87 FR 194 pgs. 61032-61033 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions
Type: NOTICEVolume: 87Number: 194Pages: 61032 - 61033
Pages: 61032, 61033Docket number: [Docket No. FDA-2022-N-0576]
FR document: [FR Doc. 2022-21852 Filed 10-6-22; 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-2022-N-0576]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA, Agency, or we) 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 November 7, 2022.
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 0910-0078. Also include the FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 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.
Investigational Device Exemptions-21 CFR Part 812
OMB Control Number 0910-0078-Extension
This information collection supports implementation of section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)), which governs exemption for devices for investigational use. An investigational device exemption (IDE) allows a device to be used in investigations involving human subjects in which the safety and effectiveness of the device is being studied. For more information regarding IDE, please visit our website at https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide.
FDA has promulgated regulations in part 812 (21 CFR part 812) intended to encourage the discovery and development of useful devices intended for human use. The regulations set forth the scope and applicability of exemption requirements for devices for investigational use, as well as establish application procedures, corresponding instruction, and provisions for emergency research. The regulations also provide for requesting waivers from the requirements and explain sponsor responsibilities, including requirements for institutional review board (IRB) review and approval. Finally, the regulations in part 812, subpart G (21 CFR 812.140, 812.145, and 812.150) provide for required recordkeeping, the inspection of records, and the preparation and submission of reports to FDA and/or IRBs that oversee medical device investigations.
In the Federal Register of May 6, 2022 (87 FR 27168), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:
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| Activity/21 CFR Section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 812.10; waivers | 1 | 1 | 1 | 1 | 1 |
| 812.20, 812.25, and 812.27; applications, investigational plans, and supplements | 229 | 1 | 229 | 80 | 18,320 |
| 812.27(b)(4)(i); prior investigations within the United States | 400 | 1 | 400 | 1 | 400 |
| 812.27(b)(4)(ii); prior investigations outside the United States | 100 | 1 | 100 | 0.25 (15 minutes) | 25 |
| 812.28; acceptance of data from clinical investigations conducted outside the United States, and supporting information | 1,500 | 1 | 1,500 | 10.25 | 15,375 |
| 812.28(c); waivers | 10 | 1 | 10 | 1 | 10 |
| 812.35 and 812.150; application supplements | 654 | 5 | 3,270 | 6 | 19,620 |
| 812.36(c); treatment IDE applications | 1 | 1 | 1 | 120 | 120 |
| 812.36(f); treatment IDE reports | 1 | 1 | 1 | 20 | 20 |
| 812.150; non-significant risk study reports | 1 | 1 | 1 | 6 | 6 |
| Total | 5,513 | 53,897 | |||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Our estimate of the average reporting burden is based on our continued experience with the information collection. We have adjusted the currently approved burden to reflect an increase we attribute to Agency rulemaking that has become effective (OMB control number 0910-AG48) since our last evaluation. Regulations in part 812 were amended to provide for reporting associated with the acceptance of data from clinical investigations conducted outside the United States.
| Activity/21 CFR Section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 812.2(c)(3); records regarding leftover specimens not individually identifiable used in certain studies | 700 | 1 | 700 | 4 | 2,800 |
| 812.28(d); records for clinical investigations conducted outside United States | 1,500 | 1 | 1,500 | 1 | 1,500 |
| 812.140; retention of records | 1,249 | 3.09 | 3,865 | 1.9937 | 7,706 |
| Total | 12,006 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
In the guidance document "Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable" (April 2006), available for download at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-informed-consent-vitro-diagnostic-device-studies-using-leftover-human-specimens-are-not, FDA communicates its enforcement policy with regard to the informed consent regulations (as required by section 520(g) of the FD&C Act and 21 CFR part 50) for in vitro diagnostic device studies that are conducted using leftover specimens and that meet the criteria for exemption from IDE regulation at 21 CFR 812.2(c)(3). We include burden that may be attributable to FDA recommendations that sponsors of studies document certain information, in table 2, row 1. We have otherwise adjusted our estimate upward of the average recordkeeping burden attributable to provisions in part 812 to reflect those requirements associated with clinical investigations conducted outside the United States, and in recognition of the required retention period for records.
Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21852 Filed 10-6-22; 8:45 am]
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