[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Page 2884]
[FR Doc No: 2010-871]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1861-DR; Docket ID FEMA-2008-0018]

Arkansas; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arkansas (FEMA-1861-DR), dated December 3, 2009, and
related determinations.

DATES: Effective Date: January 1, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Kevin L.
Hannes, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of W. Michael Moore as
Federal Coordinating Officer for this disaster.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-871 Filed 1-15-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46763-46764]
[FR Doc No: 2012-19087]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0724]

Documents to Support Submission of an Electronic Common Technical
Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the following final versions of documents that support
making regulatory submissions in electronic format using the electronic
Common Technical Document (eCTD) specifications: ``The eCTD Backbone
Files Specification for Module 1, version 2.0'' (which includes the
U.S. regional document type definition (DTD), version 3.0) and
``Comprehensive Table of Contents Headings and Hierarchy, version
2.0.'' Supporting technical files are also being made available on the
Agency Web site. These documents represent FDA's major updates to
Module 1 of the eCTD, which contains regional information. FDA is not
prepared at present to accept submissions utilizing this new version
because eCTD software vendors need time to update their software to
accommodate this information and because its use will require software
upgrades within the Agency. FDA estimates it will be able to receive
submissions utilizing Module 1 Specifications 2.0 by September 2013,
but this is not a firm date and we will give 30 days advance notice to
industry.

ADDRESSES: Submit written requests for single copies of the documents
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm 2201, Silver Spring, MD 20993-0002; or Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
documents.

FOR FURTHER INFORMATION CONTACT: Virginia Hussong, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm 1161, Silver Spring, MD 20993, email:
<EMAIL_ADDRESS>or Mary Padgett, Center for Biologics Evaluation and
Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The eCTD is an International Conference on Harmonisation (ICH)
standard based on specifications developed by ICH and its member
parties. FDA's Center for Drug Evaluation and Research (CDER) and
Center for Biologics Evaluation and Research (CBER) have been receiving
submissions in the eCTD format since 2003, and the eCTD has been the
standard for electronic submissions to CDER and CBER since January 1,
2008. The majority of new electronic submissions are now received in
eCTD format. Since adoption of the eCTD standard, it has become
necessary to update the administrative portion of the eCTD (Module 1)
to reflect regulatory changes, to provide clarification of business
rules for submission processing and review, to refine the
characterization of promotional marketing and advertising material, and
to facilitate automated processing of submissions. In preparation for
the Module 1 update, FDA made available draft technical documentation
for public comment in a Federal Register notice dated October 26, 2011
(Docket No. FDA-2011-N-0724). After considering comments submitted, FDA
revised the draft documentation and is making available final versions
of the following documents:
     ``The eCTD Backbone Files Specification for Module 1,
version 2.0,'' which provides specifications for creating the eCTD
backbone file for Module 1 for submission to CDER and CBER. It should
be used in conjunction with the guidance for industry ``Providing
Regulatory Submissions in Electronic Format--Human Pharmaceutical
Product Applications and Related Submissions Using the eCTD
Specifications,'' which can be found online (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf), and which will be revised as part of the implementation
of the updated eCTD backbone files specification.
     ``Comprehensive Table of Contents Headings and Hierarchy,
version 2.0,'' which reflects updated headings that are specified in
the draft document entitled ``The eCTD Backbone Files Specification for
Module 1, version 2.0,'' as well as mappings to regulations and
legislation.
    Supporting technical files are also being made available on the
Agency Web site. The documents include changes that:
     Allow submission of promotional label and advertising
materials to CDER in eCTD format;
     Provide for processing of grouped submissions (e.g., a
supplement that can be applied to more than one new drug application or
biologics license application);
     Provide detailed contact information so that companies can
specify points of contact to discuss technical matters that may arise
with a submission;
     Clarify headings;
     Use attributes in place of certain headings to provide
flexibility for future changes without revising the specification
itself.
    FDA is not prepared at present to accept submissions utilizing this
new version because eCTD software vendors need time to update their
software to accommodate this information and because its use will
require software upgrades within the Agency. FDA estimates it will be
able to receive submissions utilizing Module 1 Specifications 2.0 by
September 2013, but this is not a firm date and we will give 30 days
advance notice to industry.

