Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 72969-72971 [2021-27812]

Download as PDF Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board’s Freedom of Information Office at https://www.federalreserve.gov/foia/ request.htm. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551–0001, not later than January 24, 2022. A. Federal Reserve Bank of Dallas (Karen Smith, Director, Applications) 2200 North Pearl Street, Dallas, Texas 75201–2272: 1. Texas State Bankshares, Inc., Harlingen, Texas; to merge with Access Bancorp, Inc., and therefore indirectly acquire AccessBank Texas, both of Denton, Texas. Board of Governors of the Federal Reserve System, December 20, 2021. Maragaret M. Shanks, Deputy Secretary of the Board. [FR Doc. 2021–27884 Filed 12–22–21; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; ACF Uniform Project Description Office of Administration, Office of Grants Policy, Administration for Children and Families, HHS. ACTION: Request for public comment. AGENCY: The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACF Uniform Project Description (UPD) (OMB #0970–0139, expiration 2/28/ 2022). There are no changes requested to the form. DATES: Comments due within 60 days of publication. In compliance with the requirements of the Paperwork SUMMARY: 72969 Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above. ADDRESSES: Copies of the proposed collection of information can be obtained and comments may be forwarded by emailing infocollection@ acf.hhs.gov. Identify all requests by the title of the information collection. SUPPLEMENTARY INFORMATION: Description: The proposed information collection would renew the ACF UPD. The UPD provides a uniform format for applicants to submit project information in response to ACF discretionary Notices of Funding Opportunities. The UPD requires applicants to describe how program objectives will be achieved and provide a rationale for the project’s budgeted costs. All ACF discretionary grant programs are required to use the UPD. ACF uses this information, along with other OMB-approved information collections (Standard Forms), to evaluate and rank applications. Use of the UPD protects the integrity of the ACF award selection process. Respondents: Applicants responding to ACF Discretionary Notices of Funding Opportunities. jspears on DSK121TN23PROD with NOTICES1 ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Total number of responses per respondent Average burden hours per response Total burden hours Annual burden hours ACF Uniform Project Description ......................................... 3,218 1 60 193,080 64,360 Estimated Total Annual Burden Hours: 64,360. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Authority: 45 CFR 75.203–75.204 and 45 CFR part 75, Appendix I. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2021–27837 Filed 12–22–21; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0980] Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: VerDate Sep<11>2014 20:50 Dec 22, 2021 Jkt 256001 PO 00000 Notice of availability. Frm 00053 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.’’ Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform ‘‘in silico’’ device testing or as part of software embedded in a device. This guidance provides a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The draft guidance is intended to improve the consistency and transparency of the review of computational modeling evidence. This draft guidance is not final nor is it in effect at this time. SUMMARY: Submit either electronic or written comments on the draft guidance DATES: E:\FR\FM\23DEN1.SGM 23DEN1 72970 Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices by February 22, 2022 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: jspears on DSK121TN23PROD with NOTICES1 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–D–0980 for ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.’’ 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 VerDate Sep<11>2014 20:50 Dec 22, 2021 Jkt 256001 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 ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions’’ to the Office of Policy, 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: Pras Pathmanathan, Center for Devices and PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1133, Silver Spring, MD 20993–0002, 301–796–3490. SUPPLEMENTARY INFORMATION: I. Background CM&S can be used in a variety of ways in medical device applications, including to perform in silico (virtual) device testing or as part of algorithms within software embedded in a device. However, regulatory submissions involving CM&S often lack clear information for why model predictions can be considered credible. This draft guidance provides a risk-based framework that can be used in the credibility assessment of CM&S used in medical device regulatory submissions. This draft guidance builds upon the FDA-recognized consensus standard American Society of Mechanical Engineers V&V 40, ‘‘Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices,’’ by providing a general framework for demonstrating CM&S credibility that incorporates the different types of evidence typically generated for regulatory submissions. The framework is intended to be applicable to any use of CM&S in a medical device submission. It is not specific to any device type, modeling discipline or clinical specialty. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.’’ 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/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This draft guidance document is also available at https://www.regulations.gov and at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download E:\FR\FM\23DEN1.SGM 23DEN1 Federal Register / Vol. 86, No. 244 / Thursday, December 23, 2021 / Notices an electronic copy of ‘‘Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500056 and complete title to III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: 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 and Meetings for Medical Device Submissions: The QSubmission Program’’. Premarket notification ............................... Premarket approval .................................. Humanitarian Device Exemption .............. Investigational Device Exemption ............. De Novo classification process ................ Q-submissions; pre-submissions .............. Dated: December 17, 2021. Lauren K. Roth, Associate Commissioner for Policy. Submit either electronic or written comments on the draft guidance by February 22, 2022 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: DATES: [FR Doc. 2021–27812 Filed 12–22–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0996] Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.’’ Physiologic Closed-Loop Control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This draft guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices. This draft guidance is not final nor is it in effect at this time. SUMMARY: jspears on DSK121TN23PROD with NOTICES1 identify the guidance you are requesting. VerDate Sep<11>2014 20:50 Dec 22, 2021 Jkt 256001 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 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 72971 OMB Control No. 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 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–D–0996 for ‘‘Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.’’ 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 E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72969-72971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27812]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0980]


