UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF CHEMICAL SAFETY AND

                                                                                POLLUTION PREVENTION

MEMORANDUM

DATE:  	February 17, 2011

SUBJECT:	Triflusulfuron-methyl: Chronic Aggregate Dietary Exposure (Food and Drinking Water) and Risk Assessment for the Section 3 Registration on Garden Beet

PC Code:  129002	DP Barcodes: D376268

Decision No.: 425459	Registration No.:  352-569

Petition No.:  9E7669	Regulatory Action:  Section 3 Registration

Risk Assessment Type:  Single Chemical Aggregate, Dietary	Case No.:  NA

TXR No.:  NA	CAS No.: 126535-15-7

MRID No.:  NA	40 CFR:  §180.492

REVIEWER:	Elizabeth Holman, Chemist

Risk Assessment Branch II  (RAB2)

Health Effects Division (HED; 7509P)

THROUGH:	Debra Rate, Ph.D., Biologist

David Soderberg, Chemist

Dietary Exposure Science Advisory Council

Health Effects Division (HED; 7509P)

and

Richard Loranger, Ph.D., Branch Senior Scientist

Risk Assessment Branch II (RAB2)

Health Effects Division (HED; 7509P)

TO:		Laura Nollen, Risk Manager Reviewer

		Barbara Madden, Review Manager #5

		Daniel (Dan) Rosenblatt, Chief

Risk Integration, Minor Use, and Emergency Response Branch

		Registration Division (7505P)

Executive Summary

™, Version 2.03), which uses food consumption data from the U.S. Department of Agriculture (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support a Section 3 registration for use of triflusulfuron-methyl [methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-trifluoroethoxy)-1,3,5-triazin-2-yl]am ino]carbonyl]amino]sulfonyl]-3-methylbenzoate] on garden beets.  Triflusulfuron-methyl is currently registered for use on sugar beets and chicory.

Acute Dietary Exposure (Food and Drinking Water) Results and Characterization

No appropriate endpoint attributable to a single dose was identified.  As no acute dietary endpoint was identified, an acute exposure analysis was not performed.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic analysis is based on tolerance level residues and 100% crop treated assumptions.  The HED-recommended tolerance level for each raw agricultural commodity (RAC) was entered as listed below:

Beet, garden, roots	0.01 ppm

Beet, garden, tops	0.02 ppm

Additionally, the existing tolerances for sugar beet (roots and tops) and chicory were also entered (a value of 0.05 ppm for each commodity).  The general U.S. population and all population subgroups have risk estimates that are well below HED’s level of concern (i.e., 100% of the chronic population adjusted dose (cPAD)).  Estimated exposures are less than 1% of the cPAD for the U.S. population and all population subgroups, including those of infants and children.

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

Triflusulfuron-methyl is a Group C (1986 Cancer Guidelines - possible human carcinogen) chemical, based on increased incidence of testicular cell adenomas in rats.  The chronic RfD is considered adequately protective of these effects and a quantitative cancer risk assessment using a cancer potency factor is not required.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to the point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk exceeds 100% of the PAD.  HED is generally concerned when estimated cancer risk exceeds one in one million.  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ;  or see SOP 99.6 (8/20/99).

A dietary risk assessment for triflusulfuron-methyl on sugar beet was completed in 2000 (D260469, M.Doherty, 8/28/2000).  This assessment is for the new proposed use on garden beet, which also incorporates the existing uses on sugar beet and chicory.  Chicory was not included in the 2000 dietary assessment.

II.	Residue Information

Triflusulfuron-methyl is a sulfonylurea herbicide that inhibits the biosynthesis of branched-chain amino acids in plants (via inhibition of the plant enzyme acetolactate synthase).  The herbicide is currently registered for food uses on sugar beet and chicory.

The petitioner has proposed a new Section 3 use on garden beets.  See Table 1 below for a summary of the HED-recommended tolerances.

Table 1.  Summary of HED- Recommended Tolerances for Proposed New Use.

Commodity	Recommended Tolerance (ppm)

Beet, garden, roots	0.01

Beet, garden, tops 	0.02

For both the existing and proposed uses, triflusulfuron-methyl parent serves as an adequate measure of misuse based on its percentage of the total radioactive residues (TRR) in the metabolism studies and the residues seen in crop field trials.

HED is making the conservative assumption of 100% crop treated.

In a previously submitted processing study for sugar beet, even at exaggerated rates (8X) for the field trial used to generate the processing study samples, no triflusulfuron-methyl was found in the sugar beet roots or processed commodities (MRID 42496869; see 6/7/93 G. J. Herndon review, D184250).  Therefore, processed commodities of sugar beet were conservatively estimated to have tolerance-level residues of the raw agricultural commodity of sugar beet.

