National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings, 62579 [2023-19564]
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Federal Register / Vol. 88, No. 175 / Tuesday, September 12, 2023 / Notices
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 fiscal year (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 fiscal year (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 fiscal year shall be equal to
the product of:
(1) The applicable fee under section
744M(a)(2) of the FD&C Act for the
preceding fiscal year; and
(2) The inflation adjustment
percentage under section 744M(c)(1)(C)
of the FD&C Act.
Thus, for FY 2024, the base of OMOR
fees taken from the preceding fiscal year
(i.e., FY 2023) are: Tier 1: $517,381 and
Tier 2: $103,476. The FY 2024 inflation
adjustment percentage is: 3.8830%.
V. Fee Schedule
The fee rates for FY 2024 are
displayed in Table 4.
TABLE 4—FEE SCHEDULE FOR FY
2024
FY 2024
fee rates
Fee category
lotter on DSK11XQN23PROD with NOTICES1
OMOR:
Tier 1 .......................................
Tier 2 .......................................
$537,471
107,494
VI. Fee Payment Options and
Procedures
The new OMOR fee rates are for the
period from October 1, 2023, through
September 30, 2024. To pay the OMOR
fees, complete an OTC Monograph User
Fee Cover Sheet, available at: https://
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) or credit card for
payments under $25,000 (Discover,
VISA, MasterCard, American Express).
FDA has partnered with the U.S.
Department of the Treasury to use
Pay.gov, a web-based payment
application, for online electronic
VerDate Sep<11>2014
17:32 Sep 11, 2023
Jkt 259001
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. 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: September 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–19609 Filed 9–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
PO 00000
Frm 00056
Fmt 4703
Sfmt 9990
62579
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Initial
Review Group; Clinical, Treatment and
Health Services Research Study Section.
Date: October 4, 2023.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2109, Bethesda, MD 20817,
(301) 443–8599, espinozala@mail.nih.gov.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Fellowship Review
Panel.
Date: October 24, 2023.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2109, Bethesda, MD 20817,
(301) 443–8599, espinozala@mail.nih.gov.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Special Emphasis
Panel for Member Conflict Applications.
Date: October 31, 2023.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge
Drive, Room 2109, Bethesda, MD 20817,
(301) 443–8599, espinozala@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.273, Alcohol Research
Programs, National Institutes of Health, HHS)
Dated: September 6, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–19564 Filed 9–11–23; 8:45 am]
BILLING CODE 4140–01–P
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[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Notices]
[Page 62579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Closed Meetings
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute on Alcohol Abuse and
Alcoholism Initial Review Group; Clinical, Treatment and Health
Services Research Study Section.
Date: October 4, 2023.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D., Scientific Review Officer,
Extramural Project Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge Drive, Room 2109, Bethesda, MD
20817, (301) 443-8599, [email protected].
Name of Committee: National Institute on Alcohol Abuse and
Alcoholism Special Emphasis Panel; NIAAA Fellowship Review Panel.
Date: October 24, 2023.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D., Scientific Review Officer,
Extramural Project Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge Drive, Room 2109, Bethesda, MD
20817, (301) 443-8599, [email protected].
Name of Committee: National Institute on Alcohol Abuse and
Alcoholism Special Emphasis Panel; NIAAA Special Emphasis Panel for
Member Conflict Applications.
Date: October 31, 2023.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Health, National Institute on
Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D., Scientific Review Officer,
Extramural Project Review Branch, National Institute on Alcohol
Abuse and Alcoholism, 6700B Rockledge Drive, Room 2109, Bethesda, MD
20817, (301) 443-8599, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.273,
Alcohol Research Programs, National Institutes of Health, HHS)
Dated: September 6, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-19564 Filed 9-11-23; 8:45 am]
BILLING CODE 4140-01-P
