[Federal Register Volume 78, Number 116 (Monday, June 17, 2013)]
[Rules and Regulations]
[Pages 36093-36097]
[FR Doc No: 2013-14213]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0716; FRL-9388-2]

Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenpyroximate in or on multiple commodities identified and discussed
later in this document. In addition, this regulation removes an
established tolerance for a certain commodity superseded by this
action. The Interregional Research Project Number 4 (IR-4) requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective June 17, 2013. Objections and
requests for hearings must be received on or before August 16, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0716, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0716 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or

before August 16, 2013. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0716, 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 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.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, November 7, 2012 (77 FR
66781) (FRL-9367-5), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 2E8072) by Interregional Research Project Number 4 (IR-4),
500 College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.566 be amended by establishing tolerances for
residues of the insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-
[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl]benzoate in or on fruit, stone, group 12-
12 at 2.0 ppm; fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 1.0 ppm; and vegetable, tuberous and corm, subgroup
1C at 0.1 ppm. That document referenced a summary of the petition
prepared by Nichino America, Inc., 4550 New Linden Hill Rd.,
Wilmington, DE 19808, the registrant, which is available in the docket,
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fenpyroximate including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fenpyroximate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Fenpyroximate was classified as having moderate acute oral and
inhalation toxicity in rats. It exhibited low dermal acute toxicity and
was neither a skin nor eye irritant. Fenpyroximate was a slight to
moderate sensitizer by the maximization test method. Subchronic and
chronic oral exposures to fenpyroximate resulted in overall systemic
toxicity (no specific target organ/tissue was identified). The most
sensitive species tested was the dog. The effects reported in the dog
included slight bradycardia, deficits in food consumption, body weight,
body-weight gain, and an increased incidence of emesis and diarrhea.
Emaciation and torpor (sluggish inactivity) were reported in female
dogs at lower dose levels than males. The highest dose tested in the
dog resulted in first- and second-degree heart block, increased urea
concentration, decreased glucose, and altered plasma electrolyte levels
among other signs of toxicity. In subchronic and chronic studies with
rats, the primary effect was decreased body-weight gain in both sexes
with hematological changes (e.g., higher counts of red blood cells) at
higher doses.
    In a rat prenatal developmental toxicity study, a fenpyroximate
dose level that marginally affected maternal body weight and food
consumption also resulted in an increased litter incidence of increased
thoracic ribs, indicating increased prenatal (qualitative)
susceptibility. In the rabbits, there were no developmental effects
reported at any of the dose levels tested. In the rat 2-generation
reproductive toxicity study, there was no indication of increased
prenatal or postnatal susceptibility; maternal toxicity (decreased body
weight) and offspring toxicity (decreased lactational weight gain in
both generations) occurred at the same dose. Reproductive parameters
were not affected. Acute and subchronic neurotoxicity studies in the
rat show no evidence that fenpyroximate specifically targets the
nervous system. In the acute neurotoxicity study, neurotoxicity signs
such as decreases in motor activity occurred in the presence of other
effects including decreases in body weight and food consumption, and in
the absence of neuropathology. Similar results were noted in a delayed
acute neurotoxicity study in the hen where no effects (neurotoxic or
otherwise) were reported. The results of the rat subchronic
neurotoxicity study did not indicate any neurotoxicity-specific
effects; deficits in body weight and food consumption were the main
effects reported. Effects reported in a rat immunotoxicity study were
limited to decreased body-weight gain, indicating the fenpyroximate
does not directly target the immune system. There is no evidence of
carcinogenic potential for fenpyroximate based on the results of
carcinogenicity studies via the oral route in either the rats or mice
resulting in the carcinogenicity classification of ``not likely'' to be
carcinogenic to humans. Genotoxicity studies including mutagenicity did
not

demonstrate any genotoxic potential resulting from fenpyroximate
exposure.
    Specific information on the studies received and the nature of the
adverse effects caused by fenpyroximate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: ``Fenpyroximate. Human-Health Risk
Assessment for Proposed Section 3 Uses on Stone Fruits (Group 12-12),
Tuberous and Corm Vegetables (Subgroup 1C), and Small Vine Climbing
Fruits Except Kiwifruit (Subgroup 13-07F), dated May 8, 2013 at
Appendix A'', p. 30 in docket ID number EPA-HQ-OPP-2012-0716-0003.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenpyroximate used for
human risk assessment is discussed in Unit III. of the final rule
published in the Federal Register of Wednesday, December 12, 2012 (77
FR 73945) (FRL-9360-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenpyroximate, EPA considered exposure under the
petitioned-for tolerances as well as all existing fenpyroximate
tolerances in 40 CFR 180.566. EPA assessed dietary exposures from
fenpyroximate in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for fenpyroximate. In estimating acute dietary exposure, EPA used the
Dietary Exposure Evaluation Model--Food Consumption Intake Database
(DEEM-FCID, ver. 3.16), which incorporates consumption information from
the U.S. Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America (NHANES/WWEIA); 2003-2008.
As to residue levels in food, EPA assumed 100 percent crop treated
(PCT), tolerance-level residues for all commodities, DEEM (ver. 7.81)
default processing factors for all commodities except for apple, pear,
and grape juice; grape, raisin; orange, grapefruit, tangerine, lemon
and lime juice; tomato paste and puree; and peppermint and spearmint
oil. Chemical-specific data were used to calculate empirical processing
factors for these commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT,
tolerance-level residues for all commodities, DEEM (ver. 7.81) default
processing factors for all commodities except for apple, pear, and
grape juice; grape, raisin; orange, grapefruit, tangerine, lemon and
lime juice; tomato paste and puree; and peppermint and spearmint oil.
Chemical-specific data were used to calculate empirical processing
factors for these commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenpyroximate does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
fenpyroximate. Tolerance-level residues and/or 100 PCT were assumed for
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for fenpyroximate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenpyroximate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) model,
the Screening Concentration in Ground Water (SCI-GROW) model, and a
Provisional Cranberry Model, the Agency calculated conservative
estimated drinking water concentrations (EDWCs) of fenpyroximate. Tier
1, EDWCs reflect exposure in drinking water to the residues of
fenpyroximate and its isomer/degradate, its cis isomer M-1, and its
carboxylic acid M-3, all of which are assumed to have similar toxicity.
    For acute exposures, EDWCs are estimated to be 43 parts per billion
(ppb) for surface water and 0.27 ppb for ground water.
    For chronic exposures, EDWCs are estimated to be 8.6 ppb for
surface water and 0.27 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 43 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 8.6 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticide, and flea and tick control on pets). Fenpyroximate is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fenpyroximate to share a common mechanism of
toxicity with any other substances, and fenpyroximate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of

