[Federal Register: August 27, 2001 (Volume 66, Number 166)]
[Notices]
[Page 45047-45048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au01-73]
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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
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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
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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]
BILLING CODE 4160-01-S