[Federal Register Volume 85, Number 238 (Thursday, December 10, 2020)]
[Rules and Regulations]
[Pages 79413-79415]
[FR Doc No: 2020-27006]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0573; Product Identifier 2020-NM-078-AD; Amendment
39-21289; AD 2020-21-16]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B,
747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and
747SP series airplanes. This AD was prompted by a determination that
the upper wing skin at engine nacelle points may be subject to
undetected cracking. This AD requires repetitive ultrasonic inspections
of the upper wing skin at certain engine strut positions for cracking;
repetitive detailed and ultrasonic inspections of the strut lower spar
fitting, diagonal brace strut end clevis, and diagonal brace wing
attach end clevis for cracking; repetitive detailed inspections of
lower link fitting at certain engine strut positions for cracking; and
applicable on-condition actions. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective January 14, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 14,
2021.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available on
the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2020-0573.

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-2020-
0573; 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: Eric Lin, Aerospace Engineer, Airframe
Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA
98198; phone and fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all The Boeing Company
Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F,
747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP series
airplanes. The NPRM published in the Federal Register on June 30, 2020
(85 FR 39108). The NPRM was prompted by a determination that the upper
wing skin at engine nacelle points may be subject to undetected
cracking. The NPRM proposed to require repetitive ultrasonic
inspections of the upper wing skin at certain engine strut positions
for cracking; repetitive detailed and ultrasonic inspections of the
strut lower spar fitting, diagonal brace strut end clevis, and diagonal
brace wing attach end clevis for cracking; repetitive detailed
inspections of lower link fitting at certain engine strut positions for
cracking; and applicable on-condition actions.
    The FAA is issuing this AD to address undetected cracking in the
upper wing skin, strut lower spar fitting, or clevis lugs at either end
of the diagonal brace and lower link fitting. This condition, if not
addressed, could adversely affect the structural integrity of the
engine strut and may lead to the separation of the strut to wing box
assembly.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comments
received. Boeing stated that it concurred with the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin 747-57A2363 RB,
dated December 23, 2019. The service information describes procedures
for ultrasonic inspections of the upper wing skin at engine strut
positions 1 through 4 for cracking; detailed and ultrasonic inspections
of the strut lower spar fitting, diagonal brace strut end clevis, and
diagonal brace wing attach end clevis for cracking; detailed
inspections of lower link fitting at engine strut positions 1 through 4
for cracking; and applicable on-condition actions. On-condition actions
include repair. 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.

Costs of Compliance

    The FAA estimates that this AD affects 125 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections....................  9 work-hours x $85 per               $0  $765 per            $95,625 per
                                  hour = $765 per                          inspection cycle.   inspection cycle.
                                  inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable the
agency to provide cost estimates for the on-condition actions specified
in this AD.

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.

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 (AD):

2020-21-16 The Boeing Company: Amendment 39-21289; Docket No. FAA-
2020-0573; Product Identifier 2020-NM-078-AD.

(a) Effective Date

    This AD is effective January 14, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400,
747-400D, 747-400F, 747SR, and 747SP series airplanes, certificated
in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a determination that the upper wing skin
at engine nacelle attachment points may be subject to undetected
cracking. The FAA is issuing this AD to address undetected cracking
in the upper wing skin, strut lower spar fitting, or clevis lugs at
either end of the diagonal brace and lower link fitting. This
condition, if not addressed, could adversely affect the structural
integrity of the engine strut and may lead to the separation of the
strut to wing box assembly.

(f) Compliance

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

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin 747-57A2363 RB, dated December 23, 2019,
do all applicable actions identified in, and in accordance with, the
Accomplishment Instructions of Boeing Alert Requirements Bulletin
747-57A2363 RB, dated December 23, 2019.

    Note 1 to paragraph (g):  Guidance for accomplishing the actions
required by this AD can be found in Boeing Alert Service Bulletin
747-57A2363, dated December 23, 2019, which is referred to in Boeing
Alert Requirements Bulletin 747-57A2363 RB, dated December 23, 2019.

(h) Exceptions to Service Information Specifications

    (1) Where Boeing Alert Requirements Bulletin 747-57A2363 RB,
dated December 23, 2019, uses the phrase ``the original issue date
of Requirements Bulletin 747-57A2363

RB,'' this AD requires using ``the effective date of this AD.''
    (2) Where Boeing Alert Requirements Bulletin 747-57A2363 RB,
dated December 23, 2019, specifies contacting Boeing for repair
instructions: This AD requires doing the repair before further
flight using a method approved in accordance with the procedures
specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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 (j)(1) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    (1) For more information about this AD, contact Eric Lin,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (k)(3) and (4) of this AD.

