[Federal Register: November 19, 2007 (Volume 72, Number 222)]
[Notices]
[Page 65038-65039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19no07-60]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No 2007N-0227]
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 19, 2007.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0375. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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; Section 523 of the Federal Food,
Drug, and Cosmetic Act (OMB Control Number 0910-0375)--Extension
Section 210 of the Food and Drug Administration Modernization Act
(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
reviewers 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
[[Page 65039]]
person review program established by FDAMA and improve the efficiency
of 510(k) review for low to moderate risk devices.
In the Federal Register of June 21, 2007 (72 FR 34257), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
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\
----------------------------------------------------------------------------------------------------------------
Section 523 of No. of Annual Frequency Total Annual Hours per
the act Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Requests for 1 1 1 24 24
accreditation
----------------------------------------------------------------------------------------------------------------
510(k) reviews 14 24 336 40 13,440
conducted by
accredited third
parties
----------------------------------------------------------------------------------------------------------------
Total 13,464
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 1.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Section 523 of No. of Annual Frequency Total Annual Hours per
the act Recordkeepers per Record Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
510(k) reviews by 14 24 336 10 3,600
third-party
reviewers
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
I. Reporting
A. Requests for Accreditation
FDA now has approximately 8 years of experience with third-party
reviews under section 523 of the act. Currently there are 11 active
accredited third parties. FDA does not expect to receive more than 1
application for accreditation per year for a total of 14 accredited
third parties who will be conducting third-party reviews.
B. 510(k) Reviews Conducted by Accredited Third Parties
FDA has received 784 510(k) submissions with a third-party review
since 2004. FDA estimates that over the next 3 years, they will
accredit 1 third-party reviewer per year for a total of 14 third
parties. Each third-party reviewer expects to review a total of 24
510(k) submissions per year for an annual total of 336 applications.
II. Recordkeeping
Third-party reviewers are required to keep records of their review
of each submission. At the end of 3 years, the agency expects to have
14 accredited persons for review with each third party reviewing on
average 24 510(k) applications per year. The agency anticipates
approximately 336 510(k) annual submissions for third-party review.
Dated: November 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22586 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S