[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42863-42864]
[FR Doc No: 2020-15295]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-1066; FDA-2019-E-1067; and FDA-2019-E-1068]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ISTENT INJECT TRABECULAR
MICRO-BYPASS SYSTEM and is publishing this notice of that determination
as required by law. FDA has made the determination because of the
submission of applications to the Director of the U.S. Patent and
Trademark Office (USPTO), Department of Commerce, for the extension of
patents which claim that medical device.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by September 14,
2020. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by January 11, 2021.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 14, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 14, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2019-E-1066, FDA-2019-E-1067; and FDA-2019-E-1068 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://

www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (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 medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device ISTENT INJECT
TRABECULAR MICRO-BYPASS SYSTEM. ISTENT INJECT TRABECULAR MICRO-BYPASS
SYSTEM is indicated in conjunction with cataract surgery for the
reduction of intraocular pressure in adult patients with mild to
moderate primary open angle glaucoma. Subsequent to this approval, the
USPTO received patent term restoration applications for ISTENT INJECT
TRABECULAR MICRO-BYPASS SYSTEM (U.S. Patent Nos. 7,867,186; 9,301,875;
and 9,597,230) from Glaukos Corporation, and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated June 21, 2019, FDA advised the USPTO
that this medical device had undergone a regulatory review period and
that the approval of ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM
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
ISTENT INJECT TRABECULAR MICRO-BYPASS SYSTEM is 2,508 days. Of this
time, 2,330 days occurred during the testing phase of the regulatory
review period, while 178 days occurred during the approval phase. These
periods of time were derived from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: August 11, 2011. FDA has verified the
applicant's claim that the date the investigational device exemption
for human tests to begin, as required under section 520(g) of the FD&C
Act became effective, was August 11, 2011.
    2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): December
26, 2017. The applicant claims December 21, 2017, as the date the
premarket approval application (PMA) for ISTENT INJECT TRABECULAR
MICRO-BYPASS SYSTEM (PMA 170043) was initially submitted. However, FDA
records indicate that PMA 170043 was submitted on December 26, 2017.
    3. The date the application was approved: June 21, 2018. FDA has
verified the applicant's claim that PMA 170043 was approved on June 21,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,345 days, 496 days, or 1,783 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: July 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15295 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Proposed Rules]
[Pages 53372-53376]
[FR Doc No: 2011-21676]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0082; FRL-8884-9]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

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

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SUMMARY: This document announces the Agency's receipt of several
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 September 26, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

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.
Potentially affected entities may include, but are not limited to:
    [emsp14]Crop production (NAICS code 111).

    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed at the end of the pesticide petition
summary of interest.

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 e-mail. 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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    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 its receipt of several 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 part 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 the data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support 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), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.
New Tolerance
    1. PP 1E7823. (EPA-HQ-OPP-2011-0113). Taminco, Inc., Two Windsor
Plaza, Suite 411, Allentown, PA, requests to establish a tolerance in
40 CFR part 180 for residues of the fungicide thiram, in or on avocado
at 8 parts per million (ppm). Detection and quantitation for thiram (as
carbon disulfide (CS2)) were conducted using a gas chromatograph (GC)
equipped with a mass spectral detector for determination of CS2. The
limit of quantitation (LOQ) was 0.05 ppm reported CS2 evolved. Contact:
Shaunta Hill,<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>    2. PP 1E7882. (EPA-HQ-OPP-2011-0569). Interregional Research
Project Number 4 (IR-4), 500 College Rd. East, Suite 201W, Princeton,
NJ 08540, requests to establish tolerances in 40 CFR part 180 for
residues of the herbicide clopyralid: (3,6-dichloro-2-
pyrindinecarboxylic acid), in or on apple at 0.05 ppm; brassica, leafy
greens, subgroup 5B at 5.0 ppm; rapeseed subgroup 20A, except gold of
pleasure, seed at 3.0 ppm; rapeseed subgroup 20A, except gold of
pleasure, meal at 6.0 ppm; and rapeseed subgroup 20A, except gold of
pleasure, forage at 3.0 ppm. An adequate analytical method is available
for enforcement of the tolerance expression in or on these commodities.
Dow AgroSciences Method No. ACR 79.5 was utilized to determine residues
of clopyralid in apples, fruits and apple fractions in support of the
proposed tolerance. This method determines clopyralid as the methyl
ester by gas chromatography using electron capture detection (GC/ECD).
This method has been successfully validated by EPA and has been
published in FDA's Pesticide Analytical Manual, Volume II (PAM II).
Contact: Laura Nollen,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    3. PP 1E7883. (EPA-HQ-OPP-2011-0563). Interregional Research
Project Number 4 (IR-4), 500 College Rd. East, Suite 201W, Princeton,
NJ 08540, requests to establish tolerances in 40 CFR part 180 for
residues of the herbicide rimsulfuron: N-((4,6-dimethoxypyrimidin-2-yl)
aminocarbonyl)-3-(ethylsulfonyl)-2-pyridinesulfonamide, in or on
chicory, roots at 0.01 ppm and chicory, tops at 0.01 ppm. Adequate
analytical methodology, high-pressure liquid chromatography (HPLC) with
electrospray ionization-tandem mass