III.  Drinking Water Data

™ into the food categories “water, direct, all sources” and “water, indirect, all sources.”

The EDWCs are based on the maximum application rates specified in the product label for the existing use on sugar beet.  The registrant is proposing the new use of the chemical on garden beets.  Based on an inspection of the new use of triflusulfuron-methyl, it was found that sugar beet still represents the scenario with the highest exposure.  The previously modeled use covers the new use.  Therefore, the drinking water assessment results do not change from the previous ones.  For electronic copy of the previous drinking water assessment refer to DP Barcode D260078.

Surface water estimates were calculated using the Tier II Pesticide Root Zone Model (PRZM, v3.12.2, 5/12/2005) and the Exposure Analysis Modeling System (EXAMS, v<IP_ADDRESS>, 4/25/2005).  These simulation models are coupled to generate daily exposures and 1-in-10 year estimated drinking water concentrations of triflusulfuron-methyl residues that may occur in surface water bodies adjacent to application sites receiving triflusulfuron-methyl through runoff and spray drift.  Groundwater estimates were calculated using the Screening Concentration in Ground Water (SCI-GROW v2.3, Jul. 29, 2003) regression model.  These models and their descriptions are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

The EDWCs for the human health risk assessment are presented in Table 2.  RAB2 has selected the most conservative estimate in order to be sufficiently protective of human health.  The maximum estimate of 0.50 ppb comes from the groundwater (SCI-GROW) estimate and was used in the chronic dietary analysis.

Table 2.  Estimated Drinking Water Concentrations (EDWCs) for Human Health Risk Assessment for Aerial Application of Triflusulfuron-Methyl on Sugar Beets.

Chemical

Chronic Surface Water  PRZM/EXAMS (ppb)

Acute and Chronic Ground Water  SCI-GROW (ppb)*

Triflusulfuron-methyl	0.005	0.50

IV.	DEEM-FCID( Program and Consumption Information

A triflusulfuron-methyl chronic dietary exposure assessment was conducted using the DEEM-FCID(, Version 2.03, which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate. The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

V.	Toxicological Information

The Health Effects Division (HED) has evaluated the toxicology database for triflusulfuron-methyl.  The RAB2 risk assessment team reviewed the toxicology data for triflusulfuron-methyl with regard to the acute and chronic reference doses and the toxicological endpoint selection.  Table 3 below provides a summary of the doses and endpoints recommended for use in the dietary exposure assessments.    SEQ CHAPTER \h \r 1 Triflusulfuron-methyl is a Group C (1986 Cancer Guidelines - possible human carcinogen) chemical, based on increased incidence of testicular cell adenomas in rats.  The chronic RfD is considered adequately protective of these effects and a quantitative cancer risk assessment using a cancer potency factor is not required.  The FQPA safety factor was reduced to 1x for all exposure scenarios.

Table 3.  Summary of Toxicological Doses and Endpoints for Triflusulfuron-Methyl for Use in Dietary and Non-Occupational Human Health Risk Assessments.

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary, General Population (including Infants and Children and Females age 13 to 49)	Not required.  An appropriate endpoint for this risk assessment was not identified.

Chronic Dietary (All Populations)	NOAEL= 2.44  mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x   	Chronic RfD = 0.0244

mg/kg/day

cPAD = 0.0244 mg/kg/day	Chronic oral toxicity/carcinogenicity in the rat

LOAEL = 30.6 mg/kg/day, based on decreased body weight/weight gain, hematological changes (primarily males) and increased interstitial cell hyperplasia (males).

Cancer (oral, dermal, inhalation)	Classification:  Group C (1986 Cancer Guidelines), based on increased incidence of testicular interstitial cell adenomas in rats.   The chronic RfD is considered adequately protective of these effects and a quantitative assessment of cancer risk using a cancer potency factor is not required.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level of concern.

VI.	Results/Discussion

As stated above, for acute and chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID( analysis estimates the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 5 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Acute Dietary (Food and Drinking Water) Exposure Analysis

No appropriate endpoint attributable to a single dose was identified.  As no acute dietary endpoint was identified, an acute exposure analysis was not performed.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The summary table below lists the results of the chronic dietary exposure analysis.  Estimated chronic dietary risk estimates are less than 1% of the cPAD for the U.S. population and all population subgroups, including those of infants and children.  Thus, all population exposures are well below HED’s level of concern.

Table 4.  Summary of Dietary Exposure and Risk for Triflusulfuron-Methyl.

