Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025, 61455-61457 [2024-16878]
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3001]
Over-the-Counter Monograph Drug
User Fee Program—OTC Monograph
Order Request Fee Rates for Fiscal
Year 2025
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the over-the-counter (OTC)
monograph order request (OMOR) fee
rates under the OTC monograph drug
user fee program (OMUFA) for fiscal
year (FY) 2025. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) authorizes
FDA to assess and collect user fees from
qualifying manufacturers of OTC
monograph drugs and submitters of
OMORs. This notice publishes the
OMOR fee rates under OMUFA for FY
2025. FDA plans to publish the FY 2025
OMUFA facility fee rates, i.e.,
monograph drug facility (MDF) and
contract manufacturing organization
(CMO) facility fee rates, in a subsequent
Federal Register notice (and anticipates
its issuance will generally align with the
timing of OMUFA facility fee rate
publication for prior fiscal years).
DATES: These OTC OMORs fees are
effective on October 1, 2024, and will
remain in effect through September 30,
2025.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo Ariyo, Office of Financial
Management, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20903, 240–
402–4989; or the User Fees Support
Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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I. Background
Section 744M of the FD&C Act (21
U.S.C. 379j–72), authorizes FDA to
assess and collect: (1) facility fees from
qualifying owners of OTC monograph
drug facilities and (2) fees from
submitters of qualifying OTC
monograph order requests. These fees
are to support FDA’s OTC monograph
drug activities, which are detailed in
section 744L(6) of the FD&C Act (21
U.S.C. 379j–71(6)) and include various
1 For OMUFA purposes, an OTC monograph drug
is a nonprescription drug without an approved new
drug application that is governed by the provisions
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FDA activities associated with OTC
monograph drugs.1
For OMUFA purposes, an OTC OMOR
is a request for an administrative order,
with respect to an OTC monograph
drug, which is submitted under section
505G(b)(5) of the FD&C Act (see section
744L(7) of the FD&C Act).
Under section 744M(a)(2)(A) of the
FD&C Act, the Agency is authorized to
assess and collect fees from submitters
of OMORs, except for OMORs that
request certain safety-related changes
(as discussed below). There are two
levels of OMOR fees, based on whether
the OMOR at issue is a Tier 1 or Tier
2 OMOR.2
For FY 2025, the OMUFA fee rates for
OTC OMORs are: Tier 1 OMOR fees
($559,777), Tier 2 OMOR fees
($111,955). These fees are effective for
the period from October 1, 2024,
through September 30, 2025. This
document is issued pursuant to section
744M(a)(2) and (c)(4)(B) of the FD&C
Act and describes the calculations used
to set the OMUFA OMOR fees for FY
2025 in accordance with the directives
in the statute.
II. Determination of FY 2025 OMOR
Fees
Under OMUFA, the FY 2025 Tier 1
OMOR fee is $559,777 and the Tier 2
OMOR fee is $111,955, including an
adjustment for inflation (see sections
744M(a)(2)(A)(i) and (ii) of the FD&C
Act, respectively). OMOR fees are not
included in the OMUFA target revenue
calculation, which is based on the
facility fees (see section 744M(b) of the
FD&C Act).
An OMOR fee is generally assessed to
each person who submits an OMOR (see
section 744M(a)(2)(A) of the FD&C Act).
OMOR fees are due on the date of the
submission of the OMOR (see section
744M(a)(2)(B) of the FD&C Act). The
payor should submit the OMOR fee that
applies to the type of OMOR they are
submitting (i.e., Tier 1 or Tier 2). FDA
will determine whether the appropriate
OMOR fee has been submitted following
receipt of the OMOR and the fee.
An OMOR fee will not be assessed if
the OMOR seeks to make certain safety
changes with respect to an OTC
monograph drug. Specifically, no fee
will be assessed if FDA finds that the
OMOR seeks to change the drug facts
labeling of an OTC monograph drug in
a way that would add to or strengthen:
(1) a contraindication, warning, or
precaution; (2) a statement about risk
of section 505G of the FD&C Act (21 U.S.C. 355h)
(see section 744L(5) of the FD&C Act);
2 Under OMUFA, a Tier 1 OMOR is defined as
any OMOR that is not a Tier 2 OMOR (see section
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Sfmt 4703
61455
associated with misuse or abuse; or (3)
an instruction about dosage and
administration that is intended to
increase the safe use of the OTC
monograph drug (see section
744M(a)(2)(C) of the FD&C Act).
