Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 18159-18160 [2023-06232]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices 2021 and FY 2022 OMUFA fees (respectively),10 11 facilities are not identified as an ‘‘OTC monograph drug facility’’ and will not be assessed a FY 2023 OMUFA facility fee if they: (1) were not registered with FDA as OTC drug manufacturers prior to the HHS declaration of the COVID–19 public health emergency on January 27, 2020; 12 (2) registered with FDA on or after the declaration of the COVID–19 public health emergency; and (3) registered for the sole purpose of producing hand sanitizer products during the COVID–19 public health emergency. We note, however, that under the FD&C Act, whether an entity is subject to OMUFA fees has no bearing on whether the entity or the entity’s products are subject to other requirements under the FD&C Act. FDA will continue to use its regulatory compliance and enforcement tools to protect consumers, including from potentially dangerous or subpotent hand sanitizers. In undertaking the statutorily directed fee calculations, the Agency also made certain assumptions, including that: (1) facilities using expired Structured Product Labeling (SPL) codes in eDRLS, that did not reregister for calendar year 2023, were no longer manufacturing and marketing OTC monograph drugs; (2) facilities that have deregistered in eDRLS have exited the market; (3) facilities that FDA believes registered incorrectly as OTC monograph drug facilities (for example, because the associated drug listings for these facilities did not include OTC monograph drugs but instead indicated such products as OTC drug products under an approved drug application or OTC animal drug products) were not engaged in manufacturing or processing the finished dosage form of an OTC monograph drug; (4) facilities that registered but did not have an active OTC monograph drug product listing associated in their registration profile were not manufacturing or processing such drug products; and (5) facilities that, at the close of FY 2022, remain on the arrears list for failure to satisfy the FY 2021 or FY 2022 facility fee are likely to be placed on the FY 2023 arrears list as well. Based on the above-referenced factors and assumptions, FDA estimates there will be 1,122 OMUFA fee-paying units. The Agency estimates that 60 percent (1,122 × 0.60 = 673, rounded) will incur 11 See 87 FR 14888, https:// www.federalregister.gov/documents/2022/03/16/ 2022-05542/over-the-counter-monograph-drug-userfee-rates-for-fiscal-year-2022. 12 See https://www.phe.gov/emergency/news/ healthactions/phe/Pages/2019-nCoV.aspx. VerDate Sep<11>2014 19:19 Mar 24, 2023 Jkt 259001 the MDF fee and 40 percent (1,122 × 0.40 = 449, rounded) will incur the CMO fee. To determine the number of full feepaying equivalents (the denominator) to be used in setting the OMUFA fees, FDA assigns a value of 1 to each MDF (673) and a value of 2⁄3 to each CMO (449 × 2⁄3 = 299) for a full facility equivalent of 972 (rounded). The target fee revenue of $25,421,000 is then divided by 972 for an MDF fee of $26,153 and a CMO fee of $17,435. 18159 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 V. Fee Schedule for FY 2023 other consequences of nonpayment. The The fee rates for FY 2023 are originating financial institution may displayed in table 2. charge a wire transfer fee. Applicable wire transfer fees must be included with TABLE 2—FEE SCHEDULE FOR FY payment to ensure fees are fully paid. Questions about wire transfer fees 2023 should be addressed to the financial FY 2023 fee institution. The account information for Fee category rates wire transfers is as follows: U.S. Department of the Treasury, TREAS OMOR: Tier 1 ................................. $517,381 NYC, 33 Liberty St., New York, NY Tier 2 ................................. 103,476 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33. If Facility Fees: MDF .................................. 26,153 needed, FDA’s tax identification CMO .................................. 17,435 number is 53–0196965. If you are assessed an FY 2023 OMUFA facility fee and believe your VI. Fee Payment Options and facility is not an OTC monograph drug Procedures facility as described in this notice, The new fee rates are for the period please contact CDERCollections@ from October 1, 2022, through fda.hhs.gov. September 30, 2023. To pay the OMOR, Dated: March 22, 2023. MDF, and CMO fees, complete an OTC Lauren K. Roth, Monograph User Fee Cover Sheet, Associate Commissioner for Policy. available at: https://userfees.fda.gov/ OA_HTML/omufaCAcdLogin.jsp. [FR Doc. 2023–06299 Filed 3–24–23; 8:45 am] A user fee identification (ID) number BILLING CODE 4164–01–P will be generated. Payment must be made in U.S. currency by electronic check or wire transfer, payable to the DEPARTMENT OF HEALTH AND order of the Food and Drug HUMAN SERVICES Administration. The preferred payment method is online using electronic check National Institutes of Health (Automated Clearing House (ACH) also Eunice Kennedy Shriver National known as eCheck) or credit card for Institute of Child Health and Human payments under $25,000 (Discover, Development; Notice of Closed VISA, MasterCard, American Express). Meeting FDA has partnered with the U.S. Department of the Treasury to use Pursuant to section 10(d) of the Pay.gov, a web-based payment Federal Advisory Committee Act, as application, for online electronic amended, notice is hereby given of the payment. The Pay.gov feature is following meeting of the National available on the FDA website after Institute of Child Health and Human completing the OTC Monograph User Development Special Emphasis Panel. Fee Cover Sheet and generating the user The meeting will be closed to the fee ID number. Secure electronic public in accordance with the payments can be submitted using the provisions set forth in sections User Fees Payment Portal at https:// 552b(c)(4) and 552b(c)(6), title 5 U.S.C., userfees.fda.gov/pay. (Note: Only full as amended. The grant applications and payments are accepted through https:// the discussions could disclose userfees.fda.gov/pay. No partial confidential trade secrets or commercial payments can be made online). Once an property such as patentable material, invoice is located, ‘‘Pay Now’’ should be and personal information concerning