exposures exceed the safe level, those levels exceed the risk cup and
are of potential concern. There are risk cups for each pertinent
duration of exposure for a pesticide because the amount of exposure
that can be incurred without adverse health effects will vary by
duration (e.g., acute, short-term, chronic). The risk cup is equal to
the PAD (either acute, chronic, or steady-state), or the maximum safe
exposure for short- and intermediate-term durations.
    Whether risks will exceed the risk cup (i.e., whether exposures are
expected to exceed safe levels) is expressed differently, depending on
the type of level of concern the Agency has identified. For dietary
assessments, the risk is expressed as a percentage of the acceptable
dose (i.e., the dose which EPA has concluded will be ``safe''). Dietary
exposures greater than 100% of the percentage of the acceptable dose
are generally cause for concern and would be considered ``unsafe''
within the meaning of FFDCA section 408(b)(2)(B). For non-dietary (and
combined dietary and non-dietary) risk assessments of threshold
effects, the toxicological level of concern is typically not expressed
as an RfD/PAD, but rather in terms of an acceptable (or target) Margin
of Exposure (MOE) between human exposure and the PoD. The ``margin''
that is being referred to in the term MOE is the ratio between the PoD
and human exposure which is calculated by dividing human exposure into
the PoD. An acceptable MOE is generally considered to be a margin at
least as high as the product of all applicable safety factors for a
pesticide. For example, when the Agency retains the default uncertainty
factors for dietary or aggregate risk (a 10X interspecies uncertainty
factor, a 10X intraspecies uncertainty factor, and a 10X FQPA safety
factor), the total uncertainty factors (or level of concern) is 1000,
and any MOE above 1000 represents exposures that are not of concern.
Like RfD/PADs, specific target MOEs are selected for exposures of
different durations and routes. For non-dietary exposures, EPA
typically examines short-term, intermediate-term, and long-term
exposures. Additionally, target MOEs may be selected based on both the
duration of exposure and the various routes of non-dietary exposure--
dermal, inhalation, and oral. Target MOEs for a given pesticide can
vary depending on the characteristics of the studies relied upon in
choosing the PoD for the various duration and route scenarios.
    In addition, in a DWLOC aggregate risk assessment, the calculated
DWLOC is compared to the EDWC. Where EPA has calculated a DWLOC, EPA
can determine whether drinking water exposures will result in aggregate
risks of concern by comparing estimated pesticide concentrations in
drinking water to the DWLOC. As noted above, an aggregate DWLOC
represents the amount of allowable safe residues of pesticide in
drinking water because it represents the room remaining in the risk cup
after accounting for the food and residential exposures. The DWLOC
provides an estimate of the allowable safe concentrations of pesticides
in drinking water for comparison to EDWCs. When the EDWC is less than
the DWLOC, there are no risk concerns for aggregate exposures because
the Agency can conclude that the contribution from drinking water when
aggregated with food and non-occupational exposures will not exceed
save levels of exposure. Conversely, an EDWC at or exceeding the DWLOC
would indicate a risk of concern, as those exposures to chlorpyrifos in
drinking water, when aggregated with exposures from food and
residential exposures, would exceed safe levels of exposure. (Ref. 31).

A. Dietary Risks From Food Exposures

    As noted above, EPA's acute and steady state dietary exposures
assessments for chlorpyrifos were highly refined and incorporated
monitoring data for almost all foods. The Agency assessed food
exposures based on approved registered uses of chlorpyrifos. This
includes field uses of chlorpyrifos but not potential exposure from
food handling establishment uses since the Agency did not identify any
registered food handling establishment uses. (Ref. 9 at 33-36).
    Considering food exposures alone, the Agency did not identify risks
of concern for either acute or steady state exposures. Acute dietary
(food only) risk estimates, which are based on risk from a single
exposure event in the 2020 HHRA were all below 100 percent of the acute
population adjusted dose for food (aPADfood) at the 99.9th
percentile of exposure and are not of concern. The population with the
highest risk estimate was females (13-49 years old) at 3.2%
aPADfood. Steady-state dietary (food only) risk estimates,
which are based on the potential risk from a 21-day exposure duration
using a 3-week rolling average (sliding by day) across the year, were
also all below 100% of the steady state PAD for food
(ssPADfood) at the 99.9th percentile of exposure and are not
of concern. The population with the highest risk estimate was children
(1-2 years old) at 9.7% ssPADfood.
    Although EPA's most recent risk assessment calculated two sets of
risk estimates as a result of the dual approach to assess the range of
risks that would occur if the Agency determined reliable data existed
to support a 1X FQPA safety factor, EPA has determined that it is
appropriate to retain the 10X FQPA safety factor, see Unit VI.C.3.
Therefore, the risk estimates associated with the 1X FQPA are not
relevant to today's action.

B. Non-Occupational, Non-Dietary (Residential) Risks

    Because there are some uses of chlorpyrifos that may result in
residential exposures, EPA assessed risk from those uses. All
residential post-application risk estimates for the registered uses of
chlorpyrifos were

below the Agency's level of concern. (Ref. 9 at 38). The residential
post-application LOC for children is 40, and the lowest risk estimate
for children (11 to less than 16 years old) was 1,200; the residential
post-application LOC for adults is 100, and the MOE is 1,000. Because
the calculated MOEs are above the Agency's level of concern, there are
no risks of concern from residential exposures.

C. Risks From Drinking Water

    As noted above, the Agency aggregated exposures to chlorpyrifos
from food and residential exposures and calculated the DWLOC, i.e., the
amount of drinking water exposures that would be considered safe. The
Agency calculated acute and steady state DWLOCs for infants (less than
1 year old); children (1 to 2 years old); youths (6-12 years old), and
adults (females 13-49 years old), which would be protective of other
subpopulations. The most sensitive acute DWLOC was 23 ppb chlorpyrifos
oxon, and the most sensitive steady state DWLOC was 4 ppb.
    As indicated above in Unit VII.B.2., the Agency estimated drinking
water contributions from registered uses of chlorpyrifos in its 2016
DWA. That document indicated that EDWCs exceed the DWLOC of 4.0 ppb on
a national level and in every region of the United States. (Ref. 28).
    While the 2020 DWA produced estimated drinking water concentrations
that were below the DWLOC of 4.0 ppb, those EDWCs were contingent upon
a limited subset of chlorpyrifos use. When assessing different
combinations of only those 11 uses in specific geographic regions, the
modeling assumed that chlorpyrifos would not be labeled for use on any
other crops and would not otherwise be used in those geographic
regions. At this time, however, the currently registered chlorpyrifos
uses go well beyond the 11 uses in the specific regions assessed in the
2020 DWA. Because the Agency is required to assess aggregate exposure
from all anticipated dietary, including food and drinking water, as
well as residential exposures, the Agency cannot rely on the 2020 DWA
to support currently labeled uses. When one assesses the potential of
all currently registered uses nationwide and in specific geographical
areas, as was done in the 2016 DWA, the estimates of drinking water
concentrations exceed the DWLOC of 4.0 ppb, in certain vulnerable
watersheds across the United States.

