Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a, 14890-14892 [2024-04163]
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14890
Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04234 Filed 2–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0022]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Cover Sheet, Form FDA 3601
and Device Facility User Fee Cover
Sheet, Form 3601a
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information and to
allow 60 days for public comment in
response to the notice. This notice
solicits comments on the extension of
this information collection.
DATES: Either electronic or written
comments on the collection of
information must be submitted by April
29, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 29, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
khammond on DSKJM1Z7X2PROD with NOTICES
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
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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–
2024–N–0022 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device User Fee Cover Sheet, Form FDA
3601 and Device Facility User Fee Cover
Sheet, Form 3601a.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
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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.
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: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including extension of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
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Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device User Fee Cover Sheet,
Form FDA 3601 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910–0511—
Extension
This information collection supports
the FDA medical device and device user
fee programs. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the Medical Device User
Fee and Modernization Act of 2002
(MDUFMA) (Pub. L. 107–250), and the
Medical Device User Fee Amendments
of 2007 (Title II of the Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110–85)),
authorizes FDA to collect user fees for
certain medical device applications.
Under this authority, companies pay a
fee for certain new medical device
applications or supplements submitted
to the Agency for review. Because the
submission of user fees concurrently
with applications and supplements is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 3601, the ‘‘Medical Device
User Fee Cover Sheet,’’ is designed to
provide the minimum necessary
information to determine whether a fee
is required for review of an application,
to determine the amount of the fee
required, and to account for and track
user fees. Form FDA 3601 and
instructions are available online for
registered users. The form provides a
cross-reference between the fees
submitted for an application with the
actual submitted application by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Devices and Radiological
Health (CDRH) and FDA’s Center for
Biologics Evaluation and Research
(CBER) to initiate the administrative
screening of new medical device
applications and supplemental
applications.
Owners or operators of places of
business (also called establishments or
facilities) that are involved in the
production and distribution of medical
devices intended for use in the United
States are required to register annually
with FDA, a process known as
establishment registration (21 CFR part
807, subparts A through D). (The
information collection for medical
device establishment registration and
listing is approved under OMB control
number 0910–0625.) All establishments
required to register must pay a user fee.
Form FDA 3601a, the ‘‘Device Facility
14891
User Fee Cover Sheet,’’ is designed to
collect payments for the annual
establishment registration fee for
medical device establishments.
Under section 704(g) of the FD&C Act
(21 U.S.C. 374(g)), FDA may accredit
persons to inspect qualified
manufacturers of class II and class III
devices. An eligible establishment is
permitted to select any FDA-accredited
person to conduct an inspection in lieu
of an FDA inspection, but the eligible
establishment must submit notice to
FDA for selection approval (see 21
U.S.C. 374(g)(1) and (g)(6)(B)). Referred
to as the ‘‘Accredited Persons Inspection
Program,’’ FDA publishes a complete
list of accredited persons and the
activities for which they are accredited
on our website at Third Party Device
Inspection,1 along with additional
information about the program.
The guidance document entitled
‘‘FDA and Industry Procedures for
Section 513(g) Requests for Information
under the Federal Food, Drug, and
Cosmetic Act’’ (December 2019) 2
provides FDA’s recommendations
regarding provision of user fees for
513(g) requests for information under
section 738(a)(2)(A)(ix) of the FD&C Act
(21 U.S.C. 379j(a)(2)(A)(ix)). Instructions
for submission and specific content
elements are discussed in the guidance
document in sections IV and V,
respectively.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
FDA form or activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
User Fee Cover Sheet
Form FDA 3601 (Medical Device User Fee Cover
Sheet).
Form FDA 3601a (Device Facility User Fee Cover
Sheet).
Subtotal ................................................................
6,182
1
6,182
0.30 (18 minutes) ..
1,855
24,086
1
24,086
0.17 (10 minutes) ...
4,095
........................
........................
30,268
................................
5,950
khammond on DSKJM1Z7X2PROD with NOTICES
Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
Request for accreditation ............................................
Notification of the intent to use an Accredited Person
1
10
1
1
1
10
80 ...........................
15 ...........................
80
150
Subtotal ................................................................
........................
........................
11
................................
230
12 ...........................
1,368
Request for Information Under Section 513(g) of the FD&C Act
Sections IV and V of Guidance; CDRH 513(g) requests.
1 https://www.fda.gov/medical-devices/
postmarket-requirements-devices/third-partyinspection-devices.
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114
1
114
2 FDA and Industry Procedures for Section 513(g)
Requests for Information under the Federal Food,
Drug, and Cosmetic Act | FDA.
