[Federal Register: September 28, 2007 (Volume 72, Number 188)]
[Rules and Regulations]
[Page 55073-55078]
[DOCID:fr28se07-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0993; FRL-8148-4]

Florasulam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for florasulam in or
on barley, grain at 0.01 ppm, barley, hay at 0.05 ppm, barley straw at
0.05 ppm, oat, grain at 0.01 ppm, oat, forage at 0.05 ppm, oat, hay at
0.05 ppm, oat, straw at 0.05 ppm, rye, grain at 0.01 ppm, rye, forage
at 0.05 ppm, rye, straw at 0.05 ppm, wheat, grain at 0.01 ppm, wheat,
forage at 0.05 ppm, wheat, hay at 0.05 ppm, and wheat, straw at 0.05
ppm. Dow AgroSciences LLC requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 28, 2007. Objections and
requests for hearings must be received on or before November 27, 2007,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0993. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail 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.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2006-0993 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before November 27, 2007.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-

HQ-OPP-2006-0993, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of January 24, 2007 (72 FR 3132) (FRL-8110-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7061) by Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis,
IN 46268. The petition requested that 40 CFR part 180 be amended by
establishing a tolerance for residues of the herbicide florasulam N-
(2,6-difluorophenyl)-8-fluoro-5-methoxy(1,2,4)triazolo(1,5-
c)pyrimidine-2-sulfonamide, in or on barley, grain at 0.01 parts per
million (ppm), barley, forage at 0.05 ppm, barley, hay at 0.05 ppm,
barley straw at 0.05 ppm, oats, grain at 0.01 ppm, oats, forage at 0.05
ppm, oats, hay at 0.05 ppm, oats, straw at 0.05 ppm, rye, grain at 0.01
ppm, rye, forage at 0.05 ppm, rye, hay at 0.05 ppm, rye, straw at 0.05
ppm, triticale, grain at 0.01 ppm, triticale, forage at 0.05 ppm,
triticale, hay at 0.05 ppm, triticale, straw at 0.05 ppm, wheat, grain
at 0.01 ppm, wheat, forage at 0.05 ppm, wheat, hay at 0.05 ppm, and
wheat, straw at 0.05 ppm. That notice referenced a summary of the
petition prepared by Dow AgroSciences, LLC, the registrant, which is
available to the public in the docket, http://www.regulations.gov.

Comments were received on the notice of filing. B. Sachau commented
that there are health implications listed for this chemical and a new
pesticide should not be approved because the safety tests required by
the EPA are insufficient. EPA's response to these comments is discussed
in Unit IV.C. of this document
    EPA is not establishing the proposed tolerances for barley, forage
and rye, hay because EPA does not consider these items to be
significant food commodities as noted in Table 1 of the OPPTS 860
guidelines. EPA is also not establishing the proposed tolerances for
triticale. Triticale is covered by the tolerance for wheat as specified
in 40 CFR 180.1(g).

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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    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 the petitioned-for tolerance
for residues of florasulam, N-(2,6-difluorophenyl)-8-fluoro-5-
methoxy(1,2,4)triazolo(1,5-c)pyrimidine-2-sulfonamide, on barley, grain
at 0.01 ppm, barley, hay at 0.05 ppm, barley, straw at 0.05 ppm, oat,
grain at 0.01 ppm, oat, forage at 0.05 ppm, oat, hay at 0.05 ppm, oat,
straw at 0.05 ppm, rye, grain at 0.01 ppm, rye, forage at 0.05 ppm,
rye, straw at 0.05 ppm, wheat, grain at 0.01 ppm, wheat, forage at 0.05
ppm, wheat, hay at 0.05 ppm, and wheat, straw at 0.05 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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. Specific information on the studies received and the nature
of the adverse effects caused by florasulam 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.
 The human health risk assessment document is

available in the docket established by this action, which is described
under ADDRESSES, and is identified as EPA-HQ-OPP-2006-0993 in that
docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for florasulam used for
human risk assessment is shown in Table 1 of this unit.

