E7-11981. Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review 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 an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for “Medical Devices Third-Party Review under the Food and Drug Administration Modernization Act of 1997 (FDAMA).”

DATES:

Submit written or electronic comments on the collection of information by August 20, 2007.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Medical Devices Third-Party Review Under the Food and Drug Administration Modernization Act--Section 523, Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0375)—Extension

Section 210 of FDAMA established section 523 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. 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 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.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

Section 523 of the Act	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
Requests for accreditation	1	1	1	24	24
510(k) reviews conducted by accredited third parties	14	24	336	40	13,440
Totals					13,464
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden¹

Section 523 of the Act	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Record	Total Hours
510(k) reviews by third-party reviewers	14	24	336	10	3,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

I. Reporting

A. Requests for Accreditation

FDA now has approximately 8 years of experience with third-party reviews under section 523 of the act. Currently there are 11 active accredited third parties. FDA does not expect to receive more than 1 application for accreditation per year for a total of 14 accredited third parties, who will be conducting third-party reviews.

B. 510(k) Reviews Conducted by Accredited Third Parties

FDA has received 784 510(k)s with a third-party review since 2004. FDA estimates that over the next 3 years, they will accredit 1 third-party reviewer per year for a total of 14 third parties. Each third-party reviewer expects to review a total of 24 510(k) submissions per year for an annual total of 336 applications.

II. Recordkeeping

Third-party reviewers are required to keep records of their review of each submission. At the end of 3 years, the agency expects to have 14 accredited persons for review with each third party reviewing on average 24 510(k) applications per year. The agency anticipates approximately 336 annual submissions of 510(k)s for third-party review.

Dated: June 14, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.