Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability, 53820-53822 [2020-19094]

Download as PDF 53820 Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices Estimated Total Annual Burden Hours: 630,960. Authority: 42 U.S.C. 601, 607, 609, 611, 613, and 1302. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2020–19304 Filed 8–28–20; 8:45 am] BILLING CODE 4184–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Cost Study of Trauma-Specific EvidenceBased Programs Used in the Regional Partnership Grants Program (New Collection) Children’s Bureau, Administration for Children and Families, HHS. ACTION: Request for public comment. AGENCY: The Children’s Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive study—the Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program. DATES: Comments due within 30 days of publication. OMB must make a decision about the collection of information SUMMARY: between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. SUPPLEMENTARY INFORMATION: Description: Since 2006, CB has awarded multiple rounds of competitive grants to state and local agencies and service providers under the RPG Program. Grants are awarded to organizations such as child welfare agencies, substance abuse treatment providers, or family court systems to develop interagency collaborations and provide services designed to increase well-being, improve permanency, and enhance the safety of children who are in or are at risk of being placed in outof-home care as a result of a parent’s or caretaker’s substance abuse. Thirty-five grantees are participating in the ongoing RPG national cross-site evaluation, which examines implementation, partnerships, outcomes, and impacts. All grantees collect data on a uniform set of performance measures and report them to CB on a semi-annual basis Total number of respondents Instrument Cost Workbook ................................................................................................ Staff Survey and Time Log .............................................................................. Estimated Total Annual Burden Hours: 402. Emily Ball Jabbour, ACF/OPRE Certifying Officer. [FR Doc. 2020–19066 Filed 8–28–20; 8:45 am] khammond on DSKJM1Z7X2PROD with NOTICES BILLING CODE 4184–29–P Food and Drug Administration [Docket No. FDA–2020–D–1564] Principles for Selecting, Developing, Modifying, and Adapting PatientReported Outcome Instruments for Use in Medical Device Evaluation; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: The Food and Drug Administration (FDA or Agency) is SUMMARY: VerDate Sep<11>2014 19:30 Aug 28, 2020 Jkt 250001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Total number of responses per respondent 9 90 DEPARTMENT OF HEALTH AND HUMAN SERVICES Authority: The Child and Family Services Improvement and Innovation Act (Pub. L. 112–34). through a web-based system. These ongoing data collection activities are approved under OMB #0970–0527. All grantees are also required to use a portion of their funding to conduct their own ‘‘local’’ program impact evaluation. This proposed cost study adds a new and unique contribution to CB’s portfolio of evaluation activities. Although the RPG cross-site evaluation will provide evidence for the effectiveness of some interventions to address the emotional effects of trauma, more information is needed about the cost of implementing these EvidenceBased Programs (EBPs). The cost study has the key objective to determine the cost of implementing three select Trauma-Specific EBPs: Parent-Child Interaction Therapy, Seeking Safety, and Trauma-Focused Cognitive Behavioral Therapy. To carry out this objective, the study team will collect detailed cost information from nine RPG round four and five grantees who are implementing these selected EBPs. For each grantee, the study team will administer two data collection instruments: (1) A Cost Workbook used to collect comprehensive information on the cost of implementing each select program (Instrument #1), and (2) a Staff Survey and Time Log used to collect information on how program staff allocate their time (Instrument #2). Respondents: Grantee staff. Annual Burden Estimates: Data collection will take place within a one year period. 1 1 Average burden hours per response 8 3.6 Total/annual burden hours 72 330 announcing the availability of the draft guidance entitled ‘‘Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.’’ The FDA encourages the collection, analysis, and integration of patient perspectives in the development, evaluation, and surveillance of medical devices, including digital health technologies. Patient-reported outcome (PRO) instruments facilitate the systematic collection of patient perspectives as scientific evidence to support the regulatory and healthcare decisionmaking process. This draft guidance describes principles that should be considered when using PRO E:\FR\FM\31AUN1.SGM 31AUN1 Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices instruments in the evaluation of medical devices and provides recommendations about the importance of ensuring the measures are ‘‘fit-for-purpose.’’ This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by October 30, 2020 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: 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’’). khammond on DSKJM1Z7X2PROD with NOTICES 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– 2020–D–1564 for ‘‘Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device VerDate Sep<11>2014 19:30 Aug 28, 2020 Jkt 250001 Evaluation.’’ 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-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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 53821 Evaluation’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993–0002, 301–796–6884 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, 240–402– 7911. SUPPLEMENTARY INFORMATION: I. Background A PRO instrument can be used in a clinical investigation to measure the effects of a medical intervention or changes in the health status of a patient. PRO instruments allow for collection of certain data as evidence of safety and effectiveness which is complementary to other clinical outcomes and/or biomarkers. Information from welldefined and reliable PRO instruments can provide valuable evidence for benefit-risk assessments and can be used in medical device labeling to communicate the effect of a treatment on patient symptoms, functioning, or quality of life when the labeling is consistent with the PRO instrument’s documented measurement capability. PRO instruments may be used to inform a patient’s eligibility for inclusion within a study, to capture safety or effectiveness outcomes, and may be aligned as primary or secondary endpoints or used as a stand-alone outcome assessment or component of a composite endpoint. FDA determines the validity evidence needed to support use of a PRO instrument for a particular regulatory purpose informed by the way it is used in the clinical investigation. FDA uses the term ‘‘fit-for-purpose’’ to describe this flexible approach. In addition to providing evidence to assess the safety and effectiveness of medical devices, PRO instruments can measure the impact of medical devices on patient well-being and other concepts that may influence payers, healthcare providers, and patients when making decisions about potential treatments or management options. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). E:\FR\FM\31AUN1.SGM 31AUN1 53822 Federal Register / Vol. 85, No. 169 / Monday, August 31, 2020 / Notices The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.’’ 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. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Persons unable to download an electronic copy of ‘‘Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 18042 to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. These collections of information 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 in the following FDA regulations and guidance have been approved by OMB as listed in the following table: OMB control No. 21 CFR part or guidance Topic 807, subpart E ............................................................................ 814, subparts A through E .......................................................... 814, subpart H ............................................................................ 812 .............................................................................................. ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 800, 801, and 809 ....................................................................... Premarket notification ................................................................ Premarket approval .................................................................... Humanitarian Device Exemption ............................................... Investigational Device Exemption .............................................. De Novo classification process .................................................. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 Q-submissions ........................................................................... 0910–0756 Medical Device Labeling Regulations ........................................ 0910–0485 Dated: August 21, 2020. Lauren K. Roth, Associate Commissioner for Policy. ACTION: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2019–N–3657; FDA– 2019–N–6085; FDA–2017–N–6381; FDA– 2017–N–0084; FDA–2013–N–0731; FDA– 2019–N–5971; FDA–2014–N–1021; and FDA–2019–N–3018] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Food and Drug Administration, HHS. 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. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information 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 SUMMARY: [FR Doc. 2020–19094 Filed 8–28–20; 8:45 am] AGENCY: Notice. 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 number khammond on DSKJM1Z7X2PROD with NOTICES Title of collection Accreditation Scheme for Conformity Assessment Pilot Program .......................................................................... General Administrative Practice and Procedures ................................................................................................... Records and Reports Concerning Experience With Approved New Animal Drugs ............................................... Adverse Event Program for Medical Devices (Medical Product Safety Network ................................................... Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice ................................................................... Recommendations to Reduce the Risk of Transfusion-Transmitted of Infection in Whole Blood and Blood Components; Agency Guidance .......................................................................................................................... Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods ............................................................ VerDate Sep<11>2014 19:30 Aug 28, 2020 Jkt 250001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1 Date approval expires 0910–0889 0910–0191 0910–0284 0910–0471 6/30/2023 7/31/2023 7/31/2023 7/31/2023 0910–0543 7/31/2023 0910–0681 0910–0817 7/31/2023 8/31/2023