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: July 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19087 Filed 8-3-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 157 (Wednesday, August 18, 2021)]
[Rules and Regulations]
[Pages 46117-46119]
[FR Doc No: 2021-17632]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0644]
RIN 1625-AA00

Safety Zone; Lower Mississippi River, Waxhaw, MS; MM 593-597

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Lower Mississippi River (LMR), between Mile
Marker 593 and 597. The safety zone is needed to protect persons,
property, and the marine environment from the potential safety hazards
associated with dredging operations in the vicinity of Waxhaw, MS.
Entry of persons or vessels into this zone is prohibited unless
authorized by the Captain of the Port Sector Lower Mississippi River or
a designated representative.

DATES: This rule is effective without actual notice from August 18,
2021 through September 15, 2021. For the purposes of enforcement,
actual notice will be used from August 13, 2021 until August 18, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0644 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MSTC Lindsey Swindle, U.S. Coast Guard; telephone 901-
521-4813, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. Immediate action
is needed to protect persons and property from the potential safety
hazards associated with dredging operations. The NPRM process would
delay the establishment of the safety zone until after the date of the
event and compromise public safety. We must establish this temporary
safety zone immediately and lack sufficient time to provide a
reasonable comment period and then consider those comments before
issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to respond to the potential safety hazards associated
with dredging operations in the vicinity of Waxhaw, MS starting August
13, 2021.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP)
Sector Lower Mississippi River (LMR) has determined that potential
hazards associated with dredging operations between Mile Marker (MM)
593 and 597, scheduled to start on August 13, 2021, would be a safety
concern for all persons and vessels on the Lower Mississippi River
between MM 593 and MM 597 through September 15, 2021. This rule is
needed to protect persons, property, infrastructure, and the marine
environment in all waters of the LMR within the safety zone while
dredging operations are being conducted.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from August 13, 2021
through September 15, 2021. The safety zone will cover all navigable
waters of

the LMR from MM 593 to MM 597. The duration of this safety zone is
intended to ensure the safety of waterway users on these navigable
waters during dredging operations.
    Entry of persons or vessels into this safety zone is prohibited
unless authorized by the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard assigned to units under the operational control
of USCG Sector Lower Mississippi River. Persons or vessels seeking to
enter the safety zones must request permission from the COTP or a
designated representative on VHF-FM channel 16 or by telephone at 314-
269-2332. If permission is granted, all persons and vessels shall
comply with the instructions of the COTP or designated representative.
The COTP or a designated representative will inform the public of the
enforcement times and date for this safety zone through Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or
Marine Safety Information Bulletins (MSIBs), as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive Orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This safety zone will
temporarily restrict navigation on the LMR from MM 593 through MM 597,
from August 13, 2021 through September 15, 2021. Moreover, The Coast
Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the safety zone, and the rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone that will prohibit entry on a one-mile stretch of the Lower
Mississippi River. It is categorically excluded from further review
under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS.

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0644 to read as follows:

Sec.  165.T08-0644  Safety Zone; Lower Mississippi River, Waxhaw, MS;
MM 593-597.

    (a) Location. The following area is a safety zone: All navigable
waters of the Lower Mississippi River from Mile Marker (MM) 593 through
MM 597.
    (b) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the Captain of the
Port Sector Lower Mississippi River (COTP) or the COTP's designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector Lower Mississippi River.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative via VHF-FM channel 16 or by telephone at<PHONE_NUMBER>.
Those in the safety zone must comply with all lawful orders or
directions given to them by the COTP or the COTP's designated
representative.
    (c) Enforcement period. This section will be enforced from August
13, 2021, through September 15, 2021.
    (d) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement times and date for this
safety zone through Broadcast Notices to Mariners, Local Notices to
Mariners, and/or Safety Marine Information Broadcasts, as appropriate.

