[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Notices]
[Pages 41575-41576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20705]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0331]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 the Third-Party Review Pilot 
Program established by FDA's Center for Devices and Radiological Health 
(CDRH) under the FDA Modernization Act of 1997 (FDAMA). Elsewhere in 
this issue of the Federal Register, FDA is publishing a notice 
announcing OMB's approval of this collection of information (OMB 
control number 0910-0375). Since this was an emergency approval that 
expires on November 30, 1998, FDA is following the normal PRA clearance 
procedures by isuing this notice.

DATES: Submit written comments on the collection of information by 
October 5, 1998.

ADDRESSES: 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: 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: 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 below.
    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.
    Title: Medical Devices; FDAMA Third-Party Review (OMB Control 
Number 0910-0375--Extension)
    Description: 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.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden<SUP>1                                 
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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 41576]]


                                 Table 2.--Estimated Annual Recordkeeping Burden<SUP>1                               
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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<SUP>2            350<SUP>2       
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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 May 22, 1998 (63 FR 28388) 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: July 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20705 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F