[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Proposed Rules]
[Pages 16133-16135]
[FR Doc No: 2022-06046]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 174 and 180

[EPA-HQ-OPP-2022-0161; FRL-9410-11-OCSPP]

Receipt of Pesticide Petitions Filed for Residues of Pesticide
Chemicals in or on Various Commodities--February 2022

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notifictions of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of initial
filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before April 21, 2022.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition (PP) of interest as shown in the
body of this document, through the Federal eRulemaking Portal at
https://www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is open to visitors by
appointment only. For the latest status information on EPA/DC services
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(202) 566-2427, email address: [email protected]; or Marietta
Echeverria, Registration Division (RD) (7505P), main telephone number:
(703) 305-7090, email address: [email protected]. The mailing address
for each contact person: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each application summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing receipt of pesticide petitions filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain data or information prescribed in FFDCA section 408(d)(2), 21
U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data supports
granting of the pesticide petitions. After considering the public
comments, EPA intends to evaluate whether and what action may be
warranted. Additional data may be needed before EPA can make a final
determination on these pesticide petitions.
    Pursuant to 40 CFR 180.7(f), summaries of the petitions that are
the subject of this document, prepared by the petitioners, are included
in dockets EPA has created for these rulemakings. The dockets for these
petitions are available at https://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further

information on the petitions may be obtained through the petition
summaries referenced in this unit.

A. Amended Tolerance Exemptions for Inerts (Except PIPS)

    PP IN-11661. (EPA-HQ-OPP-2022-0189). The United States Department
of Agriculture, Animal and Plant Health Inspection Service (4700 River
Road, Unit 149, Riverdale, MD 20737), requests to amend 40 CFR part
180.930 to add iron oxide (Fe3O4) (CAS No. 1317-
61-9) as an inert ingredient (colorant) in pesticide formulations at no
more than 2,000 parts per million (ppm) (0.2% by weight) in the final
formulation when applied to animals. No analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.

B. Amended Tolerances for Non-Inerts

    1. PP 1F8929. (EPA-HQ-OPP-2021-0555). Gowan Company, LLC 370 S Main
St., Yuma, AZ 85366, requests to amend the tolerance(s) in 40 CFR
180.416 for residues of the herbicide ethalfluralin in or on 3-07A.
Onion, bulb subgroup at 0.01 ppm. The capillary gas chromatography with
mass selective detection (GC/MSD) is used to measure and evaluate the
chemical ethalfluralin. Contact: RD.
    2. PP 1F8940. (EPA-HQ-OPP-2021-0787). SePRO Corporation, 11550
North Meridian Street, Suite 600, Carmel, IN 46032, requests to amend
the tolerances in 40 CFR 180.420(d) by removing the existing tolerances
for indirect or inadvertent residues of the herbicide fluridone,
including its metabolites and degradates, in or on berry, group 13;
fruit, citrus, group 10; fruit, pome, group 11; hop, dried cones; and
nut, tree, group 14 at 0.1 ppm and animal feed, nongrass, group 18 and
grass, forage at 0.15 ppm. Contact: RD.

C. New Tolerance Exemptions for Inerts (Except PIPS)

    1. PP IN-11599. (EPA-HQ-OPP-2021-0645). Valent BioSciences LLC
(1910 Innovation Way, Suite 100, Libertyville, Il. 60048) requests to
establish an exemption from the requirement of a tolerance for residues
of arbuscular mychorrhizae (funnelformis mosseae, rhizophagus
irregularis, rhizophagus etunicatum, claroideoglomus clarus,
claroideoglomus luteum, claroideoglomus claroideum, septoglomus
deserticola, gigaspora margarita, paraglomus brasiliensis) for use as
an inert ingredient (biostimulant) in pesticide formulations applied to
growing crops pre-harvest under 40 CFR 180.920. The petitioner believes
no analytical method is needed because it is not required for an
exemption from the requirement of a tolerance. Contact: RD.
    2. PP IN-11669. (EPA-HQ-OPP-2022-0188). Spring Regulatory Sciences
(6620 Cypresswood Dr., Suite 250, Spring, TX 77379), on behalf Nouryon
Chemicals LLC USA (131 S Dearborn, Suite 1000, Chicago, IL 60603-5566),
requests to establish an exemption from the requirement of a tolerance
for cellulose, ethyl 2-hydroxyethyl ether (CAS Number: 9004-58-4), with
a minimum number average molecular weight of 165,000 daltons, when used
as a pesticide inert ingredient (thickener carrier) in pesticide
formulations under 40 CFR 180.960. The petitioner believes no
analytical method is needed because it is not required for an exemption
from the requirement of a tolerance. Contact: RD