Assessing the Credibility of Computational Modeling and 
Simulation in Medical Device Submissions; Draft Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Assessing the 
Credibility of Computational Modeling and Simulation in Medical Device 
Submissions.'' Computational modeling and simulation (CM&S) can be used 
in a variety of ways in medical device applications, including to 
perform ``in silico'' device testing or as part of software embedded in 
a device. This guidance provides a risk-based framework that can be 
used in the credibility assessment of computational modeling and 
simulation (CM&S) used in medical device regulatory submissions. The 
draft guidance is intended to improve the consistency and transparency 
of the review of computational modeling evidence. 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

[[Page 72970]]

by February 22, 2022 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-2021-D-0980 for ``Assessing the Credibility of Computational 
Modeling and Simulation in Medical Device Submissions.'' 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 
``Assessing the Credibility of Computational Modeling and Simulation in 
Medical Device Submissions'' to the Office of Policy, 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: Pras Pathmanathan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1133, Silver Spring, MD 20993-0002, 301-
796-3490.

SUPPLEMENTARY INFORMATION:

I. Background

    CM&S can be used in a variety of ways in medical device 
applications, including to perform in silico (virtual) device testing 
or as part of algorithms within software embedded in a device. However, 
regulatory submissions involving CM&S often lack clear information for 
why model predictions can be considered credible. This draft guidance 
provides a risk-based framework that can be used in the credibility 
assessment of CM&S used in medical device regulatory submissions. This 
draft guidance builds upon the FDA-recognized consensus standard 
American Society of Mechanical Engineers V&V 40, ``Assessing 
Credibility of Computational Modeling Through Verification and 
Validation: Application to Medical Devices,'' by providing a general 
framework for demonstrating CM&S credibility that incorporates the 
different types of evidence typically generated for regulatory 
submissions. The framework is intended to be applicable to any use of 
CM&S in a medical device submission. It is not specific to any device 
type, modeling discipline or clinical specialty.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Assessing 
the Credibility of Computational Modeling and Simulation in Medical 
Device Submissions.'' 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document 
is also available at https://www.regulations.gov and at https://
www.fda.gov/regulatory-information/search-fda-guidance-documents. 
Persons unable to download

[[Page 72971]]

an electronic copy of ``Assessing the Credibility of Computational 
Modeling and Simulation in Medical Device Submissions'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1500056 and 
complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidances have been 
approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB Control
     21 CFR part; or guidance               Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback and         Q-submissions; pre-        0910-0756
 Meetings for Medical Device         submissions.
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------


    Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27812 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P

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