87 FR 245 pgs. 78693-78694 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices
Type: NOTICEVolume: 87Number: 245Pages: 78693 - 78694
Pages: 78693, 78694Docket number: [Docket No. FDA-2012-D-0530]
FR document: [FR Doc. 2022-27815 Filed 12-21-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
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:
Submit written comments (including recommendations) on the collection of information by January 23, 2023.
ADDRESSES:
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 Review-Open for Public Comments" or by using the search function. The OMB control number for this information collection is 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, PRAStaff@fda.hhs.gov.
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-Submissions Program for Medical Devices
OMB Control Number 0910-0756-Revision
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-Submission types and other uses of the Q-Submission Program.
Respondents are medical device manufacturers subject to FDA's laws and regulations. FDA's annual estimate of 3,700 submissions is based on recent trends. FDA's administrative and technical staffs, who are familiar with Q-Submissions, estimate that an average of 137 hours is needed to prepare a Q-Submission.
Early Payor Feedback Program
Prior to submitting a Pre-Submission, medical device sponsors may request that one or more payor organizations join a Pre-Submission meeting. Payors include public payors such as Centers for Medicare & Medicaid Services, private health plans, health technology assessment groups, and others who provide input into coverage, procurement, and reimbursement decisions. To facilitate such opportunities to obtain payor input, FDA provides information about our Early Payor Feedback Program (EPFP) and a list of current payor participants on our website ( https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force ). For payors to decide which devices to provide feedback on, we have developed a voluntary form for manufacturers to provide basic information regarding their device. This form is shared with the payors from whom the manufacturer is requesting feedback. We expect preparation and submission of the form to take no more than 2 hours.
eSTAR for Q-Submissions
[top] Under section 745A(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(b)), amended by
We estimate a setup burden of 5 minutes for new eSTAR users. Respondents will only need to set up eSTAR the first time they use it. We note that because some respondents may have already undergone eSTAR set up for other types of submission, e.g., premarket notification, fewer respondents may need to undergo eSTAR setup than estimated.
In the Federal Register of August 9, 2022 (87 FR 48488), 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:
| Activity | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" | |||||
| Q-Submissions: | |||||
| CDRH | 2,160 | 1 | 2,160 | 137 | 295,920 |
| CBER | 60 | 1 | 60 | 137 | 8,220 |
| Q-Submissions using eSTAR (21 CFR part 814, subparts A through E; section 745A(b) of the FD&C Act) | |||||
| CDRH | 1,440 | 1 | 1,440 | 69 | 99,360 |
| CBER | 40 | 1 | 40 | 69 | 2,760 |
| eSTAR setup | 1,480 | 1 | 1,480 | 0.08 (5 minutes) | 118 |
| Manufacturer request to participate in EPFP | 30 | 1 | 30 | 2 | 60 |
| Total | 406,438 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Including the EPFP form represents a revision to this information collection request. Our estimated burden for the information collection reflects the availability of eSTAR to assist electronic preparation of Q-submissions and addition of the EPFP form, resulting in an overall decrease of 85,803 hours.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27815 Filed 12-21-22; 8:45 am]
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