Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments, 24842-24843 [2024-07493]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 24842 Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 019941 ............ EMLA ............................... Lidocaine; Prilocaine ........ 2.5%; 2.5% ....................... Cream; Topical ................. NDA 020105 ............ NDA 020125 ............ TRIOSTAT ....................... ACCURETIC .................... Liothyronine Sodium ........ Hydrochlorothiazide; Quinapril Hydrochloride. Injectable; Injection .......... Tablet; Oral ...................... NDA 020406 ............ PREVACID ....................... Lansoprazole .................... EQ 0.01 mg Base/mL ...... 12.5 mg, EQ 10 mg Base; 12.5 mg, EQ 20 mg Base; 25 mg, EQ 20 mg Base. 15 mg ............................... Teva Branded Pharmaceutical Products R & D Inc. Par Sterile Products, LLC. Pfizer Pharmaceuticals Ltd. NDA NDA NDA NDA ............ ............ ............ ............ ALBENZA ......................... ALDARA ........................... SUSTIVA .......................... ALOCRIL .......................... Albendazole ..................... Imiquimod ......................... Efavirenz .......................... Nedocromil Sodium .......... 200 mg ............................. 5% .................................... 50 mg; 200 mg ................. 2% .................................... NDA 021526 ............ RANEXA .......................... Ranolazine ....................... 500 mg; 1 g ...................... NDA 021565 ............ ELESTAT ......................... Epinastine Hydrochloride 0.05% ............................... NDA 021775 ............ ENTEREG ........................ Alvimopan ........................ 12 mg ............................... Solution/Drops; Ophthalmic. Capsule; Oral ................... NDA 021790 ............ DACOGEN ....................... Decitabine ........................ 50 mg/Vial ........................ Injectable; Intravenous ..... NDA 050095 ............ NDA 050795 ............ CAPASTAT SULFATE ..... DORYX ............................ Capreomycin Sulfate ........ Doxycycline Hyclate ......... Injectable; Injection .......... Tablet, Delayed Release; Oral. NDA 050801 ............ EVOCLIN ......................... Clindamycin Phosphate ... EQ 1 g Base/Vial ............. EQ 50 mg Base; EQ 100 mg Base; EQ 120 mg Base. 1% .................................... NDA 200179 ............ STAXYN ........................... Vardenafil Hydrochloride .. 10 mg ............................... NDA 202515 ............ MORPHINE SULFATE .... Morphine Sulfate .............. 15 mg/mL ......................... Tablet, Orally Disintegrating; Oral. Injectable; Injection .......... NDA 203667 ............ MINASTRIN 24 FE .......... 0.02mg, 1mg .................... Tablet; Oral ...................... NDA 210854 ............ XOFLUZA ......................... Ethinyl Estradiol; Norethindrone Acetate. Baloxavir Marboxil ............ 20 mg ............................... Tablet; Oral ...................... 020666 020723 020972 021009 FDA has reviewed its records and, under § 314.161, has determined that the drug products listed were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Approved ANDAs that refer to the drug products listed are unaffected by the discontinued marketing of the products subject to these applications. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: April 4, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–07494 Filed 4–8–24; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:57 Apr 08, 2024 Jkt 262001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1875] Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled ‘‘Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.’’ The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. DATES: The public meeting will be held on June 6, 2024, from 9:30 a.m. to 10:40 a.m. via ZoomGov. Either electronic or written comments on this public meeting must be submitted by July 6, SUMMARY: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 Capsule, Delayed Release Pellets; Oral. Tablet; Oral ...................... Cream; Topical ................. Capsule; Oral ................... Solution/Drops; Ophthalmic. Tablet, Extended Release; Oral. Aerosol, Foam; Topical .... Takeda Pharmaceuticals USA, Inc. Impax Laboratories Inc. Bausch Health US LLC. Bristol Myers Squibb Co. Allergan Inc. Menarini International Operations Luxembourg SA. Allergan Inc. Cubist Pharmaceuticals, Inc. Otsuka Pharmaceutical Co., Ltd. Epic Pharma, LLC. Mayne Pharma International Pty Ltd. Mylan Pharmaceuticals Inc. Bayer Healthcare Pharmaceuticals Inc. Hospira, A Pfizer Company. Allergan Pharmaceuticals International, Ltd. Genentech, Inc. 2024. See the SUPPLEMENTARY section for registration date and information. ADDRESSES: The public meeting will be held virtually due to extenuating circumstances. 