this tolerance action, therefore, EPA has assumed that fenpyroximate
does not have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is evidence of
increased prenatal (qualitative) susceptibility in a rat prenatal
developmental toxicity study. A dose level that marginally affected
maternal body weight and food consumption also resulted in an increased
litter incidence of increased thoracic ribs. However, concern for
prenatal and postnatal toxicity to fenpyroximate is low because:
    i. There was a clear NOAEL in the rat prenatal developmental
toxicity study;
    ii. The NOAEL for this developmental study is being used as POD for
the acute dietary risk assessment for the population of concern-females
13-49 years old;
    iii. In the rabbit, there were no developmental effects reported at
the levels tested; and
    iv. In the rat 2-generation reproductive toxicity study, there was
no indication of increased prenatal or postnatal susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X for all exposure scenarios. That decision is
based on the following findings:
    i. The toxicity database for fenpyroximate is complete.
    ii. There is no indication that fenpyroximate is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is evidence that fenpyroximate results in increased
susceptibility in utero rats or rabbits in the prenatal developmental
studies or in young rats in the 2-generation reproduction study.
Increased (qualitative) prenatal susceptibility was seen following oral
exposures in the rat developmental toxicity study, but the concern for
these effects is low, for the reasons noted in Unit III.D.2. Therefore,
a 10X FQPA safety factor is not necessary to account for this increased
susceptibility of infants and children.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessment utilizes tolerance-
level residues (established or recommended) and 100 PCT for all
proposed/established commodities. By using these assumptions, the acute
and chronic exposures/risks will not be underestimated. The dietary
drinking water assessment utilizes water concentration values generated
by models and associated modeling parameters, which are designed to
provide conservative, health-protective, high-end estimates of water
concentrations that will not likely be exceeded. There are no
registered or proposed residential uses. These assessments will not
underestimate the exposure and risks posed by fenpyroximate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fenpyroximate will occupy 13% of the aPAD for females 13-49 years
old and 6.2% of the aPAD for children 1-2 years old, the population
group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenpyroximate from food and water will utilize 15% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenpyroximate.
    3. Short- and intermediate-term risks. Short-, and intermediate-
term aggregate exposure takes into account short-, and intermediate-
term residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short-, and
intermediate-term adverse effects were identified; however,
fenpyroximate is not registered for any use patterns that would result
in short-, and intermediate-term residential exposures. Therefore, no
further assessment of short-, and intermediate-term risks is necessary.
EPA relies on the chronic dietary risk assessment for evaluating short-
, and intermediate-term risks for fenpyroximate.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenpyroximate is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography method with
nitrogen/phosphorus detection (GC/NPD), Method S19) is available to
enforce the tolerance expression. Method S19 has passed an Agency
validation and has a limit of quantitation (LOQ) of 0.05 ppm for the
combined residues of fenpyroximate and M-1 in snap beans and avocados.
A data-gathering liquid chromatography/mass spectroscopy/mass
spectroscopy (LC/MS/MS) method is also available.
    These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the

international maximum residue limits (MRLs) established by the Codex
Alimentarius Commission (Codex), as required by FFDCA section
408(b)(4). The Codex Alimentarius is a joint United Nations Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    Codex MRLs are established for residues of fenpyroximate per se in
grapes (fresh and dried). Harmonization with the Codex MRLs is not
possible because the U.S. tolerance expression includes an additional
isomer and the U.S. use pattern requires a higher numerical value.

C. Revisions to Petitioned-For Tolerances

    As EPA explained in its latest crop group rulemaking (77 FR 50617,
August 22, 2012), EPA will attempt to conform petitions seeking
tolerances for crop groups to the newer established crop groups, rather
than establish new tolerances under the pre-existing crop groups, as
part of its effort to eventually convert tolerances for any pre-
existing crop group to tolerances with coverage under the revised crop
group. Therefore, although the petitioner requested tolerances for
``Fruit, stone, group 12'', EPA evaluated and is establishing
tolerances for the crop group ``Fruit, stone, group 12-12.''
    Lastly, the Agency is removing the entry for ``grape'' from the
table at 40 CFR 180.566 (a)(1) since the tolerance for ``Fruit, small,
vine climbing, except fuzzy kiwifruit, subgroup 13-07F'' at 1.0 ppm
established by this action will subsume the existing tolerance.

V. Conclusion

    Therefore, tolerances are established for residues the insecticide
fenpyroximate, including its metabolites and degradates, in or on the
commodities Fruit, small, vine climbing, except fuzzy kiwifruit,
subgroup 13-07F at 1.0 ppm; Fruit, stone, group 12-12 at 2.0; and
Vegetable, tuberous and corm, subgroup 1C at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 3, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.566 is amended by removing the entry for ``grape, 1.0''
and by alphabetically adding the following entries to the table in
paragraph (a)(1) to read as follows:

Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                 1.0
 subgroup 13-07F...........................................
Fruit, stone, group 12-12..................................          2.0

                                * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.10
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-14213 Filed 6-14-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54726-54727]
[FR Doc No: 2019-22221]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Noise Exposure Map Notice; Burlington International Airport,
South Burlington, Vermont

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
determination that the noise exposure maps for Burlington International
Airport, as submitted by the City of Burlington, Vermont, under the
provisions of Title I of the Aviation Safety and Noise Abatement Act of
1979, are in compliance with applicable requirements.

DATES: Applicable Date: The effective date of the FAA's determination
on the noise exposure maps is September 26, 2019.

FOR FURTHER INFORMATION CONTACT: Richard Doucette, Federal Aviation
Administration, New England Region, Airports Division, 1200 District
Ave., Burlington, Massachusetts 01803.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA finds
that the noise exposure maps submitted for Burlington International
Airport are in compliance with applicable requirements of Part 150,
effective September 26, 2019.
    Under Section 103 of Title I of the Aviation Safety and Noise
Abatement Act of 1979 (hereinafter referred to as ``the Act''), an
airport operator may submit to the FAA noise exposure maps that meet
applicable regulations and that depict non-compatible land uses as of
the date of submission of such maps, a description of projected
aircraft operations, and the ways in which such operations will affect
such maps. The Act requires such maps to be developed in consultation
with interested and affected parties in the local community, government
agencies, and persons using the airport.
    An airport operator who has submitted such noise exposure maps that
are found by FAA to be in compliance with the requirements of 14 CFR
part 150, promulgated pursuant to Title I of the Act, may submit a
noise compatibility program for FAA approval that sets forth the
measures the operator has taken, or proposes, for the introduction of
additional non-compatible uses.
    The FAA has completed its review of the noise exposure map and
related descriptions submitted by the City of Burlington, Vermont. The
specific maps under consideration were ``Figure 12, 2018 Existing
Conditions Noise Exposure Map'' on page 39 and ``Figure 13, 2023
Forecast Conditions Noise Exposure Map'' on page 41 in the submission.
The FAA has determined that these maps for Burlington International
Airport are in compliance with applicable requirements. This
determination is effective on September 26, 2019.
    FAA's determination on an airport operator's noise exposure maps is
limited to a finding that the maps were developed in accordance with
the procedures contained in Appendix A of Part 150. Such determination
does not constitute approval of the applicant's data, information or
plans, or a commitment to approve a noise compatibility program or to
fund the implementation of that program.
    If questions arise concerning the precise relationship of specific
properties to noise exposure contours depicted on a noise exposure map
submitted under Section 103 of the Act, it should be noted that the FAA
is not involved in any way in determining the relative locations of
specific properties with regard to the depicted noise contours, or in
interpreting the noise exposure maps to resolve questions concerning,
for example, which properties should be covered by the provisions of
Section 107 of the Act. These functions are inseparable from the
ultimate land use control and planning responsibilities of local
government. These local responsibilities are not changed in any way
under Part 150 or through FAA's review of a noise exposure map.
Therefore, the

