Notice2024-21435
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 182 (Thursday, September 19, 2024)</title>
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[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76851-76853]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21435]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0022]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 October 21, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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 0910-0511. 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,
<a href="/cdn-cgi/l/email-protection#b7e7e5f6e4c3d6d1d1f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="abfbf9eaf8dfcacdcdebcdcfca85c3c3d885ccc4dd">[email protected]</span></a>.
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 User Fee Cover Sheet, Form FDA 3601 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910-0511--Revision
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
[[Page 76852]]
(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\ <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic</a>.
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In the Federal Register of February 29, 2024 (89 FR 14890), 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\
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Number of Total
FDA form or activity Number of responses per annual Average burden per response Total
respondents respondent responses hours
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User Fee Cover Sheet
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Form FDA 3601 (Medical Device 6,182 1 6,182 0.30 (18 minutes)........... 1,855
User Fee Cover Sheet).
Form FDA 3601a (Device Facility 24,086 1 24,086 0.17 (10 minutes)........... 4,095
User Fee 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 10 1 10 15.......................... 150
use an 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; 114 1 114 12.......................... 1,368
CDRH 513(g) requests.
Sections IV and V of Guidance; 4 1 4 12.......................... 48
CBER 513(g) 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
[[Page 76853]]
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 (AP)). 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 APs to perform
certain inspections. While all firms remain subject to inspection by
FDA, eligible manufacturers have the option of requesting inspection by
an AP. A device establishment is eligible for inspection by APs 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 AP
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 AP 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 modifications to our burden
estimate. In our March 2023 change request submission, we erroneously
excluded the information collection entitled, ``Notification of the
intent to use an Accredited Person.'' We have included the information
collection activity to this renewal. The information collection,
therefore, reflects a cumulative increase in burden by 10 annual
responses and 150 burden hours.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21435 Filed 9-18-24; 8:45 am]
BILLING CODE 4164-01-P
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