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 July 6, 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. INFORMATION 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 E:\FR\FM\09APN1.SGM 09APN1 Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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– 2019–N–1875 for ‘‘Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments.’’ 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 VerDate Sep<11>2014 19:57 Apr 08, 2024 Jkt 262001 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: Kichelle Joseph, Office of Finance, Budget, Acquisitions, and Planning, Food and Drug Administration, 4041 Powder Mill Rd., Rm. 72064, Beltsville, MD 20705, 301–796–7251, OFBAPBusinessManagementServices@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The meeting will include presentations from FDA on the 5-year plan for the Prescription Drug User Fee Act (PDUFA) VII, Biosimilar User Fee Act (BsUFA) III, and Generic Drug User Fee Amendments (GDUFA) III; and the Agency’s progress in implementing resource capacity planning as part of fee setting and modernized time reporting. This meeting is intended to satisfy FDA’s commitment to host an annual public meeting in the third quarter of each fiscal year and can be found in the Commitment Letters listed below (sections II.B.2 of PDUFA VII (p. 58), III.B.2 of BsUFA III (p. 33), and VIII.D.3 of GDUFA III (p.40–41)). PDUFA VII, BsUFA III, and GDUFA III represent the reauthorization of these user fee programs for FYs 2023–2027 as part of the FDA User Fee Reauthorization Act of 2022, which was signed by the President on September 30, 2022. The complete set of performance goals for each program are available at: • PDUFA VII: https://www.fda.gov/ media/151712/download • BsUFA III: https://www.fda.gov/ media/152279/download • GDUFA III: https://www.fda.gov/ media/153631/download PO 00000 Frm 00068 Fmt 4703 Sfmt 9990 24843 Each of these user fee programs’ Commitment Letters included a set of commitments related to financial management. These included commitments to publish a 5-year financial plan and update that plan annually, continue activities to mature FDA’s resource capacity planning capability, and modernize time reporting practices. In addition, each user fee program includes a commitment to host a public meeting in the third quarter of each fiscal year to discuss specific topics. II. Topics for Discussion at the Public Meeting This meeting will provide FDA with the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VII, BsUFA III, and GDUFA III. These topics include the 5-year financial plans for each of these programs and FDA’s progress toward implementing resource capacity planning as part of fee setting and modernized time reporting. III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following website: https://fda.zoomgov.com/ webinar/register/WN_ RyzDcgPYQ8uJT9TWfgyPOw. Please provide complete contact information for each attendee, including name, title, affiliation, and email. Persons interested in attending this public meeting must register by June 3, 2024, at 11:59 p.m. Eastern Time. If registration closes before the day of the public meeting, the Webinar Registration website will be updated. If you need special accommodations due to a disability, please indicate this during registration or contact Kichelle Joseph at OFBAPBusinessManagementServices@ fda.hhs.gov no later than June 3, 2024. Streaming Webcast of the Public Meeting: This public meeting will be webcast. To register for the public meeting and obtain the webcast information, please visit the following website: https://fda.zoomgov.com/ webinar/register/WN_ RyzDcgPYQ8uJT9TWfgyPOw. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management Staff (see ADDRESSES). Dated: April 4, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–07493 Filed 4–8–24; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\09APN1.SGM 09APN1

