A Risk-Based Approach to Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Correction, 27521 [2023-09264]

Download as PDF Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices * 10. Amgen Inc., ‘‘Enbrel (etanercept): Highlights of Prescribing Information,’’ revised April 2021, available at https:// www.pi.amgen.com/∼/media/amgen/ repositorysites/pi-amgen-com/enbrel/ enbrel_pi.pdf, accessed May 16, 2022. * 11. Reuter, E., ‘‘‘Smart Pill’ Startup EtectRx Strikes Partnership with Pear Therapeutics,’’ Med City News, January 14, 2021, available at https:// medcitynews.com/2021/01/smart-pillstartup-etectrx-strikes-partnership-withpear-therapeutics, accessed May 16, 2022. 12. The Medical Futurist, ‘‘The Present and Future of Digital Pills,’’ July 21, 2020, available at https://medicalfuturist.com/ the-present-and-future-of-digital-pills, accessed May 16, 2022. 13. George, C.E., ‘‘Should a Psychiatrist Prescribe a Nanodrug to Help Parents Monitor a Teen’s Adherence?,’’ AMA Journal of Ethics, Vol. 21, Issue 4, Article e317–323, 2019, doi:10.1001/ amajethics.2019.317. * 14. Yang, M., ‘‘A Psychiatrist’s Perspective on the Digital Pill,’’ KevinMD.com, December 2, 2017, available at https:// www.kevinmd.com/blog/2017/12/ psychiatrists-perspective-digitalpill.html, accessed May 16, 2022. Dated: April 27, 2023. Lauren K. Roth, Associate Commissioner for Policy. Notice; establishment of a public docket; request for information and comments. ACTION: A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers; Guidance for Industry; Correction Food and Drug Administration, HHS. Notice of availability; correction. ACTION: ddrumheller on DSK120RN23PROD with NOTICES1 Food and Drug Administration, HHS. [Docket No. FDA–2019–D–0362] The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of April 12, 2023. The document announced the availability of a final guidance entitled ‘‘A Risk-Based Approach to Monitoring of Clinical Investigations—Questions and Answers; Guidance for Industry.’’ The notice of availability for this final guidance was published with an incorrect OMB control number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Mona Shing, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration 18:14 May 01, 2023 BILLING CODE 4164–01–P Methodological Challenges Related to Patient Experience Data; Request for Information and Comments DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 [FR Doc. 2023–09264 Filed 5–1–23; 8:45 am] [Docket No. FDA–2023–N–1506] BILLING CODE 4164–01–P SUMMARY: Dated: April 27, 2023. Lauren K. Roth, Associate Commissioner for Policy. Food and Drug Administration [FR Doc. 2023–09268 Filed 5–1–23; 8:45 am] AGENCY: Ave., Bldg. 51, Rm. 3355, Silver Spring, MD 20993–0002, 301–796–0910. SUPPLEMENTARY INFORMATION: In the Federal Register of April 12, 2023 (88 FR 22038), in FR Doc. 2023–07687, the following correction is made: 1. On page 22040, in the first column, in the last sentence of ‘‘II. Paperwork Reduction Act of 1995,’’ the OMB control number 0910–0733 is corrected to read: ‘‘. . .and the collections of information in FDA’s guidance for industry entitled ‘‘Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring’’ have been approved under OMB control number 0910– 0014.’’ The correction changes the OMB control number from a number that was discontinued to an active one. The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on methodological challenges related to patient experience data in the context of the benefit-risk assessment and product labeling, and other areas of greatest interest or concern to public stakeholders. Public comments will help FDA plan two public workshops focused on methodological challenges and identify priorities for future work. DATES: Although you can comment at any time, to ensure the Agency considers your comment in our development of the workshops, submit either electronic or written information and comments by July 3, 2023. ADDRESSES: You may submit comments and information at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 27521 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–1506 for ‘‘Methodological Challenges Related to Patient Experience Data.’’ Received comments 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 E:\FR\FM\02MYN1.SGM 02MYN1

Agencies

[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Page 27521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0362]


A Risk-Based Approach to Monitoring of Clinical Investigations--
Questions and Answers; Guidance for Industry; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of April 12, 2023. The document 
announced the availability of a final guidance entitled ``A Risk-Based 
Approach to Monitoring of Clinical Investigations--Questions and 
Answers; Guidance for Industry.'' The notice of availability for this 
final guidance was published with an incorrect OMB control number. This 
document corrects that error.

FOR FURTHER INFORMATION CONTACT: Mona Shing, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3355, Silver Spring, MD 20993-0002, 301-796-0910.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 12, 2023 
(88 FR 22038), in FR Doc. 2023-07687, the following correction is made:
    1. On page 22040, in the first column, in the last sentence of 
``II. Paperwork Reduction Act of 1995,'' the OMB control number 0910-
0733 is corrected to read: ``. . .and the collections of information in 
FDA's guidance for industry entitled ``Oversight of Clinical 
Investigations--A Risk-Based Approach to Monitoring'' have been 
approved under OMB control number 0910-0014.'' The correction changes 
the OMB control number from a number that was discontinued to an active 
one.

    Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09264 Filed 5-1-23; 8:45 am]
BILLING CODE 4164-01-P

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