[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)] [Notices] [Pages 41575-41576] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-20705] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98N-0331] Agency Information Collection Activities: Proposed Collection; Comment Request 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 the Third-Party Review Pilot Program established by FDA's Center for Devices and Radiological Health (CDRH) under the FDA Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing OMB's approval of this collection of information (OMB control number 0910-0375). Since this was an emergency approval that expires on November 30, 1998, FDA is following the normal PRA clearance procedures by isuing this notice. DATES: Submit written comments on the collection of information by October 5, 1998. ADDRESSES: Submit written comments on the collection of information to the Dockets Management Branch (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: Margaret R. Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223. 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 below. With respect to the following collection of information, FDA invites comments on: (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. Title: Medical Devices; FDAMA Third-Party Review (OMB Control Number 0910-0375--Extension) Description: Section 210 of FDAMA establishes a new section 523 of the Federal Food, Drug, and Cosmetic Act (the act), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. As with the Third-Party Review Pilot Program previously conducted by FDA, participation in this Third-Party Review Pilot Program by accredited persons is entirely voluntary. A third party wishing to participate will submit a request for accreditation. Accredited third-party reviewers will have the ability to review a manufacturer's 510(k) 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. This information collection will allow FDA to implement the Accredited Person Review Program established by FDAMA and improve the efficiency of 510(k) review for low to moderate-risk devices. Description of Respondents: Businesses or other for profit organizations. FDA estimates the burden of this collection of information as follows: Table 1.--Estimated Annual Reporting Burden1 ---------------------------------------------------------------------------------------------------------------- No. of Item No. of Responses Per Total Annual Hours per Total Hours Respondents Respondent Responses Respondent ---------------------------------------------------------------------------------------------------------------- Requests for accreditation 40 1 40 24 960 510(k) reviews conducted by accredited third parties 35 4 140 40 5,600 Total hours 6,560 ---------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 41576]] Table 2.--Estimated Annual Recordkeeping Burden1 ---------------------------------------------------------------------------------------------------------------- Annual Item No. of Frequency per Total Annual Hours per Total Hours Recordkeepers Recordkeeping Records Recordkeeper ---------------------------------------------------------------------------------------------------------------- 510(k) reviews 35 4 140 102 3502 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Due to clerical error, the recordkeeping burden hours for 510(k) reviews that appeared in a notice issued in the Federal Register of May 22, 1998 (63 FR 28388) were incorrect. Table 2 of this document contains the correct estimates. The burdens are explained as follows: 1. Reporting a. Requests for accreditation: Under the agency's Third-Party Review Pilot Program, the agency received 37 applications for recognition as third-party reviewers, of which the agency recognized 7. Under this expanded program, the agency anticipates that it will not see a significant increase in the number of applicants. Therefore, the agency is estimating that it will receive 40 applications. The agency anticipates that it will accredit 35 of the applicants to conduct third-party reviews. b. 510(k) reviews conducted by accredited third parties: In 18 months under the Third-Party Review Pilot Program, FDA received only 22 510(k)'s that were requested and were eligible for review by third parties. Because the new program is not as limited in time, and is expanded in scope, the agency anticipates that the number of 510(k)'s submitted for third-party review will increase. The agency anticipates that it will receive approximately 140 third-party review submissions annually, i.e., approximately 4 annual reviews per each of the estimated 35 accredited reviewers. 2. Recordkeeping Third-party reviewers are required to keep records of their review of each submission. The agency anticipates approximately 140 annual submissions of 510(k)'s for third-party review. The agency estimates that each third-party reviewer will require approximately 10 annual hours to maintain records of their reviews and reports. Dated: July 24, 1998. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 98-20705 Filed 8-3-98; 8:45 am] BILLING CODE 4160-01-F