spectrometry (ESI-MS/MS) detection, is available for enforcement
purposes. Contact: Andrew Ertman,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    4. PP 1E7885. (EPA-HQ-OPP-2011-0564). Interregional Research
Project Number 4 (IR-4), 500 College Rd. East, Suite 201W, Princeton,
NJ 08540, requests to establish tolerances in 40 CFR part 180 for
residues of the herbicide thifensulfuron methyl [Methyl-3-[[[[(4-
methoxy-6-methyl-1,3,5-triazin-2-yl) amino]carbonyl]amino] sulfonyl]-2-
thiophenecarboxylate], in or on chicory, roots at 0.01 ppm and chicory,
tops at 0.01 ppm, for each analyte. Adequate analytical methodology,
HPLC with ESI-MS/MS detection, is available for enforcement purposes.
Contact: Andrew Ertman,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    5. PP 0F7805. (EPA-HQ-OPP-2010-1079). Syngenta Crop Protection,
Inc., Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC
27419, requests to establish tolerances in 40 CFR part 180 for residues
of the insecticide thiamethoxam [3-[(2-chloro-5-
thiazolyl)methyl]tetrahydro-5-methyl-N-nitro-4H-1,3,5-oxadiazin-4-
imine] (CAS Reg. No. 153719-23-4) and its metabolite [N-(2-chloro-
thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine], in or on buckwheat,
grain at 0.02 ppm; buckwheat, forage at 0.50 ppm; buckwheat, hay at
0.02 ppm; buckwheat, straw at 0.02 ppm; oat, grain at 0.02 ppm; oat,
forage at 0.50 ppm, oat, hay at 0.02 ppm; oat, straw at 0.02 ppm; pearl
millet, grain at 0.02 ppm; pearl millet, forage at 0.02 ppm; pearl
millet, stover at 0.02 ppm; proso millet, grain at 0.02 ppm; proso
millet, forage at 0.02 ppm; proso millet, stover at 0.02 ppm; proso
millet, straw at 0.02 ppm; rye, grain at 0.02 ppm; rye, forage at 0.50
ppm; rye, straw at 0.02 ppm; teosinte, grain at 0.02 ppm; teosinte,
forage at 0.10 ppm; teosinte, stover at 0.05 ppm; triticale, grain at
0.02 ppm; triticale, forage at 0.05 ppm; triticale, hay at 0.02 ppm;
triticale, straw at 0.02 ppm; wild rice, grain at 0.02 ppm. This
revised Notice of Filing is an amendment to reflect specific proposed
grain tolerance and their respective animal feed commodities listed in
the revised Section F of the tolerance petition, PP0F7805. Syngenta
Crop Protection, Inc. has submitted practical analytical methodology
for detecting and measuring levels of thiamethoxam in or on raw
agricultural commodities. This method is based on crop specific cleanup
procedures and determination by liquid chromatography with either
ultraviolet (UV) or MS detections. Contact: Gene Benbow, (703) 347-
0235, e-mail address<EMAIL_ADDRESS>    6. PP 1F7873. (EPA-HQ-OPP-2011-0578). E. I. du Pont de Nemours and
Company, 1007 Market St., Wilmington, DE 19898-0001, requests to
establish tolerances in 40 CFR part 180 for residues of the combined
residues of the insecticide indoxacarb, [(S)-methyl-7-chloro-2,5-
dihydro-2-[[(methoxycarbonyl) [4-(trifluoromethoxy)-
phenyl]amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-
carboxylate], its R-enantiomer [(R)-methyl 7-chloro-2,5-dihydro-2-
[[(methoxycarbonyl) [4-(trifluoromethoxy) phenyl]amino]carbonyl]indeno
[1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate] and the metabolites:
     IN-JT333: Methyl 7-chloro-2,5-dihydro-2-[[[4-
(trifluoromethoxy)phenyl]-amino]carbonyl]indeno[1,2-
e][1,3,4]oxadiazine-4a(3H)-carboxylate
     IN-KT319: (E)-methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-
[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]-
carbonyl]hydrazono]-1H-indene-2-carboxylate
     IN-JU873: Methyl 5-chloro-2,3-dihydro-2-hydroxy-1-[[[[4-
