[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 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 41576]]
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 4 140 102 3502
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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