III. OMOR Fee Adjustment for Inflation
Under OMUFA, the OMOR fee is
adjusted for inflation for FY 2022 and
each subsequent FY (see section
744M(c)(1)(B) of the FD&C Act). That
provision states that the dollar amount
of the inflation adjustment to the fee for
OMORs is equal to the product of the
applicable fee for the preceding fiscal
year and the inflation adjustment
percentage.3 For FY 2025, the inflation
adjustment percentage is equal to the
sum of:
• The average annual percent change
in the cost, per full-time equivalent
position of FDA, of all personnel
compensation and benefits paid with
respect to such positions for the first 3
years of the preceding 4 FYs, multiplied
by the proportion of personnel
compensation and benefits costs to total
costs of OTC monograph drug activities
for the first 3 years of the preceding 4
FYs (see section 744M(c)(1)(C)(ii)(I) of
the FD&C Act); and
• The average annual percent change
that occurred in the Consumer Price
Index for urban consumers
(Washington-Baltimore, DC-MD-VAWV; Not Seasonally Adjusted; All items;
Annual Index) for the first 3 years of the
preceding 4 years of available data
multiplied by the proportion of all costs
other than personnel compensation and
benefits costs to total costs of OTC
monograph drug activities for the first 3
years of the preceding 4 FYs (see section
744M(c)(1)(C)(ii)(II) of the FD&C Act).
As a result of a geographical revision
made by the Bureau of Labor and
Statistics in January 2018, the
‘‘Washington, DC-Baltimore’’ index was
discontinued and replaced with two
separate indices (i.e., the ‘‘WashingtonArlington-Alexandria’’ and ‘‘BaltimoreColumbia-Towson’’ indices). To
continue applying a CPI that best
reflects the geographic region in which
FDA is located and that provides the
most current data available, the
‘‘Washington-Arlington-Alexandria’’
index is used in calculating the inflation
adjustment percentage.
Table 1 summarizes the actual cost
and FTE data for the specified FYs,
provides the percent changes from the
previous FYs, and provides the average
744L(8) of the FD&C Act). Tier 2 OMORs are
detailed in section 744L(9) of the FD&C Act.
3 See section 744M(c)(1)(C) of the FD&C Act.
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
percent changes over the first 3 of the
4 FYs preceding FY 2025. The 3-year
average is 3.8539 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES
2021
Total PC&B ..........................................................................................
Total FTE .............................................................................................
PC&B per FTE .....................................................................................
Percent Change from Previous Year ...................................................
Under the statute, this 3.8539 percent
is multiplied by the proportion of PC&B
costs to the total FDA costs of OTC
monograph drug activities for the first 3
2022
$3,039,513,000
18,501
$164,289
0.1811%
$3,165,477,000
18,474
$171,348
4.2967%
years of the preceding 4 FYs (see section
744M(c)(1)(C)(ii) of the FD&C Act).
Table 2 shows the PC&B and the total
obligations for OTC monograph drug
3-Year
average
2023
$3,436,513,000
18,729
$183,486
7.0838%
........................
........................
........................
3.8539%
activities for the first 3 of the preceding
4 FYs.
TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF OTC MONOGRAPH DRUG ACTIVITIES
2021
Total PC&B ..........................................................................................
Total Costs ...........................................................................................
PC&B Percent ......................................................................................
The payroll adjustment is 3.8539
percent from table 1 multiplied by
58.1262 percent resulting in 2.2401
percent.
2022
$23,133,775
$35,030,659
66.0387%
Table 3 provides the summary data
for the percent changes in the specified
CPI for the Washington-ArlingtonAlexandria, DC-VA-MD-WV. The data
are published by the Bureau of Labor
3-Year
average
2023
$25,415,237
$49,644,273
51.1947%
$39,133,075
$68,480,052
57.1452%
........................
........................