Population Subgroup*

Acute Dietary

Chronic Dietary

Cancer

Dietary Exposure (mg/kg/day)

% aPAD

Dietary Exposure

(mg/kg/day)

% cPAD

Dietary Exposure

(mg/kg/day)

Risk

General U.S. Population	N/A

No acute dietary endpoint was identified	N/A	0.000025	<1%

N/A

N/A

All Infants (< 1 year old)

	0.000050   	<1%

Children 1-2 years old

	0.000052	<1%

Children 3-5 years old

	0.000056	<1%

Children 6-12 years old

	0.000041	<1%

Youth 13-19 years old

	0.000023	<1%

Adults 20-49 years old

	0.000020	<1%

Adults 50+ years old

	0.000019	<1%

Females 13-49 years old

	0.000021	<1%

VII.	Characterization of Inputs/Outputs

As the exposure estimates to all population subgroups were so low, it was not necessary to make refinements to the chronic dietary analysis.  If it had been necessary to refine the analysis, average field trial values could have been used in place of tolerance level residues.  In addition, estimates of percent crop treated could have been used.

VIII.	Conclusions

Based on very conservative assumptions, the chronic dietary risk estimates are well below HED’s level of concern for the general U.S. population and all population subgroups, including those comprised of infants and children.  In addition, cancer risk from dietary exposure to triflusulfuron-methyl is not of concern to HED (the cRfD is protective of cancer effects).  Based on the conservative nature of the chronic dietary endpoint and the drinking water assessment, exposure and risk to triflusulfuron-methyl are not expected to be underestimated.

IX.	List of Attachments

Attachment 1: Residue Input File for Chronic Analysis

Attachment 2: Results of Chronic Dietary Exposure Analysis

Attachment 1:  Triflusulfuron-methyl Residue Input File

Filename: F:\Triflusulfuron\Dietary\Triflusulfuron-methyl Chronic final.R98

Chemical: Triflusulfuron-methyl

RfD(Chronic): .0244 mg/kg bw/day  NOEL(Chronic): 2.44 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 02-17-2011/09:08:08/8          Program ver. 2.03

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

86010000 O    Water, direct, all sources         0.000500   1.000  1.000

86020000 O    Water, indirect, all sources       0.000500   1.000  1.000

01010500 1AB  Beet, garden, roots                0.010000   1.000  1.000

01010501 1AB  Beet, garden, roots-babyfood       0.010000   1.000  1.000

01010520 1A   Beet, sugar                        0.050000   1.000  1.000

01010521 1A   Beet, sugar-babyfood               0.050000   1.000  1.000

01010530 1A   Beet, sugar, molasses              0.050000   1.000  1.000

01010531 1A   Beet, sugar, molasses-babyfood     0.050000   1.000  1.000

01011000 1AB  Chicory, roots                     0.050000   1.000  1.000

02000510 2    Beet, garden, tops                 0.020000   1.000  1.000

02001010 2    Chicory, tops                      0.050000   1.000  1.000

Attachment 2:  Results of Triflusulfuron-methyl Chronic Dietary Exposure Analysis

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for TRIFLUSULFURON-METHYL            (1994-98 data)

Residue file name: F:\Triflusulfuron\Dietary\Triflusulfuron-methyl Chronic final.R98

                                                     Adjustment factor #2 used.

Analysis Date 02-17-2011/09:16:12     Residue file dated: 02-17-2011/09:08:08/8

Reference dose (RfD, Chronic) = .0244 mg/kg bw/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent of

           Subgroup                       body wt/day             Rfd

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

U.S. Population (total)                     0.000025                 0.1%

U.S. Population (spring season)             0.000026                 0.1%

U.S. Population (summer season)             0.000026                 0.1%

U.S. Population (autumn season)             0.000025                 0.1%

U.S. Population (winter season)             0.000025                 0.1%

Northeast region                            0.000024                 0.1%

Midwest region                              0.000027                 0.1%

Southern region                             0.000024                 0.1%

Western region                              0.000026                 0.1%

Hispanics                                   0.000026                 0.1%

Non-hispanic whites                         0.000025                 0.1%

Non-hispanic blacks                         0.000025                 0.1%

Non-hisp/non-white/non-black                0.000025                 0.1%

All infants (< 1 year)                      0.000050                 0.2%

Nursing infants                             0.000019                 0.1%

Non-nursing infants                         0.000061                 0.3%

Children 1-6  yrs                           0.000054                 0.2%

Children 7-12 yrs                           0.000039                 0.2%

Females 13-19 (not preg or nursing)         0.000022                 0.1%

Females 20+ (not preg or nursing)           0.000020                 0.1%

Females 13-50 yrs                           0.000022                 0.1%

Females 13+ (preg/not nursing)              0.000025                 0.1%

Females 13+ (nursing)                       0.000027                 0.1%

Males 13-19 yrs                             0.000024                 0.1%

Males 20+ yrs                               0.000019                 0.1%

Seniors 55+                                 0.000019                 0.1%

Children 1-2 yrs                            0.000052                 0.2%

Children 3-5 yrs                            0.000056                 0.2%

Children 6-12 yrs                           0.000041                 0.2%

Youth 13-19 yrs                             0.000023                 0.1%

Adults 20-49 yrs                            0.000020                 0.1%

Adults 50+ yrs                              0.000019                 0.1%

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Females 13-49 yrs                           0.000021                 0.1%