D. Aggregate Exposure and Determination Concerning Safety

    As noted above, in accordance with FFDCA section 408(b)(2), EPA
must, when establishing or leaving in effect tolerances for residues of
a pesticide chemical, determine that the tolerances are safe. That is,
EPA must determine 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.'' (21 U.S.C. 346a(b)(2)).
    As discussed earlier in this Unit, exposures from food and non-
occupational exposures individually or together do not exceed EPA's
levels of concern. The Agency determined that risks from exposures to
chlorpyrifos residues in food comprised 3.2% of the aPAD for females
(13-49 years old) and 9.7% of the ssPAD for children (1-2 years old),
the highest exposed subpopulations. Combining those exposures with
relevant residential exposures, the Agency calculated the allowable
levels of drinking water concentrations. Based on the Agency's
assessment of drinking water concentrations based on the currently
registered uses, however, drinking water exposures significantly add to
those risks. When considering the drinking water contribution from
currently registered uses, the Agency's levels of concern are exceeded
when combined with food and residential exposures.
    As indicated above, the Agency calculated acute and steady-state
DWLOCs, and the lowest DWLOC is for steady-state exposures to infants
at 4.0 ppb; therefore, any EDWCs of chlorpyrifos oxon exceeding 4.0 ppb
indicate that aggregate exposures of chlorpyrifos would be unsafe. The
Agency's 2016 DWA demonstrates that DWLOC will be exceeded for some
people whose drinking water is derived from certain vulnerable
watersheds throughout the United States, which means that drinking
water contributions will result in aggregate exposures that exceed the
Agency's determined safe level of exposure. When taking into
consideration aggregate exposures based on current labeled uses, the
EDWCs exceed the DWLOC of 4.0 ppb. For example, as noted above in Unit
VII.B.2., the 2016 DWA presented EDWCs for uses of chlorpyrifos,
including concentrations based on use on golf courses and agricultural
crops. For those uses alone, the Agency estimated concentrations
exceeding 4.0 ppb in every region in the country; See Table 25 of the
2016 DWA. (Ref. 28 at 73-74.) Comparing the calculated EDWCs from the
2016 DWA with the DWLOC calculated in the 2020 HHRA shows that drinking
water concentrations from chlorpyrifos uses will exceed the safe
allowable level for contributions from drinking water. This means that
aggregate exposure (food, drinking water, and residential exposures)
exceeds the Agency's safe level for chlorpyrifos exposure. Because the
FFDCA requires EPA to aggregate all dietary and non-occupational
exposure, EPA cannot conclude that there is a reasonable certainty that
no harm will result from aggregate exposure to chlorpyrifos residues
when taking into consideration all labeled uses.
    It is worth noting that the Agency's Proposed Interim Registration
Review Decision (PID) recognized that there might be limited
combinations of uses in certain geographic areas that could be
considered safe, if the assessment only includes those specific uses in
those areas. The PID noted that ``[w]hen considering all currently
registered agricultural and non-agricultural uses of chlorpyrifos,
aggregate exposures are of concern. If considering only the uses that
result in DWLOCs below the EDWCs, aggregate exposures are not of
concern.'' (Ref. 32 at 19). The PID proposed limiting chlorpyrifos
applications to specific crops in certain regions where the EDWCs for
those uses were calculated to be lower than the DWLOC. (Id. at 40). The
Agency's ability to make the safety finding for any remaining uses
would be contingent upon significant changes to the existing
registrations, including use cancellations, geographical limitations,
and other label changes.
    Consequently, while the 2020 PID suggested that there may be
limited combinations of uses that could be safe, FFDCA section
408(b)(2) requires EPA to aggregate all dietary and non-occupational
exposures to chlorpyrifos in making a safety finding. Without effective
mitigation upon which to base a reduced aggregate exposure calculation,
the products as currently registered present risks above the Agency's
levels of concern. Based on the data available at this time and the
aggregate exposures expected from currently registered uses, the Agency
cannot, at this time, determine that aggregate exposures to residues of
chlorpyrifos, including all anticipated dietary exposures and all other
non-occupational exposures for which there is reliable information, are
safe. Accordingly, as directed by the statute and in compliance with
the Court's order, EPA is revoking all chlorpyrifos tolerances.

IX. Procedural Matters

A. When do these actions become effective?

    The revocations of the tolerances for all commodities will become
effective on February 28, 2022. The Agency has set the expiration date
for these tolerances to satisfy its international trade obligations
described in Unit X.
    Any commodities listed in this rule treated with the pesticide
subject to this rule, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(l)(5).
Under this section, any residues of these pesticides in or on such food
shall not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA,
and
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance that was in effect at the time of
the application. Evidence to show that food was lawfully treated may
include records that verify the dates when the pesticide was applied to
such food.

B. Response to Comments

    Today's action responds to the Ninth Circuit's order to issue a
final rule in response to the 2007 Petition. As such this rule is not
finalizing the proposal published in the Federal Register issue of
November 6, 2015, nor is it implementing or resolving any registration
review activity. Thus, this document is not responding to comments
received on the 2015 proposal or the most recent registration review
documents. Those activities are separate and apart from the procedural
posture of this final rule action. Moreover, as the registration review
process is ongoing, including a separate review of the comments
submitted, the Agency intends to respond to the most recent comments in
as part of that process, rather than in this rule.

C. Are the Agency's actions consistent with international obligations?

    The tolerance revocations in this final rule are not discriminatory
and are designed to ensure that both domestically produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
    EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S.
tolerances and in reassessing them. Codex MRLs are established by the
Codex Committee on Pesticide Residues, a committee within the Codex
Alimentarius Commission, an international organization formed to
promote the coordination of international food standards. The FFDCA
requires EPA to take Codex MRLs into consideration when establishing
new tolerances, and it is EPA's policy to harmonize U.S. tolerances
with Codex MRLs to the extent possible, provided that the MRLs achieve
the level of protection required under FFDCA. In the current instance,
EPA has determined that the current U.S. tolerances for chlorpyrifos
are not safe and must be revoked. EPA has developed guidance concerning
submissions for import tolerance support (65 FR 35069, June 1, 2000)
(FRL-6559-3).
    Under the World Trade Organization Agreement on the Application of
Sanitary and Phytosanitary Measures (SPS Agreement), to which the
United States is a party, Members are required to, except in urgent
circumstances, ``allow a reasonable interval between the publication of
a sanitary or phytosanitary regulation and its entry into force in
order to allow time for producers in exporting Members, and
particularly in developing country Members, to adapt their products and
methods of production to the requirements of the importing Member.''
(Ref. 33). The WTO has interpreted the phrase ``reasonable interval''
to mean normally a period of not less than six months. (Ref. 34). In
accordance with its obligations, EPA intends to notify the WTO of this
regulation and is providing a ``reasonable interval'' by establishing
an expiration date for the existing tolerances to allow those
tolerances to remain in effect for a period of six months after the
effective date of this final rule. After the six-month period expires,
the tolerances for residues chlorpyrifos in or on food will no longer
be in effect.

