or manufacturing-use product
                                                   that requires no data
                                                   submission or data matrix.
                                                   For microbial pesticides, the
                                                   active ingredient(s) must not
                                                   be re-isolated.2 3
B670............................             126  New product; registered source               7           5,363
                                                   of active ingredient(s); no
                                                   change in an established
                                                   tolerance or tolerance
                                                   exemption; requires: (1)
                                                   Submission of product
                                                   specific data; or (2)
                                                   citation of previously
                                                   reviewed and accepted data;
                                                   or (3) submission or citation
                                                   of data generated at
                                                   government expense; or (4)
                                                   submission or citation of a
                                                   scientifically-sound
                                                   rationale based on publicly
                                                   available literature or other
                                                   relevant information that
                                                   addresses the data
                                                   requirement; or (5)
                                                   submission of a request for a
                                                   data requirement to be waived
                                                   supported by a scientifically-
                                                   sound rationale explaining
                                                   why the data requirement does
                                                   not apply.2 3
B671............................             127  New product; unregistered                   17          13,403
                                                   source of active
                                                   ingredient(s); requires a
                                                   petition to amend an
                                                   established tolerance or
                                                   tolerance exemption;
                                                   requires: (1) Submission of
                                                   product specific data; or (2)
                                                   citation of previously
                                                   reviewed and accepted data;
                                                   or (3) submission or citation
                                                   of data generated at
                                                   government expense; or (4)
                                                   submission or citation of a
                                                   scientifically-sound
                                                   rationale based on publicly
                                                   available literature or other
                                                   relevant information that
                                                   addresses the data
                                                   requirement; or (5)
                                                   submission of a request for a
                                                   data requirement to be waived
                                                   supported by a scientifically-
                                                   sound rationale explaining
                                                   why the data requirement does
                                                   not apply.2 3
B672............................             128  New product; unregistered                   13           9,574
                                                   source of active
                                                   ingredient(s); non-food use
                                                   or food use with a tolerance
                                                   or tolerance exemption
                                                   previously established for
                                                   the active ingredient(s);
                                                   requires: (1) Submission of
                                                   product specific data; or (2)
                                                   citation of previously
                                                   reviewed and accepted data;
                                                   or (3) submission or citation
                                                   of data generated at
                                                   government expense; or (4)
                                                   submission or citation of a
                                                   scientifically-sound
                                                   rationale based on publicly
                                                   available literature or other
                                                   relevant information that
                                                   addresses the data
                                                   requirement; or (5)
                                                   submission of a request for a
                                                   data requirement to be waived
                                                   supported by a scientifically-
                                                   sound rationale explaining
                                                   why the data requirement does
                                                   not apply.2 3

B673............................             129  New product MUP/EP;                         10           5,363
                                                   unregistered source of active
                                                   ingredient(s); citation of
                                                   Technical Grade Active
                                                   Ingredient (TGAI) data
                                                   previously reviewed and
                                                   accepted by the Agency.
                                                   Requires an Agency
                                                   determination that the cited
                                                   data supports the new
                                                   product.2 3
B674............................             130  New product MUP; Repack of                   4           1,342
                                                   identical registered end-use
                                                   product as a manufacturing-
                                                   use product; same registered
                                                   uses only.2 3
B675............................             131  New Product MUP; registered                 10           9,574
                                                   source of active ingredient;
                                                   submission of completely new
                                                   generic data package;
                                                   registered uses only.2 3
B676............................             132  New product; more than one                  13           9,574
                                                   active ingredient where one
                                                   active ingredient is an
                                                   unregistered source; product
                                                   chemistry data must be
                                                   submitted; requires: (1)
                                                   Submission of product
                                                   specific data, and (2)
                                                   citation of previously
                                                   reviewed and accepted data;
                                                   or (3) submission or citation
                                                   of data generated at
                                                   government expense; or (4)
                                                   submission or citation of a
                                                   scientifically-sound
                                                   rationale based on publicly
                                                   available literature or other
                                                   relevant information that
                                                   addresses the data
                                                   requirement; or (5)
                                                   submission of a request for a
                                                   data requirement to be waived
                                                   supported by a scientifically-
                                                   sound rationale explaining
                                                   why the data requirement does
                                                   not apply.2 3
B677............................             133  New end-use non-food animal                 10           9,261
                                                   product with submission of
                                                   two or more target animal
                                                   safety studies; includes data
                                                   and/or waivers of data for
                                                   only:
                                                   Product chemistry and/
                                                   or
                                                   acute toxicity and/or
                                                   public health pest
                                                   efficacy and/or
                                                   animal safety studies
                                                   and/or
                                                   child resistant
                                                   packaging.2 3
----------------------------------------------------------------------------------------------------------------
\1\ A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended
  to end on the next business day.
\2\ An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
\3\ Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