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

Triflusulfuron-methyl                             Dietary Exposure Assessment                                      DP Barcode: D376268

PC Code: 129002

                    Page   PAGE  1  of   NUMPAGES  10


[Federal Register Volume 81, Number 130 (Thursday, July 7, 2016)]
[Notices]
[Pages 44390-44393]
[FR Doc No: 2016-16122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78222; File No. SR-MIAX-2016-18]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend the MIAX Options Fee Schedule

July 1, 2016.
    Pursuant to the provisions of Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on June 28, 2016, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (``Fee Schedule'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Fee Schedule to clarify the
circumstances that trigger the assessment of fees to, and billing of,
Member or Non-Member users of the Exchange's System \3\ for certain
non-transactional fees, as set forth below. The Exchange is not
proposing any new fees that are not currently charged; the Exchange is
simply proposing to clarify that the Exchange will assess the fees only
when the Member or Non-Member user is credentialed (as defined below)
to use the System in the production environment, thus ensuring that
Member and Non-Member users of the System are not billed unnecessarily
before they are ready to begin using the System. The Exchange is also
proposing several technical clarifying amendments to the Fee Schedule
as described below.
---------------------------------------------------------------------------

    \3\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
---------------------------------------------------------------------------

    New users of the System (and existing users of the System that seek
to add connectivity) require testing and certification prior to actual
use in the production environment. It has been the Exchange's
experience that such users frequently must engage in internal business
and technological decision-making and production processes that extend
beyond the timing of their application, testing and certification with
the Exchange for use of the System in the production environment. In
order to ensure that Member and Non-Member users of the System are not
assessed fees and billed unnecessarily during this time, the Exchange
is proposing the below changes to the Fee Schedule relating to the
timing of such assessment and billing.
    The Exchange proposes to amend Section 3)a) of the Fee Schedule to
provide that MIAX will assess a one-time Membership Application Fee on
the earlier of (i) the date the applicant is certified in the
membership system, or (ii) once an application for MIAX membership is
finally denied.
    The Exchange also proposes to amend Section 3)b) of the Fee
Schedule to provide that Monthly Trading Permit Fees will be assessed
with respect to Electronic Exchange Members (``EEMs'') \4\ (other than
Clearing Firms) in any month the EEM is certified in the membership
system and the EEM is authorized by the Exchange (hereinafter,
``credentialed'') to use one or more Financial Information Exchange
(``FIX'') Ports \5\ in the production environment. Further, the
Exchange proposes that Monthly Trading Permit Fees will be assessed
with respect to EEM-Clearing Firms in any month the Clearing Firm is
certified in the membership system to clear transactions on the
Exchange. Finally, the Exchange proposes that Monthly Trading Permit
Fees will be assessed with respect to Market Makers in any month the
Market Maker is certified in the membership system, is credentialed to
use one or more MIAX Express Interface (``MEI'') \6\ Ports in the
production environment and is assigned to quote in one or more
classes.\7\
---------------------------------------------------------------------------

    \4\ The term ``Electronic Exchange Member'' means the holder of
a Trading Permit who is not a Market Maker. Electronic Exchange
Members are deemed ``members'' under the Exchange Act. See Exchange
Rule 100.
    \5\ A FIX Port is an interface with MIAX systems that enables
the Port user (typically an Electronic Exchange Member or a Market
Maker) to submit orders electronically to MIAX.
    \6\ MIAX Express Interface is a connection to MIAX systems that
enables Market Makers to submit electronic quotes to MIAX.
    \7\ The calculation of the Trading Permit Fee for the first
month in which the Trading Permit is issued will be pro-rated based
on the number of trading days on which the Trading Permit was in
effect divided by the total number of trading days in that month
multiplied by the monthly rate.
---------------------------------------------------------------------------

