Advancing Real-World Evidence Program, 63786-63787 [2022-22795]

Download as PDF 63786 Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices Food and Drug Administration [Docket Nos. FDA–2013–N–0375, FDA– 2013–N–1147, FDA–2010–N–0083, FDA– 2013–N–0115, FDA–2013–N–1588, and FDA– 2016–N–1593] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794, PRAStaff@fda.hhs.gov. The following is a list of FDA information SUPPLEMENTARY INFORMATION: Notice. collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB control No. Title of collection Agreement for Shipments of Devices for Sterilization ............................................................................................ Environmental Impact Considerations ..................................................................................................................... Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed .......... Manufactured Food Regulatory Program Standards .............................................................................................. Tobacco Products, Exemptions From Substantial Equivalence Requirements ...................................................... Medical Device Accessories .................................................................................................................................... Dated: October 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2022–22762 Filed 10–19–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–2455] Advancing Real-World Evidence Program Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice. I. Background The Food and Drug Administration (FDA or Agency) is announcing the Advancing Real-World Evidence (RWE) Program to fulfill FDA’s commitment under the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022. DATES: The Advancing RWE Program will proceed from the date of this notice through September 30, 2027. Sponsors may submit meeting requests for the program through March 31, 2027. ADDRESSES: For additional information about the Program, please refer to FDA’s web page at https://www.fda.gov/drugs/ development-resources/advancing-realworld-evidence-program. In connection with the seventh iteration of the Prescription Drug User Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022, FDA committed to establishing the ‘‘Advancing Real-World Evidence (RWE) Program,’’ which seeks to identify approaches for generating RWE that meet regulatory requirements in support of labeling for effectiveness (e.g., new indications, populations, dosing information) or for meeting postapproval study requirements. FDA is establishing and publicly communicating the Advancing RWE Program to satisfy this commitment. The Advancing RWE Program provides sponsors who are selected into the Program the opportunity to meet with AGENCY: SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Nahleen Lopez, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6360, Silver Spring, MD 20993–0002, 240– 402–2659, Nahleen.Lopez@fda.hhs.gov, with the subject line ‘‘Advancing RWE Program’’; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911, Stephen.Ripley@ fda.hhs.gov, with the subject line ‘‘Advancing RWE Program.’’ SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:50 Oct 19, 2022 Jkt 259001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 0910–0131 0910–0322 0910–0339 0910–0601 0910–0684 0910–0823 Date approval expires 9/30/2025 9/30/2025 9/30/2025 9/30/2025 9/30/2025 9/30/2025 Agency staff—before protocol development or study initiation—to discuss the use of RWE in medical product development. The Advancing RWE Program is an optional pathway for sponsors submitting RWE proposals; established procedures to engage with the Agency will continue to be available. Meetings under the Advancing RWE Program will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. Oncology applications will include participation from the Oncology Center of Excellence. FDA will grant up to four meetings between CDER or CBER and a sponsor selected into the Advancing RWE Program to discuss approaches for generating RWE that can meet regulatory requirements. To promote awareness of characteristics of RWE that can support regulatory decisions, study designs discussed through the program may be presented by FDA in a public forum (e.g., in a guidance or public workshop). The Advancing RWE Program website includes current program eligibility criteria; format, content, and instructions for submission of initial and followup meeting requests; and information regarding a required disclosure agreement. The Program’s website address is https://www.fda.gov/ drugs/development-resources/ E:\FR\FM\20OCN1.SGM 20OCN1 Federal Register / Vol. 87, No. 202 / Thursday, October 20, 2022 / Notices advancing-real-world-evidenceprogram. II. Paperwork Reduction Act of 1995 This notice refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3521). The collections of information resulting from formal meetings between sponsors or applicants and FDA have been approved under OMB control number 0910–001. The collections of information in 21 CFR part 312 (investigational new drug applications) have been approved under OMB control number 0910–0014. Dated: October 17, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–22795 Filed 10–19–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Electronic Submissions Food and Drug Administration [Docket No. FDA–2022–N–1400] Complex Innovative Design Paired Meeting Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The seventh iteration of the Prescription Drug User Amendments (PDUFA VII), included as part of the FDA User Fee Reauthorization Act of 2022, highlights the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The Food and Drug Administration (FDA or Agency) is announcing the continuation of the paired meeting program established under the sixth iteration of PDUFA that affords sponsors, who are selected, the opportunity to meet with Agency staff to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the program will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) during fiscal years 2023 to 2027. For each sponsor whose meeting request is granted, two meetings will be held between the sponsor and CDER or CBER that will provide an opportunity for medical product developers to discuss their CID proposals. To promote innovation in this area, trial designs developed through the paired meeting program may be presented by FDA (e.g., in a guidance or public workshop) as lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 16:50 Oct 19, 2022 Jkt 259001 case studies, including trial designs for drugs that have not yet been approved by FDA. DATES: The CID Paired Meeting Program will proceed from October 1, 2022, through September 30, 2027. Sponsors may submit meeting requests for the program through June 30, 2027. Either electronic or written comments about this meeting program must be submitted by November 3, 2022. ADDRESSES: You may submit comments about the CID paired meetings program 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 November 3, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. 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 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 63787 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– 2022–N–1400 for ‘‘Complex Innovative Design Paired Meeting Program.’’ 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: CDER: Scott Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Notices]
[Pages 63786-63787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2455]