(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 the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin 747-57A2363 RB, dated
December 23, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 7, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-27006 Filed 12-9-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Page 56774]
[FR Doc No: 2011-23410]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4021-DR; Docket ID FEMA-2011-0001]

New Jersey; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New Jersey (FEMA-4021-DR), dated August 31, 2011, and
related determinations.

DATES: Effective Date: September 3, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New Jersey is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 31, 2011.

    Middlesex County for Individual Assistance.
    Atlantic, Cape May, Cumberland, and Salem Counties for
Individual Assistance (already designated for Public Assistance).
    Camden, Gloucester, Hunterdon, Monmouth, Sussex, and Warren
Counties for Individual Assistance and Public Assistance.
    Mercer County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-23410 Filed 9-13-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Notices]
[Page 47081-47083]
[DOCID:fr22au07-147]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0018]

Logging Operations; Extension of the Office of Management and
Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comment.

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SUMMARY: OSHA solicits public comment concerning its proposal to extend
OMB approval of the information collection requirements specified in
its Standard on Logging Operations (29 CFR 1910.266).

DATES: Comments must be submitted (postmarked, sent, or received) by
October 22, 2007.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, OSHA Docket No. OSHA-2007-
0018, U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., EST.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2007-0018). All comments, including any
personal information you provide, are placed in the public docket
without change, and may be made available online at http://www.regulations.gov
.

For further information on submitting comments see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at

the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;

however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue, NW., Washington, DC 20210; telephone (202)
693-2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    Paragraph (f)(1)(iii) of the Standard requires the employer to
assure that operating and maintenance instructions are available on
machines or in the area where the machine is being operated. Paragraph
(g)(3) requires the employer to assure that operating and maintenance
instructions are available in each vehicle.
    Paragraph (i)(1) of the Standard requires employers to provide
training for each employee, including supervisors. To meet this
requirement, employers must conduct the training at the frequencies
specified by paragraph (i)(2). Paragraph (i)(3) specifies that an
employee's/supervisor's training must consist of the following
elements: Safe work practices, including the use, operation, and
maintenance of tools, machines, and vehicles the employee/supervisor
uses or operates, as well as procedures, practices, and requirements of
the employer's worksite; recognition and control of health and safety
hazards associated with the employee's/supervisor's specific work tasks
and logging operations in general; and the requirements of the
Standard.
    Paragraph (i)(10)(i) specifies that employers must verify that they
are in compliance with the training requirements in paragraph (i). This
certification must be in writing and provide the following information:
The name/identifier of the employee/supervisor; the date(s) of the
training; and either the signature of the employer or the individual
who conducted the training. Paragraph (i)(10)(ii) requires employers to
maintain the most recent certification for training completed by an
employee/supervisor.
    Training employees/supervisors in safe work practices and to
recognize and control the safety and health hazards associated with
their work tasks and overall logging operations enables them to prevent
serious accidents by using specific procedures and equipment in a safe
manner to avoid or to control dangerous exposures to these hazards.
    Establishing and maintaining written certification of the training
that each employee/supervisor has received (i.e., job and first aid)
assures the employer that the training specified by the Standard has
been conducted, and at the required frequencies. With regard to first-
aid training, the certification assures that the employee's/
supervisor's training certificate is currently valid. In addition,
these records provide the most efficient means for an OSHA compliance
officer to determine whether an employer performed the required
training at the necessary and appropriate frequencies.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirements contained in the Standard on Logging Operations
(29 CFR 1910.266). The Agency is requesting to increase its existing
burden hours from 30,751 hours to 31,286 hours for a total increase of
535 hours. The Agency will summarize the comments submitted in response
to this notice and will include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Logging Operations (29 CFR 1910.266).
    OMB Number: 1218-0198.
    Affected Public: Business or other for-profit.
    Number of Respondents: 11,447.
    Frequency of Recordkeeping: Initially; on occasion.
    Average Time per Response: Varies from 1 minute (.02 hour) to
maintain training certification records to 3 hours to conduct initial
training.
    Total Annual Hours Requested: 31,286.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal

eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2007-0018). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket

Office (see the section of this notice titled ADDRESSES). The
additional materials must clearly identify your electronic comments by
your name, date, and the docket number so the Agency can attach them to
your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov.
 Therefore, OSHA cautions commenters about

submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://www.regulations.gov
 index, some information (e.g., copyrighted

material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit

comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2002 (67 FR
65008).

    Signed at Washington, DC, on August 15, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
 [FR Doc. E7-16437 Filed 8-21-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50132-50134]
[FR Doc No: 2021-19221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1529]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Reclassification Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with reclassification of medical devices.

DATES: Submit either electronic or written comments on the collection
of information by November 8, 2021.

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 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 8, 2021. 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-2013-N-1529 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Reclassification Petitions for
Medical Devices.'' 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,<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>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have 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.

