Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff; Availability, 68179-68180 [2022-24707]

Download as PDF Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices khammond on DSKJM1Z7X2PROD with NOTICES hematopoietic stem cell transplant. Subsequent to this approval, the USPTO received a patent term restoration application for PREVYMIS (U.S. Patent No. RE46791) from AiCuris Antiinfective Cures GmbH, and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated June 21, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of PREVYMIS (NDA 209939) represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for PREVYMIS–RE46791 (NDA 209939) is 3,157 days. Of this time, 2,911 days occurred during the testing phase of the regulatory review period, while 246 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: March 20, 2009. The applicant claims February 19, 2009, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was March 20, 2009, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: March 8, 2017. FDA has verified the applicant’s claim that NDA 209939 for PREVYMIS was initially submitted on March 8, 2017. 3. The date the application was approved: November 8, 2017. FDA has verified the applicant’s claim that NDA 209939 was approved on November 8, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension for patent number RE46791, this applicant seeks 1,701 days of patent term extension. Note: We have determined that the regulatory review period for the human drug product, PREVYMIS, approved under NDA 209939 is the same as the regulatory review period determined for VerDate Sep<11>2014 17:30 Nov 10, 2022 Jkt 259001 the human drug product, PREVYMIS, approved under NDA 209940. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 68179 Documents.’’ FDA is issuing this guidance to promote clarity regarding references to the terms ‘‘device’’ and ‘‘counterfeit device’’ in guidance, regulatory documents, communications, and other public documents. DATES: The announcement of the guidance is published in the Federal Register on November 14, 2022. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES 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’’). Food and Drug Administration Written/Paper Submissions [Docket No. FDA–2021–D–0997] 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– 2021–D–0997 for ‘‘Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Dated: November 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–24718 Filed 11–10–22; 8:45 am] BILLING CODE 4164–01–P Referencing the Definition of ‘‘Device’’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; 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, Agency, or we) is announcing the availability of a final guidance entitled ‘‘Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public SUMMARY: PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\14NON1.SGM 14NON1 khammond on DSKJM1Z7X2PROD with NOTICES 68180 Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices Documents.’’ 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 information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance VerDate Sep<11>2014 17:30 Nov 10, 2022 Jkt 259001 document entitled ‘‘Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents’’ to the Office of Policy, 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: Eli Tomar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5462, Silver Spring, MD 20993–0002, 301–796–0699; 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 For many years, the definition of ‘‘device’’ has been codified at section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)). As a result of the enactment of the Safeguarding Therapeutics Act (Pub. L. 116–304), the definition of ‘‘device’’ was redesignated as subsection (h)(1) and a new definition of ‘‘counterfeit device’’ was codified at subsection (h)(2) of section 201 of the FD&C Act. FDA is issuing this final guidance to clarify how the Agency intends to interpret existing references to section 201(h) of the FD&C Act and how we intend to reference the definitions of ‘‘device’’ and ‘‘counterfeit device’’ going forward. This guidance is intended to provide clarity on references to the terms ‘‘device’’ and ‘‘counterfeit device’’—as well as references to section 201(h) of the FD&C Act—in guidance, regulatory documents, and other communications and documents for FDA staff, industry, and other stakeholders. To minimize the potential for miscommunication, FDA also encourage stakeholders, to the extent practicable, to align with the conventions described in the guidance. A notice of availability of the draft guidance appeared in the Federal Register of December 16, 2021 (86 FR 71507). FDA considered comments received and revised the guidance to improve clarity, including adding PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 examples of how the policy in the guidance should be applied. 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 ‘‘Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.’’ 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 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. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. Persons unable to download an electronic copy of ‘‘Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 21008 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 FDA concludes that this guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. Dated: November 8, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–24707 Filed 11–10–22; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\14NON1.SGM 14NON1

Agencies

[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68179-68180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0997]


Referencing the Definition of ``Device'' in the Federal Food, 
Drug, and Cosmetic Act in Guidance, Regulatory Documents, 
Communications, and Other Public Documents; 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, Agency, or we) is 
announcing the availability of a final guidance entitled ``Referencing 
the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act 
in Guidance, Regulatory Documents, Communications, and Other Public 
Documents.'' FDA is issuing this guidance to promote clarity regarding 
references to the terms ``device'' and ``counterfeit device'' in 
guidance, regulatory documents, communications, and other public 
documents.

DATES: The announcement of the guidance is published in the Federal 
Register on November 14, 2022.

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'').

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-2021-D-0997 for ``Referencing the Definition of `Device' in the 
Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, 
Communications, and Other Public

[[Page 68180]]

Documents.'' 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 guidance document entitled 
``Referencing the Definition of `Device' in the Federal Food, Drug, and 
Cosmetic Act in Guidance, Regulatory Documents, Communications, and 
Other Public Documents'' to the Office of Policy, 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: Eli Tomar, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5462, Silver Spring, MD 20993-0002, 301-796-0699; 
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

    For many years, the definition of ``device'' has been codified at 
section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 321(h)). As a result of the enactment of the Safeguarding 
Therapeutics Act (Pub. L. 116-304), the definition of ``device'' was 
redesignated as subsection (h)(1) and a new definition of ``counterfeit 
device'' was codified at subsection (h)(2) of section 201 of the FD&C 
Act.
    FDA is issuing this final guidance to clarify how the Agency 
intends to interpret existing references to section 201(h) of the FD&C 
Act and how we intend to reference the definitions of ``device'' and 
``counterfeit device'' going forward. This guidance is intended to 
provide clarity on references to the terms ``device'' and ``counterfeit 
device''--as well as references to section 201(h) of the FD&C Act--in 
guidance, regulatory documents, and other communications and documents 
for FDA staff, industry, and other stakeholders. To minimize the 
potential for miscommunication, FDA also encourage stakeholders, to the 
extent practicable, to align with the conventions described in the 
guidance.
    A notice of availability of the draft guidance appeared in the 
Federal Register of December 16, 2021 (86 FR 71507). FDA considered 
comments received and revised the guidance to improve clarity, 
including adding examples of how the policy in the guidance should be 
applied.
    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 ``Referencing the Definition of `Device' in 
the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory 
Documents, Communications, and Other Public Documents.'' 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 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. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of 
``Referencing the Definition of `Device' in the Federal Food, Drug, and 
Cosmetic Act in Guidance, Regulatory Documents, Communications, and 
Other Public Documents'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 21008 and complete title to identify the 
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    FDA concludes that this guidance contains no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

    Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24707 Filed 11-10-22; 8:45 am]
BILLING CODE 4164-01-P

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