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                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                  OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION
MEMORANDUM

Date:	17-December-2013

Subject:	Addendum to DP Barcodes D404359 and D411652: Linuron.  Petition for the Establishment of Permanent Tolerances and Registration for Use on Coriander, Dill, Parsley, Pea (Dry), and Horseradish; and Submission of Residue Analytical Methods of Plants and Animal Matrices.  Summary of Analytical Chemistry and Residue Data.

PC Code:  035506
DP Barcodes:  D416651
Decision No.:  469722
Registration No.:  61842-23
Petition No.:  2E8083
Regulatory Action:  Section 3
Risk Assessment Type:  NA
Case No.:  NA
TXR No.:  NA
CAS No.:  330-55-2
MRID No.:  NA
40 CFR:§180.184

From:	Nancy Tsaur, Chemist
	Risk Assessment Branch 3 (RAB3)
	Health Effects Division (7509P)

Through:	Christine Olinger, Branch Chief
	Risk Assessment Branch 3 (RAB3)
	Health Effects Division (7509P)

To: 	Kristin Rury, Biologist, Risk Assessor
	Risk Assessment Branch 3 (RAB3)
	Health Effects Division (7509P)

	and

	Laura Nollen/Barbara Madden, RM05
	Risk Integration Minor Use and Emergency Response Branch (RIMUERB)
	Registration Division (7505P)

This document serves as an addendum to the original residue data review from August 14, 2013.  The addendum updates corrected values for the recommended tolerances, tolerance derivation, and input/output values for the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures.

                               Table of Contents

1.0	Executive Summary	3
2.0	Regulatory Recommendations	3
2.1	Tolerance Considerations	3
2.1.1	Recommended Tolerances	3
2.1.2	Revisions to Petitioned-For Tolerances	4
2.1.3	International Harmonization	4
3.0	Residue Data: Crop Field Trials (860.1500)	4
4.0	Tolerance Derivation	5
Appendix A.  OECD MRL Calculation Procedure Inputs/Outputs	8

1.0	Executive Summary

The Interregional Research Project No. 4 (IR-4) has submitted a petition (PP#2E8083) for tolerances on coriander, dill, parsley, pea (dry), and horseradish; and has proposed to add these uses to the Tessenderlo Kerley label for Lorox(R) DF (EPA Reg. No. 61842-23).  IR-4 has submitted crop field trials utilizing comparable formulations, all of which consist of 50% active ingredient (ai) in a dry flowable formulation.  The residue chemistry database is adequate for tolerance assessment of the proposed uses.

2.0	Regulatory Recommendations

HED has examined the residue chemistry database for linuron and concluded that, provided a revised label and a revised Section F are submitted, there are no residue chemistry deficiencies that would preclude granting Section 3 registration for the requested crop commodity uses of linuron, or establishment of tolerances for residues of linuron.  The specific tolerance recommendations are discussed in Section 2.1.1.

2.1	Tolerance Considerations

2.1.1	Recommended Tolerances

In addition to the recommended tolerances listed below in Table 1, the tolerance with regional registration under 40 CFR §180.184(c) for parsley, leaves (0.25 ppm) should be deleted.

Table 1.  Tolerance Summary for Linuron.
                                   Commodity
                           Proposed Tolerance (ppm)
                        HED-Recommended Tolerance (ppm)
                                  Comments[a]
                 (OECD calculation adjustments to tolerances)

                                   DP404359
                                   DP416651

                            Cilantro, fresh leaves
                                      3.0
                                      1.5
                                      3.0
                  Corrected OECD Calculation Procedure values
                            Cilantro, dried leaves
                                      27
                                      10
                                      10
                          9X PF x HAFT of 1.055 ppm
                                Coriander, seed
                                     0.01
                                     0.05
                                     0.01
                                LOQ of 0.01 ppm
                            Dillweed, fresh leaves
                                      1.5
                                      0.6
                                      1.5
                  Corrected OECD Calculation Procedure values
                            Dillweed, dried leaves
                                      7.1
                                      3.0
                                      5.0
                           9X PF x HAFT of 0.56 ppm
                                  Dill, seed
                                      0.3
                                      0.5
                                      0.5
                             5 x Mean of 0.09 ppm
                                   Dill, oil
                                      4.8
                                      2.0
                                      2.0
                          3.21 PF x HAFT of 0.56 ppm
                                  Horseradish
                                     0.05
                                     0.05
                                     0.05
                                LOQ of 0.05 ppm
                                Parsley, leaves
                                      3.0
                                      4.0
                                      4.0
                             5 x Mean of 0.75 ppm
                             Parsley, dried leaves
                                      8.3
                                      3.0
                                      9.0
                          9X PF x HAFT of 1.015 ppm
                                Pea, dry, seed
                                     0.08
                                     0.06
                                     0.09
                  Corrected OECD Calculation Procedure values
a	OECD = Organization for Economic Cooperation and Development. PF = processing factor. HAFT = highest average field trial. LOQ = limit of quantitation.

2.1.2	Revisions to Petitioned-For Tolerances

All of the petitioned-for tolerance levels (except for fresh cilantro, coriander seed, fresh dillweed, and horseradish) must be revised to reflect the tolerance levels recommended by HED for linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible to 3,4-dichloroaniline (DCA), calculated as linuron, in or on the commodities.

The Organization for Economic Cooperation and Development (OECD) calculation procedures were used to calculate the tolerance levels for the following three commodities: cilantro, fresh leaves; dillweed, fresh leaves; and pea, dry, seed.  Based on the OECD calculations, the tolerance level for pea, dry, seed should be increased.

Instead of using the OECD calculator due to a limited number of field trials, the formula of 5X the mean was used to establish tolerance levels for the following two commodities: dill, seed; and parsley, leaves.  Based on this calculation method, both tolerance levels should be increased.

For the dried herbs (cilantro, dillweed, and parsley), the formula of the highest average field trial (HAFT) multiplied by the herb processing (drying) factor of 9X was used to calculate the recommended tolerance levels (the processing factor was derived from dividing the average  dried cilantro commodity residue by the average fresh cilantro residue).  Based on this calculation method, the tolerance levels for dried cilantro and dillweed should be decreased, and the tolerance for dried parsley should be increased.

For dill oil, the formula of the HAFT multiplied by the herb processing (oil extraction) factor of 3.21X was used to calculate the recommended tolerance level (the processing factor was derived from dividing the average dill oil commodity residue by the average fresh dill residue).  Based on this calculation method, the dill oil tolerance should be decreased.

2.1.3	International Harmonization

There are no established maximum residue limits (MRLs) for linuron in Codex for any agricultural commodity.  Furthermore, no Canadian or Mexican MRLs have been established for linuron.  Therefore, there are no harmonization issues that exist with respect to U.S. tolerances.

3.0	Residue Data: Crop Field Trials (860.1500)
DER References: MRIDs 48928501, 48928502, 48928503, 48928504, 45633501, 45633502

All of the field trials were conducted according to the proposed label use directions in the appropriate representative geographical regions.  Adjuvants were not used in any of the field trials.  Residue decline studies were not conducted.

The available residue data, as shown in Table 2, are acceptable and reflect the proposed use patterns provided in Section B.  The number and geographical locations of the field trials are in accordance with the test guidelines.  Furthermore, an acceptable method was used for residue quantitation and the data are supported by adequate storage stability data.

