Bone Anchors-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability, 12563-12565 [2020-04361]

Download as PDF 12563 Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices information sharing. AHRQ personnel are able to systematically search the information collected and stored in the ARRS database. Personnel will also use the information to address internal and/ or external requests for information regarding grant progress, preliminary findings, and other requests, such as Freedom of Information Act requests, and producing responses related to federally mandated programs and regulations. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondents. It will take grantees and vendors an estimated 15 minutes to enter the necessary data into the ARRS System and reporting will occur four Number of respondents Form name times annually. The total annualized burden hours are estimated to be 500 hours. Exhibit 2 shows the estimated annualized cost burden for the respondents. The total estimated cost burden for respondents is $19,710. Exhibit 1 Estimated Annualized Burden Hours Number of responses per respondent Hours per response Total burden hours Data entry into ARRS ...................................................................................... 500 4 15/60 500 Total .......................................................................................................... 500 N/A N/A 500 Exhibit 2 Burden Estimated Annualized Cost Number of respondents Form name Total burden hours Average hourly wage rate * Total cost burden Data entry into ARRS ...................................................................................... 500 500 $39.42 $19,710 Total .......................................................................................................... 500 500 N/A 19,710 * Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2015,’’ U.S. Department of Labor, Bureau of Labor Statistics, https://www.bls.gov/oes/current/oes_ nat.htm#29-0000. lotter on DSKBCFDHB2PROD with NOTICES Request for Comments In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501–3521, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ’s health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. VerDate Sep<11>2014 17:19 Mar 02, 2020 Jkt 250001 Dated: February 26, 2020. Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2020–04277 Filed 3–2–20; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–4436] Bone Anchors—Premarket Notification (510(k)) Submissions; 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 a final guidance entitled ‘‘Bone Anchors— Premarket Notification (510(k)) Submissions.’’ This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. FDA is clarifying and providing current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description. SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 The announcement of the guidance is published in the Federal Register on March 3, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: 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 E:\FR\FM\03MRN1.SGM 03MRN1 12564 Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). lotter on DSKBCFDHB2PROD 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– 2016–D–4436 for ‘‘Bone Anchors— Premarket Notification (510(k)) 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. • 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. 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 guidance document entitled ‘‘Bone Anchors— Premarket Notification (510(k)) Submissions’’ 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: Laurence Coyne, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4512, Silver Spring, MD 20993–0002, 301–796–6450. SUPPLEMENTARY INFORMATION: I. Background This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices, which are indicated for attachment of soft tissue to bone. FDA is clarifying and providing current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description. FDA considered comments received on the draft guidance that appeared in the Federal Register of January 3, 2017 (82 FR 128). FDA revised the guidance as appropriate in response to the comments. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Bone Anchors— Premarket Notification (510(k)) 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. III. Electronic Access Persons interested in obtaining a copy of the 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 is also available at https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Bone Anchors—Premarket Notification (510(k)) 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 1400005 and the complete guidance title to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This 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 regulations have been approved by OMB as listed in the following table: OMB control No. 21 CFR part Topic 807, subpart E .......................................... 812 ............................................................ 801 ............................................................ 820 ............................................................ Premarket notification .................................................................................................. Investigational Device Exemption ................................................................................ Medical Device Labeling Regulations .......................................................................... Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation ..... VerDate Sep<11>2014 17:19 Mar 02, 2020 Jkt 250001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\03MRN1.SGM 03MRN1 0910–0120 0910–0078 0910–0485 0910–0073 Federal Register / Vol. 85, No. 42 / Tuesday, March 3, 2020 / Notices Dated: February 27, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04361 Filed 3–2–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–P–3082] Determination That NEO TECT KIT (Kit for the Preparation of Technetium TC– 99m Depreotide Injection) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to the product, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Michelle T. Weiner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993–0002, 240– 402–0374, Michelle.Weiner@ fda.hhs.gov. SUMMARY: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was approved previously. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the lotter on DSKBCFDHB2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:19 Mar 02, 2020 Jkt 250001 ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but it must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) is the subject of NDA 021012, currently held by CIS Bio International SA, approved on August 3, 1999. NEO TECT KIT is a scintigraphic imaging agent that identifies somatostatin receptor-bearing pulmonary masses in patients presenting with pulmonary lesions on computed tomography and/or chest x ray who have known malignancy or who are highly suspect for malignancy. NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) is listed as Discontinued in the Orange Book. Andarix Pharmaceuticals, Inc. submitted a citizen petition dated June 25, 2019 (Docket No. FDA–2019–P– 3082), under 21 CFR 10.30, requesting that the Agency determine whether NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) was withdrawn from sale voluntarily for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records with respect to NEO TECT KIT and based on the information we have at this time, FDA has determined under § 314.161 that NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) was not withdrawn from sale for reasons of safety or effectiveness. FDA carefully reviewed its files for records concerning the withdrawal of NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) from sale. In addition, the Agency independently evaluated relevant literature and data for possible post-marketing adverse events. We have found no information that would indicate that this drug PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 12565 product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to NEO TECT KIT (Kit for the Preparation of Technetium Tc 99m Depreotide Injection) may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: February 24, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04319 Filed 3–2–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–E–2615 and FDA– 2018–E–2616] Determination of Regulatory Review Period for Purposes of Patent Extension; ILUMYA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ILUMYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by May 4, 2020. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for SUMMARY: E:\FR\FM\03MRN1.SGM 03MRN1

Agencies

[Federal Register Volume 85, Number 42 (Tuesday, March 3, 2020)]
[Notices]
[Pages 12563-12565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04361]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4436]


Bone Anchors--Premarket Notification (510(k)) Submissions; 
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 a final guidance entitled ``Bone Anchors--Premarket 
Notification (510(k)) Submissions.'' This guidance document provides 
recommendations for 510(k) submissions for bone anchor (suture anchor) 
devices. FDA is clarifying and providing current thinking on the 
recommended content for a bone anchor 510(k) submission, including 
performance testing recommendations and device description.

DATES: The announcement of the guidance is published in the Federal 
Register on March 3, 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

[[Page 12564]]

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-2016-D-4436 for ``Bone Anchors--Premarket Notification (510(k)) 
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.
     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 guidance document entitled 
``Bone Anchors--Premarket Notification (510(k)) Submissions'' 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: Laurence Coyne, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4512, Silver Spring, MD 20993-0002, 301-796-6450.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance document provides recommendations for 510(k) 
submissions for bone anchor (suture anchor) devices, which are 
indicated for attachment of soft tissue to bone. FDA is clarifying and 
providing current thinking on the recommended content for a bone anchor 
510(k) submission, including performance testing recommendations and 
device description. FDA considered comments received on the draft 
guidance that appeared in the Federal Register of January 3, 2017 (82 
FR 128). FDA revised the guidance as appropriate in response to the 
comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Bone Anchors--Premarket Notification 
(510(k)) 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.

III. Electronic Access

    Persons interested in obtaining a copy of the 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 is also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Bone Anchors--Premarket 
Notification (510(k)) Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1400005 and the complete guidance title 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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 regulations have been approved by OMB as listed in the 
following table:

------------------------------------------------------------------------
                                                            OMB control
          21 CFR part                     Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
812............................  Investigational Device        0910-0078
                                  Exemption.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------



[[Page 12565]]

    Dated: February 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04361 Filed 3-2-20; 8:45 am]
 BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.