[Federal Register: November 9, 2009 (Volume 74, Number 215)]
[Notices]
[Page 57733]
[DOCID:fr09no09-101]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending October
24, 2009

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1383 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.

    Docket Number: DOT-OST-2009-0262.
    Date Filed: October 20, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: TC123 North Atlantic (except between USA and Korea, Rep.
of, Malaysia) Resolutions and Specified Fares Tables (Memo 0455).
Intended effective date: 1 April 2010.

    Docket Number: DOT-OST-2009-0263.
    Date Filed: October 21, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: TC123 Mid Atlantic, Resolutions and Specified Fares Tables
(Memo 0456). Intended effective date: 1 April 2010.

    Docket Number: DOT-OST-2009-0264.
    Date Filed: October 21, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: TC123 South Atlantic, Resolutions and Specified Fares
Tables (Memo 0457).
    Intended effective date: 1 April 2010.

    Docket Number: DOT-OST-2009-0265.
    Date Filed: October 21, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: TC123 North Atlantic, between USA and Korea, Rep. of
Malaysia, Resolutions and Specified Fares Tables (Memo 0458). Intended
effective date: 1 April 2010.

    Docket Number: DOT-OST-2009-0269.
    Date Filed: October 21, 2009.
    Parties: Members of the International Air Transport Association.
    Subject: CSC/31/Meet/005/09 dated 8 April 2009. CSC/Mail Vote/002/
2009 dated 29 September 2009. Finally Adopted Resolutions: 600a, 600f,
600g, 600h, 600i, and Recommended Practice 1670. Intended effective
date: 23 December 2009.

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. E9-26905 Filed 11-6-09; 8:45 am]

BILLING CODE 4910-9X-P


                                 ATTACHMENT F

             Work Sheets used to Calculate Respondent Labor Costs

This attachment is available as part of the electronic docket EPA-HQ-OPP-2022-0150
                  and is part of the ICR's Supporting Statement.

Respondent Labor Costs:

Agricultural Workers (NAICS  452092)

 Item

                                    Formula

                               Labor Category[2]

                             Certified Applicator

                     Pesticide Handlers & Applicators
Unloaded Hourly Rate[1]
 = W
                                    $17.73
                                     $14.98
Benefits Percentage[3]
Lb = B/W
                                      45%
                                      45%
Benefits per hour
B = W*Lb
                                    $7.98
                                    $6.74
Loaded Hourly Rate
Wb = W + B = W(1+Lb)
                                    $25.71
                                    $21.72
 Source: Bureau of Labor Statistics, NAICS 452092 -  Agricultural Workers, May 2021, http://www.bls.gov/oes/current/naics
 Standard Occupational Codes:
   Management:  	11-0000, Management Occupations
   Technical:        	19-0000, Life Physical, and Social Science Occupations
   Administrative:          43-0000, Office, Clerical and Administrative Support Occupations
 Total benefits/wages based on May 2021 Employer costs for employee compensation, All Civilian nonfarm workers, ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ececqrtn.pdf
 U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34.  The loading for indirect costs is within the range of 20-70% of the loaded labor rate (wage + benefits) suggested in EPA guidance.

Registrants (Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing) (NAICS: 325300)

 Item

                                    Formula

                               Labor Category[2]

                                  Managerial
                                   Technical
                                   Clerical
Unloaded Hourly Rate[1]
 = W
                                    $69.64
                                    $37.44
                                    $25.59
Benefits Percentage[3]
Lb = B/W
                                      45%
                                      45%
                                      45%
Benefits per hour
B = W*Lb
                                    $31.34
                                    $16.85
                                    $11.52
Loaded Hourly Rate
Wb = W + B = W(1+Lb)
                                   $100.98
                                    $54.29
                                    $37.11
Overhead Percentage[4]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $50.49
                                    $27.14
                                    $18.55
Fully Loaded Hourly Rate
Wf = Wb + OH
 = W + B + OH
                                   $151.47
                                    $81.43
                                    $55.66
 Source: Bureau of Labor Statistics, NAICS 325300 -  Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing, May 2021, http://www.bls.gov/oes/current/naics
 Standard Occupational Codes:
   Management:  	11-0000, Management Occupations
   Technical:        	19-0000, Life Physical, and Social Science Occupations
   Administrative:          43-0000, Office, Clerical and Administrative Support Occupations
 Total benefits/wages based on May 2021 Employer costs for employee compensation, All Civilian nonfarm workers, ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ececqrtn.pdf
 U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34.  The loading for indirect costs is within the range of 20-70% of the loaded labor rate (wage + benefits) suggested in EPA guidance.