D. New Tolerance Exemptions for Non-Inerts (Except PIPS)

    PP IF8923. (EPA-HQ-OPP-2021 -0781). Vestaron Corporation 600 Park
Offices, Suite 117, Research Triangle, NC 27709, requests to establish
an exemption from the requirement of a tolerance in 40 CFR part 180 for
residues of the insecticide U1-AGTX-Ta1b-QA in or on all food
commodities. The petitioner believes no analytical method is needed
because an exemption from tolerance without numerical limitations is
requested and analytical methods that are normally utilized for
detection of compounds in crop plants are incapable of quantifying the
negligible levels of U1-AGTX-Ta1b-QA that are predicted to be present
in raw or processed agricultural commodities. Contact: BPPD.

E. New Tolerance Exemptions for PIPS

    PP 1E8948. (EPA-HQ-OPP-2022-0205). State University of New York
(SUNY) College of Environmental Science and Forestry, 1 Forestry Dr.,
Syracuse, NY 13210, requests to establish an exemption from the
requirement of a tolerance in 40 CFR part 174 for residues of the
plant-incorporated protectant (PIP) oxalate oxidase enzyme and the
genetic material necessary for its production in or on American
Chestnut (Castanea spp. and their hybrids). The petitioner believes no
analytical method is needed because an analytical method for residues
is not applicable as an exemption from the requirement of a tolerance
is proposed. Contact: BPPD.

F. New Tolerances for Non-Inerts

    1. PP 1F8934. (EPA-HQ-OPP-2021-0641). Syngenta Crop Protection,
LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300,
requests to establish a tolerance in 40 CFR part 180 for residues of
the insecticide isocycloseram in or on almond, hulls at 6 ppm; almond,
oil at 1 ppm; almond, roasted at 0.5 ppm; apple, wet pomace at 1 ppm;
barley, grain at 0.01 ppm; barley, hay at 0.01 ppm; barley, straw at
0.01 ppm; buckwheat, grain at 0.01 ppm; buckwheat, forage at 0.01 ppm;
buckwheat, hay at 0.01 ppm; buckwheat, straw at 0.01 ppm; corn, field,
grain at 0.01 ppm; corn, field, forage at 2 ppm; corn, field, stover at
1.5 ppm; corn, pop, grain at 0.01 ppm; corn, pop, stover at 1.5 ppm;
cotton, gin byproducts at 10 ppm; cottonseed, subgroup 20C at 0.5 ppm;
fruit, citrus, group 10-10 at 0.4 ppm; fruit, pome, group 11-10 at 0.4
ppm; fruit, stone, group 12-12 at 1 ppm; grain, cereal, forage, fodder
and straw, group 16 at 0.01 ppm; nut, tree, group 14-12 at 0.15 ppm;
oat, grain at 0.01 ppm; oat, forage at 0.01 ppm; oat, hay at 0.01 ppm;
oat, straw at 0.01 ppm; onion, bulb, subgroup 3-07A at 0.01 ppm; onion,
green, subgroup 3-07B at 0.9 ppm; orange, citrus oil at 190 ppm;
orange, dried pulp at 9 ppm; orange, peel at 5 ppm; orange, wet pulp at
3 ppm; peas and bean, dried shelled, except soybean, subgroup 6C at
0.01 ppm; peanut, nutmeat at 0.01 ppm; pearl millet, grain at 0.01 ppm;
pearl millet, forage at 0.01 ppm; pearl millet, hay at 0.01 ppm; pearl
millet, straw at 0.01 ppm; peas, hay at 0.01 ppm; peas, vine at 0.01
ppm; plum, prunes at 4 ppm; proso millet, grain at 0.01 ppm; proso
millet, forage at 0.01 ppm; proso millet, hay at 0.01 ppm; proso
millet, straw at 0.01 ppm; rapeseed, subgroup 20A at 0.01 ppm; rye,
grain at 0.01 ppm; rye, forage at 0.01 ppm; rye, hay at 0.01 ppm; rye,
straw at 0.01 ppm; soybean, seed at 0.15 ppm; soybean, hulls at 0.5
ppm; teosinte, grain at 0.01 ppm; teosinte, forage at 0.01 ppm;
teosinte, hay at 0.01 ppm; teosinte, straw at 0.01 ppm; tomato, dried
pomace at 35 ppm; tomato, sun-dried at 3 ppm; tomato, wet pomace at 10
ppm; triticale, grain at 0.01 ppm; triticale, forage at 0.01 ppm;
triticale, straw at 0.01 ppm; vegetables, brassica, head and stem,
group 5-16 at 4 ppm; vegetables, cucurbit, group 9 at 0.1 ppm;
vegetables, fruiting, subgroup 8-10A at 0.5 ppm; vegetables, fruiting,
subgroup 8-10B at 0.6 ppm; vegetables, leafy, group 4-16 at 9 ppm;
vegetables, tuberous and corm, subgroup 1C at 0.01 ppm; wheat, grain at
0.01 ppm; wheat, forage at 0.01 ppm; wheat, hay at 0.01