Agencies

[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24842-24843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1875]


Financial Transparency and Efficiency of the Prescription Drug 
User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee 
Amendments; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the following public meeting entitled ``Financial 
Transparency and Efficiency of the Prescription Drug User Fee Act, 
Biosimilar User Fee Act, and Generic Drug User Fee Amendments.'' The 
topic to be discussed is the financial transparency and efficiency of 
the Prescription Drug User Fee Act, Biosimilar User Fee Act, and 
Generic Drug User Fee Amendments.

DATES: The public meeting will be held on June 6, 2024, from 9:30 a.m. 
to 10:40 a.m. via ZoomGov. Either electronic or written comments on 
this public meeting must be submitted by July 6, 2024. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public meeting will be held virtually due to extenuating 
circumstances.
    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 July 6, 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

[[Page 24843]]

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-2019-N-1875 for ``Financial Transparency and Efficiency of the 
Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic 
Drug User Fee Amendments; Public Meeting; Request for Comments.'' 
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 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-2015-09-18/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: Kichelle Joseph, Office of Finance, 
Budget, Acquisitions, and Planning, Food and Drug Administration, 4041 
Powder Mill Rd., Rm. 72064, Beltsville, MD 20705, 301-796-7251, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The meeting will include presentations from FDA on the 5-year plan 
for the Prescription Drug User Fee Act (PDUFA) VII, Biosimilar User Fee 
Act (BsUFA) III, and Generic Drug User Fee Amendments (GDUFA) III; and 
the Agency's progress in implementing resource capacity planning as 
part of fee setting and modernized time reporting. This meeting is 
intended to satisfy FDA's commitment to host an annual public meeting 
in the third quarter of each fiscal year and can be found in the 
Commitment Letters listed below (sections II.B.2 of PDUFA VII (p. 58), 
III.B.2 of BsUFA III (p. 33), and VIII.D.3 of GDUFA III (p.40-41)).
    PDUFA VII, BsUFA III, and GDUFA III represent the reauthorization 
of these user fee programs for FYs 2023-2027 as part of the FDA User 
Fee Reauthorization Act of 2022, which was signed by the President on 
September 30, 2022. The complete set of performance goals for each 
program are available at:

 PDUFA VII: https://www.fda.gov/media/151712/download
 BsUFA III: https://www.fda.gov/media/152279/download
 GDUFA III: https://www.fda.gov/media/153631/download

    Each of these user fee programs' Commitment Letters included a set 
of commitments related to financial management. These included 
commitments to publish a 5-year financial plan and update that plan 
annually, continue activities to mature FDA's resource capacity 
planning capability, and modernize time reporting practices. In 
addition, each user fee program includes a commitment to host a public 
meeting in the third quarter of each fiscal year to discuss specific 
topics.

II. Topics for Discussion at the Public Meeting

    This meeting will provide FDA with the opportunity to update 
interested public stakeholders on topics related to the financial 
management of PDUFA VII, BsUFA III, and GDUFA III. These topics include 
the 5-year financial plans for each of these programs and FDA's 
progress toward implementing resource capacity planning as part of fee 
setting and modernized time reporting.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://fda.zoomgov.com/webinar/register/WN_RyzDcgPYQ8uJT9TWfgyPOw. Please provide complete contact information 
for each attendee, including name, title, affiliation, and email.
    Persons interested in attending this public meeting must register 
by June 3, 2024, at 11:59 p.m. Eastern Time. If registration closes 
before the day of the public meeting, the Webinar Registration website 
will be updated.
    If you need special accommodations due to a disability, please 
indicate this during registration or contact Kichelle Joseph at 
[email protected] no later than June 3, 2024.
    Streaming Webcast of the Public Meeting: This public meeting will 
be webcast. To register for the public meeting and obtain the webcast 
information, please visit the following website: https://fda.zoomgov.com/webinar/register/WN_RyzDcgPYQ8uJT9TWfgyPOw.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management 
Staff (see ADDRESSES).

    Dated: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07493 Filed 4-8-24; 8:45 am]
BILLING CODE 4164-01-P

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