[Federal Register Volume 62, Number 136 (Wednesday, July 16, 1997)] [Notices] [Pages 38098-38099] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-18595] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97N-0264] Agency Information Collection Activities; Submission for OMB Review; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Submit written comments on the collection of information by August 15, 1997. ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA. FOR FURTHER INFORMATION CONTACT: Judith V. Bigelow, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1479. [[Page 38099]] SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA (44 U.S.C. 3507), FDA has submitted the following proposed collection of information to OMB for review and clearance. Information Required in a Premarket Notification Submission (21 CFR 807.87, 807.92, and 807.93) (OMB Control Number 0910-0281-- Reinstatement) Under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)), a premarket notification must be filed before the introduction or delivery for introduction of a device intended for human use. Under Sec. 807.87 (21 CFR 807.87), premarket notifications are required to contain certain information, including the device name, establishment registration number, class of the device, the device's proposed labeling, action taken by the person required to register to comply with performance standards, and a 510(k) summary as described in Sec. 807.92 (21 CFR 807.92) or a 510(k) statement as described in Sec. 807.93 (21 CFR 807.93). In addition, Sec. 807.87(i) requires that those filing premarket notification who claim substantial equivalence to certain devices as described in Sec. 807.87(i), that are classified into class III, must submit to FDA a summary of safety and effectiveness problems and a citation to the information upon which the summary is based. The premarket notification submitter must also furnish FDA with a certification that a reasonable search has been conducted of all known information. The information collected in the premarket notification is necessary to enhance FDA's ability to ensure that only premarket notification submissions for devices that are as safe and as effective as legally marketed predicate devices are cleared for marketing. In addition, FDA makes publicly available this information concerning devices for which a marketing order has been issued, in order to provide to the public the agency's basis for equivalence determinations. Respondents to this collection of information are medical device manufacturers and distributors. FDA estimates the burden of this collection of information as follows: Table 1.--Estimated Annual Reporting Burden ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Respondents Response Responses Response ---------------------------------------------------------------------------------------------------------------- 807.87(h) and 807.92 (simple 510(k) summaries) 2,592 1 2,592 8 20,736 807.87(h) and 807.92 (complex 510(k) summaries) 247 1 247 12 2,964 807.87(h) and 807.93 (510(k) statements) 2,896 1 2,896 1 2,896 807.87(i) and 807.94 (certifications) 208 1 208 40 8,320 Total 34,916 ---------------------------------------------------------------------------------------------------------------- There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases these estimates on conversations with industry and trade association representatives, and from internal review of the documents listed in the table above. Under Sec. 807.93, anyone submitting a 510(k) statement must make that information available to anyone who requests it. Table 2.--Estimated Annual Recordkeeping Burden ---------------------------------------------------------------------------------------------------------------- Annual 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper ---------------------------------------------------------------------------------------------------------------- 807.93 2,896 10 28,960 0.5 14,480 Total 14,480 ---------------------------------------------------------------------------------------------------------------- There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 7, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-18595 Filed 7-15-97; 8:45 am] BILLING CODE 4160-01-F