40594 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Proposed Rules 

PART 7—RULES OF PRACTICE IN 

FILINGS PURSUANT TO THE 

PROTOCOL RELATING TO THE 

MADRID AGREEMENT CONCERNING 

THE INTERNATIONAL REGISTRATION 

OF MARKS 

■ 3. The authority citation for 37 CFR 

part 7 continues to read as follows: 

Authority: 15 U.S.C. 1123, 35 U.S.C. 2, 

unless otherwise noted. 

■ 4. Amend § 7.37 by revising paragraph 

(h) to read as follows: 

§ 7.37 Requirements for a complete 

affidavit or declaration of use in commerce 

or excusable nonuse. 

* * * * * 

(h) The Office may require the holder 

to furnish such information, exhibits, 

affidavits or declarations, and such 

additional specimens as may be 

reasonably necessary to the proper 

examination of the affidavit or 

declaration under section 71 of the Act 

or for the Office to assess and promote 

the accuracy and integrity of the 

register. 

* * * * * 

Dated: June 16, 2016. 

Michelle K. Lee, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2016–14791 Filed 6–21–16; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 174 and 180 

[EPA–HQ–OPP–2015–0032; FRL–9947–32] 

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. 

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 July 22, 2016. 

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 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. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/

dockets. 

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (BPPD) 

(7511P), main telephone number: (703) 

305–7090; email address: 

BPPDFRNotices@epa.gov., Susan Lewis, 

Registration Division (RD) (7505P), main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

The mailing address for each contact 

person is: 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 pesticide petition 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). 

If you have any questions regarding 

the applicability of this action to a 

particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT for the division 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 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 

http://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 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), 21 U.S.C. 346a(d)(2); 

however, EPA has not fully evaluated 


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Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Proposed Rules 40595 

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 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 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. 

New Tolerances 

PP 5F8380. EPA–HQ–OPP–2015– 

0745. Bayer CropScience, 2 TW 

Alexander Drive, P.O. Box 12014, 

Research Triangle Park, NC 27709, 

requests to establish a tolerance in 40 

CFR part 180.555 for residues of the 

fungicide trifloxystrobin in or on: 

Cotton, gin byproducts at 3 parts per 

million (ppm); and cotton, undelinted 

seed (Crop subgroup 20C) at 0.5 ppm. 

Either gas chromatography with 

nitrogen-phosphorus detection, or 

liquid chromatography/mass 

spectrometry/mass spectrometry (LC/

MS/MS) are used to measure and 

evaluate the chemical trifloxystrobin 

and the free form of its acid metabolite 

CGA–321113 ((E,E)-methoxyimino-[2-[1- 

(3-trifluoromethyl-phenyl)- 

ethylideneaminooxymethyl]- 

phenyl]acetic acid). Contact: RD. 

PP 5F8417. EPA–HQ–OPP–2015– 

0787. K–I Chemical USA. Inc., 11 

Martine Ave., Suite 970, White Plains, 

NY 10606, requests to establish 

tolerances in 40 CFR 180.659 for 

residues of the herbicide, pyroxasulfone 

(3-[(5-(difluoromethoxy)-1-methyl-3- 

(trifluoromethyl) pyrazole-4- 

ylmethylsulfonyl]-4,5-dihydro-5,5- 

dimethyl-1,2-oxazole) and its 

metabolites in or on dried shelled peas 

and beans (crop subgroup 6C) at 0.09 

ppm, flax at 0.01 ppm, peanut at 0.2 

ppm, and peanut hay at 2 ppm. The LC/ 

MS/MS has been proposed to enforce 

the tolerance expression for 

pyroxasulfone. Contact: RD. 

PP 5F8421. EPA–HQ–OPP–2015– 

0825. BASF Corporation, 26 Davis 

Drive, P.O. Box 13528, Research 

Triangle Park, NC 27709, requests to 

establish a tolerance in 40 CFR part 180 

for residues of the herbicide 

topramezone (3-(4,5-Dihydro-isoxazol-3- 

yl)-4-methanesulfonyl-2-methylphenyl]- 

(5-hydroxyl-1-methyl-1H-pyrazol-4- 

yl)methanone) in or on sugarcane, cane 

at 0.01 ppm. The LC/MS/MS is used to 

measure and evaluate the chemical 

topramezone (3-(4,5-Dihydro-isoxazol-3- 

yl)-4-methanesulfonyl-2-methylphenyl]- 

(5-hydroxyl-1-methyl-1H-pyrazol-4- 

yl)methanone). Contact: RD. 