X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review

    The Office of Management and Budget (OMB) has exempted tolerance
regulations from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because
this action has been exempted from review under Executive Order 12866,
this final rule is not subject to Executive Order 13563 (76 FR 3821,
January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This final rule does not contain any information collection
activities subject to OMB review and approval under the PRA, 44 U.S.C.
3501 et seq. An agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under PRA, unless it has been approved by OMB and displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.

C. Regulatory Flexibility Act (RFA)

    The RFA, 5 U.S.C. 601 et seq., generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedures
Act or any other statute. Since this rule, which is issued under FFDCA
section 408(d)(4)(A)(i) (21 U.S.C. 346a(d)(4)(A)(i)) directly in
response to a petition under FFDCA section 408(d), does not require the
issuance of a proposed rule, the RFA requirements do not apply.

D. Unfunded Mandates Reform Act (UMRA)

    EPA has determined that this action does not impose any enforceable
duty, contain any unfunded mandate, or otherwise have any effect on
small governments subject to the requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132: Federalism

    This action will not have federalism implications because it is not
expected to have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This final rule directly regulates growers, food processors,
food handlers and food retailers, not States. This action does not
alter the relationships or distribution of power and responsibilities
established

by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    For the same reasons, this action will not have Tribal implications
because it is not expected to have substantial direct effects on Indian
Tribes, significantly or uniquely affect the communities of Indian
Tribal governments, and does not involve or impose any requirements
that affect Indian Tribes. Accordingly, the requirements of Executive
Order 13175 (65 FR 67249, November 9, 2000), do not apply to this
action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this action is not a significant regulatory
action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    In addition, since this action does not involve any technical
standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to
this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994). Nevertheless, the revocation of the
tolerances will reduce exposure to the pesticide and lead to a
reduction in chlorpyrifos use on food crops. While EPA has not
conducted a formal EJ analysis for this rule, the revocation of
tolerances will likely reduce disproportionate impacts on EJ
communities that are impacted by chlorpyrifos applications on crops.

K. Congressional Review Act (CRA)

    This action is subject to the CRA (5 U.S.C. 801 et seq.), and EPA
will submit a rule report containing this rule and other required
information to each House of the Congress and to the Comptroller
General of the United States. This action is not a ``major rule'' as
defined by 5 U.S.C. 804(2).

XI. References

    The following is a list of the documents that are specifically
referenced in this document. The docket, identified by docket ID number
docket number EPA-HQ-OPP-2021-0523, includes these documents and other
information considered by EPA, including documents that are referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. All
records in docket are part of the record for this rulemaking. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. The Petition from NRDC and PANNA, EPA's various responses to it,
and the objections submitted on the Petition denial are available in
docket number EPA-HQ-OPP-2007-1005 available at https://www.regulations.gov.
2. U.S. EPA. Chlorpyrifos Final Work Plan. 2009. Available at:
https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0020.
3. FIFRA Scientific Advisory Panel (2008). ``The Agency's Evaluation
of the Toxicity Profile of Chlorpyrifos.'' Report from the FIFRA
Scientific Advisory Panel Meeting of September 16-19, 2008.
Available at: https://www.regulations.gov/docket/EPA-HQ-OPP-2008-0274/document.
4. U.S. EPA (2010). Draft Framework and Case Studies on Atrazine,
Human Incidents, and the Agricultural Health Study: Incorporation of
Epidemiology and Human Incident Data into Human Health Risk
Assessment available at: https://www.regulations.gov/document/EPA-HQ-OPP-2009-0851-0004.
5. U.S. EPA (2016). Office of Pesticide Programs' Framework for
Incorporating Human Epidemiologic & Incident Data in Risk
Assessments for Pesticides. (2016) Available at: https://www3.epa.gov/pesticides/EPA-HQ-OPP-2008-0316-DRAFT-0075.pdf.
6. FIFRA Scientific Advisory Panel (2012). ``Scientific Issues
Associated with Chlorpyrifos''. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2012-0040-0029.
7. U.S. EPA (2014). Chlorpyrifos: Revised Human Health Risk
Assessment for Registration Review. Available in docket number EPA-
HQ-OPP-2008-0850, https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0195.
8. U.S. EPA (2016). Scientific Advisory Panel for Chlorpyrifos:
Analysis of Biomonitoring Data. Available at: https://www.epa.gov/sites/default/files/2016-07/documents/chlorpyrifos_sap_april_2016_final_minutes.pdf.
9. U.S. EPA (2020). Chlorpyrifos Human Health Risk Assessment.
Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0944.
10. U.S. EPA (2020). Updated Chlorpyrifos Refined Drinking Water
Assessment for Registration Review. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0941.
11. A User's Guide to Available EPA Information on Assessing
Exposure to Pesticides in Food (June 21, 2000). Available at:
https://www.doh.wa.gov/Portals/1/Documents/4000/PASW_exposurefood.pdf.
12. U.S. EPA (2000). Chlorpyrifos Human Health Risk Assessment.
Available at: https://archive.epa.gov/scipoly/sap/meetings/web/pdf/hed_ra.pdf.
13. U.S. EPA (2011). Chlorpyrifos: Preliminary Human Health Risk
Assessment for Registration Review. Available in docket number EPA-
HQ-OPP-2008-0850, https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0025.
14. U.S. EPA (2016). Summary Reviews for Additional Epidemiological
Literature Studies from Prospective Birth Cohort Studies. Available
in docket number EPA-HQ-OPP-2015-0653 at https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0438.
15. U.S. EPA (2020). The Use of New Approach Methodologies (NAMs) to
Derive Extrapolation Factors and Evaluate Developmental
Neurotoxicity for Human Health Risk Assessment. Available in docket
number EPA-HQ-OPP-2020-0263 at https://www.regulations.gov/document/EPA-HQ-OPP-2020-0263-0033.
16. U.S. EPA (2020). Transmittal of Meeting Minutes and Final Report
of the Federal Insecticide, Fungicide, and Rodenticide Act,
Scientific Advisory Panel (FIFRA SAP) Virtual Meeting held on
September 15-18, 2020. Available in docket number EPA-HQ-2020-0263
at https://www.regulations.gov/document/EPA-HQ-OPP-2020-0263-0054.
17. U.S. EPA (2006). Revised Organophosphorous Pesticide Cumulative
Risk Assessment. Available at http://www.epa.gov/pesticides/cumulative/2006-op/index.htm.
18. U.S. EPA (2012). Standard Operating Procedures for Residential
Pesticide Exposure Assessment https://www.epa.gov/sites/default/files/2015-08/documents/usepa-opp-hed_residential_sops_oct2012.pdf.
19. FIFRA Scientific Advisory Panel (2002). ``Organophosphate
Pesticides: Preliminary OP Cumulative Risk Assessment.'' Information
on how to obtain the meeting report is available at http://www2.epa.gov/sap/fifra-scientific-advisory-panel-meetings.
20. U.S. EPA (2000). Choosing a Percentile of Acute Dietary Exposure
as a Threshold of Regulatory Concern. Available at:

