[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63227-63228]
[FR Doc No: 2015-26434]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Reclassification Petitions for
Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Reclassification Petitions for
Medical Devices'' has been approved by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver

Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 16, 2015, the Agency submitted a
proposed collection of information entitled ``Reclassification
Petitions for Medical Devices'' to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0138.
The approval expires on September 30, 2018. A copy of the supporting
statement for this information collection is available on the Internet
at http://www.reginfo.gov/public/do/PRAMain.

    Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26434 Filed 10-16-15; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.   I believe the development of e-vaporizers to be the most significant invention of the 21st century,  to take a 25 year smoke as myself to completely quit combustible smoking in less than a week is a gift that I will forever be grateful.  Please extend this review and allow this new incredible technology section of business to continue to develop.


vehicles or Sec.  86.1014-84 for light-duty trucks and, if a
manufacturer requests such a hearing, will be made only after an
initial decision by the Presiding Officer.

[FR Doc. E7-2667 Filed 2-23-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 148 (Wednesday, August 3, 2022)]
[Notices]
[Page 47411]
[FR Doc No: 2022-16591]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 5944-024]

Moretown Hydroelectric, LLC; Notice Soliciting Scoping Comments
and Extending Comment Period

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Minor License.
    b. Project No.: 5944-024.
    c. Date filed: November 30, 2020.
    d. Applicant: Moretown Hydroelectric, LLC.
    e. Name of Project: Moretown No. 8 Project.
    f. Location: On the Mad River, immediately downstream from the Town
of Moretown, Washington County, Vermont. The project does not occupy
federal land.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Arion Thiboumery, Moretown Hydroelectric,
LLC, 1273 Fowler Rd. Plainfield, VT 05667;<PHONE_NUMBER> or email at
ion.net">[email protected]ion.net.
    i. FERC Contact: Maryam Zavareh at<PHONE_NUMBER>, or email at
[email protected].
    j. Deadline for filing scoping comments: August 29, 2022. The
commission is reissuing the notice and extending the comment due date.
Due to a mailing error, not all recipients received the original
notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene and protests using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please
contact FERC Online Support at [email protected], (866) 208-
3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, you may submit a paper copy. Submissions sent via the U.S.
Postal Service must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. All
filings must clearly identify the project name and docket number on the
first page: Moretown Hydroelectric Project (P-5944-024).
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application is not ready for environmental analysis at this
time.
    l. The project consists of the following existing facilities: (1) a
333-foot-long, 31-foot-high concrete gravity dam with a 164-foot-long
overflow spillway and a crest elevation of 524.7 feet; (2) a 36-acre
impoundment with a normal maximum elevation of 524.7; (3) a 40-foot-
long, 17-foot-wide, 28-foot-high concrete intake structure with a
trashrack; (4) a 40-foot-long, 8.5-foot-diameter buried steel penstock;
(5) a 39.4-foot-long, 19.7-foot-wide concrete powerhouse containing a
single 1.25-megawatt Kaplan turbine-generator unit; (6) a tailrace; (7)
a 106-foot-long, 12.5-kilovolt transmission line; and (8) appurtenant
facilities. The Moretown Project is operated in a run-of-river mode
with an average annual generation of 2,094 megawatt-hours.
    Moretown hydroelectric LLC proposes to continue to operate the
project in a run-of-river mode.
    m. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents via the internet through
the Commission's Home Page (http://www.ferc.gov) using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at [email protected] or call toll-free,<PHONE_NUMBER> or
TYY,<PHONE_NUMBER>.
    n. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. Scoping Process.
    Commission staff will prepare either an environmental assessment
(EA) or an Environmental Impact Statement (EIS) that describes and
evaluates the probable effects of the licensee's proposed action and
alternatives. The EA or EIS will consider both site-specific and
cumulative environmental impacts and reasonable alternatives to the
proposed action. The Commission's scoping process will help determine
the required level of analysis and satisfy the National Environmental
Policy Act (NEPA) scoping requirements, irrespective of whether the
Commission prepares an EA or an EIS.
    At this time, we do not anticipate holding on-site scoping
meetings. Instead, we are soliciting written comments and suggestions
on the preliminary list of issues and alternatives to be addressed in
the NEPA document, as described in scoping document 1 (SD1), issued
July 28, 2022.
    Copies of the SD1 outlining the subject areas to be addressed in
the NEPA document were distributed to the parties on the Commission's
mailing list and the applicant's distribution list. Copies of SD1 may
be viewed on the web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, call 1-866-
208-3676 or for TTY,<PHONE_NUMBER>.