responsibility for the detailed overlaying of noise exposure contours
onto the map depicting properties on the surface rests exclusively with
the airport operator that submitted the map or with those public
agencies and planning agencies with which consultation is required
under Section 103 of the Act. The FAA has relied on the certification
by the airport operator, under Section 150.21 of Part 150, that the
statutorily required consultation has been accomplished.
    Copies of the noise exposure maps and of the FAA's evaluation of
the maps are available for examination at the following locations:
    Burlington International Airport, 1200 Airport Drive #1, South
Burlington, Vermont 05403.
    Federal Aviation Administration, New England Region, Airports
Division, 1200 District Avenue, Burlington, Massachusetts 01803.
    Questions may be directed to the individual named above under the
heading: FOR FURTHER INFORMATION CONTACT.

    Issued in Burlington, Massachusetts on September 26, 2019.
Richard P. Doucette,
Environmental Program Manager, FAA New England Region, Airports
Division.
[FR Doc. 2019-22221 Filed 10-9-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45577-45578]
[FR Doc No: 2015-18648]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2011-0126]

 Reports, Forms and Record Keeping Requirements; Agency
Information Collection Activity Under OMB Review

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

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for

review and comment. The ICR describes the nature of the information
collections and their expected burden. The Federal Register Notice with
a 60-day comment period was published on January 2, 2015 [80 FR 99].

DATES: Comments must be submitted on or before August 31, 2015.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Kil-Jae Hong, NHTSA, 1200 New Jersey
Avenue SE., W52-232, NPO-520, Washington, DC 20590. Ms. Hong's
telephone number is<PHONE_NUMBER> and email address is<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with the Paperwork Reduction
Act of 1995, NHTSA conducted a qualitative phase of Consumer Research
which included Focus Groups. Based upon the qualitative phase research
results, NHTSA developed the communications materials its Fuel Economy
Consumer Education Program. This notice announces that the ICR for a
quantitative study of the communications materials, abstracted below,
has been forwarded to OMB requesting review and comment. The ICR
describes the nature of the information collection and its expected
burden. This is a request for new collection.
    Title: 49 CFR 575--Consumer Information Regulations (sections 103
and 105) Quantitative Research.
    OMB Number: Not Assigned.
    Type of Request: New collection.
    Abstract: The Energy Independence and Security Act of 2007 (EISA),
enacted in December 2007, included a requirement that the National
Highway Traffic Safety Administration (NHTSA) develop a consumer
information and education campaign to improve consumer understanding of
automobile performance with regard to fuel economy, Greenhouse Gases
(GHG) emissions and other pollutant emissions; of automobile use of
alternative fuels; and of thermal management technologies used on
automobiles to save fuel. A critical step in developing the consumer
information program was to conduct proper market research to understand
consumers' knowledge surrounding these issues, evaluate potential
consumer-facing messages in terms of clarity and understand the
communications channels in which these messages should be present. The
research allowed NHTSA to refine messaging to enhance comprehension and
usefulness and help guide the development of an effective
communications plan. The consumer market research informed NHTSA that
digital assets would be the best format and distribution through web
and mobile channels would be the best media. The assets being tested
during this quantitative study are a result from the qualitative focus
groups, and include an animated infographic, video, and fact sheets.
    Affected Public: Passenger vehicle consumers.
    Estimated Total Annual Burden: 666.67 hours.
    Number of Respondents: 2,000.
    The estimated annual burden hour for the online survey is 666.67
hours. Based on the Bureau of Labor and Statistics' median hourly wage
(all occupations) in the May 2013 National Occupational Employment and
Wage Estimates, NHTSA estimates that it would cost an average of $16.87
per hour if all respondents were interviewed on the job. Therefore, the
agency estimates that the cost associated with the burden hours is
$11,247 ($16.87 per hour x 666.67 interviewing hours).
    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 Departments estimate 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. Comment to OMB is most effective if OMB
receives it within 30 days of publication.

Colleen Coggins,
Acting Senior Associate Administrator, Policy and Operations.
[FR Doc. 2015-18648 Filed 7-29-15; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Proposed Rules]
[Page 9716-9718]
[DOCID:fr05mr07-17]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2007-0021]
RIN 1218-AC16

Announcement of Stakeholder Meetings on Occupational Exposure to
Ionizing Radiation

AGENCY: Occupational Safety and Health Administration, Labor.

ACTION: Announcement of stakeholder meetings.

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SUMMARY: The Occupational Safety and Health Administration (OSHA)
invites interested parties to participate in informal stakeholder
meetings on Occupational Exposure to Ionizing Radiation. These meetings
are a continuation of OSHA's information collection efforts on ionizing
radiation.

DATES: Stakeholder meetings: The stakeholder meeting dates are:
    1. 8:30 a.m.-4:30 p.m., March 16, 2007, Washington, DC.
    2. 8:30 a.m.-4:30 p.m., March 26, 2007, Orlando, FL.
    Notice of intention to attend a stakeholder meeting: You must
submit a notice of intention to attend the Washington, DC, or Orlando,
FL, stakeholder meeting by March 9, 2007.

ADDRESSES: Stakeholder meetings: The stakeholder meeting locations are:
    1. Frances Perkins Building, U.S. Department of Labor, 200
Constitution Avenue, NW., Washington, DC 20210.
    2. For the location of the Orlando, FL, stakeholder meeting,
contact Liset Navas at<PHONE_NUMBER>.
    Notices of intention to attend a stakeholder meeting: You may
submit your notice of intention to attend a stakeholder meeting by any
of the following methods:
    Electronic: OSHA encourages you to submit your notice of intention
to attend to<EMAIL_ADDRESS>    Facsimile: You may fax your notice of intention to attend to (202)
693-1678.
    Regular mail, express delivery, hand delivery, messenger and
courier service: Submit your notice of intention to attend to Liset
Navas, OSHA, Directorate of Standards and Guidance, Room N-3718, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone<PHONE_NUMBER>. The Department of Labor's and OSHA's
normal hours of operation are 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: For further information on the stakeholder meetings
and submitting notices of intention to attend one of the meetings, see
the ``Public Participation'' heading in the SUPPLEMENTARY INFORMATION
section of this notice.
    Because of security-related procedures, the use of regular mail may
cause a significant delay in the receipt of notices of intention to
attend. For information about security procedures concerning the
delivery of materials by hand, express mail, messenger or courier
service, please contact Liset Navas at<PHONE_NUMBER>.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This document, non-attributed notes from

the stakeholder meetings, as well as news releases and other relevant
information, will also be available at OSHA's Web page at http://www.osha.gov
.