    The Exchange also proposes to amend Section 4)a) of the Fee
Schedule to state that Application Programming Interface (``API'')
Testing and Certification Fees for EEMs (other than Clearing Firms)
will be assessed (i) initially per API for FIX, FIX Drop Copy (``FXD'')
\8\ and Clearing Trade Drop (``CTD'') \9\ in the month the EEM has been
credentialed to use one or more ports in the production

environment for the tested API,\10\ and (ii) each time an EEM initiates
a change to its system that requires testing and certification. The
Exchange further proposes that API Testing and Certification Fees for
EEM-Clearing Firms will be assessed (i) initially per API in the month
the EEM-Clearing Firm has been credentialed to use one or more CTD
ports in the production environment, and (ii) each time an EEM-Clearing
Firm initiates a change to its system that requires testing and
certification. The Exchange additionally proposes that API Testing and
Certification Fees for Market Makers will be assessed (i) initially per
API for CTD and MEI \11\ in the month the Market Maker has been
credentialed to use one or more ports in the production environment for
the tested API and the Market Maker has been assigned to quote in one
or more classes, and (ii) each time a Market Maker initiates a change
to its system that requires testing and certification. Consistent with
the current practice, such fees will not be assessed in situations
where the Exchange initiates a change to its System requiring testing
and certification by Members of the Exchange. The Exchange is proposing
to clarify that the fees will not be assessed when the Exchange-
initiated change is mandatory.
---------------------------------------------------------------------------

    \8\ The FIX Drop Copy Port is a messaging interface that will
provide a copy of real-time trade execution, trade correction and
trade cancellation information to FIX Drop Copy Port users who
subscribe to the service.
    \9\ CTD provides Exchange members with real-time clearing trade
updates. The updates include the member's clearing trade messages on
a low latency, real-time basis. The trade messages are routed to a
member's connection containing certain information. The information
includes, among other things, the following: (i) Trade date and
time; (ii) symbol information; (iii) trade price/size information;
(iv) member type (for example, and without limitation, Market Maker,
Electronic Exchange Member, Broker-Dealer); and (v) Exchange Member
Participant Identifier (``MPID'') for each side of the transaction,
including clearing member MPID.
    \10\ FIX, FXD and CTD are types of APIs.
    \11\ MEI is a type of API.
---------------------------------------------------------------------------

    The Exchange also proposes to amend Section 4)b) of the Fee
Schedule to provide that API Testing and Certification Fees for Third
Party Vendors, Service Bureaus and other non-Members will be assessed
(i) initially per API for FIX, FXD, CTD and MEI in the month the Non-
Member has been credentialed to use one or more ports in the production
environment for the tested API, and (ii) each time a Third Party
Vendor, Service Bureau, or other non-Member initiates a change to its
system that requires testing and certification. The Exchange also
proposes that such fees will not be assessed in situations where the
Exchange initiates a mandatory change to its System requiring testing
and certification by Non-Members of the Exchange.
    The Exchange additionally proposes to amend Section 4)(c) of the
Fee Schedule to provide that Member Network Connectivity Testing and
Certification Fees will be assessed (i) initially per connection in the
month the Individual Firm has been credentialed to use any API or
Market Data feeds in the production environment utilizing the tested
network connection, and (ii) each time an Individual Firm initiates a
change to its system that requires network connectivity testing and
certification. The Exchange also proposes that such fees will not be
assessed in situations where the Exchange initiates a mandatory change
to its System requiring testing and certification by Members of the
Exchange.
    The Exchange proposes to amend Section 4)d) of the Fee Schedule to
provide that Non-Member Network Connectivity Testing and Certification
Fees will be assessed (i) initially per connection in the month the
Service Bureau, Extranet Provider or other Non-Member has been
credentialed to use any API or Market Data feeds in the production
environment using the tested network connection, and (ii) each time a
Service Bureau, Extranet Provider or other non-Member initiates a
change to its system that requires network connectivity testing and
certification. The Exchange also proposes that such fees will not be
assessed in situations where the Exchange initiates a mandatory change
to its System requiring testing and certification by Members of the
Exchange.
    The Exchange proposes to amend Section 5)a) of the Fee Schedule to
provide that Monthly Member Network Connectivity Fees for the
applicable connectivity will be assessed in any month the Member is
credentialed to use any of the MIAX APIs or Market Data feeds in the
production environment and will be pro-rated when a Member makes a
change to the connectivity (by adding or deleting connections) with
such pro-rated fees based on the number of trading days that the Member
has been credentialed to use any of the MIAX APIs or Market Data feeds
in the production environment through such connection, divided by the
total number of trading days in such month multiplied by the applicable
monthly rate.
    The Exchange proposes to amend Section 5)b) of the Fee Schedule to
provide that Monthly Non-Member Network Connectivity Fees for the
applicable connectivity will be assessed in each month the Non-Member
has been credentialed to use any of the MIAX APIs or Market Data feeds
in the production environment and will be pro-rated when a Non-Member
makes a change to the connectivity (by adding or deleting connections)
with such pro-rated fees based on the number of trading days that the
Non-Member has been credentialed to use any of the MIAX APIs or Market
Data feeds via the network connection in the production environment
through such connection, divided by the total number of trading days in
such month multiplied by the applicable monthly rate.
    The Exchange proposes to amend Section 5)d)i) of the Fee Schedule
to provide that MIAX will assess monthly FIX Port Fees on Members in
each month the Member is credentialed to use a FIX Port in the
production environment and based upon the number of credentialed FIX
Ports.
    The Exchange further proposes to amend Section 5)d)ii) of the Fee
Schedule to provide that MIAX will assess monthly MEI Port Fees on
Market Makers in each month the Member has been credentialed to use the
MEI Port in the production environment and has been assigned to quote
in at least one class. The amount of the monthly MEI Port Fee will be
based upon the number of classes in which the Market Maker was assigned
to quote in any given day within the calendar month, and upon the class
volume percentages set forth in the MEI Port Fee table in Section
5)d)ii). The class volume percentage is based on the total national
average daily volume in classes listed on MIAX in the prior calendar
quarter.
    The Exchange also proposes to amend Section 5)d)iii) of the Fee
Schedule to provide that CTD Port Fees will be assessed in any month
the Member is credentialed to use the CTD Port in the production
environment.
    The Exchange also proposes to amend Section 5)d)iv) of the Fee
Schedule to provide that FXD Port Fees will be assessed in any month
the Member is credentialed to use the FXD Port in the production
environment.
    The Exchange proposes to amend Section 5)e) of the Fee Schedule to
provide that MIAX Member Participant Identifier (``MPID'') Fees will be
assessed in each month the Member is credentialed to use such MPIDs in
the production environment.
    The Exchange additionally proposes to amend Section 6 of the Fee
Schedule to provide that, with respect to each of the Exchange's data
feeds including MIAX Top of Market (``ToM''), Administrative
Information Subscriber (``AIS'') and MIAX Order Feed (``MOR''), MIAX
will assess Market Data Fees applicable to such data feed on Internal
and External Distributors in each month the Distributor is credentialed
to use such data feed in the production environment.
    The purpose of the proposed rule change is to provide all users of
the Exchange with greater transparency as to when non-transactional
fees will be assessed to such users. The Exchange believes that
defining the timing in the Fee Schedule will benefit all market

