[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Rules and Regulations]
[Pages 65857-65860]
[FR Doc No: 2016-22187]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-3992; Directorate Identifier 2015-NM-075-AD;
Amendment 39-18653; AD 2016-19-04]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 787-8 airplanes. This AD was prompted by a
report of uncommanded movement by a captain's seat during a landing
rollout due to a failure in the seat horizontal actuator. This AD
requires repetitive tests of the captain and first officer seat
assemblies for proper operation, and corrective action if necessary.
This AD also requires installation of new captain and first officer
seat assemblies, which terminates the repetitive tests. We are issuing
this AD to prevent a seat actuator clutch failure, which could result
in a loss of seat locking and uncommanded motion of the captain's or
first officer's seat; uncommanded seat movement could result in reduced
controllability of the airplane.

DATES: This AD is effective October 31, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 31,
2016.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-
5000, extension 1; fax:<PHONE_NUMBER>; Internet: https://www.myboeingfleet.com. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2016-3992.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
3992; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Brandon Lucero, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 787-8 airplanes. The NPRM published in the Federal Register on
March 7, 2016 (81 FR 11687) (``the

NPRM''). The NPRM was prompted by a report of uncommanded movement by a
captain's seat during a landing rollout due to a failure in the seat
horizontal actuator. The NPRM proposed to require repetitive tests of
the captain and first officer seat assemblies for proper operation, and
corrective action if necessary. The NPRM also proposed to require
installation of new captain and first officer seat assemblies, which
would terminate the repetitive tests. We are issuing this AD to prevent
a seat actuator clutch failure, which could result in a loss of seat
locking and uncommanded motion of the captain's or first officer's
seat; uncommanded seat movement could result in reduced controllability
of the airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Request To Remove Service Bulletin Issue Number and Date

    Boeing requested that we revise the NPRM to not specify the Service
Bulletin issue number and date, or alternatively to include ``or
subsequent'' when referencing Boeing Alert Service Bulletin B787-81205-
SB250054-00, Issue 001, dated December 19, 2014.
    Boeing commented that the seat supplier is currently working on a
related nuisance issue of intermittent electrical operation of the
seat-powered adjustment system. Boeing stated that the resolution to
this issue may result in changes to the part numbers of the actuators
and seat assemblies, and revision to the service bulletin issue number
and date.
    We do not agree with the commenter's request to remove the issue
number and date of the service information. We cannot allow use of
``later-approved revisions'' in an AD when referring to the service
document. Doing so violates Office of the Federal Register (OFR)
regulations for approval of materials ``incorporated by reference,'' as
specified in 1 CFR 51.1(f). If for any reason the issue and date of the
service bulletin should change, the FAA may consider issuing an
alternative method of compliance (AMOC) to allow use of a later
revision. We have not changed this AD in this regard.

Request To Remove the Replacement Seat Part Numbers

    Boeing requested that we remove the replacement seat part numbers
to be installed as terminating action from this AD, and instead specify
that seats be replaced with part numbers ``as specified in Boeing Alert
Service Bulletin B787-81205-SB250054-00.''
    Boeing commented that the seat supplier is currently working on a
related nuisance issue of intermittent electrical operation of the
seat-powered adjustment system. The resolution to this issue may result
in change to the part numbers of the actuators and seat assemblies.
    We partially agree with the commenter's request. We have changed
paragraph (h) of this AD to remove the part numbers of the actuators
and seat assemblies from this AD and to include the part numbers
specified in Boeing Alert Service Bulletin B787-81205-SB250054-00.
However, we have included the revision level and date of the service
information for the reasons noted in the previous comment response. The
FAA may consider issuing an AMOC to allow use of a later revision of
the service information.

Request To Allow Credit for Prior Accomplishment of Service Bulletins

    United Airlines requested that the AD allow credit for prior
accomplishment of Boeing and Ipeco service information.
    We already provide credit in paragraph (f) of this AD for prior
accomplishment of Boeing Alert Service Bulletin B787-81205-SB250054-00,
Issue 001, dated December 19, 2014, if accomplished before the
effective date of this AD. In addition, credit is not necessary for
using the Ipeco service information referenced in Boeing Alert Service
Bulletin B787-81205-SB250054-00, Issue 001, dated December 19, 2014,
because this AD does not specifically require using Ipeco service
information. No change to this AD is necessary.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin B787-81205-SB250054-00,
Issue 001, dated December 19, 2014. This service information provides
procedures for installation of new captain and first officer seat
assemblies, a test of the captain and first officer seat assemblies,
and corrective action if necessary. 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

    We estimate that this AD affects 18 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                   Labor cost          Parts cost       Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Operational test................  2 work-hours x $85  $0................  $170 per test       $3,060 per test
                                   per hour = $170                         cycle.              cycle.
                                   per test cycle.
Seat assembly installation......  3 work-hours x $85  $15,141 per seat x  $30,537 to replace  $549,666.
                                   per hour = $255     2 seats = $30,282.  two seats.
                                   to replace two
                                   seats.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary corrective
actions that would be required based on the results of the operational
tests. We have no way of determining the number of aircraft that might
need these actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replacement of captain seat vertical actuator.  2 work-hours x $85 per hour =             $7,500          $7,670
                                                 $170.
Replacement of captain seat horizontal          2 work-hours x $85 per hour =              7,500           7,670
 actuator.                                       $170.
Replacement of first officer seat vertical      2 work-hours x $85 per hour =              7,500           7,670
 actuator.                                       $170.
Replacement of first officer seat horizontal    2 work-hours x $85 per hour =              7,500           7,670
 actuator.                                       $170.
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Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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):

2016-19-04 The Boeing Company: Amendment 39-18653; Docket No. FAA-
2016-3992; Directorate Identifier 2015-NM-075-AD.

(a) Effective Date

    This AD is effective October 31, 2016.

 (b) Affected ADs

    None.

 (c) Applicability

    This AD applies to The Boeing Company Model 787-8 airplanes,
certificated in any category, as identified in Boeing Alert Service
Bulletin B787-81205-SB250054-00, Issue 001, dated December 19, 2014.

 (d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

 (e) Unsafe Condition

    This AD was prompted by a report of uncommanded movement by a
captain's seat during a landing rollout due to a failure in the seat
horizontal actuator. We are issuing this AD to prevent a seat
actuator clutch failure, which could result in a loss of seat
locking and uncommanded motion of the captain's or first officer's
seat; uncommanded seat motion could result in reduced
controllability of the airplane.

 (f) Compliance

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

 (g) Repetitive Tests of Captain and First Officer Seat Assembly
Operation

    Within 1,000 flight hours after the effective date of this AD,
test the operation of the captain and first officer seat assemblies
and do all applicable corrective actions, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin B787-
81205-SB250054-00, Issue 001, dated December 19, 2014. Do all
applicable corrective actions before further flight. Repeat the
operational test thereafter at intervals not to exceed 1,000 flight
hours until the installation required by paragraph (h) of this AD is
done.

 (h) New Seat Installation

    Within 72 months after the effective date of this AD, do the
actions specified in paragraphs (h)(1) and (h)(2) of this AD.
Installing the seat specified in paragraph (h)(1) or (h)(2) of this
AD, as applicable, is terminating action for the repetitive
operational tests required by paragraph (g) of this AD for that seat
only.
    (1) Install a new captain seat assembly, in accordance with
paragraph 2.F., ``Part 3: Terminating Action: Captain Seat Assembly
Replacement,'' of the Accomplishment Instructions of Boeing Alert
Service Bulletin B787-81205-SB250054-00, Issue 001, dated December
19, 2014.
    (2) Install a new first officer seat assembly, in accordance
with paragraph 2.I., ``Part 6: Terminating Action: First Officer
Seat Assembly Replacement,'' of the Accomplishment Instructions of
Boeing Alert Service Bulletin B787-81205-SB250054-00, Issue 001,
dated December 19, 2014.