    Dated: July 28, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-16591 Filed 8-2-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Notices]
[Pages 6957-6958]
[FR Doc No: 2015-02574]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9922-84-OA]

Announcement of the Board of Directors for the National
Environmental Education Foundation

AGENCY: Office of External Affairs and Environmental Education,
Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The National Environmental Education and Training Foundation
(doing business as The National Environmental Education Foundation or
NEEF) was created by Section 10 of Public Law 101-619, the National
Environmental Education Act of 1990. It is a private 501(c)(3) non-
profit organization established to promote and support education and
training as necessary tools to further environmental protection and
sustainable, environmentally sound development. It provides the common
ground upon which leaders from business and industry, all levels of
government, public interest groups, and others can work cooperatively
to expand the reach of environmental education and training programs
beyond the traditional classroom. The Foundation promotes innovative
environmental education and training programs such as environmental
education for medical healthcare providers and broadcast
meteorologists; it also develops partnerships with government and other
organizations to administer projects that promote the development of an
environmentally literal public. The Administrator of the U.S.
Environmental Protection Agency, as required by the terms of the Act,
announces the following appointment to the National Environmental
Education Foundation Board of Directors. The appointee is Raul Perea-
Henze, M.D., M.P.H., managing director of HORUS Advisors as a strategy
advisor in healthcare, global affairs and government relations.

FOR FURTHER INFORMATION CONTACT: For information regarding this Notice
of Appointment, please contact Mr. Brian Bond, Senior Advisor to the
Administrator for Public Engagement, U.S. EPA, 1200 Pennsylvania Ave.
NW., Washington, DC 20460. General information concerning NEEF can be
found on their Web site at: http://www.neefusa.org.

SUPPLEMENTARY INFORMATION:

Additional Considerations

    Great care has been taken to assure that this new appointee not
only has the highest degree of expertise and commitment, but also
brings to the Board diverse points of view relating to environmental
education. This appointment is a four-year term which may be renewed
once for an additional four years pending successful re-election by the
NEEF nominating committee.
    This appointee will join the current Board members which include:
     Decker Anstrom (NEEF Chairman) Former U.S. Ambassador,
Retired Chairman, The Weather Channel Companies
     Trish Silber (NEEF Vice Chair) President, Aliniad
Consulting Partners, Inc.
     Diane Wood (NEEF Secretary) President, National
Environmental Education Foundation
     Carlos Alcazar, Founder and Chairman, Culture ONE World
     Megan Reilly Cayten, Co-Founder and Chief Executive
Officer, Catrinka, LLC
     Philippe Cousteau, Co-Founder and CEO, EarthEcho
International
     David M. Kiser, Vice President, Environment, Health,
Safety and Sustainability, International Paper
     Wonya Lucas, President, Lucas Strategic Consulting
     Shannon Schuyler, Principal, Corporate Responsibility
Leader, PricewaterhouseCoopers (PwC)
     Jacqueline M. Thomas, Vice President of Corporate
Responsibility, Toyota Motor Sales USA Inc.

Background

    Section 10(a) of the National Environmental Education Act of 1990
mandates a National Environmental Education Foundation. The Foundation
is established in order to extend the contribution of environmental
education and training to meeting critical environmental protection
needs, both in this country and internationally; to facilitate the
cooperation, coordination, and contribution of public and private
resources to create an environmentally advanced educational system; and
to foster an open and effective partnership among Federal, State, and
local government, business, industry, academic institutions, community
based environmental groups, and international organizations.