Reclassification Petitions for Medical Devices

OMB Control Number 0910-0138--Extension

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes the
following three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness: Class I (general controls), class II (special
controls), and class III (premarket approval) (section 513(a)(1) of the
FD&C Act (21 U.S.C. 360c(a)(1)). To change a device classification, FDA
can initiate a reclassification, or an interested person can petition
FDA to reclassify a device based on new information (section 513(e) of
the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety
and Innovation Act (FDASIA) was enacted, changing the reclassification
process under section 513(e) of the FD&C Act from rulemaking to an
administrative order process. To reclassify a device under section
513(e) of the FD&C Act, FDA must do the following before making the
reclassification final: (1) Publish a proposed order in the Federal
Register which includes the proposed reclassification and a summary of
the valid scientific evidence that supports the reclassification, (2)
convene a device classification panel meeting, and (3) consider
comments from the relevant public docket.
    FDASIA also amended the provisions of the FD&C Act authorizing FDA
to require submission of a premarket approval application (PMA) for a
preamendments class III device (referred to as a ``call for PMAs'').
Preamendments devices are devices that were in commercial distribution
before the enactment of the 1976 Amendments. Under the FD&C Act,
preamendments devices classified into class III may be marketed upon
clearance of a 510(k) submission, and submission of a PMA is not
required until FDA has issued a final order requiring premarket
approval (section 515(b) of the FD&C Act (21 U.S.C. 360e(b)). As
amended by FDASIA, the FD&C Act requires that FDA, in its call for
PMAs, publish a proposed order in the Federal Register, hold a
classification panel meeting, and consider comments on the proposed
order (section 515(b) of the FD&C Act, as amended by FDASIA).
    Under the FD&C Act, FDA's call for PMAs must, among other things,
contain an opportunity for interested persons to request a change in
the classification of the device based on new information (section
515(b)(2) of the FD&C Act). After consideration of comments on the
proposed order and findings, FDA must either: (1) Finalize the call for
PMAs by issuing an administrative order requiring approval of a PMA and
publishing in the Federal Register findings with respect to: (i) The
degree of risk of illness or injury designed to be eliminated or
reduced by requiring the device to have an approved PMA or a declared
completed product development protocol and (ii) the benefit to the
public from the use of the device; or (2) publish a notice in the
Federal Register terminating the proceeding and initiate a
reclassification proceeding based on new information (section 515(b)(3)
of the FD&C Act, as amended by FDASIA; see section 513(e) of the FD&C
Act).
    The FD&C Act, as amended by FDASIA, now requires the use of
administrative orders, rather than rulemaking, when FDA calls for PMAs
for a preamendments device remaining in class III (section 515(b) of
the FD&C Act, as amended by FDASIA).
    FDA refers to a device that was not in commercial distribution
before the 1976 Amendments as a postamendments device. Postamendments
devices are classified automatically into class III by statute, without
any rulemaking process (section 513(f)(1) of the FD&C Act). A
postamendments device remains in class III and is subject to the PMA
requirements unless and until: (1) FDA reclassifies the device into
class I or II; (2) FDA issues an order classifying the device into
class I or II via the De Novo classification process (see section
513(f)(2) of the FD&C Act); or (3) FDA issues an order finding the
device to be substantially equivalent to a predicate device that does
not require the filing of a PMA (see section 513(i) of the FD&C Act).
    FDA may initiate, or the manufacturer or importer of a device may
petition for, the reclassification of a postamendments device
classified into class III by operation of law (section 513(f)(3) of the
FD&C Act). This FDA-initiated reclassification process consists of a
proposed reclassification order, optional panel consultation, and a
final reclassification order published in the Federal Register
following consideration of comments and any panel recommendations or
comments (Sec.  860.134(c) (21 CFR 860.134(c))). The reclassification
order may, as appropriate, establish special controls to provide
reasonable assurance of the safety and effectiveness of the device
(Sec.  860.134(d)).
    Under the 1976 Amendments, Congress classified all those devices
previously regulated as new drugs into class III (generally referred to
as transitional devices). Under the FD&C Act, FDA may initiate, or the
manufacturer or importer of a device may petition for, the
reclassification of a transitional device remaining in class III
(section 520(l)(2) of the FD&C Act (21 U.S.C. 360j(l)(2)). The process
for reclassification of transitional devices initiated by FDA is
detailed in 21 CFR 860.136(c). This process consists of a proposed
reclassification order, optional panel consultation, and a final

reclassification order published in the Federal Register following
consideration of comments and any panel recommendations or comments.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
          21 CFR section; information collection activity               Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   860.123; supporting data for reclassification petitions.....               6                1                6              497           2,982
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19221 Filed 9-3-21; 8:45 am]
BILLING CODE 4164-01-P