 (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. 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 ACO, send it to the
attention of the person identified in paragraph (j) 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 Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, 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.
    (4) For service information that contains steps that are labeled
as Required for Compliance (RC), the provisions of

paragraphs (i)(4)(i) and (i)(4)(ii) of this AD, apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. An AMOC is required for any deviations to RC steps,
including substeps and identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

 (j) Related Information

    For more information about this AD, contact Brandon Lucero,
Aerospace Engineer, Cabin Safety and Environmental Systems Branch,
ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601
Lind Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax:
425-917-6590; 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 the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin B787-81205-SB250054-00, Issue
001, dated December 19, 2014.
    (ii) Reserved.
    (3) For The Boeing Company service information identified in
this AD, contact Boeing Commercial Airplanes, Attention: Data &
Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-
2207; telephone:<PHONE_NUMBER>, extension 1; fax:<PHONE_NUMBER>;
Internet: https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on September 6, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-22187 Filed 9-23-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: March 17, 2006 (Volume 71, Number 52)]
[Rules and Regulations]
[Page 13775-13776]
[DOCID:fr17mr06-13]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket No. FEMA-7913]

Suspension of Community Eligibility

AGENCY: Mitigation Division, Federal Emergency Management Agency
(FEMA), Department of Homeland Security.

ACTION: Final rule.

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SUMMARY: This rule identifies communities, where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP), that are scheduled for suspension on the effective
dates listed within this rule because of noncompliance with the
floodplain management requirements of the program. If FEMA receives
documentation that the community has adopted the required floodplain
management measures prior to the effective suspension date given in
this rule, the suspension will not occur and a notice of this will be
provided by publication in the Federal Register on a subsequent date.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

ADDRESSES: If you want to determine whether a particular community was
suspended on the suspension date, contact the appropriate FEMA Regional
Office or the NFIP servicing contractor.

FOR FURTHER INFORMATION CONTACT: William H. Lesser, Mitigation
Division, 500 C Street, SW., Room 412, Washington, DC 20472, (202) 646-
2807.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
flood insurance which is generally not otherwise available. In return,
communities agree to adopt and administer local floodplain management
aimed at protecting lives and new construction from future flooding.
Section 1315 of the National Flood Insurance Act of 1968, as amended,
42 U.S.C. 4022, prohibits flood insurance coverage as authorized under
the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body
adopts adequate floodplain management measures with effective
enforcement measures. The communities listed in this document no longer
meet that statutory requirement for compliance with program
regulations, 44 CFR part 59 et seq. Accordingly, the communities will
be suspended on the effective date in the third column. As of that
date, flood insurance will no longer be available in the community.
However, some of these communities may adopt and submit the required
documentation of legally enforceable floodplain management measures
after this rule is published but prior to the actual suspension date.
These communities will not be suspended and will continue their
eligibility for the sale of insurance. A notice withdrawing the
suspension of the communities will be published in the Federal
Register.
    In addition, FEMA has identified the Special Flood Hazard Areas
(SFHAs) in these communities by publishing a Flood Insurance Rate Map
(FIRM). The date of the FIRM, if one has been published, is indicated
in the fourth column of the table. No direct Federal financial
assistance (except assistance pursuant to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act not in connection with a
flood) may legally be provided for construction or acquisition of
buildings in identified SFHAs for communities not participating in the
NFIP and identified for more than a year, on FEMA's initial flood
insurance map of the community as having flood-prone areas (section
202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a),
as amended). This prohibition against certain types of Federal
assistance becomes effective for the communities listed on the date
shown in the last column. The Administrator finds that notice and
public comment under 5 U.S.C. 553(b) are impracticable and unnecessary
because communities listed in this final rule have been adequately
notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were

made, this final rule may take effect within less than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR Part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance coverage unless an appropriate
public body adopts adequate floodplain management measures with
effective enforcement measures. The communities listed no longer comply
with the statutory requirements, and after the effective date, flood
insurance will no longer be available in the communities unless
remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

0
Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for part 64 is revised to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
The tables published under the authority of Sec.  64.6 are amended as
follows:

----------------------------------------------------------------------------------------------------------------
                                                   Effective date
                                                   authorization/
                                    Community     cancellation of     Current effective    Date certain Federal
       State and location              No.         sale of flood          map date         assistance no longer
                                                    insurance in                            available in SFHAs
                                                     community
----------------------------------------------------------------------------------------------------------------
            Region V

Ohio:
    Washington County,                  390566  December 24, 1975,   02/16/2006........  03/02/2006
     Unincorporated Areas.                       Emerg; February
                                                 18, 1981, Reg;
                                                 February 16, 2006,
                                                 Susp.

            Region VI

Arkansas:
    Quitman, Town of, Cleburne          050280  December 22, 1982,   ......do..........   Do.
     County.                                     Emerg; October 15,
                                                 1985, Reg;
                                                 February 16, 2006,
                                                 Susp.

           Region VII
Missouri:
    Annapolis, City of, Iron            290763  July 27, 1976,       ......do..........   Do.
     County.                                     Emerg; August 1,
                                                 1986, Reg;
                                                 February 16, 2006,
                                                 Susp.
     Browning, City of, Linn            290619  July 25, 1975,       01/19/2006........   Do.
     County.                                     Emerg; September
                                                 18, 1985, Reg;
                                                 January 19, 2006,
                                                 Susp.
----------------------------------------------------------------------------------------------------------------
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

Michael K. Buckley,
Deputy Director, Mitigation Division, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 06-2593 Filed 3-16-06; 8:45 am]

BILLING CODE 9110-12-P


[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Notices]
[Pages 78353-78354]
[FR Doc No: 2023-25109]

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ENVIRONMENTAL PROTECTION AGENCY

[Docket ID: EPA-HQ-OEJECR-2023-0530; FRL: 11540-01-OEJECR]

Agency Information Collection Activities; Proposed Information
Collection Request; Comment Request; Environmental Justice Thriving
Communities Technical Assistance Centers (TCTAC) Program: Post-Award
Reporting and Public Outreach Information Collections

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), Environmental Justice
Thriving Communities Technical Assistance Centers (TCTAC) Program:
Post-Award Reporting and Public Outreach Information Collections (EPA
ICR Number 2794.01, OMB Control Number 2035-NEW) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. Before doing so, EPA is soliciting public
comments on specific aspects of the proposed information collection as
described below. This is a request for approval of a new collection.
This notice allows for 60 days for public comments.

DATES: Comments must be submitted on or before January 16, 2024.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OEJECR-2023-0530, to EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.