    The Foundation is a charitable and nonprofit corporation whose
income is exempt from tax, and donations to which are tax deductible to
the same extent as those organizations listed pursuant to section
501(c) of the Internal Revenue Code of 1986. The Foundation is not an
agency or establishment of the United States. The purposes of the
Foundation are--
    (A) Subject to the limitation contained in the final sentence of
subsection (d) herein, to encourage, accept, leverage, and administer
private gifts for the benefit of, or in connection with, the
environmental education and training activities and services of the
United States Environmental Protection Agency;
    (B) to conduct such other environmental education activities as
will further the development of an environmentally conscious and
responsible public, a well-trained and environmentally literate
workforce, and an environmentally advanced educational system;
    (C) to participate with foreign entities and individuals in the
conduct and coordination of activities that will further opportunities
for environmental education and training to address environmental
issues and problems involving the United States and Canada or Mexico.
    The Foundation develops, supports, and/or operates programs and
projects to educate and train educational and environmental
professionals, and to assist them in the development and delivery of
environmental education and training programs and studies.
    The Foundation has a governing Board of Directors (hereafter
referred to in this section as `the Board'), which consists of 13
directors, each of whom shall be knowledgeable or experienced in the
environment, education and/or training. The Board oversees the
activities of the Foundation and assures that the activities of the
Foundation are consistent with the environmental and education goals
and policies of the Environmental Protection Agency and with the
intents and purposes of the Act. The membership of the Board, to the
extent practicable, represents diverse points of view relating to
environmental education and training. Members of the Board are
appointed by the Administrator of the Environmental Protection Agency.
    Within 90 days of the date of the enactment of the National
Environmental Education Act, and as appropriate thereafter, the
Administrator will publish in the Federal Register an announcement of
appointments of Directors of the Board. Such appointments become final
and effective 90 days after publication in the Federal Register. The
directors are appointed for terms of 4 years. The Administrator shall
appoint an individual to serve as a director in the event of a vacancy
on the Board within 60 days of said vacancy in the manner in which the
original appointment was made. No individual may serve more than 2
consecutive terms as a director.

    Dated: February 3, 2015.
Gina McCarthy,
Administrator.

Raul Perea-Henze, M.D., M.P.H.

    Dr. Perea-Henze, M.D., M.P.H. is currently managing director of
HORUS Advisors as a strategy advisor in healthcare, global affairs and
government relations.
    He worked in the private sector, as senior executive at Merck &
Co., Inc. and Pfizer Inc. Among his many responsibilities at these
companies he assisted in shaping corporate responsibility, philanthropy
and external affairs participating in committees at the Institute of
Medicine, World Medical Association, The Clinton Global Initiative and
the Gates Foundation.
    In the public sector, he served as assistant secretary for policy
and planning at the U.S. Department of Veterans Affairs where he had
direct oversight for a $9 billion portfolio of priority programs.
Before joining the VA in 2010, he was an advisor to the Obama
Presidential Transition Team. He was deputy assistant secretary for
management and budget at the U.S. Department of Commerce from 1999 to
2001.
    He has a medical degree from the University of Chihuahua in Mexico
and a master's degree in public health from Yale University. We believe
he will be a great addition to the NEEF board and we respectfully
submit his name for appointment to the NEEF Board of Directors.

[FR Doc. 2015-02574 Filed 2-6-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Notices]
[Pages 61601-61605]
[FR Doc No: 2022-22099]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration.

[Docket No. FDA-2022-N-2354]

Generic Drug User Fee Rates for Fiscal Year 2023

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act or
statute), as amended by the Generic Drug User Fee Amendments of 2022
(GDUFA III), authorizes the Food and Drug Administration (FDA, Agency,
or we) to assess and collect fees for abbreviated new drug applications
(ANDAs); drug master files (DMFs); generic drug active pharmaceutical
ingredient (API) facilities, finished dosage form (FDF) facilities, and
contract manufacturing organization (CMO) facilities; and generic drug
applicant program user fees. In this document, FDA is announcing fiscal
year (FY) 2023 rates for GDUFA III fees. These fees are effective on
October 1, 2022, and will remain in effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Robert Marcarelli, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304, and the User Fees Support Staff at
[email protected],<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42), as amended by GDUFA III, authorize FDA to assess and collect fees
associated with human generic drug products. Fees are assessed on: (1)
certain types of applications for human generic drug products; (2)
certain facilities where APIs and FDFs are produced; (3) certain

DMFs associated with human generic drug products; and (4) generic drug
applicants who have ANDAs (the program fee) (see section 744B(a)(2)
through (5) of the FD&C Act). For more information about GDUFA III,
please refer to the FDA website (https://www.fda.gov/gdufa).
    For FY 2023, the generic drug fee rates are: ANDA ($240,582), DMF
($78,293), domestic API facility ($37,544), foreign API facility
($52,544), domestic FDF facility ($213,134), foreign FDF facility
($228,134), domestic CMO facility ($51,152), foreign CMO facility
($66,152), large size operation generic drug applicant program
($1,620,556), medium size operation generic drug applicant program
($648,222), and small business generic drug applicant program
($162,056). These fees are effective on October 1, 2022, and will
remain in effect through September 30, 2023. The fee rates for FY 2023
are set out in table 1.