Table 2.  Summary of Residues from Field Trials with Linuron.
                                  Crop Matrix
                                  Analyte[b]
                                 Applic. Rate
                                 (lb ai/acre)
                                  PHI (days)
                                       n
                              Residues[a,b] (ppm)

                                     Min.
                                     Max.
                                     HAFT
                                     Mean
                                      SD
 Coriander: Proposed Use = 2.0 lb ai/acre total application rate, 21-day PHI.
                            Fresh Leaves and Stems
                                    Linuron
                                 1.997 - 2.118
                                     19-21
                                       8
                                     0.08
                                     1.14
                                     1.055
                                     0.65
                                      0.4
                            Dried Leaves and Stems

                                      19
                                       1
                                      8.5
                                      NA
                                      NA
                                      NA
                                     Seed

                                      155
                                       2
                                   <0.01
                                      NA
                                      NA
                                      NA
    Dill: Proposed Use = 2.0 lb ai/acre total application rate, 21-day PHI.
                            Fresh Leaves and Stems
                                    Linuron
                                 2.005 - 2.026
                                    20 - 22
                                       7
                                      0.3
                                     0.67
                                     0.56
                                     0.48
                                      0.1
                            Dried Leaves and Stems

                                      22
                                       2
                                      1.8
                                      3.5
                                     2.65
                                     2.65
                                      1.2
                                     Seed

                                    59 - 85
                                       4
                                     0.06
                                     0.12
                                     0.12
                                     0.09
                                     0.03
                                      Oil

                                      48
                                       1
                                      1.8
                                      NA
                                      NA
                                      NA
  Parsley: Proposed Use = 1.5 lb ai/acre total application rate, 30-day PHI.
                            Fresh Leaves and Stems
                                    Linuron
                                     1.510
                                    29 - 32
                                       4
                                     0.43
                                      1.3
                                     1.02
                                     0.75
                                     0.387
                            Dried Leaves and Stems

                                     1.511
                                      29
                                       1
                                      2.8
                                      2.8
                                      2.8
                                      NA
Pea (Dry): Proposed Use = 1.0 lb ai/acre total application rate, unspecified PHI.
                                   Pea (Dry)

                                 0.972 - 1.015
                                    65 - 92
                                      12
                                   <0.01
                                     0.052
                                     0.051
                                     0.014
                                     0.018
Horseradish: Proposed Use = 1.5 lb ai/acre total application rate, unspecified PHI.
                                     Roots
                                    Linuron
                                 1.43  -  1.55
                                   77 - 100
                                       3
                                   <0.05
                                      NA
                                      NA
                                      NA
a	HAFT = highest average field trial.  SD = Standard Deviation.  For samples with no detectable residues (< 0.01 ppm) the LOQ value (0.01 ppm) was used to calculate the Mean and Standard Deviation.
b	Residues were converted to and measured as 3,4-DCA.  Values were converted to linuron equivalents.

4.0	Tolerance Derivation

As shown in Appendix A, the statistical goal of the OECD calculation procedures is to produce an MRL/tolerance proposal in the region of the 95[th] percentile of the underlying residues distribution.

Coriander (MRID 48928501)
The dataset used to establish a tolerance for linuron consisted of field trial data on coriander representing two applications within -5% to +10% of 1 lb ai/A per application for a total of 2 lb ai/A per crop, and 19- to 21-day PHIs.  The average residue values used to calculate the tolerance are provided below.  Combined residues of linuron and its metabolites hydrolyzed to 3,4-DCA were quantifiable (LOQ = 0.01 ppm) in/on samples.

For fresh coriander, data from four field trials were used in the OECD tolerance calculation procedures for fresh coriander, resulting in a recommended tolerance of 3.0 ppm.  (Note that the correct commodity term is cilantro, fresh leaves).

For dried coriander, a 9X concentration factor was derived from a single residue field trial where the coriander was dried (calculated by dividing the average dried cilantro commodity residue by the average fresh cilantro residue), resulting in a recommended tolerance of 10 ppm (calculated by: HAFT of fresh coriander residue 1.055 ppm x processing factor 9).  (Note that the correct commodity term is cilantro, dried leaves).

For coriander seed, no detectable residues were found, resulting in a recommended tolerance of 0.01 ppm (at the LOQ 0.01 ppm).

Dill (MRID 48928502)
The dataset used to establish a tolerance for linuron consisted of field trial data on dill representing two applications within -5% to +10% of 1 lb ai/A per application for a total of 2 lb ai/A per crop, and 20- to 22- day PHIs.  The average residue values used to calculate the tolerance are provided below.  Combined residues of linuron and its metabolites hydrolyzed to3,4-DCA were quantifiable (LOQ = 0.01 ppm) in/on all samples.

For fresh dill, data from three field trials were used in the OECD tolerance calculation procedures for fresh dill, resulting in a recommended tolerance of 1.5 ppm.

For dried dill, the 9X processing factor derived for coriander was used, resulting in a recommended tolerance of 5.0 ppm (calculated by: HAFT of fresh dill 0.56 ppm x concentration factor 9).  Since all fresh herbs contain comparable water content, the processing factor for dried herbs should be the same.  By using the highest processing factor value derived from coriander (at 9X), HED is being sufficiently protective that the residues of linuron are not underestimated in dried herb commodities.

For dill seed, the OECD calculation procedures could not be used because there were only two field trials, thus resulting in a recommended tolerance of 0.5 ppm (calculated by: 5 x mean dill oil residue 0.09 ppm).

For dill oil, a 3.21X concentration factor was derived from a single residue field trial (calculated by dividing the average dill oil commodity residue by the average fresh dill residue), resulting in a recommended tolerance of 2.0 ppm (calculated by: HAFT of fresh dill 0.56 ppm x concentration factor 3.21).

Horseradish (MRIDs 45633501 and 45633502)
The dataset used to establish a tolerance for linuron consisted of field trial data on horseradish representing one application within -5% to +10% of 1.5 lb ai/A per application, and 76- to 100-day PHIs.  The average residue values used to calculate the tolerance are provided below.  An LOQ was not statistically calculated in this study, but the Lowest Limit of Method Validation (LLMV) was determined to be 0.05 ppm.

For horseradish, data from three field trials indicated that detectable residues were not found.  Thus, data consisting of <LOQ values from three field trials were used in the OECD tolerance calculation procedures, resulting in a recommended tolerance equivalent to the LOQ of 0.05 ppm.

Parsley (MRID 48928503)
The dataset used to establish a tolerance for linuron consisted of field trial data on parsley representing one application of 1.51 lb ai/A and 29- to 32-day PHIs.  The average residue values used to calculate the tolerance are provided below.  Although the LOQ were not statistically calculated in this study, all combined residues of linuron and its metabolites hydrolyzed to 3,4-DCA were quantifiable in/on samples above the LLMV (0.05 ppm).

For fresh parsley, the OECD calculation procedures could not be used because there were only two field trials, thus resulting in a recommended tolerance of 4.0 ppm (calculated by: 5 x mean fresh parsley residue 0.75 ppm).

For dried parsley, the 9X processing factor derived for coriander was used, resulting in a recommended tolerance of 9.0 ppm (calculated by: HAFT of fresh parsley 1.015 ppm x concentration factor 9).  Since all fresh herbs contain comparable water content, the processing factor for dried herbs should be the same.  By using the highest processing factor value derived from coriander (at 9X), HED is being sufficiently protective that the residues of linuron are not underestimated in dried herb commodities.

Pea (Dry) (MRID 48928504)
The dataset used to establish a tolerance for linuron consisted of field trial data on peas (dry) representing one application within -5% to +10% of 1 lb ai/A, and 65- to 92-day PHIs.  The average residue values used to calculate the tolerance are provided below.  Combined residues of linuron and its metabolites hydrolyzed to3,4-DCA were quantifiable in/on two of six trials.

For dry peas, data from all six field trials were used in the OECD calculation procedures, resulting in a recommended tolerance of 0.09 ppm.
Appendix A.  OECD MRL Calculation Procedure Inputs/Outputs

Coriander (MRID 48928501) (Cilantro, Fresh)
2.0 lb ai/A; 19-21 day PHIs

                               Residues (mg/kg)
                                     0.940
                                       1
                                     0.086
                                       1
                                     0.525
                                       1
                                     1.055
                                       1

Compound

                                    Linuron
Crop

                                Fresh Coriander
Region / Country

                                  CA/OR/TN/TX
GAP

Total number of data (n)

                                       4

Percentage of censored data

                                      0%
Number of non-censored data

                                       4

Lowest residue

                                     0.086
Highest residue

                                     1.055
Median residue

                                     0.733

Mean

                                     0.651
Standard deviation (SD)

                                     0.441

Correction factor for censoring (CF)

                                     1.000

Proposed MRL estimate

- Highest residue

                                     1.055
- Mean + 4 SD

                                     2.414
- CF x 3 Mean

                                     1.954
Unrounded MRL

                                     2.414

Rounded MRL

                                       3

High uncertainty of MRL estimate due to small dataset.

