Food and Drug Administration Public Meeting on Financial Efficiency of Human Drug User Fee Programs; Public Meeting; Request for Comments, 27089-27090 [2021-10566]

Download as PDF Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices Affected Public: Individuals; Business or Other For-Profit Institutions; Not-ForProfit Institutions; State, Local, or Tribal Government. Projected average burden estimates for the next three years: Estimated Annual Number of Respondents: 91,425. Average Expected Annual Number of Activities: 39. Average Number of Respondents per Activity: 2,344. Responses per Respondent: 1. Annual Responses: 91,425. Average Minutes per Response: 3 minutes. Annual Burden Hours: 3,900 hours. Frequency: On occasion. Request for Comments: Agency and public comment is invited specifically on the need for and practical utility of this information collection, the accuracy of OGE’s burden estimate, the enhancement of quality, utility and clarity of the information collected, and the minimization of burden (including the use of information technology). Comments received in response to this notice will be summarized for, and may be included with, the OGE generic information collection request. The comments will also become a matter of public record. Notice of public meeting; request for comments. 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’’). The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ‘‘FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.’’ The topic to be discussed is the financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Generic Drug User Fee Amendments. DATES: The public meeting will be held on June 18, 2021, from 9:30 a.m. to 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 Approved: May 14, 2021. Emory Rounds, Director, U.S. Office of Government Ethics. [FR Doc. 2021–10531 Filed 5–18–21; 8:45 am] BILLING CODE 6345–03–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–N–0431] Food and Drug Administration Public Meeting on Financial Efficiency of Human Drug User Fee Programs; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES 11:30 a.m. Eastern Time via WebEx Events. Submit either electronic or written comments on this public meeting by July 19, 2021. 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. Electronic comments must be submitted on or before July 19, 2021. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 19, 2021. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. VerDate Sep<11>2014 18:35 May 18, 2021 Jkt 253001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 27089 identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–N–0431 for ‘‘FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.’’ 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-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: Monica Ellerbe, Food and Drug Administration, Office of Finance, Budget, Acquisition, and Planning, 4041 Powder Mill Rd., Rm. 72044, Beltsville, E:\FR\FM\19MYN1.SGM 19MYN1 27090 Federal Register / Vol. 86, No. 95 / Wednesday, May 19, 2021 / Notices MD 20750, 301–796–5276, Monica.Ellerbe@fda.hhs.gov. II. Topics for Discussion at the Public Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES SUPPLEMENTARY INFORMATION: This meeting will provide FDA the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VI, BsUFA II, and GDUFA II. FDA will present the 5-year financial plans for each of these programs and update participants on the progress towards implementing resource capacity planning and modernizing its time reporting approach. In addition, FDA will provide an update on the Agency’s progress in addressing the findings from the independent third-party evaluation of the resource management associated with PDUFA, BsUFA, and GDUFA that concluded and was published in FY 2019. To view the evaluation assessment report, please visit here: https://www.fda.gov/media/127605/ download. Food and Drug Administration I. Background The meeting will include presentations from FDA on: (1) The 5year plan for the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II; (2) the Agency’s progress in implementing resource capacity planning and modernized time reporting; and (3) the Agency’s progress in addressing the findings from the independent thirdparty evaluation of the resource management associated with PDUFA, BsUFA, and GDUFA that concluded and was published in fiscal year (FY) 2019. This meeting is intended to satisfy FDA’s commitment to host an annual public meeting in the third quarter of each fiscal year beginning in FY 2019 and can be found in the Commitment letters listed below (II.B.3 of PDUFA VI (p. 38), IV.B.3 of BsUFA II (p. 28), and VI.B.4 of GDUFA II (p.22)). This public meeting is intended to meet performance commitments included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs were reauthorized as part of the FDA Reauthorization Act of 2017 (FDARA) signed by the President on August 18, 2017. The complete set of performance goals for each program are available at: khammond on DSKJM1Z7X2PROD with NOTICES • PDUFA VI program: https:// www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/ UCM511438.pdf • BsUFA II program: https:// www.fda.gov/downloads/forindustry/ userfees/biosimilaruserfeeactbsufa/ ucm521121.pdf • GDUFA II program: https:// www.fda.gov/downloads/forindustry/ userfees/genericdruguserfees/ ucm525234.pdf Each of these user fee programs includes a set of commitments related to financial management. These include commitments to publish a 5-year financial plan that should be updated annually, develop resource capacity planning capability and to modernize time reporting practices, and have a third-party evaluation of resource management practices for these user fee programs. In addition, each user fee program includes a commitment to host a public meeting in the third quarter of each fiscal year, beginning in FY 2019, to discuss specific topics. VerDate Sep<11>2014 16:43 May 18, 2021 Jkt 253001 III. Participating in the Public Meeting Registration: To register for the public meeting, please visit the following website: https://www.survey monkey.com/r/FDA_2021_User_Fees_ Public_Meeting_Registration. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Persons interested in attending this public meeting must register by June 15, 2021, at 11:59 p.m. Eastern Time. If you need special accommodations due to a disability, please contact Monica Ellerbe no later than June 15, 2021, 11:59 p.m. Eastern Time. Streaming Webcast of the Public Meeting: The webcast for this public meeting is https://fda1.webex.com/fda1/ onstage/g.php?MTID=e1c96ecf18f93 ce5f76a24967fa89af65; Password: FDApm2021. 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 be viewed at the Dockets Management Staff (see ADDRESSES). Dated: May 14, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–10566 Filed 5–18–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 [Docket No. FDA–2021–D–0351] Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention.’’ This guidance addresses FDA’s current thinking regarding clinical trials for drugs for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adults, including recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. This guidance details a recent change in our recommendations regarding the necessary evidence and recommended endpoint assessments needed to support a determination of efficacy for the indication of the prevention of CINV. Previously, drug development programs seeking an indication for the prevention of CINV typically selected a primary efficacy endpoint of complete response, defined as no vomiting and no use of rescue antiemetic medication, with additional direct evaluation of nausea frequency and severity positioned as exploratory assessments. To promote consistency and interpretability in the assessment of nausea both within and across development programs, FDA now recommends sponsors analyze a primary endpoint of complete response (i.e., a binary endpoint defined as no vomiting and no use of rescue antiemetic medication) and a secondary endpoint of the absence of nausea (i.e., a binary endpoint defined as no reported nausea and no use of rescue antiemetic medication) by evaluating the difference in the proportions of responders across treatment arms to establish efficacy for the prevention of CINV. DATES: Submit either electronic or written comments on the draft guidance by July 19, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: E:\FR\FM\19MYN1.SGM 19MYN1