States, Tribes, Territories (NAICS 999200)

 Item

                                    Formula

                               Labor Category[2]

                                  Managerial
                                   Technical
                                   Clerical
Unloaded Hourly Rate[1]
 = W
                                    $47.69
                                    $32.49
                                    $21.79
Benefits Percentage[3]
Lb = B/W
                                      45%
                                      45%
                                      45%
Benefits per hour
B = W*Lb
                                    $21.46
                                    $14.62
                                    $9.81
Loaded Hourly Rate
Wb = W + B = W(1+Lb)
                                    $69.15
                                    $47.11
                                    $31.60
Overhead Percentage[4]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $34.58
                                    $23.56
                                    $15.80
Fully Loaded Hourly Rate
Wf = Wb + OH
 = W + B + OH
                                   $103.73
                                    $70.67
                                    $47.39
 Source: Bureau of Labor Statistics, NAICS 999200  -  State Government, May 2021, http://www.bls.gov/oes/current/naics
 Standard Occupational Codes:
   Management:  	11-0000, Management Occupations
   Technical:        	19-0000, Life Physical, and Social Science Occupations
   Administrative:          43-0000, Office, Clerical and Administrative Support Occupations
 Total benefits/wages based on May 2021 Employer costs for employee compensation, All Civilian nonfarm workers, ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ececqrtn.pdf
 U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34.  The loading for indirect costs is within the range of 20-70% of the loaded labor rate (wage + benefits) suggested in EPA guidance.

     Work Sheets used to Calculate EPA and Federal Government Labor Costs
This attachment is available as part of the electronic docket EPA-HQ-OPP-2020-0150
                and is part of the ICR's Supporting Statement

EPA / Federal Government Labor Costs (NAICS 999100)

Item
                                    Formula
                               Labor Category[2]

                                  Managerial
                                   Technical
                                Administrative
Unloaded Hourly Rate[1]
= W
                            $                 63.67
                               $          42.00
                            $                 23.24
Benefits Percentage[3]
Lb = B/W
                                      45%
                                      45%
                                      45%
Benefits per hour
B = W*Lb
                                    $28.65
                                    $18.90
                                    $10.46
Loaded Hourly Rate
Wb = W+B = W(1+Lb)
                                    $92.32
                                    $60.90
                                    $33.70
Overhead Percentage[4]
Lo = OH/Wb
                                      50%
                                      50%
                                      50%
Overhead per hour
OH = Wb*Lo
                                    $46.16
                                    $30.45
                                    $16.85
Fully Loaded Hourly Rate
Wf = Wb+OH = W+B+OH
                                   $138.48
                                    $91.35
                                    $50.55
 Source: Bureau of Labor Statistics, NAICS 999100  -  Federal Executive Branch, May 2021, http://www.bls.gov/oes/current/naics
 Standard Occupational Codes:
   Management:              11-0000, Management Occupations
   Technical:                   19-0000, Life Physical, and Social Science Occupations
   Administrative:           43-0000, Office, Clerical and Administrative Support Occupations
 Total benefits/wages based on May 2021 Employer costs for employee compensation, All Civilian nonfarm workers, ftp://ftp.bls.gov/pub/special.requests/ocwc/ect/ececqrtn.pdf
 U.S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pp. 2-34.  The loading for indirect costs is within the range of 20-70% of the loaded labor rate (wage + benefits) suggested in EPA guidance.