Agencies

[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Pages 53820-53822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19094]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1564]


Principles for Selecting, Developing, Modifying, and Adapting 
Patient-Reported Outcome Instruments for Use in Medical Device 
Evaluation; Draft Guidance for Industry, Food and Drug Administration 
Staff, and Other Stakeholders; Availability

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

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Principles for 
Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome 
Instruments for Use in Medical Device Evaluation.'' The FDA encourages 
the collection, analysis, and integration of patient perspectives in 
the development, evaluation, and surveillance of medical devices, 
including digital health technologies. Patient-reported outcome (PRO) 
instruments facilitate the systematic collection of patient 
perspectives as scientific evidence to support the regulatory and 
healthcare decision-making process. This draft guidance describes 
principles that should be considered when using PRO

[[Page 53821]]

instruments in the evaluation of medical devices and provides 
recommendations about the importance of ensuring the measures are 
``fit-for-purpose.'' This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by October 30, 2020 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:

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-2020-D-1564 for ``Principles for Selecting, Developing, Modifying, 
and Adapting Patient-Reported Outcome Instruments for Use in Medical 
Device Evaluation.'' 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)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Principles for Selecting, Developing, Modifying, and Adapting 
Patient-Reported Outcome Instruments for Use in Medical Device 
Evaluation'' to the Office of Policy, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Michelle Tarver, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-
796-6884 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, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    A PRO instrument can be used in a clinical investigation to measure 
the effects of a medical intervention or changes in the health status 
of a patient. PRO instruments allow for collection of certain data as 
evidence of safety and effectiveness which is complementary to other 
clinical outcomes and/or biomarkers. Information from well-defined and 
reliable PRO instruments can provide valuable evidence for benefit-risk 
assessments and can be used in medical device labeling to communicate 
the effect of a treatment on patient symptoms, functioning, or quality 
of life when the labeling is consistent with the PRO instrument's 
documented measurement capability. PRO instruments may be used to 
inform a patient's eligibility for inclusion within a study, to capture 
safety or effectiveness outcomes, and may be aligned as primary or 
secondary endpoints or used as a stand-alone outcome assessment or 
component of a composite endpoint. FDA determines the validity evidence 
needed to support use of a PRO instrument for a particular regulatory 
purpose informed by the way it is used in the clinical investigation. 
FDA uses the term ``fit-for-purpose'' to describe this flexible 
approach. In addition to providing evidence to assess the safety and 
effectiveness of medical devices, PRO instruments can measure the 
impact of medical devices on patient well-being and other concepts that 
may influence payers, healthcare providers, and patients when making 
decisions about potential treatments or management options.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

[[Page 53822]]

The draft guidance, when finalized, will represent the current thinking 
of FDA on ``Principles for Selecting, Developing, Modifying, and 
Adapting Patient-Reported Outcome Instruments for Use in Medical Device 
Evaluation.'' 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. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all Center for Devices and Radiological Health guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to 
download an electronic copy of ``Principles for Selecting, Developing, 
Modifying, and Adapting Patient-Reported Outcome Instruments for Use in 
Medical Device Evaluation'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 18042 to identify the guidance you are 
requesting.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. These collections of information 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 in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
------------------------------------------------------------------------


    Dated: August 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-19094 Filed 8-28-20; 8:45 am]
BILLING CODE 4164-01-P

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