https://www.epa.gov/sites/production/files/2015-07/documents/trac2b054_0.pdf.
21. EPA's Exposure Factors Handbook. Available at: https://www.epa.gov/expobox/about-exposure-factors-handbook.
22. U.S. EPA (2014). Guidance for Applying Quantitative Data to
Develop Data-Derived Extrapolation Factors for Interspecies and
Intraspecies Extrapolation. Available at: https://www.epa.gov/sites/default/files/2015-01/documents/ddef-final.pdf.
23. U.S. EPA (2014). Chlorpyrifos Acute and Steady Dietary (Food
Only) Exposure Analysis to Support Registration Review. Available
at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0197.
24. U.S. EPA (2020). Framework for Conducting Pesticide Drinking
Water Assessments for Surface Water. Environmental Fate and Effects
Division. Office of Pesticide Programs. Office of Chemical Safety
and Pollution Prevention. U.S. Environmental Protection Agency.
Available at: https://www.epa.gov/sites/default/files/2020-09/documents/framework-conducting-pesticide-dw-sw.pdf.
25. FIFRA Scientific Advisory Panel (2019) ``Approaches for
Quantitative Use of Surface Water Monitoring Data in Pesticide
Drinking Water Assessments.'' Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2019-0417-0019.
26. U.S. EPA (2001). General Principles for Performing Aggregate
Exposure and Risk Assessments. Available at: https://www.epa.gov/sites/default/files/2015-07/documents/aggregate.pdf.
27. U.S. EPA (2020). Appendix B. Case Study for Integrating a
Distributional Approach to Using Percent Crop Area (PCA) and Percent
Crop Treated (PCT) into Drinking Water Assessment. Available at:
https://www.regulations.gov/document/EPA-HQ-OPP-2020-0279-0002.
28. U.S. EPA (2016). Chlorpyrifos Refined Drinking Water Assessment
for Registration Review. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0437.
29. U.S. EPA (2014). Chlorpyrifos Updated Drinking Water Assessment
for Registration Review. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0198.
30. U.S. EPA (2015). Proposed Rule: Tolerance Revocations:
Chlorpyrifos. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2015-0653-0001.
31. U.S. EPA (2011). Finalization of Guidance on Incorporation of
Water Treatment Effects on Pesticide Removal and Transformations in
Drinking Water Exposure Assessments. Available at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/finalization-guidance-incorporation-water-treatment.
32. U.S. EPA (2020). Chlorpyrifos Proposed Interim Registration
Review Decision. Available at: https://www.regulations.gov/document/EPA-HQ-OPP-2008-0850-0971.
33. For more information on World Trade Organization's Agreement on
the Application of Sanitary and Phytosanitary Measures (SPS
Agreement), please see: https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.
34. For more information on World Trade Organization (2001)
Implementation-Related Issues and Concerns, please see: https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/WT/Min01/17.pdf&Open=True.

List of Subjects in 40 CFR Part 180

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

    Dated: August 18, 2021.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons set forth in the preamble, 40 CFR part
180 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. In Sec.  180.342, add introductory text to read as follows:

Sec.  180.342  Chlorpyrifos; tolerances for residues.

    This section and all tolerances contained herein expire and are
revoked on February 28, 2022.
* * * * *
[FR Doc. 2021-18091 Filed 8-27-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 59 (Monday, March 28, 2016)]
[Proposed Rules]
[Pages 17107-17109]
[FR Doc No: 2016-06818]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-5284; Directorate Identifier 2016-CE-006-AD]
RIN 2120-AA64

Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Pilatus Aircraft Ltd. Models PC-12, PC-12/45, PC-12/47, and PC-
12/47E airplanes. This proposed AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as incorrect
installation instructions of the torlon plates in the airplane
maintenance manual resulting in the incorrect installation of the
torlon plates in the forward wing-to-fuselage attachment. We are
issuing this proposed AD to require actions to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by May 12, 2016.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
PILATUS AIRCRAFT LTD., Customer Support Manager, CH-6371 STANS,
Switzerland; phone: +41 (0)41 619 33 33; fax: +41 (0)41 619 73 11;
email<EMAIL_ADDRESS>internet: http://www.pilatus-
aircraft.com. You may review this referenced service information at the
FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5284; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Doug Rudolph, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-5284;
Directorate Identifier 2016-CE-006-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD No.: 2016-0037, dated February 26, 2016 (referred to after this as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Incorrect installations of torlon plates in the forward lower
wing-to-fuselage attachment were reported on aeroplanes in service.
Investigation determined that wrong torlon plate installation
instructions were published in June 2007 in Revision (Rev.) 18 to 27
of the Aircraft Maintenance Manual (AMM) 02049, Data Module (DM) 12-
A-57-00-00A-520A-A and DM 12-A-57-00-00A-720A-A, for the PC-12, PC-
12/45 and PC-12/47 aeroplanes, and in the initial issue to Rev. 10
of AMM 02300, in DM 12-B-57-00-00A-520A-A and DM 12-B-57-00-00A-
720A-A, for PC-12/47E aeroplanes.
    This condition, if not corrected, could lead to additional loads
at the wing-to-fuselage interface, which detrimentally affects the
fatigue life of the structural joint.
    To address this potential unsafe condition, Pilatus issued
Service Bulletin (SB) No. 57-007 to provide inspection instructions
to verify the correct installation of torlon plates in the wing-to-
fuselage attachments, and the rectification instructions for
incorrect installed torlon plates.
    For the reason described above, this AD requires a one-time
inspection of the forward lower wing-to-fuselage attachments, both
left hand (LH) and right hand (RH) sides and, depending on findings,
accomplishment of applicable corrective action(s).

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
5284.

Related Service Information Under 1 CFR Part 51

    Pilatus Aircraft Limited has issued PILATUS AIRCRAFT LTD. PILATUS
PC-12 Service Bulletin No: 57-007, dated September 29, 2015. The
service information describes procedures for inspecting the
installation of the torlon plates in the wing-to-fuselage attachment
fittings and, if necessary, instructions to install them in the correct
sequence. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section of this
NPRM.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 268 products of U.S.
registry.

We also estimate that it would take about 1 work-hour per wing per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $45,560, or $170 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 3 work-hours per wing and require parts costing $1,000 per
wing, for a total cost of $2,510 per product. We have no way of
determining the number of products that may need these actions.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

Pilatus Aircraft Ltd.: Docket No. FAA-2016-5284; Directorate
Identifier 2016-CE-006-AD.

(a) Comments Due Date

    We must receive comments by May 12, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pilatus Aircraft Ltd. PC-12, PC-12/45, PC-12/
47, and PC-12/47E airplanes, all serial numbers delivered before
January 1, 2015, certificated in any category.

    Note 1 to paragraph (c) of this AD: The date of delivery may be
found as the issue date of the EASA Form 52, which is part of the
airplane records.

