Notice2024-04163
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
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Published
February 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 41 (Thursday, February 29, 2024)</title>
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[Federal Register Volume 89, Number 41 (Thursday, February 29, 2024)]
[Notices]
[Pages 14890-14892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-04163]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#ebbbb9aab89f8a8d8dab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="bbebe9fae8cfdaddddfbdddfda95d3d3c895dcd4cd">[email protected]</span></a>.
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.
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\1\ <a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/third-party-inspection-devices">https://www.fda.gov/medical-devices/postmarket-requirements-devices/third-party-inspection-devices</a>.
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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.
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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
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