[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]


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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 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.
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    \1\ https://www.fda.gov/medical-devices/postmarket-requirements-devices/third-party-inspection-devices.
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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.

[[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