(d) Subject

    Air Transport Association of America (ATA) Code 57: Wings.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as incorrect
installation instructions of the torlon plates in the airplane
maintenance manual resulting in the incorrect installation of the
torlon plates in the forward wing-to-fuselage attachment. We are
issuing this AD to identify and correct incorrectly installed torlon
plates which could cause additional loads affecting the fatigue life
at the wing-to-fuselage interface.

(f) Actions and Compliance

    Do the actions in paragraphs (f)(1) through (f)(4) of this AD.
If paragraphs (f)(1), (f)(2), and (f)(3) of this AD have already
been done before the effective date of this AD, then only paragraph
(f)(4) of this AD applies.
    (1) For any airplane that has had a wing removed and reinstalled
or replaced between June 2007 and the effective date of this AD:
Within the next 12 months after the effective date of this AD,
inspect the torlon plates in the forward lower wing-to-fuselage
attachments (both left hand (LH) and right hand (RH) sides) for
correct installation following the accomplishment instructions in
PILATUS AIRCRAFT LTD. PILATUS PC-12 Service Bulletin No: 57-007,
dated September 29, 2015.
    (2) For any airplane that has had a wing removed and reinstalled
or replaced, between June 2007 and the effective date of this AD: If
an incorrect installation of the torlon plates is found during the
inspection required in paragraph (f)(1) of this AD, remove the
affected torlon plates, visually inspect the torlon plates and the
affected lugs using a mirror and light source (if necessary) for any
damage, and reinstall the torlon plates in the correct sequence,
following the accomplishment instructions in paragraph 3.C. of
PILATUS AIRCRAFT LTD. PILATUS PC-12 Service Bulletin No: 57-007,
dated September 29, 2015.
    (3) For any airplane that has had a wing removed and reinstalled
or replaced, between June 2007 and the effective date of this AD: If
any damage is found during the inspection of the torlon plates and
lugs required in paragraph (f)(2) of this AD, before further flight,
contact PILATUS AIRCRAFT, LTD. for FAA-approved repair instructions
and accomplish those instructions accordingly. You may find contact
information for PILATUS AIRCRAFT, LTD. in paragraph (h) of this AD.
    (4) For all airplanes: As of the effective date of this AD, do
not install or re-install a wing on any airplane, unless concurrent
with the wing installation, the torlon plates of the forward lower
wing-to-fuselage attachment (both LH and RH sides) of the airplane
are inspected and found to be installed correctly in accordance with
the accomplishment instructions in paragraph 3.B. of PILATUS
AIRCRAFT LTD. PILATUS PC-12 Service Bulletin No: 57-007, dated
September 29, 2015.

    Note 2 to paragraph (f)(4) of this AD:  Installation of a wing
on an airplane in accordance with the instructions of PILATUS
aircraft maintenance manual (AMM) 02049, Revision 28 or later, or
AMM 02300, Revision 11 or later, is an acceptable alternative method
to comply with this inspection requirement.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Doug Rudolph, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust,

Room 301, Kansas City, Missouri 64106; telephone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>Before using any
approved AMOC on any airplane to which the AMOC applies, notify your
appropriate principal inspector (PI) in the FAA Flight Standards
District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI EASA AD No.: 2016-0037, dated February 26, 2016,
for related information. You may examine the MCAI on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2016-5284. For service information related to this AD, contact
PILATUS AIRCRAFT LTD., Customer Support Manager, CH-6371 STANS,
Switzerland; phone: +41 (0)41 619 33 33; fax: +41 (0)41 619 73 11;
email<EMAIL_ADDRESS>internet: http://
www.pilatus-aircraft.com. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on March 18, 2016.
Pat Mullen,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-06818 Filed 3-25-16; 8:45 am]
 BILLING CODE 4910-13-P


54451 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Notices In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA Dockets. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA Dockets without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date and Federal Register citation.

II. Background A. What Action is the Agency Taking?

The Agency has issued a RED for the pesticide active ingredient dinocap. Under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended in 1988, EPA is conducting an accelerated reregistration program to reevaluate existing pesticides to make sure they meet current scientific and regulatory standards. The RED for dinocap consists of a voluntary cancellation of all products registered in the U. S. Because the registrant, Dow AgroSciences, LLC, has expressed interest in retaining existing tolerances for apples and grapes for import purposes, the RED presents only a dietary risk assessment for those uses and specifically addresses the data requirements for support of the import tolerances. The RED also provides background information on the pesticide registration, reregistration and tolerance reassessment, an overview of the uses and health effects associated with dinocap and a summary of what data are required to support the tolerances on apples and grapes imported into the U. S., in the absence of a U. S. registration. The reregistration program is being conducted under congressionally mandated time frames, and EPA recognizes both the need to make timely reregistration decisions and to involve the public. Therefore, EPA is issuing this RED for dinocap as a final document with a 30   day public comment period that is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the RED. If any comment significantly affects this RED, EPA will amend the RED by publishing the amendment in the Federal Register.

B. What Is the Agency's Authority for Taking This Action? The legal authority for this RED falls under FIFRA, as amended in 1988 and 1996. Section 4( g)( 2)( A) of FIFRA directs that, after submission of all data concerning a pesticide active ingredient, `` the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,'' before calling in product specific data on individual enduse products, and either reregistering products or taking `` other appropriate regulatory action.''

List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: August 26, 2003. Betty Shackleford, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 03   23276 Filed 9   16   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0184; FRL   7324   7]

Molinate; Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of requests from Syngenta Crop Protection, Inc. and Helm Agro US, Inc. to voluntarily cancel the registrations for all of their products containing S ethyl hexahydro 1H azepine 1 carbothioate ( molinate). At the close of the comment period, EPA intends to issue an order granting these cancellation requests, unless the Agency receives substantive comments within the comment period that would merit its further review of these requests, or the requests have been withdrawn.

DATES: Comments must be received by October 17, 2003. Unless the Agency receives substantive comments within the comment period that would merit its further review of these requests, or the requests have been withdrawn by October 17, 2003, EPA intends to issue an order canceling these registrations at the close of the comment period.