                    Table 1--Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                         Fees rates for
              Generic drug fee category                     FY 2023
------------------------------------------------------------------------
Applications
    Abbreviated New Drug Application (ANDA)..........           $240,582
    Drug Master File (DMF)...........................             78,293
Facilities
    Active Pharmaceutical Ingredient (API)--Domestic.             37,544
    API--Foreign.....................................             52,544
    Finished Dosage Form (FDF)--Domestic.............            213,134
    FDF--Foreign.....................................            228,134
    Contract Manufacturing Organization (CMO)--......             51,152
Domestic
    CMO--Foreign.....................................             66,152
GDUFA Program
    Large size operation generic drug applicant......          1,620,556
    Medium size operation generic drug applicant.....            648,222
    Small business operation generic drug applicant..            162,056
------------------------------------------------------------------------

II. Fee Revenue Amount for FY 2023

    The fee revenue amount for FY 2023 for GDUFA III is $582,500,000.
Since this is the first fiscal year of the GDUFA III authorization
period, there is no inflation adjustment. Applicable inflation
adjustments shall be made beginning with FY 2024.
    Beginning with FY 2024, FDA shall, in addition to the inflation
adjustment, apply the capacity planning adjustment under section
744B(c)(2) of the FD&C Act to further adjust, as needed, the fee
revenue and fees to reflect changes in the resource capacity needs of
FDA for human generic drug activities.
    Beginning with FY 2024, FDA may, in addition to the inflation and
capacity planning Adjustments, apply the operating reserve adjustment
under section 744B(c)(3) of the FD&C Act to further increase the fee
revenue and fees if necessary to provide operating reserves of
carryover user fees for human generic drug activities for not more than
the number of weeks specified in such section (or as applicable, shall
apply such adjustment to decrease the fee revenues and fees to provide
for not more than 12 weeks of such operating reserves).

III. Fee Amounts for FY 2023

    GDUFA III directs FDA to use the annual revenue amount determined
under the statute as a starting point to set the fee rates for each fee
type. The fee revenue amount for FY 2023 is $582,500,000. The ANDA,
DMF, API facility, FDF facility, CMO facility, and generic drug
applicant program fee (GDUFA program fee) calculations for FY 2023 are
described in this document.

A. ANDA Filing Fee

    Under GDUFA III, the FY 2023 ANDA filing fee is owed by each
applicant that submits an ANDA on or after October 1, 2022. This fee is
due on the submission date of the ANDA. Section 744B(b)(2)(B) of the
FD&C Act specifies that the ANDA fee will make up 33 percent of the
$582,500,000, which is $192,225,000.
    To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2023. The
submissions are broken down into three categories: new originals
(submissions that have not been received by FDA previously);
submissions that FDA refused to receive (RTR) for reasons other than
failure to pay fees; and applications that are resubmitted after an RTR
decision for reasons other than failure to pay fees. An ANDA counts as
one FAE; however, 75 percent of the fee paid for an ANDA that has been
RTR shall be refunded according to GDUFA III if: (1) the ANDA is
refused for a cause other than failure to pay fees or (2) the ANDA has
been withdrawn prior to receipt (section 744B(a)(3)(D)(i) of the FD&C
Act). Therefore, an ANDA that is considered not to have been received
by FDA due to reasons other than failure to pay fees or withdrawn prior
to receipt counts as one-fourth of an FAE. After an ANDA has been RTR,
the applicant has the option of resubmitting. For user fee purposes,
these resubmissions are equivalent to new original submissions: ANDA
resubmissions are charged the full amount for an application (one FAE).
    FDA utilized data from ANDAs submitted from October 1, 2020, to
April 30, 2022, to estimate the number of new original ANDAs that will
incur filing fees in FY 2023. For FY 2023, FDA estimates that
approximately 800 new original ANDAs will be submitted and incur filing
fees. Not all of the new original ANDAs will be received by FDA and
some of those not received will be resubmitted in the same fiscal year.
Therefore, FDA expects that the FAE count for ANDAs will be 799 for FY
2023.
    The FY 2023 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2023 (799) into the fee revenue amount
to be derived from ANDA application fees in FY 2023 ($192,225,000). The
result, rounded to the nearest dollar, is a fee of $240,582 per ANDA.
    The statute provides that those ANDAs that include information
about the production of APIs other than by reference to a DMF will pay
an additional fee that is based on the number of such APIs and the
number of

facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA anticipates that this additional
fee is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs.

