adding the option of repairing certain conditions in
accordance with FAA-acceptable methods; however, the actions do not
require referring to the CR&O manual for information.
    Request: Regarding inspection and removal of hardware, Bell Textron
Inc., requested the FAA revise the required actions of the proposed AD
to require also determining if the case was previously repaired by Bell
or a Bell Service Center (FAA or Bell approved repair with
traceability), and if the case is found with a suspected unapproved
repair, removing the case from service indefinitely.
    FAA Response: The FAA disagrees with this request. The FAA
currently has no information regarding repairs outside the scope of
FAA-accepted methods having been accomplished on main transmission
support cases affected by the proposed AD. Accordingly, the FAA has
made no changes to this final rule based on that comment.
    Request: Bell Textron Inc., requested the FAA revise the required
actions of the proposed AD to require that if a case that has never
been repaired exhibits corrosion on the bushing, lug face, or threaded
hole(s) that is beyond repairable limits, contacting Bell Product
Support for evaluation and a possible Bell approved Expanded Repair;
Bell Textron Inc., added that the case can be returned to Bell or a
Bell Service Center for evaluation and possible repair.
    FAA Response: The FAA disagrees with this request. To require
operators to contact the manufacture for repair instructions, as
suggested by the commenter, would be delegating the FAA's rulemaking
authority to that manufacturer. Additionally, the FAA does not have the
authority to direct operators to return defective components to the
manufacturer. However, operators may choose to contact Bell Product
Support as this AD does not prohibit an operator from

contacting a manufacturer. Additionally, operators may request approval
of any specific actions, including any specific corrective actions, as
an alternative method of compliance (AMOC) under the provisions of
paragraph (h) of this AD.

Recommendation To Allow Ferry Flights

    Regarding the action to accomplish an FPI before further flight for
helicopters with a main transmission that has accumulated 6,000 or more
total hours TIS in paragraph (g)(2)(i) of the proposed AD, Bell Textron
Inc., recommended the FAA allow a ferry flight to the nearest repair
facility where the upper washers can be removed for a detailed 10X
magnifying glass inspection. Bell Textron Inc., further stated that if
a crack is suspected, to perform an FPI, and if a crack is found, to
remove the affected support case from service. Bell Textron Inc.,
explained that the removal of all 8 washers for an FPI of the support
case could be accomplished at the next scheduled overhaul as required
by chapter 5 of the maintenance manual.
    The proposed AD, as published, specifies no limitations for
issuance of a special flight permit (SFP) (ferry flight). Accordingly,
SFPs may be issued in accordance with 14 CFR 21.197 and 21.199.
Additionally, the FAA has revised the initial action to accomplish an
FPI on a main transmission that has accumulated 6,000 or more total
hours TIS by extending the compliance time from ``before further
flight'' to ``within 300 hours TIS'' and allowing credit if the action
has previously been done within the last 6,000 hours TIS. Lastly, the
FAA has revised the initial action to accomplish an FPI on a main
transmission that has accumulated less than 6,000 total hours TIS from
``before accumulating 6,000 total hours TIS on the main transmission''
to ``before accumulating 6,300 total hours TIS on the main
transmission.''

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for removing a note, minor
editorial changes, and any other changes described previously, this AD
is adopted as proposed in the NPRM. None of the changes will increase
the economic burden on any operator.

Costs of Compliance

    The FAA estimates that this AD affects up to 621 helicopters of
U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Visually inspecting the main transmission mount assembly takes
about 1 work-hour, for an estimated cost of $85 per helicopter and
$52,785 for the U.S. fleet, per inspection cycle. Accomplishing an FPI
of the main transmission support case lateral mounts will take about 1
work-hour for an estimated cost of $85 per helicopter, and $52,785 for
the U.S. fleet, per inspection cycle.
    The FAA has no way of determining the costs pertaining to necessary
repairs that are required to be done in accordance with FAA-acceptable
methods. Replacing the transmission support case assembly hardware
parts including 8 washers, 8 screws, and 4 bushings will take about 1
work-hour and parts will cost up to $100 per part for an estimated cost
of up to $2,085 per helicopter. Replacing the main transmission support
case assembly will take up to 60 work-hours and parts will cost up to
$54,501 for an estimated cost of up to $59,601 per helicopter.