FOR FURTHER INFORMATION CONTACT: Aarti Iyer, Office of the Chief
Financial Officer, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; email address: [email protected];
phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This is a request for approval of a new
collection. An agency may not conduct or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.
    This notice allows 60 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate forms of information technology. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: To help expand historically underserved and overburdened
communities' access to critical resources, the U.S. Environmental
Protection Agency (EPA) has collaborated with the U.S. Department of
Energy to develop the Environmental Justice Thriving Communities
Technical Assistance Centers (TCTAC) Program. The 18 Centers will
operate in cooperative agreements with EPA to remove barriers and
improve access for communities who wish to apply for financial
assistance awards to tackle their environmental justice concerns. The
Centers will provide assistance and training to build capacity in:
identifying sources of funding; navigating grant application systems;
compiling strong grant proposals; managing grants; and developing
partnerships and coalitions. With this Information Collection Request
(ICR), EPA seeks authorization to collect post-award information from
each Center to track their progress. Collection of this information
enables EPA to assess and manage the TCTAC Program, which ensures
responsible stewardship of public funds; rigorous evidence-based
learning and improvement; and transparent accountability to the
American public. This ICR also requests authorization for the Centers
to collect input and insights from communities who seek to obtain
technical assistance services, as well as stakeholders who have
valuable experience and expertise in community engagement and
empowerment. These information collections will enable the Centers to
document local priorities, needs, and norms to ensure that they develop
useful and relevant technical assistance and training services.
Furthermore, feedback about these services will enable the Centers to
conduct self-assessments to identify best practices and areas for
improvement. Lastly, this ICR requests authorization for the National
Centers in the TCTAC Program to conduct quarterly needs assessments for
the Regional Centers, in order to identify the best ways in which the
National Centers can support, expand, and bolster the technical
assistance that local communities may need.
    Form Numbers: None.
    Respondents/affected entities: To be determined.
    Respondent's obligation to respond: Mandatory for grant recipients
as per reporting requirements included in EPA regulations 2 CFR parts
200 and 1500, and voluntary for public outreach information collections
via surveys and focus groups.
    Estimated number of respondents: To be determined. This data will
be available for the next public review period.
    Frequency of response: To be determined. This data will be
available for the next public review period.
    Total estimated burden: To be determined. This data will be
available for the next public review period.
    Total estimated cost: To be determined. This data will be available
for the next public review period.
    Changes in the Estimates: This is a new collection therefore there
is no change in burden.

Matthew Tejada,
Deputy Assistant Administrator for Environmental Justice, Office of
Environmental Justice and External Civil Rights.
[FR Doc. 2023-25109 Filed 11-14-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Notices]
[Pages 45583-45584]
[FR Doc No: 2014-18516]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

First Meeting: RTCA Special Committee 232, Airborne Selective
Calling Equipment

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Meeting notice of RTCA Special Committee 232, Airborne
Selective Calling Equipment.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
first meeting of RTCA Special Committee 232, Airborne Selective Calling
Equipment.

DATES: The meeting will be held September 3-5, from 9 a.m.-12 p.m.

ADDRESSES: The meeting will be held at RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington DC 20036.

FOR FURTHER INFORMATION CONTACT: You may contact the RTCA Secretariat,
1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone
at<PHONE_NUMBER>, fax at<PHONE_NUMBER>, or Web site http://www.rtca.org for directions.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of Special Committee 216.

September 3-5

 Welcome/Introductions/Administrative Remarks.
 Agenda Overview.
 RTCA Overview.
    [cir] Background on RTCA, MOPS, and Process.
 Review of Selective Calling (SELCAL) Code Pool Expansion.
 SC-232 Scope and Terms of Reference.
 SC-232 Structure and Organization of Work.
 Other Business.
 Date and Place of Next Meetings.

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on July 28, 2014.
Mohannad Dawoud,
Management Analyst, NextGen, Business Operations Group, Federal
Aviation Administration.
[FR Doc. 2014-18516 Filed 8-4-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 9, 2007 (Volume 72, Number 153)]
[Notices]
[Page 44907]
[DOCID:fr09au07-117]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56198; File No. SR-Phlx-2007-45]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Order Granting Approval of Proposed Rule Change To Establish New
Procedures To Follow When Trading Halts on the Primary Market for the
Underlying Security

August 3, 2007.
    On June 14, 2007, the Philadelphia Stock Exchange, Inc. (``Phlx''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to amend Exchange Rules 1047, Trading Rotations,
Halts and Suspensions concerning equity options, 1047A, Trading
Rotations, Halts or Reopenings concerning index options, and OFPA G-2,
Trading Rotations, Halts or Reopenings, to establish new procedures to
follow when trading halts on the primary market for the underlying
security. The proposed rule change was published for notice and comment
in the Federal Register on July 3, 2007.\3\ The Commission received no
comments on the proposal.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 55958 (June 26,
2007), 72 FR 36538.36538.
---------------------------------------------------------------------------

    The Commission has reviewed carefully the proposed rule change and
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities exchange \4\ and, in particular, the requirements
of section 6(b)(5) of the Act,\5\ in that the proposed rule change is
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest. The proposed rule change would permit specialists to
halt trading in equity options in the overlying option when trading is
halted on the primary market in the underlying security, and in index
options when trading on the primary market in underlying securities
representing more than 10% of the current index value is halted, before
receiving approval from an Options Exchange Official, provided such
approval is granted within five minutes following the halt of trading
in the option. Because the proposed rule change is intended to reduce
the period of time following a trading halt on the primary market in
the underlying security before trading the overlying option is halted,
thus enabling specialists to halt trading in the overlying option more
expeditiously, the Commission believes the proposed rule change is
reasonably designed to allow Exchange options specialists and
Registered Options Traders to better manage their market risk.
---------------------------------------------------------------------------

    \4\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to section 19(b)(2) of the Act
\6\, that the proposed rule change (SR-Phlx-2007-45) be, and it hereby
is, approved.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
Florence E. Harmon,
Deputy Secretary.
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

 [FR Doc. E7-15548 Filed 8-8-07; 8:45 am]

BILLING CODE 8010-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:	9/23/09

SUBJECT:	Spirodiclofen: Occupational and Residential Exposure/Risk
Assessment for the Tropical Fruit Subgroup

PC Code:  124871	DP Barcode:   D363346

Decision No.: 404221	Registration No.:  264-831

Petition No.: 8F7500	Regulatory Action:  Section 3 Registrations

Risk Assessment Type: ORE	Case No.: NA

TXR No.:  NA	CAS No.: 148477-71-8

MRID No.:  456973-13	40 CFR: §180.566

FROM:	Lata Venkateshwara, Environmental Scientist

		Health Effects Division/Risk Assessment Branch 1 (7509P)  SEQ CHAPTER
\h \r 1

THROUGH:	Kelly M. Lowe, Environmental Scientist

Dana Vogel, Branch Chief

Health Effects Division/Risk Assessment Branch 1 (7509P)

TO:		Rita Kumar, PM (11)		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1

		Registration Division

Introduction

The registrant, Bayer CropScience, has requested registration of the
miticide spirodiclofen for use on the tropical fruit subgroup (avocado,
black sapote, canistel, mamey sapote, mango, papaya, sapodilla and star
apple).  Bayer CropScience have requested these crops be added to the
end use product, ENVIDOR® 2 SC Miticide (EPA Reg. No 264-831).  No
residential uses are being requested at this time.  This memorandum only
addresses risk from occupational exposure to the proposed new uses of
spirodiclofen.  An aggregate human risk assessment for these new uses is
presented in a separate Health Effects Division (HED) memorandum.

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc240349222"  1.0	Executive
Summary	  PAGEREF _Toc240349222 \h  3

  HYPERLINK \l "_Toc240349223"  2.0	Hazard Profile	  PAGEREF
_Toc240349223 \h  4

  HYPERLINK \l "_Toc240349224"  3.0	Use Profile	  PAGEREF _Toc240349224
\h  6

  HYPERLINK \l "_Toc240349225"  4.0	Occupational Exposure	  PAGEREF
_Toc240349225 \h  6

  HYPERLINK \l "_Toc240349226"  4.1	Short and Intermediate Term
Non-Cancer Exposures	  PAGEREF _Toc240349226 \h  6

  HYPERLINK \l "_Toc240349227"  4.1.1	Occupational Handler Exposure and
Risk	  PAGEREF _Toc240349227 \h  6

  HYPERLINK \l "_Toc240349228"  4.1.2	Occupational Postapplication
Exposure and Risk	  PAGEREF _Toc240349228 \h  10

  HYPERLINK \l "_Toc240349229"  4.2	Cancer Exposures	  PAGEREF
_Toc240349229 \h  12

  HYPERLINK \l "_Toc240349230"  4.2.1	Occupational Handler Cancer
Exposure and Risk	  PAGEREF _Toc240349230 \h  12

  HYPERLINK \l "_Toc240349231"  4.2.2	Occupational Postapplication
Cancer Exposure and Risk	  PAGEREF _Toc240349231 \h  15

  HYPERLINK \l "_Toc240349232"  5.0 Non-Occupational/Residential
Exposure	  PAGEREF _Toc240349232 \h  16

  HYPERLINK \l "_Toc240349233"  6.0	Non-Occupational Off-Target Exposure
  PAGEREF _Toc240349233 \h  16

 1.0	Executive Summary

This document presents an occupational exposure/risk assessment of new
spirodiclofen uses.  The formulated end-use product for the proposed
crop uses are labeled under the trade name: ENVIDOR® 2 SC Miticide.

