[Federal Register Volume 66, Number 166 (Monday, August 27, 2001)]
[Notices]
[Pages 45047-45048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21529]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0222]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Third-Party Review Under FDAMA

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

[[Page 45048]]

clearance under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
September 26, 2001.

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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy 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 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 Under FDAMA (OMB Control No. 
0910-0375)--Extension

    Section 210 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) established a new 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. As with the third-party pilot program 
conducted previously by FDA, 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. 
Accredited third-party reviewers 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 reviews 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 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.
    In the Federal Register of May 29, 2001 (66 FR 29142), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                           No. of        Annual Frequency     Total Annual        Hours per
        Item             Respondents       per Response         Responses         Response         Total Hours
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Requests for                40                  1                 40                24               960
 accreditation
510k reviews                35                  4                140                40             5,600
 conducted by
 accredited third
 parties
                                                                                               -----------------
  Total                                                                                            6,560
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                                       No. of         Annual Frequency per     Total Annual          Hours per
                      Item                          Recordkeepers        Recordkeeping            Records          Recordkeeper        Total Hours
-----------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews                                          35                     4                1,140                  10              1,400
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 the 18 
months under the third-party review pilot program, FDA received only 22 
510(k)s that requested and were eligible for review by third parties. 
Because the third-party review 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 remain the same as they were 
during the last OMB approval in 1998. 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 estimate of the times required for record preparation and 
maintenance is based on agency communication with industry. Other 
information needed to calculate the total burden hours (i.e., adverse 
drug reaction, lack of effectiveness, and product defect reports) is 
derived from agency records and experience.

    Dated: August 20, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21529 Filed 8-24-01; 8:45 am]
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