selected to be redirected to Pay.gov. individuals associated with the grant Electronic payment options are based on applications, the disclosure of which PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1 18160 Federal Register / Vol. 88, No. 58 / Monday, March 27, 2023 / Notices would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; Prevention and Treatment through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings Implementation Science Network (PATC3H– IN) Clinical Research Centers. Date: May 1, 2023. Closed: 9:30 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Luis E. Dettin, Ph.D., MS, MA, Scientific Review Officer, Scientific Review Branch, Eunice Kennedy Shriver National Institute, of Child Health and Human Development, National Institutes of Health ,6710B Rockledge Drive, Room 2131B, Bethesda, MD 20892, 301–827–8231, luis_ dettin@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.865, Research for Mothers and Children, National Institutes of Health, HHS) Dated: March 21, 2023. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. 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. Contact Person: Beata Buzas, Ph.D., Scientific Review Officer, Extramural Project Review Branch, Office of Extramural Activities, National Institute on Alcohol Abuse and Alcoholism, 6700B Rockledge Drive, Room 2116, Bethesda, MD 20892, 301– 443–0800, bbuzas@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Dated: March 21, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–06238 Filed 3–24–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2023–06232 Filed 3–24–23; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Heart, Lung, and Blood Institute; Notice of Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health ddrumheller on DSK120RN23PROD with NOTICES1 National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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; Neuroscience and Behavior Study Section. Date: June 13, 2023. Time: 9:00 a.m. to 5:00 p.m. VerDate Sep<11>2014 19:19 Mar 24, 2023 Jkt 259001 Notice is hereby given of a change in the meeting of the Sleep Disorders Research Advisory Board, April 6, 2023, 12 p.m. to 5 p.m., and April 7, 2023, 9 a.m. to 2 p.m., National Institutes of Health, Two Rockledge Centre, Rockledge I, 6705 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on March 16, 2023, 88 FRN 16275. This notice is being amended to change the meeting start time for April 6, 2023 from 12:00 p.m. to 1:00 p.m. Also, the in person location is amended for both days to Two Rockledge Centre, 6701 Rockledge Drive, Suite 260, Bethesda, MD 20817. Dated: March 20, 2023. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–06085 Filed 3–24–23; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG–2023–0179] National Towing Safety Advisory Committee; April 2023 Meeting U.S. Coast Guard, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee meeting. AGENCY: The National Towing Safety Advisory Committee (Committee) will meet to review and discuss matters relating to shallow-draft inland navigation, coastal waterway navigation, and towing safety. The meeting will be open to the public. DATES: Meeting: The Committee will hold a meeting on Wednesday, April 12, 2023, from 8 a.m. until 5 p.m. Eastern Daylight Time (EDT). Please note the meeting may close early if the Committee has completed its business. Comments and supporting documentation: To ensure your comments are received by Committee members before the meeting, submit your written comments no later than March 29, 2023. ADDRESSES: The meeting will be held at the Crowley Maritime Corporation Headquarters located at 9487 Regency Square Boulevard, Jacksonville, FL 32225 (https://www.crowley.com/?utm_ source=gmb&utm_ medium=jacksonville&utm_ campaign=corporate&utm_ content=office). The National Towing Safety Advisory Committee is committed to ensuring all participants have equal access regardless of disability status. If you require reasonable accommodation due to a disability to fully participate, please email Mr. Matthew D. Layman at Matthew.D.Layman@uscg.mil or call at 202–372–1421 as soon as possible. Instructions: You are free to submit comments at any time, including orally at the meeting as time permits, but if you want Committee members to review your comment before the meeting, please submit your comments no later than March 29, 2023. We are particularly interested in comments regarding the topics in the ‘‘Agenda’’ section below. We encourage you to submit comments through Federal eRulemaking Portal at https:// www.regulations.gov. If your material cannot be submitted using https:// www.regulations.gov, call or email the individual in the FOR FURTHER SUMMARY: E:\FR\FM\27MRN1.SGM 27MRN1

Agencies

[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Notices]
[Pages 18159-18160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06232]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
Human Development; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meeting of the 
National Institute of Child Health and Human Development Special 
Emphasis Panel.
    The meeting 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

[[Page 18160]]

would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Prevention and Treatment through 
a Comprehensive Care Continuum for HIV-affected Adolescents in 
Resource Constrained Settings Implementation Science Network 
(PATC\3\H-IN) Clinical Research Centers.
    Date: May 1, 2023.
    Closed: 9:30 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Eunice Kennedy Shriver National Institute of Child Health 
and Human Development, National Institutes of Health, 6710B 
Rockledge Drive, Room 2131B, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Luis E. Dettin, Ph.D., MS, MA, Scientific Review 
Officer, Scientific Review Branch, Eunice Kennedy Shriver National 
Institute, of Child Health and Human Development, National 
Institutes of Health ,6710B Rockledge Drive, Room 2131B, Bethesda, 
MD 20892, 301-827-8231, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.865, 
Research for Mothers and Children, National Institutes of Health, 
HHS)

    Dated: March 21, 2023.
David W. Freeman,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-06232 Filed 3-24-23; 8:45 am]
BILLING CODE 4140-01-P
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