Hazard Profile

In the 2008 risk assessment (Memo, M. Clock-Rust, 01-Apr-08, DP339672),
the Agency identified short-term dermal and inhalation endpoints based
on a subchronic oral toxicity study in dogs.  For intermediate- and
long-term dermal and inhalation risk assessments, a chronic oral
toxicity study in dogs was selected.  An oral study was selected because
the endpoint of concern (i.e., adrenal, testes, etc.) was not measured
in the 28-day dermal toxicity study.

A dermal-absorption factor of 2% is used for all dermal exposure
assessments since dermal endpoints are from an oral study.  The dermal
absorption factor is based on a primate dermal-absorption study.  In the
absence of an available 21/28 day inhalation study toxicity by the
inhalation route is considered to be equivalent to the toxicity by the
oral route of exposure.

The HED Cancer Assessment Review Committee (CARC) classified
spirodiclofen as “Likely to be Carcinogenic to Humans” and assigned
a Q1* (mg/kg/day)-1 of 1.49 x 10-2 in human equivalents based on male
testes Leydig cell adenoma.  Therefore, a low-dose extrapolations method
was used for human cancer risk assessment.  The level of concern (LOC)
for short-term dermal and inhalation scenarios is 300 and the LOC for
intermediate and long-term scenarios is 100.

Use Profile

Spirodiclofen is part of a new class of chemicals called tetronic acid
insecticides.  Tectronic acids are primarily acaricides with
insecticidal uses at higher doses.  The mode of action occurs through
the inhibition of lipid biosynthesis, which inhibits the ability to
develop through the various mite growth stages and the ability to
reproduce in adults.  Spirodiclofen is structurally similar to
spiromesifen, which is also a tetronic acid insecticide.  Spirodiclofen
is currently registered for use on grapes, citrus fruits, pome fruits,
stone fruits, tree nuts, Christmas tree plantations, and hops.  There
are no registered or proposed residential uses.  Spirodiclofen is
proposed by  Bayer CropScience for used in a 0.28 - 0.31  lb active
ingredient (ai)/acre soluble concentrate (ENVIDOR® SC Miticide) on
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla
and star apple.

Occupational Exposure/Risk

No chemical-specific handler exposure data were submitted in support of
this Section 3 registration.  It is the policy of the HED to use data
from the Pesticide Handlers Exposure Database (PHED) Version 1.1 as
presented in PHED Surrogate Exposure Guide (8/98) to assess handler
exposures for regulatory actions when chemical-specific monitoring data
are not available (HED Science Advisory Council for Exposure (ExpoSAC)
Draft SOP # 7, dated 1/28/99).

s ≥ 300) at baseline except for aerial handler which was with
engineering controls.

All post-application risks are also not of concern (i.e., MOEs ≥ 300).
 The proposed label for ENVIDOR® has a 12- hour restricted entry
interval (REI).   Spirodiclofen is classified as Toxicity Category III
for acute oral and acute dermal toxicity; and Toxicity Category IV for
acute inhalation, primary eye irritation and primary dermal irritation.
It is a dermal sensitizer.  Under the conditions described herein (i.e.,
regarding hazard identification and application practices), the interim
worker protection standard (WPS) REI of 12 hours is adequate to protect
agricultural worker from post-application exposures.

Residential Exposure/Risk

Spirodiclofen is not proposed or registered for any residential uses.

Review of Human Research

This risk assessment relies in part on data from Pesticide Handlers
Exposure Database (PHED) studies in which adult human subjects were
intentionally exposed to a pesticide or other chemical.  These studies
have been reviewed and have been determined to be ethical.

2.0	Hazard Profile

The toxicological factors used in this assessment are taken from:  Memo,
M. Clock-Rust, 01-Apr-08, DP339672, “Human-Health Risk Assessment for
Spirodiclofen for Use on Hops.”  The acute toxicity categories for
spirodiclofen are summarized in Table 1. The doses selected for this
risk assessment are summarized in Table 2.

In the 2008 risk assessment, the Agency identified a short-term duration
dermal toxicological endpoint from a subchronic oral toxicity study in
the dog.  The point of departure (POD) is the Lowest Observable Adverse
Effect Level (LOAEL), 8.4 mg/kg/day.  The toxic effects noted were
increased adrenal gland weight which corroborated with histopathology
findings (cytoplasmic vacuoles in the Zona fasciculata of the adrenals).
 A dermal absorption rate of 2% was identified to extrapolate dermal
exposure from oral study data.  The level of concern is an uncertainty
factor (UF) of 300 (i.e., 10X for intraspecies variation, 10X for
interspecies variation and 3X for use of a LOAEL versus a No Observable
Adverse Effect Level (NOAEL)).

The short-term duration inhalation toxicological endpoint is the same as
identified (above) for short-term duration dermal exposures.  It is
identified from the same subchronic feeding study in the dog.  The toxic
effects are the same as noted above.  Since no inhalation absorption
data are available, toxicity by the inhalation route is considered to be
equivalent to toxicity by the oral route of exposure.  The level of
concern is for MOEs < 300.

The HED Cancer Assessment Review Committee (CARC) met on 5 May 2004 to
discuss the carcinogenic potential of spirodiclofen (Memo, L. Brunsman,
TXR NO. 0052535, “Spirodiclofen Quantitative Risk Assessment (Q1*)
Based on Wistar Rat and CD-1 Mouse Dietary Studies with 3/4's
Interspecies Scaling Factor”, 6 May 2004).  The CARC classified
spirodiclofen as “Likely to be Carcinogenic to Humans” and assigned
a Q1* value of 1.49 x 10-2 mg a.i./kg bw/day.   Therefore, a low-dose
extrapolation method was used for human cancer risk assessment.
Quantification of cancer risk used a Q1* (mg/kg/day)-1 of 1.49 x 10-2 in
human equivalents based on male rat testes Leydig cell adenoma.

Spirodiclofen is classified as Toxicity Category III for acute oral and
acute dermal toxicity; and Toxicity Category IV for acute inhalation,
primary eye irritation and primary dermal irritation.  It is a dermal
sensitizer.