                                  Table 14--Biopesticides Division--Amendments
----------------------------------------------------------------------------------------------------------------
                                                                                Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B621............................             134  Amendment; Experimental Use                  7           5,363
                                                   Permit; no change to an
                                                   established temporary
                                                   tolerance or tolerance
                                                   exemption.3
B622............................             135  Amendment; Experimental Use                 11          13,403
                                                   Permit; petition to amend an
                                                   established or temporary
                                                   tolerance or tolerance
                                                   exemption.3
B641............................             136  Amendment of an established                 13          13,403
                                                   tolerance or tolerance
                                                   exemption.
B680............................             137  Amendment; registered sources                5           5,363
                                                   of active ingredient(s); no
                                                   new use(s); no changes to an
                                                   established tolerance or
                                                   tolerance exemption. Requires
                                                   data submission.2 3
B681............................             138  Amendment; unregistered source               7           6,383
                                                   of active ingredient(s).
                                                   Requires data submission.2 3
B683............................             139  Label amendment; requires                    6           5,363
                                                   review/update of previous
                                                   risk assessment(s) without
                                                   data submission (e.g.,
                                                   labeling changes to REI, PPE,
                                                   PHI).2 3
B684............................             140  Amending non-food animal                     8           9,261
                                                   product that includes
                                                   submission of target animal
                                                   safety data; previously
                                                   registered.2 3
B685............................       141 (new)  Amendment; add a new                         5           5,363
                                                   biochemical unregistered
                                                   source of active ingredient
                                                   or a new microbial production
                                                   site. Requires submission of
                                                   analysis of samples data and
                                                   source/production site-
                                                   specific manufacturing
                                                   process description.3
----------------------------------------------------------------------------------------------------------------
1A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.

2 (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.
3Where the action involves approval of a new or amended label, on or before the end date of the decision review
  time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
  Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
  applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the
  draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

                                     Table 15--Biopesticides Division--SCLP
----------------------------------------------------------------------------------------------------------------
                                                                                Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B690............................             142  New active ingredient; food or               7           2,682
                                                   non-food use.2 6
B700............................             143  Experimental Use Permit                      7           1,342
                                                   application; new active
                                                   ingredient or new use.6
B701............................             144  Extend or amend Experimental                 4           1,342
                                                   Use Permit.6
B710............................             145  New product; registered source               4           1,342
                                                   of active ingredient(s);
                                                   identical or substantially
                                                   similar in composition and
                                                   use to a registered product;
                                                   no change in an established
                                                   tolerance or tolerance
                                                   exemption. No data review, or
                                                   only product chemistry data;
                                                   cite-all data citation, or
                                                   selective data citation where
                                                   applicant owns all required
                                                   data or authorization from
                                                   data owner is demonstrated.
                                                   Category includes 100% re-
                                                   package of registered end-use
                                                   or manufacturing-use product
                                                   that requires no data
                                                   submission or data matrix.3 6
B720............................             146  New product; registered source               5           1,342
                                                   of active ingredient(s);
                                                   requires: (1) Submission of
                                                   product specific data; or (2)
                                                   citation of previously
                                                   reviewed and accepted data;
                                                   or (3) submission or citation
                                                   of data generated at
                                                   government expense; or (4)
                                                   submission or citation of a
                                                   scientifically-sound
                                                   rationale based on publicly
                                                   available literature or other
                                                   relevant information that
                                                   addresses the data
                                                   requirement; or (5)
                                                   submission of a request for a
                                                   data requirement to be waived
                                                   supported by a scientifically-
                                                   sound rationale explaining
                                                   why the data requirement does
                                                   not apply.3 6
B721............................             147  New product; unregistered                    7           2,810
                                                   source of active ingredient.3
                                                   6
B722............................             148  New use and/or amendment;                    7           2,601
                                                   petition to establish a
                                                   tolerance or tolerance
                                                   exemption.4 5 6
B730............................             149  Label amendment requiring data               5           1,342
                                                   submission.4 6
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 All requests for new uses (food and/or nonfood) contained in any application for a new active ingredient or a
  first food use are covered by the base fee for that new active ingredient or first food use application and
  retain the same decision time review period as the new active ingredient or first food use application. The
  application must be received by the Agency in one package. The base fee for the category covers a maximum of
  five new products. Each application for an additional new product registration and new inert approval that is
  submitted in the new active ingredient application package or first food use application package is subject to
  the registration service fee for a new product or a new inert approval. All such associated applications that
  are submitted together will be subject to the new active ingredient or first food use decision review time. In
  the case of a new active ingredient application, until that new active ingredient is approved, any subsequent
  application for another new product containing the same active ingredient or an amendment to the proposed
  labeling will be deemed a new active ingredient application, subject to the registration service fee and
  decision review time for a new active ingredient. In the case of a first food use application, until that
  first food use is approved, any subsequent application for an additional new food use or uses will be subject
  to the registration service fee and decision review time for a first food use.
Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant
  at the applicant's initiative to support the application after completion of the technical deficiency
  screening, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new active ingredient or first food use application.
3 An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
4 (a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-
  track amendments are to be completed within the timelines specified in FIFRA section 3(c)(3)(B) and are not
  subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the
  Antimicrobials Division are to be completed within the timelines specified in FIFRA section 3(h) and are not
  subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR
  Notices, such as PR Notice 98-10, continue under PR Notice timelines and are not subject to registration
  service fees. (e) Submissions with data and requiring data review are subject to registration service fees.

