Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 71507-71508 [2021-27266]

Download as PDF Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Notices 71507 ACL estimates the burden associated with this collection of information as follows: Number of respondents Respondent/data collection activity Annual burden hours Legal Training, Case Consultation, Technical Assistance Requests ....... Outcome Measurement ............................................................................. 20,000 5,000 1 min 42 sec .................................... 1 min 3 sec ...................................... 700 71.59 Total ................................................................................................... 25,000 4 min 39 sec .................................... 700 Dated: December 12, 2021. Alison Barkoff, Principal Deputy Administrator. [FR Doc. 2021–27258 Filed 12–15–21; 8:45 am] BILLING CODE 4154–01–P 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the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other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 FDA is issuing this draft guidance to promote clarity regarding references to the terms ‘‘device’’ and ‘‘counterfeit device’’ in guidance, regulatory documents, communications, and other public documents. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by February 14, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: khammond on DSKJM1Z7X2PROD with NOTICES Minutes per response Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. VerDate Sep<11>2014 16:54 Dec 15, 2021 Jkt 256001 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 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. PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 • 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 E:\FR\FM\16DEN1.SGM 16DEN1 71508 Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Notices khammond on DSKJM1Z7X2PROD with NOTICES single hard copy of the draft 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, 240–893–1926, 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). As a result of the enactment of the Safeguarding Therapeutics Act (Pub. L. 116–304), the definition of ‘‘device’’ was redesignated as paragraph (h)(1) and a new definition of ‘‘counterfeit device’’ was codified at paragraph (h)(2) of section 201 of the FD&C Act. FDA is issuing this draft 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, when finalized, 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. 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 ‘‘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 VerDate Sep<11>2014 16:54 Dec 15, 2021 Jkt 256001 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. 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 tentatively concludes that this draft 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: December 9, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–27266 Filed 12–15–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training and Primary SUMMARY: PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 Care Medicine and Dentistry (ACTPCMD) will hold public meetings for the 2022 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisorycommittees/primarycare-dentist/ index.html. ACTPCMD meetings will be held on: • February 17, 2022, 10:00 a.m.–5:00 p.m. Eastern Time (ET) and February 18, 2022, 10:00 a.m.–2:00 p.m. ET; and • August 2, 2022, 10:00 a.m.–5:00 p.m. ET. ADDRESSES: Meetings will be held virtually and by teleconference. No inperson meetings will be conducted in 2022. For updates on how the meetings will be held, visit the ACTPCMD website 30 business days before the date of the meeting, where instructions for joining meetings will be posted. For meeting information updates, go to the ACTPCMD website meeting page at https://www.hrsa.gov/advisorycommittees/primarycare-dentist/ meetings.html. DATES: FOR FURTHER INFORMATION CONTACT: Shane Rogers, Designated Federal Official, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Room 15N142, Rockville, Maryland 20857; 301–443–5260; or SRogers@hrsa.gov. SUPPLEMENTARY INFORMATION: The ACTPCMD provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on policy, program development, and other matters of significance concerning the activities under Section 747 of Title VII of the Public Health Service (PHS) Act, as it existed upon the enactment of Section 749 of the PHS Act in 1998. ACTPCMD prepares an annual report describing the activities of the committee, including findings and recommendations made by the committee concerning the activities under Section 747, as well as training programs in oral health and dentistry. The annual report is submitted to the Secretary as well as the Chairman and ranking members of the Senate Committee on Health, Education, Labor and Pensions and the House of Representatives Committee on Energy and Commerce. The ACTPCMD develops, publishes and implements performance measures and guidelines for longitudinal evaluations of programs authorized under Title VII, Part C of the PHS Act, and recommends appropriation levels for programs under this Part. Since priorities dictate E:\FR\FM\16DEN1.SGM 16DEN1

Agencies

[Federal Register Volume 86, Number 239 (Thursday, December 16, 2021)]
[Notices]
[Pages 71507-71508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27266]


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

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; Draft 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 the draft 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 draft guidance to promote clarity 
regarding references to the terms ``device'' and ``counterfeit device'' 
in guidance, regulatory documents, communications, and other public 
documents. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit either electronic or written comments on the draft 
guidance by February 14, 2022 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-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 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

[[Page 71508]]

single hard copy of the draft 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, 240-893-1926, 
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). 
As a result of the enactment of the Safeguarding Therapeutics Act (Pub. 
L. 116-304), the definition of ``device'' was redesignated as paragraph 
(h)(1) and a new definition of ``counterfeit device'' was codified at 
paragraph (h)(2) of section 201 of the FD&C Act.
    FDA is issuing this draft 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, when finalized, 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.
    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 ``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 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. 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 tentatively concludes that this draft 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: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27266 Filed 12-15-21; 8:45 am]
BILLING CODE 4164-01-P

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