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the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
| Published date | 16 December 2021 |
| Citation | 86 FR 71507 |
| Record Number | 2021-27266 |
| Section | Notices |
| Court | Food And Drug Administration |
71507
Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / Notices
ACL estimates the burden associated
with this collection of information as
follows:
Respondent/data collection activity Number of
respondents Minutes per
response Annual burden
hours
Legal Training, Case Consultation, Technical Assistance Requests ....... 20,000 1 min 42 sec .................................... 700
Outcome Measurement ............................................................................. 5,000 1 min 3 sec ...................................... 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Other Public Documents; Draft
Guidance for Industry and Food and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.
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announcing the availability of the draft
guidance entitled ‘‘Referencing the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 FDA is issuing this draft
guidance to promote clarity regarding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 This draft
guidance is not final nor is it in effect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written comments on the draft guidance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draft guidance before it begins work on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
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Federal Register / Vol. 86, No. 239 / Thursday, December 16, 2021 / 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
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 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
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION
: Notice.
SUMMARY
: In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Training and Primary
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/advisory-
committees/primarycare-dentist/
index.html.
DATES
: 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 in-
person 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/advisory-
committees/primarycare-dentist/
meetings.html.
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
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