FOR FURTHER INFORMATION CONTACT: Wilhelmena Livingston, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8025, e mail address: livingston. wilhelmena@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0184. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the VerDate jul< 14> 2003 16: 45 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 17SEN1. SGM 17SEN1 54452 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Notices Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in EPA's Dockets. Information claimed as CBI and other information whose disclosure is restricted by statue, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but, will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and to Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statue. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Docket. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket/ and follow the online instructions for submitting comments. Once in the system select `` search,'' and then key in docket ID number OPP   2003   0184. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0184. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0184. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2003   0184. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency? Do not submit any information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM as CBI the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's VerDate jul< 14> 2003 16: 45 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 17SEN1. SGM 17SEN1 54453 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Notices electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. Background What Action is the Agency Taking? This notice announces receipt by the Agency of requests from Syngenta Protection Crop, Inc. and Helm Agro US, Inc. to cancel the registration of 14 pesticide products registered under section 3 or 24( c) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). The 14 registrations constitute all registrations held by Syngenta Crop Protection, Incorporated and Helm Agro US, Incorporated of products containing S ethyl hexahydro 1H azepine 1 carbothioate ( molinate). These requests are submitted pursuant to section 6( f) of FIFRA. On June 2, 2003, Syngenta Crop Protection, Inc., and on August 7, 2003, Helm Agro US, Inc. submitted a letter to EPA requesting cancellation, effective June 30, 2008, of the registrations of all their molinate products, and to modify the terms and conditions of its molinate registration until the cancellation is effective. Syngenta and Helm also requested that the Administrator waive the 180   day waiting period under FIFRA section 6( f)( 1)( C)( ii). Molinate ( S ethyl hexahydro 1Hazepine 1 carbothiate) is a thiocarbamate herbicide registered for use primarily for the control of water grass in rice. Rice is grown in California and the south central/ south eastern states of Arkansas, Louisiana, Missouri, Texas, and Tennessee. The registrations subject to the requests for cancellation are listed in Table 1 of this unit:

TABLE 1.   REGISTRATIONS WITH PENDING REQUESTS FOR CANCELLATION Registration number Product name Chemical name 100   981 Riceco Molinate Technical Molinate 100   982 Riceco Touche Molinate 100   983 Molinate 15G Molinate 100   1021 Ordram 8   E An Emulsufiable Liquid Herbicide Molinate 100   1036 Arrosolo 3   3E Molinate 100   1039 Ordram 15   G Molinate 100   1040 Ordram Techncial Herbicide Molinate 100   1102 Ordram 15   GM Rice Herbicide Molinate 74530   7 Molinate Technical Molinate CA77015900 Ordram 8   E An Emulsufiable Liquid Herbicide Molinate CA84017200 Ordram 8   E An Emulsufiable Liquid Herbicide Molinate CA85005300 Ordram 8   E An Emulsufiable Liquid Herbicide Molinate TX81002600 Ordram 8   E An Emulsufiable Liquid Herbicide Molinate TN93000700 Ordram 15   G Molinate At the close of the comment period, EPA intends to issue an order granting these cancellation requests, unless the Agency receives substantive comments within the comment period that would merit its further review of these requests, or the requests have been withdrawn. Users of these pesticides or anyone else desiring the retention of a registration should send in their comments to EPA. In addition, they may wish to contact the applicable registrant directly. Table 2 of this unit includes the name and address of record for the registrants of the products in Table 1 of this unit: TABLE 2.   REGISTRANTS REQUESTING VOLUNTARY CANCELLATION EPA Company number Company name and address 100 Syngenta Crop Protection, Inc., P. O. Box 18300, Greensboro, NC 27419   8300 74530 Helm Agro US, Inc., Nordkanalstrasse 28 D   20097, Hamburg, Germany A. Modification of the Terms and Conditions of the Molinate Registrations The 2002 sales level of the molinate active ingredient will be the maximum amount that Syngenta and Helm will sell or distribute in 2004, 2005, and 2006. Syngenta and Helm may not sell or distribute any more than 75% of the 2002 sales levels in the year 2007, and sell or distribute more than 50% of the 2002 sales levels in the year 2008. Syngenta and Helm will provide annual production/ sales reports to the Agency beginning in the year 2004 through 2009. Syngenta and Helm will also provide inventory reports for the years 2007, 2008, and 2009. These VerDate jul< 14> 2003 16: 45 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 17SEN1. SGM 17SEN1 54454 Federal Register / Vol. 68, No. 180 / Wednesday, September 17, 2003 / Notices 1 Prometheus Radio Project v. FCC, No. 03   3388 ( 3d Cir. Sept. 3, 2003) ( per curiam) ( order granting motion to stay effective date of FCC's new ownership rules) (`` Order''). 2 Report and Order in MB Docket No. 02   277 and MM Docket Nos. 01   235, 01   317, and 00   244 ( adopted June 2, 2003) ( published in summary form in the Federal Register, 68 FR 48265 ( August 5, 2003)) (`` Report and Order''). 3 Order at 3. reports will be submitted by September 30 of each year to the Chemical Review Manager for molinate. Failure by either registrant to comply with the sale or distribution limits contained in the molinate registration constitutes grounds for immediate cancellation of the registration without opportunity for a hearing.

III. What Is the Agency's Authority for Taking this Action? Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register and provide a 30   day period in which the public may comment before the Agency may act on the request for voluntary cancellation. In the case of minor agricultural uses, section 6( f)( 1)( c) of FIFRA provides for a 180   day comment period under certain circumstances. In this case, both molinate registrants requested that EPA waive the 180   day comment period. Accordingly, pursuant to section 6( f)( 1)( c)( ii) of FIFRA, EPA is waiving the 180   day comment period, and will provide interested parties 30 days to comment on the action.

IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under FOR FURTHER INFORMATION CONTACT, postmarked before October 17, 2003. This written withdrawal of the request for cancellation will apply only to the applicable FIFRA section 6( f)( 1) request listed in this notice. If the product( s) have been subject to a previous cancellation action, the effective date of cancellation and all other provisions of any earlier cancellation action are controlling. The withdrawal request must also include a commitment to pay any reregistration fees due, and to fulfill any applicable unsatisfied data requirements. Any person, including the registrant, who wants to support the continued registration of molinate, must fulfill all outstanding data gaps. In addition, EPA must find that molinate is eligible for reregistration.

V. Provisions for Disposition of Existing Stocks The Agency intends to issue a cancellation order following the consideration of all comments received during the comment period, unless the comments warrant further review of this request. Any cancellation order issued in response to this request will have an expected effective date of June 30, 2008. After that date, Syngenta and Helm may not sell or distribute any molinate products except as detailed in the cancellation order as follows. Syngenta and Helm will be permitted to distribute the molinate active ingredient in 2009 for the purposes of facilitating usage by August 31, 2009. No use of products containing molinate will be permitted after the 2009 growing season ( August 31, 2009).

List of Subjects Environmental protection, Pesticides and pests.

Dated: September 4, 2003. Betty Shackleford, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 03   23430 Filed 9   16   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ FRL   7560   6]

Stallings Salvage Superfund Site, Monroe, North Carolina; Notice of Proposed Settlement AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of proposed settlement.

SUMMARY: The United States Environmental Protection Agency is proposing to enter into a settlement with the Estate of Paul Stallings, by and through its Executor, Morris Stallings, as Executor of the Estate of Paul Stallings; Morris Stallings as attorney in fact for Paul Stallings under the durable power of attorney dated June 2, 1994; and Morris Stallings for recovery of past response costs pursuant to section 122( h)( 1) of the Comprehensive Environmental Response, Compensation, and Liability Act ( CERCLA), 42 U. S. C. 9622( h)( 1) concerning the Stallings Salvage Superfund Site located in Monroe, Union County, North Carolina. EPA will consider public comments on the proposed settlement until October 17, 2003. EPA may withdraw from or modify the proposed settlement should such comments disclose facts or considerations which indicate the proposed settlement is inappropriate, improper or inadequate. Copies of the proposed settlement are available from: Ms. Paula V. Batchelor, U. S. EPA, Region 4, Waste Management Divison, 61 Forsyth Street, SW., Atlanta, Georgia 30303, ( 404) 562   8887. Written comments may be submitted to Ms. Batchelor within 30 calendar days of the date of this publication.

