# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act
**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 (the PRA).
**DATES:**
Fax written comments on the collection of information by January 27, 2011.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to *[email protected].* All comments should be identified with the OMB control number 0910-0375. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, e-mail: *[email protected].*
**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 Devices; Third Party Review Program Under the Food and Drug Administration Modernization Act—(OMB Control Number 0910-0375)—Extension**
Section 210 of the Food and Drug Administration Modernization Act (FDAMA) established section 523 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket notifications (510(k)s). Participation in this third-party review program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation to FDA. Accredited third-party reviewers have the ability to review a manufacturer's 510(k) of the FD&C Act (21 U.S.C. 360) submission for selected devices. After reviewing a submission, the reviewer will forward a copy of the 510(k) submission, along with the reviewer's documented review and recommendation to FDA. Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
This information collection will allow FDA to continue to implement the accredited person review program established by FDAMA and improve the efficiency of 510(k) review for low- to moderate-risk devices.
Respondents to this information collection are businesses or other for-profit organizations.
**I. Reporting**
**510(k) Reviews Conducted by Accredited Third Parties**
According to FDA's data in 2009, the Agency has experienced that the number of 510(k)s submitted for third-party review is approximately 260 annually, which is 26 annual reviews per each of the 10 accredited reviewers.
**II. Recordkeeping**
Third party reviewers are required to keep records of their review of each submission. According to FDA's in 2009, the Agency anticipates approximately 260 submissions of 510(k)s for third-party review per year.
In the *Federal Register* of September 22, 2010 (75 FR 57801), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment; however, it was not PRA related.
FDA estimates the burden of this collection of information as follows:
| Section 523 of the FD&C Act | No. of | Annual | Total annual responses | Hours per | Total hours |
| --- | --- | --- | --- | --- | --- |
| Requests for accreditation | 1 | 1 | 1 | 24 | 24 |
| 510(k) reviews conducted by accredited third parties | 10 | 26 | 260 | 40 | 10,400 |
| Total | | | | | 10,424 |
| Section 523 of the FD&C Act | No. of | Annual | Total annual records | Hours | Total hours |
| --- | --- | --- | --- | --- | --- |
| 510(k) reviews | 10 | 26 | 260 | 10 | 2,600 |
Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.