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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2019-D-4247]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice of availability.

# SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 1, 2019.

# DATES:

                        The announcement of the guidance is published in the                         **Federal Register**                         on February 28, 2022.                    

# ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

### 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.”       ( print page 11078)      

*Instructions:*                     All submissions received must include the Docket No. FDA-2019-D-4247 for “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” 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 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.                

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

                    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the                     **SUPPLEMENTARY INFORMATION**                     section for electronic access to the guidance document.                

# FOR FURTHER INFORMATION CONTACT:

                         Shannon Cole, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-796-9208,                         *Shannon.Cole@fda.hhs.gov,*                         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.                    

# SUPPLEMENTARY INFORMATION:

## I. Background

FDA is announcing the availability of a guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development guidance documents that FDA committed to develop to describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision making. The purpose of Guidance 2 is to present a range of methods and established best research practices to identify what is important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease. In particular, the methods and best practices presented can help elicit relevant information from patients and other stakeholders, such as how their disease affects their daily lives; what they find most troublesome; and the challenges, problems, and burdens of the treatment for the disease.

This guidance finalizes the draft guidance entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients” issued on October 1, 2019 (84 FR 52114). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft to the final guidance include incorporating the definitions of relevant terms within the body of the document instead of as part of a glossary. In addition, editorial changes and methodological clarifications were made to improve clarity.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

## II. Paperwork Reduction Act of 1995

This guidance refers to collections of information from individuals under treatment or clinical examination in connection with research, which are not subject to review by the Office of Management and Budget (OMB) under 5 CFR 1320.3(h)(5). Therefore, clearance by the OMB under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. This guidance also refers to previously approved FDA collections of information. The previously approved collections of information are subject to review by OMB under the PRA. The information collections described in this guidance are submitted to FDA to support the medical product's effectiveness and to support claims in approved medical product labeling (see 21 CFR 314.50, 314.126, and 601.2). The information collections have been approved under OMB control numbers 0910-0001 and 0910-0338. The collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130.

## III. Additional Information

                    Section 3002 of Title III, Subtitle A, of the 21st Century Cures Act (Pub. L. 114-255) directs FDA to develop patient-focused drug development guidance to address a number of areas including under section 3002(c)(2): Methodological approaches that may be used to develop and identify what is important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the                           ( print page 11079)                        management of the patient's disease. In addition, FDA committed to meet certain performance goals under the sixth authorization of the Prescription Drug User Fee Act. These goal commitments were developed in consultation with patient and consumer advocates, healthcare professionals, and other public stakeholders, as part of negotiations with regulated industry. Section J.1 of the commitment letter, “Enhancing the Incorporation of the Patient's Voice in Drug Development and Decision-Making” (                    *https://www.fda.gov/​downloads/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​UCM511438.pdf*), outlines work, including the development of a series of guidance documents and associated public workshops to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform drug development, and, as appropriate, regulatory decision making.                

## IV. Electronic Access

                    Persons with access to the internet may obtain the guidance at                     *https://www.fda.gov/​drugs/​guidance-compliance-regulatory-information/​guidances-drugs, https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances,**https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents,*                     or                     *https://www.regulations.gov.*

Dated: February 22, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2022-04152 Filed 2-25-22; 8:45 am]

BILLING CODE 4164-01-P