58.1262%
Statistics on its website: https://
data.bls.gov/pdq/
SurveyOutputServlet?data_
tool=dropmap&series_
id=CUURS35ASA0,CUUSS35ASA0.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA, DC-VAMD-WV AREA
Year
2021
Annual CPI ...........................................................................................
Annual Percent Change ......................................................................
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The statute specifies that this 4.5616
percent be multiplied by the proportion
of all costs other than PC&B to total
costs of OTC monograph drug activities.
Because 58.1262 percent was obligated
for PC&B (as shown in table 2), 41.8738
percent is the portion of costs other than
PC&B (100 percent minus 58.1262
percent equals 41.8738 percent). The
non-payroll adjustment is 4.5616
percent times 41.8738 percent, or 1.9101
percent.
Next, we add the payroll adjustment
(2.2401 percent) to the non-payroll
adjustment (1.9101 percent), for a total
inflation adjustment of 4.1502 percent
(rounded) for FY 2025.
IV. OMOR Fee Calculations
Under section 744M(a)(2)(A) of the
FD&C Act, each person that submits a
qualifying OMOR shall be subject to a
fee for an OMOR. The amount of such
fee shall be:
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17:29 Jul 30, 2024
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2022
277.73
3.9568%
(1) For a Tier 1 OTC monograph order
request, $500,000, adjusted for inflation
for the FY (see section 744M(c)(1)(B) of
the FD&C Act); and
(2) For a Tier 2 OTC monograph order
request, $100,000, adjusted for inflation
for the FY (see section 744M(c)(1)(B) of
the FD&C Act).
In addition, under section
744M(c)(1)(B) of the FD&C Act and for
purposes of section 744M(a)(2) of the
FD&C Act, the dollar amount of the
inflation adjustment to the fee for
OMORs for FY 2022 and each
subsequent FY shall be equal to the
product of:
(1) The applicable fee under section
744M(a)(2) of the FD&C Act for the
preceding FY; and
(2) The inflation adjustment
percentage under section 744M(c)(1)(C)
of the FD&C Act.
Thus, for FY 2025, the base of OMOR
fees taken from the preceding FY (i.e.,
FY 2024) are: Tier 1: $537,471 and Tier
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Frm 00060
Fmt 4703
Sfmt 4703
3-Year
average
2023
296.12
6.6212%
305.32
3.1069%
........................
4.5616%
2: $107,494. The FY 2025 inflation
adjustment percentage is: 4.1502%.
V. Fee Schedule
The fee rates for FY 2025 are
displayed in Table 4.
TABLE 4—FEE SCHEDULE FOR FY
2025
Fee category
OMOR:
Tier 1 .....................................
Tier 2 .....................................
FY 2025
fee rates
$559,777
111,955
VI. Fee Payment Options and
Procedures
The new OMOR fee rates are for the
period from October 1, 2024, through
September 30, 2025. To pay the OMOR
fees, complete an OTC Monograph User
Fee Cover Sheet, available at: https://
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Federal Register / Vol. 89, No. 147 / Wednesday, July 31, 2024 / Notices
userfees.fda.gov/OA_HTML/
omufaCAcdLogin.jsp.
A user fee identification (ID) number
will be generated. Payment must be
made in U.S. currency by electronic
check or wire transfer, payable to the
order of the Food and Drug
Administration. The preferred payment
method is online using electronic check
(Automated Clearing House (ACH) also
known as eCheck).
FDA has partnered with the U.S.
Department of the Treasury to use
Pay.gov, a web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA website after
completing the OTC Monograph 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 through https://
userfees.fda.gov/pay. 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 that are less
than $25,000 (Discover, VISA,
MasterCard, American Express). 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.
For payments made by wire transfer,
include the unique user fee ID number
to ensure that the payment is applied to
the correct fee(s). Without the unique
user fee ID number, the payment may
not be applied, which could result in
FDA not filing an OMOR request, or
other consequences of nonpayment. 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 account information for
wire transfers is as follows: U.S.
Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33. If
needed, FDA’s tax identification
number is 53–0196965.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16878 Filed 7–30–24; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3029]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA Food Safety
and Nutrition Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed reinstatement
of an existing collection of information,
and to allow 60 days for public
comment in response to the notice. This
notice solicits comments on a collection
of information used to conduct a
voluntary consumer survey entitled,
‘‘FDA Food Safety and Nutrition
Survey.’’
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by
September 30, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
September 30, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
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61457
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–3029 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; FDA
Food Safety and Nutrition Survey.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
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]]>Agencies
[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Notices]
[Pages 61455-61457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16878]
[[Page 61455]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3001]
Over-the-Counter Monograph Drug User Fee Program--OTC Monograph
Order Request Fee Rates for Fiscal Year 2025
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the over-the-counter (OTC) monograph order request (OMOR)
fee rates under the OTC monograph drug user fee program (OMUFA) for
fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C
Act) authorizes FDA to assess and collect user fees from qualifying
manufacturers of OTC monograph drugs and submitters of OMORs. This
notice publishes the OMOR fee rates under OMUFA for FY 2025. FDA plans
to publish the FY 2025 OMUFA facility fee rates, i.e., monograph drug
facility (MDF) and contract manufacturing organization (CMO) facility
fee rates, in a subsequent Federal Register notice (and anticipates its
issuance will generally align with the timing of OMUFA facility fee
rate publication for prior fiscal years).
DATES: These OTC OMORs fees are effective on October 1, 2024, and will
remain in effect through September 30, 2025.
FOR FURTHER INFORMATION CONTACT: Olufunmilayo Ariyo, Office of
Financial Management, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20903, 240-402-4989; or the User Fees Support
Staff at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 744M of the FD&C Act (21 U.S.C. 379j-72), authorizes FDA to
assess and collect: (1) facility fees from qualifying owners of OTC
monograph drug facilities and (2) fees from submitters of qualifying
OTC monograph order requests. These fees are to support FDA's OTC
monograph drug activities, which are detailed in section 744L(6) of the
FD&C Act (21 U.S.C. 379j-71(6)) and include various FDA activities
associated with OTC monograph drugs.\1\
---------------------------------------------------------------------------
\1\ For OMUFA purposes, an OTC monograph drug is a
nonprescription drug without an approved new drug application that
is governed by the provisions of section 505G of the FD&C Act (21
U.S.C. 355h) (see section 744L(5) of the FD&C Act);
---------------------------------------------------------------------------
For OMUFA purposes, an OTC OMOR is a request for an administrative
order, with respect to an OTC monograph drug, which is submitted under
section 505G(b)(5) of the FD&C Act (see section 744L(7) of the FD&C
Act).
Under section 744M(a)(2)(A) of the FD&C Act, the Agency is
authorized to assess and collect fees from submitters of OMORs, except
for OMORs that request certain safety-related changes (as discussed
below). There are two levels of OMOR fees, based on whether the OMOR at
issue is a Tier 1 or Tier 2 OMOR.\2\
---------------------------------------------------------------------------
\2\ Under OMUFA, a Tier 1 OMOR is defined as any OMOR that is
not a Tier 2 OMOR (see section 744L(8) of the FD&C Act). Tier 2
OMORs are detailed in section 744L(9) of the FD&C Act.
---------------------------------------------------------------------------
For FY 2025, the OMUFA fee rates for OTC OMORs are: Tier 1 OMOR
fees ($559,777), Tier 2 OMOR fees ($111,955). These fees are effective
for the period from October 1, 2024, through September 30, 2025. This
document is issued pursuant to section 744M(a)(2) and (c)(4)(B) of the
FD&C Act and describes the calculations used to set the OMUFA OMOR fees
for FY 2025 in accordance with the directives in the statute.
II. Determination of FY 2025 OMOR Fees
Under OMUFA, the FY 2025 Tier 1 OMOR fee is $559,777 and the Tier 2
OMOR fee is $111,955, including an adjustment for inflation (see
sections 744M(a)(2)(A)(i) and (ii) of the FD&C Act, respectively). OMOR
fees are not included in the OMUFA target revenue calculation, which is
based on the facility fees (see section 744M(b) of the FD&C Act).