(triflurormethoxy)-phenyl]amino]carbonyl]hydrazono]-1H-indene-2-
carboxylate
     IN-KG433: Methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-
[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-
hydrazono]-1H-indene-2-carboxylate, and
     IN-KB687: Methyl [4-(trifluoromethoxy)phenyl]carbamate, in
or on egg at 0.2 ppm; poultry, fat at 0.2 ppm; poultry, meat at 0.06
ppm; and poultry, meat byproducts at 0.06 ppm. The plant residue
enforcement method detects and quantitates indoxacarb in various
matrices including sweet corn, lettuce, tomato, broccoli, apple, grape,
cottonseed, tomato, peanut, and soybean commodity samples by HPLC UV.
The limit of quantitation in the method allows monitoring of crops with
indoxacarb residues at or above the levels proposed in these
tolerances. Contact: Julie Chao,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    7. PP 1F7886. (EPA-HQ-OPP-2011-0593). Valent U.S.A. Corporation,
1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596, requests to
establish a tolerance in 40 CFR part 180 for residues of the herbicide
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or
on pea and bean (except soybean), dried shelled, crop subgroup 6C at
0.1 ppm for seed; rapeseed, crop subgroup 20A at 0.35 ppm for seed;
rapeseed, crop subgroup 20A at 0.04 ppm for meal; and rapeseed, crop
subgroup 20A at 0.02 ppm for refined oil; sunflower, crop subgroup 20B
at 0.5 ppm for seed; sunflower, crop subgroup 20B at 0.03 ppm for meal;
sunflower, crop subgroup 20B at 0.02 ppm for refined oil; wheat at 0.35
ppm for grain; wheat at 5 ppm for straw; wheat at 0.02 ppm for forage
(pre-emergence); wheat at 0.02 ppm for hay (pre-emergence); wheat at
0.35 ppm for bran; wheat at 0.05 ppm for flour; wheat at 0.35 ppm for
germ; wheat at 0.08 ppm for middlings; wheat at 0.11 ppm for shorts;
and wheat at 110 ppm for aspirated grain fractions. Practical
analytical methods for detecting and measuring levels of flumioxazin
have been developed and validated in/on all appropriate agricultural
commodities and respective processing fractions. The LOQ of flumioxazin
in the methods is 0.02 ppm which will allow monitoring of food with
residues at the levels proposed for the tolerances. Contact: Bethany
Benbow,<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>Amended Tolerance
    1. PP 1E7882. (EPA-HQ-OPP-2011-0569). Interregional Research
Project Number 4 (IR-4), 500 College Rd. East, Suite 201W, Princeton,
NJ 08540, requests to remove the tolerances in 40 CFR 180.431 for
residues of the herbicide clopyralid: (3,6-dichloro-2-
pyrindinecarboxylic acid), in or on canola, seed at 3.0 ppm; canola,
meal at 6.0 ppm; flax, seed at 3.0 ppm; flax, meal at 6.0 ppm;
rapeseed, seed at 3.0 ppm; rapeseed, forage at 3.0 ppm; and mustard
greens at 5.0 ppm upon the approval of the aforementioned tolerances
under ``New Tolerance''. Contact: Laura Nollen,<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>    2. PP 1F7886. (EPA-HQ-OPP-2011-0593). Valent U.S.A. Corporation,
1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596, requests to
remove the tolerances in 40 CFR 180.568 for residues of the herbicide
flumioxazin, 2-[7-fluoro-3,4dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole1,3(2H)-dione, in or on
beans, dry seed at 0.05 ppm upon the approval of the tolerance on Crop
Subgroup 6C under ``New Tolerance''. Contact: Bethany Benbow, (703)
347-8072, e-mail address<EMAIL_ADDRESS>New Tolerance Exemption
    1. PP 1E7858. (EPA-HQ-OPP-2011-0525). Joint Inerts Task Force,
Cluster

