[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64711-64713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18553]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0425]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Notification

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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 premarket notification.

DATES:  Submit written or electronic comments on the collection of 
information by January 2, 2007.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

[[Page 64712]]


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 in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Premarket Notification--21 CFR Part 807; Subpart E--(OMB Control Number 
0910-0120)

    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) require 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 or 
be reclassified into class I or class II before being marketed. The FDA 
makes the final decision of whether a device is equivalent or not 
equivalent.
    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) 
(Public Law 107-250) added section 510(o) to the act to establish new 
regulatory requirements for reprocessed single-use devices (SUDs). 
MDUFMA was signed into law on October 26, 2002.
    Section 510(o) of the act requires that FDA review the types of 
reprocessed SUDs subject to premarket notification requirements and 
identify which of these devices require the submission of validation 
data to ensure their substantial equivalence to predicate devices. 
Section 510(o) also requires that FDA review critical and semicritical 
reprocessed SUDs that are currently exempt from premarket notification 
requirements and determine which of these devices require the 
submission of premarket notifications to ensure their substantial 
equivalence to predicate devices.
    FDA has identified the reprocessed SUDs that require the submission 
of validation data to date. The requirement to submit validation data 
for certain reprocessed SUDs has been incorporated into the premarket 
notification program. As with all other devices, new premarket 
notifications for reprocessed SUDs will be required as new 
manufacturers enter the market or manufacturers with cleared premarket 
notifications make significant changes to their device. The burden 
estimates below include the burden for submitting premarket 
notifications for reprocessed SUDs with the burden for all other 
devices. FDA may amend the lists of reprocessed SUDs that require the 
submission of premarket notifications with validation data as 
necessary.
    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 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. Certification of 
conformance to a recognized standard may allow a manufacturer to submit 
an abbreviated 510(k). FDA is now seeking approval of a form (Form FDA 
3654) that will standardize certification of conformance to a 
recognized standard. FDA believes that use of this form will simplify 
the certification process for 510(k) submitters and the review process 
for FDA.
    Form FDA 3514, a summary cover sheet form, has been created to 
assist respondents in categorizing 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 humanitarian device exemptions. The total burden (1,000 
hours) for Form FDA 3514 has been included in this information 
collection. Form FDA 3654 is used in the following information 
collections: 0910-0078, 0910-0231, and 0910-0332, but the burden is 
approved under this information collection (0910-0120).
    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) (510(k) 
summary) or a statement certifying that the submitter will make 
available upon request the information in the 510(k) (510(k) 
statement). If the 510(k) submitter includes a 510(k) statement in the 
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 premarket 
notification submission is determined to be substantially equivalent. 
The information provided will be a duplicate of the premarket 
notification submission including any safety and effectiveness 
information, but excluding all patient identifiers and trade secret and 
confidential information.
    The most likely respondents to this information collection will 
primarily be medical device manufacturers including

[[Page 64713]]

reprocessors of SUDs, and initial importers of devices.
    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 FDA  Number     Respondents        per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807, subpart E (807.81 and 807.87/      .................              3,700                  1              3,700                 80            296,000
 510(k))
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     3514              2,000                  1              2,000                0.5              1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     3654                150                  1                150                  1                150
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals                                                                                                                                           297,150
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
           21 CFR Section             Form FDA  Number    Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.93                               .................              2,000                    10             20,000                0.5             10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             10,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on conversations with industry and 
trade association representatives, and from internal review of the 
documents listed in tables 1 and 2.

    Dated: October 30, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18553 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S