5 Amendment applications to add the new use(s) to registered product labels are covered by the base fee for the
  new use(s). All items in the covered application must be submitted together in one package. Each application
  for an additional new product registration and new inert approval(s) that is submitted in the new use
  application package is subject to the registration service fee for a new product or a new inert approval.
  However, if a new use application only proposes to register the new use for a new product and there are no
  amendments in the application, then review of one new product application is covered by the new use fee. All
  such associated applications that are submitted together will be subject to the new use decision review time.
  Any application for a new product or an amendment to the proposed labeling (a) submitted subsequent to
  submission of the new use application and (b) prior to conclusion of its decision review time and (c)
  containing the same new uses, will be deemed a separate new-use application, subject to a separate
  registration service fee and new decision review time for a new use. If the new-use application includes non-
  food (indoor and/or outdoor), and food (outdoor and/or indoor) uses, the appropriate fee is due for each type
  of new use and the longest decision review time applies to all of the new uses requested in the application.
  Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the
  applicant at the applicant's initiative to support the application after completion of the technical
  deficiency screen, and (c) is not itself a covered registration application, must be assessed 25% of the full
  registration service fee for the new use application.
6 Where the action involves approval of a new or amended label, on or before the end date of the decision review
  time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
  Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
  applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the
  draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

                                 Table 16--Biopesticides Division--Other Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Decision
             EPA No.                 New CR No.                Action               review time     FY'20-FY'21
                                                                                (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B614.............................             150  Pre-application; Conditional                3           2,657
                                                    Ruling on rationales for
                                                    addressing a data
                                                    requirement in lieu of data;
                                                    applicant-initiated; applies
                                                    to one (1) rationale at a
                                                    time.
B615.............................             151  Rebuttal of agency reviewed                 3           2,657
                                                    protocol, applicant
                                                    initiated.
B682.............................             152  Protocol review; applicant                  3           2,554
                                                    initiated; excludes time for
                                                    HSRB review.
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or federal holiday, will be extended to
  end on the next business day.

                                      Table 17--Biopesticides Division--PIP
----------------------------------------------------------------------------------------------------------------
                                                                                Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
B740............................             153  Experimental Use Permit                      6         100,511
                                                   application; no petition for
                                                   tolerance/tolerance
                                                   exemption. Includes:
                                                  1. Non-food/feed use(s) for a
                                                   new 2 or registered 3 PIP 12;
                                                  2. food/feed use(s) for a new
                                                   or registered PIP with crop
                                                   destruct 12;
                                                  3. food/feed use(s) for a new
                                                   or registered PIP in which an
                                                   established tolerance/
                                                   tolerance exemption exists
                                                   for the intended use(s).4 12
B741............................       154 (new)  Experimental Use Permit                     12         167,515
                                                   application; no petition for
                                                   tolerance/tolerance
                                                   exemption. Includes:
                                                  1. Non-food/feed use(s) for a
                                                   new 2 or registered 3 PIP;
                                                  2. food/feed use(s) for a new
                                                   or registered PIP with crop
                                                   destruct;
                                                  3. food/feed use(s) for a new
                                                   or registered PIP in which an
                                                   established tolerance/
                                                   tolerance exemption exists
                                                   for the intended use(s);
                                                  SAP Review.12
B750............................             155  Experimental Use Permit                      9         134,012
                                                   application; with a petition
                                                   to establish a temporary or
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient. Includes new food/
                                                   feed use for a registered 3
                                                   PIP.4 12
B770............................             156  Experimental Use Permit                     15         201,017
                                                   application; new 2 PIP; with
                                                   petition to establish a
                                                   temporary tolerance/tolerance
                                                   exemption for the active
                                                   ingredient; credit 75% of
                                                   B771 fee toward registration
                                                   application for a new active
                                                   ingredient that follows; SAP
                                                   review.5 12
B771............................             157  Experimental Use Permit                     10         134,012
                                                   application; new 2 PIP; with
                                                   petition to establish a
                                                   temporary tolerance/tolerance
                                                   exemption for the active
                                                   ingredient; credit 75% of
                                                   B771 fee toward registration
                                                   application for a new active
                                                   ingredient that follows.12
B772............................             158  Application to amend or extend               3          13,403
                                                   an Experimental Use Permit;
                                                   no petition since the
                                                   established tolerance/
                                                   tolerance exemption for the
                                                   active ingredient is
                                                   unaffected.12
B773............................             159  Application to amend or extend               5          33,506
                                                   an Experimental Use Permit;
                                                   with petition to extend a
                                                   temporary tolerance/tolerance
                                                   exemption for the active
                                                   ingredient.12
B780............................             160  Registration application; new               12         167,514
                                                   2 PIP; non-food/feed.12
B790............................             161  Registration application; new               18         234,519
                                                   2 PIP; non-food/feed; SAP
                                                   review.5 12

