Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period, 42843-42845 [2021-16695]

Download as PDF Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices and adjust results based on those factors. The mode experiment is designed to examine the effects of the shortened survey on response rates and scores and to provide precise adjustment estimates for survey items and composites on the shortened survey instrument. Information from this mode experiment will help CMS determine whether an additional mode of administration (i.e., Web data collection) should be included and a shortened survey instrument should be used in the current national implementation of the HHCAHPS Survey. Form Number: CMS–10784 (OMB control number: 0938–New); Frequency: Annually; Affected Public: Individuals or Households; Number of Respondents: 6,280; Total Annual Responses: 6,280; Total Annual Hours: 1,049. (For policy questions regarding this collection contact Lori E. Teichman at 410–786–6684). Dated: August 2, 2021. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2021–16755 Filed 8–4–21; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–P–0271] Determination That VOTRIENT (Pazopanib Hydrochloride) Tablets, 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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(FDA or Agency) has determined that VOTRIENT (pazopanib hydrochloride) tablets, 400 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pazopanib hydrochloride tablets, 400 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6212, Silver Spring, MD 20993–0002, 240– 402–9674, Sungjoon.Chi@fda.hhs.gov. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:07 Aug 04, 2021 Jkt 253001 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 previously approved. 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 ‘‘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 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. VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, are the subject of NDA 022465, held by Novartis Pharmaceuticals Corp., and initially approved on October 19, 2009. VOTRIENT is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma. VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, are currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated March 5, 2021 (Docket No. FDA–2021– P–0271), under 21 CFR 10.30, requesting that the Agency determine whether VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, were withdrawn from sale for reasons of safety or effectiveness. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 42843 After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, 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 VOTRIENT (pazopanib hydrochloride) tablets, 400 mg, 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: July 29, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–16692 Filed 8–4–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3741] Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability; extension of comment period. AGENCY: E:\FR\FM\05AUN1.SGM 05AUN1 42844 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ‘‘Remanufacturing of Medical Devices.’’ The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the notice of availability published June 24, 2021 (86 FR 33305). Submit either electronic or written comments on the draft guidance by September 22, 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: 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’’). khammond on DSKJM1Z7X2PROD 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 VerDate Sep<11>2014 17:07 Aug 04, 2021 Jkt 253001 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– 2018–N–3741 for ‘‘Remanufacturing of Medical Devices.’’ 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-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 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Remanufacturing of Medical Devices’’ 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 or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Katelyn Bittleman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993–0002, 240–402–1478; Joshua Silverstein, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993–0002, 301–796–5155; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240–402– 7911. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 24, 2021, FDA published a notice of availability with a 60-day comment period to request comments on the draft guidance for industry and FDA staff entitled ‘‘Remanufacturing of Medical Devices.’’ The Agency has received a request for a 30-day extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response. FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until September 22, 2021. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues. 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 ‘‘Remanufacturing of Medical E:\FR\FM\05AUN1.SGM 05AUN1 Federal Register / Vol. 86, No. 148 / Thursday, August 5, 2021 / Notices Devices.’’ 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 or from the Center for Biologics Evaluation and Research at https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. This guidance document is also available at https://www.regulations.gov and https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Persons unable to download an electronic copy of ‘‘Remanufacturing of Medical Devices’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17048 and complete title to identify the guidance you are requesting. Dated: July 30, 2021. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by September 7, 2021. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https:// www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. The OMB control number for this information collection is 0910–0799. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: intervals (1998, 2003, and 2008) to observe and document trends in the occurrence of the following foodborne illness risk factors: • Food from Unsafe Sources, • Poor Personal Hygiene, • Inadequate Cooking, • Improper Holding/Time and Temperature, and • Contaminated Equipment/CrossContamination. FDA developed reports summarizing the findings for each of the three data collection periods, which were released in 2000, 2004, and 2009 (Refs. 1 to 3). Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types (Ref. 4). Using this 10-year survey as a foundation, in 2013 to 2014, FDA initiated a new study period. This study will span 10 years. FDA completed the baseline data collection in select healthcare, schools, and retail food store facility types in 2015 to 2016, and these data are being evaluated for trends and significance. A second data collection began in 2019 to 2020 and will be completed if it is safe to do so (pending COVID–19 pandemic), and an additional data collection is planned for 2023 to 2024 (the subject of this information collection request extension). Three data collections are necessary to trend the data. OMB Control Number 0910–0799— Extension Food and Drug Administration [Docket No. FDA–2018–N–0270] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types khammond on DSKJM1Z7X2PROD with NOTICES Notice. Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types [FR Doc. 2021–16695 Filed 8–4–21; 8:45 am] Food and Drug Administration, Health and Human Services (HHS). AGENCY: ACTION: 42845 I. Background From 1998 to 2008, FDA’s National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data were collected by FDA Specialists in retail and foodservice establishments at 5-year TABLE 1—DESCRIPTION OF THE FACILITY TYPES INCLUDED IN THE SURVEY Facility type Description Healthcare Facilities ........................ VerDate Sep<11>2014 17:07 Aug 04, 2021 Jkt 253001 Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible populations as defined as follows: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\05AUN1.SGM 05AUN1

Agencies

[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42843-42845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3741]


Remanufacturing of Medical Devices; Draft Guidance for Industry 
and Food and Drug Administration Staff; Availability; Extension of 
Comment Period

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice of availability; extension of comment period.

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

[[Page 42844]]

SUMMARY: The Food and Drug Administration (FDA or Agency) is extending 
the comment period for the notice of availability that appeared in the 
Federal Register of June 24, 2021. In the notice of availability, FDA 
requested comments on draft guidance for industry and FDA staff 
entitled ``Remanufacturing of Medical Devices.'' The Agency is taking 
this action in response to a request for an extension to allow 
interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the notice of 
availability published June 24, 2021 (86 FR 33305). Submit either 
electronic or written comments on the draft guidance by September 22, 
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:

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-2018-N-3741 for ``Remanufacturing of Medical Devices.'' 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 
``Remanufacturing of Medical Devices'' 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 or to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.

FOR FURTHER INFORMATION CONTACT: Katelyn Bittleman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4250, Silver Spring, MD 20993-0002, 240-
402-1478; Joshua Silverstein, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1615, Silver Spring, MD 20993-0002, 301-796-5155; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 24, 2021, FDA published a notice of 
availability with a 60-day comment period to request comments on the 
draft guidance for industry and FDA staff entitled ``Remanufacturing of 
Medical Devices.''
    The Agency has received a request for a 30-day extension of the 
comment period. The request conveyed concern that the current 60-day 
comment period does not allow sufficient time to develop a meaningful 
or thoughtful response.
    FDA has considered the request and is extending the comment period 
for the notice of availability for 30 days, until September 22, 2021. 
The Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
guidance on these important issues.
    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 
``Remanufacturing of Medical

[[Page 42845]]

Devices.'' 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 or from the Center for 
Biologics Evaluation and Research at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. This guidance document is also available at 
https://www.regulations.gov and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download 
an electronic copy of ``Remanufacturing of Medical Devices'' may send 
an email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 17048 and complete 
title to identify the guidance you are requesting.

    Dated: July 30, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-16695 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P

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