B. DMF Fee

    Under GDUFA III, the DMF fee is owed by each person that owns a
type II API DMF that is referenced, on or after October 1, 2012, in a
generic drug submission by an initial letter of authorization. This is
a one-time fee for each DMF. This fee is due on the earlier of the date
on which the first generic drug submission is submitted that references
the associated DMF or the date on which the DMF holder requests the
initial completeness assessment. Under section 744B(a)(2)(D)(iii) of
the FD&C Act, if a DMF has successfully undergone an initial
completeness assessment and the fee is paid, the DMF will be placed on
a publicly available list documenting DMFs available for reference.
    To calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. We assessed DMFs from October 1, 2020, to April
30, 2022, and concluded that averaging the number of fee-paying DMFs
provided the most accurate model for predicting fee-paying DMFs for FY
2023. The monthly average of paid DMF submissions FDA received in FY
2021 and FY 2022 is 31. To determine the FY 2023 projected number of
fee-paying DMFs, the average of 31 DMF submissions is multiplied by 12
months, which results in 372 estimated FY 2023 fee-paying DMFs. FDA is
estimating 372 fee-paying DMFs for FY 2023.
    The FY 2023 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2023. Section
744B(b)(2)(A) of the FD&C Act specifies that the DMF fees will make up
5 percent of the $582,500,000, which is $29,125,000. Dividing the DMF
revenue amount ($29,125,000) by the estimated fee-paying DMFs (372),
and rounding to the nearest dollar, yields a DMF fee of $78,293 for FY
2023.

C. Foreign Facility Fee Differential

    Under GDUFA III, the fee for a facility located outside the United
States and its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United States and
its territories and possessions. The basis for this differential is the
extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.

D. FDF and CMO Facility Fees

    Under GDUFA III, the annual FDF facility fee is owed by each person
who owns an FDF facility that is identified in at least one approved
generic drug submission owned by that person or its affiliates. The CMO
facility fee is owed by each person who owns an FDF facility that is
identified in at least one approved ANDA but is not identified in an
approved ANDA held by the owner of that facility or its affiliates.
Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF and CMO
facility fee revenue will make up 20 percent of the $582,500,000, which
is $116,500,000.
    To calculate the fees, data from FDA's Integrity Services (IS) were
utilized as the primary source of facility information for determining
the denominators of each facility fee type. IS is the master data
steward for all facility information provided in generic drug
submissions received by FDA. A facility's reference status in an
approved generic drug submission is extracted directly from submission
data rather than relying on data from self-identification. This
information provided the number of facilities referenced as FDF
manufacturers in at least one approved generic drug submission. Based
on FDA's IS data, the FDF and CMO facility denominators are 176 FDF
domestic, 293 FDF foreign, 90 CMO domestic, and 114 CMO foreign
facilities for FY 2023.
    GDUFA III specifies that the CMO facility fee is to be equal to 24
percent of the FDF facility fee. Therefore, to generate the target
collection revenue amount from FDF and CMO facility fees
($116,500,000), FDA must weight a CMO facility as 24 percent of an FDF
facility. FDA set fees based on the estimate of 176 FDF domestic, 293
FDF foreign, 21.60 CMO domestic (90 multiplied by 24 percent), and
27.36 CMO foreign facilities (114 multiplied by 24 percent), which
equals 518 total weighted FDF and CMO facilities for FY 2023.
    To calculate the fee for domestic facilities, FDA first determines
the total fee revenue that will result from the foreign facility
differential by subtracting the fee revenue resulting from the foreign
facility fee differential from the target collection revenue amount
($116,500,000) as follows: the foreign facility fee differential
revenue equals the foreign facility fee differential ($15,000)
multiplied by the number of FDF foreign facilities (293) plus the
foreign facility fee differential ($15,000) multiplied by the number of
CMO foreign facilities (114), totaling $6,105,000. This results in
foreign fee differential revenue of $6,105,000 from the total FDF and
CMO facility fee target collection revenue.
    Subtracting the foreign facility differential fee revenue
($6,105,000) from the total FDF and CMO facility target collection
revenue ($116,500,000) results in a remaining facility fee revenue
balance of $110,395,000. To determine the domestic FDF facility fee,
FDA divides the $110,395,000 by the total weighted number of FDF and
CMO facilities (518), which results in a domestic FDF facility fee of
$213,134. The foreign FDF facility fee is $15,000 more than the
domestic FDF facility fee, or $228,134.
    According to GDUFA III, the domestic CMO fee is calculated as 24
percent of the amount of the domestic FDF facility fee. Therefore, the
domestic CMO fee is $51,152, rounded to the nearest dollar. The foreign
CMO fee is calculated as the domestic CMO fee plus the foreign fee
differential of $15,000. Therefore, the foreign CMO fee is $66,152.