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14892
Federal Register / Vol. 89, No. 41 / Thursday, February 29, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Total annual
responses
Average burden per
response
Total hours
Sections IV and V of Guidance; CBER 513(g) requests.
4
1
4
12 ...........................
48
Subtotal ................................................................
........................
........................
118
................................
1,416
Total ..............................................................
........................
........................
........................
................................
7,596
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
User Fee Cover Sheet
According to FDA’s database system,
manufacturers of products subject to
MDUFMA submit an average of 6,182
applications annually and submit an
average of 24,086 Device Facility User
Fee applications. However, not all
manufacturers will have any cover sheet
submissions in a given year and some
may have multiple cover sheet
submissions. The estimated hours per
response are based on past FDA
experience with the various cover sheet
submissions and range from 5 to 30
minutes. The hours per response are
based on the average of these estimates
(18 minutes). The total hours are
rounded to the nearest whole number.
Inspection by Accredited Persons
Program Under Section 704 of the FD&C
Act
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
FDA form or activity
Section 704(g) of the FD&C Act
provides for accreditation of persons for
the purpose of conducting inspections
and provides the minimum
requirements a person must meet to be
accredited to conduct inspections (an
Accredited Person). The burden
estimate for requests for accreditation is
based on the number of applications
we’ve received. Once an organization is
accredited, it will not be required to
reapply.
The AP Program permits eligible
manufacturers to use Accredited
Persons to perform certain inspections.
While all firms remain subject to
inspection by FDA, eligible
manufacturers have the option of
requesting inspection by an Accredited
Person. A device establishment is
eligible for inspection by Accredited
Persons if the establishment meets
certain conditions of section 704(g)(6) of
the FD&C Act, including that they
provide notice of their intention to use
an Accredited Person to conduct
inspections of the establishment.
We estimate there are 4,000 domestic
manufacturers and 4,000 foreign
manufacturers that are eligible for
inclusion under the AP program. Based
on informal communications with
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16:39 Feb 28, 2024
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industry, approximately 10 of these
manufacturers may submit a request to
use an Accredited Person in any given
year.
Request for Information Under Section
513(g) of the FD&C Act
Respondents may elect to prepare
their 513(g) request for information
using CDRH’s electronic Submission
Template and Resource (eSTAR)
voluntary guided submission
preparation tool, which was developed
to improve submission consistency and
enhance efficiency in the review
process. The total number of annual
responses is based on the average
number of 513(g) requests received each
year by CDRH and CBER respectively.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04163 Filed 2–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2022–E–0920; FDA–
2022–E–0921; FDA–2022–E–0923]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CAMCEVI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for CAMCEVI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
SUMMARY:
PO 00000
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of Commerce, for the extension of a
patent which claims that human drug
product.
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 29, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 27, 2024. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 29, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
ADDRESSES:
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
E:\FR\FM\29FEN1.SGM
29FEN1
]]>Agencies
[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14890-14892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04163]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0022]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and
Device Facility User Fee Cover Sheet, Form 3601a
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on the extension of this information collection.
DATES: Either electronic or written comments on the collection of
information must be submitted by April 29, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 29, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2024-N-0022 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device User Fee Cover
Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form
3601a.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.
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: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
[[Page 14891]]
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910-0511--Extension
This information collection supports the FDA medical device and
device user fee programs. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA) (Pub. L. 107-250), and the Medical Device User Fee
Amendments of 2007 (Title II of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Pub. L. 110-85)), authorizes FDA to
collect user fees for certain medical device applications. Under this
authority, companies pay a fee for certain new medical device
applications or supplements submitted to the Agency for review. Because
the submission of user fees concurrently with applications and
supplements is required, the review of an application cannot begin
until the fee is submitted. Form FDA 3601, the ``Medical Device User
Fee Cover Sheet,'' is designed to provide the minimum necessary
information to determine whether a fee is required for review of an
application, to determine the amount of the fee required, and to
account for and track user fees. Form FDA 3601 and instructions are
available online for registered users. The form provides a cross-
reference between the fees submitted for an application with the actual
submitted application by using a unique number tracking system. The
information collected is used by FDA's Center for Devices and
Radiological Health (CDRH) and FDA's Center for Biologics Evaluation
and Research (CBER) to initiate the administrative screening of new
medical device applications and supplemental applications.
Owners or operators of places of business (also called
establishments or facilities) that are involved in the production and
distribution of medical devices intended for use in the United States
are required to register annually with FDA, a process known as
establishment registration (21 CFR part 807, subparts A through D).
(The information collection for medical device establishment
registration and listing is approved under OMB control number 0910-
0625.) All establishments required to register must pay a user fee.