Dill (MRID 48928502)
2.0 lb ai/A; 20-22 day PHIs

                               Residues (mg/kg)
                                     0.335
                                       1
                                     0.490
                                       1
                                     0.560
                                       1

Compound

                                    Linuron
Crop

                                  Fresh Dill
Region / Country

                                   CA/FL/WA
GAP

Total number of data (n)

                                       3

Percentage of censored data

                                      0%
Number of non-censored data

                                       3

Lowest residue

                                     0.335
Highest residue

                                     0.560
Median residue

                                     0.490

Mean

                                     0.462
Standard deviation (SD)

                                     0.115

Correction factor for censoring (CF)

                                     1.000

Proposed MRL estimate

- Highest residue

                                     0.560
- Mean + 4 SD

                                     0.922
- CF x 3 Mean

                                     1.385
Unrounded MRL

                                     1.385

Rounded MRL

                                      1.5

High uncertainty of MRL estimate due to small dataset.

Pea (Dry) (MRID 48928504)
1.0 lb ai/A; 65-92 day PHIs

                               Residues (mg/kg)
                                     0.015
                                       1
                                     0.010
                                       *
                                     0.010
                                       *
                                     0.010
                                       *
                                     0.051
                                       1
                                     0.010
                                       *

Compound

                                    Linuron
Crop

                                   Pea (Dry)
Region / Country

                                   ID/ND/WA
GAP

Total number of data (n)

                                       6

Percentage of censored data

                                      67%
Number of non-censored data

                                       2

Lowest residue

                                     0.010
Highest residue

                                     0.051
Median residue

                                     0.010

Mean

                                     0.018
Standard deviation (SD)

                                     0.016

Correction factor for censoring (CF)

                                     0.556

Proposed MRL estimate

- Highest residue

                                     0.051
- Mean + 4 SD

                                     0.083
- CF x 3 Mean

                                     0.029
Unrounded MRL

                                     0.083

Rounded MRL

                                     0.09

High uncertainty of MRL estimate due to small dataset and high level of censoring.

Horseradish (MRIDs 45633501 and 45633502)
1.5 lb ai/A; 76-100 day PHIs

                               Residues (mg/kg)
                                   <0.05
                                       *
                                   <0.05
                                       *
                                   <0.05
                                       *

Compound

                                    Linuron
Crop

                                  Horseradish
Region / Country

                                   MD/WI/NJ
GAP

Total number of data (n)

                                       3

Percentage of censored data

                                     100%
Number of non-censored data

                                       0

Lowest residue

                                     0.050
Highest residue

                                     0.050
Median residue

                                     0.050

Mean

                                     0.050
Standard deviation (SD)

                                     0.000

Correction factor for censoring (CF)

                                     0.333

Proposed MRL estimate

- Highest residue

                                     0.050
- Mean + 4 SD

                                     0.050
- CF x 3 Mean

                                     0.050
Unrounded MRL

                                     0.050

Rounded MRL

                                     0.05

High uncertainty of MRL estimate due to small dataset and high level of censoring.


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Proposed Rules]
[Pages 29917-29918]
[FR Doc No: 2012-12155]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0829; Airspace Docket No. 11-ASW-9]

Proposed Amendment of Class E Airspace; Sweetwater, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class E airspace at Sweetwater,
TX. Additional controlled airspace is necessary to accommodate new
Standard Instrument Approach Procedures (SIAP) at Avenger Field
Airport. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rules (IFR) operations for SIAPs at the
airport. Geographic coordinates would also be updated, as well as the
airport name.

DATES: 0901 UTC. Comments must be received on or before July 5, 2012.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2011-0829/Airspace Docket No. 11-
ASW-9, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: 817-321-
7716.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2011-0829/
Airspace Docket No. 11-ASW-9.'' The postcard will be date/time stamped
and returned to the commenter.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Central Service Center, 2601 Meacham Blvd., Fort
Worth, TX 76137.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by amending Class E airspace extending upward from
700 feet above the surface to accommodate new standard instrument
approach procedures at Avenger Field Airport, Sweetwater, TX.
Controlled airspace is needed for the safety and management of IFR
operations at the airport. Geographic coordinates would also be updated
to coincide with the FAA's aeronautical database. Also, the airport
formerly called Avenger Field is amended to read Avenger Field Airport.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9V, dated August 9, 2011 and effective September 15, 2011, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend controlled airspace at Avenger Field Airport,
Sweetwater, TX.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9V, Airspace Designations and Reporting Points, dated August 9,
2011, and effective September 15, 2011, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ASW TX E5 Sweetwater, TX [Amended]

Sweetwater, Avenger Field Airport, TX
    (Lat. 32[deg]28'03'' N., long. 100[deg]28'00'' W.)
Sweetwater RBN
    (Lat. 32[deg]27'42'' N., long. 100[deg]27'56'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Avenger Field Airport, and within 2.5
miles each side of the 348[deg] bearing from the Sweetwater RBN,
extending from the 6.6-mile radius to 7.4 miles north of the
airport, and within 2 miles each side of the 174[deg] bearing from
the airport extending from the 6.6-mile radius to 12 miles south of
the airport.

    Issued in Fort Worth, TX, on May 10, 2012.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-12155 Filed 5-18-12; 8:45 am]
BILLING CODE 4910-13-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (7/1/2007)

EPA Registration Division contact: [insert name and telephone number with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert “NA-Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert company name],” with the information specific to your action.

TEMPLATE:

 Bayer CropScience

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC  27709 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

	1. by changing the existing tolerances for residues of

	2. to establish an exemption from the requirement of a tolerance for

	trifloxystrobin (Benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl ester) and the free form of its acid metabolite CGA–321113 ((E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-ethylideneaminooxym ethyl]-phenyl]acetic acid) in or on the raw agricultural commodity corn, field, forage at 6.0 parts per million (ppm), corn, sweet, forage at 7.0 parts per million (ppm), and corn, sweet, stover at 4.0 parts per million (ppm).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism   SEQ CHAPTER \h \r 1 The metabolism of trifloxystrobin in plants (cucumbers, apples, wheat, sugar beets and peanuts) is well understood. Identified metabolic pathways are substantially similar in plants and animals (goat, rat and hen). EPA has determined that trifloxystrobin parent and its metabolite CGA-321113 are the residue of concern for tolerance setting purposes..

	2. Analytical method.   SEQ CHAPTER \h \r 1 A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The limit of detection (LOD) for each analyte of this method is 0.08 ng injected, and the limit of quantitation (LOQ) is 0.02 ppm. The method is based on crop specific cleanup procedures and determination by gas chromatography with nitrogen-phosphorus detection.  A newer analytical method employing identical solvent mixtures and solvent to matrix ratio (as the first method), deuterated internal standards, and liquid chromatography/mass spectrometry-mass spectrometry (LC/MS-MS) with an electrospray interface, operated in the positive ion mode is available.  The limits of detection (LOD) range from 0.0019 ppm to 0.0034 ppm for corn matrices and the limit of quantitation is 0.01 ppm.

	3. Magnitude of residues. A total of 34 field trials were conducted to measure the magnitude of trifloxystrobin residue in corn treated four times with a 5- to 7-day interval between sprays with trifloxystrobin 500 SC (containing 4.172 lb ai/gal) at a target rate of 3.8 fl oz formulated product/A/application (0.125 lb ai/A/application) for a total of 0.500 lb ai/A.

