2019-24803. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) 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:

Fax written comments on the collection of information by December 16, 2019.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: [phone], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0756. 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, [e-mail].

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.

Q-Submission Program for Medical Devices

OMB Control Number 0910-0756—Extension

The guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” (https://www.fda.gov/​media/​114034/​download) provides an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with FDA regarding certain potential or planned medical device submissions reviewed by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). The guidance provides recommendations regarding certain types of Q-Submissions, such as Pre-Submissions, Submission Issue Requests, Study Risk Determinations, Informational Meetings, and other Q-Submissions Types and other uses of the Q-Submission Program.

For clarity and consistency with the guidance that describes the program, we are requesting that the title of the information collection request, OMB control number 0910-0756, be changed to “Q-Submission Program for Medical Devices.”

In the Federal Register of August 13, 2019 (84 FR 40069), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

FDA Center	Number of respondents	Annual frequency per response	Total annual responses	Hours per response	Total hours
CDRH	3,502	1	3,502	137	479,774
CBER	91	1	91	137	12,467
Total					492,241
1 There are no capital costs or operating and maintenance cost associated with this of information.

Respondents are medical device manufacturers subject to FDA's laws and regulations. FDA's annual estimate of 3,593 submissions is based on experienced recent trends. FDA's administrative and technical staffs, who are familiar with Q-Submissions, estimate that an average of 137 hours is required to prepare a Q-Submission.

Our estimated burden for the information collection reflects an overall increase of 143,713 hours. We attribute this adjustment to an increase in the number of submissions we received based on FY18 data.

Dated: November 6, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.