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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 October 21, 2024.
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 0910-0511. 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.
Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910-0511—Revision
This information collection supports the FDA medical device and device user fee programs. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85)), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is submitted. Form FDA 3601, the “Medical Device User Fee Cover Sheet,” is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. Form FDA 3601 and instructions are available online for registered users. The form provides a cross-reference between the fees submitted for an application with the actual submitted application by using a unique number tracking system. The information collected is used by FDA's Center for Devices and Radiological Health (CDRH) and FDA's Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new medical device applications and supplemental applications.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with FDA, a process known as establishment registration (21 CFR part 807, subparts A through D). (The information collection for medical device establishment registration and listing is approved under OMB control number 0910-0625.) All establishments required to register must pay a user fee. Form FDA 3601a, the “Device Facility User Fee Cover Sheet,” is designed to collect payments for the annual establishment registration fee for medical device establishments.
Under section 704(g) of the FD&C Act (21 U.S.C. 374(g)), FDA may accredit persons to inspect qualified manufacturers of class II and class III devices. An eligible establishment is permitted to select any FDA-accredited person to conduct an inspection in lieu of an FDA inspection, but the eligible establishment must submit notice to FDA for selection approval (see 21 U.S.C. 374(g)(1) and (g)(6)(B)). Referred to as the “Accredited Persons Inspection Program,” FDA publishes a complete list of accredited persons and the activities for which they are accredited on our website at Third Party Device Inspection, along with additional information about the program.
The guidance document entitled “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act” (December 2019) provides FDA's recommendations regarding provision of user fees for 513(g) requests for information under section 738(a)(2)(A)(ix) of the FD&C Act (21 U.S.C. 379j(a)(2)(A)(ix)). Instructions for submission and specific content elements are discussed in the guidance document in sections IV and V, respectively.
In the Federal Register of February 29, 2024 (89 FR 14890), 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