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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations TABLE 3ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section
De Novo request860.200, 860.210, 860.220, 860.230, 860.240b.
Written notice of withdrawal 860.250a4.
Total

lotter on DSK11XQN23PROD with RULES1

1 Numbers
Total annual responses
Average burden per response
Total operating and maintenance costs
Total hours
68

1

68

182

12,376

$88

5

1

5

0.17 10 minutes

1

7

12,377

95

have been rounded.

The information collection request ICR previously approved for the De Novo classification process OMB
control number 09100844, includes separate information collections ICs for De Novo requests submitted under section 513f2i of the FD&C Act estimated 100-hour burden per response and those submitted under section 513f2ii estimated 180-hour burden per response, with burden estimates further separated by those sent to CDRH and those sent to the Center for Biologics Evaluation and Research.
For administrative efficiency, in this ICR revision, we are consolidating the separate ICs for requests submitted under section 513f2i or ii of the FD&C Act into a single IC for all De Novo requests submitted to FDA.
Therefore, this final rule simply provides a burden estimate for all De Novo requests without distinguishing between those submitted under 513f2i or ii of the FD&C Act. This estimate includes estimated burdens associated with the initial request purpose and applicability in 860.200, format and content 860.210 and 860.220, supplements and amendments 860.240b, and time to ensure that all the format and content requirements are met before submission 860.230. Based on our recent experience with the De Novo Program, FDA estimates that the average burden per response for a De Novo request is 182 hours. Additionally, we adjusted the estimated number of respondents based on updated data.
The estimated burden for 860.230
includes 2 hours per response for manufacturers to review their De Novo request for compliance with the acceptance criteria listed in 860.230 to determine if it is complete and to complete the checklists recommended in the guidance Acceptance Review for De Novo Classification Requests Ref.16. The information collections contained in the guidance, including 2
hours for review of the De Novo request
VerDate Sep<11>2014

Number of responses per respondent
Number of respondents
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for completeness and the checklists, were approved by OMB since publication of the proposed rule.
We estimate that the average burden per response for written notice of withdrawal of a De Novo request, as described in 860.250a4, is 10
minutes 0.17 hours. The burden table in the proposed rule erroneously listed 10 hours, rather than 10 minutes, for the average burden per response. We have corrected the error. The average burden per response is based on estimates by FDA administrative and technical staff who are familiar with the requirements for submission of a De Novo request and related materials, have consulted and advised manufacturers on submissions, and have reviewed the documentation submitted. We expect that we will receive approximately five notices of withdrawal per year. There is no change to the currently approved burden estimate for withdrawal of a De Novo request.
These adjustments resulted in a 1,647hour increase to the previously approved total burden estimate.
We received several comments related to the proposed rule. Descriptions of the comments on the proposed rule and FDAs responses are provided in section V of this final rule. Comments and responses related to the provisions that underlie the information collection are described in the following sections:
section V.B, regarding general comments; section V.D, De Novo request information disclosure; section V.F, regarding definitions; section V.G, regarding De Novo request format;
section V.H, regarding De Novo request content; section V.I, regarding criteria for accepting a De Novo request; section V.J, regarding criteria for granting or declining a De Novo request; and section V.K, regarding availability of the De Novo classification process for combination products. We have not made changes to the estimated burden as a result of the comments.

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The estimate of the annual reporting burden provided in the proposed rule included printing and shipping for the complete paper submission and eCopy.
Under 860.210 of the final rule, each De Novo request must be provided as a single version in electronic format.
Therefore, we have adjusted the operating and maintenance cost in the final rule to include the cost of the eCopy and shipping of the eCopy.
The cost per eCopy CDs, DVDs, and flash drives ranges from $0.25 to $2.50
per eCopy. All forms of eCopy media cost roughly $0.22 to ship. We estimate the average cost per eCopy, plus shipping, for a De Novo request or a request for withdrawal to be $1.30 per submission.
The annual cost estimate for De Novo requests is $88 68 submissions $1.30
rounded. The annual cost estimate for requests for withdrawal is $7 5 requests $1.30 rounded. Therefore, we estimate the total annual operating and maintenance costs of this information collection to be $95. This is a decrease of $7,188 to the currently approved total annual operating and maintenance cost estimate.
This final rule also refers to previously approved collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in the guidance entitled De Novo Classification Process Evaluation of Automatic Class III
Designation Ref. 5 have been approved under OMB control number 09100844; the collections of information in the guidance entitled Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission ProgramGuidance for Industry and Food and Drug Administration Staff Ref. 13 have been approved under OMB control number 09100756; the collections of information in the guidances entitled Guidance for Industry and Food and Drug Administration StaffUser Fees
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