[Federal Register Volume 71, Number 207 (Thursday, October 26, 2006)]
[Notices]
[Pages 62595-62597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0408]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Annual Reports for Approved Premarket Approval Applications; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Annual Reports for 
Approved Premarket Approval Applications.'' This draft guidance 
document outlines the information required by a certain FDA regulation 
in periodic reports (usually referred to as annual reports) and FDA's 
recommendations for the level of detail that manufacturers should 
provide. This draft guidance is not final nor is it in effect at this 
time.

DATES: Submit written or electronic comments on this draft guidance by 
January 24, 2007. Submit written or electronic comments on the 
collection of information by December 26, 2006.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Annual Reports for Approved Premarket 
Approval Applications'' to the Division of Small Manufacturers, 
International, and Consumer Assistance (HFZ-220), Center for Devices 
and Radiological Health, Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
240-276-3151. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the guidance.
    Submit written comments concerning this draft guidance and the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    For device issues: Laura Byrd, Center for Devices and Radiological 
Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-2186.
    For biologics issues: Leonard Wilson,

[[Page 62596]]

Center for Biologics Evaluation and Research (HFM-25), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document outlines the information required by 
Sec.  814.84(b) (21 CFR 814.84(b)) in periodic reports (usually 
referred to as annual reports) and FDA's recommendations for the level 
of detail that manufacturers should provide. We also outline the 
principles and procedures that the Center for Devices and Radiological 
Health (CDRH) and the Center for Biologics Evaluation and Research 
(CBER) follow when we review these reports, identify the steps FDA 
staff generally take when reviewing annual reports, the resources 
available to assist staff in conducting their reviews, and the possible 
outcomes of a review. This draft guidance is not final nor is it in 
effect at this time.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on ``Annual 
Reports for Approved Premarket Approval Applications.'' It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To receive ``Annual Reports for Approved 
Premarket Approval Applications'' you may either send an e-mail request 
to [email protected] to receive an electronic copy of the document or 
send a fax request to 240-276-3151 to receive a hard copy. Please use 
the document number (1585) to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 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.
    Title: Annual Reports for Approved Premarket Approval Applications.
    Description: Devices subject to premarket approval under section 
515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) are 
also subject to periodic reports imposed by the premarket approval 
application (PMA) approval order (Sec.  814.82(a) (21 CFR 814.82(a)) 
and Sec.  814.84(b)). FDA typically specifies that an applicant submit 
a report 1 year from the date of approval of the original PMA and 
annually thereafter. Therefore the periodic report is usually referred 
to as the annual report. Although this draft guidance addresses 
``annual reports,'' there may be circumstances where FDA specifies more 
frequent periodic reports. FDA believes this draft guidance will also 
be relevant to the more frequent reports.
    This draft guidance document describes FDA's recommendation for the 
level of detail that should be provided in the annual report. This 
draft guidance suggests that an annual report should include a cover 
letter that includes the following information: (1) PMA number; (2) 
device name (including any model names and numbers); (3) company name; 
(4) date of report; (5) reporting period; and (5) approval date.
    This draft guidance recommends that the annual report also include 
information regarding manufacturing, design, or labeling changes made 
during the reporting period, in which the following information should 
be included: (1) The change made; (2) the rationale for making the 
change; (3) any validation or other testing that was performed, 
including a description of the method and acceptance criteria; and (4) 
the implementation date. This guidance recommends creating a separate 
table for manufacturing changes, design changes, and labeling changes. 
Furthermore, if any manufacturing, design, or labeling change is 
associated with any written communication to practitioners or patients, 
this draft guidance recommends that the applicant include a copy of the 
communication in the annual report.
    For manufacturing, design, or labeling changes not reported in a 
PMA Supplement or a 30-day notice, this draft guidance recommends 
including a brief summary of the risk analysis performed to assess the 
effect of the changes made during the reporting period. If the risk 
analysis was performed in conformance to any consensus standards, these 
should be identified. If system-level testing of the cumulative changes 
were not conducted, then the risk analysis should also assess whether 
incremental testing was adequate to assure continued safety and 
effectiveness of the device in the absence of system level testing. If 
any changes to the design, manufacture, or labeling that have been made 
during the reporting period are associated with medical device 
reporting requirements, failures, or recalls of any kind, corrective 
actions (21 CFR 820.100), complaints, or in response to FDA warning 
letters or inspection findings

[[Page 62597]]

(FDA Form 483), this draft guidance recommends that the applicant do 
the following: (1) Describe their investigation of the cause or source 
of the problem; and (2) explain their decision to change the device 
design, labeling, or manufacturing process by describing how the 
actions taken have corrected the problem and mitigated the harm.
    This draft guidance also recommends including a discussion of how 
the results and conclusions in clinical investigations or nonclinical 
laboratory studies or reports in scientific literature could impact the 
known safety and effectiveness profile of the device. If changes to the 
device or its labeling are based on clinical investigations or 
nonclinical laboratory studies or reports in scientific literature, 
this draft guidance recommends informing FDA of a plan for submitting a 
PMA Supplement or 30-day notice for these changes; or in the 
alternative, explaining why such a submission is not appropriate.
    To help FDA assess the public health impact of the information 
provided in annual reports, this draft guidance also asks applicants to 
provide data about the number of devices shipped or sold during the 
reporting period. For device implants, data regarding the number of 
devices actually implanted should be provided, if it is available.
    Finally, this draft guidance suggests that a redacted copy of the 
annual report may be provided in order to be publicly posted on FDA's 
Web site.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in Sec. Sec.  814.82(a)(7) and 814.84(b) have been approved under OMB 
Control No. 0910-0231.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  Information
  Collection          No. of       Annual Frequency per      Total Annual       Hours per Response   Total Hours
   Activity        Respondents           Response              Responses
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Annual Report                 434                     1                   434                   0.5          217
 Cover Letter
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Rationale for                 434                     1                   434                     3        1,302
 Changes
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Summary of                    434                     1                   434                     4        1,736
 Risk Analysis
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Evaluation of                 434                     1                   434                     7        3,038
 Clinical
 Investigation
 s, Non-
 Clinical
 Laboratory
 Studies, or
 Scientific
 Literature
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Information on                434                     1                   434                     5        2,170
 Devices
 Shipped,
 Sold, or
 Implanted
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Redacted Copy                 434                     1                   434                     4        1,736
 of Annual
 Report
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Total                         434                     1                   434                  29.5       10,199
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The industry-wide burden estimate is based on an FDA actual average 
fiscal year (FY) annual rate of receipt of 434 annual reports, using FY 
2003 through 2005 data. The burden data for annual reports is based on 
FDA estimates.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: October 17, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-17908 Filed 10-25-06; 8:45 am]
BILLING CODE 4160-01-S