[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76851-76853]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21435]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 0910-0511. 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, 
[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 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    \2\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.
---------------------------------------------------------------------------

    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\
----------------------------------------------------------------------------------------------------------------
                                                 Number of       Total
      FDA form or activity        Number of    responses per     annual     Average burden per response   Total
                                 respondents    respondent     responses                                  hours
----------------------------------------------------------------------------------------------------------------
                                              User Fee Cover Sheet
----------------------------------------------------------------------------------------------------------------
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).
                                --------------------------------------------------------------------------------
    Subtotal...................  ...........  ..............       30,268  ............................    5,950
----------------------------------------------------------------------------------------------------------------
                   Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
----------------------------------------------------------------------------------------------------------------
Request for accreditation......            1               1            1  80..........................       80
Notification of the intent to             10               1           10  15..........................      150
 use an Accredited Person.
                                --------------------------------------------------------------------------------
    Subtotal...................  ...........  ..............           11  ............................      230
----------------------------------------------------------------------------------------------------------------
                          Request for Information Under Section 513(g) of the FD&C Act
----------------------------------------------------------------------------------------------------------------
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.
                                --------------------------------------------------------------------------------
    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

[[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