Document ID: FDA-2012-N-0536-0015
Agency: fda
Document Type: Notice
Title: 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 FDA 3601a
Posted Date: 2021-09-03T04:00Z

[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49542-49543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19113]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0536]

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 FDA 3601a

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 4, 2021.

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, 
PRAStaff@fda.hhs.gov.

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

    The Federal Food, Drug, and Cosmetic Act, as amended by the Medical 
Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), and 
the Medical Device User Fee Amendments of 2007 (Title II of the Food 
and Drug

[[Page 49543]]

Administration Amendments Act of 2007), 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. 
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 and FDA's Center for 
Biologics Evaluation and Research to initiate the administrative 
screening of new medical device applications and supplemental 
applications.
    We are revising the information collection to add Form FDA 3601a, 
the ``Device Facility User Fee Cover Sheet.'' 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.
    The total number of annual responses for Form FDA 3601 is based on 
the average number of cover sheet submissions received by FDA in recent 
years. The number of received annual responses includes cover sheets 
for applications that were qualified for small businesses and fee 
waivers or reductions. The estimated hours per response are based on 
past FDA experience with the various cover sheet submissions and range 
from 5 to 30 minutes. For this analysis, we estimate 18 minutes per 
coversheet.
    The total number of annual responses for Form FDA 3601a is based on 
the average number of cover sheet submissions received by FDA in recent 
years. Based on past FDA experience with various cover sheet 
submissions, we estimate 10 minutes per response.
    In the Federal Register of June 12, 2020 (85 FR 35939), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although two comments were received, only 
one was responsive to the four collection of information topics 
solicited.
    FDA's response to the comment is that the establishment 
registration fee is not eligible for a reduced small business fee. This 
can be found on our website at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden 1 2
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                                                                 Number of
                FDA Form No.                     Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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3601........................................           6,182               1           6,182  0.30 (18 minutes).........................           1,855
3601a.......................................          24,086               1          24,086  0.17 (10 minutes).........................           4,095
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    Total...................................  ..............  ..............          30,268  ..........................................           5,950
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.

    Our estimated burden for the information collection reflects an 
overall increase of 4,036 hours and a corresponding increase of 23,889 
responses/records. We attribute these increases to two factors: We have 
revised the burden estimate to include Form FDA 3601a and we have 
adjusted the number of respondents for Form FDA 3601 to reflect our 
current data.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19113 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P