[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29142-29143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13301]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0222]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; 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 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 July 30, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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: Peggy 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 in this document.
    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.

Medical Devices; Third-Party Review Under FDAMA (OMB Control No. 
0910-0375)--Extension

    Section 210 of FDAMA established 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 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)

[[Page 29143]]

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

                                 Table 1.--Estimated Annual Reporting Burden \1\
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                                                      Annual
              Item                    No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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 Requests for accreditation.....       40               1              40              24             960
 510(k) reviews conducted by           35               4             140              40           5,600
 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      Total Annual          Hours per
                        Item                             Recordkeepers     per Recordkeeper         Records          Recordkeeper         Total Hours
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 510(k) reviews.....................................        35                    4                 140                  10               1,400
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  Total ............................................                                                                                      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) are 
derived from agency records and experience.

    Dated: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13301 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S