      Table 1.--Summary of Toxicological Dose and Endpoints for Florasulam for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                              Uncertainty
                                                             Factors/ FQPA
                                             Point of       Safety Factors/
           Exposure/Scenario                Departure       RfD, PAD, Level     Study and Toxicological Effects
                                                             of Concern for
                                                            Risk Assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary                                         N/A                N/A             No appropriate endpoint
(Females 13-49 years of age)..........                                                               identified.
----------------------------------------------------------------------------------------------------------------
Acute dietary                                         N/A                N/A             No appropriate endpoint
(General population including infants                                           identified. The effects observed
 and children)........................                                           in an acute neurotoxicity study
                                                                                were seen at a very high dose
                                                                                2,000 mg/kg/day) that is
                                                                              considered not applicable to human
                                                                                exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                           NOAEL= 5 mg/kg/          UFA = 10X            Chronic toxicity - dogs.
(All populations).....................                day          UFH = 10X      LOAEL = 50 mg/kg/day, based on
                                                              l FQPA SF = 1X  decreased body weights (17%), body
                                                           cPAD = 0.05 mg/kg/       weight gains (68%), and food
                                                                         day         consumption in the females;
                                                                               adverse liver alterations; slight
                                                                                vacuolation of the zona
                                                                                reticularis and zona fasciculate
                                                                                in the adrenal gland (fatty
                                                                                change) in both sexes.
----------------------------------------------------------------------------------------------------------------
Short-term dermal                                     N/A                N/A             No appropriate endpoint
(1 to 30 days) (Residential)..........                                        identified. 28-day dermal toxicity
                                                                                study - rats.
                                                                                LOAEL = not determined, no
                                                                                systemic effect up to the limit
                                                                                dose of 1,000 mg/kg/day.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-term (1-30 days)        NOAEL = 5 mg/kg/          UFA = 10X        90-day oral toxicity - dogs.
                                                      day          UFH = 10X       LOAEL = 50 mg/kg/day based on
                                               IAF = 100%       FQPA SF = 1X     increased incidence/severity of
                                                             Residential LOC  hepatic vacuolation in both sexes.
                                                               for MOE = 100
                                                               (Residential)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                      ``Not likely to be Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose
  (a = acute, c = chronic). RfD = reference dose. N/A = not applicable. LOC = level of concern. MOE = margin of
  exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to florasulam, EPA considered exposure under the petitioned-
for tolerances . EPA assessed dietary exposures from florasulam 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.
    No such effects were identified in the toxicological studies for
florasulam; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Method (DEEM-FCID)
and the food consumption data from the USDA 1994-1996, and 1998 CSFII.
As to residue levels in food, EPA assumed all foods for which there are
tolerances were treated and contain tolerance-level residues.
    iii. Cancer. There were no treatment-related tumors observed in
carcinogenicity studies in rats and mice. Because EPA has concluded
that florasulam is not a carcinogen, a cancer exposure assessment was
not needed.
    iv. Anticipated residue and percent crop treated (PCT) information.
The chronic analyses assumed tolerance level residues, 100% crop
treated (CT), and DEEM \TM\ default processing factors for all
registered and proposed commodities. For those processed commodities in
the DEEM-FCID \TM\ residue list which were not in DEEM \TM\, a
processing factor of 1 was assumed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for florasulam in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
florasulam. 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
.

