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Federal Register / Vol. 86, No. 165 / Monday, August 30, 2021 / Notices
and 301d of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 355a and 331d.
Dated: August 17, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118586 Filed 82721; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket Nos. FDA2021D0603 and FDA
2021D0604

Safety and Performance Based Pathway Device-Specific Guidances;
Draft Guidances for Industry and Food and Drug Administration Staff;
Availability Food and Drug Administration, Health and Human Services HHS.
ACTION: Notice of availability.
AGENCY:

The Food and Drug Administration FDA or Agency is announcing the availability of two draft device-specific guidance documents for the Safety and Performance Based Pathwayspecifically, Denture Base ResinsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff and Facet Screw SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff. The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled Safety and Performance Based Pathway. These draft guidance documents are not final nor are they in effect at this time.
DATES: Submit either electronic or written comments on the draft guidance by October 29, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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:
SUMMARY:

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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
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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 elses 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 HFA305, 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
2021D0603 for Denture Base ResinsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff and Docket No. FDA2021D0604 for Facet Screw SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff. Received comments will be placed in the dockets 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, 2404027500.
Confidential SubmissionsTo 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
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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 FDAs 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, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
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 Denture Base ResinsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff or Facet Screw SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff 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 209930002. Send one self-addressed adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT:

Jason Ryans, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire
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