participants by assisting them in the decision-making process for the
timing of their readiness to use the Exchange's System. Moreover,
establishing in the fee schedule the timing of certain non-transaction
fees enhances transparency on the Exchange and lets all market
participants know that they will not be assessed such fees until such
time as they are credentialed to use and avail themselves of the
Exchange's System.
    The Exchange is also proposing minor technical amendments to the
Fee Schedule throughout the Fee Schedule (e.g., replacing the term
``MM'' with the term ``Market Maker'' and capitalizing the word
``Member'') to make consistent defined terms used throughout the Fee
Schedule. These changes are intended for clarity and ease of reference.
    The proposed rule change will become effective July 1, 2016.
2. Statutory Basis
    The Exchange believes that its proposed rule change is consistent
with Section 6(b) of the Act \12\ in general, and furthers the
objectives of Sections 6(b)(4) of the Act,\13\ in that it is an
equitable allocation of reasonable fees and other charges among
Exchange Members and other persons using its facilities, and Section
6(b)(5) of the Act,\14\ in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanisms of a free and open market and
a national market system and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule change furthers the objectives of Section 6(b)(4)
of the Act \15\ because it will apply equally to all MIAX participants
within the various categories set forth in the proposed rule change.
The Exchange further believes that it is equitable and reasonable to
amend the Fee Schedule to charge participants for these non-transaction
fees only when they are credentialed to use the facilities of the
Exchange, and not before that time.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The proposed rule change is consistent with Section 6(b)(5) of the
Act,\16\ in that it is designed to protect investors and the public
interest and to promote just and equitable principles of trade by
adding transparency to the Exchange's marketplace and by broadening the
description of non-transactional fees to include the timing of
assessment of such fees, and by ensuring that these fees will only be
assessed on MIAX participants when they are credentialed to use the
facilities of the Exchange.
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The Exchange believes that
the proposed changes would increase both intermarket and intramarket
competition by defining the timing of non-transactional fee assessments
for all users of the Exchange, thereby creating greater clarity around
the Exchange's assessment of such fees for participants that wish to
begin and continue using the Exchange's facilities, and enabling them
to assess the competitive nature of the fees. This should benefit all
market participants and improve competition on the Exchange.
    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues if they
deem fee levels at a particular venue to be excessive. In such an
environment, the Exchange must continually adjust its fees and rebates
to remain competitive with other exchanges and to attract order flow to
the Exchange. The Exchange believes that the proposal will enhance
competition, because market participants will have more clarity
surrounding when they will be assessed non-transactional fees and will
also understand that they will not be assessed such fees until such
time as they are ready to use the Exchange.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \17\ and Rule 19b-4(f)(6) \18\
thereunder.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \19\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\20\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative by July 1, 2016. The Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest because it will allow the Exchange to
clarify the circumstances that trigger the assessment of fees to, and
billing of Member and Non-Member users of the Exchange's System so as
to assess existing non-transactional fees only on Member and Non-Member
users that are credentialed to use the System. The Commission notes
that the Exchange is not proposing any new fees, but is clarifying that
the Exchange will only assess certain non-transaction fees when the
Member or non-Member user is credentialed to use the Exchange's system.
Thus, the proposed rule change which will ensure that users will not be
billed until they are ready to begin using the Exchange system.
Accordingly, the Commission hereby waives the 30-day operative delay
and designates the proposed rule change as operative upon filing.\21\
---------------------------------------------------------------------------