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

    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) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

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:

2022-20-14 Bell Textron Inc., and Various Restricted Category
Helicopters: Amendment 39-22198; Docket No. FAA-2022-0460; Project
Identifier AD-2021-00824-R.

(a) Effective Date

    This airworthiness directive (AD) is effective December 27,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the following:
    (1) Bell Textron Inc., Model 204B, 205A, 205A-1, 205B, 210, 212,
412, 412CF, and 412EP helicopters, certificated in any category; and
    (2) Various restricted category helicopters:
    (i) Model HH-1K helicopters; current type certificate holders
include, but are not limited to, Rotorcraft Development Corporation;
    (ii) Southwest Florida Aviation International, Inc., Model
SW205A-1 helicopters;
    (iii) Model TH-1F helicopters; current type certificate holders
include, but are not limited to, Robinson Air Crane Inc.; Rotorcraft
Development Corporation; and Tamarack Helicopters, Inc.;
    (iv) Model TH-1L helicopters; current type certificate holders
include, but are not limited to, Bell Textron Inc.; Overseas
Aircraft Support, Inc. (type certificate previously held by JTBAM,
Inc.); and Rotorcraft Development Corporation;

    (v) Model UH-1A helicopters; current type certificate holders
include, but are not limited to, Richards Heavylift Helo, Inc.;
    (vi) Model UH-1B helicopters; current type certificate holders
include, but are not limited to, International Helicopters, Inc.;
Overseas Aircraft Support, Inc.; Red Tail Flying Services, LLC;
Richards Heavylift Helo, Inc.; Rotorcraft Development Corporation;
Southwest Florida Aviation International, Inc.; and WSH, LLC (type
certificate previously held by San Joaquin Helicopters);

    Note 1 to paragraph (c)(2)(vi): Helicopters with an SW204 or
SW204HP designation are Southwest Florida Aviation International,
Inc., Model UH-1B helicopters.

    (vii) Model UH-1E helicopters; current type certificate holders
include, but are not limited to, Bell Textron Inc.; Overseas
Aircraft Support, Inc.; Rotorcraft Development Corporation; Smith
Helicopters; and West Coast Fabrications;
    (viii) Model UH-1F helicopters; current type certificate holders
include, but are not limited to, AST, Inc.; California Department of
Forestry; Robinson Air Crane, Inc.; Rotorcraft Development
Corporation; and Tamarack Helicopters, Inc.;
    (ix) Model UH-1H helicopters; current type certificate holders
include, but are not limited to, Arrow Falcon Exporters, Inc.;
Global Helicopter Technology, Inc.; Hagglund Helicopters, LLC;
JJASPP Engineering Services LLC; Northwest Rotorcraft, LLC; Overseas
Aircraft Support, Inc.; Richards Heavylift Helo, Inc.; Rotorcraft
Development Corporation; Southwest Florida Aviation International,
Inc.; and Tamarack Helicopters, Inc.;

    Note 2 to paragraph (c)(2)(ix): Helicopters with an SW205
designation are Southwest Florida Aviation International, Inc.,
Model UH-1H helicopters.

    (x) Model UH-1L helicopters; current type certificate holders
include, but are not limited to, Bell Textron Inc.; Overseas
Aircraft Support, Inc.; and Rotorcraft Development Corporation; and
    (xi) Model UH-1P helicopters; current type certificate holders
include, but are not limited to, Robinson Air Crane, Inc.; and
Rotorcraft Development Corporation.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6320, Main Rotor
Gearbox.