An OMOR fee is generally assessed to each person who submits an
OMOR (see section 744M(a)(2)(A) of the FD&C Act). OMOR fees are due on
the date of the submission of the OMOR (see section 744M(a)(2)(B) of
the FD&C Act). The payor should submit the OMOR fee that applies to the
type of OMOR they are submitting (i.e., Tier 1 or Tier 2). FDA will
determine whether the appropriate OMOR fee has been submitted following
receipt of the OMOR and the fee.
An OMOR fee will not be assessed if the OMOR seeks to make certain
safety changes with respect to an OTC monograph drug. Specifically, no
fee will be assessed if FDA finds that the OMOR seeks to change the
drug facts labeling of an OTC monograph drug in a way that would add to
or strengthen: (1) a contraindication, warning, or precaution; (2) a
statement about risk associated with misuse or abuse; or (3) an
instruction about dosage and administration that is intended to
increase the safe use of the OTC monograph drug (see section
744M(a)(2)(C) of the FD&C Act).
III. OMOR Fee Adjustment for Inflation
Under OMUFA, the OMOR fee is adjusted for inflation for FY 2022 and
each subsequent FY (see section 744M(c)(1)(B) of the FD&C Act). That
provision states that the dollar amount of the inflation adjustment to
the fee for OMORs is equal to the product of the applicable fee for the
preceding fiscal year and the inflation adjustment percentage.\3\ For
FY 2025, the inflation adjustment percentage is equal to the sum of:
---------------------------------------------------------------------------
\3\ See section 744M(c)(1)(C) of the FD&C Act.
---------------------------------------------------------------------------
The average annual percent change in the cost, per full-
time equivalent position of FDA, of all personnel compensation and
benefits paid with respect to such positions for the first 3 years of
the preceding 4 FYs, multiplied by the proportion of personnel
compensation and benefits costs to total costs of OTC monograph drug
activities for the first 3 years of the preceding 4 FYs (see section
744M(c)(1)(C)(ii)(I) of the FD&C Act); and
The average annual percent change that occurred in the
Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-
VA-WV; Not Seasonally Adjusted; All items; Annual Index) for the first
3 years of the preceding 4 years of available data multiplied by the
proportion of all costs other than personnel compensation and benefits
costs to total costs of OTC monograph drug activities for the first 3
years of the preceding 4 FYs (see section 744M(c)(1)(C)(ii)(II) of the
FD&C Act).
As a result of a geographical revision made by the Bureau of Labor
and Statistics in January 2018, the ``Washington, DC-Baltimore'' index
was discontinued and replaced with two separate indices (i.e., the
``Washington-Arlington-Alexandria'' and ``Baltimore-Columbia-Towson''
indices). To continue applying a CPI that best reflects the geographic
region in which FDA is located and that provides the most current data
available, the ``Washington-Arlington-Alexandria'' index is used in
calculating the inflation adjustment percentage.
Table 1 summarizes the actual cost and FTE data for the specified
FYs, provides the percent changes from the previous FYs, and provides
the average
[[Page 61456]]
percent changes over the first 3 of the 4 FYs preceding FY 2025. The 3-
year average is 3.8539 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $3,039,513,000 $3,165,477,000 $3,436,513,000 ..............
Total FTE................................. 18,501 18,474 18,729 ..............
PC&B per FTE.............................. $164,289 $171,348 $183,486 ..............
Percent Change from Previous Year......... 0.1811% 4.2967% 7.0838% 3.8539%
----------------------------------------------------------------------------------------------------------------
Under the statute, this 3.8539 percent is multiplied by the
proportion of PC&B costs to the total FDA costs of OTC monograph drug
activities for the first 3 years of the preceding 4 FYs (see section
744M(c)(1)(C)(ii) of the FD&C Act).
Table 2 shows the PC&B and the total obligations for OTC monograph
drug activities for the first 3 of the preceding 4 FYs.
Table 2--PC&B as a Percent of Total Cost of OTC Monograph Drug Activities
----------------------------------------------------------------------------------------------------------------
2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B................................ $23,133,775 $25,415,237 $39,133,075 ..............
Total Costs............................... $35,030,659 $49,644,273 $68,480,052 ..............