    Dated: August 13, 2021.
R.S. Rhodes,
Captain, U.S. Coast Guard, Captain of the Port Sector Lower Mississippi
River.
[FR Doc. 2021-17632 Filed 8-17-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45323-45328]
[FR Doc No: 2022-16174]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1620]

Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the fee rates and payment procedures for fiscal year (FY)
2023 generic new animal drug user fees. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended by the Animal Generic Drug User Fee
Amendments of 2018 (AGDUFA III), authorizes FDA to collect user fees
for certain abbreviated applications for generic new animal drugs, for
certain generic new animal drug products, and for certain sponsors of
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2023.

DATES: The application fee rates are effective for all abbreviated
applications for a generic new animal drug submitted on or after
October 1, 2022, and will remain in effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm or contact Lisa Kable, Center for Veterinary Medicine (HFV-
10), Food and Drug Administration, 7500 Standish Pl., Rockville, MD
20855,<PHONE_NUMBER>, [email protected]. For general questions, you
may also email FDA's Center for Veterinary Medicine (CVM) at:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 741 of the FD&C Act (21 U.S.C. 379j-21) as amended by
AGDUFA III, establishes three different types of user fees: (1) fees
for certain types of abbreviated applications for generic new animal
drugs; (2) annual fees for certain generic new animal drug products;
and (3) annual fees for certain sponsors of abbreviated applications
for generic new animal drugs and/or investigational submissions for
generic new animal drugs (21 U.S.C. 379j-21(a)). When certain
conditions are met, FDA will waive or reduce fees for generic new
animal drugs intended solely to provide for a minor use or minor
species indication (21 U.S.C. 379j-21(d)).
    For FYs 2019 through 2023, the FD&C Act establishes the base
revenue amount for each fiscal year (21 U.S.C. 379j-21(b)(1)). Base
revenue amounts are subject to adjustment for inflation and workload
(21 U.S.C. 379j-21(c)(2) and (3)). Beginning with FY 2021, the annual
fee revenue amounts are also subject to adjustment to reduce workload-
based increases by the amount of certain excess collections (21 U.S.C.
379j-21(c)(3)(B)). Fees for applications, products, and sponsors are to
be established each year by FDA so that the percentages of the total
revenue that are derived from each type of user fee will be as follows:
(1) 25 percent shall be derived from fees for abbreviated applications
for a generic new animal drug; (2) 37.5 percent shall be derived from
fees for generic new animal drug products; and (3) 37.5 percent shall
be derived from fees for generic new animal drug sponsors (21 U.S.C.
379j-

21(b)(2)). The target revenue amounts for each fee category for FY
2023, are as follows: for application fees, the target revenue amount
is $7,325,750; for product fees, the target revenue amount is
$10,988,625; and for sponsor fees, the target revenue amount is
$10,988,625.
    For FY 2023, the generic new animal drug user fee rates are:
$494,983 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $247,492 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4) of the FD&C Act; $18,881 for each generic new animal
drug product; $283,870 for each generic new animal drug sponsor paying
100 percent of the sponsor fee; $212,903 for each generic new animal
drug sponsor paying 75 percent of the sponsor fee; and $141,935 for
each generic new animal drug sponsor paying 50 percent of the sponsor
fee. FDA will issue invoices for FY 2023 product and sponsor fees by
December 31, 2022, and payment will be due by January 31, 2023. The
application fee rates are effective for all abbreviated applications
for a generic new animal drug submitted on or after October 1, 2022,
and will remain in effect through September 30, 2023. Applications will
not be accepted for review until FDA has received full payment of
application fees and any other fees owed under the AGDUFA program.

II. Revenue Amount for FY 2023

A. Statutory Fee Revenue Amount

    AGDUFA III, Title II of Public Law 115-234, specifies that the
aggregate base fee revenue amount for FY 2023 for all generic new
animal drug user fee categories is $18,336,340 (21 U.S.C. 379j-
21(b)(1)).