    The 5-OH degradate formed by demethylation of florasulam is by far
the predominant environmental residue reaching maximum levels of 70% of
applied material in the hydrolysis and metabolism (soil, aquatic)
studies. This degradate is assumed to be of comparable toxicity to the
parent. On this basis, the residues of concern in drinking water are
the parent and 5-OH degradate. The Agency determined separate estimated
drinking water concentrations (EDWCs) for these two compounds using
FIRST (FQPA Index Reservoir Screening Tool) and SCI-GROW2 (Screening
Concentration in Ground Water) models.
    The modeled water residues were incorporated in the DEEM-FCID into
the food categories ``water, direct, all sources'' and ``water,
indirect, all sources.'' To arrive at the total EDWC, the maximum
chronic surface water value for the parent was added to the maximum
chronic surface water value for the major degradate. For the parent,
the chronic aerial spray value (16.8 ppTr) was higher than the ground
spray value. For the degradate, the ground spray value was the higher
of the two (217.5 ppTr). Adding the 2 values (16.8 + 217.5) results in
the total chronic EDWC of 234 ppTr, or 0.234 ppb. This information can
be found under docket identification (ID) number EPA-HQ-OPP-2006-0993.
    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,
termiticides, and flea and tick control on pets).
    Florasulam is not registered for use on any sites that would result
in residential exposure. Therefore, a residential exposure assessment
was not conducted.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to florasulam and any other
substances and florasulam does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that florasulam has 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 website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1.In general. Section 408 of FFDCA provides that EPA shall apply an
additional (``10X'') tenfold 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. In applying
this provision, EPA either retains the default value of 10X when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility and no residual uncertainties with regard to
pre- and/or postnatal toxicity following in utero exposure to rats or
rabbits and pre and/or post-natal exposures to rats.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for florasulam is complete.
    ii. There is no indication that florasulam is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that florasulam results in increased
susceptibility following in utero exposure to rats or rabbits in the
prenatal developmental studies or in young rats in the 2-generation
reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. Conservative ground and
surface water modeling estimates were used. These assessments will not
underestimate the dietary exposure and risks posed by florasulam. There
are no registered or proposed residential uses of florasulam.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. No acute dietary endpoint was identified; therefore,
florasulam is not expected to pose an acute risk.
    2. Chronic risk. The chronic dietary exposure analysis included
both food and drinking water. The general U.S. population and all
population subgroups have risk estimates that are below the level of
concern. The most highly exposed population subgroup is children (1-2
years) which utilizes <  1% of the cPAD. The general U.S. population
utilizes < 1% of the cPAD. There are no residential uses for florasulam
that result in chronic residential exposure to florasulam.
    3. Short-term risk/Intermediate-term risk. Short-term aggregate
exposure takes into account residential exposure plus chronic exposure
to food and water (considered to be a background exposure level).
Intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
    Florasulam is not registered for use on any sites that would result
in residential exposure. Therefore, short-term and intermediate-term
aggregate risk assessments were not conducted.
    4. Aggregate cancer risk for U.S. population. Exposure to
florasulam did not result in a treatment-related increase in tumor
formation in rats or mice; therefore, florasulam is not expected to
pose a cancer risk.
    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 florasulam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (capillary gas chromatography with
mass selective detection (GC/MSD) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

B. International Residue Limits

    Maximum residue levels (MRLs) are established in Canada for
residues of florasulam in barley, oats, and wheat grain at 0.01 ppm. No
harmonization issues exist since the same tolerance level is
recommended for the use in the United States. There are no Codex MRLs.

C. Response to Comments

    One comment was received in response to the notice of filing from
B. Sachau, 15 Elm St., Florham Park, NJ 07932. The commenter objected
to the sale or use of this product and the acceptance of anything
except a zero tolerance. The commenter also indicated health
implications from this chemical. However, the comment contained no
scientific data or evidence to rebut the Agency's conclusion that there
is a reasonable certainty that no harm will result from aggregate
expose to florasulam, including all anticipated dietary exposure and
all other exposures for which there is reliable information. The
commenter also questioned the rigor of the safety testing submitted on
florasulam; however, the comment was in the form of a conclusory
statement and provided no supporting documentation or rationale for the
position taken.

V. Conclusion

    Therefore, the tolerance is established for residues of florasulam,
N-(2,6-difluorophenyl)-8-fluoro-5-methoxy(1,2,4)triazolo(1,5-
c)pyrimidine-2-sulfonamide, in or on barley, grain at 0.01 ppm, barley,
hay at 0.05 ppm, barley, straw at 0.05 ppm, oat, grain at 0.01 ppm,
oat, forage at 0.05 ppm, oat, hay at 0.05 ppm, oat, straw at 0.05 ppm,
rye, grain at 0.01 ppm, rye, forage at 0.05 ppm, rye, straw at 0.05
ppm, wheat, grain at 0.01 ppm, wheat, forage at 0.05 ppm, wheat, hay at
0.05 ppm, and wheat, straw at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This
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) (Public Law 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: September 23, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.

0
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 180.633 is added to read as follows:

Sec.  180.633  Florasulam; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide florasulam N-(2,6-difluorophenyl)-8-fluoro-5-
methoxy(1,2,4)triazolo(1,5-c)pyrimidine-2-sulfonamide in or on the
following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Barley, grain........................................               0.01
Barley, hay..........................................               0.05
Barley, straw........................................               0.05
Oat, forage..........................................               0.05
Oat, grain...........................................               0.01
Oat, hay.............................................               0.05
Oat, straw...........................................               0.05
Rye, forage..........................................               0.05
Rye, grain...........................................               0.01

Rye, straw...........................................               0.05
Wheat, forage........................................               0.05
Wheat, grain.........................................               0.01
Wheat, hay...........................................               0.05
Wheat, straw.........................................               0.05
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. E7-19219 Filed 9-27-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 69 (Wednesday, April 10, 2013)]
[Rules and Regulations]
[Pages 21273-21274]
[FR Doc No: 2013-08293]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2013-0002]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: The date of issuance of the Flood Insurance Rate Map (FIRM)
showing BFEs and modified BFEs for each community. This date may be
obtained by contacting the office where the maps are available for
inspection as indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive

Officer of each community. The respective addresses are listed in the
table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Associate Administrator for
Mitigation has resolved any appeals resulting from this notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community. The BFEs and modified BFEs are
made final in the communities listed below. Elevations at selected
locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.
    Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

0
1. The authority citation for part 67 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                      * Elevation in
                                                                      feet (NGVD) +
                                                                    Elevation in feet
                                                                     (NAVD)
           Flooding source(s)              Location of referenced     Depth in feet       Communities affected
                                                 elevation            above ground -
                                                                       Elevation in
                                                                       meters (MSL)
                                                                         Modified
----------------------------------------------------------------------------------------------------------------
                                           Arlington County., Virginia
                                             Docket No.: FEMA-B-1117
----------------------------------------------------------------------------------------------------------------
Four Mile Run..........................  At the confluence with                   +10  Arlington County.
                                          the Potomac River.
                                         Just downstream of                       +11
                                          Jefferson Davis Memorial
                                          Highway (U.S. Route 1).
Pimmit Run (Backwater effects from       From the confluence with                 +40  Arlington County.
 Potomac River).                          the Potomac River to a
                                          point located
                                          approximately 112 feet
                                          downstream of Chain
                                          Bridge Road.
Potomac River..........................  At the confluence with                   +10  Arlington County.
                                          Four Mile Run.
                                         Approximately 0.39 mile                  +41
                                          upstream of Chain Bridge
                                          Road.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
- Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES

Arlington County.
Maps are available for inspection at the Arlington County Government Building, 2100 Clarendon Boulevard,
 Arlington, VA 22021.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2013-08293 Filed 4-9-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 85, Number 249 (Tuesday, December 29, 2020)]
[Notices]
[Pages 85646-85648]
[FR Doc No: 2020-28714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2246]

Fee Rates Under the Over-the-Counter Monograph Drug User Fee
Program for Fiscal Year 2021

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates under the Over-the-Counter (OTC) Monograph Drug user fee program
for fiscal year (FY) 2021. On March 27, 2020, a new section was added
to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by the
Coronavirus Aid, Relief, and Economic Security Act, which authorizes
FDA to assess and collect user fees from qualifying manufacturers of
OTC monograph drugs and submitters of OTC monograph order requests. FDA
refers to the OTC Monograph Drug user fee program as ``OMUFA''
throughout this document. This notice establishes the OMUFA fee rates
for FY 2021.

FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 744M of the FD&C Act (21 U.S.C. 379j-72) authorizes FDA to
assess and collect: (1) Facility fees from qualifying owners of OTC
monograph drug facilities and (2) fees from submitters of qualifying
OTC monograph order requests. These fees are to support FDA's OTC
monograph drug activities, which are detailed in section 744L(6) of the
FD&C Act (21 U.S.C. 379j-71(6)) and include various FDA activities
associated with OTC monograph drugs and inspection of facilities
associated with such products. For OMUFA purposes:
     An OTC monograph drug is a nonprescription drug without an
approved new drug application which is governed by the provisions of
section 505G of the FD&C Act ((21 U.S.C. 355h); see section 744L(5) of
the FD&C Act);
     An OTC monograph drug facility is a foreign or domestic
business or other entity that, in addition to meeting other criteria,
is engaged in manufacturing or processing the finished dosage form of
an OTC monograph drug (see section 744L(10) of the FD&C Act). The
Agency refers to such facility as Monograph Drug Facility (MDF);
     A contract manufacturing organization (CMO) facility is an
OTC monograph drug facility where neither the owner nor any affiliate
of the owner or facility sells the OTC monograph drug produced at such
facility directly to wholesalers, retailers, or consumers in the United
States (see section 744L(2) of the FD&C Act); and
     An OTC monograph order request (OMOR) is a request for an
administrative order, with respect to an OTC monograph drug, which is
submitted under section 505G(b)(5) of the FD&C Act (see section 744L(7)
of the FD&C Act).
    FDA will assess and collect facility fees with respect to the two
types of OTC monograph drug facilities--MDF and CMO facilities. A full
facility fee will be assessed to each qualifying person that owns a
facility identified as an MDF (see section 744M(a)(1)(A) of the FD&C
Act), and a reduced facility fee of two-thirds will be assessed to each
qualifying person that owns a facility identified as a CMO facility
(see section 744M(a)(1)(B)(ii) of the FD&C Act). The facility fees are
due 45 days after the date of publication \1\ of this notice (see
section 744M(a)(1)(D)(i) of the FD&C Act). As discussed below, OTC
monograph drug facilities are exempt from FY 2021 facility fees if they
had ceased OTC monograph drug activities, and updated their
registration with FDA to that effect, prior to December 31, 2019 (see
section 744M(a)(1)(B)(i) of the FD&C Act).
---------------------------------------------------------------------------