Table 1.  Acute Toxicity Profile for Spirodiclofen

OPPTS Guideline	Study Type	Results

Toxicity Category

870.1100

Acute oral toxicity / rat

LD50 => 2000 mg/kg (males and females)

III

870.1200

Acute dermal toxicity / rat

LD50 => 2000 mg/kg (males and females)

III

870.1300

Acute inhalation toxicity / rat

LC50 => 5.03 mg/L (males and females)

IV

870.2400

Primary eye irritation / rabbit

Non-irritating

IV

870.2500

Primary dermal irritation / rabbit

Non-irritating

IV

870.2600

Dermal sensitization / guinea pig

Sensitizer

–

Table 2.  Summary of Toxicology Endpoint Selection for Spirodiclofen
for These Specific Uses

Exposure

Scenario	Dose Used in Risk Assessment, UF	FQPA SF and Level of Concern
for Risk Assessment	Study and Toxicological Effects

Short-term Incidental Oral;

Short-term Dermal;

Short-term Inhalation

(1-30 Days)	LOAEL = 8.4 mg/kg/day

(dermal-absorption rate= 2%)

	Occupational LOC for MOE = 300	Subchronic Oral Toxicity Study in Dogs

LOAEL= 8.4 mg/kg/day based on  increased adrenal gland weight (two out
of four animals) which corroborated with histopathology findings
(cytoplasmic vacuoles in the Zona fasciculata of the adrenal glands) in
females; a NOAEL for females was not established.

Long-term Dermal; Long-term Inhalation

(>6 Months)	Oral

NOAEL= 1.38

mg/kg/day

(dermal-absorption rate = 2%)	Occupational LOC for MOE = 100	Chronic
Oral Toxicity Study in Dogs

See above under Chronic Dietary.

Cancer

(Oral, dermal, inhalation)	Classification: “Likely to be Carcinogenic
to Humans”

with Q1* (mg/kg/day)-1 = 1.49 x 10-2.

3.0	Use Profile

Table 3 summarizes the proposed use pattern and formulation specified in
the end-use product containing spirodiclofen.   The label directions for
ENVIDOR®  2 SC Miticide (EPA Reg. No. 264-831) recommend a maximum
application rate of 20 fluid ounces per acre or 0.31 lb ai/A for
avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
and star apple.  The label does not provide an application interval and
states to apply no more than one application per crop season.

Table 3.  Summary of Proposed Use Pattern for Spirodiclofen

Crop Type/Use Site	Max Single Application Rate (lb ai/A)	Application
Equipment	Application Interval	Maximum lb ai per crop, season or year
Max # applications 	Pre-harvest Interval

ENVIDOR® Miticide  (EPA Reg #264-831)

2 lb ai/gal liquid or 240 grams per liter

Soluble Concentrate Liquid

REI = 12 hours

Tropical Fruit Subgroup1 	0.31 	Airblast, aerial 	Not provided	0.31 lb
ai/acre	1 app per crop season	2 day

Crops include avocado, black sapote, canistel, mamey sapote, mango,
papaya, sapodilla, and star apple

4.0	Occupational Exposure

4.1	Short and Intermediate Term Non-Cancer Exposures

4.1.1	Occupational Handler Exposure and Risk Estimates

There is potential for occupational handler exposure from the proposed
uses on agricultural crops. It is anticipated that the following
scenarios could result in handler exposure:

	Mixer/Loaders:

		1) 	Mixing/Loading Liquids for Airblast Applications (PHED);

		2) 	Mixing/Loading Liquids for Aerial Applications (PHED);

Applicators:

		3)   Applying Sprays via Airblast Equipment (PHED);

4)   Applying Sprays via Aerial Equipment (PHED); and

Flagger:

		5)   Flagging to support aerial applications (PHED).

No chemical-specific data were available with which to assess potential
exposure to pesticide handlers.  The estimates of exposure to pesticide
handlers are based upon surrogate study data available in the Pesticide
Handlers Exposure Database (PHED, August, 1998). For pesticide handlers,
HED presents estimates of dermal exposure for “baseline” (i.e.,
workers wearing a single layer of work clothing consisting of a long
sleeved shirt, long pants, shoes plus socks and no protective gloves),
as well as for “baseline” and the use of protective gloves or other
personal protective equipment (PPE), as might be necessary. The
spirodiclofen product label directs mixers, loaders, applicators and
other handlers to wear a long-sleeve shirt, long pants, waterproof
gloves and shoes plus socks.

Handler exposure is expected to be short-term based on information
provided on the proposed label (e.g., only one application allowed per
crop season).  The average adult body weight of 70 kg was used for
estimating inhalation and dermal dose.  Intermediate and long-term
exposures are not expected, therefore, an intermediate and long-term
assessment was not conducted.

Daily dermal or inhalation handler exposures are estimated for each
applicable handler task with the application rate, the area treated in a
day, and the applicable dermal or inhalation unit exposure using the
following formula:

Daily Exposure (mg ai/day) = Unit Exposure (mg ai/lb ai handled) x
Application Rate (lbs ai/area) x Daily Area Treated (area/day)

Where:

Daily Exposure		=	Amount (mg ai/day) deposited on the surface of the
skin that is available for dermal absorption or amount inhaled that is
available for inhalation absorption;

Unit Exposure 		=	Unit exposure value (mg ai/lb ai) derived from August
1998 PHED data;

Application Rate		=	Normalized application rate based on a logical unit
treatment, such as acres; and

	Daily Area Treated 	=	Normalized application area based on a logical
unit treatment such as acres (A/day).

The daily dermal or inhalation dose is calculated by normalizing the
daily exposure by body weight and adjusting, if necessary, with an
appropriate dermal or inhalation absorption factor using the following
formula:

Average Daily Dose (mg/kg/day) = Daily Exposure (mg ai/day) x
(Absorption Factor (%/100)) / Body Weight (kg)

Where:

Average Daily Dose 		= 	Absorbed dose received from exposure to a
pesticide in a given scenario (mg ai/kg body weight/day);

Daily Exposure 			=	Amount (mg ai/day) deposited on the surface of the
skin that is available for dermal absorption or amount inhaled that is
available for inhalation absorption;

Absorption Factor 		= 	A measure of the amount of chemical that crosses
a biological boundary such as the skin or lungs (% of the total
available absorbed); and

Body Weight 			= 	Body weight determined to represent the population of
interest in a risk assessment (kg).

Non-cancer dermal and inhalation risks for each applicable handler
scenario are calculated using a MOE, which is a ratio of the NOAEL or
LOAEL to the daily dose.  All MOE values were calculated using the
formula below:

MOE= NOAEL or LOAEL (mg/kg/day) / Average Daily Dose (mg/kg/day)

Total Average Daily Dose:  When the dermal and inhalation endpoints,
effects, and routes of exposure are the same, the doses may be added
together to obtain a total dose using the following formula:

TOTAL Average Daily Dose = Dermal Dose (mg/kg/day) + Inhalation Dose
(mg/kg/day)

Table 4 presents the estimated risks for workers based on the short-term
dermal and inhalation exposures with baseline attire, or with additional
PPE.  HED has determined that risks are not of concern for short-term
exposures (i.e., MOEs > 300) with the PPE required on the label.

HED has no data to assess exposures to pilots using open cockpits.  The
only data available for exposure to pilots is in enclosed cockpits.
Therefore, risks to pilots are assessed using the engineering control
(enclosed cockpits) and baseline attire (long-sleeve shirt, long pants,
shoed and socks); pilots are not required to wear gloves.  There were no
risks of concern for aerial applicators.