No total trifloxystrobin residue in sweet corn (K+CWHR) was above the limit of quantitation (LOQ) of 0.01 ppm at a 0-day PHI. The HAFT total trifloxystrobin residue in sweet corn (K+CWHR) at a 7-day PHI was 0.011 ppm with a maximum of 0.015 ppm. The HAFT total trifloxystrobin residue in sweet corn forage at a 0-day PHI was 3.9 ppm with a maximum of 4.0 ppm. The HAFT total trifloxystrobin residue in sweet corn forage at a 7-day PHI was 2.3 ppm with a maximum of 2.6 ppm. The HAFT total trifloxystrobin residue in sweet corn stover at a 14-day PHI was 3.3 ppm with a maximum of 3.4 ppm. The HAFT total trifloxystrobin residue in field corn forage at a 0-day PHI was 4.0 ppm with a maximum of 5.0 ppm. The HAFT total trifloxystrobin residue in field corn forage at a 7-day PHI was 2.8 ppm with a maximum of 2.8 ppm. The HAFT total trifloxystrobin residue in field corn grain at a 14-day PHI was 0.022 ppm with a maximum of 0.028 ppm. The HAFT total trifloxystrobin residue in field corn stover at a 14-day PHI was 4.1 ppm with a maximum of 4.5 ppm. No total trifloxystrobin residue in pop corn grain was above the LOQ of 0.010 ppm at a 14-day PHI. The HAFT total trifloxystrobin residue in field pop stover at a 14-day PHI was 2.2 ppm with a maximum of 2.3 ppm.]

B. Toxicological Profile

	1. Acute toxicity.  There is a full battery of acute toxicity studies for trifloxystrobin. Trifloxystrobin is of mild acute toxicity by oral, dermal, or inhalation routes of exposure (Cat. IV), however it is a strong dermal sensitizer. Trifloxystrobin is a mild ocular (Cat III) and dermal irritant (Cat IV).

100 mg/kg/day. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increased incidence of enlarged thymus at 1000 mg/kg/day. The developmental NOEL was 1000 mg/kg/day.

	In the rabbit developmental study, body weight loss and reduced food consumption were observed in the dams at 50 mg/kg. No teratogenic effects or any other effects were seen on pregnancy or fetal parameters except for the increase in skeletal anomaly of fused sternebrae-3 and -4 at the top dose level of 500 mg/kg. This finding is regarded as a marginal effect on skeletal development that could have resulted from the 40-65% lower food intake during treatment at this dose level. The developmental NOEL was 250 mg/kg.

750 ppm, especially in females during lactation. Consequently, the reduced pup weight gain during lactation (750 ppm) and the slight delay in eye opening (1500 ppm) are judged to be a secondary effect of maternal toxicity. No other fetal effects or any reproductive changes were noted.  The low developmental NOEL, 50 ppm (3.8 mg/kg) seen in this study was probably due to the lack of intermediate dose levels between 50 and 750 ppm. The reproductive NOAEL was 1500 ppm (=110.6 mg/kg/day).

	4. Subchronic toxicity.   SEQ CHAPTER \h \r 1 In a subchronic study in rats a NOAEL = 500 ppm (30.6-32.8 mg/kg/day) was found based on decreased body weights (males), hypertrophy of hepatocytes (males), and pancreatic atrophy observed at the LOAEL of 2000 ppm (127-133 mg/kg/day).

In mice, a NOAEL was determined at 500 ppm (76.9-110 mg/kg/day) based on increased liver weights and necrosis of hepatocytes observed at the LOAEL of 2000 ppm (315-425 mg/kg/day).

A subchronic feeding study in dogs resulted in a NOAEL = 30 mg/kg/day. Increased liver weight and hepatocyte hypertrophy in males were observed at the LOAEL of 150 mg/kg/day.

In a 28–day dermal toxicity study in rats the NOAEL was found at 100 mg/kg/day. Increased liver and kidney weight were observed at the LOAEL of 1,000 mg/kg/day.

	5. Chronic toxicity. A chronic feeding study in dogs established a no-observed adverse effect level (NOAEL) of 5 mg/kg bw/day. The lowest effect level (LOAEL) for this study was found at 50 mg/kg bw/day, based on clinical signs, increased liver weight and hepatocellular hypertrophy.

In a carcinogenicity study in mice liver effects were observed at doses of and above the LOAEL of 1000 ppm (131.1 mg/kg/day). The NOAEL was determined to be 300 ppm (39.4 mg/kg/day).

A chronic toxicity/carcinogenicity study in rats established a NOAEL of 250 ppm (9.81–11.37 mg/kg/day). Decreased mean body weight and decreased mean body weight gain (compared to control) were observed at the LOAEL of 750 ppm (29.7–34.5 mg/kg/day).

The compound did not cause any treatment-related increase in general tumor incidence, any elevated incidence of rare tumors, or shortened time to the development of palpable or rapidly lethal tumors in the 18-month mouse and the 24-month rat studies.  An ad hoc subcommittee of the Cancer Assessment Review Committee on May 27, 1999 determined that trifloxystrobin should be classified as a "Not Likely Human Carcinogen," based on the lack of evidence for carcinogenicity in rats and mice.

	6. Animal metabolism.   SEQ CHAPTER \h \r 1 Trifloxystrobin is moderately absorbed from the gastrointestinal tract of rats and is rapidly distributed. Subsequent to a single oral dose, the half life of elimination is about 2 days and excretion is primarily via bile. Trifloxystrobin is extensively metabolized by the rat into about 35 metabolites, but the primary actions are on the methyl ester (hydrolysis into an acid), the methoxyimino group (O-demethylation), and the methyl side chain (oxidation to a primary alcohol). Metabolism is dose dependent as it was almost complete at low doses but only about 60% complete at high doses.

In the goat, elimination of orally administered trifloxystrobin is primarily via the feces. The major residues were the parent compound and the acid metabolite (CGA-321113) plus its conjugates. In the hen, trifloxystrobin is found as the major compound in tissues and in the excreta, but hydroxylation of the trifluormethyl-phenyl moiety and other transformations, including methyl ester hydrolysis and demethylation of the methoxyimino group, are also seen. In conclusion, the major pathways of metabolism in the rat, goat, and hen are the same.

	7. Metabolite toxicology.   SEQ CHAPTER \h \r 1 Metabolism of trifloxystrobin has been well characterized in plants, soil, and animals. In plants and soil, photolytically induced isomerization results in a few minor metabolites not seen in the rat; however, most of the applied materials remained as parent compound as shown in the apple and cucumber studies. All quantitatively major plant and/or soil metabolites were also seen in the rat. The toxicity of the major acid metabolite, CGA-321113 (formed by hydrolysis of the methyl ester), has been evaluated in cultured rat hepatocytes and found to be 20-times less cytotoxic than the parent compound. Additional toxicity studies were conducted for several minor metabolites seen uniquely in plants and/or soil. The studies indicate that these metabolites, including CGA-357261, CGA-373466, and NOA-414412, are not mutagenic to bacteria and are of low acute toxicity (LD50 >2000 mg/kg). In conclusion, the metabolism and toxicity profiles support the use of an analytical enforcement method that accounts for parent trifloxystrobin.

	8. Endocrine disruption.   SEQ CHAPTER \h \r 1 Trifloxystrobin does not belong to a class of chemicals known for having adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that trifloxystrobin might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long-term effect related to the endocrine system.

C. Aggregate Exposure

	1. Dietary exposure.   SEQ CHAPTER \h \r 1 Assessments, using the DEEM FCID Version 2.0, 1994-1996, 98 CSFII software,  were conducted to evaluate potential risks due to chronic and acute dietary exposure of the U.S. population and selected population subgroups to residues of trifloxystrobin.  These analyses cover all registered crops plus the increased residue levels in corn and sweet corn residues.