PP 6E8464. EPA–HQ–OPP–2016– 

0257. Interregional Research No. 4 (IR– 

4), Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 201 

W, Princeton, NJ 08540, requests to 

establish tolerances in 40 CFR part 

180.627 for residues of the fungicide 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide], including 

its metabolites and degradates, in or on 

the raw agricultural commodities: Basil, 

dried leaves at 200 ppm; basil, fresh 

leaves at 30 ppm; bean, succulent at 0.9 

ppm; citrus, dried pulp at 0.048 ppm; 

citrus, oil at 1.94 ppm; hop, dried cones 

at 15 ppm; fruit, citrus, group10–10 at 

0.02 ppm; fruit, small, vine climbing, 

except fuzzy kiwifruit, subgroup 13–07F 

at 2.0 ppm; and vegetable, fruiting, 

group 8–10 at 1.60 ppm. The analytical 

method consisting of high pressure LC/ 

MS/MS is used to measure and evaluate 

the chemical fluopicolide. Contact: RD. 

PP 6E8467. EPA–HQ–OPP–2016– 

0255. IR–4, Rutgers, The State 

University of New Jersey, 500 College 

Road East, Suite 201 W, Princeton, NJ 

08540, requests to establish tolerances 

in 40 CFR part 180 for the residues of 

the insecticide spirotetramat (cis-3-(2,5- 

dimethlyphenyl)-8-methoxy-2-oxo-1- 

azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate) and its metabolites cis-3-(2,5- 

dimethylphenyl)-4-hydroxy-8-methoxy1-azaspiro[4.5]dec-3-en-2-one, cis-3- 

(2,5-dimethylphenyl)-3-hydroxy-8- 

methoxy-1-azaspiro[4.5]decane-2,4- 

dione, cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro[4.5]dec-3-en4-yl beta-D-glucopyranoside, and cis-3- 

(2,5-dimethylphenyl)-4-hydroxy-8- 

methoxy-1-azaspiro[4.5]decan-2-one, 

calculated as the stoichiometric 

equivalent of spirotetramat, in or on the 

raw agricultural commodities carrot, 

roots at 0.15 ppm; fruit, stone, group 

12–12 at 4.5 ppm; and nut, tree, group 

14–12 at 0.25 ppm. Analytical 

methodology to determine residues of 

spirotetramat in raw agricultural 

commodities includes high pressure LC/ 

MS/MS using the stable isotopically 

labeled analytes as internal standards. 

The limit of quantification (LOQ) for 

each analyte is 0.01 ppm for all 

commodities. This method is used to 

measure and evaluate spirotetramat. 

Contact RD. 

PP 6E8477. EPA–HQ–OPP–2013– 

0235. IR–4, 500 College Road East, Suite 

201 W, Princeton, NJ 08540, requests to 

establish a tolerance in 40 CFR part 180 

for residues of the insecticide 

chlorantraniliprole, 3-bromo-N-[4- 

chloro-2-methyl-6-[(methylamino)- 

carbonyl]phenyl]-1-(3-chloro-2- 

pyridinyl)-1H-pyrazole-5-carboxamide 

in or on the raw agricultural 

commodities teff, forage at 40 ppm; teff, 

grain at 6.0 ppm; teff, hay at 40 ppm; 

teff, straw at 40 ppm; quinoa, forage at 

40 ppm; quinoa, grain at 6.0 ppm; 

quinoa, hay at 40 ppm; and quinoa, 

straw at 40 ppm. Analytical 

methodology has been developed and 

validated for enforcement purposes. 

Contact: RD. 

Amended Tolerances 

PP 5F8380. EPA–HQ–OPP–2015– 

0745. Bayer CropScience, 2 TW 

Alexander Drive, P.O. Box 12014, 

Research Triangle Park, NC 27709, 

requests to amend the tolerance in 40 

CFR 180.555 for residues of the 

fungicide trifloxystrobin in or on corn, 

field, forage at 8 ppm. Either a method 

based on gas chromatography with 

nitrogen-phosphorus detection, or LC/

MS/MS are used to measure and 

evaluate the chemical trifloxystrobin 

and the free form of its acid metabolite 

CGA–321113 ((E,E)-methoxyimino-[2-[1- 

(3-trifluoromethyl-phenyl)- 

ethylideneaminooxymethyl]- 

phenyl]acetic acid). Contact: RD. 

