Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories, 49850-49851 [2022-17296]
Download as PDF
<![CDATA[
49850
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form name
Eligible Participants .........................................
Eligible Participant ..........................................
Peer Recruiters ...............................................
Behavioral Assessment PWID .......................
Behavioral Assessment HET .........................
Recruiter Debriefing .......................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–17358 Filed 8–11–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0577]
Proposed Information Collection
Activity; Evaluation of LifeSet
Correction
In notice document 2022–16791,
appearing on pages 48033 through
48034 in the issue of Friday, August 5,
2022, make the following corrections:
1. On page 48034, in the table, on the
third row, in the second cell, ‘‘LifeSet
Team
Supervisors’’ should appear below
‘‘LifeSet Specialists’’.
2. On the same page, in the same
table, remove the fourth row including
the text ‘‘LifeSet Team Supervisors’’.
[FR Doc. C1–2022–16791 Filed 8–11–22; 8:45 am]
Submit written comments
(including recommendations) on the
collection of information by September
12, 2022.
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 0910–0823. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
DATES:
Medical Device Accessories
BILLING CODE 0099–10–D
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1593]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Accessories
AGENCY:
Food and Drug Administration,
HHS.
jspears on DSK121TN23PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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.
SUMMARY:
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
OMB Control Number 0910–0823—
Extension
FDA’s guidance document entitled
‘‘Medical Device Accessories—
Describing Accessories and
Classification Pathways’’ 1 is intended to
provide guidance to industry and FDA
staff about the regulation of accessories
to medical devices, to describe FDA’s
policy concerning the classification of
accessories, and to discuss the
application of this policy to devices that
are commonly used as accessories to
other medical devices. In addition, the
guidance explains what devices FDA
generally considers an ‘‘accessory’’ and
describes the processes under section
513(f)(6) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(f)(6)) to
1 The guidance document is available on FDA’s
website (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
medical-device-accessories-describing-accessoriesand-classification-pathways).
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
3,333
3,333
3,333
Number of
responses per
respondent
1
1
1
Average
burden
per response
(in hours)
43/60
31/60
2/60
allow requests for risk- and regulatory
control-based classification of
accessories.
The FDA Reauthorization Act of 2017
(FDARA) (Pub. L. 115–52) changed how
FDA regulates medical device
accessories. Specifically, section 707 of
FDARA added section 513(f)(6) to the
statute and requires that FDA, upon
request, classify existing and new
accessories notwithstanding the
classification of any other device with
which such accessory is intended to be
used. This means that the classification
of an accessory may not be the same as
its parent device, depending on the risks
of the accessory when used as intended
and the level of regulatory controls
necessary for reasonable assurance of
safety and effectiveness of the accessory.
Until an accessory is distinctly
classified, its existing classification will
continue to apply. This provision does
not preclude a manufacturer from
submitting a De Novo request for an
accessory.
Depending on an accessory’s
regulatory history, there are different
submission types, tracking mechanisms,
and deadlines:
(1) Existing accessory types are those
that have been identified in a
classification regulation or granted
marketing authorization as part of a
510(k), premarket approval application
(PMA), or De Novo request (approved
under OMB control numbers 0910–
0120, 0910–0231, and 0910–0844,
respectively). Manufacturers with
marketing authorization for an existing
accessory may request appropriate
classification through a new stand-alone
premarket submission (Existing
Accessory Request). Upon request, FDA
is required to meet with a manufacturer
or importer to discuss the appropriate
classification of an existing accessory
prior to submitting a written request.
Existing Accessory Requests will be
initially tracked as ‘‘Q-submissions’’
(approved under OMB control number
0910–0756). FDA has a statutory
deadline of 85 calendar days to respond
to an Existing Accessory Request.
(2) New accessory types are those that
have not been granted marketing
authorization as part of a 510(k), PMA,
E:\FR\FM\12AUN1.SGM
12AUN1
49851
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
or De Novo request. Manufacturers may
include new accessories into a 510(k) or
PMA with the parent device (New
Accessory Request). New Accessory
Requests will have the same deadline as
the 510(k) or PMA. Therefore, new
accessory types should follow the
applicable Medical Device User Fee
Amendments of 2017 deadline for the
parent submission. The decision for
New Accessory Requests will be
accessory type. If FDA denies the
Accessory Request, FDA must issue a
letter with a detailed description and
justification for our determination.
In the Federal Register of March 16,
2022 (87 FR 14891), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
separate from the decision for the
marketing application.
For both Existing and New Accessory
Requests, manufacturers must request
proper classification of their accessory
in the submission and include draft
special controls, if requesting
classification into class II. The processes
that we use to classify an accessory will
be like those used for De Novo requests.
If FDA grants the Accessory Request,
FDA must issue an order establishing a
new classification regulation for the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; guidance for industry (GFI) section
Total annual
responses
Average
burden per
response
Total hours
Existing Accessory Request; GFI VI.A ................................
New Accessory Request ......................................................