The EPA has established an acute Population Adjusted Dose (aPAD) of 2.5 mg/kg/day for acute dietary risk assessments based on a NOAEL of 250 mg/kg bw/day from a rabbit developmental toxicity study and an uncertainty factor or 100. The FQPA SF was reduced to 1x based on toxicological considerations by the FQPA Safety Factor Committee (HED Doc. No. 013545, B. Tarplee, 01/JUL/1999), the conservative residue assumptions used in the dietary and residential exposure risk assessments, and the completeness of the residue chemistry and environmental fate databases (DP Num: 3 17330, B. O'Keefe,1 6/AUG/2006).  For chronic dietary analyses, the EPA established a chronic Population Adjusted Dose (cPAD) of 0.038 mg/kg/day based on a NOAEL of 3.8 mg/kg bw/day from the rat reproduction toxicity study and an uncertainty factor of 100.

Results from the acute and chronic dietary exposure analyses described below demonstrate a reasonable certainty that no harm to the overall U.S. population or any population subgroup will result from the use of trifloxystrobin on currently registered uses plus the proposed changes to corn and sweet corn tolerances.

	i. Food.    SEQ CHAPTER \h \r 1 For food, a Tier 1 acute and a Tier 2 chronic dietary exposure assessments were performed. Acute exposure, expressed at the 95th percentile of exposure, was 0.79 % of the aPAD for Females 13-49 years old (only population subgroup of concern).  The chronic exposure was 20.4 % cPAD for the Total US Population and 51.5 % cPAD for the most sensitive population, All Infants < 1-year old.

	ii. Drinking water. Acute and chronic exposure estimates from water are included in the exposure values given above for food. These exposure estimates for water are based on EPA’s surface water estimated environmental concentrations (EECs) of trifloxystrobin and CGA-321113 for acute exposure and for chronic exposures at 140 ppb. These values are listed in the Federal Register (71 FR 55313).

	2. Non-dietary exposure. The proposed increased use rates in corn are below the highest rates already registered.  As such, non-dietary exposure from these changes are covered by previous non-dietary risk assessments performed by EPA.   SEQ CHAPTER \h \r 1 As published in the Federal Register (FR Vol 68, no. 175, 10-Sep-03, FR Vol 73, no. 1, 02-Jan-08), the EPA considered chronic, short term and intermediate term risk from residential uses of trifloxystrobin. The EPA determined that the risk did not exceed the Agency’s level of concern.

D. Cumulative Effects

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n a common mechanism of toxicity, trifloxystrobin does not appear to produce a toxic metabolite produced by other substances. Therefore EPA has not assumed that trifloxystrobin has a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population.   SEQ CHAPTER \h \r 1 Based on the information supplied above under Aggregate Exposure, there is reasonable certainty that exposure from trifloxystrobin will result in no harm to the adult U.S. population.

	2. Infants and children. Based on the information supplied above under Aggregate Exposure, there is reasonable certainty that exposure from trifloxystrobin will result in no harm to the infants and children.

F. International Tolerances

	International tolerances and CODEX tolerances for trifloxystrobin are established for many crops in many countries.  Sweet corn tolerances (parent trifloxystrobin only) exist in many European countries at 0.02 ppm and in Brazil at 0.05 ppm.  No trifloxystrobin field corn or pop corn tolerances have been set internationally.

 PAGE

 PAGE   6


[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47100-47101]
[FR Doc No: 2021-18029]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2020-0675; FRL-8870-01-ORD]

Availability of the Draft IRIS Toxicological Review of
Perfluorobutanoic Acid (PFBA) and Related Compound Ammonium
Perfluorobutanoic Acid

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing a 60-
day public comment period associated with release of the IRIS
Toxicological Review of Perfluorobutanoic acid (PFBA) and Related
Compound Ammonium Perfluorobutanoic Acid. The draft document was
prepared by the Center for Public Health and Environmental Assessment
(CPHEA) within EPA's Office of Research and Development (ORD). EPA is
releasing this draft IRIS assessment for public comment in advance of a
contract-led peer review. Public comments received will be provided to
the external peer reviewers. Eastern Research Group, Inc. (ERG), a
contractor to EPA, will convene a public meeting to discuss the draft
report with the public during Step 4 of the IRIS Process. The external
peer reviewers will consider public comments submitted in response to
this notice and provided at the public meeting when reviewing this
document. EPA will consider all comments received when revising the
document post-peer review. This draft assessment is not final as
described in EPA's information quality guidelines, and it does not
represent, and should not be construed to represent Agency policy or
views.

DATES: The 60-day public comment period begins August 23, 2021 and ends
October 22, 2021. Comments must be received on or before October 22,
2021.

ADDRESSES: The IRIS Toxicological Review of Perfluorobutanoic acid
(PFBA) and Related Compound Ammonium Perfluorobutanoic Acid will be
available via the internet on the IRIS website at https://www.epa.gov/iris/iris-recent-additions and in the public docket at http://www.regulations.gov, Docket ID No. EPA-HQ-ORD-2020-0675.

FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the ORD Docket at the EPA Headquarters Docket Center;
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email:
<EMAIL_ADDRESS>    For technical information on the IRIS Toxicological Review of
Perfluorobutanoic acid (PFBA) and Related Compound Ammonium
Perfluorobutanoic Acid, contact Ms. Vicki Soto, CPHEA; telephone: 202-
564-3077; or email<EMAIL_ADDRESS>The IRIS Program will provide
updates through the IRIS website (https://www.epa.gov/iris) and via
EPA's IRIS listserv. To register for the IRIS listserv, visit the IRIS
website (https://www.epa.gov/iris) or visit https://www.epa.gov/iris/forms/staying-connected-integrated-risk-information-system#connect.

SUPPLEMENTARY INFORMATION:

I. Information on IRIS PFAS Assessments

    Per- and polyfluoroalkyl substances (PFAS) are a large class of
man-made chemicals widely used in consumer products and industrial
processes. The basic structure of PFAS consists of a carbon chain
surrounded by fluorine atoms, with different chemicals possessing
different end groups. The five toxicity assessments being developed
according to the scope and methods outlined in the publicly posted
systematic review protocol (https://cfpub.epa.gov/ncea/iris_drafts/recordisplay.cfm?deid=345065) build upon several other PFAS assessments
that have already been developed, and represent only one component of
the broader PFAS action plan underway at the U.S. EPA (https://www.epa.gov/pfas/epas-pfas-action-plan).

II. How To Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2020-
0675 for the draft IRIS Toxicological Review of Perfluorobutanoic acid
(PFBA) and Related Compound Ammonium Perfluorobutanoic Acid, by one of
the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>. Due to COVID-19, there may be a delay
in processing comments submitted by fax.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center (ORD Docket), Mail Code: 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460. The phone number is<PHONE_NUMBER>. Due to COVID-
19, there may be a delay in processing comments submitted by mail.

    Note:  The EPA Docket Center and Reading Room may be closed to
public visitors to reduce the risk of transmitting COVID-19. Docket
Center staff will continue to provide remote customer service via
email, phone, and webform. The public can submit comments via
www.Regulations.gov or email. No hand deliveries are currently being
accepted.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2020-0675. Please ensure that your comments are submitted within the
specified comment period. Comments received after the closing date will
be marked ``late,'' and may only be considered if time permits. It is
EPA's policy to include all comments it receives in the public docket
without change and to make the comments available online at
www.regulations.gov, including any personal information provided,
unless a comment includes information claimed to be Confidential
Business Information (CBI) or other information for which disclosure is
restricted by statute. Do not submit information through
www.regulations.gov or email that you consider to be CBI or otherwise
protected. The www.regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to EPA without going through
www.regulations.gov, your email address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at www.epa.gov/epahome/dockets.htm.
    Docket: Documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at

the ORD Docket in the EPA Headquarters Docket Center.