PP 6E8464. EPA–HQ–OPP–2016– 

0257. IR–4, Rutgers, The State 

University of New Jersey, 500 College 

Road East, Suite 201 W, Princeton, NJ 

08540, requests to amend the tolerances 

in 40 CFR 180.627, upon establishment 

of the tolerances referenced above under 

‘‘New Tolerances’’, to remove existing 

tolerances for residues of the fungicide 

fluopicolide [2,6-dichloro-N-[[3-chloro5-(trifluoromethyl)-2- 

pyridinyl]methyl]benzamide], including 

its metabolites and degradates, in or on 

the raw agricultural commodities grape 

at 2.0 ppm and vegetable, fruiting, group 

8 at 1.60 ppm. The analytical method 

consisting of LC/MS/MS is used to 

measure and evaluate the chemical 

fluopicolide. Contact: RD. 

PP 6E8467. EPA–HQ–OPP–2016– 

0255. IR–4, IR–4 Project Headquarters, 

500 College Road East, Suite 201 W, 

Princeton, New Jersey, 08540, requests 

to amend 40 CFR part 180.641 by 

removing the established tolerances for 


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40596 Federal Register / Vol. 81, No. 120 / Wednesday, June 22, 2016 / Proposed Rules 

the residues of the insecticide 

spirotetramat (cis-3-(2,5- 

dimethlyphenyl)-8-methoxy-2-oxo-1- 

azaspiro[4.5]dec-3-en-4-yl-ethyl 

carbonate) and its metabolites cis-3-(2,5- 

dimethylphenyl)-4-hydroxy-8-methoxy1-azaspiro[4.5]dec-3-en-2-one, cis-3- 

(2,5-dimethylphenyl)-3-hydroxy-8- 

methoxy-1-azaspiro[4.5]decane-2,4- 

dione, cis-3-(2,5-dimethylphenyl)-8- 

methoxy-2-oxo-1-azaspiro[4.5]dec-3-en4-yl beta-D-glucopyranoside, and cis-3- 

(2,5-dimethylphenyl)-4-hydroxy-8- 

methoxy-1-azaspiro[4.5]decan-2-one, 

calculated as the stoichiometric 

equivalent of spirotetramat, in or on 

fruit, stone, group 12 at 4.5 ppm; nut, 

tree, group 14 at 0.25 ppm; and 

pistachio at 0.25 ppm upon 

establishment of aforementioned ‘‘New 

Tolerances under PP 6E8467’’. Contact 

RD. 

New Tolerance Exemptions 

PP 5F8410. EPA–HQ–OPP–2016– 

0284. AFS009 Plant Protection, Inc., 104 

T.W. Alexander Dr., Building 18, 

Research Triangle Park, NC 27709, 

requests to establish an exemption from 

the requirement of a tolerance in 40 CFR 

part 180 for residues of the fungicide 

Pseudomonas chlororaphis subsp. 

aurantiaca strain AFS009 in or on all 

food commodities. The petitioner 

believes no analytical method is needed 

because it is expected that, when used 

as proposed, Pseudomonas chlororaphis 

subsp. aurantiaca strain AFS009 would 

not result in residues that are of 

toxicological concern. Contact: BPPD. 

PP 6G8453. EPA–HQ–OPP–2016– 

0279. Monsanto Company, 800 N. 

Lindbergh Blvd., St. Louis, MO 63167, 

requests to establish a temporary 

exemption from the requirement of a 

tolerance in 40 CFR part 174 for 

residues of the plant-incorporated 

protectant (PIP) Bacillus thuringiensis 

Cry51Aa2.834_16 (mCry51Aa2) protein 

in or on cotton. The petitioner believes 

no analytical method is needed because 

this petition is requesting a temporary 

exemption from the requirement of a 

tolerance without numerical limitation. 

Contact: BPPD. 

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

Dated: June 13, 2016. 

Daniel J. Rosenblatt, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 2016–14816 Filed 6–21–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 431 and 457 

[CMS–6068–P] 

RIN 0938–AS74 

Medicaid/CHIP Program; Medicaid 

Program and Children’s Health 

Insurance Program (CHIP); Changes to 

the Medicaid Eligibility Quality Control 

and Payment Error Rate Measurement 

Programs in Response to the 

Affordable Care Act 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

update the Medicaid Eligibility Quality 

Control (MEQC) and Payment Error Rate 

Measurement (PERM) programs based 

on the changes to Medicaid and the 

Children’s Health Insurance Program 

(CHIP) eligibility under the Patient 

Protection and Affordable Care Act. 

This proposed rule would also 

implement various other improvements 

to the PERM program. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on August 22, 2016. 

ADDRESSES: In commenting, please refer 

to file code CMS–6068–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–6068–P, P.O. Box 8016, Baltimore, 

MD 21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–6068–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call (410) 786–7195 in advance to 

schedule your arrival with one of our 

staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Bridgett Rider, (410) 786–2602. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http://

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. EST. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 


sradovich on DSK3TPTVN1PROD with PROPOSALS