    \19\ 17 CFR 240.19b-4(f)(6).
    \20\ 17 CFR 240.19b-4(f)(6)(iii).
    \21\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2016-18 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-MIAX-2016-18. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MIAX-2016-18, and should be
submitted on or before July 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-16122 Filed 7-6-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 171 (Wednesday, September 6, 2017)]
[Notices]
[Pages 42101-42103]
[FR Doc No: 2017-18815]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4852]

Design Considerations and Premarket Submission Recommendations
for Interoperable Medical Devices; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Design Considerations and
Pre-market Submission Recommendations for Interoperable Medical
Devices.'' FDA is issuing this guidance to assist industry and FDA
staff in identifying specific considerations related to the ability of
electronic medical devices to safely and effectively exchange and use
exchanged information. This document highlights considerations that
should be included in the development and design of interoperable
medical devices and provides recommendations for the content of
premarket submissions and labeling for such devices.

DATES: The announcement of the guidance is published in the Federal
Register on September 6, 2017.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2015-D-4852 for ``Design Considerations and Premarket Submission
Recommendations for Interoperable Medical Devices.'' Received comments
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 office 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 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.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Design Considerations and Premarket Submission Recommendations for
Interoperable Medical Devices'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Heather Agler, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
and Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 301-240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The need and desire to connect medical devices to other products,
technologies, and systems is growing in the health care community. As
electronic medical devices are increasingly connected to each other and
to other technology, the ability of these connected systems to safely
and effectively exchange information and use the information that has
been exchanged becomes increasingly important. Advancing the ability of
medical devices to exchange and use information safely and effectively
with other medical devices, as well as other technology, offers the
potential to increase efficiency in patient care.
    FDA intends to promote the development and availability of safe and
effective interoperable medical devices. FDA is issuing this guidance
to assist industry and FDA staff in identifying specific considerations
related to the ability of electronic medical devices to safely and
effectively exchange information and use exchanged information. This
document highlights considerations that should be included in the
development and design of interoperable medical devices and

provides recommendations for the content of premarket submissions and
labeling for such devices.
    In the Federal Register of January 26, 2016 (81 FR 4303), FDA
announced the availability of the draft of this guidance and interested
persons were invited to comment by March 28, 2016. The comment period
was extended on February 23, 2016 (81 FR 8966), to April 28, 2016. FDA
has considered all of the public comments received in finalizing this
guidance.
    FDA recognizes and anticipates that the Agency and industry may
need up to 60 days to perform activities to operationalize the policies
within the guidance. If new information regarding device
interoperability as outlined in this guidance is not included in a
premarket submission received by FDA before or up to 60 days after the
publication of this guidance, CDRH staff does not generally intend to
request such information during the review of the submission. CDRH
does, however, intend to review any such information if submitted.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Design Considerations and Premarket
Submission Recommendations for Interoperable Medical Devices.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; the collections of information in 21 CFR
part 812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subparts A through E, have been
approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 814, subpart H have been approved under OMB
control number 0910-0332; the collections of information in 21 CFR part
601 have been approved under OMB control number 0910-0338; the
collections of information in 21 CFR parts 801 and 809 have been
approved under OMB control number 0910-0485; and the collections of
information in 21 CFR parts 610 and 660 have been approved under OMB
control number 0910-0338.

IV. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Design Considerations and Premarket Submission
Recommendations for Interoperable Medical Devices'' may send an email
request to<EMAIL_ADDRESS>to receive an electronic copy of
the document. Please use the document number 1500015 to identify the
guidance you are requesting.

    Dated: August 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18815 Filed 9-5-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Page 25112]
[FR Doc No: 2018-11670]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket Number DOT-NHTSA-2018-0034]

Notice and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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

SUMMARY: The Department of Transportation (DOT) invites public comments
about our intention to request the Office of Management and Budget
(OMB) approval to start a new information collection. Before a Federal
agency can collect certain information from the public, it must receive
approval from the Office of Management and Budget (OMB). Under
procedures established by the Paperwork Reduction Act of 1995, before
seeking OMB approval, Federal agencies must solicit public comment on
proposed collections of information, including extensions and
reinstatement of previously approved collections.

