[Federal Register: August 10, 2004 (Volume 69, Number 153)]
[Notices]               
[Page 48508-48509]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au04-94]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0332]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Devices; Third-Party Review Under the Food and 
Drug Administration Modernization Act

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 information 
collection, 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 Modernization Act of 1997 (FDAMA).

DATES: Submit written and electronic comments on the collection of 
information by October 12, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on the 

collection of information to the Division of Dockets Management (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 Robbins, Office of Management 
Programs (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 these topics: (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.

[[Page 48509]]

Medical Devices; Third-Party Review Under FDAMA (OMB Control Number 
0910-0375)--Extension

    Section 210 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) established 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. 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 to FDA. 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, usually a period of 3 
years. 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\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
                      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for                      15                  1                 15                 24                360
 accreditation
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510(k) reviews                    15                 14                210                 40              8,400
 conducted by
 accredited 3d
 parties
----------------------------------------------------------------------------------------------------------------
Totals                                                                                                     8,760
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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
                     Recordkeepers     per Recordkeeper       Records          Recordkeeper       Total Hours
----------------------------------------------------------------------------------------------------------------
510(k) reviews                    15                 14                210                 10              2,100
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Totals                                                                                                     2,100
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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:

I. 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. In the past 3 years, the agency has 
averaged receipt of 15 applications for recognition of third-party 
review accredited persons. The agency has accredited 15 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 22 submissions of 510(k)s that requested and were eligible for 
review by third parties. The agency has experienced that the number of 
510(k)s submitted annually for third-party review since the last OMB 
approval in 2001 is approximately 210 annually, which is 14 annual 
reviews per each of the estimated 15 accredited reviewers.

II. 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.

    Dated: July 30, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-18167 Filed 8-9-04; 8:45 am]

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