Table 4.  Occupational Handler Dermal and Inhalation Exposures and Risk
Estimates

Dermal and

Inhalation Unit Exposures

(mg/lb ai)	Application rate

(lb ai/A)a	Area Treated Daily (A)b	Short-term Doses (mg/kg/day)c
Short-term MOEsd

Mixer/Loader – Airblast Application

Dermal

Baselinee: 2.9

Inhalation

Baselinef: 0.0012	0.31	40	Dermal

Baseline: 0.01	Combined Baseline:

 0.01	Dermal

Baseline: 820	Combined Baseline: 800

	Inhalation

Baseline: 0.0002

Inhalation

Baseline: 40,000

	Mixer/Loader – Aerial Application

Dermal

Baseline: 2.9

Single layer w/glovesh: 0.023

Inhalation

Baseline: 0.0012	0.31	350	Dermal

Baseline: 0.09

Single layer w/gloves: 0.00071

Combined Baseline:

0.092

Combined Single layer w/gloves: 0.0027

	Dermal

Baseline: 93

Single layer w/ gloves: 12,000	Combined Baseline:  92

Combined Single layer w/gloves: 3,300

	Inhalation

Baseline: 0.002

Inhalation

Baseline: 4,500

	Applicator –Airblast Application

Dermal

Baseline: 0.36

Inhalation

Baseline: 0.0045	0.31	40	Dermal Baseline: 0.0013	Combined Baseline:

0.0021	Dermal

Baseline: 6,600	Combined Baseline:  4,100

	Inhalation Baseline: 0.0008

Inhalation

Baseline: 11,000

	Applicator –Aerial Application

Dermal

Engineering Controlg:

0.005

Inhalation

Engineering Controlg:

0.000068	0.31	350	Dermal Engineering Control: 0.00016	Combined
Engineering control: 0.00027	Dermal

Engineering Control: 54,000 	Combined Engineering control: 32,000

	Inhalation Engineering Control: 0.00011

Inhalation

Engineering Control: 80,000

	Flagger –Aerial Application

 Dermal

Baseline: 0.011

Inhalation

Baseline: 0.00074	0.31	350	Dermal Baseline: 0.00034	Combined Baseline:
0.0009

	Dermal

Baseline: 25,000	Combined Baseline: 9,500

	Inhalation Baseline: 0.00054

Inhalation

Baseline: 15,000

	a	Application rates are the maximum (single) recommended rates provided
on the spirodiclofen product labels.

b	Area treated per day values are HED estimates based on ExpoSAC Policy
#9 “Standard Values for Daily Acres Treated in Agriculture,”
industry sources, and HED estimates.

c	Dose (mg/kg/day) = Unit exposure(mg/lb ai) x App Rate (lb ai/acre) x
Area Treated (acres/day) x  %Absorption (2% dermal and 100% inhalation
assumed) / Body weight.  The body weight is 70 kg for the inhalation and
dermal dose.

d	MOE = NOAEL or LOAEL/Dose; where the short-term dermal and inhalation
LOAEL =  8.4 mg/kg/day.

e	Baseline Dermal:  Long-sleeve shirt, long pants, and no gloves.

f	Baseline Inhalation: no respirator.

g	Eng Con Dermal and Inhalation Engineering control for the aerial
application scenario is an enclosed cockpit and baseline attire
(long-sleeve shirt, long pants, shoes, and socks).

h	PPE - SL w/ gloves: Single layer plus chemical-resistant gloves.

.

4.1.2	Occupational Post-application Exposure and Risk Estimates

Since spirodiclofen is applied as a foliar spray.  HED expects that
post-application exposure will occur since spirodiclofen is applied as a
foliar spray.  Post-application exposure is expected to be short-term
based on information provided on the proposed label.  Post-application
data has been submitted previously for the use of spirodiclofen on
citrus and apple.  Post-application exposures have been assessed using
the submitted dislodgeable foliar residue data as well as dermal
transfer coefficients from HED’s ExpoSAC Policy Number 3.1
“Agricultural Transfer Coefficients” (August, 2000).    Table 5
summarizes the scenarios assessed.  In addition, the following
assumptions were used in the calculations:

Assumptions:

Exposure Duration			=	8 hours per day

Body Weight				=	70 kg

Dermal Absorption			= 	2%

Table 5: Anticipated Postapplication Activities and Dermal Transfer
Coefficients

Proposed Crops	Policy Crop Group Category	Application Rate (lb ai/acre)
Transfer Coefficients (cm2/hr)	Activities

Avocado, black sapote, canistel, mamey sapote, mango, papaya, sapodilla,
 and star apple	Tropical Fruit Subgroup	0.31	1500	Harvesting

	3000	Thinning

The information in the table is based on proprietary and non-proprietary
data.

A DFR study was submitted to the Agency by Bayer Corporation which
examined the dissipation of residues on citrus and apple trees following
application of spirodiclofen (ENVIDOR® 2 SC Miticide).   The study was
reviewed by HED and deemed acceptable for use in occupational
post-application risk assessments (Memo, M. Dow, D285247, MRID
456973-13, June 29, 2004).  In the study, there were three test sites
for citrus (California, Florida and Texas) and two apple test sites
(Washington and Ontario, Canada).  A single application was made at all
test sites using typical, orchard, airblast equipment.  Maximum residues
were identified at the Washington site for apples and those residue
values were used in this risk assessment to estimate exposure from
treatment of tropical fruit.  Since the maximum application rate for
apples in the study was 0.11 lb ai/A, an adjustment of the residues was
performed to account for the maximum application rate in this assessment
(0.31 lb ai/A).  A summary of the DFR data is provided in Table 6.

Table 6: Summary of Apple DFR Data Used for Postapplication Assessment

Trial Location	Actual Application Rate

(lbs ai/A)	Label Recommended Maximum Application Rate

(lbs ai/A)	Day after treatment	DFR data provided in study	Adjusted DFR
data for difference in application ratesa

Washington	0.11	0.31	0	0.169	0.476

	1	0.165	0.465

	2	0.161	0.454

	3	0.157	0.443

	4	0.154	0.433

	5	0.150	0.423

	6	0.146	0.413

	7	0.143	0.403

	8	0.140	0.394

	9	0.136	0.384

	10	0.133	0.375

	11	0.130	0.366

	12	0.127	0.358

	13	0.124	0.349

	14	0.121	0.341

	15	0.118	0.333

	16	0.115	0.325

	17	0.113	0.318

	18	0.110	0.310

	19	0.107	0.303

	20	0.105	0.296

	21	0.102	0.289

	22	0.100	0.282

	23	0.098	0.275

	24	0.095	0.269

	25	0.093	0.263

	26	0.091	0.256

	27	0.089	0.250

	28	0.087	0.245

	29	0.085	0.239

	30	0.083	0.233

a.	DFR data in study collected after an application at a rate of 0.11 lb
ai/A.  Maximum application rate assessed for spirodiclofen is 0.31 lb
ai/A; therefore, the DFR data was adjusted to reflect this difference
(0.31 lb ai/A / 0.11 lb ai/A *DFR data)

Equations/Calculations:

Daily dermal exposures were calculated on each postapplication day after
application using the following equation:

Daily Dermal Doset  =  [DFRt (µg/cm2) x 0.001 mg/µg x TC (cm2/hr) x DA
x ET (hrs)]  /  BW (kg)

Where,

		DFRt 	=	dislodgeable foliage residue on day "t" (ug/cm2);

		TC	=	transfer coefficient (cm2/hr);

		DA	=	dermal absorption factor (2%)	;

	     	ET	=	exposure time (8 hr/day); and

		BW	=	body weight (70 kg).

Once daily exposures are calculated, the calculation of daily absorbed
dose and the resulting Margin of Exposures use the same algorithms that
are described above for the handler exposures.  These calculations are
completed for each day or appropriate block of time after application.

HED has determined that short-term risk estimates are not of concern
(i.e., MOEs > 300) on the day of treatment (i.e., Day 0) for all
postapplication exposure activities.  Table 7 presents a summary of
occupational postapplication risks associated with use of spirodiclofen.

Table 7.  Post-application Risk Estimates for Spirodiclofen

Crop	Application  Rate

(lb ai/A)	Transfer Coefficient

(cm2/hr)	DFR (ug/cm2)	Days After Treatment	Daily Dose1

(mg/kg/ay)	MOE2

Tropical Fruit Subgroup	0.31	1,500	0.476	0

(12 hours)	0.0016	5,100

3,000

	0.003	2,600

The information in the table is based on proprietary and non-proprietary
data.