ppm; wheat, straw at 0.01 ppm; cattle, fat at 0.03 ppm; cattle, kidney
at 0.03 ppm; cattle, liver at 0.05 ppm; cattle, meat at 0.01 ppm;
cattle, meat byproducts at 0.05 ppm; milk at 0.01 ppm; milk, cream at
0.01 ppm; goat, fat at 0.03 ppm; goat, kidney at 0.03 ppm; goat, liver
at 0.05 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.05 ppm;
horse, fat at 0.03 ppm; horse, kidney at 0.03 ppm; horse, liver at 0.05
ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.05 ppm;
sheep, fat at 0.03 ppm; sheep, kidney at 0.03 ppm; sheep, liver at 0.05
ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts at 0.05 ppm;
poultry (muscle, fat, offal) at 0.01 ppm; birds' egg at 0.01 ppm. For
Analytical Method Food: QuEChERS multi-residue method has been
validated and independently validated for post-registration monitoring
of SYN547407 for compliance with MRLs and import tolerances in plant
commodities at an LOQ of 0.01 mg/kg. For Analytical Method Livestock:
QuEChERS multi-residue method (EN 15662:2008) has been validated and
independently validated for post-registration monitoring of SYN547407
in all animal commodities (and SYN549436 and SYN549544 in ruminant
liver and kidney) for compliance with MRLs and import tolerances for
animal commodities at an LOQ of 0.01 mg/kg. Contact: RD.
    2. PP 1E8910. (EPA-HQ-OPP-2022-0139). Dow AgroSciences LLC, 9330
Zionsville Rd., Indianapolis, IN 46268, requests to establish a
tolerance in 40 CFR part 180 for residues of the insecticide
methoxyfenozide in or on coffee at 0.15 ppm and sugarcane at 0.03 ppm.
The Liquid Chromatography with Tandem Mass Spectrometry Detection
(Method GRM 02.25) is used to measure and evaluate the methoxyfenozide
residues. Contact: RD.
    3. PP 1F8940. (EPA-HQ-OPP-2021-0787). SePRO Corporation, 11550
North Meridian Street, Suite 600, Carmel, IN 46032, requests to
establish tolerances in 40 CFR 180.420(a)(2) for residues of the
herbicide fluridone, 1-methyl-3-phenyl-5-[3-(trifluoromethyl)phenyl]-
4(1H)-pyridinone, including its metabolites and degradates, in or on
the raw agricultural commodities of berry and small fruit, group 13-07;
fruit, citrus, group 10-10; fruit, pome, group 11-10; tropical and
subtropical, small fruit, edible peel subgroup 23A; tropical and
subtropical, medium to large fruit, smooth, inedible peel subgroup 24B;
hop, dried cones; nut, tree, group 14-12; and rice, grain at 0.1 ppm
and animal feed, nongrass, group 18 and grass, forage, fodder and hay,
group 17 at 0.15 ppm. The enzyme-linked immunosorbant assay (ELISA),
high performance liquid chromatography with ultraviolet detection
(HLPC/UV), liquid chromatography with tandem mass spectroscopy (LC-
MSMS) and QuEChERS are used to measure and evaluate the chemical
residues. Contact: RD.
    4. PP 1F8950. (EPA-HQ-OPP-2021-0788). Nippon Soda Co., Ltd., Shin-
Ohtemachi Bldg., 2-1, 2-Chome Ohtemachi, Chiyoda-ku, Tokyo, 100-8165,
Japan, requests to establish a tolerance in 40 CFR part 180 for
residues of the fungicide, cyflufenamid, in or on sugar beets at 0.07
ppm. Solvent extraction and analysis by LC/MS/MS are used to measure
and evaluate the chemical Cyflufenamid. Contact: RD.
    5. PP 1F8972. (EPA-HQ-OPP-2022-0134). Tessenderlo Kerley, Inc./
NovaSource, 2910 N 44th Street, Suite 100, Phoenix, AZ 85018 USA,
requests to establish a tolerance in 40 CFR part 180 for residues of
the herbicide linuron in or on alfalfa, forage at 1.0 ppm and alfalfa,
hay at 3.0 ppm. The HPLC-MS/MS residue analytical method is used to
measure and evaluate the chemical linuron. Contact: RD.
    6. PP 1F8978. (EPA-HQ-OPP-2022-0257). Belchim Crop Protection US
Corporation, 2751 Centreville Road, Suit 100, Wilmington, Delaware
19808, requests to establish a tolerance in 40 CFR part 180 for
residues of the herbicide pyridate in or on dry peas and soybeans at
0.05 ppm. The HPLC-MS/MS residue analytical method is used to measure
and evaluate the chemical pyridate and the herbicidal active principle,
CL 9673. Contact: RD.