B800............................             162  Registration application; new               13         180,915
                                                   2 PIP; with petition to
                                                   establish permanent tolerance/
                                                   tolerance exemption for the
                                                   active ingredient based on an
                                                   existing temporary tolerance/
                                                   tolerance exemption.12
B810............................             163  Registration application; new               19         247,920
                                                   2 PIP; with petition to
                                                   establish permanent tolerance/
                                                   tolerance exemption for the
                                                   active ingredient based on an
                                                   existing temporary tolerance/
                                                   tolerance exemption. SAP
                                                   review.5 12
B820............................             164  Registration application; new               15         214,419
                                                   2 PIP; with petition to
                                                   establish or amend a
                                                   permanent tolerance/tolerance
                                                   exemption of an active
                                                   ingredient.12
B840............................             165  Registration application; new               21         281,424
                                                   2 PIP; with petition to
                                                   establish or amend a
                                                   permanent tolerance/tolerance
                                                   exemption of an active
                                                   ingredient. SAP review.5 12
B851............................             166  Registration application; new                9         134,012
                                                   event of a previously
                                                   registered PIP active
                                                   ingredient(s); no petition
                                                   since permanent tolerance/
                                                   tolerance exemption is
                                                   already established for the
                                                   active ingredient(s).12
B870............................             167  Registration application;                    9          40,205
                                                   registered 3 PIP; new
                                                   product; new use; no petition
                                                   since a permanent tolerance/
                                                   tolerance exemption is
                                                   already established for the
                                                   active ingredient(s).4 12
B880............................             168  Registration application;                    9          33,506
                                                   registered 3 PIP; new product
                                                   or new terms of registration;
                                                   additional data submitted; no
                                                   petition since a permanent
                                                   tolerance/tolerance exemption
                                                   is already established for
                                                   the active ingredient(s).6 7
                                                   12
B881............................             169  Registration application;                   15         100,511
                                                   registered 3 PIP; new product
                                                   or new terms of registration;
                                                   additional data submitted; no
                                                   petition since a permanent
                                                   tolerance/tolerance exemption
                                                   is already established for
                                                   the active ingredient(s). SAP
                                                   review.5 6 7 12
B882............................       170 (new)  Registration application; new               15         201,017
                                                   2 PIP, seed increase with
                                                   negotiated acreage cap and
                                                   time-limited registration;
                                                   with petition to establish a
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient based on an
                                                   existing temporary tolerance/
                                                   tolerance exemption; SAP
                                                   Review.8 12
B883............................             171  Registration application; new                9         134,012
                                                   2 PIP, seed increase with
                                                   negotiated acreage cap and
                                                   time-limited registration;
                                                   with petition to establish a
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient based on an
                                                   existing temporary tolerance/
                                                   tolerance exemption.8 12
B884............................             172  Registration application; new               12         167,514
                                                   2 PIP, seed increase with
                                                   negotiated acreage cap and
                                                   time-limited registration;
                                                   with petition to establish a
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient.8 12
B885............................             173  Registration application;                    6          33,506
                                                   registered 2 PIP, seed
                                                   increase; breeding stack of
                                                   previously approved PIPs,
                                                   same crop; no petition since
                                                   a permanent tolerance/
                                                   tolerance exemption is
                                                   already established for the
                                                   active ingredient(s).9 12
B886............................       174 (new)  Registration application; new               18         234,519
                                                   2 PIP seed increase with
                                                   negotiated acreage cap and
                                                   time-limited registration;
                                                   with petition to establish a
                                                   permanent tolerance/tolerance
                                                   exemption for the active
                                                   ingredient. SAP Review.8 12
B890............................             175  Application to amend a seed                  9          67,007
                                                   increase registration;
                                                   converts registration to
                                                   commercial registration; no
                                                   petition since permanent
                                                   tolerance/tolerance exemption
                                                   is already established for
                                                   the active ingredient(s).12
B891............................             176  Application to amend a seed                 15         134,012
                                                   increase registration;
                                                   converts registration to a
                                                   commercial registration; no
                                                   petition since a permanent
                                                   tolerance/tolerance exemption
                                                   already established for the
                                                   active ingredient(s); SAP
                                                   review.5 12
B900............................             177  Application to amend a                       6          13,403
                                                   registration, including
                                                   actions such as extending an
                                                   expiration date, modifying an
                                                   IRM plan, or adding an insect
                                                   to be controlled.10 11 12
B901............................             178  Application to amend a                      12          80,407
                                                   registration, including
                                                   actions such as extending an
                                                   expiration date, modifying an
                                                   IRM plan, or adding an insect
                                                   to be controlled. SAP
                                                   review.10 11 12
B902............................             179  PIP Protocol review                          3           6,703
B903............................             180  Inert ingredient tolerance                   6          67,007
                                                   exemption; e.g., a marker
                                                   such as NPT II; reviewed in
                                                   BPPD.
B904............................             181  Import tolerance or tolerance                9         134,012
                                                   exemption; processed
                                                   commodities/food only (inert
                                                   or active ingredient).
B905............................       182 (new)  SAP Review                                   6          67,007
B906............................       183 (new)  Petition to establish a                      3          33,503
                                                   temporary tolerance/tolerance
                                                   exemption for one or more
                                                   active ingredients.
B907............................       184 (new)  Petition to establish a                      3          13,403
                                                   temporary tolerance/tolerance
                                                   exemption for one or more
                                                   active ingredients based on
                                                   an existing temporary
                                                   tolerance/tolerance
                                                   exemption.