1:  Daily Dose = [DFR (ug/cm2) x TC (cm2/hr) x 0.001 mg/µg x Dermal
Absorption (2%) x 8 hrs/day] ÷ Body Weight (70 kg)

2:  LOAEL/Daily Dose (Short-term LOAEL = 8.4 mg/kg/day)

4.2	Cancer Exposure Estimates  tc \l3 "2.1.4 	Cancer Permethrin Handler
Exposure and Risk Assessment

This section presents the occupational handler exposure and cancer risk
assessment from spirodiclofen.

4.2.1	Occupational Handler Cancer Exposure and Risk Estimates

Cancer risk estimates resulting from exposures to spirodiclofen were
calculated using a linear low-dose extrapolation approach in which a
Lifetime Average Daily Dose (LADD) is first calculated and then compared
with a Q1*  that has been calculated for spirodiclofen based on dose
response data (Q1*  = 1.49 x 10-2 (mg/kg/day)-1).  Absorbed average
daily dose (ADD) levels were used as the basis for calculating the LADD
values.  These values also serve as the basis for the cancer risk
estimates.  Dermal and inhalation ADD values were first added together
to obtain combined ADD values.  LADD values were then calculated and
multiplied by the Q1* to obtain cancer risk estimates.

To estimate the carcinogenic risk from absorbed average daily dose, the
values must be amortized over the working lifetime of occupational
handlers.  Based on use scenario and use patterns, it is anticipated
that commercial applicators would apply spirodiclofen approximately 30
days per year.  It was estimated that an individual farmer would handle
spirodiclofen approximately 10 days per year.  As a result, HED
considered two handler populations (commercial and private handlers) for
the cancer risk assessment.  Finally, a 35 year career and a 70 year
lifespan were used to complete the calculations.  Generally, HED
considers occupational cancer risks estimates in the 10 -6 10 -4 range
to be not of concern.  LADD values were calculated using the following
equation:

LADD	=	ADD * (Exposure Frequency / 365 days per year) * (Exposure
duration * Lifetime)

Where:

Lifetime Average Daily Dose	=	the amount as absorbed dose received from
exposure to a pesticide or

degradate in a given scenario over a lifetime (mg/kg/day, also referred
to as LADD);

Average Daily Dose 		= 	the amount as absorbed dose received from
exposure to a pesticide or

degradate in a given scenario on a daily basis (mg/kg/day, also referred
to as ADD);

Exposure Frequency 		= 	the annual frequency of exposure to an
individual (days/year);

Exposure Duration 		= 	the amount of a lifetime that an individual is
exposed (35 years for

occupational); and

Lifetime				= 	the average life expectancy of an individual (70 years).

Estimated cancer risk calculations were completed by multiplying the
LADD values by the Q1* for spirodiclofen (Q1*  = 1.49 x 10-2
(mg/kg/day)-1).  Cancer risk estimates were calculated using the
following equation:

 EQ Estimated Cancer Risk  =  LADD  x  Q1*

Where:

Estimated Cancer Risk		=	Probability of excess cancer cases over a
lifetime (unitless);

Lifetime Average Daily Dose 	= 	the amount as absorbed dose received
from exposure to a pesticide or

degradate in a given scenario over a lifetime (mg//kg/day); and

Q1* 				= 	Quantitative dose response factor used for linear, low-dose
response

cancer risk calculations (mg/kg/day)-1.

Estimated spirodiclofen cancer risks for handlers are summarized below
in Tables 8 and 9. In most scenarios, estimated cancer risks are below 1
x 10-6 at some level of risk mitigation.  Cancer risk estimates are
below 1 x 10-4 with the single layer clothing, gloves, and no
respiratory  protection.  Therefore, there are no concerns for
occupational cancer risk for handlers.

  SEQ CHAPTER \h \r 1

Table 8.  Handler Cancer Risk Estimates for Commercial Spirodiclofen
Handlers

Scenario	Mitigation	Dermal  Dose a (mg/kg/day)	Inhalation Dose a
(mg/kg/day)	Combined ADD b (mg/kg/day)	Commercial

LADD  c

(mg/kg/day)	Commercial

Cancer

Risk d

Mixer/Loader

Mixing/loading liquids airblast application (1)	Baseline Dermal and
Inhalation	0.01	0.0002	0.01	4.3E-04	6.4E-06

	Single layer w/gloves + Baseline Inhalation	0.000081

0.00029	1.2E-05	1.8E-07

Mixing/loading liquids for  aerial application (2)	Baseline Dermal and
Inhalation	0.09	0.002	0.092	3.8E-03	5.6E-05

	Single layer w/gloves + Baseline

Inhalation

0.00071

0.0027

0.00011

1.6E-06

Applicator

Applying spray using airblast (3)	Baseline Dermal and Inhalation

	0.0013	0.0008	0.0021	8.5E-05	1.3E-06

Applying spray using aerial (4)	Engineering Controls Dermal and
Inhalation

0.00016

0.00011

	0.00027	1.1E-05	1.6E-07

Flagger

Flagging

during aerial application (5)	Baseline Dermal and Inhalation	0.00034
0.0005	0.0009	3.6E-05	5.4E-07

a.   Dermal Dose and Inhalation Doses (mg/kg/day) = See Table 4.

b.   Combined ADD (mg/kg/day) = Dermal Dose (mg/kg/day) + Inhalation
Dose (mg/kg/day)

c.   Commercial Applicator LADD (mg/kg/day) = ADD x [(30 days/yr)/ (365
days/yr)] x (35 yrs/70yrs)

d    Commercial Applicator Cancer Risk = Commercial LADD  x  Q* [1.49 x
10-2 (mg/kg/day)-1]

  SEQ CHAPTER \h \r 1

Table 9.  Handler Cancer Risk Estimates for Private Spirodiclofen
Handlers

Scenario	Mitigation	Dermal  Dose a (mg/kg/day)	Inhalation Dose a
(mg/kg/day)	Combined ADD b (mg/kg/day)	Private

LADD  c

(mg/kg/day)	Private

Cancer

Risk d

Mixer/Loader

Mixing/loading liquids airblast application (1)	Baseline Dermal and
Inhalation	0.01	0.0002	0.01	1.4E-04	2.1E-06

Mixing/loading liquids for  aerial application (2)	Baseline Dermal and
Inhalation	0.09	0.0002	0.092	1.3E-03	1.9E-05

	Single layer w/ gloves + Baseline Inhalation 	0.00071

0.0027	3.5E-05	5.3E-07

Applicator

Applying spray using airblast (3)	Baseline Dermal and Inhalation	0.0013
0.0008	0.0021	2.8E-05	4.2E-07

Applying spray using aerial (4)	Engineering Controls Dermal and
Inhalation

0.00016

0.00011

0.00027

3.6E-06

5.3E-08

Flagger

Flagging

during aerial application (5)	Baseline Dermal and Inhalation	0.00034
0.0005	0.0009	1.2E-05	1.8E-07

a.   Dermal and Inhalation Dose (mg/kg/day)  = See Table 4.

b.   Combined ADD (mg/kg/day) = Dermal Dose (mg/kg/day) + Inhalation
Dose  (mg/kg/day)

c.   Private Applicator LADD (mg/kg/day) = ADD x [(10 days/yr)/ (365
days/yr)] x (35 yrs/70yrs)

d    Privatel Applicator Cancer Risk = Private LADD  x  Q* [1.49 x 10-2
(mg/kg/day)-1]

4.2.2	Occupational Post-application Cancer Exposure and Risk Estimates
tc \l3 "2.2.4	Occupational Postapplication Exposure and Risk Estimates
for Cancer

The occupational exposure and cancer risk calculations for
post-application workers are presented in this section.  The use of
dissipation data and the manner in which daily post-application dermal
exposures were calculated are inherently different than with handler
exposures.  However, once daily exposures are calculated, the
calculation of LADD (Lifetime Average Daily Dose) and the resulting
cancer risk estimates use the same algorithms that are described above
for the handler exposures.