(e) Unsafe Condition

    This AD was prompted by reports of cracks found in the main
transmission support case possibly due to corrosion. The FAA is
issuing this AD to detect and address corrosion and other mechanical
damage of the main transmission support case assembly. The unsafe
condition, if not addressed, could result in cracking at the upper
or lower surfaces of the lateral mounts, loss of load carrying
capabilities of the main transmission, and subsequent loss of
control of the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) Within 3,000 hours time-in-service (TIS) accumulated by the
main transmission after the effective date of this AD, and
thereafter at intervals not to exceed 3,000 hours TIS accumulated by
the main transmission, remove the screws and washers from the upper
and lower surfaces of the main transmission support case lateral
mounts and accomplish the following:
    (i) Visually inspect each screw for corrosion and thread damage.
If there is any corrosion or thread damage, before further flight,
remove the screw from service.
    (ii) Visually inspect each upper and lower washer for corrosion
and pitting.
    (A) If there is any corrosion or pitting that exceeds 10% of any
surface or is deeper than 0.01 inch (0.3 mm), before further fight,
remove the washer from service.
    (B) If there is any corrosion or pitting that is 10% or less of
any surface or has a depth of 0.01 inch (0.3 mm) or less, before
further flight, remove the washer from service or repair the washer
in accordance with FAA-acceptable methods.
    (iii) Visually inspect each installed bushing for corrosion and
pitting.
    (A) If there is any corrosion or pitting inside the bushing bore
that exceeds 10% of the surface or is deeper than 0.005 inch (0.13
mm), or if there is any corrosion or pitting on the bushing flange
or chamfer that exceeds 10% of the surface or is deeper than 0.01
inch (0.3 mm), before further fight, remove the bushing from
service.
    (B) If there is any corrosion or pitting inside the bushing bore
that is 10% or less of the surface or has a depth of 0.005 inch
(0.13 mm) or less, or if there is any corrosion or pitting on the
bushing flange or chamfer that is 10% or less of the surface or has
a depth of 0.01 inch (0.3 mm) or less, before further fight, remove
the bushing from service or repair the bushing in accordance with
FAA-acceptable methods.
    (iv) Visually inspect each upper and lower main transmission
support case lateral mount machined surface adjacent to each washer
and each lateral mount threaded screw hole for corrosion and
mechanical damage. For the purposes of this AD, mechanical damage
may be indicated by a crack or pitting.
    (A) Before further flight, remove the main transmission support
case assembly from service if any of the following exist:
    (1) The depth of any pitting exceeds 0.03 inch (0.8 mm),
    (2) The area of pitting for each pad surface exceeds 0.75 square
inch (483.87 square mm) or exceeds 50% of any 0.50 inch (12.7 mm)
diameter, or
    (3) Any mechanical damage to the threaded holes (8-32 NC-2B x
0.62 deep) exceeds 1 thread depth.
    (B) Before further flight, remove the main transmission support
case assembly from service or repair the main transmission support
case assembly in accordance with FAA-acceptable methods, if any of
the following exist:
    (1) The depth of any pitting is 0.03 inch (0.8 mm) or less.
    (2) The area of pitting for each pad surface is 0.75 square inch
(483.87 square mm) or less, or 50% or less of any 0.50 inch (12.7
mm) diameter, or
    (3) Any mechanical damage to the threaded holes (8-32 NC-2B x
0.62 deep) has a depth of 1 thread or less.
    (2) Fluorescent penetrant inspect (FPI) all surfaces of the main
transmission support case lateral mounts for a crack at the
compliance times identified in paragraph (g)(2)(i) or (ii) of this
AD.
    (i) For helicopters with a main transmission that has
accumulated 6,000 or more total hours TIS, within 300 hours TIS
after the effective date of this AD, unless already done within the
last 6,000 hours TIS.
    (ii) For helicopters with a main transmission that has
accumulated less than 6,000 total hours TIS, before accumulating
6,300 total hours TIS on the main transmission.
    (iii) If there is any crack, before further flight, remove the
main transmission support case assembly from service.
    (3) Thereafter following paragraph (g)(2) of this AD, at
intervals not to exceed 6,000 hours TIS accumulated by the main
transmission, FPI all surfaces of the main transmission support case
lateral mounts for a crack. If there is any crack, before further
flight, remove the main transmission support case assembly from
service.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, DSCO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (i) of this AD. Information may be emailed
to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    For more information about this AD, contact Hye Yoon Jang,
Aerospace Engineer, Delegation Oversight Section, DSCO Branch,
Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort
Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].

(j) Material Incorporated by Reference

    None.

    Issued on September 22, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-20914 Filed 11-18-22; 8:45 am]
BILLING CODE 4910-13-P