FOR FURTHER INFORMATION CONTACT: Michael Seymour, Director, OSHA,
Office of Physical Hazards, Directorate of Standards and Guidance, Room
N-3718, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The use of ionizing radiation has increased significantly in recent
years. Today, ionizing radiation is used in a

wide variety of workplaces and operations, including security
operations, hospitals and medical offices, dental offices,
manufacturing worksites, research facilities, forestry and other
agricultural worksites, and wastewater treatment plants.
    In 2005, OSHA initiated information collection efforts to obtain
data, information, and comment on the increased workplace use of
ionizing radiation and other related issues. These efforts started with
the publication of a Request for Information (RFI) on May 3, 2005 (70
FR 22828). OSHA received 51 comments in response to the RFI. To
supplement this information, OSHA is inviting interested parties to
attend informal stakeholder meetings on the Occupational Exposure to
Ionizing Radiation. OSHA will use the data and materials obtained
through these information collections efforts to determine, in
conjunction with other Federal agencies, whether regulatory action is
necessary to protect employees from ionizing radiation exposure.
    OSHA's existing standard on Ionizing Radiation (29 CFR 1910.1096)
was adopted in 1971 pursuant to section 6(a) of the Act (29 U.S.C.
655). The standard has remained largely unchanged since that time.
    OSHA's Ionizing Radiation standard applies to all workplaces except
agricultural operations and those workplaces exempted from OSHA
jurisdiction under section 4(b)(1) of the Occupational Safety and
Health Act of 1970 (the Act) (29 U.S.C. 653). Section 4(b)(1) states:

    Nothing in this Act shall apply to working conditions of
employees with respect to which other Federal agencies, and State
agencies acting under section 274 of the Atomic Energy Act of 1954,
as amended (42 U.S.C. 2021), exercise statutory authority to
prescribe or enforce standards or regulations affecting occupational
safety and health.

    The Nuclear Regulatory Commission (NRC) has statutory authority for
licensing and regulating nuclear facilities and materials as mandated
by the Atomic Energy Act of 1954 (as amended)(42 U.S.C. 2011 et seq.),
the Energy Reorganization Act of 1974 (as amended), the Nuclear
Nonproliferation Act of 1978, and other applicable statutes.
Specifically, the NRC has the authority to regulate source, byproduct
and certain special nuclear materials (e.g., nuclear reactor fuel).
This authority covers radiation hazards in NRC-licensed nuclear
facilities produced by radioactive materials and plant conditions that
affect the safety of radioactive materials and thus present an
increased radiation hazard to workers.
    In 1988, OSHA and NRC signed a memorandum of understanding (MOU)
delineating the general areas of responsibility of each agency (CPL
2.86, December 22, 1989). The MOU specifies that at NRC-licensed
facilities OSHA has authority to regulate occupational ionizing
radiation sources not regulated by NRC (CPL 2.86). Examples of non-NRC
regulated radiation sources include X-ray equipment, accelerators,
electron microscopes, betatrons, and some naturally occurring radiation
sources (CPL 2.86). (See the Ionizing Radiation RFI (70 FR 22828) for
additional information on sources of ionizing radiation exposure,
workplace uses of ionizing radiation, and health effects of ionizing
radiation exposure.)
    Most recently, the Energy Policy Act of 2005 authorized NRC to
regulate material made radioactive by accelerators by adding
``accelerator-produced material'' to the definition of ``byproduct
material'' that NRC is authorized to license and regulate. The Energy
Policy Act directed NRC to issue licensing and compliance oversight
regulations to carry out the legislation. Until NRC issues and begins
enforcing those regulations, OSHA retains authority over both
accelerators and the materials they produce.

Stakeholder Meetings

    OSHA intends to hold four stakeholder meetings on Occupational
Exposure to Ionizing Radiation, two of which the Agency is announcing
in this notice. OSHA will publish a Federal Register notice announcing
the other two stakeholder meetings when meeting arrangements are
finalized. The first stakeholder meeting, to be held in Washington, DC,
will cover the uses of ionizing radiation in the healing arts,
including medicine, dentistry, chiropractor services and veterinary
medicine. The second stakeholder meeting, to be held in Orlando, FL, in
conjunction with the Annual Research Symposium of the American Society
for Nondestructive Testing, will cover nondestructive testing. The
other two stakeholder meetings will cover non-medical use of
accelerators and the use of ionizing radiation in security operations.
OSHA encourages interested parties to attend only the stakeholder
meeting that deals with their industry, occupation, or operation.
    The stakeholder meetings will be an opportunity for informal
discussion and the exchange of data, ideas, and points of view. To make
the stakeholder meetings as productive as possible, OSHA requests that
interested parties attending stakeholder meetings be prepared to
discuss the following issues relating to occupational exposure to
ionizing radiation in their respective industries, occupations, or
operations:
     Uses of ionizing radiation;
     Available exposure data;
     Controls utilized to minimize exposure; and
     Training.

In addition, OSHA will use the stakeholder meetings to discuss comments
and materials received in response to the RFI.

    Each stakeholder meeting will begin with OSHA's presentation on
Agency responsibilities related to occupational exposure to ionizing
radiation followed by stakeholder questions. OSHA will devote the
remainder of each meeting to informal discussions on the topics above
and related issues. In particular, OSHA is interested in hearing
firsthand from employers and employees and in reviewing exposure data.
Meeting participants are not expected to prepare and present formal
testimony.

Public Participation--Submission of Notices of Intention To Attend and
Access to Docket

    You may submit notices of intention to attend one of the
stakeholder meetings (1) electronically, (2) by facsimile, or (3) by
hard copy. All notices must identify the Agency name and docket number
for this notice (Docket No. OSHA-2007-0021). Because of security-
related procedures, the use of regular mail may cause a significant
delay in the receipt of notices of intention to attend. For information
about security procedures concerning the delivery of materials by hand,
express mail, messenger or courier service, please contact Liset Navas
at<PHONE_NUMBER>.
    Notices of intention to attend a stakeholder meeting must include
the following information:
     Name and contact information;
     Affiliation (e.g., organization, association), if any;
     The stakeholder meeting you plan to attend;
     Whether you wish to be an active participant or observer;
and
     Whether you need any special accommodations in order to
attend or participate in a stakeholder meeting.
    For access to comments and materials received in response to the
RFI, go to OSHA Docket No. H-016 on OSHA's Web page at http://www.osha.gov.
 Contact the OSHA Docket Office, Docket No. H-016, Room N-

2625, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210; telephone<PHONE_NUMBER> (OSHA's TTY number is
(877) 889-5627) for

information about materials in the RFI docket that are not available
through OSHA's Web page and for assistance in using the Web page to
locate docket submissions.
    Electronic copies of this Federal Register notice are available at
http://www.regulations.gov. This document, as well as news releases and

other relevant information, also are available at OSHA's Web page at
http://www.osha.gov.