    Authority: 21 U.S.C. 346a.

    Dated: March 14, 2022.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2022-06046 Filed 3-21-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 42 (Wednesday, March 4, 2015)]
[Rules and Regulations]
[Pages 11535-11536]
[FR Doc No: 2015-04044]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

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

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0328; Directorate Identifier 2014-NE-07-AD;
Amendment 39-18108; AD 2015-04-06]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Rolls-Royce plc (RR) RB211 Trent 875-17, 877-17, 884-17, 884B-17, 892-
17, 892B-17, and 895-17 turbofan engines. This AD requires modification
of the engine by installing upgraded software in the electronic engine
control (EEC) or by removing any EEC that incorporates a software
standard prior to B7.2 and installing an EEC eligible for installation.
This AD was prompted by failure of the intermediate pressure (IP)
turbine disk drive arm and subsequent overspeed and burst of the IP
turbine disk on an RR RB211 Trent turbofan engine. We are issuing this
AD to prevent overspeed of the IP turbine disk, resulting in failure of
the turbine blades or the IP turbine disk and subsequent uncontained
release of the turbine disk and/or blades, which could lead to damage
to the engine and damage to the airplane.

DATES: This AD becomes effective April 8, 2015.

ADDRESSES: For service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England,
DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email:
http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://www.aeromanager.com. You may view this service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0328; 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 mandatory continuing airworthiness information
(MCAI), the regulatory evaluation, any comments received, and other
information. The address for the Docket Office (phone:<PHONE_NUMBER>) is
Document Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; 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 the specified products. The
NPRM was published in the Federal Register on July 11, 2014 (79 FR
40018). The NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    A Trent engine experienced an engine internal fire, caused by
combustion of carbon deposits inside the high/intermediate (HP/IP)
oil vent tubes. The consequent chain of events resulted in the
failure of the IP turbine disk drive arm. Similar engine
architecture exists on Trent 800 series engines.
    This condition, if not corrected, could lead to uncontained
multiple turbine blade failures or an IP turbine disk burst,
possibly resulting in damage to, and reduced control of, the
aeroplane.
    Prompted by these findings, an Intermediate Pressure Turbine
Overspeed System (IPTOS) protection scheme has been developed for
Trent 800 engines installed on Boeing 777 aeroplanes.
    For the reasons described above, this AD requires introduction
of the IPTOS protection function by installation of a new software
standard (B7.2) in the engine electronic controller (EEC), which
will protect against IP turbine overspeed when IP shaft failure is
detected.

    Since we issued the NPRM (79 FR 40018, July 11, 2014), we issued a
supplemental NPRM (79 FR 70475, November 26, 2014) to amend the costs
of compliance and to more clearly state certain compliance
requirements. Since we issued the supplemental NPRM, we changed
paragraph (e) of this AD for clarity.