B908............................       185 (new)  Petition to establish a                      3          46,905
                                                   temporary tolerance/tolerance
                                                   exemption for one or more
                                                   active ingredients or inert
                                                   ingredients
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 New PIP = a PIP with an active ingredient that has not been registered.
3 Registered PIP = a PIP with an active ingredient that is currently registered.
4 Transfer registered PIP through conventional breeding for new food/feed use, such as from field corn to sweet
  corn.
5 The scientific data involved in this category are complex. EPA often seeks technical advice from the
  Scientific Advisory Panel (SAP) on risks that pesticides pose to wildlife, farm workers, pesticide
  applicators, non-target species, as well as insect resistance, and novel scientific issues surrounding new
  technologies. The scientists of the SAP neither make nor recommend policy decisions. They provide advice on
  the science used to make these decisions. Their advice is invaluable to the EPA as it strives to protect
  humans and the environment from risks posed by pesticides. Due to the time it takes to schedule and prepare
  for meetings with the SAP, additional time and costs are needed.
6 Registered PIPs stacked through conventional breeding.
7 Deployment of a registered PIP with a different IRM plan (e.g., seed blend).
8 The negotiated acreage cap will depend upon EPA's determination of the potential environmental exposure,
  risk(s) to non-target organisms, and the risk of targeted pest developing resistance to the pesticidal
  substance. The uncertainty of these risks may reduce the allowable acreage, based upon the quantity and type
  of non-target organism data submitted and the lack of insect resistance management data, which is usually not
  required for seed-increase registrations. Registrants are encouraged to consult with EPA prior to submission
  of a registration application in this category.
9 Application can be submitted prior to or concurrently with an application for commercial registration.
10 For example, IRM plan modifications that are applicant-initiated.
11 EPA-initiated amendments shall not be charged fees.
12 Where the action involves approval of a new or amended label, on or before the end date of the decision
  review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by
  the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency.
  The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with
  the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the registrant's written or electronic
  confirmation of agreement to the Agency.

                                           Table 18--Inert Ingredients
----------------------------------------------------------------------------------------------------------------
                                                                                Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
I001............................             186  Approval of new food use inert              13          28,350
                                                   ingredient 2 3
I002............................             187  Amend currently approved inert              11           7,875
                                                   ingredient tolerance or
                                                   exemption from tolerance; new
                                                   data.2
I003............................             188  Amend currently approved inert               9           3,474
                                                   ingredient tolerance or
                                                   exemption from tolerance; no
                                                   new data.2
I004............................             189  Approval of new non-food use                 6          11,577
                                                   inert ingredient.2
I005............................             190  Amend currently approved non-                6           5,789
                                                   food use inert ingredient
                                                   with new use pattern; new
                                                   data.2
I006............................             191  Amend currently approved non-                3           3,474
                                                   food use inert ingredient
                                                   with new use pattern; no new
                                                   data.2
I007............................             192  Approval of substantially                    4           1,737
                                                   similar non-food use inert
                                                   ingredients when original
                                                   inert is compositionally
                                                   similar with similar use
                                                   pattern.2
I008............................             193  Approval of new or amended                   5           3,937
                                                   polymer inert ingredient,
                                                   food use.2
I009............................             194  Approval of new or amended                   4           3,242
                                                   polymer inert ingredient, non-
                                                   food use.2
I010............................             195  Petition to amend a single                   6           1,737
                                                   tolerance exemption
                                                   descriptor, or single non-
                                                   food use descriptor, to add
                                                   <=10 CASRNs; no new data.2
I011............................       196 (new)  Approval of new food use                    24         627,568
                                                   safener with tolerance or
                                                   exemption from tolerance.2 8
I012............................       197 (new)  Approval of new non-food use                21         436,004
                                                   safener.2 8
I013............................       198 (new)  Approval of additional food                 15          66,124
                                                   use for previously approved
                                                   safener with tolerance or
                                                   exemption from tolerance.2
I014............................       199 (new)  Approval of additional non-                 15          26,427
                                                   food use for previously
                                                   approved safener.2
I015............................       200 (new)  Approval of new generic data                24         283,215
                                                   for previously approved food
                                                   use safener.2
I016............................       201 (new)  Approval of amendment(s) to                 13          58,565
                                                   tolerance and label for
                                                   previously approved safener.2
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
3 If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.