Support Team 5, EPA Company Number 84941, c/o CropLife America, 1156
15th St., NW., Suite 400, Washington, DC 20005, requests to establish
an exemption from the requirement of a tolerance for residues of
following descriptor and compounds under 40 CFR 180.910 pre- and post-
harvest uses not to exceed 7% in pesticide formulations when used as a
pesticide inert: [[[alpha]]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-
[[omega]]-hydroxypoly (oxyethylene) produced by the condensation of 1
mole of p-(1,1,3,3- tetramethylbutyl) phenol with a range of 1-14 or
30-70 moles of ethylene oxide: If a blend of products is used, the
average range number of moles of ethylene oxide reacted to produce any
product that is a component of the blend shall be in the range of 1-14
or 30-70 (Chemical Name (CAS No.)): Poly (oxy-1, 2-ethanediyl),
[alpha]-[4-(1,1,3,3-tetramethylbutyl) phenyl]-[omega]-hydroxy- (9036-
19-5); Poly (oxy-1, 2-ethanediyl), [alpha]-[4-(1,1,3,3-
tetramethylbutyl) phenyl]-[omega]-hydroxy-] (9002-93-1). The petitioner
believes no analytical method is needed because this information is not
required for the establishment of a tolerance exemption. Contact: Kerry
Leifer,<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>    2. PP 1E7860. (EPA-HQ-OPP-2011-0526). Joint Inerts Task Force,
Cluster Support Team 9, EPA Company Number 84943, c/o CropLife America,
1156 15th St., NW., Suite 400, Washington, DC 20005, requests to
establish an exemption from the requirement of a tolerance for residues
of Nonylphenol Ethoxylate Phosphate and Sulfate Derivatives (NPEPSD)
under the following descriptors and compounds under 40 CFR 180.910
(pre- and post-harvest uses) and 40 CFR 180.930 (animal uses) not to
exceed 7% in pesticide formulations when used as a pesticide inert
ingredient:
    NPE Phosphate Derivatives (NPEPD): [alpha]-(p-Nonylphenyl)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and mono
hydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4-14 moles or 30 moles (Chemical
Name (CAS No.)): Poly (oxy-1, 2-ethanediyl), [alpha]-(nonylphenyl)-
[omega]-hydroxy-, phosphate (51811-79-1); Ethanol, 2-amino-, compd.
with [alpha]-(nonylphenyl)-[omega]-hydroxypoly(oxy-1,2-ethanediyl)
phosphate (59139-23-0); Poly(oxy-1,2-ethanediyl), [alpha]-
(nonylphenyl)-[omega]-hydroxy-, phosphate, magnesium salt Poly(oxy-1,2-
ethanediyl), [alpha]-(nonylphnyl)-[omega]-hydroxy-, phosphate,
magnesium salt (67922-57-0); Poly(oxy-1,2-ethanediyl), [alpha]-(4-
nonylphenyl)-[omega]-hydroxy-, phosphate, sodium salt (68412-53-3);
Poly(oxy-1,2-ethanediyl), [alpha]-(4-nonylphenyl)-[omega]-hydroxy-,
phosphate, sodium salt (68553-97-9); Poly(oxy-1,2-ethanediyl), [alpha]-
(4-nonylphenyl)-[omega]-hydroxy-, phosphate, sodium salt (68553-97-9);
Poly(oxy-1,2-ethanediyl), [alpha]-(nonylphenyl)-[omega]-hydroxy-,
branched, phosphate, sodium salt (68954-84-7); Poly(oxy-1,2-
ethanediyl), [alpha]-(nonylphenyl)-[omega]-hydroxy-, phosphate, calcium
salt (99821-14-4); Poly(oxy-1,2-ethanediyl), [alpha]-(4-nonylphenyl)-
[omega]-hydroxy-, branched, phosphates (152143-22-1); Poly(oxy-1,2-
ethanediyl), [alpha]-(4-nonylphenyl)-[omega]-hydroxy-, phosphate
(51609-41-7); Poly(oxy-1,2-ethanediyl), [alpha]-(nonylphenyl)-[omega]-
hydroxy-, phosphate, sodium salt (37340-60-6); Poly(oxy-1,2-
ethanediyl), [alpha]-phosphono-[omega]-(4-nonylphenoxy)-, dipotassium
salt (106151-63-7); Poly(oxy-1,2-ethanediyl), [alpha]-(nonylphenyl)-
[omega]-hydroxy-, branched, phosphates, potassium salts (68584-47-4);
Poly(oxy-1,2-ethanediyl), [alpha]-(nonylphenyl)-[omega]-hydroxy-,
phosphate-, potassium salt (52503-15-8); Polyphosphoric acids, esters
with polyethylene glycol nonylphenyl ether (68458-49-1).
    NPE Sulfate Derivatives (NPESD): [alpha]-(p-nonylphenol)-[omega]-
hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium,
potassium, sodium, and zinc salts the nonyl group is propylene trimer
isomer and the poly(oxyethylene) content averages 4 moles (Chemical
Name (CAS No.)): Poly (oxy-1, 2-ethanediyl), [alpha]-sulfo-[omega]-
(nonylphenoxy), sodium salt (9014-90-8); Poly (oxy-1, 2-ethanediyl),
[alpha]-sulfo-[omega]-(nonylphenoxy), ammonium salt (9051-57-4); Poly
(oxy-1, 2-ethanediyl), [alpha]-sulfo-[omega]-(nonylphenoxy), acid
(9081-17-8); Poly (oxy-1, 2-ethanediyl), [alpha]-sulfo-[omega]-
(nonylphenoxy), branched, ammonium salt (68649-55-8); Poly (oxy-1, 2-
ethanediyl), [alpha]-sulfo-[omega]-(nonylphenoxy), branched (68891-33-
8).
    The petitioner believes no analytical method is needed because this
information is not required for the establishment of a tolerance
exemption. Contact: Kerry Leifer,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    3. PP 1E7875. (EPA-HQ-OPP-2011-0583). Akzo Nobel Surface Chemistry,
LLC, 909 Mueller Ave., Chattanooga, TN 37406, requests to establish an
exemption from the requirement of a tolerance for residues of 2-
propanoic acid, 2-methyl-, polymer with methyl 2-methyl-2-propenoate
and alpha-(2-methyl-1-oxo-2-propen-1-yl)-omega-methoxypoly(oxy-1,2-
ethanediyl, graft (CAS No. 111740-36-4) when used as a pesticide inert
ingredient as a dispersant in pesticide formulations under 40 CFR
180.960. This petition requests the elimination of the need to
establish a maximum permissible level for residues of methacrylic acid-
methyl methacrylate-polyethylene glycol monomethyl ether methacrylate
graft copolymer in or on all raw agricultural commodities. The
petitioner believes no analytical method is needed because this
information is generally not required when all criteria for polymer
exemption per 40 CFR 723.250 are met. Akzo Nobel is petitioning for an
exemption from the requirement of a tolerance without any numerical
limitations. Contact: Alganesh Debesai,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    4. PP 1E7879. (EPA-HQ-OPP-2011-0587). Loveland Products, Inc., 3005
Rocky Mountain Ave., Loveland, CO 80538, requests to establish an
exemption from the requirement of a tolerance for residues of 2-
hydroxy-4-methoxybenzophenone (common name) (HMB), (CAS nomenclature:
methanone, (2-hydroxy-4-methoxyphenyl) phenyl-; CAS No. 131-57-7) when
used as a pesticide inert ingredient as a UV-stabilizer at no more than
25% in pesticide formulations under 40 CFR 180.920 (pre-harvest uses).
This petition proposes to establish exemptions from the requirement of
a tolerance for residues of 2-hydroxy-4-methoxybenzophenone (HMB) in or
on all raw agricultural commodities. The petitioner believes no
analytical method is needed because the petition proposes to establish
exemptions from the requirement of a tolerance and no analytical method
is generally required for establishment of a tolerance exemption.
Contact: Deirdre Sunderland,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    5. PP 1E7880. (EPA-HQ-OPP-2011-0606). Clariant Corporation, 4000
Monroe Rd., Charlotte, NC 28205, requests to establish an exemption
from the requirement of a tolerance for residues of Poly(oxy-1,2-
ethanediyl), [alpha]-hydro-[omega]-hydroxy-, Mn 17000 amu and CAS No.
25322-68-3 under 40 CFR 180.960 when used as a pesticide inert
ingredient in pesticide formulations as a solubilizer without
limitations. Clariant Corporation is petitioning that Poly(oxy-1,2-
ethanediyl), [alpha]-hydro-[omega]-hydroxy- be exempt from the
requirement of a tolerance based upon the definition of a low-risk
polymer under 40 CFR 723.250. Therefore, an analytical method to
determine residues on treated crops is