B. Inflation Adjustment to Fee Revenue Amount

    AGDUFA III specifies that the annual fee revenue amount is to be
adjusted for inflation increases for FY 2020 and subsequent fiscal
years, using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (see 21 U.S.C. 379j-
21(c)(2)). The component of the inflation adjustment for payroll costs
shall be one plus the average annual percent change in the cost of all
PC&B paid per full-time equivalent position (FTE) at FDA for the first
3 of the 4 preceding fiscal years of available data, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years of available data. The data on total PC&B
paid and numbers of FTE paid, from which the average cost per FTE can
be derived, are published in FDA's Justification of Estimates for
Appropriations Committees.
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years, provides the percent change from the previous fiscal
year, and provides the average percent change over the first 3 of the 4
fiscal years preceding FY 2023. The 3-year average is 1.3918 percent.

              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
                                                                                3-year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,620,052,000    $2,875,592,000    $3,039,513,000  ..............
Total FTE.................................             17144             17535             18501  ..............
PC&B per FTE..............................          $152,826          $163,992          $164,829  ..............
Percent Change From Previous Year.........          -3.3120%           7.3063%           0.1811%         1.3918%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.3918 percent should be multiplied
by the proportion of PC&B costs to total FDA costs. Table 2 shows the
amount of PC&B and the total amount obligated by FDA for the same 3
FYs.

                                Table 2--PC&B as a Percent of Total Costs at FDA
----------------------------------------------------------------------------------------------------------------
                                                                                3-year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................    $2,620,052,000    $2,875,592,000    $3,039,513,000  ..............
Total Costs...............................    $5,663,389,000    $6,039,321,000    $6,049,798,000  ..............
PC&B Percent..............................          46.2630%          47.6145%          50.2416%        48.0397%
----------------------------------------------------------------------------------------------------------------

    The portion of the inflation adjustment relating to payroll costs
is 1.3918 percent multiplied by 48.0397 percent, or 0.6686 percent.
    The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 of the preceding 4
years of available data multiplied by the average proportion of all
costs other than PC&B costs to total FDA costs for the first 3 of the 4
preceding fiscal years. As a result of a geographical revision made by
the Bureau of Labor Statistics in January 2018,\1\ the ``Washington-
Baltimore, DC-MD-VA-WV'' index was discontinued and replaced with two
separate indices (i.e., ``Washington-Arlington-Alexandria, DC-VA-MD-
WV'' and ``Baltimore-Columbia-Towson, MD''). To continue applying a CPI
that best reflects the geographic region in which FDA is headquartered
and that provides the most current data available, FDA is using the
Washington-Arlington-Alexandria index, less food and energy, in
calculating the relevant adjustment factors for FY 2020 and subsequent
years. Table 3 provides the summary data for the percent change in the
specified CPI for the Washington-Arlington-Alexandria area. The data
from the Bureau of Labor Statistics are shown in table 3.
---------------------------------------------------------------------------

    \1\ Available at: https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

  Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI, Less Food and
                                                     Energy
----------------------------------------------------------------------------------------------------------------
                                                                                3-Year
                                                 FY 2019           FY 2020           FY 2021          average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................            275.84            278.44            287.14  ..............
Annual Percent Change.....................           1.2580%           0.9411%           3.1271%         1.7754%
----------------------------------------------------------------------------------------------------------------

    To calculate the inflation adjustment for non-payroll costs, we
multiply 1.7754 percent by the proportion of all costs other than PC&B
to total FDA costs. Since 48.0397 percent was obligated for PC&B as
shown in table 2, 51.9603 percent is the portion of costs other than
PC&B (100 percent minus 48.0397 percent equals 51.9603 percent). The
portion of the inflation adjustment relating to non-payroll costs is
1.7754 percent times 51.9603 percent, or 0.9225 percent.
    Next, we add the payroll component (0.6686 percent) to the non-
payroll component (0.9225 percent), for an inflation adjustment of
1.5911 percent for FY 2023.
    AGDUFA III provides for the inflation adjustment to be compounded
each fiscal year after FY 2020 (see 21 U.S.C. 379j-21(c)(2)). The
inflation adjustment for FY 2023 (1.5911 percent) is compounded by
adding 1 and then multiplying by 1 plus the inflation adjustment factor
for FY 2022 (5.7121 percent), as published in the Federal Register on
July 23, 2021 (86 FR 39028), which equals 1.0739 (rounded) (1.0159
times 1.0571) for FY 2023. We then multiply the base revenue amount for
FY 2023 ($18,336,340) by 1.073941, yielding an inflation adjusted
amount of $19,692,147.

