[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35939-35940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12768]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0536]
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 FDA 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 revision of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments revising the information collection by adding Form
FDA 3601a, entitled ``Device Facility User Fee Cover Sheet,'' which is
submitted along with registration and listing fee payments.
DATES: Submit either electronic or written comments on the collection
of information by August 11, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 11, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 11, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is 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-2012-N-0536 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 FDA
3601(a).'' 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.
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
each proposed revision of an
[[Page 35940]]
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
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--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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden1 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: June 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12768 Filed 6-11-20; 8:45 am]
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