not relevant. Contact: Elizabeth Fertich,<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: August 17, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-21676 Filed 8-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 18 (Friday, January 27, 2023)]
[Notices]
[Pages 5332-5334]
[FR Doc No: 2023-01712]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0720; FRL-10524-01-OCSPP]

Pesticide Registration Review; Pesticide Dockets Opened for
Review and Comment; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of the EPA's
preliminary work plans for the following chemicals: abscisic acid,
Bacillus thuringiensis Cry1Ac in MON 87701 soybean, fluensulfone. With
this document, the EPA is opening the public comment period for
registration review for these chemicals.

DATES: Comments must be received on or before March 28, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0720, 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 and visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information, contact: The Chemical Review
Manager for the pesticide of interest identified in Table 1 in Unit IV.
    For general questions on the registration review program, contact:
Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified in Table 1 in Unit IV.

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

    1. Submitting CBI. Do not submit this information to the 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 the 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/commenting-epa-dockets.
    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. Background

    Registration review is the EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. Registration review dockets contain
information that will assist the public in understanding the types of
information and issues that the agency may consider during the course
of registration reviews. As part of the registration review process,
the Agency has completed preliminary workplans for all pesticides
listed in Table 1 in Unit IV. Through this program, the EPA is ensuring
that each pesticide's registration is based on current scientific and
other knowledge, including its effects on human health and the
environment.

III. Authority

    The EPA is conducting its registration review of the chemicals
listed in Table 1 in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. Registration Reviews

A. What action is the Agency taking?

    A pesticide's registration review begins when the agency
establishes a docket for the pesticide's registration review case and
opens the docket for public review and comment. Pursuant to 40 CFR
155.50, this notice announces the availability of the EPA's preliminary
work plans for the pesticides shown in Table 1 and opens a 60-day
public comment period on the work plans.

                     Table 1--Preliminary Work Plans Being Made Available for Public Comment
----------------------------------------------------------------------------------------------------------------
                                                                          Chemical review manager and contact
  Registration review case name and No.          Docket ID No.                        information
----------------------------------------------------------------------------------------------------------------
Abscisic Acid Case Number 6310..........  EPA-HQ-OPP-2022-0784.......  Andrew Queen, [email protected], (202)
                                                                        566-1539.
Bacillus thuringiensis Cry1Ac in MON      EPA-HQ-OPP-2022-0543.......  Michael Glikes, [email protected],
 87701 Soybean Case Number 6600.<PHONE_NUMBER>.
Fluensulfone Case Number 7464...........  EPA-HQ-OPP-2022-0438.......  Kelsi Grogan, [email protected], (202)
                                                                        566-2228.
----------------------------------------------------------------------------------------------------------------

B. Docket Content

    The registration review docket contains information that the agency
may consider in the course of the registration review. The agency may
include information from its files including, but not limited to, the
following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
agency is asking that interested persons identify any additional
information they believe the agency should consider during the
registration reviews of these pesticides. The agency identifies in each
docket the areas where public comment is specifically requested, though
comment in any area is welcome.
    The registration review final rule at 40 CFR 155.50(b) provides for
a minimum 60-day public comment period on all preliminary registration
review work plans. This comment period is intended to provide an
opportunity for public input and a mechanism for initiating any
necessary changes to a pesticide's workplan. All comments should be
submitted using the methods in ADDRESSES and must be received by the
EPA on or before the closing date. These comments will become part of
the docket for the pesticides included in Table 1 in Unit IV. Comments
received after the close of the comment period will be marked ``late.''
The EPA is not required to consider these late comments.
    The agency will carefully consider all comments received by the
closing date and may provide a ``Response to Comments Memorandum'' in
the docket. The final registration review work plan will explain the
effect that any comments had on the final work plan and provide the
agency's response to significant comments.
    Background on the registration review program is provided at:
https://www.epa.gov/pesticide-reevaluation.
    Authority: 7 U.S.C. 136 et seq.