Comments

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

Request To Modify the Installation Prohibition Paragraph

    American Airlines (AA) requested that we modify the Installation
Prohibition paragraph (f) to allow installation of an EEC with a
software standard earlier than B7.2, and coincident on-wing upgrade of
the software standard to B7.2 or later, but prohibit operation of an
engine that incorporates a software standard earlier than B7.2. AA
states that the EEC original equipment manufacturer does not update the
software as part of a component shop visit.
    We agree. We modified the Installation Prohibition paragraph (f) to
allow installation of an EEC with a software standard earlier than
B7.2, but to prohibit operation of an engine with a software standard
earlier than B7.2.

Conclusion

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

Costs of Compliance

    We estimate that this AD affects about 140 engines installed on
airplanes of U.S. registry. We also estimate that it would take about 2
hours per engine to

comply with this AD. The average labor rate is $85 per hour. Based on
these figures, we estimate the cost of this AD on U.S. operators to be
$23,800.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, 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):

2015-04-06 Rolls-Royce plc Turbofan Engines: Amendment 39-18108;
Docket No. FAA-2014-0328; Directorate Identifier 2014-NE-07-AD.

(a) Effective Date

    This AD becomes effective April 8, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211 Trent 875-17,
877-17, 884-17, 884B-17, 892-17, 892B-17, and 895-17 turbofan
engines.

(d) Reason

    This AD was prompted by failure of the intermediate pressure
(IP) turbine disk drive arm and subsequent overspeed and burst of
the IP turbine disk on an RR RB211 Trent turbofan engine. We are
issuing this AD to prevent overspeed of the IP turbine disk,
resulting in failure of the turbine blades or the IP turbine disk
and subsequent uncontained release of the turbine disk and/or
blades, which could lead to damage to the engine and damage to the
airplane.

(e) Actions and Compliance

    Twelve months after the effective date of this AD, do not
operate any engine with an electronic engine control (EEC) software
standard earlier than B7.2.

(f) Installation Prohibition

    After removing any software standard earlier than B7.2 from an
ECC on any engine, do not operate that engine with any software
standard earlier than B7.2.

(g) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(h) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2014-0051,
dated March 6, 2014, for more information. You may examine the MCAI
in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0328-0003.
    (3) RR Alert Service Bulletin No. RB.211-73-AH001, dated July
17, 2013, which is not incorporated by reference in this AD, can be
obtained from Rolls-Royce plc, using the contact information in
paragraph (h)(4) of this AD.
    (4) For service information identified in this AD, contact
Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby,
England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-
249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; or
Internet: https://www.aeromanager.com.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

(i) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on February 19, 2015.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-04044 Filed 3-3-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Notices] [Pages 52839-52840] [FR Doc No: 2018-22696]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-3918]

Determination of Regulatory Review Period for Purposes of Patent

Extension; AFSTYLA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has

determined the regulatory review period for AFSTYLA and is publishing

this notice of that determination as required by law. FDA has made the

determination because of the submission of an application to the

Director of the U.S. Patent and Trademark Office (USPTO), Department of

Commerce, for the extension of a patent which claims that human

biological product.

DATES: Anyone with knowledge that any of the dates as published (see

the SUPPLEMENTARY INFORMATION section) are incorrect may submit either

electronic or written comments and ask for a redetermination by

December 17, 2018. Furthermore, any interested person may petition FDA

for a determination regarding whether the applicant for extension acted

with due diligence during the regulatory review period by April 16,

2019. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for

more information.

ADDRESSES: You may submit comments as follows. Please note that late,

untimely filed comments will not be considered. Electronic comments

must be submitted on or before December 17, 2018. The https://www.regulations.gov electronic filing system will accept comments until

11:59 p.m. Eastern Time at the end of December 17, 2018. Comments

received by mail/hand delivery/courier (for written/paper submissions)

will be considered timely if they are postmarked or the delivery

service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:

     Federal eRulemaking Portal: https://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted

electronically, including attachments, to https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be

made public, you are solely responsible for ensuring that your comment

does not include any confidential information that you or a third party

may not wish to be posted, such as medical information, your or anyone

else's Social Security number, or confidential business information,

such as a manufacturing process. Please note that if you include your

name, contact information, or other information that identifies you in

the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential

information that you do not wish to be made available to the public,

submit the comment as a written/paper submission and in the manner

detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand delivery/Courier (for written/paper

submissions): Dockets Management Staff (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

     For written/paper comments submitted to the Dockets

Management Staff, FDA will post your comment, as well as any

attachments, except for information submitted, marked and identified,

as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.