Form FDA 3601a, the ``Device Facility User Fee Cover Sheet,'' is
designed to collect payments for the annual establishment registration
fee for medical device establishments.
Under section 704(g) of the FD&C Act (21 U.S.C. 374(g)), FDA may
accredit persons to inspect qualified manufacturers of class II and
class III devices. An eligible establishment is permitted to select any
FDA-accredited person to conduct an inspection in lieu of an FDA
inspection, but the eligible establishment must submit notice to FDA
for selection approval (see 21 U.S.C. 374(g)(1) and (g)(6)(B)).
Referred to as the ``Accredited Persons Inspection Program,'' FDA
publishes a complete list of accredited persons and the activities for
which they are accredited on our website at Third Party Device
Inspection,\1\ along with additional information about the program.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/medical-devices/postmarket-requirements-devices/third-party-inspection-devices.
---------------------------------------------------------------------------
The guidance document entitled ``FDA and Industry Procedures for
Section 513(g) Requests for Information under the Federal Food, Drug,
and Cosmetic Act'' (December 2019) \2\ provides FDA's recommendations
regarding provision of user fees for 513(g) requests for information
under section 738(a)(2)(A)(ix) of the FD&C Act (21 U.S.C.
379j(a)(2)(A)(ix)). Instructions for submission and specific content
elements are discussed in the guidance document in sections IV and V,
respectively.
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\2\ FDA and Industry Procedures for Section 513(g) Requests for
Information under the Federal Food, Drug, and Cosmetic Act [verbar]
FDA.
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FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
FDA form or activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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User Fee Cover Sheet
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Form FDA 3601 (Medical Device User Fee Cover 6,182 1 6,182 0.30 (18 minutes)........................ 1,855
Sheet).
Form FDA 3601a (Device Facility User Fee 24,086 1 24,086 0.17 (10 minutes)........................ 4,095
Cover Sheet).
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Subtotal................................. .............. .............. 30,268 ......................................... 5,950
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Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
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Request for accreditation.................... 1 1 1 80....................................... 80
Notification of the intent to use an 10 1 10 15....................................... 150
Accredited Person.
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Subtotal................................. .............. .............. 11 ......................................... 230
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Request for Information Under Section 513(g) of the FD&C Act
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Sections IV and V of Guidance; CDRH 513(g) 114 1 114 12....................................... 1,368
requests.
[[Page 14892]]
Sections IV and V of Guidance; CBER 513(g) 4 1 4 12....................................... 48
requests.
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Subtotal................................. .............. .............. 118 ......................................... 1,416
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Total................................ .............. .............. .............. ......................................... 7,596
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
User Fee Cover Sheet
According to FDA's database system, manufacturers of products
subject to MDUFMA submit an average of 6,182 applications annually and
submit an average of 24,086 Device Facility User Fee applications.
However, not all manufacturers will have any cover sheet submissions in
a given year and some may have multiple cover sheet submissions. The
estimated hours per response are based on past FDA experience with the
various cover sheet submissions and range from 5 to 30 minutes. The
hours per response are based on the average of these estimates (18
minutes). The total hours are rounded to the nearest whole number.
Inspection by Accredited Persons Program Under Section 704 of the FD&C
Act
Section 704(g) of the FD&C Act provides for accreditation of
persons for the purpose of conducting inspections and provides the
minimum requirements a person must meet to be accredited to conduct
inspections (an Accredited Person). The burden estimate for requests
for accreditation is based on the number of applications we've
received. Once an organization is accredited, it will not be required
to reapply.
The AP Program permits eligible manufacturers to use Accredited
Persons to perform certain inspections. While all firms remain subject
to inspection by FDA, eligible manufacturers have the option of
requesting inspection by an Accredited Person. A device establishment
is eligible for inspection by Accredited Persons if the establishment
meets certain conditions of section 704(g)(6) of the FD&C Act,
including that they provide notice of their intention to use an
Accredited Person to conduct inspections of the establishment.
We estimate there are 4,000 domestic manufacturers and 4,000
foreign manufacturers that are eligible for inclusion under the AP
program. Based on informal communications with industry, approximately
10 of these manufacturers may submit a request to use an Accredited
Person in any given year.
Request for Information Under Section 513(g) of the FD&C Act
Respondents may elect to prepare their 513(g) request for
information using CDRH's electronic Submission Template and Resource
(eSTAR) voluntary guided submission preparation tool, which was
developed to improve submission consistency and enhance efficiency in
the review process. The total number of annual responses is based on
the average number of 513(g) requests received each year by CDRH and
CBER respectively.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: February 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04163 Filed 2-28-24; 8:45 am]
BILLING CODE 4164-01-P