Agencies

[Federal Register Volume 86, Number 95 (Wednesday, May 19, 2021)]
[Notices]
[Pages 27089-27090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10566]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0431]


Food and Drug Administration Public Meeting on Financial 
Efficiency of Human Drug User Fee Programs; 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, the Agency, or we) is 
announcing the following public meeting entitled ``FDA Public Meeting 
on Financial Efficiency of Human Drug User Fee Programs.'' The topic to 
be discussed is the financial transparency and efficiency of the 
Prescription Drug User Fee Act, the Biosimilar User Fee Act, and 
Generic Drug User Fee Amendments.

DATES: The public meeting will be held on June 18, 2021, from 9:30 a.m. 
to 11:30 a.m. Eastern Time via WebEx Events. Submit either electronic 
or written comments on this public meeting by July 19, 2021. 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. Electronic comments must be 
submitted on or before July 19, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of July 19, 2021. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is 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-2021-N-0431 for ``FDA Public Meeting on Financial Efficiency of 
Human Drug User Fee Programs.'' 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: Monica Ellerbe, Food and Drug 
Administration, Office of Finance, Budget, Acquisition, and Planning, 
4041 Powder Mill Rd., Rm. 72044, Beltsville,

[[Page 27090]]

MD 20750, 301-796-5276, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The meeting will include presentations from FDA on: (1) The 5-year 
plan for the Prescription Drug User Fee Act (PDUFA) VI, Biosimilar User 
Fee Act (BsUFA) II, and Generic Drug User Fee Amendments (GDUFA) II; 
(2) the Agency's progress in implementing resource capacity planning 
and modernized time reporting; and (3) the Agency's progress in 
addressing the findings from the independent third-party evaluation of 
the resource management associated with PDUFA, BsUFA, and GDUFA that 
concluded and was published in fiscal year (FY) 2019. This meeting is 
intended to satisfy FDA's commitment to host an annual public meeting 
in the third quarter of each fiscal year beginning in FY 2019 and can 
be found in the Commitment letters listed below (II.B.3 of PDUFA VI (p. 
38), IV.B.3 of BsUFA II (p. 28), and VI.B.4 of GDUFA II (p.22)).
    This public meeting is intended to meet performance commitments 
included in PDUFA VI, BsUFA II, and GDUFA II. These user fee programs 
were reauthorized as part of the FDA Reauthorization Act of 2017 
(FDARA) signed by the President on August 18, 2017. The complete set of 
performance goals for each program are available at:

 PDUFA VI program: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf
 BsUFA II program: https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf
 GDUFA II program: https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf

    Each of these user fee programs includes a set of commitments 
related to financial management. These include commitments to publish a 
5-year financial plan that should be updated annually, develop resource 
capacity planning capability and to modernize time reporting practices, 
and have a third-party evaluation of resource management practices for 
these user fee programs. In addition, each user fee program includes a 
commitment to host a public meeting in the third quarter of each fiscal 
year, beginning in FY 2019, to discuss specific topics.

II. Topics for Discussion at the Public Meeting

    This meeting will provide FDA the opportunity to update interested 
public stakeholders on topics related to the financial management of 
PDUFA VI, BsUFA II, and GDUFA II. FDA will present the 5-year financial 
plans for each of these programs and update participants on the 
progress towards implementing resource capacity planning and 
modernizing its time reporting approach. In addition, FDA will provide 
an update on the Agency's progress in addressing the findings from the 
independent third-party evaluation of the resource management 
associated with PDUFA, BsUFA, and GDUFA that concluded and was 
published in FY 2019. To view the evaluation assessment report, please 
visit here: https://www.fda.gov/media/127605/download.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website: https://www.surveymonkey.com/r/FDA_2021_User_Fees_Public_Meeting_Registration. Please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Persons interested in attending this public meeting must register 
by June 15, 2021, at 11:59 p.m. Eastern Time.
    If you need special accommodations due to a disability, please 
contact Monica Ellerbe no later than June 15, 2021, 11:59 p.m. Eastern 
Time.
    Streaming Webcast of the Public Meeting: The webcast for this 
public meeting is https://fda1.webex.com/fda1/onstage/g.php?MTID=e1c96ecf18f93ce5f76a24967fa89af65; Password: FDApm2021.
    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 be viewed at the Dockets Management Staff 
(see ADDRESSES).

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10566 Filed 5-18-21; 8:45 am]
BILLING CODE 4164-01-P
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