FDA-2016-E-3918 for ``Determination of Regulatory Review Period for

Purposes of Patent Extension; AFSTYLA.'' Received comments, those filed

in a timely manner (see ADDRESSES), will be placed in the docket and,

except for those submitted as ``Confidential Submissions,'' publicly

viewable at https://www.regulations.gov or at the Dockets Management

Staff between 9 a.m. and 4 p.m., Monday through Friday.

     Confidential Submissions--To submit a comment with

confidential information that you do not wish to be made publicly

available, submit your comments only as a written/paper submission. You

should submit two copies total. One copy will include the information

you claim to be confidential with a heading or cover note that states

``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will

review this copy, including the claimed confidential information, in

its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be

available for public viewing and posted on https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. If you do not wish

your name and contact information to be made publicly available, you

can provide this information on the cover sheet and not in the body of

your comments and you must identify this information as

``confidential.'' Any information marked as ``confidential'' will not

be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and

other applicable disclosure law. For more information about FDA's

posting of comments to public dockets, see 80 FR 56469, September 18,

2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or

the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in

the heading of this document, into the ``Search'' box and follow the

prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,

Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory

Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.

51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984

(Pub. L. 98-417) and the Generic Animal Drug and Patent Term

Restoration Act (Pub. L. 100-670) generally provide that a patent may

be extended for a period of up to 5 years so long as the patented item

(human drug product, animal drug product, medical device, food

additive, or color additive) was subject to regulatory review by FDA

before the item was marketed. Under these acts, a product's regulatory

review period forms the basis for determining the amount of extension

an applicant may receive.

    A regulatory review period consists of two periods of time: A

testing phase and an approval phase. For human biological products, the

testing phase begins when the exemption to permit the clinical

investigations of the biological product becomes effective and runs

until the approval phase

begins. The approval phase starts with the initial submission of an

application to market the human biological product and continues until

FDA grants permission to market the biological product. Although only a

portion of a regulatory review period may count toward the actual

amount of extension that the Director of USPTO may award (for example,

half the testing phase must be subtracted as well as any time that may

have occurred before the patent was issued), FDA's determination of the

length of a regulatory review period for a human biological product

will include all of the testing phase and approval phase as specified

in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human biologic product AFSTYLA

(Antihemophilic Factor (Recombinant), Single Chain). AFSTYLA is

indicated in children and adults with hemophilia A (congenital Factor

VIII deficiency) for: (1) On-demand treatment and control of bleeding

episodes, (2) routine prophylaxis to reduce the frequency of bleeding

episodes, and (3) perioperative management of bleeding. Subsequent to

this approval, the USPTO received a patent term restoration application

for AFSTYLA (U.S. Patent No. 7,041,635) from SK Chemicals Co, LTD., and

the USPTO requested FDA's assistance in determining this patent's

eligibility for patent term restoration. In a letter dated August 1,

2017, FDA advised the USPTO that this human biological product had

undergone a regulatory review period and that the approval of AFSTYLA

represented the first permitted commercial marketing or use of the

product. Thereafter, the USPTO requested that FDA determine the

product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for

AFSTYLA is 1,734 days. Of this time, 1,371 days occurred during the

testing phase of the regulatory review period, while 363 days occurred

during the approval phase. These periods of time were derived from the

following dates:

    1. The date an exemption under section 505(i) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 28,

2011. FDA has verified the applicant's claim that the date the

investigational new drug application became effective was on August 28,

2011.

    2. The date the application was initially submitted with respect to

the human biological product under section 351 of the Public Health

Service Act (42 U.S.C. 262): May 29, 2015. FDA has verified the

applicant's claim that the biologics license application (BLA) for

AFSTYLA (BLA 125591) was initially submitted on May 29, 2015.

    3. The date the application was approved: May 25, 2016. FDA has

verified the applicant's claim that BLA 125591 was approved on May 25,

2016.