Timothy Watkins,
Acting Director, Center for Public Health & Environmental Assessment.
[FR Doc. 2021-18029 Filed 8-20-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Notices]
[Pages 39453-39454]
[FR Doc No: 2018-17026]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-0998]

Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets,
1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that PROLIXIN (fluphenazine hydrochloride) tablets, 1
milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale
for reasons of safety or effectiveness. This determination will allow
FDA to approve abbreviated new drug applications (ANDAs) for
fluphenazine hydrochloride tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, if
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of an NDA.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    PROLIXIN (fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg,
and 10 mg, is the subject of NDA 011751, held by Apothecon
Pharmaceuticals, a Bristol-Myers Squibb Company, and initially approved
on March 15, 1967. PROLIXIN is indicated in the management of
manifestations of psychotic disorders.
    In a letter dated October 5, 2006, Bristol-Myers Squibb Company
requested withdrawal of NDA 011751 for PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg. In the Federal
Register of February 11, 2009 (74 FR 6896), FDA announced that it was
withdrawing approval of NDA 011751, effective March 13, 2009.
    Hyman, Phelps & McNamara, P.C. submitted a citizen petition dated
March 5, 2018 (Docket No. FDA-2018-P-0998), under 21 CFR 10.30,
requesting that the Agency determine whether PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, was withdrawn
from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that PROLIXIN (fluphenazine hydrochloride) tablets,
1 mg, 2.5 mg, 5 mg, and 10 mg, was not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that PROLIXIN (fluphenazine hydrochloride)
tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of PROLIXIN (fluphenazine
hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, from sale. We
have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have found no information
that would indicate that this drug product was

withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PROLIXIN
(fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to PROLIXIN
(fluphenazine hydrochloride) tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg,
may be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17026 Filed 8-8-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: October 1, 2010 (Volume 75, Number 190)]
[Notices]
[Page 60773-60776]
[DOCID:fr01oc10-83]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2008-0017]

Voluntary Private Sector Accreditation and Certification
Preparedness Program

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of PS-Prep Small Business Preparedness Plan; Request for
Comment.

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SUMMARY: The Department of Homeland Security (DHS) announces an initial
plan to address small business concerns in the Voluntary Private Sector
Accreditation and Certification Preparedness Program (PS-Prep Program).
This initial plan identifies the separate classifications and the
methods of certification available for small businesses under the PS-
Prep Program. The purpose of this notice is to (1) present the plan for
small business preparedness, and (2) invite public comment on the plan.
DHS will continue to refine this plan, and will take comments into
consideration in doing so.
    Instructions: DHS will review any comments received for small
business considerations or the PS-Prep Program generally and, when
merited, will publish a Federal Register notice providing the results
of that review.
    Those interested may submit comments, identified by Docket ID FEMA-
2008-0017, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. (Note: This process
applies to all government requests for comments--even though as in the
case of PS-Prep, they may not be for regulatory purposes.)
     Fax:<PHONE_NUMBER>.
     Mail/Hand Delivery/Courier: Office of Chief Counsel,
Federal Emergency Management Agency, 500 C Street, SW., Room 840,
Washington, DC 20472-3100.
    All submissions received must include the agency name and Docket ID
FEMA-2008-0017. All submissions will be posted, without change, to the
Federal eRulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Because comments are made
available to the public, submitters should take caution to not include
any sensitive, personal information, trade secret, or any commercial or
financial information which is obtained from any person and which is
deemed privileged or confidential. Submitters may wish to read the
Privacy Act notice available on the Privacy Notice link located at the
bottom of http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments received, go to the Federal eRulemaking Portal at http://
www.regulations.gov. Submitted comments may also be inspected at FEMA,
Office of Chief Counsel, 500 C Street, SW., Room 840, Washington, DC
20472.

FOR FURTHER INFORMATION CONTACT: Mr. Marcus Pollock, National
Integration Center, National Preparedness Directorate, Protection and
National Preparedness, Federal Emergency Management Agency, 500 C
Street, SW., Washington, DC 20472. Phone:<PHONE_NUMBER> or E-mail: FEMA-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Implementing Recommendations of the 9/11 Commission Act of
2007, Congress in Public Law 110-53 (the 9/11 Act) mandated DHS to
establish a voluntary private sector preparedness accreditation and
certification program. This program, now known as the PS-Prep Program,
will assess whether a private sector entity voluntarily complies with
one or more preparedness standards adopted by DHS. It will do so
through a system of accreditation and certification developed by DHS in
close coordination with the private sector.
    The 9/11 Act contains a provision, now codified at 6 U.S.C.
321m(b)(2)(D), which requires the PS-Prep Program to ``establish
separate classifications and methods of certification for small
business concerns* * *.'' The definition of ``small business concerns''
is found in the Small Business Administration's regulations at 13 CFR
part 121, published in accordance with Section 3 of the Small Business
Act (15 U.S.C. 632).
    DHS published a notice in the Federal Register on December 24,
2008, describing DHS implementation of the PS-Prep Program, requesting
comment on the PS-Prep Program and the target criteria for selecting
preparedness standards, and requesting recommendations for standards
that DHS should consider. See 73 FR 79140. After reviewing the
responses to the December 2008 notice, DHS published a notice in the
Federal Register on October 16, 2009, which proposed the adoption of
three standards for use in the PS-Prep Program and sought public
comment. See 74 FR 53286. After reviewing comments received, DHS
published a notice formally adopting those three standards on June 16,
2010. See 75 FR 34148.
    DHS received additional information and comments about small
business aspects of the PS-Prep Program through several public meetings
in Washington, DC, 10 public meetings across the country, and multiple
meetings with government agencies and organizations interested in
preparedness and small business. These comments further defined small
business and provided recommendations regarding appropriate
considerations for separate classifications and methods for small
business.

A. DHS Standards Adoption for the PS-Prep Program

    DHS announced formal adoption of the following three standards on
June 16, 2010 (PS-Prep standards).
    1. ASIS International, ``Organizational Resilience: Security
Preparedness, and Continuity Management Systems--Requirements with
Guidance for Use,'' ASIS SPC. 1-2009 (2009 Edition).
    2. British Standards Institution, ``Business Continuity Management
Part 1: Code of Practice for Business Continuity Management,'' BS
25999-1: 2006 (2006 Edition); and ``Business Continuity Management Part
2: Specification for Business Continuity Management,'' BS 25999-2: 2007
(2007 Edition).
    3. National Fire Protection Association, ``Standard on Disaster/
Emergency Management and Business Continuity Programs,'' NPFA-1600
(2007 and 2010 Editions).

B. Initiation of the PS-Prep Accreditation and Certification Process

    With the formal adoption of the three PS-Prep standards, the
American National Standards Institute--American Society for Quality
(ANSI-ASQ) National Accreditation Board (ANAB), the designated PS-Prep
accrediting body, will finalize its process for accrediting third-party
certifying bodies (CBs) for the PS-Prep Program. Businesses may
voluntarily choose to seek third-party certification through

CBs accredited by ANAB. See http://www.anab.org/accreditation/
preparedness.aspx.

C. Prior Solicitation of Comments Regarding Small Business Aspects

    DHS received information and comments about small business aspects
of the PS-Prep Program from many sources. These comments further
reflected the concerns of small businesses and provided suggestions
regarding appropriate considerations for separate classifications and
methods of certification for small business.
    Comments and suggestions included the following:
     Include affordable methods for providing support for
implementing preparedness appropriate for small businesses.
     Provide a developmental model with progressive steps prior
to third-party certification.
     Provide education, tools, technical assistance, and
methods for self-assessment as part of a developmental model.
     Build on existing programs which use preparedness
education and best practices.
     Include outreach and education through multiple sources to
provide education and technical support that is accessible and
convenient for small business.
     Include outreach through new and pre-existing networks to
enhance awareness of the PS-Prep Program, its value, and ways to
participate.
    The draft Program outlined in this notice addresses, in part, the
comments, concerns, and suggestions received during PS-Prep outreach
activities to date.