DATES: Comments must be received on or before July 30, 2018.

ADDRESSES: You may submit comments [identified by Docket No. DOT-NHTSA-
2018-0034] through one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail or Hand Delivery: Docket Management Facility, U.S.
Department of Transportation, 1200 New Jersey Avenue SE, West Building,
Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except on Federal holidays.

FOR FURTHER INFORMATION CONTACT: Michael Frenchik, Office of Data
Acquisition, Safety Systems Management Division (NSA-0130), Room W53-
303, 1200 New Jersey Avenue SE, Washington, DC 20590. Mr. Frenchik's
telephone number is<PHONE_NUMBER>. Please identify the relevant
collection of information by referring to its OMB Control Number.

SUPPLEMENTARY INFORMATION:
    Title: State Data Transfer for Vehicle Crash Information.
    OMB Control Number: xxxx-xxxx.
    Type of Request: Collection of motor vehicle crash data.
    Abstract: The U.S. Department of Transportation, National Highway
Traffic Safety Administration (NHTSA) was established by Congress to
save lives, prevent injuries, and reduce economic costs due to motor
vehicle crashes through education, research, safety standards, and
enforcement activity. Within NHTSA, the National Center for Statistics
and Analysis is responsible for providing timely, complete, and high-
quality data for use by NHTSA, other Federal, State, and local
governmental agencies, as well as others in motor vehicle safety
research and analysis to reduce crashes, injuries, deaths, and
associated medical costs. NHTSA conducts these activities pursuant to
49 U.S.C. Chapter 301.
    Historically, NHTSA has been collecting vehicle crash data from
States through several programs, including, the State Data System
(SDS), the Fatality Analysis Reporting System (FARS), the Crash Report
Sampling System (CRSS) and the Crash Investigation Sampling System
(CISS). Even though each of these data collection programs collects
data for its own focus area, all these programs include crash data from
the States' crash data systems. Each of these programs retrieves data
from the States separately. The process of retrieving data from States
is also not automated, requiring manual data entry. The following are
brief descriptions of these data collection programs:
     FARS is a nationwide census of fatalities suffered in
motor vehicle traffic crashes;
     CRSS is a nationally representative sample of police-
reported crashes involving all types of motor vehicles, pedestrians,
and cyclists, ranging from property-damage-only crashes to those that
result in fatalities;
     CISS is a nationally representative sample of minor,
serious, and fatal crashes involving at least one passenger vehicle--
cars, light trucks, sport utility vehicles, and vans--towed from the
scene;
     SDS collects vehicle crash data files from a limited
number of States.
    Over the last decade or so, efforts have been underway to
consolidate, improve, and automate data management at Federal and State
levels. Many States have built centralized databases for their crash
data. With the adoption of new data management technologies and
increased adoption of the Model Minimum Uniform Crash Criteria (MMUCC)
guideline, the timing is now ideal to pursue the electronic transfer of
State crash data to NHTSA. The State Data Transfer effort will automate
the transfer of the State's motor vehicle crash data, including crashes
resulting in fatalities, injuries and property damage only, into a
federal data warehouse. NHTSA will use the data collected in this
federal data warehouse to replace the manual data collection and coding
to the extent possible for SDS, FARS, CRSS, and CISS. Data in this
federal data warehouse will also be available to other federal agencies
to analyze safety trends and identify safety issues across the nation.
Through NHTSA's State Data Transfer collection effort, NHTSA seeks to
reduce or eliminate the redundant processes and have more accurate,
high quality and timely data to help save lives, prevent injuries, and
reduce economic costs due to motor vehicle crashes.
    Affected Public: State Governments.
    Estimated Number of Respondents: 15.
    Frequency: Mutually agreed upon between NHTSA and States;
potentially from daily to annual.
    Estimated Total One-Time Initial Implementation Burden Hours: 200
hours per State.
    Estimated Total One-Time Initial Implementation Burden Cost: $8,800
per State.
    Estimated Total Annual Maintenance Burden Hours: 5 hours per State.
    Estimated Total Annual Maintenance Burden Cost: $1,000 per State.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for the Department's
performance; (b) the accuracy of the estimated burden; (c) ways for the
Department to enhance the quality, utility and clarity of the
information collection; and (d) ways that the burden could be minimized
without reducing the quality of the collected information. The agency
will summarize and/or include your comments in the request for OMB's
clearance of this information collection.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

Terry T. Shelton,
Associate Administrator, National Center for Statistics and Analysis.
[FR Doc. 2018-11670 Filed 5-30-18; 8:45 am]
 BILLING CODE 4910-59-P