[Federal Register: November 10, 2004 (Volume 69, Number 217)]
[Notices]
[Page 65201-65202]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no04-120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0332]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Third-Party Review Under the Food and Drug Administration Modernization
Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 10, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: 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 the Food and Drug
Administration Modernization Act--(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.
In the Federal Register of August 10, 2004 (69 FR 48508), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per Hours per
21 CFR Section No. of Recordkeepers Record Total Annual Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for accreditation 15 1 15 24 360
510(k) reviews conducted by accredited 15 14 210 40 8,400
third parties
Totals ........................ ........................ ........................ ............... 8,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 65202]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
21 CFR Section No. of Recordkeepers per Record Records Recordkeeper Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) reviews 15 14 210 10 2,100
Totals ........................ .................. .................. ............... 2,100
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: November 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24994 Filed 11-9-04; 8:45 am]
BILLING CODE 4160-01-S