[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)]
[Notices]
[Pages 25302-25303]
[FR Doc No: 2015-10335]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0156]

Determination of Regulatory Review Period for Purposes of Patent
Extension; KAZANO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for KAZANO and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, rm. 3180, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product KAZANO
(alogliptin benzoate and metformin hydrochloride). KAZANO is indicated
as an adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus. Subsequent to this approval, the
USPTO received a patent term restoration application for KAZANO (U.S.
Patent No. 8,288,539) from Takeda Pharmaceutical Company Limited, and
the USPTO requested FDA's assistance in determining this

patent's eligibility for patent term restoration. In a letter dated May
2, 2014, FDA advised the USPTO that this human drug product had
undergone a regulatory review period and that the approval of KAZANO
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
KAZANO is 1,365 days. Of this time, 934 days occurred during the
testing phase of the regulatory review period, while 431 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: May 3, 2009. The applicant claims May 4, 2009, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was May 3,
2009, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: November
22, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for KAZANO (NDA 203-414) was submitted on November
22, 2011.
    3. The date the application was approved: January 25, 2013. FDA has
verified the applicant's claim that NDA 203-414 was approved on January
25, 2013.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 102 days of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 6, 2015. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by November 2, 2015. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10335 Filed 5-1-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Notices]
[Pages 25035-25036]
[FR Doc No: 2017-11150]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80761; File No. SR-GEMX-2017-16]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Cancel and
Replace Rule

May 24, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 11, 2017, Nasdaq GEMX, LLC (``GEMX'' or ``Exchange'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III, below, which Items
have been prepared by the Exchange. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to conform its cancel and replace rule change
with that of Nasdaq ISE, LLC (``ISE'') which was recently filed.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 80432 (April 11,
2017), 82 FR 18191 (April 17, 2017) (SR-ISE-2017-03) (Order
Approving Proposed Rule Change, as Modified by Amendment No. 1, to
Amend Various Rules in Connection with a System Migration to Nasdaq
INET Technology).
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange is proposing to amend Supplementary Material .02 to
GEMX Rule 715 to conform this rule to ISE's recently approved rule. ISE
recently received approval for a similar cancel and replace rule at
Supplementary Material .02 to ISE Rule 715.\4\ The ISE rule includes
additional information concerning the handling of cancel and replace
orders. With this amendment, the Exchange is memorializing the same
additional detail within its rule as to the manner in which the System
handles cancel and replace orders. Specifically, the Exchange proposes
to make clear that if the replacement portion of a Cancel and Replace
order does not satisfy the system's price or other reasonability checks
(e.g. Nasdaq GEMX Rule 710; Nasdaq GEMX Rule 711(c); and Nasdaq GEMX
Rule 714(b)(2)) the existing order shall be cancelled and not replaced.
This additional language serves to add detail to the current rule.
---------------------------------------------------------------------------

    \4\ Id.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\5\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\6\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
The Exchange believes that memorializing what happens to a cancel and
replace order that does not meet the price checks will add transparency
and specificity to the Rules thereby protecting investors and the
public interest by reducing the potential for investor confusion.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to make
clear that if the replacement portion of a Cancel and Replace order
does not satisfy the system's price or other reasonability [sic], the
existing order shall be cancelled and not replaced will bring more
clarity to market participants with respect to the operation of a
cancel and replace. The rule is not being substantively amended, rather
more detail is being added to the rule text.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \7\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-GEMX-2017-16 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-GEMX-2017-16. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-GEMX-2017-16 and should be
submitted on or before June 21, 2017.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-11150 Filed 5-30-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 140 (Monday, July 24, 2023)]
[Notices]
[Page 47494]
[FR Doc No: 2023-15623]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-11169-01-OA]

Public Meeting of the Science Advisory Board Environmental
Justice Screen (EJScreen) Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office is announcing a public meeting of the Science
Advisory Board Environmental Justice Screen (EJScreen) Review Panel.
The purpose of the meeting is to review and discuss the Panel's draft
report on the EPA's EJScreen mapping and screening tool.

DATES:
    Public meeting: The Science Advisory Board EJScreen Review Panel
will meet on August 14, 2023, from 12 p.m. to 4 p.m. Eastern Time.
    Comments: See the section titled ``Procedures for providing public
input'' under SUPPLEMENTARY INFORMATION for instructions and deadlines.