    This determination of the regulatory review period establishes the

maximum potential length of a patent extension. However, the USPTO

applies several statutory limitations in its calculations of the actual

period for patent extension. In its application for patent extension,

this applicant seeks 1,047 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are

incorrect may submit either electronic or written comments and, under

21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as

specified in Sec.  60.30 (21 CFR 60.30), any interested person may

petition FDA for a determination regarding whether the applicant for

extension acted with due diligence during the regulatory review period.

To meet its burden, the petition must comply with all the requirements

of Sec.  60.30, including but not limited to: Must be timely (see

DATES), must be filed in accordance with Sec.  10.20, must contain

sufficient facts to merit an FDA investigation, and must certify that a

true and complete copy of the petition has been served upon the patent

applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,

1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to https://www.regulations.gov at

Docket No. FDA-2013-S-0610. Submit written petitions (two copies are

required) to the Dockets Management Staff (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 12, 2018.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2018-22696 Filed 10-17-18; 8:45 am]

 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48119-48121]
[FR Doc No: 2017-22269]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2011-0064]

Forging Machines; 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.

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

SUMMARY: OSHA is soliciting public comments concerning its proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements contained in the Forging Machines
Standard.

DATES: Comments must be submitted (postmarked, sent, or received) by
December 15, 2017.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, 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 these methods, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2011-0064,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Docket Office's normal business hours, 10:00 a.m.
to 3:00 p.m., ET.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2011-0064). 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 materials 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<EMAIL_ADDRESS>or
Todd Owen<EMAIL_ADDRESS>telephone<PHONE_NUMBER>.

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 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).
    The following sections describe who uses the information collected
under each requirement, as well as how they use it. The purpose of
these requirements is to reduce employees' risk of death or serious
injury by ensuring that forging machines used by them are in safe
operating condition, and that employees are able to clearly and
properly identify manually operated valves and switches.
    Inspection of Forging Machines, Guards, and Point-of-Operation
Protection Devices (paragraphs (a)(2)(i) and (a)(2)(ii)). Paragraph
(a)(2)(i) requires employers to establish periodic and regular
maintenance safety checks, and to develop and maintain a certification
record of each inspection. The certification record must include the
date of inspection, the signature of the person who performed the
inspection, and the serial number (or other identifier) of the forging
machine inspected. Under paragraph (a)(2)(ii), employers are to
schedule regular and frequent inspections of guards and point-of-
operation protection devices, and prepare a certification record of
each inspection that contains the date of the inspection, the signature
of the person who performed the inspection, and the serial number (or
other identifier) of the equipment inspected. These inspection
certification records provide assurance to employers, employees, and
OSHA compliance officers that forging machines, guards, and point-of-
operation protection devices have been inspected, and will operate
properly and safely, to prevent impact injury and death to employees
during forging operations. These records also provide the most
efficient means for the compliance officers to determine that an
employer is complying with the Standard.
    Identification of Manually Controlled Valves and Switches
(paragraphs (c), (h)(3), (i)(1) and (i)(2)). These paragraphs require
proper and clear identification of manually operated valves and
switches on presses, upsetters, boltheading equipment, and rivet-making
machines, respectively. Marking valves and switches provide information
to employees to ensure that they operate the forging machines correctly
and safely.

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 Forging Machines Standard (29
CFR 1910.218). The Agency is requesting an increase in its current
burden hours from 187,264 hours to 192,053 hours, a total increase of
4,789 hours. The adjustment is primarily due to minor modifications in
calculating burden 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: Forging Machines (29 CFR 1910.218).
    OMB Number: 1218-0228.
    Affected Public: Business or other for-profits.
    Number of Respondents: 27,700.
    Total Responses: 1,440,400.
    Frequency of Responses: Biweekly.
    Average Time per Response: Various.
    Estimated Total Burden Hours: 192,053.
    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 materials must identify the Agency
name and the OSHA docket number for the ICR (Docket No. OSHA-2011-
0064). You may supplement submissions by uploading documents
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
and 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
dates 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

    Loren Sweatt, Deputy 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. 5-2007 (72 FR
31159).

    Signed at Washington, DC, on October 10, 2017.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2017-22269 Filed 10-13-17; 8:45 am]
 BILLING CODE 4510-26-P