89 FR 182 pgs. 76851-76853 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a

Next Article Next

Type: NOTICEVolume: 89Number: 182Pages: 76851 - 76853

Docket number: [Docket No. FDA-2024-N-0022]

FR document: [FR Doc. 2024-21435 Filed 9-18-24; 8:45 am]

Agency: Health and Human Services Department

Sub Agency: Food and Drug Administration

Official PDF Version: PDF Version

Pages: 76851, 76852, 76853

[top]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0022]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a

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

[top] 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, ¹ along with additional information about the program.

Footnotes:

¹ ? https://www.fda.gov/medical-devices/postmarket-requirements-devices/third-party-inspection-devices.

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)? ² 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.

Footnotes:

² ? https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic.

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:

FDA form or activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
User Fee Cover Sheet
Form FDA 3601 (Medical Device User Fee Cover Sheet)	6,182	1	6,182	0.30 (18 minutes)	1,855
Form FDA 3601a (Device Facility User Fee Cover Sheet)	24,086	1	24,086	0.17 (10 minutes)	4,095
Subtotal			30,268		5,950
Inspection by Accredited Persons Program Under Section 704 of the FD&C Act
Request for accreditation	1	1	1	80	80
Notification of the intent to use an Accredited Person	10	1	10	15	150
Subtotal			11		230
Request for Information Under Section 513(g) of the FD&C Act
Sections IV and V of Guidance; CDRH 513(g) requests	114	1	114	12	1,368
Sections IV and V of Guidance; CBER 513(g) requests	4	1	4	12	48
Subtotal			118		1,416
Total					7,596
¹ ?There are no capital costs or operating and maintenance costs associated with this collection of information.

User Fee Cover Sheet

[top] According to FDA's database system, manufacturers of products subject to MDUFMA submit an average of 6,182 applications annually and submit an average of 24,086 Device Facility User Fee applications. However, not all manufacturers will have any cover sheet submissions in a given year and some may have multiple cover sheet submissions. The estimated hours per

response are based on past FDA experience with the various cover sheet submissions and range from 5 to 30 minutes. The hours per response are based on the average of these estimates (18 minutes). The total hours are rounded to the nearest whole number.

Inspection by Accredited Persons Program Under Section 704 of the FD&C Act

Section 704(g) of the FD&C Act provides for accreditation of persons for the purpose of conducting inspections and provides the minimum requirements a person must meet to be accredited to conduct inspections (an Accredited Person (AP)). The burden estimate for requests for accreditation is based on the number of applications we've received. Once an organization is accredited, it will not be required to reapply.

The AP Program permits eligible manufacturers to use APs to perform certain inspections. While all firms remain subject to inspection by FDA, eligible manufacturers have the option of requesting inspection by an AP. A device establishment is eligible for inspection by APs if the establishment meets certain conditions of section 704(g)(6) of the FD&C Act, including that they provide notice of their intention to use an AP to conduct inspections of the establishment.

We estimate there are 4,000 domestic manufacturers and 4,000 foreign manufacturers that are eligible for inclusion under the AP program. Based on informal communications with industry, approximately 10 of these manufacturers may submit a request to use an AP in any given year.

Request for Information Under Section 513(g) of the FD&C Act

Respondents may elect to prepare their 513(g) request for information using CDRH's electronic Submission Template and Resource (eSTAR) voluntary guided submission preparation tool, which was developed to improve submission consistency and enhance efficiency in the review process. The total number of annual responses is based on the average number of 513(g) requests received each year by CDRH and CBER respectively.

Based on a review of the information collection since our last request for OMB approval, we have made modifications to our burden estimate. In our March 2023 change request submission, we erroneously excluded the information collection entitled, "Notification of the intent to use an Accredited Person." We have included the information collection activity to this renewal. The information collection, therefore, reflects a cumulative increase in burden by 10 annual responses and 150 burden hours.

Dated: September 16, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2024-21435 Filed 9-18-24; 8:45 am]

BILLING CODE 4164-01-P