C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount

    The fee revenue amounts established in AGDUFA III for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-21(c)(3)).
    To determine whether a workload adjustment applies, FDA calculates
the weighted average of the change in the total number of each of the
four types of applications and submissions specified in the workload
adjustment provision (abbreviated applications for generic new animal
drugs, manufacturing supplemental abbreviated applications for generic
new animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions) received over the 5-year period that ended on September
30, 2018 (the base years), and the average number of each of these
types of applications and submissions over the most recent 5-year
period that ended May 31, 2022.
    The results of these calculations are presented in the first two
columns of table 4. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application, reflecting how much of the total FDA generic
new animal drug review workload was accounted for by each type of
application or submission in the table during the most recent 5 years.
Column 5 is the weighted percent change in each category of workload
and was derived by multiplying the weighting factor in each line in
column 4 by the percent change from the base years in column 3. At the
bottom right of the table the sum of the values in column 5 is
calculated, reflecting a total change in workload of 77.5221 percent
for FY 2023. This is the workload adjuster for FY 2023.

                                     Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
                                     Column 1        Column 2        Column 3        Column 4        Column 5
                                 -------------------------------------------------------------------------------
        Application type              5-year
                                  average  (base   Latest 5-year  Percent change     Weighting       Weighted
                                      years)          average                         factor      percent change
----------------------------------------------------------------------------------------------------------------
Abbreviated Application for a              24.00           27.00         12.5000            0.15          1.8953
 Generic New Animal Drug
 (ANADAs).......................
Manufacturing Supplements ANADAs          169.40          219.60         29.6340            0.24          7.2536
Generic Investigational Study              69.20          155.40        124.5665            0.46         57.2176
 Submissions....................
Generic Investigational Protocol           34.40           61.00         77.3256            0.14         11.1556
 Submissions....................
                                 -------------------------------------------------------------------------------
    FY 2023 AGDUFA III Workload   ..............  ..............  ..............  ..............        77.52221
     Adjuster...................
----------------------------------------------------------------------------------------------------------------

    The statutory revenue amount after the inflation adjustment
($19,692,147) must now be increased by 77.5221 percent to reflect the
changes in review workload (workload adjustment), for a workload and
inflation-adjusted amount of $34,957,913.

D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections

    Under section 741(c)(3)(B) of the FD&C Act, for FYs 2021 through
2023, if application of the workload adjustment increases the amount of
fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections for the second preceding fiscal year, up to the
amount of the fee revenue increase for workload. The workload and
inflation-adjusted amount ($34,957,913) is subtracted by the inflation
adjusted amount ($19,692,147) to get the workload adjustment amount
($15,265,766). Then the excess fees collected from FY 2021 as of May
31, 2022 ($5,655,218) are subtracted from the workload adjustment
amount ($15,265,766) to get a reduced workload adjustment amount of
$9,610,548. Next, the reduced workload adjustment amount ($9,610,548)
is added to the inflation-adjusted revenue amount ($19,692,147), for a
total fee revenue target of $29,303,000 (rounded to the nearest
thousand dollars).

E. Final Year Adjustment

    For FY 2023, FDA may, in addition to other adjustments under
section 741(c) of the FD&C Act, further increase the fees, if such an
adjustment is necessary, to provide for up to 3 months of

operating reserves of carryover user fees for the process for the
review of generic animal drug applications for the first 3 months of FY
2024. If FDA has carryover balances for the process for the review of
generic new animal drug applications in excess of 3 months of such
operating reserves, then this adjustment will not be made (see 21
U.S.C. 379j-21(c)(4)). Since FDA currently has an excess of 3 months of
such operating reserves, this adjustment will not be made for FY 2023.