Authority

    This notice was prepared under the direction of Edwin G. Foulke,
Jr., Assistant Secretary for Occupational Safety and Health. It is
issued under Sections 4 and 8 of the Occupational Safety and Health Act
of 1970 (29 U.S.C. 653, 657), and Secretary of Labor's Order No. 5-2002
(67 FR 65008).

    Signed at Washington, DC on this 27th day of February, 2007.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor.
[FR Doc. E7-3689 Filed 3-2-07; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Proposed Rules]
[Pages 38867-38872]
[FR Doc No: 2013-15504]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. FDA-2012-N-0303]

Gastroenterology-Urology Devices; Reclassification of Implanted
Blood Access Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
administrative order to reclassify the implanted blood access device
preamendments class III device into class II (special controls) and
subject to premarket notification, and to further clarify the
identification. FDA is proposing this reclassification under the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new
information pertaining to the device. This action implements certain
statutory requirements.

DATES: Submit either electronic or written comments on the proposed
order by July 29, 2013. See section XII for the proposed effective date
of any final order that may publish based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-0303, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-0303 for this order. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The FD&C Act establishes a comprehensive system for the regulation
of medical devices intended for human use. Section 513 of the FD&C Act
(21 U.S.C. 360c) established three categories (classes) of devices,
reflecting the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR Part 807).
    On July 9, 2012, the Food and Drug Administration Safety and
Innovation Act (FDASIA) was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended the device reclassification procedures under
section 513(e) of the FD&C Act, changing the process for reclassifying
a device from rulemaking to an administrative order. Prior to the
enactment of FDASIA, FDA published a proposed rule under section 513(e)
proposing the reclassification of implanted blood access devices for
hemodialysis (77 FR 36951; June 20, 2012). FDA is issuing this proposed
administrative order to comply with the new procedural requirement
created by FDASIA when reclassifying a preamendments class III device.
Also as required by section 513(e) of the FD&C Act, FDA has scheduled a
panel meeting to discuss the proposed reclassification for June 27,
2013 (78 FR 25747; May 2, 2013). The three comments submitted in
response to the proposed rule on implanted blood access devices for
hemodialysis will be considered under this proposed administrative
order and do not need to be resubmitted. No objections to the proposed
reclassification were submitted. This

action is intended solely to fulfill the procedural requirements for
reclassification implemented by FDASIA. FDA is also issuing the draft
guidance, ``Implanted Blood Access Devices for Hemodialysis,'' which
provides recommendations on how to comply with the special controls
that are necessary to provide a reasonable assurance of the safety and
effectiveness of the device.
    Section 513(e) of the FD&C Act provides that FDA may, by
administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
or an interested person may petition FDA to reclassify a preamendments
device. The term ``new information,'' as used in section 513(e) of the
FD&C Act, includes information developed as a result of a reevaluation
of the data before the Agency when the device was originally
classified, as well as information not presented, not available, or not
developed at that time. (See, e.g., Holland-Rantos Co. v. United States
Dep't of Health, Educ., & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir.
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard,
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent regulatory action where the
reevaluation is made in light of newly available regulatory authority
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762
F.Supp. 382, 388-391 (D.D.C. 1991)), or in light of changes in
``medical science.'' (See Upjohn v. Finch supra, 422 F.2d at 951.)
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g.,
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens
Association v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474
U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the valid scientific
evidence upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
premarket approval application (PMA). (See section 520(c) of the FD&C
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by
the Food and Drug Administration Modernization Act of 1997 (FDAMA),
provides that FDA may use, for reclassification of a device, certain
information in a PMA 6 years after the application has been approved.
This includes information from clinical and preclinical tests or
studies that demonstrate the safety or effectiveness of the device, but
does not include descriptions of methods of manufacture or product
composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments from all affected stakeholders, including
patients, payors, and providers. In addition, the proposed order must
set forth the proposed reclassification, and a substantive summary of
the valid scientific evidence concerning the proposed reclassification,
including the public health benefits of the use of the device, and the
nature and incidence (if known) of the risk of the device. (See section
513(e)(1)(A)(i) of the FD&C Act.)
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    As discussed in the preamble to the proposed rule (46 FR 7616;
January 23, 1981), the Gastroenterology-Urology Devices Panel
recommended that both implanted and nonimplanted blood access devices
be classified into class II. Although FDA agreed with the panel
recommendation for nonimplanted blood access devices, FDA disagreed
with the panel for implanted blood access devices and proposed that
implanted blood access devices be classified into class III because FDA
believed that the device presented a potential unreasonable risk of
illness or injury to the patient. FDA also noted that the implanted
blood access device is part of a life-supporting and life-sustaining
system and that general controls and performance standards were
insufficient to provide reasonable assurance of the safety and
effectiveness of implanted blood access devices.
    In 1983, FDA classified implanted blood access devices into class
III, but the accessories to these devices into class II (48 FR 53012;
November 23, 1983). In 1987, FDA published a clarification by inserting
language in the codified language stating that no effective date had
been established for the requirement for premarket approval for
implanted blood access devices (52 FR 17732 at 17738; May 11, 1987).
    In 2009, FDA published an order for the submission of information
on implanted blood access devices (74 FR 16214; April 9, 2009). In
response to that order, FDA received information in support of
reclassification from 15 device manufacturers who all recommended that
implanted blood access devices be reclassified to class II. The
manufacturers stated that safety and effectiveness of these devices may
be assured by bench testing, biocompatibility testing, sterility
testing, expiration date testing, labeling, and standards.
    On June 20, 2012, FDA published a proposed rule proposing the
reclassification of implanted blood access devices for hemodialysis
from class III to class II (77 FR 36951) and announced the availability
of a draft Special Controls Guidance Document that, when finalized,
would serve as a special control, if FDA reclassified these devices.
FDA believed that the special controls as described in the guidance
document entitled ``Class II Special Controls Guidance Document:
Implanted Blood Access Devices for Hemodialysis'' would be sufficient
to mitigate the risks to health associated with implanted blood access
devices for hemodialysis.
    The proposed rule provided for a comment period that was open until
September 18, 2012. FDA received three comments that suggested
modifications to the proposed Special Controls Guidance Document. These
were considered by FDA.
    On July 9, 2012, FDASIA was enacted, which amended the device
reclassification procedures under sections 513 and 515 of the FD&C Act
(21 U.S.C. 360c and 360e, respectively), changing the process for
taking final administrative action for these devices. Accordingly, FDA
is issuing a proposed administrative order to comply with the new
procedural requirement created by FDASIA when reclassifying a
preamendments class III device. Further, FDA intends to codify the
proposed special controls within the Sec.  876.5540(b)(1) (21 CFR
876.5540(b)(1)) classification regulation.