    \1\ Although under section 744M(c)(4)(A) of the FD&C Act, FDA
was to publish this notice not later than the second Monday in May
of 2020, we note that under section 744M(f)(1) of the FD&C Act,
OMUFA fees ``shall be collected and available for obligation only to
the extent and in the amount provided in advance in appropriations
Acts''. An appropriation of FY 2021 OMUFA fees was provided under
section 123 of the Continuing Appropriations Act, 2021, Division A
of Public Law 116-159 (October 1, 2020).
---------------------------------------------------------------------------

    In addition to facility fees, the Agency will assess and collect
fees from submitters of OMORs, except for OMORs which request certain
safety-related changes (as discussed below). There are two levels of
OMOR fees, based on whether the OMOR at issue is a Tier 1 or Tier 2
OMOR.\2\
---------------------------------------------------------------------------

    \2\ Under OMUFA, a Tier 1 OMOR is defined as any OMOR which is
not a Tier 2 OMOR (see section 744L(8) of the FD&C Act). Tier 2
OMORs are detailed in section 744L(9) of the FD&C Act.
---------------------------------------------------------------------------

    For FY 2021, the OMUFA fee rates are as follows: Tier 1 OMOR fees
($500,000), Tier 2 OMOR fees ($100,000), MDF facility fees ($14,060),
and CMO facility fees ($9,373). These fees are effective as of October
1, 2020, and will remain in effect through September 30, 2021. This
document describes the calculations used to set the OMUFA facility fees
and OMOR fees for FY 2021.

II. Facility Fee Revenue Amount for FY 2021

A. Base Fee Revenue Amount

    Under OMUFA, FDA sets annual facility fees to generate the total
facility fee revenues for each fiscal year established by section
744M(b) of the FD&C Act. The yearly base revenue amount is the starting
point for setting annual facility fee rates. The base revenue amount
for FY 2021 is $8,000,000 (see section 744M(b)(3)(A) of the FD&C Act).

B. Fee Revenue Adjustment for Inflation

    Under OMUFA, the annual base revenue amount for facility fees is
adjusted for inflation for FY 2022 and each subsequent FY (see section

744M(c)(1) of the FD&C Act). Because the adjustment for inflation does
not apply until FY 2022, the FY 2021 facility fee revenue is not
subject to an inflation adjustment by FDA.

C. Fee Revenue Adjustment for Additional Direct Cost

    Under OMUFA, $14,000,000 is added to the facility fee revenues for
FY 2021 to account for additional direct costs (see section
744M(c)(3)(A) of the FD&C Act).

D. Fee Revenue Adjustment for Operating Reserve

    Under OMUFA, FDA may further increase the FY 2021 facility fee
revenue and fees if such an adjustment is necessary in order to provide
up to 3 weeks of operating reserves of carryover user fees for OTC
monograph drug activities (see section 744M(c)(2)(A) of the FD&C Act).
However, under the statute, if the carryover balance exceeds 10 weeks
of operating reserves, FDA is required to decrease fees to provide for
not more than 10 weeks of operating reserves of carryover user fees
(see section 744M(c)(2)(C) of the FD&C Act).
    FDA is applying the operating reserve adjustment to increase the FY
2021 facility fee revenue and fees to enable the Agency to maintain 3
weeks of operating reserves of carryover user fees. To determine the 3-
week operating reserve amount, the FY 2021 annual base revenue adjusted
for additional direct costs (i.e., $8,000,000 + $14,000,000 =
$22,000,000), is divided by 52, and then multiplied by 3. The 3-week
operating reserve amount for FY 2021 is $1,269,231.
    As a result of the above calculations, the final FY 2021 OMUFA
target facility fee revenue is $23,269,000 (rounded to the nearest
thousand dollars).