II. PS-Prep Small Business Preparedness Plan

    Using the size standards found at 13 CFR part 121 and authorized by
15 U.S.C. 632, the vast majority of the commerce in the United States
is represented by small businesses. According to the 2007 Economic
Census, there are approximately 7.6 million establishments with fewer
than 500 employees, and they employ approximately 96 million employees.
U.S. society's well-being depends on these businesses for goods and
services. Should disaster strike, continued access to those services
and products is an important part of recovery and resilience.
    The resources required to obtain third-party certification to one
of the DHS-adopted preparedness standards may pose a challenge and
potential barrier for many small businesses. In the 9/11 Act, Congress
recognized that differences in scale and resources require different
strategies to effectively promote and implement preparedness for small
businesses. Therefore, Congress directed DHS to ``establish separate
classifications and methods of certification for small business
concerns * * *.''
    DHS is proposing to use three ``classifications'' of businesses
when determining eligibility for participation in the two
``certification methods'' (see below). Small business concerns referred
to in the PS-Prep Program's authorizing legislation are addressed
through the creation of these classifications and through the provision
of an additional, different method of certification, available only for
small businesses and small not-for-profit concerns. Certification is
the desired outcome of a formal process by which entities are assessed
to determine their conformity to one or more of the PS-Prep standards.

A. Classifications of Businesses for PS-Prep

    The three classifications of private sector entities for the PS-
Prep Program are: (1) Small businesses as defined in the Small Business
Administration's regulations at 13 CFR part 121, published in
accordance with 15 U.S.C. 632; (2) other non-governmental entities with
fewer than 500 employees that do not meet the requirements of 13 CFR
part 121 and 15 U.S.C. 632; and (3) all private sector entities. These
classifications will be used to distinguish eligibility of entities
participating in the two methods of certification available under the
PS-Prep Program.
    For small businesses, 15 U.S.C. 632 provides the criteria for
establishing size standards and the definitions of terms used
throughout the Small Business Act. The responsibility of establishing
size standards is given to the Administrator of the Small Business
Administration. The Administrator has defined small businesses through
established numerical definitions, or ``size standards,'' for all for-
profit industries. The complete list of size standards can be found in
the table at 13 CFR 121.201, or see http://www.sba.gov/
contractingopportunities/officials/size/table/index.html.
    Classification (2), as described above, is intended to capture
those small, not-for-profit entities which fall outside of the for-
profit based definition for small business as found in 15 U.S.C. 632
and 13 CFR part 121. DHS recognizes that there are small not-for-profit
entities which may also desire to achieve conformity with a DHS-adopted
preparedness standard, but which face the same issues of limited
resources and scale as small businesses. DHS has determined to enable
these entities to participate in the PS-Prep Program, by creating
classification (2) for not-for-profit entities with fewer than 500
employees. DHS's reasoning for choosing these qualifications is based
on the Small Business Administration's regulations at 13 CFR part 121,
which identify 500 or fewer employees as a common size for small
organizations.
    DHS will consider refining classification (2) to include a measure
of gross receipts. A possible basis for this refinement would be the
Internal Revenue Service's gross receipts requirements for tax-exempt
501(c)(3) organizations eligible to file form 990-N (annual gross
receipts less than or equal to $25,000), or form 990-EZ (annual gross
receipts between $25,001 and $500,000). Religious and other
organizations exempt from filing and having fewer than 500 employees
would still qualify to use the PS-Prep self-certification method. DHS
seeks comment on this proposed method of defining classification (2).
    Classification (3), all private sector entities, captures any
private sector entity wishing to participate in the PS-Prep Program.
Therefore, a small business would qualify for both classification (1)
and classification (3). However, those entities which do not meet the
requirements for classifications (1) and (2) would be included only in
classification (3). The purpose of these classifications is to qualify
for participation in the two methods of certification available in the
PS-Prep Program.

B. Methods of Certification for PS-Prep

    There will exist two methods for certification under the PS-Prep
Program: (1) Self-declaration of conformity, and (2) third-party
certification. Entities that can be classified as (1) small businesses
as defined in 13 CFR part 121, published in accordance with 15 U.S.C.
632, or (2) other non-governmental entities with fewer than 500
employees, that do not meet requirements of 13 CFR part 121 and 15
U.S.C. 632, are eligible for both methods of certification. All other
entities which do not meet the requirements for classifications (1) or
(2) will be classified as (3), all private sector entities, and are
only eligible for the third-party certification method.
    Although DHS has at this time identified the two methods of
certification described herein, other methods will be examined and
considered. DHS reserves the right to

add other methods to the PS-Prep Program following future notice and
opportunity for comment.
    Businesses that successfully conform to any DHS-adopted PS-Prep
standard, as measured by one of the methods outlined in this notice,
may receive recognition from DHS. The process for and type of
recognition that may be provided are still under consideration and more
information will be provided in subsequent announcements or notices.
1. Self-Declaration of Conformity
    Any private sector entity that is a member of classifications (1)
or (2) as described above may assess and attest to its conformity to
one or more of the PS-Prep standards.
    The self-declaration of conformity process will be similar to what
is sometimes known as a manufacturer's or supplier's declaration of
conformance. This is based on an accepted industry practice whereby
manufacturers or suppliers formally declare that their products or
services conform to relevant standards. DHS proposes that self-
declaration will be based upon the International Organization for
Standardization/International Electrotechnical Commission (ISO/IEC)
standard 17050-1, ``Conformity Assessment--Supplier's Declaration
Assessment--Supplier's declaration of conformity--Part 1: General
requirements'' and ISO/IEC standard 17050-2, ``Conformity Assessment--
Supplier's declaration of conformity--Part 2: Supporting
documentation.'' Together, these parts of the standard specify general
requirements for a supplier's declaration of conformity in cases where
conformity of an object to a specified requirement must be attested.
    In the United States, ISO/IEC standard 17050-1 and 17050-2 are
available for the respective fees of $49.00 and $37.00. To purchase,
search the American National Standards Institute online store, at
http://webstore.ansi.org/default.aspx. In addition, FEMA will maintain
a copy of the standard, and make it available upon request for viewing
in person at FEMA's reading room, located at 500 C Street, SW., Room
840, Washington, DC 20472. Due to licensing and copyright restrictions,
however, these documents will be available for review only, not for
copying.
    DHS is still considering the plan for management and oversight of
the self-declaration of conformity process, and will provide more
information through subsequent announcements or notices. DHS will
consider other processes of self-declaration of conformity. One example
may be a comprehensive, Web-based self-assessment that could include a
document review of key business continuity protocols.
2. Third-Party Certification
    Any private sector entity may undertake an independent, third-party
validation that it conforms to one or more of the PS-Prep standards,
using a certifying body (CB) that is accredited by ANAB. This is the
general certification scheme outlined in PS-Prep's authorizing
legislation. This process is notably more rigorous and measurable than
self-declaration of conformity. Many CBs have a conformity assessment
process that tailors to the needs and possible resource constraints of
small businesses. Under this method, any entity is eligible to seek
certification from an ANAB-accredited CB. For more information, see the
prior Federal Register notices referenced above and http://
www.anab.org/accreditation/preparedness.aspx.

C. Additional Small Business Support

    DHS recognizes that some small businesses may desire additional
guidance and assistance to help them in achieving preparedness and to
prepare for participating in a method of certification. Participation
in such guidance and support activities is not required to participate
in the PS-Prep Program. However, small businesses might find it useful
as they seek conformance to one of the DHS-adopted preparedness
standards.
    There are a number of public and private entities that provide
programs and activities that support preparedness. These entities
include academic institutions, community-based non-profit, and for-
profit institutions that provide education, training, assessment and
technical assistance to small business. DHS encourages the development
of tools and programs that will assist small businesses in improving
preparedness and reaching conformance to an adopted standard.
Businesses may participate in a variety of preparedness related
activities such as classroom or web-based courses, technical assistance
to conduct a hazard and/or vulnerability assessments, or to establish
governance or planning activities.
    DHS will develop guidance for small businesses based on public
input from this Federal Register notice and other outreach activities.
This guidance will assist small businesses in identifying organizations
that can help them both improve their preparedness and potentially
become certified to one of the DHS-adopted standards using one of the
methods outlined herein. This guidance will include attributes that
these organizations' small business support activities have or should
have. These attributes will be used by DHS to evaluate organizations
that provide small business support services. For example, the
organizations providing support to small businesses should have some or
all of the elements listed below:
     Demonstrated expertise and experience in preparedness and
small business concerns.
     A recognized program sponsorship, preferably at a national
organization level (e.g., American Red Cross, Ready.gov, etc.) or at a
State or Tribal government level.
     Web-based and/or local delivery mechanisms for
accessibility to small business at a local level.
     Relevant programs or components that are demonstrated to
be affordable to small business.
     Intent to develop substantive relationships between its
program or component tools and elements of PS-Prep standards.
     Administrative mechanisms for tracking participants in
order to recognize achievement or progress.
    By choosing a support organization with elements like these, small
businesses should be able to increase their preparedness in an
affordable manner with the support of a reputable organization that
uses proven practices.

