[Federal Register: October 26, 2006 (Volume 71, Number 207)]
[Notices]
[Page 62595-62597]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc06-44]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Annual Reports for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 This draft guidance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 This draft guidance is not final nor is it in effect at this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DATES: Submit written or electronic comments on this draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Annual Reports for Approved Premarket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Submit written comments concerning this draft guidance and the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh.
A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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\
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Information
Collection No. of Annual Frequency per Total Annual Hours per Response Total Hours
Activity Respondents Response Responses
----------------------------------------------------------------------------------------------------------------
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