4 Any other covered application that is associated with and dependent on the HSRB review will be subject to its
  separate registration service fee. The decision review times for the associated actions run concurrently but
  will end at the date of the latest review time.
5 Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
6 An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.
7 Where the action involves approval of a new or amended label, on or before the end date of the decision review
  time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
  Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
  applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the
  draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the applicant's written or electronic
  confirmation of agreement to the Agency.
8 If a new safener is submitted in the same package as a new active ingredient, and that new active ingredient
  is determined to be reduced risk, then the safener would get the same reduced timeframe as the new active
  ingredient.

                               Table 19--External Review and Miscellaneous Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Decision
             EPA No.                New CR No.                Action                review time     FY'20-FY'21
                                                                                (months) 1       fees ($)
----------------------------------------------------------------------------------------------------------------
M001............................             202  Study protocol requiring Human               9           8,335
                                                   Studies Review Board review
                                                   as defined in 40 CFR Part 26
                                                   in support of an active
                                                   ingredient.4
M002............................             203  Completed study requiring                    9           8,335
                                                   Human Studies Review Board
                                                   review as defined in 40 CFR
                                                   Part 26 in support of an
                                                   active ingredient.4
M003............................             204  External technical peer review              12          67,143
                                                   of new active ingredient,
                                                   product, or amendment (e.g.,
                                                   consultation with FIFRA
                                                   Scientific Advisory Panel)
                                                   for an action with a decision
                                                   timeframe of less than 12
                                                   months. Applicant initiated
                                                   request based on a
                                                   requirement of the
                                                   Administrator, as defined by
                                                   FIFRA Sec.   25(d), in
                                                   support of a novel active
                                                   ingredient, or unique use
                                                   pattern or application
                                                   technology. Excludes PIP
                                                   active ingredients.5
M004............................             205  External technical peer review              18          67,143
                                                   of new active ingredient,
                                                   product, or amendment (e.g.,
                                                   consultation with FIFRA
                                                   Scientific Advisory Panel)
                                                   for an action with a decision
                                                   timeframe of greater than 12
                                                   months. Applicant initiated
                                                   request based on a
                                                   requirement of the
                                                   Administrator, as defined by
                                                   FIFRA Sec.   25(d), in
                                                   support of a novel active
                                                   ingredient, or unique use
                                                   pattern or application
                                                   technology. Excludes PIP
                                                   active ingredients.5
M005............................             206  New Product: Combination,                    9          23,153
                                                   Contains a combination of
                                                   active ingredients from a
                                                   registered and/or
                                                   unregistered source;
                                                   conventional, antimicrobial
                                                   and/or biopesticide. Requires
                                                   coordination with other
                                                   regulatory divisions to
                                                   conduct review of data, label
                                                   and/or verify the validity of
                                                   existing data as cited. Only
                                                   existing uses for each active
                                                   ingredient in the combination
                                                   product.6 7
M006............................             207  Request for up to 5 letters of               1             291
                                                   certification (Gold Seal) for
                                                   one actively registered
                                                   product (excludes distributor
                                                   products).8
M007............................             208  Request to extend Exclusive                 12           5,789
                                                   Use of data as provided by
                                                   FIFRA section 3(c)(1)(F)(ii).
M008............................             209  Request to grant Exclusive Use              15           1,737
                                                   of data as provided by FIFRA
                                                   Section 3(c)(1)(F)(vi) for a
                                                   minor use, when a FIFRA
                                                   Section 2(ll)(2)
                                                   determination is required.
M009............................       210 (new)  Non-FIFRA Regulated                          4           2,482
                                                   Determination: Applicant
                                                   initiated, per product.
M010............................       211 (new)  Conditional ruling on pre-                   4           2,482
                                                   application, product
                                                   substantial similarity.
M011............................       212 (new)  Label amendment to add the DfE               4           3,831
                                                   logo; requires data review;
                                                   no other label changes.9
----------------------------------------------------------------------------------------------------------------
1 A decision review time that would otherwise end on a Saturday, Sunday, or Federal holiday, will be extended to
  end on the next business day.
2 If another covered application is submitted that depends upon an application to approve an inert ingredient,
  each application will be subject to its respective registration service fee. The decision review time line for
  both submissions will be the longest of the associated applications. If the application covers multiple
  ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for
  approval of those ingredients.
3 If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of
  an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of
  the data for such clearance of such product is not subject to a registration service fee for the tolerance
  action for two years from the effective date of the rule.
4 Any other covered application that is associated with and dependent on the HSRB review will be subject to its
  separate registration service fee. The decision review times for the associated actions run concurrently but
  will end at the date of the latest review time.
5 Any other covered application that is associated with and dependent on the SAP review will be subject to its
  separate registration service fee. The decision review time for the associated action will be extended by the
  decision review time for the SAP review.
6 An application for a new end-use product using a source of active ingredient that (a) is not yet registered
  but (b) has an application pending with the Agency for review, will be considered an application for a new
  product with an unregistered source of active ingredient.