III. Request for Comment

    This notice describes the plan for implementing separate
classifications and methods of certification for small businesses. DHS
intends for the third-party certification method to be formally
announced in September 2010 and will continue to refine the PS-Prep
Small Business Preparedness Plan based on public feedback. DHS invites
comments on the PS-Prep Small Business Preparedness Plan as outlined in
this notice and, specifically, invites comments regarding the
following:
     The classifications of businesses in the PS-Prep Program,
including how they are used to distinguish eligibility for the methods
of certification outlined in this notice.
     The methods of certification (self-declaration of
conformity and/or third-party certification).
     The use of the ISO/IEC 17050-Parts 1 and 2 to guide the
self-declaration of conformity process.
     Recommendations for:
    [cir] Information to include in the guidance for small business
support activities attributes referenced in

Section II.C., above, including the types of organizations and programs
to consider and the attributes that should be considered.
    [cir] Additional approaches to providing support for small business
education, training, and development.
    [cir] How businesses can be recognized under each method of
certification.
    [cir] Whether classification (2) as discussed in II.A, above,
should be based upon the Internal Revenue Service's use of gross
receipts to determine reporting requirements for tax-exempt 501(c)(3)
organizations.
    [cir] How to encourage small businesses considering participation
in self-declaration of conformity to participate in third-party
certification instead.
    [cir] Recommendations on the use of a limited conformity assessment
process that would include an off-site document review without an
accompanying on-site assessment. A limited conformity assessment
process may potentially reduce some of the costs associated with
conformity assessment.
    [cir] Recommendations on whether DHS should consider other methods
of certification for the PS-Prep Program, and what those methods might
entail.
    [cir] Recommendations on whether the use of this process should be
associated with either self-declaration or third-party assessment, or
both.

    Authority:  6 U.S.C. 321m(b)(2)(D).

    Dated: September 24, 2010.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-24673 Filed 9-30-10; 8:45 am]
BILLING CODE 9111-46-P


[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Notices]
[Pages 3789-3790]
[FR Doc No: 2017-00561]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2337-077]

PacifiCorp Energy; Notice of Application Tendered for Filing With
the Commission and Establishing Procedural Schedule for Licensing and
Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2337-077.
    c. Date Filed: December 30, 2016.
    d. Applicant: PacifiCorp Energy.
    e. Name of Project: Prospect No. 3 Hydroelectric Project.
    f. Location: On the South Fork Rogue River, in Jackson County,
Oregon. The project occupies 38.1 acres of United States lands within
the Rogue River-Siskiyou National Forest under the jurisdiction of the
U.S. Forest Service (Forest Service).
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Steve Albertelli, Relicensing Project
Manager, PacifiCorp Energy, 925 South Grape Street, Building 5,
Medford, OR 97501;<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    i. FERC Contact: Dianne Rodman at<PHONE_NUMBER> or email at
<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. Project Description: The existing project consists of: (1) A 24-
foot-high, 172-foot-long concrete diversion dam with an integrated 98-
foot-long ungated, uncontrolled ogee spillway section; (2) a 1-acre
reservoir that extends 550 feet upstream from the dam with a gross
storage capacity of 19 acre-feet at normal full pool elevation of 3,375
feet above sea level; (3) an 18-foot-wide intake structure at the north
end of the dam on the right bank with trash rack; (4) a 15,894-foot-
long flow conveyance system (project waterway) consisting of: A 273-
foot-long concrete-lined canal fitted with a 25-foot-long, 9.75-foot-
wide fish screen; a 66-inch-diameter, 5,448-foot-long woodstave pipe; a
5,805-foot-long concrete-lined canal; a 5-foot-wide, 6.5-foot-high,
698-foot-long concrete-lined horseshoe-shaped tunnel; a 416-foot-long
canal to the forebay with a 2,486-foot-long side channel spillway
discharging to Daniel Creek; and a 66-inch to 48-inch-diameter, 3,254-
foot-long riveted steel penstock; (5) a powerhouse containing one
vertical-shaft Francis-type turbine with an installed capacity of 7.2
megawatts; (6) a 20-foot-long, 20-foot-wide, 5-foot-deep concrete
tailrace; (7) a 66-inch-diameter, 887-foot-long wood-stave inverted
siphon that routes flow from the tailrace to the non-project Middle
Fork Canal; (8) a 6.97-mile-long, 69-kilovolt transmission line
interconnecting at the Prospect Central substation; (9) an 86-foot-
long, 15-pool concrete pool-and-weir ladder to provide upstream fish
passage past the dam; and (10) appurtenant facilities. The project
produces an average of 35.05 gigawatt-hours annually.
    PacifiCorp proposes to: Improve fish ladder function by
constructing an auxiliary bypass flow system, realigning and extending
the existing fish bypass return pipe, and narrowing the weir notches;
replace the existing woodstave pipe and inverted wooden siphon with
steel structures to eliminate leakage; rehabilitate the temporary
vehicle-access bridge over the new steel pipe to meet current Forest
Service standards; construct a road spur to facilitate pass-through of
materials dredged from the reservoir to the bypassed reach; upgrade the
six existing wildlife crossings of the project waterway's canal by
widening the crossings and constructing five new wildlife crossings;
and install a communications link on the U.S. Geological Survey's South
Fork Rogue gage.
    PacifiCorp also proposes to increase the project's minimum flow
releases and ramping rates limits, as well as extending the project
boundary to include the inverted siphon and access roads.
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, please contact FERC Online

Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Procedural Schedule:
    The application will be processed according to the following
preliminary Hydro Licensing Schedule. Revisions to the schedule may be
made as appropriate.

------------------------------------------------------------------------
               Milestone                           Target date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready    March 2017.
 for Environmental Analysis.
Filing of recommendations, preliminary  April 2017.
 terms and conditions, and fishway
 prescriptions.
Commission issues Environmental         October 2017.
 Assessment (EA).
Comments on EA........................  November 2017.
Modified terms and conditions.........  January 2018.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: January 6, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-00561 Filed 1-11-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Page 27522]
[FR Doc No: 2023-09206]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1259]

Advancing the Utilization and Supporting the Implementation of
Innovative Manufacturing Approaches; Public Workshop; Request for
Comments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments; correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``Advancing the Utilization and Supporting the Implementation
of Innovative Manufacturing Approaches'' that appeared in the Federal
Register of April 24, 2023. The document announced a public workshop.
The document was published with an incorrect topic for discussion. This
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy,
Legislation, and International Affairs, Food and Drug Administration,
301-796-9115, [email protected].

SUPPLEMENTARY INFORMATION:
    In the Federal Register of April 24, 2023, in FR Doc. 2023-08545
(88 FR 24807), on page 24808, the following correction is made:
     On page 24808, in the second column, in Section II,
``Topics for Discussion at the Public Workshop,'' the fifth topic,
``Science- and risk-based approaches for developing and accessing
innovative technologies across platform products and sites to
streamline adoption.'' is corrected to read ``Science- and risk-based
approaches for developing and assessing innovative technologies across
platform products and sites to streamline adoption.''

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09206 Filed 5-1-23; 8:45 am]
BILLING CODE 4164-01-P