F. FY 2023 Fee Revenue Amounts

    AGDUFA III specifies that the revenue amount of $29,303,000 for FY
2023 is to be divided as follows: 25 percent, or a total of $7,325,750,
is to come from application fees; 37.5 percent, or a total of
$10,988,625, is to come from product fees; and 37.5 percent, or a total
of $10,988,625, is to come from sponsor fees (21 U.S.C. 379j-21(b)).

III. Abbreviated Application Fee Calculations for FY 2023

A. Application Fee Revenues and Numbers of Fee-Paying Applications

    Each person who submits an abbreviated application for a generic
new animal drug shall be subject to an application fee, with limited
exceptions (21 U.S.C. 379j-21(a)(1)). The term ``abbreviated
application for a generic new animal drug'' means an abbreviated
application for the approval of any generic new animal drug submitted
under section 512(b)(2) of the FD&C Act (21 U.S.C. 379j-21(k)(1)). The
application fees are to be set so that they will generate $7,325,750 in
fee revenue for FY 2023.
    To set fees for abbreviated applications for generic new animal
drugs to realize $7,325,750, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2023.
    The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates annually. In
estimating the fee revenue to be generated by generic new animal drug
applications in FY 2023, FDA is assuming that the number of
applications for which fees will be paid in FY 2023 will equal the
average number of applications over the 5 most recently completed
fiscal years of the AGDUFA program (FY 2017-FY 2021).
    Also, under AGDUFA III, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug (21 U.S.C. 379j-21(a)(1)(C)(ii)).
    The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed fiscal years is 11.6 applications not subject to the criteria
in section 512(d)(4) of the FD&C Act and 6.4 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number that are subject
to such criteria results in a total of 14.80 anticipated full fees.
    Based on the previous assumptions, FDA is estimating that it will
receive a total of 14.80 fee-paying generic new animal drug
applications in FY 2023 (11.6 original applications paying a full fee
and 6.4 applications paying a half fee).

B. Application Fee Rates for FY 2023

    FDA must set the fee rates for FY 2023 so that the estimated 14.80
abbreviated applications that pay the fee will generate a total of
$7,325,750. To generate this amount, the fee for a generic new animal
drug application will have to be $494,983 and for those applications
that are subject to the criteria set forth in section 512(d)(4) of the
FD&C Act, 50 percent of that amount, or $247,492.

IV. Generic New Animal Drug Product Fee Calculations for FY 2023

A. Product Fee Revenues and Numbers of Fee-Paying Products

    The generic new animal drug product fee must be paid annually by
the person named as the applicant in an abbreviated application or
supplemental abbreviated application for a generic new animal drug
product submitted for listing under section 510 of the FD&C Act (21
U.S.C. 360) and who had an abbreviated application or supplemental
abbreviated application for a generic new animal drug product pending
at FDA after September 1, 2008 (see 21 U.S.C. 379j-21(a)(2)). The term
``generic new animal drug product'' means each specific strength or
potency of a particular active ingredient or ingredients in final
dosage form marketed by a particular manufacturer or distributor, which
is uniquely identified by the labeler code and product code portions of
the National Drug Code, and for which an abbreviated application for a
generic new animal drug or supplemental abbreviated application for a
generic new animal drug has been approved (21 U.S.C. 379j-21(k)(6)).
The product fees are to be set so that they will generate $10,988,625
in fee revenue for FY 2023.
    To set generic new animal drug product fees to realize $10,988,625,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2023. FDA gathered data on all generic
new animal drug products that have been submitted for listing under
section 510 of the FD&C Act and matched this to the list of all persons
who had a generic new animal drug application or supplemental
abbreviated application pending after September 1, 2008. As of May
2022, FDA estimates that there is a total of 588 products submitted for
listing by persons who had an abbreviated application for a generic new
animal drug or supplemental abbreviated application for a generic new
animal drug pending after September 1, 2008. Based on this, FDA
believes that a total of 588 products will be subject to this fee in FY
2023.
    In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2023, FDA is estimating that 1 percent of the
products invoiced, or 6 products, will qualify for a minor use/minor
species fee waiver (see 21 U.S.C. 379j-21(d)). FDA has made this
estimate at 1 percent this year, based on historical data over the past
5 completed fiscal years of the AGDUFA program.
    Accordingly, the Agency estimates that a total of 582 (588 minus 6)
products will be subject to product fees in FY 2023.

