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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
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for 513g Requests for Information Ref. 17 and FDA and Industry Procedures for Section 513g Requests for Information under the Federal Food, Drug, and Cosmetic ActGuidance for Industry and Food and Drug Administration Staff Ref. 18 have been approved under OMB control number 09100705; and the collections of information in the guidance entitled Emergency Use Authorization of Medical Products and Related Authorities Ref. 19 have been approved under OMB control number 09100595. The collections of information in Title 21 of the Code of Federal Regulations CFR are approved under the following OMB control numbers: part 3 under 09100523; parts 50 and 56 under 09100130; part 54
under 09100396; part 58 under 0910
0119; parts 801 and 809 under 0910
0485; part 807, subpart E, under 0910
0120; part 812 under 09100078; part 814, subparts A through E under 0910
0231; part 814, subpart H under 0910
0332; part 820 under 09100073; part 860, subpart C under 09100138.
The information collection provisions in this final rule have been submitted to OMB for review as required by section 3507d of the Paperwork Reduction Act of 1995.
Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMBs decision to approve, modify, or disapprove the information collection provisions in this final rule. 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.
X. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have
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determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.
XII. References The following references are on display in the Dockets Management Staff see ADDRESSES and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https
www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. FDA, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/contentpremarket-submissions-managementcybersecurity-medical-devices.
2. FDA, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-content-premarketsubmissions-software-containedmedical-devices.
3. FDA, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/factorsconsider-when-making-benefit-riskdeterminations-medical-devicepremarket-approval-and-de.
4. FDA, Patient Preference Information Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/patient-preferenceinformation-voluntary-submissionreview-premarket-approval-applications.
5. FDA, De Novo Classification Process Evaluation of Automatic Class III
Designation, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/denovo-classification-process-evaluationautomatic-class-iii-designation.
6. FDA, CDRH Patient Engagement web page, available at https www.fda.gov/about-

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fda/about-center-devices-andradiological-health/cdrh-patientengagement.
7. FDA, Procedures for Meetings of the Medical Devices Advisory Committee, available at https www.fda.gov/
regulatory-information/search-fdaguidance-documents/proceduresmeetings-medical-devices-advisorycommittee.
8. FDA, eCopy Program for Medical Device Submissions, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/ecopyprogram-medical-device-submissions.
9. FDA, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
consideration-uncertainty-makingbenefit-risk-determinations-medicaldevice-premarket-approvals-de.
10. FDA, The 510k Program: Evaluating Substantial Equivalence in Premarket Notifications 510k, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/510k-program-evaluatingsubstantial-equivalence-premarketnotifications-510k.
11. FDA, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, available at https www.fda.gov/
regulatory-information/search-fdaguidance-documents/appropriate-usevoluntary-consensus-standardspremarket-submissions-medical-devices.
12. FDA, The Least Burdensome Provisions:
Concept and Principles, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/least-burdensomeprovisions-concept-and-principles.
13. FDA, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program, available at https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
requests-feedback-and-meetingsmedical-device-submissions-qsubmission-program.
14. FDA, Use of Electronic Health Record Data in Clinical Investigations, available at https www.fda.gov/
regulatory-information/search-fdaguidance-documents/use-electronichealth-record-data-clinicalinvestigations-guidance-industry.
15. FDA, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, available at https www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/recommended-content-andformat-non-clinical-bench-performancetesting-information-premarket.
16. FDA, Acceptance Review for De Novo Classification Requests, available at https www.fda.gov/regulatoryinformation/search-fda-guidance-

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