E. API Facility Fee

    Under GDUFA III, the annual API facility fee is owed by each person
who owns a facility that is identified in: at least one approved
generic drug submission or a Type II API DMF referenced in at least one
approved generic drug submission. Section 744B(b)(2)(D) of the FD&C Act
specifies the API facility fee will make up 6 percent of $582,500,000
in fee revenue, which is $34,950,000.
    To calculate the API facility fee, data from FDA's IS were utilized
as the primary source of facility information for determining the
denominator. As stated above, IS is the master data steward for all
facility information provided in generic drug submissions received by
FDA. A facility's reference status in an approved generic drug
submission is extracted directly from submission data rather than
relying on data from self-identification. This information provided the
number of facilities referenced as API manufacturers in at least one
approved generic drug submission.
    The total number of API facilities identified was 688; of that
number, 80 were domestic and 608 were foreign facilities. The foreign
facility differential is $15,000. To calculate the fee for domestic
facilities, FDA must first subtract the fee revenue that will result
from the foreign facility fee differential. FDA takes the foreign
facility differential ($15,000) and multiplies it by the number of
foreign facilities (608) to determine the total fee revenue that

will result from the foreign facility differential. As a result of this
calculation, the foreign fee differential revenue will make up
$9,120,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($9,120,000) from the total API
facility target revenue ($34,950,000) results in a remaining balance of
$25,830,000. To determine the domestic API facility fee, we divide the
$25,830,000 by the total number of facilities (688), which gives us a
domestic API facility fee of $37,544. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $52,544.

F. Generic Drug Applicant Program Fee

    Under GDUFA III, if a person and its affiliates own at least one
but not more than five approved ANDAs on October 1, 2022, the person
and its affiliates shall owe a small business GDUFA program fee. If a
person and its affiliates own at least 6 but not more than 19 approved
ANDAs, the person and its affiliates shall owe a medium size operation
GDUFA program fee. If a person and its affiliates own at least 20
approved ANDAs, the person and its affiliates shall owe a large size
operation GDUFA program fee. Section 744B(b)(2)(E) of the FD&C Act
specifies the GDUFA program fee will make up 36 percent of $582,500,000
in fee revenue, which is $209,700,000.
    To determine the appropriate number of parent companies for each
tier, FDA asked companies to claim their ANDAs and affiliates in the
Center for Drug Evaluation and Research (CDER) NextGen Portal. The
companies were able to confirm relationships currently present in FDA's
records, while also reporting newly approved ANDAs, newly acquired
ANDAs, and new affiliations.
    In determining the appropriate number of approved ANDAs, FDA has
factored in a number of variables that could affect the collection of
the target revenue: (1) inactive ANDAs: applicants who have not
submitted an annual report for one or more of their approved
applications within the past 2 years; (2) Program Fee Arrears List:
parent companies that are on the arrears list for any fiscal year; (3)
Large Tier Adjustment: the frequency of large-tiered companies dropping
to the medium tier and medium-tiered companies moving to the large tier
after the completion of the program fee methodology and tier
determination; (4) Center for Biologics Evaluation and Research (CBER)
approved ANDAs: applicants and their affiliates with CBER-approved
ANDAs in addition to CDER's approved ANDAs; and (5) withdrawals of
approved ANDAs by April 1: applicants who have submitted a written
request for withdrawal of approval by April 1 of the previous fiscal
year.
    The list of original approved ANDAs from the Generic Drug Review
Platform as of April 30, 2022, shows 253 applicants in the small
business tier, 75 applicants in the medium size tier, and 79 applicants
in the large size tier. Factoring in all the variables, we estimate
there will be 220 applicants in the small business tier, 76 applicants
in the medium size tier, and 77 applicants in the large size tier for
FY 2023.
    To calculate the GDUFA program fee, GDUFA III provides that large
size operation generic drug applicants pay the full fee, medium size
operation applicants pay two-fifths of the full fee, and small business
applicants pay one-tenth of the full fee. To generate the target
collection revenue amount from GDUFA program fees ($209,700,000), we
must weigh medium and small tiered applicants as a subset of a large
size operation generic drug applicant. FDA will set fees based on the
weighted estimate of 22 applicants in the small business tier (220
multiplied by 10 percent), 30.4 applicants in the medium size tier (76
multiplied by 40 percent), and 77 applicants in the large size tier,
arriving at 129.4 total weighted applicants for FY 2023.
    To generate the large size operation GDUFA program fee, FDA divides
the target revenue amount of $209,700,000 by 129.4, which equals
$1,620,556. The medium size operation GDUFA program fee is 40 percent
of the full fee ($648,222), and the small business operation GDUFA
program fee is 10 percent of the full fee ($162,056).