PC&B Percent.............................. 66.0387% 51.1947% 57.1452% 58.1262%
----------------------------------------------------------------------------------------------------------------
The payroll adjustment is 3.8539 percent from table 1 multiplied by
58.1262 percent resulting in 2.2401 percent.
Table 3 provides the summary data for the percent changes in the
specified CPI for the Washington-Arlington-Alexandria, DC-VA-MD-WV. The
data are published by the Bureau of Labor Statistics on its website:
https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.
Table 3--Annual and 3-Year Average Percent Change in CPI for Washington-Arlington-Alexandria, DC-VA-MD-WV Area
----------------------------------------------------------------------------------------------------------------
Year 2021 2022 2023 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI................................ 277.73 296.12 305.32 ..............
Annual Percent Change..................... 3.9568% 6.6212% 3.1069% 4.5616%
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 4.5616 percent be multiplied by the
proportion of all costs other than PC&B to total costs of OTC monograph
drug activities. Because 58.1262 percent was obligated for PC&B (as
shown in table 2), 41.8738 percent is the portion of costs other than
PC&B (100 percent minus 58.1262 percent equals 41.8738 percent). The
non-payroll adjustment is 4.5616 percent times 41.8738 percent, or
1.9101 percent.
Next, we add the payroll adjustment (2.2401 percent) to the non-
payroll adjustment (1.9101 percent), for a total inflation adjustment
of 4.1502 percent (rounded) for FY 2025.
IV. OMOR Fee Calculations
Under section 744M(a)(2)(A) of the FD&C Act, each person that
submits a qualifying OMOR shall be subject to a fee for an OMOR. The
amount of such fee shall be:
(1) For a Tier 1 OTC monograph order request, $500,000, adjusted
for inflation for the FY (see section 744M(c)(1)(B) of the FD&C Act);
and
(2) For a Tier 2 OTC monograph order request, $100,000, adjusted
for inflation for the FY (see section 744M(c)(1)(B) of the FD&C Act).
In addition, under section 744M(c)(1)(B) of the FD&C Act and for
purposes of section 744M(a)(2) of the FD&C Act, the dollar amount of
the inflation adjustment to the fee for OMORs for FY 2022 and each
subsequent FY shall be equal to the product of:
(1) The applicable fee under section 744M(a)(2) of the FD&C Act for
the preceding FY; and
(2) The inflation adjustment percentage under section 744M(c)(1)(C)
of the FD&C Act.
Thus, for FY 2025, the base of OMOR fees taken from the preceding
FY (i.e., FY 2024) are: Tier 1: $537,471 and Tier 2: $107,494. The FY
2025 inflation adjustment percentage is: 4.1502%.
V. Fee Schedule
The fee rates for FY 2025 are displayed in Table 4.
Table 4--Fee Schedule for FY 2025
------------------------------------------------------------------------
FY 2025 fee
Fee category rates
------------------------------------------------------------------------
OMOR:
Tier 1................................................... $559,777
Tier 2................................................... 111,955
------------------------------------------------------------------------
VI. Fee Payment Options and Procedures
The new OMOR fee rates are for the period from October 1, 2024,
through September 30, 2025. To pay the OMOR fees, complete an OTC
Monograph User Fee Cover Sheet, available at: https://
[[Page 61457]]
userfees.fda.gov/OA_HTML/omufaCAcdLogin.jsp.
A user fee identification (ID) number will be generated. Payment
must be made in U.S. currency by electronic check or wire transfer,
payable to the order of the Food and Drug Administration. The preferred
payment method is online using electronic check (Automated Clearing
House (ACH) also known as eCheck).
FDA has partnered with the U.S. Department of the Treasury to use
Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA website after
completing the OTC Monograph 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 through https://userfees.fda.gov/pay.
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 that are less than $25,000 (Discover, VISA,
MasterCard, American Express). 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.
For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied,
which could result in FDA not filing an OMOR request, or other
consequences of nonpayment. 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 account information for wire transfers is as follows: U.S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If
needed, FDA's tax identification number is 53-0196965.
Dated: July 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16878 Filed 7-30-24; 8:45 am]
BILLING CODE 4164-01-P
