[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]
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