10
5
1
1
10
5
40
40
400
200
Total ..............................................................................
........................
........................
........................
........................
600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
GL16(R1)) entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Porcines
(Revision 1).’’ This draft guidance has
been developed for veterinary use by the
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products (VICH).
This revision clarifies the definition of
adequate infection in individual
animals, updates considerations for
field studies, and makes additional
clarifying changes.
DATES: Submit either electronic or
written comments on the draft guidance
by October 11, 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:
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2022–D–1494]
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
Based on an evaluation of the
information collection, we have reduced
the estimated number of existing
requests from 15 to 10, and we have
reduced the estimated number of new
requests from 10 to 5. This adjustment
results in an overall reduction to the
information collection by 10 responses
and 400 hours annually. We believe
these adjustments more accurately
reflect the current number of requests
associated with medical device
accessory classifications.
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17296 Filed 8–11–22; 8:45 am]
BILLING CODE 4164–01–P
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products;
Effectiveness of Anthelmintics:
Specific Recommendations for
Porcines (Revision 1); Draft Guidance
for Industry; Availability
jspears on DSK121TN23PROD with NOTICES
Number of
responses per
respondent
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #110 (VICH
SUMMARY:
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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–
2022–D–1494 for ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Porcines
(Revision 1).’’ 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
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49850-49851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17296]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1593]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Accessories
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 12, 2022.
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 0910-0823. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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.
Medical Device Accessories
OMB Control Number 0910-0823--Extension
FDA's guidance document entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways'' \1\ is intended to
provide guidance to industry and FDA staff about the regulation of
accessories to medical devices, to describe FDA's policy concerning the
classification of accessories, and to discuss the application of this
policy to devices that are commonly used as accessories to other
medical devices. In addition, the guidance explains what devices FDA
generally considers an ``accessory'' and describes the processes under
section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360c(f)(6)) to allow requests for risk- and regulatory control-
based classification of accessories.
---------------------------------------------------------------------------
\1\ The guidance document is available on FDA's website (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways).
---------------------------------------------------------------------------
The FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52)
changed how FDA regulates medical device accessories. Specifically,
section 707 of FDARA added section 513(f)(6) to the statute and
requires that FDA, upon request, classify existing and new accessories
notwithstanding the classification of any other device with which such
accessory is intended to be used. This means that the classification of
an accessory may not be the same as its parent device, depending on the
risks of the accessory when used as intended and the level of
regulatory controls necessary for reasonable assurance of safety and
effectiveness of the accessory. Until an accessory is distinctly
classified, its existing classification will continue to apply. This
provision does not preclude a manufacturer from submitting a De Novo
request for an accessory.
Depending on an accessory's regulatory history, there are different
submission types, tracking mechanisms, and deadlines:
(1) Existing accessory types are those that have been identified in
a classification regulation or granted marketing authorization as part
of a 510(k), premarket approval application (PMA), or De Novo request
(approved under OMB control numbers 0910-0120, 0910-0231, and 0910-
0844, respectively). Manufacturers with marketing authorization for an
existing accessory may request appropriate classification through a new
stand-alone premarket submission (Existing Accessory Request). Upon
request, FDA is required to meet with a manufacturer or importer to
discuss the appropriate classification of an existing accessory prior
to submitting a written request. Existing Accessory Requests will be
initially tracked as ``Q-submissions'' (approved under OMB control
number 0910-0756). FDA has a statutory deadline of 85 calendar days to
respond to an Existing Accessory Request.
(2) New accessory types are those that have not been granted
marketing authorization as part of a 510(k), PMA,
[[Page 49851]]
or De Novo request. Manufacturers may include new accessories into a
510(k) or PMA with the parent device (New Accessory Request). New
Accessory Requests will have the same deadline as the 510(k) or PMA.
Therefore, new accessory types should follow the applicable Medical
Device User Fee Amendments of 2017 deadline for the parent submission.
The decision for New Accessory Requests will be separate from the
decision for the marketing application.
For both Existing and New Accessory Requests, manufacturers must
request proper classification of their accessory in the submission and
include draft special controls, if requesting classification into class
II. The processes that we use to classify an accessory will be like
those used for De Novo requests. If FDA grants the Accessory Request,
FDA must issue an order establishing a new classification regulation
for the accessory type. If FDA denies the Accessory Request, FDA must
issue a letter with a detailed description and justification for our
determination.
In the Federal Register of March 16, 2022 (87 FR 14891), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity; guidance for industry Number of responses per Total annual burden per Total hours
(GFI) section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Existing Accessory Request; GFI 10 1 10 40 400
VI.A...........................
New Accessory Request........... 5 1 5 40 200
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on an evaluation of the information collection, we have
reduced the estimated number of existing requests from 15 to 10, and we
have reduced the estimated number of new requests from 10 to 5. This
adjustment results in an overall reduction to the information
collection by 10 responses and 400 hours annually. We believe these
adjustments more accurately reflect the current number of requests
associated with medical device accessory classifications.
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17296 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P