7 Where the action involves approval of a new or amended label, on or before the end date of the decision review
  time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the
  Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The
  applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the
  draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-
  stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the
  Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without
  prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases
  described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the
  final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as
  in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-
  stamped label to the registrant within 2 business days following the applicant's written or electronic
  confirmation of agreement to the Agency.
8 Due to low fee and short time frame this category is not eligible for small business waivers. Gold seal
  applies to one registered product
9 This category includes amendments the sole purpose of which are to add DfE (or equivalent terms that do not
  use ``safe'' or derivatives of ``safe'') logos to a label. DfE is a voluntary program. A label bearing a DfE
  logo is not considered an Agency endorsement because the ingredients in the qualifying product must meet
  objective, scientific criteria established and widely publicized by EPA.

V. How To Pay Fees

    Applicants must submit fee payments at the time of application, and
EPA will reject any application that does not contain evidence that the
fee has been paid. EPA has developed a website at https://www.epa.gov/pria-fees/pria-4-fee-determination-decision-tree to help applicants
identify the fee category and the fee. All fees should be rounded up to
the whole dollar. Due to changes mandated by the U.S. Department of the
Treasury, checks, bank drafts and money orders are no longer acceptable
as of September 30, 2015. Credit card payments are only acceptable for
amounts less than or equal to $24,999. All payments equal to or above
$25,000 can be made by electronic funds transfer via the government
payment website, https://www.pay.gov/.
    More detailed instructions on how to make an application payment in
association with a PRIA application are provided at the following
website, https://www.epa.gov/pria-fees/paying-pria-application-fees.

VI. How To Submit Applications

    Applicants are able to make PRIA submissions electronically via the
Pesticide Submission Portal. The Portal is accessed through EPA's
Central Data Exchange (CDX) network and requires user registration.
Registrants currently submitting CDs or DVDs using the e-Dossier
downloadable tool or their own builder tools using EPA's XML guidance
can use the portal and forego courier delivery costs. Information on
how to submit applications electronically via the Pesticide Submission
Portal are provided at https://www.epa.gov/pesticide-registration/electronic-submissions-pesticide-applications.
    Paper submissions to the Agency should be made at the address given
in Unit VII. The applicant should attach documentation that the fee has
been paid which in most cases will be pay.gov payment acknowledgement.
    If the applicant is applying for a fee waiver, the applicant should
provide sufficient documentation as described in FIFRA section 33(b)(7)
and https://www.epa.gov/pria-fees/pria-fee-waivers-small-businesses.
The fee waiver request should be easy to identify and separate from the
rest of the application and submitted with documentation that at least
25% of the fee has been paid.
    If evidence of fee payment (electronic acknowledgement) is not
submitted with the application, EPA will reject the application and
will not process it further.
    After EPA receives an application and payment, EPA performs a
screen on the application to determine that the category is correct and
that the proper fee amount has been paid. If either is incorrect, EPA
will notify the applicant and require payment of any additional amount
due. A refund will be provided in case of an overpayment. EPA will not
process the application further until the proper fee has been paid for
the category of application or a request for a fee waiver accompanies
the application and the appropriate portion of the fee has been paid.
    EPA will assign a unique identification number to each covered
application for which payment has been made. EPA notifies the applicant
of the unique identification number. This information is sent by email
if EPA has either an email address on file or an email address is
provided on the application.

VII. Addresses for Applications

    New covered applications should be identified in the title line
with the mail code REGFEE.
     By U.S. Postal Service mail. Document Processing Desk
(REGFEE), Office of Pesticide Programs (7504P), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460-
0001.
     By courier. Document Processing Desk (REGFEE), Office of
Pesticide Programs, U.S. Environmental Protection Agency, Room S-4900,
One Potomac Yard (South Bldg.), 2777 S. Crystal Drive, Arlington, VA
22202-4501.
    Couriers and delivery personnel must present a valid picture
identification card to gain access to the building. Hours of operation
for the Document Processing Desk are 8 a.m. to 4:00 p.m., Monday
through Friday, excluding Federal holidays.
    List of Subjects: Environmental protection, Administrative practice
and procedure, Pesticides.