ADDRESSES: The August 14, 2023, meeting will be conducted virtually.
Please refer to the SAB website at https://sab.epa.gov for information
on how to attend the meeting.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning this document may contact Dr. Zaida
Figueroa, Designated Federal Officer (DFO), by telephone at (202) 566-
2643 or via email at [email protected]. General information about
the SAB, as well as any updates concerning the meeting announced in
this document, can be found on the SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDDAA),
codified at 42 U.S.C. 4365, to provide independent scientific and
technical advice to the EPA Administrator on the scientific and
technical basis for agency positions and regulations. The SAB is a
Federal Advisory Committee chartered under the Federal Advisory
Committee Act (FACA), 5 U.S. Code 10. The SAB will comply with the
provisions of FACA and all appropriate SAB Staff Office procedural
policies. Pursuant to FACA and EPA policy, notice is hereby given that
the Science Advisory Board EJScreen Review Panel will hold a public
meeting to review and discuss the Panel's draft report on the EPA's
EJScreen mapping and screening tool.
    Availability of meeting materials: All meeting materials, including
the agenda, will be available on the SAB web page at https://sab.epa.gov.
    Procedures for providing public input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to the EPA.
Members of the public can submit relevant comments pertaining to the
committee's charge or meeting materials. Input from the public to the
SAB will have the most impact if it provides specific scientific or
technical information or analysis for the SAB to consider or if it
relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should follow the
instructions below to submit comments.
    Oral statements: In general, individuals or groups requesting an
oral presentation at a meeting conducted virtually will be limited to
three minutes. Each person making an oral statement should consider
providing written comments as well as their oral statement so that the
points presented orally can be expanded upon in writing. Persons
interested in providing oral statements should contact the DFO, in
writing (preferably via email) at the contact information noted above
in FOR FURTHER INFORMATION CONTACT, by August 10, 2023, to be placed on
the list of registered speakers.
    Written statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by SAB members,
statements should be submitted to the DFO by August 10, 2023, for
consideration at the August 14, 2023, meeting. Written statements
should be supplied to the DFO at the contact information above via
email. Submitters are requested to provide an unsigned version of each
document because the SAB Staff Office does not publish documents with
signatures on its website. Members of the public should be aware that
their personal contact information if included in any written comments,
may be posted to the SAB website. Copyrighted material will not be
posted without the explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact the DFO, at the contact
information noted above, preferably at least ten days prior to the
meeting, to give the EPA as much time as possible to process your
request.

V. Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2023-15623 Filed 7-21-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50158-50159]
[FR Doc No: 2023-16228]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-1574]

Determination That Progesterone Injection, USP, 50 Milligrams/
Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Progesterone Injection, USP, 50 milligrams/milliliter
(mg/mL), was not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

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

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and

Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an
ANDA to market a generic version of a previously approved drug product.
To obtain approval, the ANDA applicant must show, among other things,
that the generic drug product: (1) has the same active ingredient(s),
dosage form, route of administration, strength, conditions of use, and
(with certain exceptions) labeling as the listed drug, which is a
version of the drug that was previously approved, and (2) is
bioequivalent to the listed drug. ANDA applicants do not have to repeat
the extensive clinical testing otherwise necessary to gain approval of
a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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 FDA's approval of 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.
    Progesterone Injection, USP, 50 mg/mL, is the subject of NDA
017362, held by Actavis Laboratories UT, Inc., and initially approved
on May 11, 1978. Progesterone Injection, USP, 50 mg/mL, is indicated in
amenorrhea and abnormal uterine bleeding due to hormonal imbalance in
the absence of organic pathology, such as submucous fibroids or uterine
cancer. Progesterone Injection, USP, 50 mg/mL, is currently listed in
the ``Discontinued Drug Product List'' section of the Orange Book.
    Dar[eacute] Bioscience, Inc., submitted a citizen petition dated
April 19, 2023 (Docket No. FDA-2023-P-1574), under 21 CFR 10.30,
requesting that the Agency determine whether Progesterone Injection,
USP, 50 mg/mL (NDA 017362), 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 Progesterone Injection, USP, 50 mg/mL, was not
withdrawn for reasons of safety or effectiveness. The petitioner has
identified no data or other information suggesting that Progesterone
Injection, USP, 50 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of Progesterone Injection, USP, 50 mg/mL,
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 Progesterone
Injection, USP, 50 mg/mL, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: July 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16228 Filed 7-31-23; 8:45 am]
BILLING CODE 4164-01-P