Dated: September 2, 2003. Rosalind Brown, Chief, Superfund Enforcement & Information Mgmt Branch, Waste Management Division. [ FR Doc. 03   23746 Filed 9   16   03; 8: 45 am]

BILLING CODE 6560   50   P FEDERAL COMMUNICATIONS COMMISSION [ DA 03   2867]

Media Bureau To Terminate Temporary Broadcast Station Application Freeze; Revised Processing Guidelines Announced AGENCY: Federal Communications Commission. ACTION: Notice.

SUMMARY: In this document, the Commission is revising the processing guidelines for broadcast station applications filed on Forms 301, 314, and 315, reinstating the June 2002 versions of Forms 301, 314 and 315, and terminating the temporary application filing freeze. The United States Court of Appeals for the Third Circuit issued an Order staying the effectiveness of the new media ownership rules adopted by the Commission on June 2, 2003, 68 FR 48265 ( August 5, 2003). DATES: Effective September 17, 2003.

FOR FURTHER INFORMATION CONTACT: Peter H. Doyle or Nina Shafran of the Audio Division, Media Bureau, at ( 202) 418   2700, or Barbara Kreisman or Jim Brown of the Video Division, Media Bureau, at ( 202) 418   1600.

SUPPLEMENTARY INFORMATION: On September 3, 2003, the United States Court of Appeals for the Third Circuit issued an Order 1 staying the effectiveness of the new media ownership rules adopted by the Commission on June 2, 2003.2 The Court ordered `` that the prior ownership rules remain in effect pending resolution of these proceedings.'' 3 In response, the Commission established a freeze on the filing of certain VerDate jul< 14> 2003 16: 45 Sep 16, 2003 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 17SEN1. SGM 17SEN1


[Federal Register Volume 84, Number 31 (Thursday, February 14, 2019)]
[Notices]
[Pages 4115-4116]
[FR Doc No: 2019-02311]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Form N-14, SEC File No. 270-297, OMB Control No. 3235-0336

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``Paperwork Reduction Act''), the
Securities and Exchange Commission (the ``Commission'') is soliciting
comments on the collection of information summarized below. The
Commission plans to submit this existing collection of information to
the Office of Management and Budget (``OMB'') for extension and
approval.
    Form N-14 (17 CFR 239.23) is the form for registration under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) (``Securities Act'') of
securities issued by management investment companies registered under
the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.)
(``Investment Company Act'') and business development companies as
defined by Section 2(a)(48) of the Investment Company Act in: (1) A
transaction of the type specified in rule 145(a) under the Securities
Act (17 CFR 230.145(a)); (2) a merger in which a vote or consent of the
security holders of the company being acquired is not required pursuant
to applicable state law; (3) an exchange offer for securities of the
issuer or another person; (4) a public reoffering or resale of any
securities acquired in an offering registered on Form N-14; or (5) two
or more of the transactions listed in (1) through (4) registered on one
registration statement. The principal purpose of Form N-14 is to make
material information regarding securities to be issued in connection
with business combination transactions available to investors. The
information required to be filed with the Commission permits
verification of compliance with securities law requirements and assures
the public availability and dissemination of such information. Without
the registration statement requirement, material information may not
necessarily be available to investors.
    We estimate that approximately 156 funds each file one new
registration statement on Form N-14 annually, and that 97 funds each
file one amendment

to a registration statement on Form N-14 annually. Based on
conversations with fund representatives, we estimate that the reporting
burden is approximately 620 hours per respondent for a new Form N-14
registration statement and 300 hours per respondent for amending the
Form N-14 registration statement. This time is spent, for example,
preparing and reviewing the registration statements. Accordingly, we
calculate the total estimated annual internal burden of responding to
Form N-14 to be approximately 125,820 hours. In addition to the burden
hours, based on conversations with fund representatives, we estimate
that the total cost burden of compliance with the information
collection requirements of Form N-14 is approximately $27,500 for
preparing and filing an initial registration statement on Form N-14 and
approximately $16,000 for preparing and filing an amendment to a
registration statement on Form N-14. This includes, for example, the
cost of goods and services purchased to prepare and update registration
statements on Form N-14, such as for the services of outside counsel.
Accordingly, we calculate the total estimated annual cost burden of
responding to Form N-14 to be approximately $5,842,000.
    Estimates of average burden hours are made solely for the purposes
of the Paperwork Reduction Act and are not derived from a comprehensive
or even representative survey or study of the costs of Commission rules
and forms. The collection of information under Form N-14 is mandatory.
The information provided under Form N-14 will not be kept confidential.
An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the Commission's estimate
of the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
C/O Candace Kenner, 100 F Street NE, Washington, DC 20549; or send an
email to<EMAIL_ADDRESS>
    Dated: February 11, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02311 Filed 2-13-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46005-46007]
[FR Doc No: 2015-18908]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]

Biosimilar User Fee Rates for Fiscal Year 2016

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for biosimilar user fees for fiscal year (FY) 2016. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar
User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user
fees for certain activities in connection with biosimilar biological
product development, certain applications and supplements for approval
of biosimilar biological products, establishments where approved
biosimilar biological products are made, and a biosimilar biological
product fee for each biosimilar biological product approved in a
biosimilar biological product application.
    BsUFA directs FDA to establish, before the beginning of each fiscal
year, the initial and annual biosimilar biological product development
(BPD) fees, the reactivation fee, and the biosimilar biological product
application, establishment, and product fees. These fees are effective
on October 1, 2015, and will remain in effect through September 30,
2016.