    Dated: September 24, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2019-21117 Filed 9-30-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 25, 2010 (Volume 75, Number 57)]
[Notices]
[Page 14437-14438]
[DOCID:fr25mr10-55]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IS10-108-000]

Platte Pipe Line Company; Notice of Technical Conference

March 18, 2010.
    Take notice that the Commission will convene a technical conference
on Thursday, April 22, 2010, at 9 a.m. (EDT), in a room to be
designated at the offices of the Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426.
    The technical conference will address all aspects of Platte's
Supplement No. 15 to its FERC Tariff No. 1456 proposing to establish a
new prorationing procedure for crude oil volumes moving on both
segments of its pipeline system,

as discussed in the Commission's Order issued on February 19, 2010.\1\
Platte's current prorationing procedure contains separate allocation
procedures for the two segments of its pipeline system. The proposed
provisions of Supplement No. 15 would allocate capacity on both
pipeline segments on the basis of historical volumes delivered to
defined destinations.
---------------------------------------------------------------------------

    \1\ Platte Pipe Line Company, 130 FERC ] 61,125 (2010).
---------------------------------------------------------------------------

    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Jenifer Lucas at<PHONE_NUMBER> or e-mail
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-6571 Filed 3-24-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 126 (Wednesday, July 1, 2015)]
[Notices]
[Pages 37716-37717]
[FR Doc No: 2015-16140]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2014-0315]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA confirms its decision to exempt 73 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on May 8, 2015. The exemptions
expire on May 8, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Room W64-224, Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday,
except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On April 7, 2015, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 73 individuals and requested
comments from the public (80 FR 18681). The public comment period
closed on May 7, 2015, and two comments were received.
    FMCSA has evaluated the eligibility of the 73 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

III. Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 73 applicants have had ITDM over a range of one to 36 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to

diabetes management, and is on a stable insulin regimen. These drivers
report no other disqualifying conditions, including diabetes-related
complications. Each meets the vision requirement at 49 CFR
391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the April 7, 2015, Federal Register
notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received two comments in this proceeding. The comments are
addressed below.
    An anonymous commenter stated that allowing insulin-dependent
drivers to operate CMVs in interstate commerce would increase safety as
more experienced drivers would be allowed to drive. This is the purpose
of the Diabetes Exemption Program.
    Charla Sloan, Transit Director of the KI BOIS Area Transit System
in Oklahoma, stated that she believes insulin-dependent drivers should
be allowed to operate CMVs in interstate commerce without an exemption.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 73 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)):

Tony W. Alonzo (TX)
Rafael M. Alvarado (TX)
Mark J. Avedisian (NY)
Timothy J. Burke (MA)
Eric E. Burton (TN)
Roger D. Cassada (VA)
Timothy W. Clark (OH)
Leonard W. Cleaves (MA)
Bruce Combs (OH)
Larry A. Cramer (SD)
Bradford A. Davies (ME)
Larry A. DeSanno (OR)
Robert S. Doering (IL)
Michael L. Domarus (MN)
Matthew G. Drabant (CO)
Adan A. Espinoza (CA)
Howard E. Fruehling (IA)
Michael F. Gabbianelli (NJ)
Christopher W. Geib (OH)
Ernest W. Gibbs (VA)
James E. Goins (NJ)
Gregory J. Goodenbour (IA)
Paul M. Gugerty, Jr. (IL)
William F. Guttormsen (NJ)
Michael D. Howell (NC)
Curtis L. Hudson (SC)
Mayer Indorsky (NY)
Raymond J. Jacobs (NY)
Lyle J. Kaehler (WI)
Charles F. Kennedy (PA)
Stephen P. Koons (PA)
Curtis G. Kirchbaum (PA)
Joseph A. Lahaderne (NY)
Walter P. Leck (PA)
Eric F. Leigh (IL)
Alvin G. Madwatkins (NJ)
Clayton B. Mathis (GA)
John R. Mauney (NC)
Derrell R. McCaskill (MD)
Darrel F. McCoy, Jr. (MO)
Eric O. McLamb (NC)
William W. McPhee (MI)
Michael S. Murray (IA)
Benjamin M. Naastad (ND)
Richard G. Niemi (WI)
Kenthia E. Norfleet (AL)
Donald M. Oakes (NH)
Philip L. Orsi (NY)
Robert E. Piernik (FL)
Harold E. Pratt (MO)
Jack C. Reed (NE)
Fernando Rivera (IL)
Timothy F. Rodehaver (OH)
Robin R. Roth (MN)
Lewis S. Russell (OR)
William J. Schmidt (MN)
Todd J. Schoeller (WI)
Gary H. Schrot (WI)
Ryan A. Snow (PA)
Kevin L. Sundh (UT)
William H. Terry (IN)
Gary E. Tilson (VA)
Duane K. Torlish, Jr. (NY)
Ronald W. Truitt (PA)
Timothy E. Vanderwiele (NY)
Leo D. Vermeire (WA)
Brian W. Walls (PA)
Gary L. Webster (VT)
Lance A. Wendinger (MN)
Allan W. Widener (GA)
Shane D. Wildoner (PA)
Roy L. Woodbury (OK)
Kyle A. Wright (WA)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: June 23, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-16140 Filed 6-30-15; 8:45 am]
BILLING CODE 4910-EX-P