IV. Fee Schedule For FY 2023

    The fee rates for FY 2023 are set out in table 2.

                    Table 2--Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                         Fees rates for
              Generic drug fee category                     FY 2023
------------------------------------------------------------------------
Applications:
    Abbreviated New Drug Application (ANDA)..........           $240,582
    Drug Master File (DMF)...........................             78,293
Facilities:
    Active Pharmaceutical Ingredient (API)--Domestic.             37,544
    API--Foreign.....................................             52,544
    Finished Dosage Form (FDF)--Domestic.............            213,134
    FDF--Foreign.....................................            228,134
    Contract Manufacturing Organization (CMO)--......             51,152
Domestic:
    CMO--Foreign.....................................             66,152
GDUFA Program:
    Large size operation generic drug applicant......          1,620,556
    Medium size operation generic drug applicant.....            648,222
    Small business operation generic drug applicant..            162,056
------------------------------------------------------------------------

V. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2022, and will remain in
effect through September 30, 2023. Under sections 744B(a)(4) and (5) of
the FD&C Act, respectively, facility and program fees are generally due
on the later of the first business day on or after October 1 of each
fiscal year or the first business day after the enactment of an
appropriations act providing for the collection and obligation of GDUFA
fees for the fiscal year. Here, that date is October 3, 2022. However,
given the late date of the GDUFA reauthorization for FYs 2023 through
2027, facility and program fees for FY 2023 should be paid within 30
days from the issue date of this notice.

    To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and
GDUFA program fees, a Generic Drug User Fee Cover Sheet must be
completed, available at https://www.fda.gov/gdufa and https://
userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and a user fee
identification (ID) number must be generated. Payment must be made in
U.S. currency drawn on a U.S. bank by electronic check, check, bank
draft, U.S. postal money order, credit card, or wire transfer. 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). FDA has partnered with the U.S.
Department of the Treasury to utilize Pay.gov, a web-based payment
application, for online electronic payment. The Pay.gov feature is
available on the FDA website after completing the Generic Drug User Fee
Cover Sheet and generating the user fee ID number.
    Secure electronic payments can be submitted using the User Fees
Payment Portal at https://userfees.fda.gov/pay. (Note: only full
payments are accepted; no partial payments can be made online.) Once an
invoice is located, ``Pay Now'' should be selected to be redirected to
Pay.gov. Electronic payment options are based on the balance due.
Payment by credit card is available for balances 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.
    The user fee ID number must be included on the check, bank draft,
or postal money order and must be made payable to the order of the Food
and Drug Administration. Payments can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. For questions concerning courier
delivery, U.S. Bank can be contacted at<PHONE_NUMBER>. This telephone
number is only for questions about courier delivery.) The FDA post
office box number (P.O. Box 979108) must be written on the check, bank
draft, or postal money order.
    For payments made by wire transfer, the unique user fee ID number
must be referenced. Without the unique user fee ID number, the payment
may not be applied. If the payment amount is not applied, the invoice
amount will be referred to collections. The originating financial
institution may charge a wire transfer fee. Applicable wire transfer
fees must be included with payment to ensure fees are fully paid.
Questions about wire transfer fees should be addressed to the financial
institution. The following account information should be used to send
payments by wire transfer: U.S. Department of the Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045, account number: 75060099, routing
number: 021030004, SWIFT: FRNYUS33. FDA's tax identification number is
53-0196965.

    Dated: October 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22099 Filed 10-6-22; 11:15 am]
BILLING CODE 4164-01-P