[Federal Register Volume 63, Number 210 (Friday, October 30, 1998)]
[Notices]
[Pages 58397-58398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0331]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Medical Devices; FDAMA Third-Party Review
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (PRA).
DATES: Submit written comments on the collection of information by
November 30, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Medical Devices; FDAMA Third-Party Review (OMB Control Number 0910-
0375--Extension)
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.
In the Federal Register of August 4, 1998 (63 FR 41575), the agency
requested comments on the proposed collections of information. No
significant comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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No. of
Item No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Respondent
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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
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 58398]]
Table 2.--Estimated Annual Recordkeeping Burden1
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Annual
Item No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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510(k) reviews 35 4 140 10 1,4002
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\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 August 4, 1998 (63 FR 41575), 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: October 26, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-29108 Filed 10-29-98; 8:45 am]
BILLING CODE 4160-01-F