III. Device Description

    Implanted blood access devices include various flexible or rigid
tubes,

such as catheters or cannulae. Chronic hemodialysis catheters are soft,
blunt-tipped plastic catheters that have a subcutaneous ``cuff'' for
tissue ingrowth. They are placed in a central vein to allow blood
access. Chronic hemodialysis catheters serve as conduits for the
removal of blood from the patient, delivery to a hemodialysis machine
for filtering, and return of filtered blood to the patient. They have
no moving parts, consisting, essentially, of flexible tubing
terminating in rigid Luer lock connectors for attachment to a dialysis
machine. Subcutaneous catheters are totally implanted below the skin
surface with no external communication. Arteriovenous shunts and vessel
tips are tubing with tapered tips that are inserted into the artery and
vein. The tubing is attached to the roughened or etched outer surface
of the tip. The tubing is external to the skin and can be accessed with
needles.
    FDA is proposing in this order to modify the identification
language from how it is presently written in Sec.  876.5540(a)(1) for
additional clarification. FDA is clarifying in the identification that
these are prescription devices and modifying the examples of devices
(e.g., catheter, cannulae) in the identification language to be
consistent with existing legally marketed devices covered by this
classification.

IV. Proposed Reclassification

    FDA is proposing that implanted blood access devices for
hemodialysis be reclassified from class III to class II. In this
proposed order, the Agency has identified special controls under
section 513(a)(1)(B) of the FD&C Act that, together with general
controls (including prescription-use restrictions) applicable to the
devices, would provide reasonable assurance of their safety and
effectiveness. Absent the special controls identified in this proposed
order, general controls applicable to the device are insufficient to
provide reasonable assurance of the safety and effectiveness of the
device. FDA believes that this new information is sufficient to
demonstrate that the proposed special controls can effectively mitigate
the risks to health identified in the next section, and that these
special controls, together with general controls, will provide a
reasonable assurance of safety and effectiveness for implanted blood
access devices.
    FDA believes that these devices can be utilized to provide access
to a patient's blood for hemodialysis or other chronic uses for 30 days
or more. When used in hemodialysis, the device is part of an artificial
kidney system for the treatment of patients with renal failure or
toxemic conditions and provides access to a patient's blood for
hemodialysis.
    FDA has considered implanted blood access devices in accordance
with the reserved criteria set forth in section 510(l) and decided that
the device requires premarket notification (510(k) of the FD&C Act).
Therefore, the Agency does not intend to exempt this proposed class II
device from premarket notification (510(k)) submission as provided
under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering available information for the classification of
these devices, FDA has evaluated the risks to health associated with
the use of implanted blood access devices for hemodialysis and
determined the following risks to health are associated with its use:
     Thrombosis in patient and catheter occlusion, or central
venous stenosis. Inadequate blood compatibility of the materials used
in this device, blood pooling between dialysis sessions, or turbulent
blood pathways could lead to potentially debilitating or fatal
thromboembolism.
     Adverse tissue reaction. Inadequate tissue compatibility
of the materials used in this device could cause an immune reaction.
     Infection and pyrogen reactions. An improperly sterilized
device could cause a skin or bloodstream infection.
     Device failure. Weakness of connections or materials could
lead to blood loss or device fragment embolization.
     Cardiac arrhythmia, hemorrhage, embolism, nerve injury, or
vessel perforation. Improper placement into the heart or blood vessel
could damage tissues and result in injuries.
     Hemolysis. Turbulence or high pressure created by narrow
openings or changes in blood flow paths could cause the destruction of
red blood cells.
     Accidental withdrawal or catheter migration. A catheter's
cuff may not allow adequate ingrowth from the surrounding subcutaneous
tissue, which could cause the device to dislodge or fall out with
subsequent blood loss.

VI. Summary of Reasons for Reclassification

    FDA believes that implanted blood access devices for hemodialysis
should be reclassified from class III to class II because special
controls, in addition to general controls, can be established to
provide reasonable assurance of the safety and effectiveness of the
device, and because general controls themselves are insufficient to
provide reasonable assurance of its safety and effectiveness. In
addition, there is now sufficient information to establish special
controls to provide such assurance.
    While current clinical practice guidelines recommend avoiding
implanted blood access devices, such as catheters, if possible, they
are still a necessary treatment option, and are used in a significant
number of hemodialysis patients. While the risks are frequently cited,
there are many advantages of implanted blood access devices, which lead
to their relatively frequent use, as described previously. In many
cases, vascular access for hemodialysis is needed urgently, and the
alternatives, such as the arteriovenous fistula or the arteriovenous
graft require weeks and months, respectively, before they can be used.
Implanted blood access devices are frequently used as the immediate
hemodialysis vascular access and also as a bridge to a more permanent
vascular access. Additionally, some patients may have inadequate
vascular anatomy to establish a more permanent vascular access and may
require continued implanted blood access device use.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to
general controls, are necessary to provide reasonable assurance of
safety and effectiveness of these devices. Therefore, in accordance
with sections 513(e) and 515(i) of the FD&C Act and Sec.  860.130,
based on new information with respect to the device and taking into
account the public health benefit of the use of the device and the
nature and known incidence of the risk of the device, FDA, on its own
initiative, is proposing to reclassify this preamendments class III
device into class II. The Agency has identified special controls that
would provide reasonable assurance of their safety and effectiveness.
Implanted blood access devices for hemodialysis are prescription
devices restricted to patient use only upon the authorization of a
practitioner licensed by law to administer or use the device (proposed
Sec.  876.5540(a); Sec.  801.109 (21 CFR 801.109) (Prescription
devices.)).
    Since 1983 when FDA classified implanted blood access devices into
class III, sufficient evidence has been developed to support a
reclassification to class II with special controls. FDA has been
reviewing these devices for many years and their risks are well

known. The risks to health are identified in section V, and FDA
believes these risks can be adequately mitigated by special controls.
Catheters continue to evolve over time with improved materials and
insertion techniques to mitigate the risks. A review of 15 publications
shows a decrease in infections and an increase in patency over three
decades (1980 to 2011) (Refs. 1 to 15). The decrease in occurrence of
serious adverse events as evidenced through FDA's Manufacturer and User
Facility Device Experience (MAUDE) database, the valid scientific
evidence to support implanted blood access devices for hemodialysis
provided in the referenced publications, and FDA's review experience
with these devices, supports FDA's conclusion that the identified
special controls, including performance testing demonstrating that the
device performs as intended under anticipated conditions of use, is
appropriately designed, and includes adequate safeguards and labeling
to inform users of inappropriate use conditions, in addition to general
controls, provide reasonable assurance of the safety and effectiveness
of implanted blood access devices.