    Dated: January 23, 2023.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2023-01712 Filed 1-26-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 20, 2009 (Volume 74, Number 53)]
[Notices]
[Page 11974-11975]
[DOCID:fr20mr09-90]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0004]

1,3-Butadiene Standard; 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 solicits comments concerning its proposal to extend OMB
approval of the information collection requirements contained in the
1,3-Butadiene Standard (29 CFR 1910.1051).

DATES: Comments must be submitted (postmarked, sent, or received) by
May 19, 2009.

ADDRESSES: Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions Online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2009-0004,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the ICR (OSHA-2009-0004). All comments, including any
personal information you provide, are placed in the public docket
without change, and may be made available Online at http://
www.regulations.gov. For further information on submitting comments see
the ``Public Participation'' heading in the section of this notice
titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the

address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may contact Jamaa Hill at the
address below to obtain a copy of the Information Collection Request
(ICR).

FOR FURTHER INFORMATION CONTACT: Jamaa N. Hill or Todd Owen,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
Room N-3609, 200 Constitution Avenue, NW., Washington, DC 20210;
telephone<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 (PRA-95) (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 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).
    In this regard, the 1,3-Butadiene Standard requires employers to
monitor employee exposure to 1,3-Butadiene; develop and maintain
compliance and exposure-goal programs if employee exposures to 1,3-
Butadiene are above the Standard's permissible exposure limits or
action level; label respirator filter elements to indicate the date and
time it is first installed on the respirator; establish medical
surveillance programs to monitor employee health, and to provide
employees with information about their exposures and the health effects
of exposure to 1,3-Butadiene.

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 OMB to extend their approval of the information
collection requirements contained in the 1,3 Butadiene Standard. OSHA
will summarize the comments submitted in response to this notice, and
will include this summary to OMB.
    Type of Review: Extension of currently approved information
collection requirements.
    Title: 1,3 Butadiene Standard (29 CFR 1910.1051).
    OMB Number: 1218-0170.
    Affected Public: Business or other for-profits; Federal government;
State, local and tribal governments.
    Number of Respondents: 115.
    Frequency: On occasion.
    Total Responses: 3,532.
    Average Time per Response: Time per response ranges from 15 seconds
(.004 hour) to write the date and time on each new cartridge label to 2
hours to complete a referral medical examination.
    Estimated Total Burden Hours: 955.
    Estimated Cost (Operation and Maintenance): $95,288.

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

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2009-0004). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled
``Addresses''). The additional materials must clearly identify your
electronic comments by your name, date, and the docket number so the
Agency can attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available at the Web site's ``User
Tips'' link. Contact the OSHA Docket Office for information about
materials not available through the Web site, and for assistance in
using the Internet to locate docket submissions.

V. Authority and Signature

    Donald G. Shalhoub, 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 31160).

    Signed at Washington, DC, this 17th day of March 2009.
Donald G. Shalhoub,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. E9-6133 Filed 3-19-09; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register: November 4, 2008 (Volume 73, Number 214)]
[Notices]
[Page 65714]
[DOCID:fr04no08-91]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Commercial Air Tour Limitations in the
Grand Canyon National Park Special Flight Rules Area

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection, Certain organizations may apply to perform
certification functions on behalf of the FAA. The FAA uses the
information gathered from Grand Canyon National Park air tour operators
to monitor their compliance with the Federal regulations.

DATES: Please submit comments by January 5, 2009.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Commercial Air Tour Limitations in the Grand Canyon National
Park Special Flight Rules Area.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0653.
    Form(s): There are no FAA Forms associated with this collection.
    Affected Public: A total of 15 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 73 minutes per
response.
    Estimated Annual Burden Hours: An estimated 94 hours annually.
    Abstract: The FAA uses the information gathered from Grand Canyon
National Park air tour operators to monitor their compliance with the
Federal regulations.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on October 27, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. E8-26289 Filed 11-3-08; 8:45 am]

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