Advancing Real-World Evidence Program

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the Advancing Real-World Evidence (RWE) Program to fulfill FDA's 
commitment under the seventh iteration of the Prescription Drug User 
Fee Amendments (PDUFA VII), incorporated as part of the FDA User Fee 
Reauthorization Act of 2022.

DATES: The Advancing RWE Program will proceed from the date of this 
notice through September 30, 2027. Sponsors may submit meeting requests 
for the program through March 31, 2027.

ADDRESSES: For additional information about the Program, please refer 
to FDA's web page at https://www.fda.gov/drugs/development-resources/advancing-real-world-evidence-program.

FOR FURTHER INFORMATION CONTACT: Nahleen Lopez, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6360, Silver Spring, MD 20993-0002, 240-
402-2659, [email protected], with the subject line ``Advancing 
RWE Program''; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911, 
[email protected], with the subject line ``Advancing RWE 
Program.''

SUPPLEMENTARY INFORMATION:

I. Background

    In connection with the seventh iteration of the Prescription Drug 
User Fee Amendments (PDUFA VII), incorporated as part of the FDA User 
Fee Reauthorization Act of 2022, FDA committed to establishing the 
``Advancing Real-World Evidence (RWE) Program,'' which seeks to 
identify approaches for generating RWE that meet regulatory 
requirements in support of labeling for effectiveness (e.g., new 
indications, populations, dosing information) or for meeting post-
approval study requirements. FDA is establishing and publicly 
communicating the Advancing RWE Program to satisfy this commitment. The 
Advancing RWE Program provides sponsors who are selected into the 
Program the opportunity to meet with Agency staff--before protocol 
development or study initiation--to discuss the use of RWE in medical 
product development. The Advancing RWE Program is an optional pathway 
for sponsors submitting RWE proposals; established procedures to engage 
with the Agency will continue to be available.
    Meetings under the Advancing RWE Program will be conducted by FDA's 
Center for Drug Evaluation and Research (CDER) or Center for Biologics 
Evaluation and Research (CBER) during fiscal years 2023 to 2027. 
Oncology applications will include participation from the Oncology 
Center of Excellence. FDA will grant up to four meetings between CDER 
or CBER and a sponsor selected into the Advancing RWE Program to 
discuss approaches for generating RWE that can meet regulatory 
requirements. To promote awareness of characteristics of RWE that can 
support regulatory decisions, study designs discussed through the 
program may be presented by FDA in a public forum (e.g., in a guidance 
or public workshop).
    The Advancing RWE Program website includes current program 
eligibility criteria; format, content, and instructions for submission 
of initial and followup meeting requests; and information regarding a 
required disclosure agreement. The Program's website address is https:/
/www.fda.gov/drugs/development-resources/

[[Page 63787]]

advancing-real-world-evidence-program.

II. Paperwork Reduction Act of 1995

    This notice refers to collections of information that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections 
of information resulting from formal meetings between sponsors or 
applicants and FDA have been approved under OMB control number 0910-
001. The collections of information in 21 CFR part 312 (investigational 
new drug applications) have been approved under OMB control number 
0910-0014.

    Dated: October 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22795 Filed 10-19-22; 8:45 am]
BILLING CODE 4164-01-P

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