B. Product Fee Rates for FY 2023

    FDA must set the fee rates for FY 2023 so that the estimated 582
products for which fees are paid will generate a total of $10,988,625.
To generate this amount will require the fee for a generic new animal
drug product, rounded to the nearest dollar, to be $18,881.

V. Generic New Animal Drug Sponsor Fee Calculations for FY 2023

A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors

    The generic new animal drug sponsor fee must be paid annually by
each person who: (1) is named as the applicant in an abbreviated
application for a generic new animal drug, except for an approved
application for which all subject products have been removed from
listing under section 510 of the FD&C Act, or has submitted an

investigational submission for a generic new animal drug that has not
been terminated or otherwise rendered inactive and (2) had an
abbreviated application for a generic new animal drug, supplemental
abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-
21(a)(3)). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with more than one and fewer
than seven approved abbreviated applications will pay 75 percent of the
sponsor fee; and applicants with one or fewer approved abbreviated
applications will pay 50 percent of the sponsor fee (see 21 U.S.C.
379j-21(a)(3)(C)). The sponsor fees are to be set so that they will
generate $10,988,625 in fee revenue for FY 2023.
    To set generic new animal drug sponsor fees to realize $10,988,625,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2023. FDA estimates that in FY 2023, 12 sponsors
will pay 100 percent fees, 18 sponsors will pay 75 percent fees, and 28
sponsors will pay 50 percent fees. That results in the equivalent of
39.5 full sponsor fees (12 times 100 percent or 12, plus 18 times 75
percent or 13.5, plus 28 times 50 percent or 14).
    FDA estimates that about 2 percent of all of these sponsors, or
0.79, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has made the estimate of the percentage of
sponsors that will not pay fees at 2 percent this year, based on
historical data over the past 5 completed FYs of the AGDUFA program.
    Accordingly, the Agency estimates that the equivalent of 38.71 full
sponsor fees (39.5 minus 0.79) are likely to be paid in FY 2023.

B. Sponsor Fee Rates for FY 2023

    FDA must set the fee rates for FY 2023 so that the estimated
equivalent of 38.71 full sponsor fees will generate a total of
$10,988,625. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest dollar,
to be $283,870. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $212,903, and the fee for those paying 50
percent of the full sponsor fee will be $141,935.

VI. Fee Schedule for FY 2023

    The fee rates for FY 2023 are summarized in table 5.

                       Table 5--FY 2023 Fee Rates
------------------------------------------------------------------------
                                                         Fee rate for FY
       Generic new animal drug user fee category              2023
------------------------------------------------------------------------
Abbreviated Application Fee for Generic New Animal              $494,983
 Drug except those subject to the criteria in section
 512(d)(4)............................................
Abbreviated Application Fee for Generic New Animal               247,492
 Drug subject to the criteria in section 512(d)(4)....
Generic New Animal Drug Product Fee...................            18,881
100% Generic New Animal Drug Sponsor Fee \1\..........           283,870
75% Generic New Animal Drug Sponsor Fee \1\...........           212,903
50% Generic New Animal Drug Sponsor Fee \1\...........           141,935
------------------------------------------------------------------------
\1\ An animal drug sponsor is subject to only one such fee each fiscal
  year.

VII. Fee Waiver or Reduction; Exemption From Fees

    The types of fee waivers and reductions that applied last fiscal
year still exist for FY 2023. In AGDUFA III, a new exemption from fees
was established as follows: Fees will not apply to any person who not
later than September 30, 2023, submits to CVM a supplemental
abbreviated application relating to a generic new animal drug approved
under section 512 of the FD&C Act, solely to add the application number
to the labeling of the drug in the manner specified in section
502(w)(3) of the FD&C Act (21 U.S.C. 352(w)(3)), if that person
otherwise would be subject to user fees under AGDUFA based only on the
submission of the supplemental abbreviated application (21 U.S.C. 379j-
21(d)(2)).