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with
general controls (including applicable prescription-use restrictions
and continuing 510(k) notification requirements), are sufficient to
mitigate the risks to health described in section V for implanted blood
access devices:
    1. Components of the device that come into human contact must be
demonstrated to be biocompatible. Material names and specific
designation numbers must be provided.
    2. Performance data must demonstrate that the device performs as
intended under anticipated conditions of use. The following performance
characteristics must be tested:
    a. Pressure versus flow rates for both arterial and venous lumens,
from the minimum flow rate to the maximum flow rate in 100 ml/min
increments, must be established. The fluid and its viscosity used
during testing must be stated.
    b. Recirculation rates for both forward and reverse flow
configurations must be established, along with the protocol used to
perform the assay, which must be provided.
    c. Priming volumes must be established.
    d. Tensile testing of joints and materials must be conducted. The
minimum acceptance criteria must be adequate for its intended use.
    e. Air leakage testing and liquid leakage testing must be
conducted.
    f. Testing of the repeated clamping of the extensions of the
catheter that simulates use over the life of the catheter must be
conducted, and retested for leakage.
    g. Mechanical hemolysis testing must be conducted.
    h. Chemical tolerance of the catheter to repeated exposure to
commonly used disinfection agents must be established.
    3. Performance data must demonstrate the sterility of the device.
    4. Performance data must support the shelf life of the device for
continued sterility, package integrity, and functionality over the
requested shelf life that must include tensile, repeated clamping, and
leakage testing.
    5. Labeling must bear all information required for the safe and
effective use of implanted blood access devices for hemodialysis
including the following:
    a. Labeling must provide arterial and venous pressure versus flow
rates, either in tabular or graphical format.
    b. Labeling must provide the arterial and venous priming volumes.
    c. Labeling must specify the forward and reverse recirculation
rates.
    d. Labeling must specify an expiration date.
    e. Labeling must identify any disinfecting agents that cannot be
used to clean any components of the device.
    f. Any contraindicated disinfecting agents due to material
incompatibility must be identified by printing a warning on the
catheter. Alternatively a label can be provided that can be affixed to
the patient's medical record with this information.
    g. The labeling must contain the following information:
Comprehensive instructions for the preparation and insertion of the
hemodialysis catheter, including recommended site of insertion, method
of insertion, a reference on the proper location for tip placement, a
method for removal of the catheter, anticoagulation, guidance for
management of obstruction and thrombus formation, and site care.
    h. The labeling must identify any coatings or additives and
summarize the results of performance testing for any coating or
material with special characteristics, such as decreased thrombus
formation or antimicrobial properties.
    6. For subcutaneous devices, the recommended type of needle for
access must be described, stated in the labeling, and test results on
repeated use of the ports must be provided.
    7. Coated devices must include a description of the coating or
additive material, duration of effectiveness, how the coating is
applied, and testing to adequately demonstrate the performance of the
coating.
    In addition, implanted blood access devices are prescription
devices restricted to patient use only upon the authorization of a
practitioner licensed by law to administer or use the device. (Proposed
Sec.  876.5540(a); Sec.  801.109 (Prescription devices.)). Under 21 CFR
807.81, the device would continue to be subject to 510(k) notification
requirements. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of a draft guidance document entitled
``Implanted Blood Access Devices for Hemodialysis,'' that, when
finalized, would provide recommendations on how to comply with the
special controls proposed in this order, if FDA reclassifies this
device (Ref. 16).

IX. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    This proposed order refers to currently 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 part 807, subpart E, have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR Part 814, subpart B, have been approved under OMB control number
0910-0231; and the collections of information under 21 CFR Part 801
have been approved under OMB control number 0910-0485.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) as amended requires FDA to issue final orders rather
than regulations, FDASIA also provides for FDA to revoke previously
issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under

section 513(e)(1)(A)(i), as amended by FDASIA, in this proposed order
we are proposing to revoke the requirements in Sec.  876.5540(b)(1)
related to the classification of implanted blood access devices as
class III devices and to codify the reclassification of implanted blood
access devices into class II (special controls).

XII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order
become effective on the date of its publication in the Federal Register
or at a later date if stated in the final order.

XIII. Comments

    Comments submitted to the previous dockets (2012-N-0303) have been
officially noted and do not need to be resubmitted. FDA will consider
previous docket comments in issuing any final orders for these devices.
Interested persons may submit either electronic comments regarding this
document or the associated guidance to http://www.regulations.gov or
written comments to the Division of Dockets Management (see ADDRESSES).
It is only necessary to send one set of comments. Identify comments
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.

XIV. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

1. Eisenhauer, E.D., R.J. Derveloy, and P.R. Hastings, ``Prospective
Evaluation of Central Venous Pressure (CVP) Catheters in a Large
City-County Hospital,'' Annals of Surgery, vol. 196, pp. 560-564,
1982.
2. Vanholder, V., N. Hoenich, and S. Ringoir, ``Morbidity and
Mortality of Central Venous Catheter Hemodialysis: A Review of 10
Years' Experience,'' Nephron, vol. 47, pp. 274-279, 1987.
3. Almirall, J., J. Gonzalez, J. Rello, et al., ``Infection of
Hemodialysis Catheters: Incidence and Mechanisms,'' American Journal
of Nephrology, vol. 9, pp. 454-459, 1989.
4. Boyle, M.J., W.F. Gawley, D.P. Hickey, et al., ``Experience Using
the Quinton Permcath for Haemodialysis in the Irish Republic,''
Nephrology Dialysis Transplantation, vol. 12, pp. 1934-1939, 1997.
5. Randolph, A.G., D.J. Cook, C.A. Gonzales, et al., ``Ultrasound
Guidance for Placement of Central Venous Catheters: A Meta-Analysis
of the Literature,'' Critical Care Medicine, vol. 24, pp. 2053-2058,
1996.
6. Arnold, W.P., ``Improvement in Hemodialysis Vascular Access
Outcomes in a Dedicated Access Center, Seminars in Dialysis, vol.
13, pp. 359-363, 2000.
7. Wivell, W., M.A. Bettmann, B. Baxter, et al., ``Outcomes and
Performance of the Tesio Twin Catheter System Placed for
Hemodialysis Access,'' Radiology, vol. 221, pp. 697-703, 2001.
8. Lund, G.B., S.O. Trerotola, P.F. Scheel, Jr, et al., ``Outcome of
Tunneled Hemodialysis Catheters Placed by Radiologists,'' Radiology,
vol. 198, pp. 467-472, 1996.
9. Trerotola, S.O., M.S. Johnson, V.J. Harris, et al., ``Outcome of
Tunneled Hemodialysis Catheters Placed via the Right Internal
Jugular Vein by Interventional Radiologists,'' Radiology, vol. 203,
pp. 489-495, 1997.
10. Prabhu, P.N., S.R. Kerns, F.W. Sabatelli, et al., ``Long-Term
Performance and Complications of the Tesio Twin Catheter System for
Hemodialysis Access,'' American Journal of Kidney Diseases, vol. 30,
pp. 213-218, 1997.
11. Schnabel, K.J., M.E. Simons, G.F. Zevallos, et al., ``Image-
Guided Insertion of the Uldall Tunneled Hemodialysis Catheter:
Technical Success and Clinical Follow-Up,'' Journal of Vascular and
Interventional Radiology, vol. 8, pp. 579-586, 1997.
12. Nassar, G.M. and J.C. Ayus, ``Infectious Complications of the
Hemodialysis Access,'' Kidney International, vol. 60, pp. 1-13,
2001.
13. Power, A., S.K. Singh, D. Ashby, et al., ``Long-term Tesio
Catheter Access for Hemodialysis Can Deliver High Dialysis Adequacy
With Low Complication Rates,'' Journal of Vascular and
Interventional Radiology, vol. 22, pp. 631-637, 2011.
14. Duncan, N.D., S. Singh, T.D. Cairns, et al., ``Tesio-Caths
Provide Effective and Safe Long-Term Vascular Access,'' Nephrology
Dialysis Transplantation, vol. 19, pp. 2816-2822, 2004.
15. Eisenstein, I., M. Tarabeih, D. Magen, et al., ``Low Infection
Rates and Prolonged Survival Times of Hemodialysis Catheters in
Infants and Children,'' Clinical Journal of the American Society of
Nephrology, vol. 6, pp. 793-798, 2011.
16. Draft guidance entitled ``Implanted Blood Access Devices for
Hemodialysis,'' available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