Post-application cancer risk estimates are summarized in Table 10 below.
  Exposure was assessed for individuals employed by multiple
establishments (i.e., commercial or migratory farmworkers) who could be
exposed up to 30 days per year. Dislodgeable foliar residue data for
spirodiclofen were used along with transfer coefficients to calculate
the LADDs.  An average DFR value was calculated using
spirodiclofen-specific dissipation data.  Based on a review of the
proposed label, it was determined that: (1) only one application is
allowed per crop season, (2) residues are assumed to dissipate over
time, and (3) it is unlikely that workers will be exposed to Day 0
residues 30 days a year.  Therefore, HED used the average residue over
30 days to estimate cancer risk.

Lifetime Average Daily Dose =  ADD  x  Exposure Frequency  x  Exposure
Duration

					        365 Days per Year 	        Lifetime

where

Lifetime Average Daily Dose 	= 	The amount as absorbed dose received
from exposure to a pesticide or degradate in a given scenario over a
lifetime (mg/kg/day, also referred to as LADD);

Average Daily Dose 		= 	The amount as absorbed dose received from
exposure to a pesticide or degradate in a given scenario on a daily
basis (mg/kg/day, also referred to as ADD);

Exposure Frequency 		= 	The annual frequency of exposure to an
individual (30 days/year);

Exposure Duration 		= 	The amount of a lifetime that an individual is
exposed (35 years for occupational); and

Lifetime				= 	The average life expectancy of an individual (70 years).

Estimated Cancer Risk = LADD x Q1*

Where:

Estimated Cancer Risk		=	Probability of excess cancer cases over a
lifetime (unitless);

Lifetime Average Daily Dose 	= 	The amount as absorbed dose received
from exposure to a pesticide or degradate in a given scenario over a
lifetime (mg/kg/day); and

Q1* 				= 	Quantitative dose response factor used for linear, low-dose
response cancer risk calculations [3.59 x 10-3 (mg/kg/day)-1].

Estimated spirodiclofen cancer risks for post-application exposure are
summarized in Table 10.  The estimated cancer risks are below or equal
to 1 x 10-6.  Therefore, there are no concerns for occupational cancer
risk for post-application workers.

Table 10.  Cancer Exposure/Risk Estimates for Spirodiclofen
Post-application Workers

Crop	DAT a	DFR b

(ug/cm2)	Transfer Coefficient  c (cm2/hr)	Daily Dose  d (mg/kg/day)	LADD
e	Cancer Risk f

Tropical Fruit Subgroup	1 - 30	0. 34	1,500

0.0012

	0.000048	7.14E-07

	3,000

0.0023

	0.000096	1.43E-06

DAT= 30 day residue average

DFR value used is based on a  DFR study  submitted to the Agency by
Bayer Corporation in 2004

Transfer Coefficients selected in accordance with SAC for Exposure
Policy 3.1 (August 2000)

Daily Dose (mg/kg/day)= DFR (µg/cm2) x 0.001 mg/ug x Tc (cm2/hr) x DA
(2%) x ET (8 hr/day)/70 kg

LADD (mg/kg/day) = DD x [(30 days/yr)/ (365 days/yr)] x (35 yrs/70yrs)

Cancer Risk = LADD  x  Q* [1.49 x 10-3 (mg/kg/day)-1]

5.0 Non-Occupational/Residential Exposure Estimates

This document only presents the assessment of proposed agricultural uses
of spirodiclofen.  No residential uses are being requested at this time
and, in addition, there are no existing spirodiclofen products
registered for residential use sites; therefore, no residential risk
assessment has been conducted.

Non-Occupational Off-Target Exposure Estimates

Spray drift is always a potential source of exposure to residents nearby
to spraying operations.  This is particularly the case with aerial
application, but, to a lesser extent, could also be a potential source
of exposure from the ground application method additionally employed for
spirodiclofen.  The Agency has been working with the Spray Drift Task
Force, EPA Regional Offices and State Lead Agencies for pesticide
regulation and other parties to develop the best spray drift management
practices.  The Agency is now requiring interim mitigation measures for
aerial applications that must be placed on product labels/labeling.  The
Agency has completed its evaluation of the new database submitted by the
Spray Drift Task Force, a membership of U.S. pesticide registrants, and
is developing a policy on how to appropriately apply the data and the
AgDRIFT computer model to its risk assessments for pesticides applied by
air, orchard airblast and ground hydraulic methods.  After the policy is
in place, the Agency may impose further refinements in spray drift
management practices to reduce off-target drift and risks associated
with aerial as well as other application types where appropriate.

Page   PAGE  3  of   NUMPAGES  17


[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Page 35789]
[FR Doc No: 2022-12625]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1222]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Labeling:
Notification Procedures for Statements on Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by July 13, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0331. Also include the FDA docket
number found in brackets in the heading of this document.

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 protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Food Labeling: Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93

OMB Control Number 0910-0331--Extension

    Section 403(r)(6) (21 U.S.C. 343(r)(6)) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and Sec.  101.93 (21 CFR 101.93) require
that, no later than 30 days after the first marketing, we be notified
by the manufacturer, packer, or distributor of a dietary supplement
that it is marketing a dietary supplement product that bears on its
label or in its labeling a statement provided for in section 403(r)(6)
of the FD&C Act. In accordance with these requirements, submissions
must include: (1) the name and address of the manufacturer, packer, or
distributor of the dietary supplement product; (2) the text of the
statement that is being made; (3) the name of the dietary ingredient or
supplement that is the subject of the statement; (4) the name of the
dietary supplement (including the brand name); and (5) the signature of
a responsible individual or the person who can certify the accuracy of
the information presented, and who must certify that the information
contained in the notice is complete and accurate, and that the
notifying firm has substantiation that the statement is truthful and
not misleading.
    Our electronic form (Form FDA 3955) allows respondents to the
information collection to electronically submit notifications to FDA
via the Food Applications Regulatory Management (FARM) system. Firms
that prefer to submit a paper notification in a format of their own
choosing will still have the option to do so; however, Form FDA 3955
prompts respondents to include certain elements in their structure/
function claim notification (SFCN) described in Sec.  101.93 in a
standard electronic format and helps respondents organize their SFCN to
include only the information needed for our review of the claim. Note
that the SFCN, whether electronic or paper, is used for all claims made
pursuant to section 403(r)(6) of the FD&C Act, including nutrient
deficiency claims and general well-being claims in addition to
structure/function claims. The electronic form, and any optional
elements prepared as attachments to the form (e.g., label), can be
submitted in electronic format via FARM. Submissions of SFCNs will
continue to be allowed in paper format. We use this information to
evaluate whether statements made for dietary ingredients or dietary
supplements are permissible under section 403(r)(6) of the FD&C Act.
    Description of Respondents: Respondents to this collection of
information include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the FD&C Act statements on
their labels or labeling.
    In the Federal Register of December 2, 2021 (86 FR 68504), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
      21 CFR section; activity; form No.          Number of     responses per    Total annual          Average burden per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.93; Statements for Dietary Supplements;             3,690               1           3,690   0.75 (45 minutes).......................           2,768
 Form FDA 3955.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. This estimate is based on our experience with this
information collection and the number of notifications received in the
past 3 years, which has remained constant.

    Dated: June 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12625 Filed 6-10-22; 8:45 am]
BILLING CODE 4164-01-P