Notice2021-19113
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
Primary source
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Published
September 3, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 169 (Friday, September 3, 2021)</title>
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[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49542-49543]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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#4c1c1e0d1f382d2a2a0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="f3a3a1b2a087929595b3959792dd9b9b80dd949c85">[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
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: <a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing">https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing</a>.
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
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