List of Subjects in 21 CFR Part 876

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR Part 876 be amended as follows:

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

0
1. The authority citation for 21 CFR Part 876 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 876.5540 is amended by revising paragraphs (a)(1), (b)(1),
and by removing paragraph (c) to read as follows:

Sec.  876.5540  Blood access device and accessories.

    (a) * * *
    (1) The implanted blood access device is a prescription device and
consists of various flexible or rigid tubes, such as catheters, or
cannulae, which are surgically implanted in appropriate blood vessels,
may come through the skin, and are intended to remain in the body for
30 days or more. This generic type of device includes: Single, double,
and triple lumen catheters with cuffs; subcutaneous ports with
catheters; shunts; cannula; vessel tips; and connectors specifically
designed to provide access to blood.
* * * * *
    (b) Classification. (1) Class II (special controls) for the
implanted blood access device. The special controls for this device
are:
    (i) Components of the device that come into human contact must be
demonstrated to be biocompatible. Material names and specific
designation numbers must be provided.
    (ii) Performance data must demonstrate that the device performs as
intended under anticipated conditions of use. The following performance
characteristics must be tested:
    (A) Pressure versus flow rates for both arterial and venous lumens,
from the minimum flow rate to the maximum flow rate in 100 ml/min
increments, must be established. The fluid and its viscosity used
during testing must be stated.
    (B) Recirculation rates for both forward and reverse flow
configurations must be established, along with the protocol used to
perform the assay, which must be provided.
    (C) Priming volumes must be established.
    (D) Tensile testing of joints and materials must be conducted. The
minimum acceptance criteria must be adequate for its intended use.
    (E) Air leakage testing and liquid leakage testing must be
conducted.
    (F) Testing of the repeated clamping of the extensions of the
catheter that simulates use over the life of the catheter must be
conducted, and retested for leakage.

    (G) Mechanical hemolysis testing must be conducted.
    (H) Chemical tolerance of the catheter to repeated exposure to
commonly used disinfection agents must be established.
    (iii) Performance data must demonstrate the sterility of the
device.
    (iv) Performance data must support the shelf life of the device for
continued sterility, package integrity, and functionality over the
requested shelf life that must include tensile, repeated clamping, and
leakage testing.
    (v) Labeling must bear all information required for the safe and
effective use of implanted blood access devices for hemodialysis
including the following:
    (A) Labeling must provide arterial and venous pressure versus flow
rates, either in tabular or graphical format.
    (B) Labeling must provide the arterial and venous priming volumes.
    (C) Labeling must specify the forward and reverse recirculation
rates.
    (D) Labeling must specify an expiration date.
    (E) Labeling must identify any disinfecting agents that cannot be
used to clean any components of the device.
    (F) Any contraindicated disinfecting agents due to material
incompatibility must be identified by printing a warning on the
catheter. Alternatively a label can be provided that can be affixed to
the patient's medical record with this information.
    (G) The labeling must contain the following information:
Comprehensive instructions for the preparation and insertion of the
hemodialysis catheter, including recommended site of insertion, method
of insertion, a reference on the proper location for tip placement, a
method for removal of the catheter, anticoagulation, guidance for
management of obstruction and thrombus formation, and site care.
    (H) The labeling must identify any coatings or additives and
summarize the results of performance testing for any coating or
material with special characteristics, such as decreased thrombus
formation or antimicrobial properties.
    (vi) For subcutaneous devices, the recommended type of needle for
access must be described, stated in the labeling, and test results on
repeated use of the ports must be provided.
    (vii) Coated devices must include a description of the coating or
additive material, duration of effectiveness, how the coating is
applied, and testing to adequately demonstrate the performance of the
coating.
* * * * *

    Dated: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15504 Filed 6-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 97 (Monday, May 20, 2013)]
[Notices]
[Pages 29427-29428]
[FR Doc No: 2013-11958]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Anti-Drug
Program for Personnel Engaged in Specified Aviation Activities

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. Information is collected to determine program compliance or
non-compliance of regulated aviation employers, oversight planning, to
determine who must provide annual Management Information System testing
information, and to communicate with entities subject to the program
regulations.

DATES: Written comments should be submitted by July 19, 2013.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

    OMB Control Number: 2120-0535.
    Title: Anti-Drug Program for Personnel Engaged in Specified
Aviation Activities.
    Form Numbers: There are no FAA forms associated with this
collection of information.
    Type of Review: Renewal of an information collection.
    Background: The FAA mandates specified aviation entities to conduct
drug and alcohol testing under its regulations, Antidrug and Alcohol
Misuse Prevention Programs for Personnel Engaged in Specified Aviation
Activities (14 CFR Part 121, appendices I and J), 49 U.S.C. 31306
(Alcohol and controlled substances testing), and the Omnibus
Transportation Employee Testing Act of 1991 (the Act). The FAA uses
information collected for determining program compliance or non-
compliance of regulated aviation employers, oversight planning,
determining who must provide annual MIS testing information, and
communicating with entities subject to the program regulations. In
addition, the information is used to ensure that appropriate action is
taken in regard to crew members and other safety-sensitive employees
who have tested positive for drugs or alcohol, or have refused to
submit to testing.
    Respondents: Approximately 7,000 affected entities annually.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 5 minutes.
    Estimated Total Annual Burden: 22,902 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    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 FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA 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.

    Issued In Washington, DC, on May 15, 2013.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2013-11958 Filed 5-17-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: January 3, 2007 (Volume 72, Number 1)]
[Notices]
[Page 167]
[DOCID:fr03ja07-74]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold the following meeting during the week
of January 1, 2007:
    A closed meeting will be held on Thursday, January 4, 2007 at 2
p.m.
    Commissioners, Counsels to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters may also be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (4), (5), (7), (8), (9)(B) and (10) and 17 CFR
200.402(a) (3), (4), (5), (7), (8), (9)(ii), and (10) permit
consideration of the scheduled matters at the Closed Meeting.
    Commissioner Campos, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting scheduled for Thursday,
January 4, 2007 will be:
    Formal orders of investigation;
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings of an
enforcement nature;
    An adjudicatory matter;
    Regulatory matters regarding financial institutions; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 28, 2006.
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-9968 Filed 12-28-06; 10:58 am]

BILLING CODE 8011-01-P