Document ID: FDA-2012-N-0536-0012
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2020-06-12T04:00Z

[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, 
PRAStaff@fda.hhs.gov.

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]
BILLING CODE 4164-01-P