III. Determination of FY 2021 OMOR Fees

    Under OMUFA, the FY 2021 Tier 1 OMOR fee is $500,000 and the Tier 2
OMOR fee is $100,000 (see section 744M(a)(2)(A)(i) and (ii) of the FD&C
Act, respectively). OMOR fees are not included in the OMUFA target
revenue calculation, which is based on the facility fees (see section
744M(b)(1) of the FD&C Act).
    An OMOR fee is generally assessed to each person who submits an
OMOR (see section 744M(a)(2)(A) of the FD&C Act). OMOR fees are due on
the date of the submission of the OMOR (see section 744M(a)(2)(B) of
the FD&C Act). The payor should submit the OMOR fee that applies to the
type of OMOR they are submitting (i.e., Tier 1 or Tier 2). FDA will
determine whether the requestor has submitted the appropriate OMOR fee
following receipt of the OMOR and the fee.
    An OMOR fee will not be assessed if the OMOR seeks to make certain
safety changes with respect to an OTC monograph drug. Specifically, no
fee will be assessed if FDA finds that the OMOR seeks to change the
drug facts labeling of an OTC monograph drug in a way that would add to
or strengthen: (1) A contraindication, warning, or precaution; (2) a
statement about risk associated with misuse or abuse; or (3) an
instruction about dosage and administration that is intended to
increase the safe use of the OTC monograph drug (see section
744M(a)(2)(C) of the FD&C Act).

IV. Facility Fee Calculations

A. Facility Fee Revenues and Fees

    For FY 2021, facility fee rates are being established to generate a
total target revenue amount equal to $23,269,000 (rounded to the
nearest thousand dollars). FDA used the methodology described below to
determine the appropriate number of MDF and CMO facilities to be used
in setting the OMUFA facility fees for FY 2021. FDA took into
consideration that the CMO facility fee is equal to two-thirds of the
amount of the MDF facility fee (see section 744M(a)(1)(B)(ii) of the
FD&C Act).

B. Estimate of the Number of Qualifying Facilities and Setting the
Facility Fees

    For FY 2021, FDA utilized the Agency's Electronic Drug Registration
and Listing System (eDRLS) to estimate the number of qualifying MDF or
CMO facilities that engage in the manufacturing or processing of the
finished dosage form of an OTC monograph drug. In setting the FY 2021
facility fees, FDA considers the fee-qualifying population of OTC
monograph drug facilities to be the population of establishments coded
in eDRLS with the business operation qualifier of ``manufactures human
over-the-counter drug products produced under a monograph'' or
``contract manufacturing for human over-the-counter drug products
produced under a monograph'' and indicating at least one of the
following business operations: Finished dosage form manufacture, label,
manufacture, pack, relabel, or repack. FDA estimated this population
through December 30, 2020, based on information provided by facilities
in eDRLS during the first three calendar quarters of 2020.
    Those facilities that only manufacture the active pharmaceutical
ingredient (or API) of an OTC monograph drug do not meet the definition
of an OTC monograph drug facility (see section 744L(10)(A)(i)(II)) of
the FD&C Act). Likewise, a facility is not considered an OTC monograph
drug facility if its only manufacturing or processing activities are
one or more of the following: (a) Production of clinical research
supplies; (b) testing; or (c) placement of outer packaging on packages
containing multiple products, for such purposes as creating multipacks,
when each monograph drug product contained within the overpackaging is
already in a final packaged form prior to placement in the outer
overpackaging (see section 744L(10)(A)(iii) of the FD&C Act). In
addition, as noted above, certain OTC monograph drug facilities are
exempt from facility fees. Under the statute, a facility fee will not
be assessed if the identified OTC monograph drug facility: (1) Has
ceased all activities related to OTC monograph drugs prior to December
31 of the year immediately preceding the applicable fiscal year; and
(2) has updated its eDRLS registration to reflect that change (see
section 744M(a)(1)(B)(i) of the FD&C Act). As the applicable fiscal
year for fee-setting under this notice is FY 2021, the year immediately
preceding the applicable fiscal year is FY 2020. December of FY 2020 is
December 2019. Thus, a FY 2021 facility fee will not be assessed with
respect to an OTC monograph drug facility that, prior to December 31,
2019, had ceased all activities related to OTC monograph drugs and
updated its eDRLS registration to that effect.
    FDA considered a number of factors that could affect collection of
the target revenue, including that FY 2021 is the first year of this
new user fee program and uncertainties related to the effects of the
COVID-19 public health emergency. In estimating the total number of
fee-paying facilities, the Agency made certain assumptions, including
that:
    (1) Facilities using expired Structured Product Labeling (SPL)
codes in eDRLS were no longer manufacturing and marketing OTC monograph
drugs;
    (2) Facilities that have deregistered in eDRLS have exited the
market;
    (3) Facilities that FDA believes registered incorrectly as OTC
monograph drug facilities (for example, because the associated drug
listings for these facilities do not include OTC monograph drugs but
instead indicate such products as OTC drug products under an approved
drug application or OTC animal drug products) are not engaged in
manufacturing or processing the finished dosage form of an OTC
monograph drug; and