FOR FURTHER INFORMATION CONTACT: Rachel Richter, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14216, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51,
379j-52, and 379j-53), as added by BsUFA (Title IV of the Food and Drug
Administration Safety and Innovation Act, Pub. L. 112-144), establish
fees for biosimilar biological products. Under section 744H(a)(1)(A) of
the FD&C Act, the initial BPD fee for a product is due when the sponsor
submits an investigational new drug (IND) application that FDA
determines is intended to support a biosimilar biological product
application or within 5 calendar days after FDA grants the first BPD
meeting, whichever occurs first. A sponsor who has paid the initial BPD
fee is considered to be participating in FDA's BPD program for that
product.
    Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has
paid the initial BPD fee for a product, the annual BPD fee is assessed
beginning with the next fiscal year. The annual BPD fee is assessed for
the product each fiscal year until the sponsor submits a marketing
application for the product that is accepted for filing, or
discontinues participation in FDA's BPD program.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has
discontinued participation in FDA's BPD program and wants to re-engage
with FDA on development of the product, the sponsor must pay a
reactivation fee to resume participation in the program. The sponsor
must pay the reactivation fee by the earlier of the following dates: No
later than 5 calendar days after FDA grants the sponsor's request for a
BPD meeting for that product or upon the date of submission of an IND
describing an investigation that FDA determines is intended to support
a biosimilar biological product application. The sponsor will be
assessed an annual BPD fee beginning with the first fiscal year after
payment of the reactivation fee.
    BsUFA also establishes fees for certain applications and
supplements, establishments where approved biosimilar biological
products are made in final dosage form, and for each biosimilar
biological product approved in a biosimilar biological product
application (section 744H(a)(2), 744H(a)(3), and 744H(a)(4),
respectively, of the FD&C Act). Under certain conditions, FDA may grant
a small business a waiver from its first biosimilar biological product
application fee (section 744H(c)(1) of the FD&C Act).
    Under BsUFA, the initial and annual BPD fee rates for a fiscal year
are equal to 10 percent of the fee rate established under the
Prescription Drug User Fee Act (PDUFA) for an application requiring
clinical data for that fiscal year. The reactivation fee is equal to 20
percent of the fee rate established under PDUFA for an application
requiring clinical data for that fiscal year. Finally, the application,
establishment, and product fee rates under BsUFA are equal to the
application, establishment, and product fee rates under PDUFA,
respectively (section 744H(b)(1) of the FD&C Act).

II. Fee Amounts for FY 2016

    BsUFA directs FDA to establish the biosimilar biological product
fee rates in each fiscal year by reference to the user fees established
under PDUFA for that fiscal year. For more information about BsUFA,
please refer to the FDA Web site at http://www.fda.gov/bsufa. PDUFA fee
calculations for FY 2016 are published elsewhere in this issue of the
Federal Register. The BsUFA fee calculations for FY 2016 are described
in this document.

A. Initial and Annual BPD Fees, Reactivation Fees

    Under BsUFA, the initial and annual BPD fees equal 10 percent of
the PDUFA fee for an application requiring clinical data, and the
reactivation fee equals 20 percent of the PDUFA fee for an application
requiring clinical data. The FY 2016 fee for an application requiring
clinical data under PDUFA is $2,374,200. Multiplying the PDUFA
application fee, $2,374,200, by 0.1 results in FY 2016 initial and
annual BPD fees of $237,420. Multiplying the PDUFA application fee,
$2,374,200, by 0.2 results in a FY 2016 reactivation fee of $474,840.

B. Application and Supplement Fees

    The FY 2016 fee for a biosimilar biological product application
requiring clinical data equals the PDUFA fee for an application
requiring clinical data, $2,374,200. The FY 2016 fee for a biosimilar
biological product application not requiring clinical data equals half
this amount, $1,187,100. However, under section 744H(a)(2)(A) of the
FD&C Act, if a sponsor submitting a biosimilar biological product
application has previously paid an initial BPD fee, annual BPD fee(s),
and/or reactivation fee(s) for the product that is the subject of the
application, the fee for the application is reduced by the cumulative
amount of these previously paid fees. The FY 2016 fee for a biosimilar
biological product supplement with clinical data is $1,187,100, which
is half the fee for a biosimilar biological product application
requiring clinical data.

C. Establishment Fee

    The FY 2016 biosimilar biological product establishment fee for
establishments where approved biosimilar biological products are made
is equal to the FY 2016 PDUFA establishment fee of $585,200.

D. Product Fee

    The FY 2016 biosimilar biological product fee for each biosimilar
biological product approved in a biosimilar biological product
application is equal to the FY 2016 PDUFA product fee of $114,450.

III. Fee Schedule for FY 2016

    The fee rates for FY 2016 are provided in table 1.

                    Table 1--Fee Schedule for FY 2016
------------------------------------------------------------------------
                                                              Fee rates
                        Fee category                         for FY 2016
------------------------------------------------------------------------
Initial BPD................................................     $237,420
    Annual BPD.............................................      237,420
Reactivation...............................................      474,840
Applications \1\
    Requiring clinical data................................    2,374,200
    Not requiring clinical data............................    1,187,100
Supplement requiring clinical data.........................    1,187,100
Establishment..............................................      585,200
Product....................................................      114,450
------------------------------------------------------------------------
\1\ Under section 744H(a)(2)(A) of the FD&C Act, if a sponsor that
  submits a biosimilar biological product application has previously
  paid an initial BPD fee, annual BPD fees, and/or reactivation fees for
  the product that is the subject of the application, the fee for the
  application is reduced by the cumulative amount of these previously
  paid fees.

IV. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, Application, and Supplement Fees

    The fees established in the new fee schedule are effective October
1, 2015. The initial BPD fee for a product is due when the sponsor
submits an IND that FDA determines is intended to support a biosimilar
biological product application for the product or within 5 calendar
days after FDA grants the first BPD meeting for the product, whichever
occurs first. Sponsors who have discontinued participation in the BPD
program must pay the reactivation fee by the earlier of the following
dates: No later than 5 calendar days after FDA grants the sponsor's
request for a BPD meeting for that product; or upon the date of
submission of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application.

    The application or supplement fee for a biosimilar biological
product is due upon submission of the application or supplement.
    To make a payment of the initial BPD, reactivation, supplement, or
application fee, complete the Biosimilar User Fee Cover Sheet,
available on FDA's Web site (http://www.fda.gov/bsufa) and generate a
user fee identification (ID) number. Payment must be made in U.S.
currency by electronic check, check, bank draft, U.S. postal money
order, or wire transfer.
    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 FDA's Web site after
completing the Biosimilar User Fee Cover Sheet and generating the user
fee ID number.
    Please include the user fee ID number on your check, bank draft, or
postal money order, and make it payable to the Food and Drug
Administration. Your payment can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If you
prefer to send a check by a courier such as Federal Express or United
Parcel Service, the courier may deliver the check and printed copy of
the cover sheet to: U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. Contact U.S. Bank at<PHONE_NUMBER>
if you have any questions concerning courier delivery.) Please make
sure that the FDA post office box number (P.O. Box 979108) is written
on the check, bank draft, or postal money order.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. Please ask your financial
institution about the fee and include it with your payment to ensure
that your fee is fully paid. The account information is as follows: New
York Federal Reserve Bank, U.S. Department of Treasury, TREAS NYC, 33
Liberty St., New York, NY 10045, Acct. No.: 75060099, Routing No.:
021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd.,
Silver Spring, MD 20993-0002.
    The tax identification number of FDA is 53-0196965.

B. Annual BPD, Establishment, and Product Fees

    FDA will issue invoices for annual BPD, biosimilar biological
product establishment, and biosimilar biological product fees under the
new fee schedule in August 2015. Payment instructions will be included
in the invoices. Payment will be due on October 1, 2015. If sponsors
join the BPD program after the annual BPD invoices have been issued in
August 2015, FDA will issue invoices in November 2015 to firms subject
to fees for FY 2016 that qualify for the annual BPD fee after the
August 2015 billing. FDA will issue invoices in November 2016 for any
annual products and establishments subject to fees for FY 2016 that
qualify for fee assessments after the August 2015 billing.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18908 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P