[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Notices]
[Page 48696-48697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au10-70]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0198]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification
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
September 10, 2010.
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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0120.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Premarket Notification--(OMB Control Number 0910-0120)--Extension
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(k)) and the implementing regulation under part 807
(21 CFR part 807, subpart E) requires a person who intends to market a
medical device to submit a premarket notification submission to FDA at
least 90 days before proposing to begin the introduction, or delivery
for introduction into interstate commerce, for commercial distribution
of a device intended for human use. Based on the information provided
in the notification, FDA must determine whether the new device is
substantially equivalent to a legally marketed device, as defined in
Sec. 807.92(a)(3). If the device is determined to be not substantially
equivalent to a legally marketed device, it must have an approved
premarket approval application (PMA), Product Development Protocol,
Humanitarian Device Exemption (HDE), Petition for Evaluation of
Automatic Class III Designation (de novo) or be reclassified
[[Page 48697]]
into class I or class II before being marketed. FDA makes the final
decision of whether a device is substantially equivalent or not
equivalent.
Section 807.81 states when a premarket notification is required. A
premarket notification is required to be submitted by a person who is:
Introducing a device to the market for the first time;
Introducing a device into commercial distribution for the
first time by a person who is required to register; and
Introducing or reintroducing a device which is
significantly changed or modified in design, components, method of
manufacturer, or the intended use that could affect the safety and
effectiveness of the device.
Section 807.87 specifies information required in a premarket
notification submission.
Section 204 of the Food and Drug Administration Modernization Act
(FDAMA) amended section 514 of the act (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions including premarket
notifications or other requirements. FDA has published and updated the
list of recognized standards regularly since enactment of FDAMA and has
allowed 510(k) submitters to certify conformance to recognized
standards to meet the requirements of Sec. 807.87. FDA Form FDA 3654,
the 510(k) Standards Data Form, standardizes the format for submitting
information on consensus standards that a 510(k) submitter chooses to
use as a portion of their premarket notification submission (The Form
FDA 3654 is not for declarations of conformance to a recognized
standard). FDA believes that use of this form will simplify the 510(k)
preparation and review process for 510(k).
Form FDA 3514, a summary coversheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, and HDEs. Under Sec. 807.87(h), each 510(k) submitter must
include in the 510(k) either a summary of the information in the 510(k)
as required by Sec. 807.92 (510(k) summary) or a statement certifying
that the submitter will make available upon request the information in
the 510(k) with certain exceptions as per Sec. 807.93 (510(k)
statement). If the 510(k) submitter includes a 510(k) statement in the
510(k) submission, Sec. 807.93 requires that the official
correspondent of the firm make available within 30 days of a request,
all information included in the submitted premarket notification on
safety and effectiveness. This information will be provided to any
person within 30 days of a request if the device described in the
510(k) submission is determined to be substantially equivalent. The
information provided will be a duplicate of the 510(k) submission
including any safety and effectiveness information, but excluding all
patient identifiers and trade secret and commercial confidential
information. According to Sec. 807.90, submitters may request
information on their 510(k) review status 90 days after the initial
log-in date of the 510(k). Thereafter, the submitter may request status
reports every 30 days following the initial status request. To obtain a
510(k) status report, the submitter should complete the status request
form, Form FDA 3541, and fax it to the Center for Devices and
Radiological Health office identified on the form. The most likely
respondents to this information collection will be specification
developers and medical device manufacturers.
In the Federal Register of May 5, 2010 (75 FR 24708), FDA published
a 60-day notice requesting public comment 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Form Number Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807 subpart E .................. 3,800 1 3,800 79 300,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87 FDA Form 3514 1,956 1 1,956 0.5 978
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.90 (a)(3) FDA Form 3541 218 1 218 0.25 55
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87(d) and (f) FDA Form 3654 1,500 1 1,500 10 15,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.92 and 807.93 .................. 2,000 10 2,000 10 20,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 336,233
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19746 Filed 8-10-10; 8:45 am]
BILLING CODE 4160-01-S