    (4) Facilities that registered but do not have an active OTC
monograph drug product listing associated in their registration profile
are not manufacturing or processing such drug products.
    Each establishment paying the facility fee is counted as one fee-
paying unit. The total estimate of fee-paying units is further analyzed
to determine the number of respective MDF and CMO fee-paying units.
    Based on the data obtained from eDRLS, FDA estimates there will be
1,712 fee-paying units. The Agency estimates that 90 percent (1,712 x
.90 = 1,541, rounded) will incur the MDF fee and 10 percent (1,712 x
.10 = 171, rounded) will incur the CMO fee.
    To determine the number of full fee-paying equivalents (the
denominator) to be used in setting the OMUFA fees, FDA assigns a value
of 1 to each MDF (1,541) and a value of \2/3\ to each CMO (171 x \2/3\
= 114) for a full facility equivalent of 1,655 (rounded). The target
fee revenue of $23,269,000 is then divided by 1,655 for an MDF fee of
$14,060 and a CMO fee of $9,373.

V. Fee Schedule for FY 2021

    The fee rates for FY 2021 are displayed in table 1.

                    Table 1--Fee Schedule for FY 2021
------------------------------------------------------------------------
                                                            FY 2021 fee
                      Fee category                             rates
------------------------------------------------------------------------
OMOR:
  Tier 1................................................        $500,000
  Tier 2................................................         100,000
Facility Fees:
  MDF...................................................          14,060
  CMO...................................................           9,373
------------------------------------------------------------------------

VI. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2020, through September
30, 2021. To pay the OMOR, MDF, and CMO fees, complete an OTC Monograph
User Fee Cover Sheet, available at: https://userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp. A user fee identification (ID) number will be
generated. Payment must be made in U.S. currency by electronic check or
wire transfer, payable to the order of the Food and Drug
Administration. The preferred payment method is online using electronic
check (Automated Clearing House (ACH) also known as eCheck) or credit
card for payments under $25,000 (Discover, VISA, MasterCard, American
Express).
    FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the OTC Monograph User Fee Cover Sheet and generating the
user fee ID number. Secure electronic payments can be submitted using
the User Fees Payment Portal at https://userfees.fda.gov/pay (Note:
Only full payments are accepted. No partial payments can be made
online). Once an invoice is located, ``Pay Now'' should be selected to
be redirected to Pay.gov. Electronic payment options are based on the
balance due. Payment by credit card is available for balances that are
less than $25,000. If the balance exceeds this amount, only the ACH
option is available. Payments must be made using U.S. bank accounts as
well as U.S. credit cards.
    For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied,
which could result in FDA not filing an application and other
penalties. The originating financial institution may charge a wire
transfer fee. Applicable wire transfer fees must be included with
payment to ensure fees are fully paid. Questions about wire transfer
fees should be addressed to the financial institution. The account
information for wire transfers is as follows: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If needed, FDA's tax
identification number is 53-0196965.

    Dated: December 22, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28714 Filed 12-28-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3906-3907]
[FR Doc No: 2014-01247]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71325; File No. SR-CME-2014-01]

Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding Modifications to CME Rule 8G802.B.2

January 16, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act''),\1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on January 8, 2014, Chicago Mercantile Exchange
Inc. (``CME'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change described in Items I, II and
III below, which Items have been prepared primarily by CME. CME filed
the proposal pursuant to Section 19(b)(3)(A) of the Act,\3\ and Rule
19b-4(f)(4)(ii) \4\ thereunder so that the proposal was effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(4)(ii).
---------------------------------------------------------------------------

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

    CME is filing a proposed rule change that is limited to its
business as a derivatives clearing organization. More specifically, the
proposed rule change would make amendments to CME Rule 8G802.B.2 (``IRS
Product Limited Recourse'') to clarify that a CME Bankruptcy Event is
also a Termination Event for IRS.

