Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide; Availability

Cited as:85 FR 26350
Court:Food And Drug Administration
Publication Date:04 May 2020
Record Number:2020-09188
Federal Register, Volume 85 Issue 86 (Monday, May 4, 2020)
[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
                [Rules and Regulations]
                [Pages 26350-26351]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-09188]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                21 CFR Part 888
                [Docket No. FDA-2015-N-3785]
                Classification of Posterior Cervical Screw Systems: Small Entity
                Compliance Guide; Availability
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notification of availability.
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                SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
                announcing the availability of a final guidance for industry entitled
                ``Classification of Posterior Cervical Screw Systems: Small Entity
                Compliance Guide.'' This small entity compliance guide (SECG) is
                intended to help small entities comply with the final rule on the
                classification of posterior cervical screw systems.
                DATES: The announcement of the guidance is published in the Federal
                Register on May 4, 2020.
                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'').
                [[Page 26351]]
                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-2015-N-3785 for ``Classification of Posterior Cervical Screw
                Systems: Small Entity Compliance Guide.'' 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.
                 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.
                 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 SECG entitled ``Classification
                of Posterior Cervical Screw Systems: Small Entity Compliance Guide'' 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: Constance Soves, Center for Devices
                and Radiological Health, Food and Drug Administration, 10903 New
                Hampshire Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-
                796-6951, [email protected].
                SUPPLEMENTARY INFORMATION:
                I. Background
                 In the Federal Register of April 1, 2019 (84 FR 12088), FDA issued
                a final rule to classify posterior cervical screw systems into class II
                (special controls) and to continue to require a premarket notification
                (510(k)) to provide a reasonable assurance of safety and effectiveness
                of the device (the final rule). The final rule, which is codified at 21
                CFR 888.3075, became effective May 1, 2019.
                 In compliance with section 212 of the Small Business Regulatory
                Enforcement Fairness Act (Pub. L. 104-121, as amended by Pub. L. 110-
                28), FDA is making this SECG available to explain the actions that a
                small entity must take to comply with the final rule.
                 This level 2 guidance is being issued consistent with our good
                guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
                represents the current thinking of FDA on this topic. It does not
                establish any rights for any person and is not binding on FDA or the
                public. An alternative approach may be used if such approach satisfies
                the requirements of the applicable statutes and regulations.
                II. Paperwork Reduction Act of 1995
                 The guidance refers to previously approved FDA 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 (PRA) (44 U.S.C. 3501-3521). The collections of information
                in 21 CFR part 807, subpart E, have been approved under OMB control
                number 0910-0120; the collections of information in 21 CFR part 801
                have been approved under OMB control number 0910-0485; and the
                collections of information in 21 CFR part 807, subparts A through D,
                have been approved under OMB control number 0910-0625.
                III. Electronic Access
                 Persons interested in obtaining a copy of the SECG 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.
                Persons unable to download an electronic copy of ``Classification of
                Posterior Cervical Screw Systems'' may send an email request to [email protected] to receive an electronic copy of the document.
                Please use the document number 20008 and complete title to identify the
                guidance you are requesting.
                 Date: April 24, 2020.
                Lowell J. Schiller,
                Principal Associate Commissioner for Policy.
                [FR Doc. 2020-09188 Filed 5-1-20; 8:45 am]
                BILLING CODE 4164-01-P