Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher for QULIPTA, 3927-3928 [2024-01108]

Download as PDF 3927 Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices Technology Security Requirements, in all correspondence. Jeffrey A. Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Governmentwide Policy. [FR Doc. 2024–01105 Filed 1–19–24; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025–2027 (ACF–118) and Extension of Child Care and Development Fund Plan Preprint for States/Territories for FFY 2022–2024 (OMB #0970–0114) Office of Child Care; Administration for Children and Families; Health and Human Services. ACTION: Request for public comments. AGENCY: The Administration for Children and Families (ACF) is requesting an extension without changes of the form ACF–118: Child Care and Development Fund Plan Preprint for States/Territories for FFY 2022–2024 (OMB #0970–0114, expiration 02/29/2024), and a separate three-year extension of the form ACF– SUMMARY: 118: Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025–2027. There are changes requested to the form ACF–118: Child Care and Development Fund Plan Preprint for States/Territories for FFY 2025–2027 to improve formatting, collect additional information about program implementation, and streamline questions. DATES: Comments due within 30 days of publication. OMB must make a decision about the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. You can also obtain copies of the proposed collection of information by emailing infocollection@ acf.hhs.gov. Identify all emailed requests by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: The Child Care and Development Fund (CCDF) Plan (the ADDRESSES: Plan) for States and Territories is required from each CCDF Lead agency in accordance with Section 658E of the Child Care and Development Block Grant Act of 1990 (CCDBG Act), as amended, CCDBG Act of 2014 (Pub. L. 113–186), and 42 U.S.C. 9858. The Plan, submitted on the ACF–118, is required triennially, and remains in effect for three years. The Plan provides ACF and the public with a description of and assurance about the states’ and territories’ child care programs. These Plans are the applications for CCDF funds. At this time, the ACF Office of Child Care (OCC) is proposing an extension of the approval of the currently approved CCDF Plan Preprint for FFY 2022–2024 to allow states and territories to continue to submit amendments for substantial program changes effective through September 30, 2024, as required. There are no changes proposed to the FFY 2022–2024 Plan Preprint. In addition, OCC is requesting comments on the proposed CCDF Plan Preprint for FFY 2025–2027. Updates were made to clarify questions, enhance the ability to align data with OCC monitoring data, reflect OCC priorities, ensure alignment with federal requirements, and facilitate grantee submission in the Child Care Automated Reporting System (CARS) data system. Respondents: State and Territory Lead Agencies. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Total number of responses per respondent Average burden hours per response Annual burden hours Child Care and Development Fund for States and Territories (ACF—118) ............. 56 0.33 150 2,800 Estimated Total Burden Hours: 8,400; however, since Plans are required triennially, and remain in effect for 3 years, the actual Total Annual Burden Hours is 2,800. Authority: Pub. L. 113–186 and 42 U.S.C. 9858. Mary B. Jones, ACF/OPRE Certifying Officer. ddrumheller on DSK120RN23PROD with NOTICES1 [FR Doc. 2024–01058 Filed 1–19–24; 8:45 am] BILLING CODE 4184–87–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–0015] Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher for QULIPTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat medical countermeasure (MCM) priority review voucher. The SUMMARY: VerDate Sep<11>2014 18:02 Jan 19, 2024 Jkt 262001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the issuance of material threat MCM priority review vouchers as well as the approval of products redeeming a voucher. FDA has determined that QULIPTA (atogepant) tablets, approved September 28, 2021, meets the redemption criteria. FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1394, email: Cathryn.Lee@ fda.hhs.gov. E:\FR\FM\22JAN1.SGM 22JAN1 3928 Federal Register / Vol. 89, No. 14 / Monday, January 22, 2024 / Notices Under section 565A of the FD&C Act (21 U.S.C. 360bbb-4a), FDA will report the issuance of material threat MCM priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the application for QULIPTA (atogepant) tablets, approved September 28, 2021, meets the redemption criteria. For further information about the material threat MCM Priority Review Voucher Program and for a link to the full text of section 565A of the FD&C Act, go to https://www.fda.gov/ emergency-preparedness-and-response/ mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions#prv. For further information about QULIPTA (atogepant) tablets go to the ‘‘Drugs@ FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. SUPPLEMENTARY INFORMATION: Dated: January 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–01108 Filed 1–19–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2023–N–5451] Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements 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 extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with Agency regulations that govern prescription drug marketing. DATES: Either electronic or written comments on the collection of ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 18:02 Jan 19, 2024 Jkt 262001 information must be submitted by March 22, 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 March 22, 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. 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 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– 2023–N–5451 for ‘‘Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 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 in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–976–5733, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined E:\FR\FM\22JAN1.SGM 22JAN1

Agencies

[Federal Register Volume 89, Number 14 (Monday, January 22, 2024)]
[Notices]
[Pages 3927-3928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0015]


Notice of Approval of Product Under Voucher: Material Threat 
Medical Countermeasure Priority Review Voucher for QULIPTA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
approval of a product redeeming a material threat medical 
countermeasure (MCM) priority review voucher. The Federal Food, Drug, 
and Cosmetic Act (FD&C Act) authorizes FDA to award priority review 
vouchers to sponsors of approved material threat MCM product 
applications that meet certain criteria. FDA is required to publish 
notice of the issuance of material threat MCM priority review vouchers 
as well as the approval of products redeeming a voucher. FDA has 
determined that QULIPTA (atogepant) tablets, approved September 28, 
2021, meets the redemption criteria.

FOR FURTHER INFORMATION CONTACT: Cathryn Lee, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1394, email: 
[email protected].

[[Page 3928]]


SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21 
U.S.C. 360bbb-4a), FDA will report the issuance of material threat MCM 
priority review vouchers and the approval of products for which a 
voucher was redeemed. FDA has determined that the application for 
QULIPTA (atogepant) tablets, approved September 28, 2021, meets the 
redemption criteria.
    For further information about the material threat MCM Priority 
Review Voucher Program and for a link to the full text of section 565A 
of the FD&C Act, go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv. For further information about 
QULIPTA (atogepant) tablets go to the ``Drugs@FDA'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01108 Filed 1-19-24; 8:45 am]
BILLING CODE 4164-01-P
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