1 In Use Testing for Heavy Duty Engines Proposed Rulemaking Presentation for American Trucking Association September 29, 2004 2 HDDE In Use Testing Overview ° Engine Manufacturers Association ( EMA) Sued Over Not To Exceed ( NTE) Provisions of 2007 HDDE Standards ° EPA, EMA, and California Air Resources Board ( ARB) Reached a Settlement Agreement to Implement a Manufacturer Run, HDDE In Use Testing Program ° Settlement also Provided Manufacturers with Detailed Guidance on How EPA would Implement NTE Requirements 3 HDDE In Use Testing Overview ° Court Ordered Rulemaking Schedule   Proposal to be Signed by June 3, 2004   Final rule one year later ° Proposal Published on June 16, 2004 ° Comment Period Closed on August 16, 2004 ° Final Rule Expected Beginning of 2005 4 HDDE In Use Testing Objectives ° Monitors NTE and Exhaust Emission Standards Compliance for MY2007 and Later HDDEs   Under real world driving conditions   Over entire useful life of the engine ° Testing Conducted and Paid For By Manufacturers with EPA Oversight ° Addresses Long Standing Need for Such In Use Information and Retains NTE 5 HDDE In Use Testing Salient Program Features ° Onboard Emission Measurement Devices Emissions ° Measured: THC, CO, NOx, PM*, CO2, and O2 ° Pilot Program 2005/ 06 ° Enforceable Starting 2007 ° Up to 25%/ Year of Engine Families Tested or 1/ Year for Small Engine Manufacturers 6 HDDE In Use Testing Salient Program Features ( Cont'd)

° Truck Procurement, Mileage, and Pre Screening   Truck owner/ operator participation is voluntary   Test vehicles obtained from at least two sources   Normal operation  routes, driver, and conditions   Only properly used and maintained vehicles   No screening out for high mileage up to reg. useful life   Must have indication of significant non idle operation ° EPA/ ARB Reserve Right to Conduct Own Testing 7 HDDE In Use Testing Vehicle Pass Criteria ° Passes if 90% of Valid NTE Samples are Less Than or Equal to NTE Threshold ° 100% of Valid NTE Samples Must be Less than 2X NTE Threshold for MY2007 through 2009   Reevaluate need for this standard MY2010 and later ° NTE Threshold = Standard + Existing Regulatory and New Instrumentation Margin   Instrument margin proposed at 5%

  Instrument margin adjusted or eliminated in future rule 8 HDDE In Use Testing Family Pass Criteria ° Two Phase Approach ° Phase 1   Vehicle sample size: 5 minimum, 10 maximum   If 5 out of 5 or 5 out of 6 pass, family passes   If 2 fail, test 4 more   If all then pass ( 8 out of 10 total), family passes 9 HDDE In Use Testing Family Pass Criteria ( Cont'd)

  If more than 2 fail, then actions could include:

  No further action ( no significant issues indicated by data)

  Mandatory Phase 2 testing if 5 or more vehicles fail,

unless manufacturer agrees to remedial action   Voluntary Phase 2 testing if EPA, ARB, and manufacturer agree when 3 or 4 vehicles fail   Pursue remedial action directly if warranted based on Phase 1 and other relevant data or considerations 10 HDDE In Use Testing Family Pass Criteria ( Cont'd)

° Phase 2   Sample size up to 10 vehicles   Pursue remedial action directly if warranted based on Phase 1 and 2 results, and other relevant data or considerations 11 HDDE In Use Testing Next Steps ° Working to Resolve Several Implementation Issues with Manufacturers ° Final Rule by Beginning of 2005 ° Continue Aggressive Development of PEMS PM Measurement Capability