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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Notices 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 FDAs Center for Devices and Radiological Health and FDAs 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 09100625. 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
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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.
FDAs 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/medicaldevices/how-study-and-market-yourdevice/device-registration-and-listing.
FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of responses per respondent
Number of respondents
FDA Form No.

Total annual responses
Average burden per response
Total hours
3601
3601a

6,182
24,086

1
1

6,182
24,086

0.30 18 minutes
0.17 10 minutes

1,855
4,095

Total

30,268

5,950

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.

2 Numbers
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.
lotter on DSK11XQN23PROD with NOTICES1

FR Doc. 202119113 Filed 9221; 8:45 am BILLING CODE 416401P

Food and Drug Administration
of information has been submitted to the Office of Management and Budget OMB for review and clearance under the Paperwork Reduction Act of 1995.

Docket No. FDA2018N1857

DATES:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA, Agency, or we is announcing that a proposed collection
SUMMARY:

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Submit written comments including recommendations on the collection of information by October 4, 2021.
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 ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100751. Also include the FDA docket number found in brackets in the heading of this document.

ADDRESSES:

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