VIII. Procedures for Paying FY 2023 Fees

A. Abbreviated Application Fees and Payment Instructions

    The FY 2023 fee established in the new fee schedule must be paid
for a generic new animal drug application subject to fees under AGDUFA
III that is submitted on or after October 1, 2022. The payment must be
made in U.S. currency from a U.S. bank by one of the following methods:
wire transfer, electronically, check, bank draft, or U.S. postal money
order made payable to the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH), also known as eCheck) or credit card (Discover, VISA,
MasterCard, American Express). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay or the Pay.gov payment option is available to you
after you submit a cover sheet. (Note: only full payments are accepted.
No partial payments can be made online.) Once you find your invoice,
select ``Pay Now'' to be redirected to Pay.gov. Electronic payment
options are based on the balance due. Payment by credit card is
available only for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S. bank accounts as well as U.S. credit cards.
    When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters ``AG'', on the upper right-hand
corner of your completed Animal Generic Drug User Fee Cover Sheet. Also
write FDA's post office box number (P.O. Box 979033) and PIN on the
enclosed check, bank draft, or money order. Mail the payment and a copy
of the completed Animal Generic Drug User Fee Cover Sheet to: Food and
Drug Administration, P.O. Box 979033, St. Louis, MO 63197-9000. Note:
In no case should the payment for the fee be submitted to FDA with the
application.
    When paying by wire transfer, the invoice number or PIN needs to be
included. Without the invoice number or PIN, the payment may not be
applied, and the invoice amount would be referred to collections. The
originating financial institution may charge a wire transfer fee. If
the financial institution charges a wire transfer fee, it is required
to add that amount to the payment to ensure that the invoice is paid in
full. Use the following account information when sending a payment by
wire

transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Name: Food and Drug Administration, Account
Number: 75060099, U.S. Department of the Treasury routing/transit
number: 021030004, SWIFT Number: FRNYUS33.
    To send a check by a courier such as FedEx, the courier must
deliver the check and printed copy of the cover sheet to: U.S. Bank,
Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO
63101. (Note: This address is for courier delivery only. If you have
any questions concerning courier delivery, contact U.S. Bank at 314-
418-4013. This telephone number is only for questions about courier
delivery.)
    It is important that the fee arrives at the bank at least a day or
two before the abbreviated application arrives at FDA's CVM. FDA
records the official abbreviated application receipt date as the later
of the following: the date the application was received by CVM, or the
date U.S. Bank notifies FDA that your payment in the full amount has
been received, or when the U.S. Department of the Treasury notifies FDA
of payment. U.S. Bank and the U.S. Department of the Treasury are
required to notify FDA within 1 working day, using the PIN described
previously.
    The tax identification number of FDA is 53-0196965.

B. Application Cover Sheet Procedures

    Step One: Create a user account and password. Log onto the AGDUFA
website at https://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and, under Application
Submission Information, click on ``Create AGDUFA User Fee Cover
Sheet.'' For security reasons, each firm submitting an application will
be assigned an organization identification number, and each user will
also be required to set up a user account and password the first time
you use this site. Online instructions will walk you through this
process.
    Step Two: Create an Animal Generic Drug User Fee Cover Sheet,
transmit it to FDA, and print a copy. After logging into your account
with your user name and password, complete the steps required to create
an Animal Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated application for a generic new animal drug. Once
you are satisfied that the data on the cover sheet are accurate and you
have finalized the cover sheet, you will be able to transmit it
electronically to FDA, and you will be able to print a copy of your
cover sheet showing your unique PIN.
    Step Three: Send the payment for your application as described in
section VIII.A.
    Step Four: Submit your application.

C. Product and Sponsor Fees

    By December 31, 2022, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2023 using this fee
schedule. Payment will be due by January 31, 2023. FDA will issue
invoices in November 2023 for any products and sponsors subject to fees
for FY 2023 that qualify for fees after the December 2022 billing.

    Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16174 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P