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

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

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

    CME is registered as a derivatives clearing organization with the
Commodity Futures Trading Commission and currently offers clearing
services for many different futures and swaps products. The purpose of
this proposed rule change is to make amendments to CME IRS rules that
will clarify and harmonize CME rules across its IRS and CDS offerings.
This filing does not involve any proposed changes to CME CDS rules.
Although these changes will be effective on filing, CME plans to
operationalize the proposed changes on January 16, 2014.
    Currently, CME's Chapter 8H rules, providing for limited recourse
for CDS, provide that a CME Bankruptcy Event (as defined in the Rules)
is also a CDS Termination Event (as defined in CME Rule 8H802.B.2).
CME's Chapter 8G rules, providing for limited recourse for IRS,
inadvertently do not similarly include a CME Bankruptcy Event as an IRS
Termination Event (as defined in CME Rule 8H802.B.2). The intent under
both rule chapters is for the limited recourse provisions to work
similarly in the event of a CME Bankruptcy Event. In order to harmonize
the provisions, CME is proposing a clarifying amendment to CME Rule
8G802.B.2.
    The changes that are described in this filing are limited to CME's
business as a derivatives clearing organization clearing products under
the exclusive jurisdiction of the Commodity Futures Trading Commission
(``CFTC'') and do not materially impact CME's security-based swap
clearing business in any way. CME notes that it has already submitted
the proposed rule change that is the subject of this filing to its
primary regulator, the CFTC, in CME Submission 13-590.
    CME believes the proposed rule change is consistent with the
requirements of the Exchange Act including Section 17A of the Exchange
Act.\5\ The proposed rule change clarifies that a CME Bankruptcy Event
is also a Termination Event for purposes of CME's IRS clearing
offering. The purpose of the proposed changes is to clarify the limited
recourse nature of CME's clearing offering and to harmonize CME's IRS
rules with its CDS rules; these purposes are designed to promote the
prompt and accurate clearance and settlement of securities transactions
and, to the extent applicable, derivatives agreements, contracts, and
transactions, to assure the safeguarding of securities and funds which
are in the custody or control of the clearing agency or for which it is
responsible, and, in general, to protect investors and the public
interest consistent with Section 17A(b)(3)(F) of the Exchange Act.\6\
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Furthermore, the proposed changes are limited in their effect to
swaps products offered under CME's authority to act as a derivatives
clearing organization. These products are under the exclusive
jurisdiction of the CFTC. As such, the proposed CME changes are limited
to CME's activities as a derivatives clearing organization clearing
swaps that are not security-based swaps or mixed swaps; CME notes that
the policies of the CFTC with respect to administering the Commodity
Exchange Act are comparable to a number of the policies underlying the
Exchange Act, such as promoting market transparency for over-the-
counter derivatives markets, promoting the prompt and accurate
clearance of transactions and protecting investors and the public
interest.
    Because the proposed changes are limited in their effect to swaps
products offered under CME's authority to act as a derivatives clearing
organization, the proposed changes are properly classified as effecting
a change in an existing service of CME that:
    (a) primarily affects the clearing operations of CME with respect
to products that are not securities, including futures that are not
security futures, and swaps that are not security-based swaps or mixed
swaps; and
    (b) does not significantly affect any securities clearing
operations of CME or

any rights or obligations of CME with respect to securities clearing or
persons using such securities-clearing service.
    As such, the changes are therefore consistent with the requirements
of Section 17A of the Exchange Act \7\ and are properly filed under
Section 19(b)(3)(A) \8\ and Rule 19b-4(f)(4)(ii) \9\ thereunder.
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    \7\ 15 U.S.C. 78q-1.
    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(4)(ii).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    CME does not believe that the proposed rule change will have any
impact, or impose any burden, on competition. The proposed rule change
merely makes clarifying amendments for the purpose of harmonizing CME's
IRS rules with its CDS rules.

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

    CME has not solicited, and does not intend to solicit, comments
regarding this proposed rule change. CME has not received any
unsolicited written comments from interested parties.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A) \10\ of the Act and paragraph (f)(4)(ii) of Rule
19b-4 \11\ thereunder. At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act. \12\
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    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(4)(ii).
    \12\ 15 U.S.C. 78s(b)(3)(C).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml), or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-CME-2014-01 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CME-2014-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours or
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of CME and on CME's
web site at http://www.cmegroup.com/market-regulation/rule-filings.html.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-CME-2014-01
and should be submitted on or before February 13, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-01247 Filed 1-22-14; 8:45 am]
BILLING CODE 8011-01-P